FDA 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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Philips works on tech to connect disparate healthcare and bio-tracking devices
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) As more medical devices that measure biodata show up in the market, healthcare electronics giant Philips...
View ArticleAstraZeneca’s Truqap combo flops in Phase 3 triple-negative breast cancer trial
AstraZeneca’s Truqap failed to boost survival in a late-stage test in certain patients with triple-negative breast cancer, dealing a blow to the company’s efforts to expand the drug’s label. In the...
View ArticleMarea Therapeutics raises $190M in debut, targeting overlooked ANGPTL4 in...
A Third Rock Ventures-incubated startup called Marea Therapeutics debuted Tuesday with $190 million to advance a drug for a genetic target for cardiometabolic diseases. The San Francisco-based biotech...
View ArticleHow two academic chemists turned San Diego startup Iambic into an AI force
SAN DIEGO — In the first months of their startup’s existence, Tom Miller and Fred Manby sent an invitation to the research chemist and drug industry blogger Derek Lowe to join their scientific advisory...
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As it deepens immunology bets, Sanofi inks small molecule pact with Belharra
Belharra Therapeutics is riding the waves of Sanofi’s bid to become an “immunology powerhouse.” The California biotech — whose name derives from a famous surf break in France’s Basque region — will get...
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Roche strikes neuro-focused partnership with RNA exon editing startup Ascidian
Roche has tapped a small Boston startup for access to a sweeping form of RNA editing that replaces large swathes of errant genetic code. Broadly known as RNA writing, scientists have said the...
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Hikma to take over several assets from Xellia, including a US manufacturing site
Generic drug company Hikma is bolstering its portfolio by acquiring parts of Xellia Pharmaceuticals’ finished dosage form business in the US. This includes Hikma taking on a manufacturing site as well...
View ArticleA new obesity biotech; UroGen aims to raise $107M
Plus, news about Otsuka, Ionis, Ability Biologics, Santhera, Mustang Bio and Vaxart: New biotech joins obesity race: Supercede Therapeutics raised an undisclosed seed round from an unnamed investor to...
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Day One enters ADC field, going after a target that once attracted AbbVie and...
Shortly after securing its first FDA approval and bagging $108 million from a priority review voucher sale, Day One Biopharmaceuticals is entering the hottest pocket of oncology drug development —...
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After two patient deaths from presumed sepsis, FDA puts partial hold on...
The FDA put three clinical studies of Zentalis’ WEE1 inhibitor on partial hold following two patient deaths likely from sepsis in one study earlier this year. The two patients were part of the Phase 2...
View ArticleTaysha teases early gene therapy data for Rett syndrome
Taysha Gene Therapies’ treatment candidate for Rett syndrome has shown hints of efficacy in a handful of adult and pediatric patients enrolled in two early-phase clinical trials. The treatment, dubbed...
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Intra-Cellular reports a depression win, setting up future competition with...
Intra-Cellular Therapies has nailed a second Phase 3 study testing its antipsychotic medication Caplyta as an adjunctive treatment for major depression. Next, it plans to go to the FDA in the second...
View ArticleTeva and US government discuss settling kickback lawsuit over Copaxone
Teva and the US government are in talks to settle a lawsuit against the company alleging a kickback scheme for its blockbuster multiple sclerosis drug Copaxone. In court documents filed over the...
View ArticleFTC backs plan to target more patent settlements it sees as anticompetitive
The Federal Trade Commission on Tuesday offered up support for a proposed rule from the US Patent and Trademark Office that could help regulators more closely track pharma patent settlements that might...
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FDA loosens side effect reporting requirements for some CAR-T therapies
The FDA is no longer requiring the reporting of two common — and sometimes serious — side effects for a handful of CAR-T therapies in an effort “to minimize the burden on the healthcare delivery...
View ArticleInternational society criticizes Utah law for permitting unapproved stem cell...
The International Society for Cell and Gene Therapy is pushing back against a Utah law that allows healthcare providers to treat patients with placental stem cell therapies that haven’t been approved...
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AbbVie adds ulcerative colitis to Skyrizi label
The FDA approved AbbVie’s Skyrizi to treat moderate to severe ulcerative colitis, adding another indication to the immunology drug’s arsenal. Rick Gonzalez AbbVie has said that UC patients make up...
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