FDA OKs IntraBio's drug less than a week after rare disease's first-ever...
Within the span of a week, the FDA gave the green light to another drug for the rare condition Niemann-Pick disease type C in the form of IntraBio’s levacetylleucine. On Friday, the FDA approved Zevra...
View ArticleMerck's LAG-3 plus Keytruda combo fails Phase 3 in colorectal cancer
Merck’s efforts to combine its PD-1 blockbuster Keytruda with an experimental LAG-3 inhibitor hit a stumbling block Wednesday morning. The company said a Phase 3 study testing the LAG-3 program...
View ArticleSanofi inks deal with I-Mab; Wave discloses $175M offering on heels of DMD data
Plus, news about BioAge, Fulcrum Therapeutics and Arcutis Biotherapeutics: Sanofi snags Greater China rights to CD73 antibody: The French pharma will pay TJ Biopharma €32 million (or about $35 million)...
View Article#EADV24: Novo's semaglutide shows potential in chronic skin condition in...
A small study conducted by researchers at St. Vincent’s University Hospital in Dublin suggests that Novo Nordisk’s GLP-1 semaglutide could treat a common and chronic skin condition called hidradenitis...
View ArticleCelldex reveals Phase 2 responses for chronic hives drug and higher rates of...
Celldex Therapeutics has unveiled 52-week results from a mid-stage study of its anti-KIT drug in chronic hives, raising anticipation for ongoing registrational studies. But the company’s shares $CLDX...
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Emergent says it has $400M in orders related to mpox outbreak
Emergent BioSolutions has secured around $400 million worth of orders for its smallpox and monkeypox products, including its vaccine being used to help protect against a mpox outbreak in Africa. The...
View ArticleBaltimore sues Biogen, saying the company colluded with PBMs to minimize...
Baltimore’s mayor and city council have sued Biogen, alleging that the Boston-based drug developer worked with pharmacy benefit managers to suppress generic versions of a popular multiple sclerosis...
View ArticleEMA to discuss Pfizer's sickle cell drug Oxbryta after patient deaths
The European Medicines Agency will meet on Thursday to discuss Oxbryta — the sickle cell treatment Pfizer inherited in its $5.4 billion acquisition of Global Blood Therapeutics — following patient...
View ArticleUK watchdog criticizes Moderna for Covid-19 trial's use of WhatsApp to dangle...
The UK’s pharma marketing watchdog, the Prescription Medicines Code of Practice Authority, is taking issue with the way Moderna allegedly sought to increase participation in a Covid-19 vaccine trial...
View ArticleJ&J folds cardiovascular and metabolic drug unit
Johnson & Johnson is winding down its pharma division’s cardiovascular and metabolic unit, Endpoints News has learned. The decision primarily impacts the sales, marketing and medical affairs teams,...
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Pfizer pulls sickle cell drug from all markets after data review showed rise...
Pfizer said it will withdraw its sickle cell disease treatment Oxbryta from all markets worldwide, after data showed an “imbalance” of fatalities and complications common to the disease. The surprise...
View ArticleSIGA is 'deeply angered' by former exec's 'inaccurate' comments about mpox...
SIGA Technologies said former chief medical officer Jay Varma’s comments about the company’s experimental mpox drug are “inaccurate and misleading.” The infectious disease drugmaker had already fired...
View ArticleAGC Biologics to lay off 95 workers; Vertex taps Lonza to manufacture Casgevy
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. AGC Biologics said it is laying off a total of 95 staffers, which...
View ArticleUpdated: FDA adcomm votes to limit Opdivo, Keytruda use in stomach,...
The FDA’s Oncologic Drugs Advisory Committee on Thursday voted 10-2 with one abstention that Merck’s Keytruda and Bristol Myers Squibb’s Opdivo are not beneficial as a first-line treatment for stomach...
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Genentech's blood cancer drug Gazyva moves toward more indications in immunology
Genentech plans to expand the label for its CD20-targeting antibody Gazyva following positive late-stage data in an autoimmune disease that impacts the kidneys. In the Phase 3 REGENCY study, a higher...
View ArticleInsilico Medicine, an early force in AI-driven drug R&D, lets IPO plans peter...
One of the original AI-driven drug discovery and development biotechs has let its plans to list on the Hong Kong stock exchange lapse for the second time in as many years. Insilico Medicine, a...
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AstraZeneca's lung cancer blockbuster Tagrisso wins label expansion in...
AstraZeneca’s blockbuster lung cancer treatment Tagrisso scored a new FDA approval on Thursday in certain EGFR-mutated early-stage patients whose non-small cell lung cancer has not spread, but can’t be...
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FDA lifts hold on Biomea’s diabetes trials
The FDA lifted a clinical hold on two trials testing Biomea Fusion’s diabetes treatment. The news, announced Thursday, sent the company’s shares $BMEA up by about 4% to $9.11, inching closer to its...
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FDA approves Bristol Myers and Karuna's schizophrenia drug, in milestone for...
The FDA on Thursday approved Bristol Myers Squibb’s new schizophrenia drug in one of the year’s most anticipated regulatory decisions. The approval gives Bristol Myers a significant foothold in the...
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Endpoints 11 winner Seaport Therapeutics: The Karuna team is back with...
↑ CEO Daphne Zohar Total raised $100 million Headquarters Boston, MA On Thursday, members of Seaport Therapeutics’ founding team watched from afar as their old company, Karuna Therapeutics, got its...
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