La larga espera por la cura de la diabetes
Un documental recoge la desesperación y la frustración de los pacientes de diabetes de tipo 1 que participan en un ensayo clínico.
Un documental recoge la desesperación y la frustración de los pacientes de diabetes de tipo 1 que participan en un ensayo clínico.
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 […]
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 […]
Mark Mentzer, Senior Director, Business Development, Connected Devices and eCOA, IQVIA In recent years, digital health technologies (DHTs) have significantly changed the way we collect […]
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 […]
Patient recruitment specialist Clariness will deploy an app aimed at helping asthma patients monitor environment triggers and report symptoms in the clinical trials its support, […]
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 […]
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 […]
A documentary captures the desperation and frustration of Type 1 diabetes patients in a clinical trial.
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’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 […]
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 […]
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 […]
Doctors who want to prescribe tecovirimat, or Tpoxx, must navigate a gantlet of bureaucratic hurdles that experts say could be quickly lifted.
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 […]
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 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 […]
What You Should Know: – H1and Lokavant today announced an extensive data-and-analytics collaboration to bring enhanced automated intelligence to drug development – As part of […]
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 […]
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 […]
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 […]
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 […]
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 […]
At the INVEST PhamaTech conference last month, five startups shared their vision for how they are seeking to reinvent clinical trials as part of the […]
Latest UK Life Sciences Competitive Indicators “ought to ring alarm bells across Government,” says ABPI. Despite the UK’s potential as an international life sciences leader, […]
A just-published report on the UK’s life sciences sector “ought to ring alarm bells across government,” according to the Association of the British Pharmaceutical Industry […]
What You Should Know: – Medable Inc., the leading SaaS platform provider for patient-centered clinical trials, today announced a new partnership with Withings Health Solutions, […]
What You Should Know: – Israeli-based ForSight Robotics, the pioneer in ophthalmic robotic surgery raises $55M in Series A funding to advance the world’s first […]
Mac Bonafede, Ph.D., MPH, VP of Real World Evidence at Veradigm Data reporting challenges during the current pandemic relate to the lack of connectivity between […]
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, […]
What You Should Know: – Wysa, a Boston, MA-based AI digital platform for mental health, today announces it has secured $20M in financing led by […]
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 […]
A pilot study has been launched by the EMA to see whether it is helpful for regulators to look at the ‘raw data’ from clinical […]
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 […]
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 […]
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 Pharmaceuticals already has a cell therapy candidate for type 1 diabetes but the company says acquiring rival ViaCyte will provide it with complementary assets […]
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 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 […]
The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) […]
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 […]
A new study found that sabizabulin reduced the risk of death by 55 percent, but some experts were cautious about overinterpreting the results.
A new study found that sabizabulin reduced the risk of death by 55 percent, but some experts were cautious about overinterpreting the results.
A new study found that sabizabulin reduced the risk of death by 55 percent, but some experts were cautious about overinterpreting the results.
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 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 […]
Trial organisers face intense competition to find and recruit eligible patients for atopic dermatitis studies. With more than 500 dermatology clinical trials currently underway, it […]
The UK government has made an additional £175 million ($212 million) in funding available for its push to make the country a go-to location for […]
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. […]
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 […]
A recent webinar by Medable discussed steps it’s taking to improve clinical trial design through decentralized clinical trials
At the 2022 Drug Information Association (DIA) annual meeting last week, it was inspiring to connect with fellow research and development (R&D) stakeholders, regulators, health […]
What You Should Know: – Today, Care Access announced the acquisition of IBPClin, a leading clinical trial center in Rio de Janeiro. As a result, Care Access will bring its innovative approach to decentralized […]
Barry Mulchrone, Senior Director& Head of Pharmacovigilance Oversight and Analytics, IQVIA Annette Williams, VP & Global Head, Lifecycle Safety, IQVIA Monitoring the safe and effective […]
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 […]
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 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 […]
Almost half (48%) of cancer clinical trials in the US have no Hispanic or Latin American subjects, and 42% have no black patients, according to […]
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 […]
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 […]
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 […]
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.
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 […]
Moderna has said it will open a new R&D and manufacturing facility in the UK which could lead to improved access by NHS patients to […]
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 […]
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 […]
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 […]
Walgreens is the latest US retail pharmacy giant to have a go at disrupting the clinical trials industry, with the launch of a new business […]
The drug, crenezumab, failed to prevent early symptoms or slow cognitive decline, the latest setback in the long quest to find effective therapies for the […]
The drug, crenezumab, failed to prevent early symptoms or slow cognitive decline, the latest setback in the long quest to find effective therapies for the […]
The drug, crenezumab, failed to prevent early symptoms or slow cognitive decline, the latest setback in the long quest to find effective therapies for the […]
What You Should Know: – Walgreens today announced the launch of its clinical trial business to redefine the patient experience and increase access and retention […]
In this episode of the pharmaphorum podcast, editor in chief Jonah Comstock welcomes Dr. Jennifer Jones-McMeans, divisional vice president for global affairs for Abbott’s vascular […]
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 […]
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 […]
The F.D.A. is also reviewing the treatment, Albrioza, but the agency’s scientists have raised questions about its effectiveness.
The F.D.A. is also reviewing the treatment, Albrioza, but the agency’s scientists have raised questions about its effectiveness.
A new clinical trial is the largest to date testing the antiparasitic drug on people with Covid.
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, […]
C.K. Wang, Chief Medical Officer of COTA, Inc. In April, FDA Commissioner Dr. Robert Califf laid out areas of challenge and opportunity when it comes […]
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 […]
Owkin has enticed another big pharma partner with its artificial intelligence-powered clinical development platform, Bristol-Myers Squibb, which is paying $80 million upfront to tap into […]
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 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 […]
For some patients with metastatic tumors not significantly affected by other forms of chemotherapy, the treatment halted their cancer’s growth.
El estudio era pequeño y los expertos dicen que hay que replicarlo. Pero para 18 pacientes oncológicos, el resultado produjo “lágrimas de felicidad”.
Taking steps to eliminate health disparities among people of color and ensuring diversity throughout the development cycle should be a strategic goal for all. Medical […]
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 […]
The study was small, and experts say it needs to be replicated. But for 18 people with colorectal cancer, the outcome led to “happy tears.”
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 […]
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 […]
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 […]
What You Should Know: – Akili’s EndeavorRx, the first and only FDA-cleared video game ADHD treatment for kids, is uniting with Roblox’s global virtual universes forming a first-of-its-kind partnership. – […]
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 […]
Josh Sackman, president and co-founder of AppliedVR, and Web Sun, president and co-founder of Komodo Health, relay how their newly formed collaboration reshapes the clinical […]
MDMA-assisted treatment for post-traumatic stress disorder “represents real hope for long-term healing,” health experts say.
In December, the FDA published a draft guidance providing its recommendations on the use of digital health data acquisition in clinical investigations, signaling that regulatory […]
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 […]
This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical […]
In the diverse world we live in, the products we produce, the services we create and the places we work should be as equally representative. […]
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 […]
Data is the powerhouse of the pharmaceutical sector. It powers drug discovery, clinical trials, and operational performance. But sizeable reservoirs of data remain unseen and […]
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. […]
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 […]
Kris Gustafson, Vice President and Global Head Patient Centered Technologies, IQVIA During the pandemic, electronic clinical outcomes assessments (eCOAs) gained prominence as sponsors looked for […]
What You Should Know: – Cerner, Elligo Health Research® and Freenome are collaborating to enable a clinical trial through the Learning Health Network to help advance early cancer detection. – Together they […]
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 […]
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 […]
Tener acceso a un medicamento experimental suele implicar procesos poco claros y decisiones éticas difíciles.
Tener acceso a un medicamento experimental suele implicar procesos poco claros y decisiones éticas difíciles.
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 […]
The limits of expanded access to experimental drugs.
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 […]
The limits of expanded access to experimental drugs.
Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.
Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.
Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.
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 […]
What You Should Know: – Osmind, a mental health EHR platform helping clinicians and researchers advance new life-saving mental health treatments, today announced a $40 […]
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 […]
Deboshree Sarkar, Product Marketing Manager, PDF Editor Product line at Foxit We live in an increasingly digital world. Across industries, companies and consumers have come […]
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 […]
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 […]
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’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 […]
INVEST PharmaTech Pitch Perfect virtual conference July 26 will give startups the opportunity to present their approaches to clinical trial innovation to a team of […]
Curebase has raised $40 million in second-round financing that will help it run more complex interventional trials for its biopharma clients, according to chief executive […]
A quick recap: Who are CDISC and what do they do? The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that aims to maximise the […]
The tests could prove useful in screening patients that coud benefit from therapies being tested for Alzheimer’s. But uptake will depend, in part, on reimbursement, […]
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 […]
Although it is well established that diversity improves outcomes and drives excellence, implementing diversity lags behind in many industries, including life sciences and healthcare. Diversity […]
The data have not yet been peer reviewed or published. But experts said the drug may give people with obesity an alternative to bariatric surgery.
The data have not yet been peer reviewed or published. But experts said the drug may give people with obesity an alternative to bariatric surgery.
The data have not yet been peer reviewed or published. But experts said the drug may give people with obesity an alternative to bariatric surgery.
The data have not yet been peer reviewed or published. But experts said the drug may give people with obesity an alternative to bariatric surgery.
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 […]
Ceryx’s device, Cysoni, is designed to pace the heart in rhythm with a person’s respiration, so that the heart rate and breathing are synced. This […]
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 […]
The data have not yet been peer reviewed or published. But experts said the drug may give people with obesity an alternative to bariatric surgery.
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 […]
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 […]
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 […]
Marc Leighton, VP of Product at Florence Healthcare Prior to COVID, major technological transformation initiatives were already underway at many clinical trial sites, sponsors, and […]
Moderna and the Pfizer-BioNTech partnership are developing versions of their coronavirus vaccines for children under 5, with emergency-use filings expected soon.
Moderna and the Pfizer-BioNTech partnership are developing versions of their coronavirus vaccines for children under 5, with emergency-use filings expected soon.
Kuldeep Singh Rajput, Founder & Chief Executive Officer of Biofourmis What You Should Know: – Biofourmis, a global leader in virtual care and digital medicine raises […]
Moderna and the Pfizer-BioNTech partnership are developing versions of their coronavirus vaccines for children under 5, with emergency-use filings expected soon.
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 […]
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 […]
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 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 […]
Reify Health has completed fourth-round financing that adds $220 million to its cash reserves and pushes its valuation up to a heady $4.8 billion, with […]
What You Should Know: – Reify Health, a leading provider of solutions that empower the clinical trial ecosystem, announced a $220M Series D funding round dedicated […]
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 […]
MedCity News is inviting all startups aiming to reinvent the clinical trials industry — that were founded in 2020 and earlier — to apply and […]
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 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 […]
In March 2020, Dr. Joseph Vinetz left the contemplative world of his Yale University infectious-disease laboratory and plunged into the covid ward at Yale New […]
Studies linked to Cassava Sciences, once a stock market favorite, have been retracted or challenged by medical journals.
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 […]
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 […]
The more rapidly we are able to produce safe, effective drugs for quick-spreading pathogens like the coronavirus, the more lives we can save.
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 […]
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 […]
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 […]
A late-stage trial was halted after strong early results, according to the company, but outside scientists have not yet seen the data.
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 […]
What You Should Know: – PathAI and GSK announced a multi-year strategic artificial intelligence (AI) partnership today with a focus on accelerating research and- building drug development programs […]
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 […]
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 […]
Officials cited data showing the new Alzheimer’s drug has serious safety risks and may not help patients.
What You Should Know: – Viz.ai, a San Francisco-based AI-powered disease detection and care coordination platform raises $1000M in Series D funding led by Tiger Global and Insight Partners. The round also […]
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 […]
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 […]
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 […]
The largest-ever study of genetics in Alzheimer’s disease patients has identified 42 new genes that appear to be linked to the neurodegenerative disorder. The new […]
What You Should Know: - Medidata, a Dassault Systèmes company, today announced that Labcorp, a leading global life sciences company, has selected Medidata’s technology platform to extend their 14-year partnership, the foundation of their initiative […]
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 […]
UK startup Sano Genetics has raised $11 million in first-round financing to develop its go-between service, which aims to overcome one of the big challenges […]
With a 6-4 vote, the group of independent advisers to the agency narrowly concluded that results from another clinical trial are needed to assess whether […]
“At some point it will become a waste of resources to continue studying an unpromising approach,” one expert said.
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 […]
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 […]
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 […]
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 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 […]
The direct recording and analysis of voice ensures that a more diverse range of patients is represented in clinical trials. This is crucial for effective therapeutic […]
Miruna Sasu, Ph.D., MBA, President & CEO at COTA, Inc. What You Should Know: – COTA, Inc., an oncology real-world data and analytics company, announced […]
The company said the vaccine produced a strong immune response in children younger than 6, but proved only about 40 percent effective in preventing symptomatic […]
What You Should Know: – Tempus, a provider of artificial intelligence and precision medicine, today announced the launch of Edge, an innovative platform that allows pathologists […]
What You Should Know: – Applied XL, a real-time information company tracking disruptions to the health of people, places, and the planet, today announced it […]
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 […]
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 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 […]
Venture Capital, Private Equity, Mergers & Acquisitions (M&A) Activity Glooko Acquires DIABNEXT® to Expand Diabetes Offerings in France Glooko, a leading provider of remote patient […]
Better Therapeutics reported that its digital therapeutic for type 2 diabetes met the main goal of a pivotal study. An FDA submission is expected in […]
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 […]
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 […]
A consortium led by the Digital Medicine Society (DiMe) has been set up to try to end inequities in access to clinical trials, focusing on […]
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 […]
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 […]
Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from […]
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 […]
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 […]
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 […]
If you listen to the nation’s largest Alzheimer’s disease advocacy organizations, you might think everyone living with Alzheimer’s wants unfettered access to Aduhelm, a controversial […]
The FDA approved drugs from Johnson & Johnson and CTI BioPharma in the past week. Complete response letters were issued to Gilead Sciences, Amryt, and […]
CancerIQ Co-Founders Feyi Olopade Ayodele & Olufunmilayo (Funmi) Olopade, MD What You Should Know: – CancerIQ, a Chicago-based platform powering early cancer detection and prevention across broad […]
David Karandish, CEO of Capacity The life of a clinical study relies on data from documentation, meetings, emails and calls; all of which can be […]
One year ago, a UK-wide vision for the country’s future research landscape promised streamlined processes, and a patient-centred, competitive environment. But how far have we […]
David Karandish, CEO of Capacity The life of a clinical study relies on data from documentation, meetings, emails and calls; all of which can be […]
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 […]
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 […]
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 […]
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 […]
Hong Kong-based Insilico Medicine has begun a Phase 1 trial of its AI-discovered and AI-designed anti-fibrotic small molecule inhibitor. Currently referred to as ISM001-055, the […]
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 […]
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 […]
What You Should Know: – EarliTec Dx, a digital health company developing novel diagnostic and therapeutic products for children with Autism Spectrum Disorder (ASD) and […]
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 […]
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 […]
What You Should Know: H1, a global healthcare professional data ecosystem to enable life sciences, academic medical institutions, health systems, and payors acquires London-based Faculty […]
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 […]
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 […]
It’s not clear whether three doses of the Pfizer-BioNTech vaccine will adequately protect young children. But the F.D.A. may authorize the first two doses anyway.
The agency will wait for data on whether three doses of Pfizer-BioNTech’s Covid vaccine are effective in young children after new, disappointing data.
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 […]
No está claro si tres dosis de la vacuna Pfizer-BioNTech protegerán adecuadamente a los niños. Pero es posible que la FDA autorice las primeras dos […]
No está claro si tres dosis de la vacuna Pfizer-BioNTech protegerán adecuadamente a los niños. Pero es posible que la FDA autorice las primeras dos […]
The panel debated whether overseas trials could be applied to a more diverse U.S. population. The decision may affect other Chinese drug trials, and spotlights […]
The panel debated whether overseas trials could be applied to a more diverse U.S. population. The decision may affect other Chinese drug trials, and spotlights […]
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 […]
CVS Health has said it will beef up its clinical trials operations, improving its ability to recruit patients from a broad demographic spectrum, via an […]
It’s not clear whether three doses of the Pfizer-BioNTech vaccine will adequately protect young children. But the F.D.A. may authorize the first two doses anyway.
In a competitive market, data that help companies find these critical resources can accelerate clinical trials and shorten time to market – sometimes by years.
What You Should Know: – Medable Inc., a Palo Alto, CA-based provider for patient-centered clinical trials, today launched the Medable Partner Network – uniting a diverse […]
“Diversity.” It’s a word that is very commonly thrown around right now, not just in pharma and healthcare but across all industries. No matter which […]
The rise in the use of decentralised clinical trial (DCTs) designs forced by COVID-19 looks set to outlast the pandemic, and digital health company Seqster […]
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 […]
CVS MinuteClinic providers will use Medable’s software platform to improve patient access, engagement and retention during clinical trials. Meanwhile, Thermo Fisher Scientific and Medidata Acorn […]
What You Should Know: – Medable and CVS Health announced a strategic collaboration that will make clinical research more accessible to patients of all demographics. […]
The last three years in pharma have seen a growing awareness of and dissatisfaction with a trend that has plagued the industry for its whole […]
From remote monitoring tech to enable clinical trials, to AI for drug discovery, to digital therapeutics and drugs with companion apps, digital innovation has 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 […]
Last year, Bayer launched a project to explore the use of artificial intelligence in clinical trials, working with Finland’s Aalto University to find ways to […]
Remote, virtual, or decentralised clinical trials are nothing new, but COVID-19 catapulted the model into the mainstream. Now, as the sector settles back into something […]
The MHRA has kicked off an eight-week consultation on proposals for changes to laws governing the conduct of clinical trials following the UK’s departure from […]
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