CHMP recommends Regeneron, Novartis drugs that still await FDA approval
The European Medicines Agency’s human medicines committee (CHMP) has recommended four new drugs for approval, including Regeneron's Lynozyfic for the treatment of relapsed and refractory multiple...
View ArticleBipartisan 'pill penalty' fix and other bills vie for inclusion in...
Industry groups are looking to push government drug price negotiation and PBM reforms into a massive Republican domestic policy bill that will likely pass on party lines. PhRMA and a nonprofit ...
View ArticleAt least seven drugmakers say they will participate in round two of IRA...
More than half of drugmakers have agreed to participate in the second round of Medicare price negotiations amid ongoing legal battles and uncertainty surrounding the new administration’s stance on the...
View ArticleThe top 100 biotech investors; FDA vaccine meeting canceled; Can Bill...
Good morning and rabbit rabbit as we begin the month of March. It was another busy week in the world of biopharma so let’s jump straight into the headlines. John Carroll examined the last year ...
View ArticleICER finds GSK inhalers offer advantages over generics
The higher prices of two COPD inhalers from GSK that are targeted in the second round of government drug price negotiations are justified because of several advantages over generic competitors,...
View ArticleAfter Phase 3 depression setback, Neumora pauses two trials to make changes,...
Brain health biotech Neumora has stopped two of its Phase 3 trials in major depressive disorder to make adjustments after the first late-stage study unexpectedly failed at the beginning of this year....
View ArticleCallio emerges with $187M and ADCs from a decade-old Singapore biotech
Frazier Life Sciences and a cadre of well-known biotech investors are coming together for a new startup in the antibody-drug conjugates field, an area of cancer treatment R&D that has remained hot....
View ArticleNovo Nordisk signs $354M partnership with AI-guided biotech for ‘risky’ new...
Novo Nordisk has formed a $354 million research collaboration with Gensaic, the protein design company said on Monday, as the Danish pharma giant works to incubate new approaches in the metabolic ...
View ArticleGenentech's TNKase gets new approval; Sanofi gives up rights to oncology...
Plus, news about Nuvation Bio, Leqembi, IN8bio and Syros: Longtime clot-busting drug gets new approval: Roche and Genentech’s TNKase (tenecteplase) was approved Monday to treat acute ...
View ArticleNovartis licenses Kyorin’s preclinical chronic hives candidate for $55M upfront
Novartis is spending $55 million on global rights to Kyorin Pharmaceutical’s preclinical drug for inflammatory diseases in a deal that comes almost two decades after Novartis’ first pact with the...
View ArticleProtagonist, Takeda's profit sharing deal under spotlight after Phase 3 blood...
Protagonist Therapeutics reported a clean Phase 3 win on Monday for rusfertide — its rare blood disorder therapy — putting it on track for a fourth-quarter FDA submission. It also brings to the fore an...
View ArticleBiohaven’s ion channel drug fails pivotal bipolar mania study
Biohaven’s potassium channel drug has failed a late-stage study in bipolar mania, according to a statement in the company’s fourth-quarter earnings report. The Phase 2/3 study included an estimated 256...
View ArticlePliant calls it quits on Phase 2b IPF study
Pliant Therapeutics has officially discontinued a mid-stage study of its chronic lung disease treatment, less than a month after the trial's safety board recommended a halt. The South San Francisco...
View ArticleGSK, Amgen and AstraZeneca tout Phase 3 data in inflammatory nasal condition
GSK, Amgen and AstraZeneca released positive data supporting their rival drugs in a condition called chronic rhinosinusitis with nasal polyps, or CRSwNP. GSK’s depemokimab and Amgen and AstraZeneca’s...
View ArticleCerebral CEO David Mou has stepped down
The CEO of mental health startup Cerebral stepped down in December 2024, Endpoints News has learned. David Mou, who became CEO in May 2022, continues to serve in his previous post of chief medical...
View ArticleSofinnova Partners raises €1.2B to invest in life sciences
Sofinnova Partners has raised €1.2 billion ($1.26 billion) across its various investment strategies over the past year, the European life sciences investor said Tuesday morning, sharing its plans to...
View Article23andMe rejects CEO's second take-private offer
A special committee of 23andMe's board rejected CEO Anne Wojcicki's latest offer to take the company private. In her second attempt, Wojcicki — along with private equity firm New Mountain Capital —...
View ArticleNIH-backed research tries to use stem cells to restore the eye’s outer layer
Thirteen out of 14 people with eye damage experienced at least some improvements to their cornea after receiving a stem cell transplant in one eye in an early-stage study. The National Institutes of...
View ArticleUnitedHealthcare’s copay-only plan is booming, despite backlash over care...
Business is booming for UnitedHealthcare’s transparent-pricing health plan, as more companies consider offering alternative types of health insurance. The plan, called Surest, aims to fix a universal...
View ArticleBourla says Pfizer could transfer production to US to sidestep Trump's tariffs
Pfizer could “quickly” transfer operations from foreign sites to its US manufacturing network as a way to mitigate any impact from President Donald Trump’s tariffs, CEO Albert Bourla said. The pharma...
View Article