Flagship Pioneering’s Senda Bio secures $123M for new ‘programmable medicines’
Biotech startup Senda Biosciences is developing technology that yields a new type of medicine with two programming components: one directs the therapy to go to […]
Pharma
Merck picks circular path to RNA and commits $250M to biotech startup Orna
Merck aims to bolster its genetic medicines pipeline through a new research alliance with Orna Therapeutics, a startup whose technology forms RNA into a circle […]
Lipid Nanoparticles Immunogenicity & Toxicity | December 6-8, 2022
Following the success of LNP-mRNA vaccines, we have seen an influx of novel types of lipids based nanocarriers over the last 12 months, progress has been […]
Lipid Nanoparticles Development Summit Europe | 18th – 20th October, 2022
The LNP Development Europe Summit is the only European conference solely dedicated to LNP formulation and process development to enable seamless scale-up, keeping GMP compliance and manufacturing. Given the rapid developments in the […]
Gilead claims breast cancer trial win but offers few details; drug application is filed with FDA
Gilead Sciences said it has statistically significant and clinically meaningful data from a pivotal test of its cancer drug, Trodelvy, in the most common type […]
Opthea lines up $260M to show how eye drug compares to blockbuster AMD meds
The wet form of age-related macular degeneration (AMD) is currently treated with eye drugs that are blockbuster sellers. Opthea Limited is developing a wet AMD […]
AstraZeneca & Daiichi drug wins another FDA approval, this time in lung cancer
On the heels of receiving a landmark FDA approval in breast cancer, AstraZeneca and Daiichi Sankyo drug Enhertu won an additional approval in non-small cell […]
Novartis warns of two patients deaths after dosing with gene therapy Zolgensma
The two deaths reported following treatment with Novartis’s Zolgensma mark the first fatal cases of acute liver failure associated with the gene therapy. Liver complications […]
Why reshoring drug production means embracing continuous manufacturing
Recent history should have the pharmaceutical industry questioning some of its fundamental assumptions. The COVID-19 pandemic led to skyrocketing demand for some products while simultaneously […]
After RNA therapy falls short in the eye, ProQR Therapeutics pivots to liver, CNS
RNA therapies developer ProQR Therapeutics is eying a future without ophthalmology. After receiving European Medicines Agency feedback for its lead program for a rare eye […]
3rd TIGIT Axis Therapies Summit
The 3rd TIGIT Axis Therapies Summit returns to unite large pharma, innovative biotechs and pioneering academics to discuss the full range of next-generation TIGIT axis targeted […]
H1 Launches AI-Powered and Evidence-Based Interactions
What You Should Know: – H1, launches an update to its flagship product, HCP Universe, the daily resource for global medical affairs and medical science […]
BMS reports data that could give its cell therapy an edge over rival J&J product
Bristol Myers Squibb has data showing that its multiple myeloma treatment Abecma beat the standard of care, preliminary Phase 3 results that could support moving […]
New Versant Ventures startup goes ‘gutless’ for next-generation gene delivery
Vector BioPharma has launched from the biotech startup incubator of Versant Ventures, which is backing the company with a $30 million Series A financing. Vector […]
Merck turns to biotech Cerevance to feed neuro pipeline with Alzheimer’s drugs
Merck is paying $25 million to kick off a research partnership with Cerevance, a startup that analyzes donor brain tissue to find novel targets for […]
Karuna Therapeutics scores phase 3 win for schizophrenia therapy KarXT
Karuna Therapeutics has unveiled positive topline results from its phase 3 EMERGENT-2 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT […]
GSK pays $100M to partner on a cancer drug with new twist on immunotherapy
GSK is partnering with Mersana Therapeutics on the development of an antibody-drug conjugate that is approaching Phase 1 testing. Unlike other ADCs that deliver a […]
Pfizer to buy sickle cell disease biotech Global Blood Therapeutics in $5.4B deal
Pfizer’s own R&D efforts in sickle cell disease have fallen short, so the pharmaceutical giant is turning to M&A to gain a presence in the […]
ODM standard for CRF design
Over the last few years, our industry has become familiar with CDISC standards. This has largely been driven by regulation, with national regulators such as FDA […]
FDA turns down Acadia Pharma drug for Alzheimer’s psychosis; new trial needed
Acadia Pharmaceuticals drug Nuplazid failed to win FDA approval for the treatment of psychosis in Alzheimer’s disease patients. The regulator said that the data submitted […]
Healthcare & Life Science M&A Activity Plummets 1H’22
What You Should Know: – The index of Healthcare & Life Science equities tracked by Stout was down 16.8% in Q2 2022, which was in […]
FDA approval of AstraZeneca drug is first for a new group of breast cancer patients
Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein […]
Amgen’s $3.7B ChemoCentryx acquisition adds a new piece to autoimmune strategy
Amgen’s drug portfolio boasts several biologic drugs that are blockbuster sellers. In acquiring ChemoCentryx for $3.7 billion, the pharmaceutical giant gains a company entirely focused […]
Disappointing data lead Pfizer to drop heart drug acquired as part of $11B deal
Pfizer is stopping work on a drug for a rare heart disease after an interim look at Phase 3 data indicated that the study was […]
Alnylam drug succeeds in heart study, setting stage for FDA filing and showdown with Pfizer
Alnylam Pharmaceuticals drug Onpattro, an FDA-approved treatment for nerve pain caused by hereditary transthyretin amyloidosis, now has Phase 3 data showing it can also help […]
The power of digital ecosystems to improve pharma supply chain operations [Sponsored]
A panel discussion from a recent Microsoft summit offered insights on how tech companies are closely collaborating with the pharma industry as they seek to […]
Connecting EHR to clinical trials: How to embrace the promise of real-world data
We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding […]
Ipsen’s latest R&D alliance brings novel T cell-activating drugs for cancer
Ipsen has been an active dealmaker lately, and it just struck another one that takes the pharmaceutical company into a new area of drug research. […]
Aiming to bring drug combos into earlier lines of cancer therapy, IDRx lands $122M
Taking inspiration from the success of drug cocktails that halt viral infections, startup IDRx aims to develop cancer drug combinations that stop tumor escape. The […]
Digital transformation: Reimagining clinical trial management [Sponsored]
Decentralized clinical trial approaches helped the pharma industry navigate through Covid-19. Now it is becoming increasingly clear that there’s a need for a hybrid approach […]
With ‘bold experiment’ in drug pricing, Arcutis aims to stand out in plaque psoriasis
The FDA approved Arcutis Biotherapeutics drug Zoryve, a topical treatment for plaque psoriasis. With the decision, the company will proceed with a pricing strategy it […]
FDA hits pause on Beam Therapeutics’ off-the-shelf cell therapy for blood cancers
Beam Therapeutics’ application to begin human testing of a cell therapy made with base-editing technology is now under an FDA clinical hold. In other clinical […]
Novartis, UC Berkeley-spawned startup snags $65M to keep key proteins out of the cell’s trash can
Vicinitas Therapeutics is developing small molecule drugs that stabilize key proteins, preventing them from going to a cell’s built-in disposal system. The startup, which stems […]
U.S. government places $1.74B order for Moderna’s new Covid-19 vaccine boosters
The U.S. government has signed a supply agreement securing 66 million doses of Moderna’s Covid-19 vaccine booster shots, which are designed to address the omicron […]
Don’t miss the MedCity INVEST PharmaTech virtual conference July 26
The conference highlights the convergence of digital health and drug development. Among the panel discussions are a focus on the state of AI in drug […]
How to accelerate clinical study build
As you know, clinical trials can be complex. Industry standards are now required for clinical trial submission. This means even more associated costs, resources, time, […]
Preventing the next pandemic: Infrastructure and global equity
In the final piece of a three-part series, Ben Hargreaves explores how manufacturing infrastructure was rapidly built up to the required capacity to ensure sufficient […]
Harvard spinout lands $40M to bring in vivo drug discovery to cancer
Technological advances are moving drug discovery work to computers, but experimental medicines still must be tested in animals. Startup Manifold Bio is developing technology that […]
FDA delay means BeiGene, Novartis must wait longer for cancer drug decision
The FDA has deferred a regulatory decision on an esophageal cancer drug from partners BeiGene and Novartis, citing the need to complete inspections of the […]
Pharma’s post-COVID opportunity to improve patient outcomes
The immediate threat to patient care from COVID-19 has diminished with the passing of the acute phase of the pandemic, but its impact continues to […]
Merck strikes a $290M deal for novel prostate cancer drug
Merck is partnering with Orion on the clinical development and potential commercialization of a new drug for advanced prostate cancer. Though Merck already has a […]
Areteia gets $350M to turn failed ALS drug into a therapy for severe asthma
New company Areteia Therapeutics launched with up to $350 million in financing and an asthma drug candidate from Knopp Biosciences. That drug, dexpramipexole, previously failed […]
Beyond the pill in an outcomes-based world
Going beyond the pill is proving to be a win/win for patients and pharma alike – because improved outcomes are better for everyone. With growing […]
Roche pays $55M for late-stage drug for rare kidney disease with no approved treatment
An Ionis Pharmaceuticals drug has positive Phase 2 results in immunoglobulin A nephropathy, leading Roche to exercise its option to license the rights to the […]
Vertex builds up pipeline of type 1 diabetes cell therapies with $320M buyout
Vertex Pharmaceuticals already has a cell therapy candidate for type 1 diabetes but the company says acquiring rival ViaCyte will provide it with complementary assets […]
Pfizer, BioNTech Covid-19 vaccine gets full FDA approval for adolescents
The FDA has granted the Pfizer and BioNTech Covid-19 full approval for use in adolescents. In other Covid-19 news, pharmacists were granted additional prescribing powers […]
AbbVie & Alector drop Alzheimer’s med from alliance, shifting focus to a 2nd drug
AbbVie paid Alector $205 million up front five years ago to begin an R&D partnership on two drugs intended to bring an immunotherapy approach to […]
Amgen joins Kernal Bio’s $25M financing as the startup brings mRNA 2.0 to cancer
Kernal Biologics has technology that enables the delivery of messenger RNA therapies to a wider range of destinations in the body. The Series A financing […]
After initial failure, Intercept Pharma feels new data can get NASH drug approval
Two years after the stinging FDA rejection of its drug for the fatty liver disease NASH, Intercept Pharmaceuticals has more safety and efficacy data from […]
With new gene therapy data in hand, Sarepta talks with FDA about approval pathways
Sarepta Therapeutics has more clinical data showing the safety and efficacy of its experimental gene therapy for Duchenne muscular dystrophy. A pivotal Phase 3 test […]
Innovaccer Launches Connected Digital Health Solution for Biopharma & Medtech
What You Should Know: – Today Innovaccer, the Health Cloud company, announced its Connected Digital Health solution, a new way for life sciences companies to […]
How the agile in pharma trend is transforming drug development [Sponsored]
Emergn Principal Consultant Mario Moreira shared insights on how pharma companies can use the principles of Value, Flow and Quality to shorten drug development timelines […]
CureVac sues BioNTech, claiming Covid-19 vaccine infringes key mRNA patents
Messenger RNA vaccine biotech CureVac is suing BioNTech, alleging that its rival’s Covid-19 vaccine infringes on intellectual property built on more than two decades of […]
AstraZeneca broadens its scope in blood cancers with $100M TeneoTwo buyout
AstraZeneca is acquiring TeneoTwo in a $100 million bet on that biotech’s lymphoma drug candidate, which is designed to go after two targets. It’s the […]
Biotech IPO freeze continues as second quarter is slowest in more than a decade
Summer weather is heating up but the market for IPOs remains cold. Bausch + Lomb’s successful return to the public markets in the second quarter […]
Novartis pays $100M to get Mallinckrodt’s ticket for a speedier FDA drug review
Novartis is acquiring an FDA priority review voucher from Mallinckrodt Pharmaceuticals. The $100 million price tag is in the neighborhood of the going rate for […]
Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal
The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. While U.S. […]
Feds commit $3.2B to lock in Covid-19 vax supply ahead of fall vaccination campaign
New Covid-19 vaccine booster shots are coming and they’ll likely include protection against the omicron variant. The U.S. government agreed to a purchasing contract covering […]
Bayer, Amgen join $120M financing for startup aiming to expand genetic meds delivery
In less than one year, ReCode Therapeutics has reeled in $200 million in financing. Big pharmaceutical companies are taking notice of the biotech startup’s technology, […]
Two for two: Sanofi snares twin European nods for enzyme replacement therapies
Sanofi won European Commission approval for two therapies that treat rare enzyme deficiencies. Xenpoyzme is the first treatment for acid sphingomyelinase deficiency (ASMD) while Nexviadyme […]
Preventing the next pandemic: Learning the lessons
In the first of a three part series, Ben Hargreaves looks at what the odds are of another pandemic arising in our lifetimes and what […]
BMS cancer drug’s expanded approval gives it an edge over a Gilead cell therapy
The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of […]
Ipsen’s $247M Epizyme acquisition brings approved cancer drug & more in pipeline
Ipsen is paying $247 million to acquire Epizyme, a cancer drug developer with one FDA-approved product: follicular lymphoma therapy Tazverik. The drug is a modest […]
As muscular dystrophy drug meets key goal, Italfarmaco plans march forward to regulators
A Duchenne muscular dystrophy drug candidate from Italfarmaco Group has encouraging preliminary data from a pivotal study. The Milan, Italy-based pharmaceutical company says it now […]
Analysis: Is Oracle Cerner Planning to Build A National EHR?
Earlier this month Oracle closed its $28.3B acquisition of Cerner and shortly after Oracle founder and CTO, Larry Ellison, outlined Oracle’s vision for Healthcare IT […]
New data for Intellia’s CRISPR therapy shows potential for one-time treatment of a rare disease
An Intellia Therapeutics therapy that uses CRISPR to perform in vivo genomic edits has clinical data showing that the therapeutic effects continue for a year […]
Biopharma firm Radius Health is going private in an $890M M&A deal
Two private equity firms have reached an $890 million deal to buy Radius Health, a company whose main asset is the commercialized osteoporosis drug Tymlos. […]
Which clinical trial innovation startups will present at INVEST PharmaTech Pitch Perfect?
The Pitch Perfect contest at MedCity INVEST PharmaTech, the free virtual conference scheduled for July 26, will spotlight five startups seeking to improve clinical trials.
Novartis picks Precision Bio to bring in vivo gene editing meds to blood disorders
Novartis is paying Precision Bio $75 million up front to begin a partnership aiming to develop in vivo gene-editing therapies for serious genetic blood disorders, […]
Athira Alzheimer’s drug fails mid-stage, but the biotech still eyes a Phase 3 path
An Alzheimer’s disease drug from Athira Pharma has failed a Phase 2 clinical trial and the biotech has a surprising theory why. Athira says standard […]
Understanding the True Impact of the COVID-19 Pandemic on the Immunocompromised
Six in 10 respondents to Health Union’s Spondyloarthritis In America 2021 survey said they feel other people in their lives don’t understand the risks of being immunocompromised. […]
US frets over pharma supply chain security
The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products was limited and regulatory inspections became difficult to carry out. […]
Aiming to catch Alnylam, AstraZeneca & Ionis plan FDA filing for rare disease drug
The planned FDA submission follows the report from AstraZeneca and Ionis Pharmaceuticals that their partnered drug, eplontersen, met the main goals of a pivotal study […]
An introduction to case report forms
Different types of CRFs A Case Report Form (CRF) is a printed, optical, or electronic document designed to record all information required to be reported […]
AbbVie’s blockbuster drug Skyrizi gets FDA nod for treating Crohn’s disease
AbbVie drug Skyrizi is now approved for Crohn’s disease, making it the first treatment for the disorder that addresses a particular protein associated with inflammation. […]
Pfizer, Moderna Covid-19 vaccines are now authorized for kids as young as 6 months
Covid-19 vaccines from Pfizer and Moderna now have FDA emergency use authorization for children as young as 6 months old. If the Centers for Disease […]
November will bring political change. Will it also change drug prices and PDUFA?
Drug prices are on the minds of patients and politicians. The November election is expected to tip the balance of power in Congress and a […]
BIO panel: How Covid-19 is preparing us to better respond to the next pandemic
Biopharmaceutical companies and public health officials have learned a great deal about pandemic response in the last two years. A panel discussion during the annual […]
Creating better alignment between digital and pharma sectors
At the MedCity INVEST PharmaTech virtual conference July 26, strategies and alignment between digital and pharma companies will be a major theme of the conference. […]
ImCheck fetches €96M for antibodies that activate immune cells against cancer
ImCheck Therapeutics aims to broaden the reach of cancer immunotherapy with antibody drugs that activate a rare but powerful type of immune cell called gamma […]
Tessa Therapeutics takes in $126M for cell therapies, and more biotech financings
Ten biotech companies were able to raise more than $500 million in combined financing in the past week. Here’s a recap of the funding activity, […]
GSK immunotherapy shows promise as alternative to surgery in certain rectal cancers
A small Memorial Sloan Kettering Cancer Center study found that all rectal cancer patients treated with GSK drug Jemperli showed a complete response at six […]
Roche bispecific drug Lunsumio lands European nod in follicular lymphoma
Follicular lymphoma patients in Europe now have a new treatment option. The European Commission approved Roche drug Lunsomio, a bispecific antibody designed to go after […]
The state of AI in drug discovery
The MedCity INVEST PhrmaTech virtual conference, scheduled for Tuesday, July 26, offers free registration and a compelling day of conversations exploring the convergence of the […]
ASCO recap: Breast cancer breakthrough, Mirati’s moves, Arcellx ascends & more
Breast cancer drugs and cell therapies were prominent in this year’s annual meeting of the American Society of Clinical Oncology. Here’s a recap of some […]
PMV’s ASCO data show signs of drugging ‘undruggable’ p53 protein across tumor types
PMV Pharmaceuticals has its first clinical data showing that its lead therapeutic candidate can hit p53, a tumor-suppressing protein long thought to be undruggable. After […]
Code Bio corrals $75M to skip viruses, use synthetic DNA for genetic meds delivery
Code Biotherapeutics uses synthetic DNA as the foundation for its genetic medicines, which the startup claims offer several key advantages compared to genetic medicines delivered […]
Becton Dickinson buys into pharmacy automation with $1.5B Parata acquisition
Becton Dickinson is getting into pharmacies with a more than $1.5 billion acquisition of Parata Systems, maker of robotics technologies that automate pharmacy tasks. The […]
Drug-industry survey blames insurer practices for barriers to care
Pharma companies often take the blame for high prescription costs. But a new, industry-sponsored survey shifts attention to insurance industry practices.
How celebrity investor Mark Cuban is tackling out-of-control drug prices
American entrepreneur and investor Mark Cuban tells us why he and his partners launched the Mark Cuban Cost Plus Drug Company (MCCPDC), a public-benefit corporation […]
AstraZeneca, Daiichi Sankyo have high hopes for drug that goes low in breast cancer
During the annual meeting of the American Society of Clinical Oncology, AstraZeneca and Daiichi Sankyo reported pivotal clinical trial data showing that their partnered cancer […]
Gilead offers more detail on breast cancer drug’s trial results. Is it enough?
Gilead Sciences has more detail about breast cancer drug Trodelvy, a blockbuster hopeful it acquired two years ago. Additional data from a pivotal study were […]
PwC Report: 5 Key Actions for Pharma Companies to Drive Value Growth
What You Should Know: – A new PwC report offers insights into how pharma companies can translate game-changing science into greater returns. – Despite many major therapeutic advancements within […]
BMS bets $4.1B on lung cancer drug that could best products from Pfizer, Roche
Bristol Myers Squibb is splashing out $4.1 billion to acquire Turning Point Therapeutics, a clinical-stage biotech whose lead drug is currently in pivotal testing as […]
Regeneron is paying $900M for full rights to cancer drug partnered with Sanofi
Regeneron Pharmaceuticals has big plans for cancer immunotherapy Libtayo and it believes it can better execute on them if it has full control of the […]
Repare relinquishes cancer drug to Roche, gets $125M to finance growing pipeline
Roche’s deep oncology pipeline is adding a drug candidate from Repare Therapeutics that works by interfering with a DNA repair mechanism of cancer cells. Repare […]
After Haleon splits from GSK, Pfizer plans to cash out to the tune of $16B
When consumer healthcare products joint venture Haleon spins out from GSK as an independent company next month, Pfizer will sell its minority stake in the […]
How pharma can make drug information accessible
Pharmaceutical drugs can work wonders for patients, whether it’s treating rare diseases or easing everyday maladies. But drugs can also be complex. What works for […]
FDA nod for Roche drug expands its use to babies with spinal muscular atrophy
Roche drug Evrysdi, one of three FDA-approved treatments for spinal muscular atrophy, is now approved for treating those younger than age 2. The regulatory decision […]
GSK gets pneumococcal vaccine contender with $2.1B Affinivax acquisition
Pfizer and Merck have each won FDA approvals in the past year for new pneumococcal vaccines, but GSK aims to top both of them with […]
ASCO 2022 ahead: Clinical trial updates and data readouts to watch for
The American Society of Clinical Oncology’s annual meeting begins this week, including the presentation of more than 2,800 abstracts. Amgen, Roche, and Sierra Oncology are […]
4th RAS-Targeted Drug Development Summit
For decades, RAS has existed as an elusive therapeutic target, and drugging this high-value oncogene was deemed impossible. Despite this, the first-ever FDA-approved KRAS G12C inhibitor has […]
Covid-19 roundup: Boosters for kids, CAR-NK cell therapy, Paxlovid rebound & more
Pfizer and BioNTech reported positive clinical data for a Covid-19 booster in children younger than 5, results released ahead of a June FDA advisory committee […]
4th Extracellular Vesicle-Based Therapeutic Development Summit
Accelerating the Discovery, Translation & Large-Scale Manufacturing of Exosomes & EVs With 3 days of unrivaled content and two dedicated tracks, this year’s summit will be […]
New Flagship Pioneering startup expands the protein universe to fuel drug discovery
ProFound Therapeutics emerged from stealth with technology that it claims has discovered tens of thousands of previously undiscovered proteins—many of them promising new drug targets. […]
Heart trouble report & clinical hold spell end of Antios, Assembly Bio HBV alliance
A clinical hold on an Antios Therapeutics drug has led to the end of a collaboration with Assembly Biosciences less than a year after their […]
Top 5 takeaways from international hybrid and virtual meeting guidance for pharma
The move to online international meetings has left pharma companies with uncertainty around contact compliance. But new joint guidance, from the IFPMA, EFPIA, and PhRMA, […]
FDA approves Roivant drug, the first novel topical plaque psoriasis med in 25 years
Plaque psoriasis drug Vtama is now approved by the FDA, making it the first novel topical treatment for the chronic autoimmune disorder in a generation. […]
[Webinar] Patient Centricity Drives Action: Research Supports Value of Social Health
As healthcare evolves to become more consumer-centric, the value of social health – the dynamic, real-time action people take to find meaningful connections and share […]
What has Covid-19 taught us about virtual clinical trials?
At the upcoming INVEST PharmaTech virtual conference scheduled for July 26, the conversations will span myriad topics at the intersection of digital health and drug […]
Biohaven drug fails another clinical test, this time in rare neuromuscular disorder
Biohaven’s migraine drug research led to an FDA-approved product with strong commercial uptake, but its other neuroscience efforts have yet to achieve the same outcomes. […]
Innoviva’s Entasis acquisition brings a novel antibiotic that’s ready for the FDA
Entasis Therapeutics is being acquired by Innoviva in a deal that brings an FDA-ready antibiotic developed to address drug-resistant strains of a bacterium that infects […]
CAR T without the toxicity: Kelonia gets $50M for a new take on cell therapy
Kelonia Therapeutics is developing cell therapies made by the in vivo engineering of a patient’s cells made possible by the targeted delivery of a genetic […]
100% survival in clinical test puts Rocket Pharma gene therapy on course to FDA
A Rocket Pharmaceuticals gene therapy for the rare immune disorder leukocyte adhesion deficiency-I has met the survival goals of a pivotal study, paving the way […]
FDA sounds caution on Foghorn cancer drug with a partial hold after patient death
The lead cancer drug candidate of Foghorn Therapeutics is now under a partial clinical hold following a patient death. According to the biotech, the patient […]
Enanta RSV drug fails a Phase 2 test, but studies continue in higher-risk patients
An antiviral that Enanta Pharmaceuticals is developing for respiratory syncytial virus infection failed to beat a placebo in its first Phase 2 test. But the […]
Flagship merges two of its biotechs to form cellular microenvironment-focused Sonata
Sonata Therapeutics is developing drugs that reprogram cellular microenvironments to send signals intended to have curative effects. Cancer is the initial focus of the biotech, […]
KOL Validation: An Opportunity To Benchmark Mindset
The benefits of conducting a regular KOL validation exercise to refresh your KOL list are well established. Such exercises implemented on a regular basis ensure […]
INVEST Pitch Perfect winner: Modality.ai makes Tina the Alexa of clinical trials
Modality.ai has developed a conversational AI system that replaces in-person interviews that are part of neurological assessments for a range of disorders. The startup was […]
Clover Therapeutics turns a new leaf as Character Bio to pursue dry AMD & more
Dry age-related macular degeneration currently has no FDA-approved treatments but the research of Clover Therapeutics has yielded two candidates. The biotech startup has made progress […]
AbbVie and Cugene partner to tackle autoimmune diseases
AbbVie and Cugene have teamed up to research autoimmune diseases and cancer in an exclusive worldwide agreement. The Chicago-based pharma firm, AbbVie, received the option […]
BenevolentAI, AstraZeneca AI-based drug discovery collaboration achieves third milestone
BenevolentAI has discovered a second novel target for idiopathic pulmonary fibrosis (IPF), which AstraZeneca has added to its drug development portfolio, resulting in a milestone […]
Do pharmaceutical businesses need to rethink what their graduate schemes offer?
As the world and the UK continues its march out of the pandemic’s shadow, the pharmaceutical and life sciences sector has been squarely in the […]
AstraZeneca extends oncology partnership with Proteros
AstraZeneca has boosted its research capacity by extending its oncology partnership with Proteros biostructures. German pharma firm Proteros specialises in structure-based drug discovery powered by […]
To focus on cancer, Chimerix sells rights to antiviral drug that defined the biotech
Chimerix is selling global rights to smallpox drug Tembexa, the biotech’s only FDA-approved product, as a way to fund clinical development of a therapy in […]
A look ahead: How medical affairs may evolve over the next five years
Covid changed things for medical affairs teams at pharmaceutical companies, causing was a fundamental shift in the way they worked and functioned. The role of […]
Claiming Akebia agreement breach, Otsuka seeks to end anemia drug pact
Otsuka Pharmaceutical is ending its alliance with Akebia Therapeutics, a move that comes less than two months after the FDA rejected their partnered anemia drug, […]
Viseven and Next Pharma Partnership Announcement
Viseven is happy to share its latest business venture – a partnership with NEXT. The two companies join forces to positively impact the future of […]
The time is right: Another shot to end cancer as we know it
Government-funded initiatives such as the Cancer Moonshot support not only the primary science that often serves as a foundation for medical advances, but also ensure […]
Eli Lilly’s diabetes portfolio grows with FDA nod for projected blockbuster drug
The FDA approved Eli Lily drug Mounjaro as a treatment for type 2 diabetes. The decision gives the pharmaceutical giant a new competitor to a […]
UCB’s FDA setback delays competition in U.S. with blockbuster J&J psoriasis drug
The FDA cited manufacturing issues in turning down UCB’s application seeking approval for bimekizumab, an antibody drug developed to treat moderate-to-severe plaque psoriasis. Bimekizumab is […]
Whats’s the future of digital medicines? Find out at INVEST PharmaTech.
Digital medicines, which span chronic conditions, mental health issues such as depression, anxiety, and addiction, is just one of the topics that will be offered […]
BMS builds on BridgeBio alliance, inking deal for rights to KRAS cancer drug
Bristol Myer Squibb is getting rights to BBP-398, a contender in the chase for drugs that address difficult-to-target KRAS mutations. Meanwhile, BridgeBio Pharma receives some […]
Startup Nuvig Therapeutics gets $47M to bring immune system back into balance
Nuvig Therapeutics is developing drugs that tap into one of the body’s natural mechanisms for controlling inflammation. Co-founder and CEO Pamela Conley, a veteran of […]
Closely watched Roche drug fails a second pivotal test in lung cancer
Roche reported that its drug tiragolumab failed to achieve one of two main goals of a Phase 3 study in non-small cell lung cancer. The […]
Content Factory 24/7: Viseven adds a Center of Excellence in India to provide around-the-clock global support for its clients
TALLINN, Estonia, May 11, 2022 – Viseven is proud to announce its latest venture – a brand new Center of Excellence in Jaipur, India. As […]
Pfizer buys its way into migraine with $11.6B Biohaven Pharma acquisition
Pfizer is turning to M&A to get its next blockbuster, buying Biohaven six months after the two companies began a commercialization pact centered on the […]
Aiming to treat Parkinson’s by replacing neurons, Aspen Neuroscience nabs $147M
Aspen Neurosciences is developing a cell therapy that uses a patient’s own stem cells to develop a personalized treatment for Parkinson’s disease. The approach is […]
How cell & gene therapy startups can warm up to investors in this “biotech nuclear winter”
Cell and gene therapy research has been hot the past few years but the overall market has cooled down in recent months. During the World […]
How is AI moving the needle in the pharmaceutical industry?
Artificial intelligence can help drug study teams solve operational, scientific and ethical challenges. For example, AI can be used to flag real-time trends emerging in […]
Regulatory recap: J&J vaccine limits, full Enhertu approval, a Vertex hold & more
The FDA amended emergency authorization of Johnson & Johnson’s Covid-19 vaccine. In other regulatory news this past week, drug approvals include a cancer drug that […]
PepGen IPO nabs $108M for muscular dystrophy drug with potential edge over Sarepta med
PepGen’s technology improves the delivery of a therapy to more tissue types and the clinical-stage biotech plans to use its IPO cash to continue developing […]
PING Conference 2022 – The Golden Age for Life Sciences Innovation
The PING Conference 2022 is back in person this year, with opportunities to network face-to-face with people from right across the life sciences ecosystem. We […]
BMS shows what’s NEX-T for CAR T, plus its strategy for next-gen cancer cell therapy
As an oncologist, Kristen Hege first encountered cancer cell therapy research in the mid-1990s. Now as a Bristol Myers Squibb executive, she oversees efforts to […]
Pharma’s path to Net Zero
Pharma is seldom top of mind when thinking about the most polluting industries, but pharmaceutical industry operations are in fact responsible for a significant portion […]
WMIF panel: How cell and gene therapy can overcome limitations of CAR T
CAR T cell therapies for cancer still pose challenges in manufacturing, safety, and the ability to address solid tumors. A panel at the World Medical […]
HilleVax’s IPO hauls in $200M for clinical test of VLP norovirus vaccine from Takeda
Takeda Pharmaceutical spinout HilleVax broke the biotech IPO drought with a $200 million stock market debut for clinical development of a norovirus vaccine. Two eye […]
Potential blockbuster BMS cardio drug gets FDA nod, first in rare heart disease
Bristol Myers Squibb drug Camzyos has FDA approval for treating obstructive hypertrophic cardiomyopathy, a rare and potentially fatal heart disorder. The drug is projected to […]
3 Keys to Eliminating Data Breakdowns in Life Sciences
Sudish Mogul, Chief Technology Officer of Healthcare Triangle Across life sciences, experts boldly predict that data is the new currency—and that mobilizing data from clinical […]
FDA lifts Pfizer gene therapy clinical hold, but trial adds new safety measures
Pfizer now has the regulatory O.K. to resume pivotal tests of its gene therapy for Duchenne muscular dystrophy—but with new limitations and safety measures. The […]
Big pharma vs small diseases: Tackling rare diseases
Rare diseases aren’t as rare as the appellation suggests. For instance, according to the US Government Accountability Office, 30 million Americans have a rare disease, […]
Biohaven migraine drug partnered with Pfizer lands twin European approvals
The European Commission approved Biohaven Pharmaceuticals migraine drug rimegepant. While the regulatory decision marks another milestone for Biohaven, it’s also a win for Pfizer, which […]
How to Provide Value that Benefits Patients (and Your Brand)
With patient-centricity, holistic health and treating the whole person as omnipresent topics of industry conversation, it’s evident that pharma plays a role in providing value […]
Cancer biotech Pheast unveils $76M to expand immunotherapy’s menu to new targets
Biotech startup Pheast is out of stealth taking a tack similar to that of cancer immunotherapy company Forty Seven, also a spinout from the Stanford […]
Understanding the microbiome as an ‘overlooked critical organ’
Compared to a ‘critical organ’ that had been largely ignored, companies working to develop microbiome-based therapies believe there is untapped potential in the area. Ben […]
Nkarta’s natural killers flash potential as next-gen cell therapies for cancer
Two natural killer (NK)cell therapy candidates from Nkarta now have preliminary Phase 1 clinical data suggesting these therapies are helping patients in two types of […]
Roche breast cancer drug fails in Phase 2 following similar stumble by rival Sanofi
Experimental Roche drug giredestrant failed to meet the main goal of a Phase 2 study in advanced breast cancer. The disappointing results allow competitors to […]
Next Generation RNA Therapeutics Summit
Are you looking to solve challenges with current RNA therapeutics, such as the degradation of RNA by RNAses, the difficulty of RNA crossing the cell […]
Covid-19 vaccines & therapies helped push medicines spending to $407B in 2021
While Covid-19 has had a significant impact on drug spending, IQVIA projects that its effect will moderate in coming years. IQVIA’s new report on U.S. […]
Biogen pulls Alzheimer’s drug application in Europe as EMA calls data insufficient
Biogen withdrew an application seeking approval in Europe for Alzheimer’s disease drug Aduhelm, a move that follows a negative opinion on the therapy issued by […]
AstraZeneca’s long-acting Covid-19 drug keeps protecting high-risk patients at 6 months
AstraZeneca’s Covid-19 antibody drug Evusheld reduced the risk of infection by 83% after six months. These results published in the New England Journal of Medicine […]
BMS joins Octant’s $80M financing and signs on as a drug discovery partner
Octant Bio’s synthetic biology approach to drug discovery is making progress, and the preclinical biotech has raised $80 million in Series B financing to continue […]
KOL Identification & Mapping Driven By Insights
Insights captured from KOL interactions represent a new way to identify and map the KOL landscape in which your brand must thrive. KOL identification and […]
Regenerative med biotech Satellite unveils tissue-based tech to restore organ function
Satellite Bio has emerged from stealth with technology for bioengineering tissue to restore organ function. The regenerative medicine startup, based on research from MIT and […]
AI startup Unlearn adds $50M for better, faster, smaller & cheaper clinical trials
Unlearn.AI’s Series B round follows a positive European Medicines Agency draft opinion finding that the company’s artificial intelligence technology can be used in Phase 2 […]
Regeneron captures new piece for cancer with $250M Checkmate Pharma buyout
Regeneron Pharmaceuticals is paying $250 million cash to acquire Checkmate Pharmaceuticals, a clinical-stage biotech developing drugs that activate the innate immune system. The biotech’s lead […]
3rd Gamma Delta T Therapies Summit
Join the 3rd Gamma Delta T Therapies Summit to learn and network with 120+ of the world’s leaders including γδT pioneer, Adrian Hayday, and together […]
FDA’s tighter scrutiny on drug class leads TG Therapeutics to pull out of cancer
TG Therapeutics is pausing its cancer drug research and withdrawing the approved cancer drug Ukoniq from the market. The move comes as the FDA places […]
Covid news roundup: Boosters for kids, breath diagnostic, a vax approval & more
Pfizer and BioNTech reported preliminary clinical data supporting use of their Covid-19 vaccine as a booster in children ages 5 to 11. In other Covid […]
A biotech’s bold vision to turn stem cell transplants into outpatient procedures
Versant Ventures has launched Cimeio Therapeutics, a biotech startup with technology that can shield transplanted stem cells or cell therapies. Shielding these cells enables them […]
BMS and Nektar end cancer drug alliance after two more clinical trial failures
Bristol Myers Squibb and Nektar Therapeutics are ending a cancer drug research alliance after data showed the combination of their respective drugs failed clinical trials […]
Cell therapy developer Be Bio hauls in $130M for pipeline in rare disease, cancer
Be Biopharma is developing cell therapies by engineering B cells to churn out therapeutic proteins with an initial focus on cancer and rare disease. The […]
Independent health comms agencies rebrand with emphasis on authenticity
In a world of a million messages, should authenticity be the common thread tying all pharma communications and marketing activities together? Authentic, knowledgeable communications designed […]
3 Reasons for Pharma Marketers to Leverage Social Health
Social health: the dynamic, real-time actions people take to find meaningful connections and share information along their health journey.Through social health, pharma marketers can reach patients […]
GlaxoSmithKline expands its cancer scope with $1.9B Sierra Oncology acquisition
GlaxoSmithKline is further building out its cancer drug portfolio by acquiring Sierra Oncology, a biotech whose FDA-ready myelofibrosis drug has clinical data showing advantages over […]
Why the drug pricing debate is focused on insulin
The treatment has been around for over a century but insulin has still become the centre of the ongoing discussion over pricing of pharmaceutical products. […]
Cell therapy biotech Aurion gets $120M to restore vision and revamp organ donor economics
Organ donation has long been a matter of demand outstripping supply, but Aurion Biotech aims to improve the supply part of the equation with a […]
FDA gives Gilead reprieve on partial hold for cancer drug studies
An FDA safety review has cleared Gilead Sciences to resume five clinical trials that were placed under a partial hold in January. The experimental Gilead […]
Startup Ansa Bio lands $68M to go long with enzymes approach to DNA synthesis
The DNA currently used in genetic medicines research is synthesized by chemical methods. Ansa Biotechnologies employs faster and less expensive enzymes-based technology, and the startup […]
Aiming to make better mRNA vaccines, BioNTech strikes up alliance with Matinas
Oral delivery of messenger RNA is one of the capabilities of Matinas BioPharma’s technology. BioNTech will explore that feature among others under a new research […]
Microbiome biotech Kaleido Biosciences shutters amid cash crunch, drug setbacks
Kaleido Biosciences, formed by Flagship Pioneering as part of a wave of biotech companies developing microbiome therapies, has laid off its entire workforce and is […]
Final CMS decision limits coverage of Biogen’s Aduhelm to those in clinical trials
Biogen’s Alzheimer’s disease drug Aduhelm will only be covered for Medicare beneficiaries participating in a clinical trial. The final coverage determination will have the effect […]
Werewolf cancer drug strikes right note with Jazz Pharma, sparking licensing deal
Jazz Pharmaceuticals is licensing rights to a Werewolf Therapeutics cytokine therapy that’s on track to reach clinical testing next year. The deal gives Jazz a […]
Pfizer broadens its RSV reach with deal for ReViral and its clinical-stage antivirals
Pfizer is already in the mix of companies pursuing vaccines for respiratory syncytial virus. The pharma giant is now broadening its scope with a deal […]
Novartis cancer drug is now first approved therapy for group of rare, genetic diseases
A Novartis drug that stops abnormal cell growth in breast cancer now has an additional FDA approval treating a group of rare disorders characterized by […]
Doceree Lands $11M for Physician-Only Platform for Precision Marketing
What You Should Know: – Doceree, a global network of HCP-only platforms for programmatic messaging raises $11M in a Series A funding round led by Eight Roads Ventures to enrich programmatic messaging offerings […]
Imara’s two trial flops in blood disorders dim drug’s prospects in heart failure
The lead drug candidate of Imara failed two separate mid-stage clinical trials evaluating it in rare, inherited hemoglobin disorders. Imara had been planning to advance […]
FDA places partial hold on Curis cancer drug after patient death in clinical trial
The FDA placed a partial hold on a Curis drug in development for treating leukemia after a patient treated in a clinical trial died. The […]
Novartis restructures to save $1B; pharma & oncology to merge into single unit
Novartis unveiled a corporate restructuring that is consolidating some operations in cash-saving moves expected to lead to $1 billion in annual savings. The shakeup means […]
CMO John Tsai exits, as Novartis starts revamp that aims to save $1bn
Novartis chief executive Vas Narasimhan, already eyeing a possible divestment of generics business Sandoz, has now turned his attention to the rest of the company. […]
Bayer reloads Leaps with €1.3 billion to step up investments in biotech innovation
Bayer is committing another €1.3 billion to Leaps by Bayer, the company’s investment arm, to support additional investments in companies developing innovative technologies in healthcare […]
Coaching Consistency
Leading tennis players train two to three hours a day to prepare for tournaments and have daily coaching input to make them game ready. It’s […]
Safety concerns sink Akebia drug for anemia from chronic kidney disease
The FDA rejected Akebia Therapeutics drug vadadustat as a treatment for anemia caused by chronic kidney disease. According to the biotech, the agency cited safety […]
VivoSense Raises $25M for Wearable Sensor Biomarkers to Advance Clinical Trials
What You Should Know: – VivoSense, an agile end-to-end scientific solutions company developing novel digital endpoints from wearable sensor data raises $25 Million in Series […]
Vying to best bigger rivals in Parkinson’s, Neuron23 nabs $100M to reach clinic
Neuron23 is developing drugs that treat neurological conditions by penetrating the blood-brain barrier to reach disease targets in the central nervous system. The biotech’s lead […]
New blow for ALS pipeline as Biogen and Ionis candidate fails Phase 1 trial
Less than six months after the late-stage failure of tofersen, Biogen and Ionis have suffered further disappointment in the amyotrophic lateral sclerosis (ALS) pipeline after […]
Data and regulatory roundup: Pfizer’s feat, an ADHD miss, Eli Lilly’s CRL & more
A pharmaceutical giant reported a Phase 3 success for a potential blockbuster drug, while four other companies reported disappointing data from their respective clinical trials. […]
AN2 Therapeutics’ IPO raises $69M to take antibiotic from Pfizer into pivotal test
AN2 is developing an antibiotic based on boron chemistry that could offer advantages over carbon-based molecules. The biotech plans to advance its drug candidate, licensed […]
Ligand Pharma turns to a SPAC to take antibody biz public, raise up to $266M
OmniAb, the antibody division of Ligand Pharmaceuticals, is set to go public through a SPAC merger that will infuse the business with up to $266 […]
Celsius Therapeutics heats up with $83M and an IBD drug on path to the clinic
Single-cell analysis biotech Celsius Therapeutics has raised $83 million to advance its pipeline of drugs for autoimmune disorders and cancer. The startup’s lead autoimmune program, […]
Big data and how it can change the game in pharma: the pharmaphorum podcast
In the latest episode of the pharmaphorum podcast, editor in chief Jonah Comstock speaks with Miruna Sasu, chief strategy officer of COTA and long-time pharma […]
Novartis targeted radiation therapy gets FDA nod for advanced prostate cancer
The FDA approved Pluvicto, a Novartis radiopharmaceutical, as a new treatment option for advanced prostate cancer. Novartis added the therapy via its $2.1 billion acquisition […]
GSK joins LifeMine’s $175M funding as partners revive fungi as a drug discovery frontier
LifeMine Therapeutics, a company that analyzes fungal genomes to find molecules that have potential as new medicines, has raised $175 million in financing. Among the […]
Cell therapy biotech Affini-T gets $175M; KRAS is lead genomic cancer target
Affini-T Therapeutics is developing new cell therapies for cancer that could overcome limitations of the first generation of cell therapies. The initial genomic cancer targets […]
FDA approves Marinus Pharma drug for rare, genetic form of epilepsy
Marinus Pharmaceuticals drug Ztalmy is now FDA approved for treating the seizures in patients who have CDKL5 deficiency, an inherited form of epilepsy. The drug […]
Welcome to 1st Rare & Genetic Neurodegenerative Drug Development Summit
Neuroscience is arguably the next great frontier in medicine and 2022 dawned with a wave of exhilarating progress for the neurodegenerative drug development community. Eli […]
BMS nabs FDA nod for first drug in new class of cancer immunotherapies
Bristol Myers Squibb’s Opdualag has been approved by the FDA, a first for a drug that goes after a new cancer target called LAG-3. The […]
Apellis Pharma eyes a shot at getting first FDA approval in rare vision disorder
Apellis Pharmaceuticals has additional clinical data that show its drug having an effect on geographic atrophy, a rare vision-loss disorder with no FDA-approved treatment. The […]
Zosano Pharma cuts staff 31%, the latest layoffs in a wave of biotech belt-tightening
Regulatory setbacks for a new migraine treatment have led Zosano Pharma to restructure, laying off about 31% of its staff. Zosano is one of several […]
No room for commercial competition in sustainable pharma
With the healthcare sector accounting for around 4% of global emissions – about the same as a small country – only an ecosystem-wide effort will […]
physIQ, CellCarta Collaborate on Study to Revolutionize Vaccine
What You Should Know: – Today, digital medicine leader physIQ and CellCarta, a global leader in precision medicine services announced they are collaborating on a groundbreaking study that could revolutionize vaccine development. […]
Sanofi and Seagen team up to grow a new crop of ADC cancer drugs
Antibody drug conjugates have made scientific and regulatory progress in recent years. Sanofi is partnering with ADC specialist Seagen in a multi-drug alliance that keeps […]
Biotech startup Eclipse Bio emerges to shed light on RNA drug research
Scientists developing new RNA drugs need to understand how proteins bind to these molecules. Eclipsebio’s technology provides that analysis and the biotech startup now has […]
HIMSS22 Day 2 Roundup: Google Partners with MEDITECH, Microsoft’s Health Cloud Strategy Expansions
Mergers & Acquisitions (M&A) Activity OptimizeRx Acquires EvinceMed, a Specialty Drug Prescription Initiation Platform OptimizeRx, a provider of point-of-care technology solutions helping patients start and […]
RNA biotech Nutcracker Therapeutics unshells $167M for drugs built on biochips
ARCH Venture Partners led the Series C round of financing for Nutcracker Therapeutics, a company developing new RNA drugs. The company’s process for developing and […]
21GRAMS and McCann Health take top spot at PM Society Awards 2022
After two years of virtual events, the PM Society celebrated its 36th annual awards with an in-person ceremony at London’s Grosvenor House on Friday 11 […]
Nektar drug key to muti-billion dollar BMS deal fails pivotal test in melanoma
Bristol Myers Squibb bet more than $1.8 billion that Nektar Therapeutics’ drug could be combined with the pharma giant’s Opdivo to expand the reach of […]
Modest activity, tolerability issues sink lead Harpoon cancer drug prospect
Harpoon Therapeutics is discontinuing work on its lead drug in prostate cancer following disappointing data in an early-stage clinical trial. Though Harpoon has other drugs […]
MorphoSys cuts R&D from Constellation deal to focus on clinical-stage cancer drugs
MorphoSys is cutting the drug discovery and R&D work of Constellation Pharmaceuticals, a company it acquired lats year in a $1.7 billion deal. This consolidation […]
Scenic Biotech scores $31M to take aim at genetic modifiers for cancer & rare disease
Targeting mutations isn’t the only way to treat genetically driven diseases. Scenic Biotech is developing molecules to target genes that suppress disease, and it has […]
Sanofi’s hemophilia A data set stage for regulatory filings, matchup with Roche
An experimental hemophilia A therapy from Sanofi and partner Sobi has met the goals of a pivotal study, and the pharmaceutical giant is now planning […]
Novartis turns to Voyager Therapeutics to get gene therapies into the brain
Novartis is paying Voyager Therapeutics $53 million up front to begin a partnership focused on the discovery of capsids for central nervous system disorder gene […]
BrightInsight & UCB Partner to Build Digital Care Solutions for Rare Diseases
What You Should Know: – BrightInsight, provider of the leading global platform for biopharma and medtech regulated digital health solutions, announced a partnership with global […]
Bloomberg: Court docs reveal J&J’s role in prison tests comparing talc to asbestos
Research of Johnson & Johnson’s baby powder included a prison study in which inmates, mostly Black men, were injected with asbestos. The study was intended […]
With lung drug from Pfizer in hand, AN2 tests IPO waters in turbulent market
Two biotechs are braving the roiling financial markets to raise money for clinical trials. AN2 Therapeutics is preparing for a pivotal test of its boron-based […]
GoodRx Acquires Pharmacy Services Platform VitaCare for $150M
What You Should Know:– GoodRx announced that it will acquire vitaCare Prescription Services, a tech-enabled pharmacy services platform that expands GoodRx’s offering to pharma manufacturers while improving patient […]
2022 Infusion Industry Outlook: Adapting Care Delivery to Meet New Realities
Roger Massengale, Chief Commercial Officer, Eitan Medical January 2022 marked two years since the outbreak of COVID-19, with the healthcare system still working to adjust […]
Alpine Immune Sciences cancer drug trial placed on partial hold after patient death
The FDA placed a partial clinical hold on a Phase 1 study testing experimental Alpine Immune Sciences cancer drug davoceticept in combination with Merck cancer […]
FDA regulatory roundup: two approvals, three rejections & one clinical hold
The FDA approved drugs from Johnson & Johnson and CTI BioPharma in the past week. Complete response letters were issued to Gilead Sciences, Amryt, and […]
Princeton spinout ArrePath gets $20M to combine AI, imaging in antibiotics R&D
Anti-infective drug discovery startup ArrePath has launched with $20 million in seed funding to advance the development of molecules that use a dual mechanism to […]
Switch on to The Age of Coaching
The pharmaceutical industry is still picking its way through the debris of the pandemic but the gloom can be illuminated by the power of coaching […]
Consumers want convenient, online doctor-finding tools
New survey data from Press Ganey suggests that pharma may be able to get an edge by integrating physician directories into brand websites. When it […]
Cancer biotech Rondo gets $67M to step on the gas with next-gen bispecific drugs
Rondo Therapeutics is developing bispecific antibody drugs capable of treating solid tumors, which have eluded this type of cancer therapy. Led by co-founders and Teneobio […]
Nonprofit drugmaker Civica Rx unveils plans for insulin biosimilars, $30 per vial
Civica Rx plans to make lower cost versions of three branded insulin products, biosimilars that are expected to reach the market in 2024. In addition […]
AbbVie makes neuro drug connection with $130M Syndesi Therapeutics acquisition
AbbVie has acquired Syndesi Therapeutics, an early clinical neuroscience startup developing drugs that have potential applications in a range of cognitive disorders. Syndesi is based […]
J&J, Legend win FDA nod for cell therapy challenger to BMS in multiple myeloma
Approval of the Johnson & Johnson and Legend Biotech cell therapy, Carvykti, marks the second CAR T-cell therapy to clear the regulatory bar for multiple […]
Janssen, Legend CAR-T therapy CARVYKTI gets FDA nod
The US Food and Drug Administration (FDA) has approved a new cell-based therapy for blood cancer, developed by Janssen and China’s Legend Biotech to treat […]
Biocon expands portfolio & market reach with $3.3B buyout of Viatris biosimilars
Biocon Biologics is acquiring the biosimilars business of its longtime partner, Viatris. The deal gives Biocon a biosimilars presence in both emerging and developed markets, […]
Crisis in the U.S. Healthcare Workforce: Why It’s Time to introduce AI
Andrew Pucher, CEO of Dascena, Inc. One of the many acute challenges during the pandemic has been the departure of approximately 18% of the U.S. […]
FDA rejects Reata Pharma chronic kidney disease drug; new trial needed
The FDA told Reata that the clinical data do not show that the drug, bardoxolone, slows the progression of the loss of kidney function in […]
Why the FTC’s recent decision to not study PBMs might hurt consumers and independent pharmacies
With its ruling to maintain the status quo, the FTC has decided to take a back-seat and force independent pharmacies to fend for themselves in […]
Accenture & Astellas Pharma Create Next-Generation Cloud-Based IT Core Platform
What You Should Know: – Accenture announced it helped Astellas Pharma Inc. create a cloud-based core IT platform that serves as the foundation for an advanced, data-driven management model for […]
Definitive Healthcare Acquires Analytical Wizards, Healthcare Analytics Platform
What You Should Know: – This week, Definite Healthcare announced the acquisition of Analytical Wizards, an advanced analytics company revolutionizing analytics in healthcare by combining […]
Biohaven pays $100M for epilepsy drug prospect; strikes deal for BMS muscle med
Neuroscience drug developer Biohaven Pharmaceuticals is expanding its pipeline to include epilepsy and spinal muscular atrophy. The drug developer is acquiring Channel Bioscience and licensing […]
EU regulator backs Idorsia’s Quviviq for adults with insomnia
A new treatment for adults with insomnia disorder has been recommended for use in Europe, giving hope to people whose lives are blighted by the […]
FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure
Eli Lilly and Boehringer Ingelheim’s blockbuster diabetes drug Jardiance (empagliflozin) has been granted approval by the US Food and Drug Administration (FDA) for a wider […]
Breakthrough in early human embryo research
A new stem cell model, discovered by researchers exploring the human genome, will help scientists to map out the key genomic changes during early development. […]
To help solve patient distrust in pharma, industry collaboration is key
The past two years have shone a spotlight on the UK life sciences industry. Pharma companies are now household names, having been thrust into the […]
Startup hC Bioscience emerges with $24M to join pursuit of transfer RNA therapies
New startup hC Bioscience is developing therapies based on transfer RNA, molecules that can be leveraged to address disease-causing proteins. The biotech joins several companies […]
Amicus rejiggers gene therapy plans as SPAC merger folds in unfriendly market
The SPAC merger that Amicus Therapeutics planned for its gene therapy assets has been called off due to market conditions. The rare disease company is […]
