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FDA asks Covid-19 vaccine makers to instead target KP.2 strain for fall season
The FDA is directing Covid-19 vaccine manufacturers to update their formulations to target the KP.2 strain of the virus, citing higher circulation levels of that strain in recent weeks. Last week, the...
View ArticleBIO CEO’s patriotic pivot; Step forward for Lilly’s Alzheimer’s drug;...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticleGilead cancer drug magrolimab showed worrying trends around death
A Gilead cancer drug whose developments have essentially been halted not only failed to improve survival odds for blood cancer patients but also came with worrying safety risks — including a higher...
View ArticleWith new data, AstraZeneca makes the case for its BTK inhibitor in a...
Combined with chemotherapy and immunotherapy, AstraZeneca’s Calquence reduced the risk of disease progression or death by 27% compared to placebo and chemoimmunotherapy in first-line mantle cell...
View ArticleNurix’s protein degrader overcomes resistance to BTK mutations in small...
Preliminary results from a small study of heavily treated patients with blood cancer suggest that an experimental protein degrader, which removes problematic proteins instead of just inhibiting them,...
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Updated: Takeda’s Ovid-licensed drug fails two Phase 3 epilepsy studies
Takeda’s enzyme therapy soticlestat, which aims to balance brain cholesterol and reduce seizures, failed two Phase 3 trials in certain forms of epilepsy. Monday’s double whammy throws cold water on...
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Elion Therapeutics raises $81M Series B for antifungal treatment
Elion Therapeutics, a biotech focused on invasive fungal infections, has raised $81 million in a Series B funding round for its early-stage candidate, it announced Monday morning. The candidate, a...
View ArticleIt’s time to nominate your favorite private biotech for this year’s Endpoints 11
I’ve got a query for you today. Do you know a truly great private biotech out there with outstanding management, super science, ambitious and novel drug development plans, and the resources and backing...
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Aerovate’s stock craters after PAH drug fails Phase 2 study
Aerovate Therapeutics’ mid-stage treatment for pulmonary arterial hypertension failed to meaningfully improve patients’ blood pressure compared to placebo across three doses, sending the company’s...
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Marinus reports mixed Phase 3 results on IV seizure drug
Marinus Pharmaceuticals reported Monday that its IV drug met only one of two key endpoints in a Phase 3 study for prolonged seizures. In the Phase 3 RAISE study, 96 patients with refractory status...
View Article#EULAR24: J&J’s Sjögren’s disease drug shows promise in Phase 2, boosting...
Johnson & Johnson detailed positive data from a mid-stage trial in people with Sjögren’s disease that, according to some analysts, could be an encouraging signal for the FcRn inhibitor class that...
View ArticleUpdated: FDA places partial hold on BioNTech-MediLink ADC after multiple deaths
The FDA placed an early-stage BioNTech trial on partial clinical hold after researchers observed multiple deaths, the company said in an SEC filing Monday. Regulators told BioNTech partner MediLink...
View ArticleArgenx drops post-Covid syndrome program; Mirum picks a dose for bile duct...
Plus, news about Y-Biologics, Navigator Medicines, Spur Therapeutics, Disc Medicine and Mereo BioPharma: Argenx axes Covid-driven POTS program: The Dutch biotech’s efgartigimod did not meaningfully...
View ArticleJ&J cements footprint in Italy with €580M in investments over the next 5 years
Johnson & Johnson Innovative Medicine (JJIM), formerly known as Janssen, is earmarking €580 million ($622 million) in investments in Italy over the next five years. The company’s first step is to...
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Amgen nabs new Blincyto approval for certain type of leukemia
The FDA on Friday gave its stamp of approval to Amgen’s Blincyto to treat both adults and children with the most common type of acute lymphoblastic leukemia, marking the third indication for the drug....
View ArticleJanssen ordered to pay $150M over false claims around HIV drugs
A jury found J&J’s Janssen liable for $150 million in damages in New Jersey federal court last week, ruling that the company owed $120 million for violating the False Claims Act and $30 million for...
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Life sciences investor Decheng Capital targets $700M for fifth fund
After $900 million and $500-plus million fund closures last week from Foresite Capital and JP Morgan, respectively, another firm wants to enter the upper echelons of life sciences investing. Decheng...
View ArticleFDA approves endometrial cancer indications for Keytruda, Imfinzi
The FDA has granted two new endometrial cancer indications to rival immunotherapies: Merck’s Keytruda and AstraZeneca’s Imfinzi. On Monday, regulators approved Merck’s PD-1 blockbuster Keytruda in...
View ArticleGSK readies Blenrep's commercial re-launch in the US, and a push in second line
GSK is gearing up for the revival of multiple myeloma drug Blenrep, having hung onto the salesforce that was assembled when the drug first nabbed accelerated approval in 2020, only to be pulled after a...
View ArticleMerck's 21-valent pneumococcal vaccine for adults wins FDA approval
Merck’s 21-valent pneumococcal vaccine was approved by the FDA on Monday, bringing a new competitor to market for Pfizer’s 20-valent product. Merck’s vaccine, called Capvaxive, was specifically...
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