Clinical stage pharmaceutical company Cantex Pharmaceuticals has obtained a global licence from Harvard University’s Office of Technology Development to develop the small-molecule drug azeliragon into […]
A Kodiak Sciences drug failed to beat a Regeneron Pharmaceuticals product in a key test in the wet form of age-related macular degeneration. The biotech […]
Sanofi and GlaxoSmithKline weathered clinical trial delays for their Covid-19 vaccine, but the partners now have data to support filings seeking regulatory authorizations. Key features […]
Nothing quite compares to the level of solace patients find in connecting with others who share similar health experiences. These interactions have become so fundamental […]
As investment in gene therapies continues to grow rapidly, more effectively engaging patients throughout development has become a priority for any company serious about building […]
The Lilly Institute for Genetic Medicine is a new facility in Boston that will focus on the R&D of RNA and DNA-based therapies. Eli Lilly […]
BioNTech is acquiring a preclinical T cell receptor program (TCR) from Medigene, as well as licenses to the biotech’s TCR technologies. The agreement helps BioNTech […]
Tzvia Bader, CEO and co-founder, TrialJectory The clinical trial industry is, once again, at an uncertain crossroads. And while it might be assumed that the […]
Agios Pharmaceuticals has its third FDA-approved product, and the first under its new rare disease strategy. The regulatory decision also marks the first approved treatment […]
Welcome to the 3rd Annual RNAi – Based Therapeutics Summit: Overcoming Barriers for Targeted siRNA Therapeutics Built with biopharmaceutical industry insights, this in person conference will bring […]
Yumanity’s corporate restructuring means the biotech is now exploring “strategic alternatives” that could include a sale of the company or its assets. The biotech’s lead […]
Several biotech companies are rising to the challenge of developing small molecules to drug RNA. Remix Therapeutics is joining the chase, but its different approach […]
SpliceBio will use its €50 million in financing to advance development of a gene therapy for Stargardt disease, a rare eye disorder. The biotech’s technology […]
What You Should Know: – Today, Medisafe, a leading digital therapeutics and patient engagement company launches its new Digital Document Exchange module to streamline the […]
Star Therapeutics aims to develop drugs for rare diseases, many of which currently have no FDA-approved treatments. The company forms startups focused on particular areas […]
Collegium Pharmaceutical’s acquisition of BioDelivery Sciences International brings a pain drug that’s administered in a different way than its current lineup of medicines. The deal […]
An Eisai drug that produced disappointing data in a myelodysplastic syndrome study is getting another shot under a newly launched Roivant Sciences subsidiary, Hemavant. Roivant […]
The biopharmaceutical industry continues to be a hotbed of activity, with more than 6,000 products in active development and a growing share of that innovation […]
The lead RNA therapy from ProQR Therapeutics has failed the main and secondary goals of a pivotal study testing it as a treatment for a […]
Natural killers cells are the focus of a growing number of companies pursuing next-generation cell therapies for cancer. Indapta Therapeutics focuses on a subset of […]
The 3rd Protein Degradation and Targeting Undruggables Summit is North America’s only in-person, industry-led conference covering clinical progress and commercial scale development of first-in-class degrader […]
Eli Lilly is among the new investors joining the Series B round of Arkuda Therapeutics, a biotech developing a drug to treat a rare, inherited […]
With staff shortages and digital skill gaps being experienced across the spectrum of healthcare, from CROs and pharma to providers, the people-led sector is facing […]
Endeavor BioMedicines aims to kill two birds with one stone—that stone being a small molecule drug. Taladegib targets a cell signaling pathway associated with both […]
A rare disease drug that Sanofi added via its $11.6 billion Bioverativ acquisition is now approved for treating the blood disorder cold agglutinin disease. The […]
Clinical-stage Arcellx raised $123.8 million from its IPO, which the company will use to advance to a pivotal test for its lead program, a CAR […]
Unity Biotechnology’s corporate restructuring is a cash-saving move that allows the company to focus resources on its lead program, a drug in Phase 2 testing […]
Gene-editing medicines developer Intellia Therapeutics is paying $45 million up front to acquire Rewrite Therapeutics. The startup’s technology brings Intellia another tool for its genetic […]
Real-World Evidence 2022: Rare Diseases and Innovative Therapies (RWE 2022) will convene the full spectrum of stakeholders working in RWE in rare diseases and innovative […]
Turbocharge the Development of Best-In-Class Treg-Directed Therapies, Maximising Stability and Function to Deliver Safe, Scalable and Efficacious Therapies Globally As Biopharma turn their focus to autoimmune drug […]
TenSixteen Bio has emerged from stealth aiming to develop drugs for diseases caused by genetic mutations accumulated as we age. The startup has been incubating […]
Andrew Bott, Director of Talent Acquisition in EMEA & APAC countries at Medidata, shared his insights on hiring trends in this sector, in response to […]
Septerna has science from a Nobel laureate and technology that finds new ways to drug GPCRs, well-validated receptors targeted by about one-third of FDA-approved medicines. […]
Gilead Sciences did not disclose details about the safety concern that led to an FDA partial clinical hold on five studies evaluating its cancer drug, […]
Sierra Oncology myelofibrosis drug momelotinib achieved the main and secondary goals of a pivotal test and the biotech now plans to seek FDA approval. Sierra […]
Leyden Labs is developing nasal spray medicines to prevent respiratory viral infections. The company’s Series B round of funding follows a licensing deal that gives […]
Merck is still at the front of the pack of companies developing new medicines to treat chronic cough, but the company was dealt a setback […]
The FDA has rejected Pfizer’s somatrogon, a long-acting form of human growth hormone designed for once-weekly dosing. The setback delays Pfizer and partner Opko Health […]
The FDA placed the partial hold on the study last November following a patient death suspected to be linked to a known complication of leukemia […]
A third dose of vaccine has been shown to effectively neutralise the Omicron variant of covid-19, according to researchers. Research led by UCLH, UCL and […]
The US regulator has granted biliary tract cancer therapy Silmitasertib orphan drug designation. There are currently no treatments for this rare cancer, and the US […]
Japan’s health ministry has authorised the use of Pfizer and BioNTech COVID-19 vaccine in children aged between five and 11. The vaccine, Comirnaty, is claimed […]
Eleusis is developing a formulation of the psychedelic compound psilocybin that overcomes limitations of pill versions of the drug. Depression is Eleusis’s lead disease target […]
Despite the targeted approach of some cancer treatments, tumors can find ways to escape, leading patients to relapse. ImmPACT Bio will apply its Series B […]
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Jyseleca (filgotinib) 200mg tablets to treat ulcerative colitis (UC) in adults whose UC is […]
The mission to treat people who suffer from allergic rhinitis has been given a boost as two pharma companies join forces. The Swiss subsidiary of […]
Epilepsy is a small part of UCB’s neurology pipeline, but its proposed Zogenix acquisition would broaden the Belgium-based drugmaker’s ability to address that market. Zogenix’s […]
Lung cancer drug sugemalimab has delivered positive results following a phase 3 trial. EQRx’s GEMSTONE-302 study evaluated the efficacy and safety of the investigational anti-PD-L1 […]
Research into single-cell sequencing has been boosted with Single Cell Discoveries and BioTuring joining forces to refine the process. The collaboration aims to “close the […]
Just months after the venture was unveiled, controversial biotechnology company Altos Labs has officially launched with $3 billion in funding secured from investors. Dubbed an […]
The success of any drug launch begins long before a regulatory agency gives the product the green light. From clinical development to commercialization, cross‑functional team […]
ProKidney is going public in a SPAC merger that infuses the biotech with $825 million for Phase 3 tests and manufacturing of its autologous cell […]
The FDA rejected the new drug application for a Levo Therapeutics treatment for the rare metabolic disorder Prader-Willi syndrome. According to Levo, the agency said […]
Poolbeg Pharma has licenced a candidate for nasal immunotherapy, developed by the University of Warwick, targeting respiratory infections, such as influenza and coronavirus. The RNA-based […]
Scotland has approved AstraZeneca’s Tagrisso (osimertinib) as a monotherapy for the for the first-line treatment of adult patients with locally advanced or metastatic non-small cell […]
A World Health Organization (WHO) panel has given the green light to two new drugs to treat COVID-19. US-based Eli Lilly’s baricitinib (Olumiant), a Janus […]
GlaxoSmithKline (GSK) claims it has rejected three unsolicited, conditional and non-binding proposals from Unilever to acquire GSK Consumer Healthcare in a deal worth approximately $68.4 […]
After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. Under […]
The man who sent the price of lifesaving drug Daraprim (pyrimethamine) rocketing from $13.50 a tablet to $750 overnight has been ordered to repay $64.6m […]
Bausch + Lomb is returning to the public markets in an IPO expected to rank among the biggest in healthcare. Speaking at the annual J.P. […]
The FDA placed a clinical hold on Denali Therapeutics’ application to begin Phase 1 testing of an antibody drug for Alzheimer’s disease. The Denali drug […]
AstraZeneca’s partnership with Scorpion Therapeutics will focus on transcription factors that are known to play a role in cancer but have been difficult to target […]
In the runup to MedCity INVEST in Chicago, we’re spotlighting the perspectives of investors and what motivates them to invest in startups. If you’re a […]
BeyondSpring Pharmaceuticals’ corporate reorganization comes about six weeks after the FDA rejected the biotech’s drug for a complication experienced by cancer patients. The company still […]
Sanofi is the latest company to strike a deal for a Parkinson’s disease drug candidate that targets the protein alpha synuclein. The asset from ABL […]
The Center for Medicare and Medicaid Services proposes covering Biogen Alzheimer’s disease drug Aduhelm only for people enrolled in a clinical trial. In explaining this […]
The report, Resilience in volatility: Modernizing the supply chain, highlights three areas that Fortune 500 and mid-size companies need to address to implement technology such […]
Bristol Myers Squibb is partnering with Century Therapeutics, placing a $150 million bet that the biotech’s technology for engineering stem cells can produce new off-the-shelf […]
As the annual J.P. Morgan HealthCare Conference kicked off Monday, two pharma giants unveiled deals that expand give them access to in-vivo gene editing technologies. […]
The field of biotechs pursuing new interleukin-2 cancer immunotherapies is filled with companies engineering different versions of that signaling protein. Avenge Bio CEO Mike Heffernan […]
It’s the first week of the new year, and the life sciences sector continued the IPO momentum of 2021 as Wall Street welcomed three new […]
Sanofi’s new alliance with artificial intelligence biotech Exscientia spans up to 15 small molecule drugs in cancer and immunology. If drugs from the partnership reach […]
Biotech startup Ambagon Therapeutics is taking a new approach to making elusive protein targets “druggable” by using molecular glues. The biotech has a pipeline of […]
A Sanofi strategy shift is leading to the end of a gene-editing alliance with Sangamo Therapeutics. Though the partnership has produced encouraging early clinical data […]
Pfizer is paying BioNTech $225 million to kick off a new alliance aiming to develop a shingles vaccine based on the same messenger RNA technology […]
Avrobio is stopping enrollment in a clinical trial for its Fabry disease program after new results showed variability in how the gene therapy was taken […]
“Most Q&As are happening on Twitter. If you’re not doing social listening you’re losing fresh insights into things like disease states.” That was just one […]
PRISYM 360 label management software has been tested by Zebra’s Global Enablement Center to support customers’ critical printing needs, reducing risk and deployment times […]
The FDA has expanded emergency authorization of Covid-19 boosters to include children 12 to 15 vaccinated with the Pfizer and BioNTech messenger RNA shot. The […]
Ovid Therapeutics is acquiring global rights to AstraZeneca molecules that address a novel target to treat epilepsy. The AstraZeneca deal comes 10 months after Takeda […]
As in previous years, cancer products topped the list of new FDA-approved therapies in 2021. But the list of drug approvals is notable for other […]
The FDA has accepted Amylyx Pharmaceuticals’ submission for amyotrophic lateral sclerosis drug AMX0035 and it expects to issue a regulatory decision by late June. A […]
Pardes Biosciences’ experimental oral antiviral for treating and preventing Covid-19 infection addresses the same target as Pfizer’s authorized pill Paxlovid, but with a potential dosing […]
With FDA approval for its atopic dermatitis drug Adbry, LEO Pharma will reach the U.S market ahead of an Eli Lilly atopic dermatitis drug that […]
BridgeBio reported its drug acoramidis missed the main goal of a pivotal study in patients with transthyretin amyloidosis affecting the heart—the same type of patients […]
The World Health Organization (WHO) recently held a virtual panel discussion during Digital Health Week with speakers from around the world to talk about global […]
Merck antiviral drug molnupiravir received emergency authorization, joining Pfizer’s Paxlovid as the only authorized oral antiviral drugs for treating Covid-19. Though the Merck and Pfizer […]
COVID-19 has changed everything – at least that’s David Hunt’s plan for pharmaceutical marketing. The former CEO of Havas Lynx recently launched a new agency […]
Novartis drug Leqvio now has the FDA’s green light, making it the first RNA interference medicine approved for lowering cholesterol. The regulatory decision sets the […]
Novartis is acquiring gene therapy developer Gyroscope Therapeutics and its lead program, a potential treatment for the vision loss disorder geographic atrophy. It’s the latest […]
Patient centricity and patient engagement have been hot topics in pharma for some time – but buzz words do not always translate into concrete action. […]
The FDA has halted tests of a Pfizer gene therapy for Duchenne muscular dystrophy. The clinical hold is one of several placed on gene therapy […]
In acquiring Amunix, Sanofi becomes the latest big pharmaceutical company to strike a deal to gain access to technology that improves the safety and efficacy […]
Novartis is partnering with BeiGene on the development of a drug that addresses TIGIT, a hot cancer immunotherapy target. The Swiss pharma giant is committing […]
The price of Biogen Alzheimer’s disease drug Aduhelm will be cut in half at the start of 2022, a move that comes as a Medicare […]
Myasthenia gravis patients now have a new FDA-approved biological treatment. Argenx drug Vyvgart provides a treatment alternative for patients who have the rare autoimmune disorder […]
The insurers referred to deals Gilead struck with Janssen, Bristol Myers Squibb to prevent the generic version of its retroviral medications from being used as […]
Ipsen is paying €120 million up front to acquire global rights to elafibranor, a Genfit drug that fell short as a treatment for NASH, but […]
Six months after Biogen was awarded regulatory approval for its Alzheimer’s disease drug Aduhelm, the company the company is laying out a timeline for the […]
Antibody drug conjugates deliver a targeted strike to tumors, but the toxic payloads of these therapies can still reach healthy tissue. Mythic Therapeutics’ FateControl technology ensures […]
Bristol Myers Squibb has notched another FDA approval for its blockbuster immunology drug Orencia, this time for preventing acute graft versus host disease in bone […]
CSL Limited makes many of its therapies from donated plasma, which posed a challenge as pandemic lockdowns led to a steep drop in plasma collections. […]
Bristol Myers Squibb is paying $150 million up front for global rights to an Immatics biologic drug designed to recruit a patient’s T cells to […]
A look at how healthcare organizations are collaborating with Microsoft to enhance patient engagement, accelerate healthcare innovation, improve clinical and operational insights, and more.
Sales of blockbuster Pfizer drug Xeljanz are under pressure from a stronger safety warning placed across that drug’s entire class. In acquiring Arena Pharmaceuticals for […]
Eli Lilly is building its cancer drug pipeline via a research alliance with Foghorn Therapeutic, a biotech whose technology discovers drugs addressing targets in a […]
FDA authorization of AstraZeneca drug Evusheld makes it the first antibody therapy for preventing infection before exposure to Covid-19, providing an option for immunocompromised patients […]
The term ‘Rising Stars’ is often used throughout the pharma industry. In general, rising stars within a given field, are the emerging leaders that stand […]
PharmStars, an accelerator for companies developing digital solutions for pharmaceutical companies, has graduated its first class of startups. The theme for this initial group was […]
Preliminary data suggest the BioNTech and Pfizer Covid-19 vaccine may have diminished protection against the omicron variant, but that levels of neutralizing antibodies can be […]
Odyssey Therapeutics is the latest startup formed by serial biotech entrepreneur Gary Glick. Odyssey’s destination is oncology and immunology drugs that address novel disease targets, […]
Microsoft seeks to change the way pharma industry companies use technology to better navigate human resource and supply chain challenges.
Nabla Bio emerged from the lab of famed Harvard scientists George Church last year, and its antibody discovery technology has already led to five partnerships […]
Adicet Bio makes its therapies from gamma delta T cells, a rare type of immune cell that the company believes offer advantages compared to other […]
Eli Lilly’s authorized antibody drug for treating and preventing Covid-19 infection in adolescents and adults is now authorized for pediatric patients, including newborns. While tests […]
AviadoBio’s gene therapies are designed to achieve widespread distribution throughout the central nervous system. The company’s lead program on track to begin human testing as […]
Specialty drugs represent a growing share of overall pharmaceutical sales, and Omnicell is acquiring specialty pharmacy technologies company ReCept Pharmacy to enter into this market. […]
Novartis is paying UCB $150 million up front to share in the development of two clinical-stage Parkinson’s disease drugs that offer new approaches to treating […]
BeyondSpring Pharmaceuticals said the FDA wants another clinical trial to demonstrate patient benefit for its drug, a small molecule developed to treat a dangerous and […]
Sanofi’s strategy to develop new messenger RNA vaccines is adding another piece. The pharmaceutical giant struck a deal to acquire Origimm Biotechnology, a startup developing […]
Radiopharmaceuticals deploy radiation to damage cancer DNA, but Curie Therapeutics sees these therapies opening the door to a wider range of ways to kill tumors. […]
Deciphera Pharmaceuticals’ corporate restructuring will slash headcount by 35% and stop work on two drug programs. Going forward, the biotech said it will focus on […]
Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022) is held on June, 20-21, 2022 in Berlin, Germany. The Congress gathers pharmaceutical companies, CMOs and CDMOs, governmental […]
Quell Therapeutics’ $156 million Series B round comes as it prepares to advance to a clinical trial testing its lead regulatory T cell therapy candidate […]
Blueprint Medicines is paying $250 million up front to acquire Lengo Therapeutics, developer of targeted cancer therapies. The startup’s lead drug candidate is on track […]
Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022) covers the current state of the pharmaceutical manufacturing and packaging industry. The Congress gathers pharmaceutical companies, CMOs and […]
The new Covid-19 variant, named Omicron, has mutations that could help it evade antibodies produced by the immune system. Scientists are conducting lab tests to […]
The FDA placed a partial clinical hold on a Kura Oncology leukemia drug following the death of one patient in the early-stage study. Kura executives […]
Takeda Pharmaceutical won FDA approval for Livtencity, an antiviral developed to treat cytomegalovirus infection in transplant patients. The agency also approved an Aadi Biosciences drug, […]
GlaxoSmithKline sees enough promise in the early clinical data of a novel NASH drug to pay its developer, Arrowhead Pharmaceuticals, $120 million up front for […]
AbbVie returned the rights to the drugs to Sosei Heptares earlier this year. Now Neurocrine Biosciences has agreed to pay the Japanese drug company $100 […]
Nephrology products company Vifor Pharma is shelling out about $252 million combined up front to acquire Sanifit Therapeutics and Inositec, developers of drugs for a […]
BioMarin Pharmaceutical’s Voxzogo is the first FDA approved therapy for achondroplasia, an inherited disorder that causes the most common form of dwarfism. With approvals in […]
Shots: Gilead has exercised its options to 3 programs in Arcus’s portfolio, including both anti-TIGIT molecules, domvanalimab & AB308 along with etrumadenant & quemliclustat & […]
Bill Martin, the Global Therapeutic Area Head of Neuroscience at The Janssen Pharmaceutical Companies of Johnson & Johnson, shared some of the promising developments in […]
The acquisition agreement comes exactly two years after the two companies began a wide-ranging alliance focused on developing RNA interference drug for metabolic disorders. The […]
The first wave of biotechs developing drugs that employ targeted protein degradation target disease-causing proteins inside the cell. Biotech startup Avilar Therapeutics, formed by RA […]
Shots: Under the existing collaboration agreement, Takeda has exercised an option to co-develop and co-commercialize DNL593 (PTV: PGRN) as brain-penetrant progranulin replacement therapy for the […]
Chroma Medicine is developing epigenetic therapies that turn genes on or off. The biotech startup has emerged from stealth mode backed by a $125 million […]
SMi Group’s 14th Annual Conference and Exhibition: Pre-Filled Syringes and Injectable Drug Devices 2022 – 12th – 13th January 2022 Sustainability for Drug Devices Focus Day […]
BRINGING IT ALL HOME: HOW LABEL MANAGEMENT SOLUTIONS CAN HELP CDMOS GROW THEIR IN-HOUSE CAPABILITIES In this blog, PRISYM ID’s Clinical Trials Sales Manager […]
Shots: The companies launch Semglee and Insulin Glargine as interchangeable biosimilars products to improve patients’ access with type 1 & 2 diabetes. Biocon and Viatris […]
Acelyrin has in-licensed izokipeb, an antibody drug developed by Affibody that could offer advantages compared to currently available monoclonal antibodies. The drug addresses the same […]
Polycythemia vera, a rare blood cancer characterized by the overproduction of red blood cells, now has its first FDA-approved drug treatment. The agency awarded the […]
Johnson & Johnson announced it plans to separate its consumer health products into a separate company, leaving the remaining business to focus on the more […]
Shots: Gaeta to receive $0.2M up front and is eligible to receive ~$7.5M in clinical and regulatory milestones based on product and indication The agreement […]
Vaxxinity, a clinical-stage biotech with vaccine technology that gets the body to produce therapeutic or protective antibodies, raised $88 million from an IPO that priced […]
Organon’s proposed acquisition of Forendo Pharma is the company’s third the company since spinning out of Merck in the summer. Clinical-stage Forendo is developing a […]
Shots: I-Mab to receive ~$35M up front & ~0.27M upon achievement of development, registration & sales milestones, $315M non-royalty payment & is eligible to receive […]
Shots: Novome to receive $15M up front & is also eligible to receive ~$590M in milestone upon the achievement of prespecified development and commercial milestones […]
Vaccine biotech Inventprise has developed technology that offers broader protection than currently available products. Its lead program, a pneumococcal vaccine candidate, is being readied for […]
Ligand Pharmaceuticals has turned a series of antibody discovery acquisitions into a growing business unit. Ligand now wants to spin it off as a separate […]
Shots: Karuna to receive $35M up front, ~$80M in development and regulatory milestones and is also eligible to receive ~$72M in sales milestones along with […]
Shots: Blueprint will receive $25M up front, ~$590M in milestones along with royalties on net sales of BLU-945 & BLU-701 in Greater China & will […]
Shots: Biohavem to receive $500M up front that consists of $150M cash & $350M in the purchase of Biohaven equity at a premium of 25% […]
Arbor Biotechnologies raised new cash to keep up the pace in the chase for new genetic medicines. The MIT spinout applies artificial intelligence and machine […]
Biohaven Pharmaceuticals has seen strong U.S. market uptake for its oral migraine drug, Nurtec. With regulatory decisions looming around the world, the company has landed […]
Alltrna, a biotech startup founded by Flagship Pioneering, is developing a new type of medicines based on a form of RNA called transfer RNA, or […]
Shots: Kronos will receive access to Tempus’ real-world data & tools to expand its preclinical/clinical development portfolio & retains an option to join Tempus’ TIME […]
Shots: Under the collaboration, the companies will jointly develop CDx solutions for the innovative assets which are being developed under I-Mab to accelerate the R&D […]
Sanofi is committing up to $60 million to Gyroscope Therapeutics, a clinical-stage biotech whose lead program could become the first gene therapy for a particular […]
The team behind the World Without Disease Accelerator, part of Janssen Research & Development, one of the Janssen Pharmaceutical companies of Johnson & Johnson, is […]
Apple Tree Partners’ latest cancer biotech company, Marengo Therapeutics, is using antibodies to selectively activate T cells to fight cancer. Led by former Merck KGaA […]
Shots: Suzhou Alphamab to receive up front & will be eligible to receive development, regulatory & commercial milestones along with royalties & will manufacture ASC22 […]
Shots: The companies collaborated to evaluate Inspirna’s RGX-104 + BMS’ Yervoy in P-Ib/II expansion study for patients with metastatic endometrial cancer whose genomes holds E2 […]
Evotec is an old player in the life sciences, but in offering new shares on the Nasdaq, the Germany-based company plans to bolster its new […]
PlateletBio trails Sanofi among others in pursuit of a new therapy for a rare blood clotting disorder that has few treatments. But the biotech startup […]
Novartis’s equity stake in Roche, shares acquired 20 years ago in a strategy to build up to a potential mega-merger, will be sold back to […]
Harvard University spinout GRO Biosciences has technology offering the potential for protein therapies that are safer and more effective than currently available biologic drugs. The […]
Not all drugs will be subject to price negotiation under the revised legislation. But the agreement sets up a framework enabling Medicare to negotiate the […]
Shots: The companies collaborated to evaluate the safety, tumor shrinkage, clinical activity & immune biomarkers of Galecto’s GB1211 (galectin-3 inhibitor) + Roche’s Tecentriq (PD-L1 checkpoint […]
Amylyx Pharmaceuticals has submitted its amyotrophic lateral sclerosis (ALS) drug for FDA review based on positive Phase 2 data after discussions with the agency over […]
Gilead Sciences and BeiGene, which started research alliances with Shoreline Biosciences earlier this year, are among the investors in the biotech’s latest financing. The preclinical-stage […]
Shots: AstraZeneca to receive $270M on completion. The transaction is expected to be close in Q4’21 while Covis will also pay an ongoing development cost […]
Shots: The MAA is based on the P-II LOTIS-2 study evaluating Zynlonta (CD19-directed ADC) in 145 patients with r/r DLBCL following two or more prior […]
Shots: The company has completed the enrolment in the P-II CALDOSE-1 trial to evaluate the efficacy & safety of IMU-838 (10/30/45mg, PO) vs PBO in […]
Shots: Curacle to receive a total of ~$2B including $6M up front & is eligible to receive ~$157.5M as development, regulatory and sales milestones along […]
The app lets people track their metrics through connected devices, and access health coaching and educational materials. It’s one of multiple that Bayer and One […]
Shots: Teva to get an exclusive license globally to develop, manufacture & commercialize anle138b &sery433. Additionally, both companies will jointly develop the products for MSA […]
Medable recently raised $304 million, its fourth funding round in the past two years. The company’s software can be used to virtually consent patients into […]
Shots: Glenmark has launched Remogliflozin (SGLT2 inhibitors, 100mg, ) + Vildagliptin (DPP4 inhibitors, 50mg,) + Metformin (500/1000mg) as FDC for the management of T2D in […]
Shots: The companies collaborated to evaluate the Evaxion’s EVX-01 + MSD’s Keytruda in P-IIb study in patients with metastatic melanoma stage III & IV. The […]
By engaging in a dialogue, patients and pharma companies can have a mutually beneficial relationship, Health Union’s Jack Barrette said at HLTH’s patient engagement track, […]
Cancer drug developer Xilio Therapeutics and Ventyx Biosciences, a company with drug candidates in cancer and autoimmune diseases, are the latest life science companies to […]
In less than two years, Egle Therapeutics launched, partnered with Takeda Pharmaceutical, and found its first cancer targets. Now the startup has €40M in Series […]
Shots: Marinomed to receive $2M up front & is eligible to receive milestones upon achievement of development, regulatory & commercial milestones along with royalties on […]
Shots: Incyte will lead the development, manufacture, and supply of both products. ST will be responsible for the regulatory, distribution, and local marketing related activities […]
ReCode Therapeutics closed an $80 million Series B round of financing that included Pfizer and Sanofi as investors. The startup’s technology uses lipid nanoparticles to […]
The FDA refused to review Stealth BioTherapeutics’ Barth syndrome drug, telling the company results in a study of just eight patients are insufficient to support […]
Shots: LCB will be eligible to receive up front and milestones along with royalties & is eligible to receive a prespecified percentage of any sublicensing […]
Shots: BehaVR to receive $5M up front, ~$18M in development milestone and R&D support along with commercial & operational support fees and is eligible to […]
The FDA amended emergency use authorization of the Moderna and Johnson & Johnson Covid-19 vaccines, permitting booster shots. But the agency went further and said […]
Shots: Dana-Farber to receive up front & will be eligible to receive development and commercial milestones along with royalties on product sales SpringWorks has also […]
Shots: OXB to receive $4.83M as an option exercise fee & ~$37.96M in development, regulatory & sales milestones along with royalty on sales of a […]
Entasis Therapeutics, the former anti-infectives unit of AstraZeneca, has positive Phase 3 data for its lead program, an antibiotic that could address drug-resistant strains of […]
Shots: Takeda is eligible to receive $10M up front in addition to $35M in Calithera Series A preferred stock and is eligible to receive clinical […]
Shots: Wave to receive $22.5M for research & preclinical expenses and is eligible to receive opt-in payment, development & commercial milestone & will lead the […]
Shots: Lipocine to receive $11.0M up front, $5.0M as licensing fees in Jan’25 & $5.0M in Jan’26, ~$160.0M as sales-based commercial milestone based on Tlando […]
An Oyster Point Pharma drug for dry eye disease has won FDA approval, the first treatment for the condition that comes as a nasal spray. […]
Biogen amyotrophic lateral sclerosis drug, tofersen, failed a Phase 3 clinical trial, but the drug showed improvement according to secondary and exploratory goals of the […]
Shots: Accent to receive ~$446M including up front, pre-clinical, clinical, regulatory, and sales-based milestone along with royalties Ipsen obtains an exclusive license to develop, manufacture […]
A new startup initiative in Israel aims to create and invest in startups that use artificial intelligence to address challenges in drug discovery and development. […]
Johnson & Johnson won the support of an FDA advisory panel, which unanimously recommended a booster shot for adults. The backing comes one day after […]
Biomanufacturing technologies company Resilience is partnering with Harvard in a deal that could see innovations from the university’s labs commercialized under new businesses. Resilience has […]
Shots: Exelixis has exercised its exclusive option under the companies’ July 2019 agreement to in-license XL114 (formerly AUR104), following the US FDA’s IND acceptance for […]
Imagine you had a crystal ball which allowed you to see into the future and understand exactly how your life science launch would pan out. […]
Biotech startup Tentarix Biotherapeutics has come out of stealth with $50 million and technology that develops biologic drugs endowed with multiple functions. The company aims […]
Rectify Pharmaceuticals is taking an approach to disease that led to a successful franchise of Vertex Pharmaceutical lung drugs and expanding it to more diseases […]
Health journeys can be complex, sometimes more complex than a Rube Goldberg machine or spelling, say, embourgeoisement or consanguineous. And certain aspects of living with […]
Digital Opinion Leaders (DOLs) and KOLs overlap, but each group is unique. Unlike traditional KOLs, DOLs have a different reach and a unique voice because […]
Shots: The companies collaborated to assess Turning Point’s elzovantinib (TPX-0022) in combination with EQRx’s aumolertinib in patients with EGFR mutant MET-amplified advanced NSCLC Turning Point […]
Takeda Pharmaceutical is partnering with startup Immusoft in a research alliance aiming to develop B cell therapies that cross the blood-brain barrier to treat rare […]
Bionano Genomics is acquiring genomics software firm BioDiscovery in a $90 million cash and stock deal. While both companies provide genomics analysis solutions, Bionano said […]
The progress of gene therapies continues to be stymied by safety risks associated with the viruses used to deliver them. Takeda Pharmaceutical is partnering with […]
Shots: Sutro to receive $4M as licensing option fee, ~$200M as an option exercise fee, development, regulatory & commercial milestones along with royalties based on […]
Pyxis Oncology’s IPO raised $168 million as the biotech steers toward the clinic with drug candidates and technology licensed from Pfizer. Theseus Pharma, IsoPlexis, and […]
ChemoCentryx has spent decades developing oral alternatives to injectable and infused biologic drugs that treat chronic autoimmune conditions. The research finally paid off with FDA […]
All of Allogene Therapeutics’ clinical trials are now under an FDA clinical hold. The halt was handed down after one patient in the company’s most […]
Shots: MD Anderson to receive payments based on the development and commercialization of Schrödinger’s WEE1 inhibitor compounds. Schrödinger to provide research funding & will unite with researchers […]
Bristol Myers Squibb drug deucravacitinib missed the main and secondary goals of a Phase 2 study in ulcerative colitis. Despite the clinical trial failure, the […]
Neumora Therapeutics unveiled $500 million in capital and a research partnership with Amgen. The startup analyzes neurological data to inform its drug research and development; […]
The gene therapy pipeline of Voyager Therapeutics has hit several setbacks in the past year, but a strategy shift to its capsid technology is now […]
A new service from MedCity News is designed to add momentum to lead generation campaigns.
Formedix has been strong advocates for the use of CDISC data standards in clinical and non-clinical research for decades, ever since we realized how it […]
Vedanta Biosciences is developing its microbiome therapy with support from the Biomedical Advanced Research and Development Authority. Under terms of that contract, the positive Phase […]
Biotech startup Exo Therapeutics aims to overcome the challenges of drugging proteins by targeting exosites, locations that modulate enzyme activity. The company has four small […]
Clinical-stage Xencor is receiving $100 million up front and a $25 million equity investment, while Johnson & Johnson’s Janssen Biotech subsidiary gets global rights to […]
TrialSpark, a startup whose software manages various aspects of clinical trials, is becoming a drug developer. Led by CEO and cofounder Benjamine Liu, the company […]
Shots: Sunovion to receive $270M up front, $620M as development milestone for 4 candidates & is also eligible to receive sales milestone. Sunovion & Otsuka […]
Merck is looking for products that diversify its portfolio beyond reliance on cancer drug Keytruda, and it sees a potential blockbuster cardiovascular drug from Acceleron […]
Shots: JCR to receive an up front for the Ex-US license & additional development & commercial milestones along with royalties on the sales of JR-141 […]
Mirum Pharmaceuticals drug Livmarli is now approved to treat pruritus caused by Alagille syndrome, a rare liver disease that can worsen to the point of […]
Amicus Therapeutics is spinning its gene therapy pipeline into a separate entity that will go public via a SPAC merger. Executives say the transaction puts […]
AbbVie drug Quilpta, developed specifically for migraine prevention, is now FDA approved, the latest product in a new class of migraine medicines. The AbbVie drug […]
Cross-border biotech Anji Pharma closed $70 million in Series B funding to advance a drug pipeline that includes metabolic and cancer drugs. The biotech’s business […]
Eisai is seeking accelerated FDA approval of lecanemab, an Alzheimer’s disease drug that is part of a research alliance with Biogen. The drug is following […]
Shots: Shionogi to receive $27.2M up front, $20.4M upon the achievement of a clinical milestone along with royalties on net sales of S-365598 (HIV integrase […]
Delix Therapeutics is developing drugs that offer the therapeutic benefits of psychedelic drugs, but without the hallucinations and other side effects that accompany these compounds. […]
Biohaven’s bet on an AstraZeneca drug for multiple system atrophy does not pan out, failing a pivotal study in the rare, neurodegenerative disorder. But a […]
Shots: Syndax to receive $117M up front, $35M as an equity investment at $24.62/share representing a premium of 31% to a closing price of $18.80, […]
Capricor Therapeutics’ cell therapy for Duchenne muscular dystrophy posted encouraging results from a Phase 2 study enrolling 20 patients. But the FDA said a Phase […]
Life sciences companies are using “digital twins” for everything from drug discovery to manufacturing. A panel of experts at MedCity News’ INVEST Digital Health conference […]
The process of discovering HCPs who are leading key opinion leaders (KOLs) in emerging and growing markets is not as straightforward as it is in […]
Biotech startup GenEdit is developing polymer nanoparticle technology to deliver genetic medicines, an approach intended to avoid the limitations of viral vectors. Already partnered with […]
Access to online social connections has transformed the patient journey, and your brand strategy can evolve with it to effectively meet patients where they are. […]
The FDA has authorized dosing of booster shots of Pfizer and BioNTech’s Covid-19 vaccine. Consistent with the recommendations of an FDA advisory committee, the agency’s […]
Atopic dermatitis patients now have a new option that comes as a topical cream. The FDA approved Incyte’s drug, Opzelura, as a treatment for the […]
Shots: Takeda will lead the regulatory approval and commercialization of maralixibat in Japan & will also be responsible for the development, including conducting clinical studies […]
The Seagen and Genmab antibody drug conjugate (ADC), named Tivdak, is approved to treat cases of cervical cancer that have returned or spread following treatment […]
Shots: The companies collaborated to evaluate the safety, tolerability & efficacy of Verastem’s VS-6766 + Amgen’s Lumakras in the P-I/II trial for patients with KRAS […]
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