Biohaven’s SMA drug fails to produce statistically significant results in a...
A late-stage study testing the efficacy of Biohaven’s taldefgrobep alpha against a rare neuromuscular disorder has proved disappointing. The experimental treatment failed to meet statistically...
View ArticleThe now-urgent automation agenda: out-of-control regulatory workloads...
A new independent survey of senior US pharma regulatory professionals suggests that commitment to AI investment is much higher than might be expected, although some outdated perceptions could be...
View ArticleGE HealthCare to Acquire Japanese Radiopharmaceutical Business
Likely to be effective next year, GE HealthCare will assume full control of Nihon Medi-Physics (NMP), a Japanese diagnostic radiopharmaceuticals and molecular imaging agents producer. Earlier GE...
View ArticleNovocure’s Wearable Therapy Shows Promise in Treating Pancreatic Cancer,...
As part of a first-line treatment for patients with inoperable pancreatic adenocarcinoma—one of the most lethal forms of cancer—Novocure’s wearable therapy has demonstrated its ability to improve...
View ArticleNovartis Shells Out $1B Upfront to PTC For Midphase Huntington Program
Novartis has paid out $1 billion upfront for worldwide rights to PTC Therapeutics’ mid-phase Huntington’s disorder study, facilitating the biotech’s swift turnaround from unsatisfactory results on an...
View ArticleCarisma to undergo staff and clinical candidate restructuring to stretch cash...
Carisma, a Philadelphia-based biotech company, is undergoing significant restructuring to extend its cash reserves into the third quarter of next year. As part of this effort, the company is reducing...
View ArticleBioAge Halts Phase 2 Obesity Study Just Two Months After IPO
BioAge Labs, a recent success in the biotechnology IPO market, has made a surprising decision to discontinue its phase 2 obesity study, just weeks after its September Nasdaq debut. The California-based...
View ArticleCorcept’s ALS Modulator Fails to Meet Primary Endpoint in Phase 2 Study
After Amylyx and PTC, Corcept has also decided to withdraw from the amyotrophic lateral sclerosis (ALS) space. Results from its Phase 2 study, designed to assess the efficacy of its selective cortisol...
View ArticleFDA Identifies Further Safety Concerns With Intercept’s Liver Drug
The Food and Drug Administration (FDA) has uncovered additional safety concerns related to a medication used to treat a rare liver disease, casting further doubt on the prospects of a drug once...
View ArticleRo Partners With Eli Lilly to Offer Zepbound, a Weight-Loss Medication, in...
Ro, a direct-to-consumer health and wellness company, has announced a partnership with Eli Lilly to provide discounted single-dose vials of the weight-loss medication Zepbound. Through this...
View ArticleRoche’s Acquisition of Spark Falls Short as Another Therapy Exits Pipeline
Roche’s 2019 acquisition of Philadelphia-based gene therapy specialist Spark Therapeutics for over $4 billion is proving disappointing, as the company has discontinued another acquired therapy....
View ArticleNovo Nordisk to Invest $1.2 Billion in New Rare Disease Drug Facility in Denmark
Danish pharmaceutical giant Novo Nordisk announced plans to invest 8.5 billion Danish crowns ($1.2 billion) in a new facility in Odense, Denmark, dedicated to producing rare disease drugs. The site...
View ArticleEurope Approves Novo Nordisk’s Ozempic for Reducing Kidney Disease Risk
Danish pharmaceutical company Novo Nordisk has received approval from the European Medicines Agency (EMA) to expand the labeling of its diabetes medication Ozempic. The updated label will now include...
View ArticleFDA Restricts Imports from Viatris’ India Facility Amid Compliance Concerns
The U.S. Food and Drug Administration (FDA) has imposed restrictions on the import of 11 products manufactured at Viatris’ drug production facility in Indore, India. This decision, announced by Viatris...
View ArticleSanofi and SK bioscience advance their 21-Valent vaccine to Phase 3
Sanofi has announced a new step forward in its collaboration with SK bioscience, providing a €50 million ($52 million) upfront payment to propel their next-generation pneumococcal conjugate vaccine...
View ArticleFDA finally approves Novo Nordisk’s once-daily hemophilia medication
Novo Nordisk got a once-daily hemophilia injection cleared days before 2025. Novo reported that the FDA approved its tissue factor pathway inhibitor (TFPI) antagonist concizumab, as a once-a-day...
View ArticleSiteOne Therapeutics Secures $100 Million to Advance Non-Opioid Painkiller...
Fifteen years ago, as concerns about the growing opioid crisis began to emerge, a Maryland-based company, SiteOne Therapeutics, was founded with the aim of developing non-opioid alternatives for pain...
View ArticleFDA Lays Out Guidelines Regarding Pulse Oximeter Accuracy Across Skin Tones
To assist in ensuring that pulse oximeters function appropriately across all skin tones, the Food and Drug Administration (FDA) has released a series of much-awaited guidelines to the industry. The new...
View ArticleOculis’ Phase 2 Study Explores OCS-05 for Optic Nerve Inflammation
A phase 2 clinical trial has assessed the effectiveness and safety of OCS-05, a peptidomimetic small molecule developed by Oculis, for patients with optic nerve inflammation. The ACUITY study,...
View ArticlePortage packages Tarus’ adenosine receptor antagonists into new business
Over two years after taking over Tarus Therapeutics, Portage Biotech is reintroducing Tarus’ adenosine receptor antagonists through a new company headed by a previous executive. The spinout, known as...
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