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Takeda budgets $230M for plasma therapy facility expansion in California
As a part of Takeda’s larger plan to boost production of its plasma-derived therapies, the company is allocating $230 million to expand its manufacturing site in Los Angeles. Giles Platford The site...
View ArticleCBER chief floats rare disease hub to better communicate across centers
SAN DIEGO – The FDA’s biologics center director Peter Marks said the agency is considering the creation of a rare disease hub to better combine the expertise of both its drug and biologics experts....
View ArticleFDA to pharma companies: Using CRO Synapse's studies 'unacceptable'
The FDA is not holding punches against India-based CRO Synapse, saying that studies conducted by the group are “unacceptable” due to data integrity issues and should not be used by pharma sponsors. The...
View ArticleZealand Pharma hits early efficacy goal for amylin weight loss candidate
Zealand Pharma’s amylin analogue weight loss candidate petrelintide helped patients lose a mean 8.6% of their body weight in a Phase 1b trial, meeting executives’ early goals and setting the stage for...
View ArticleScientists just discovered a new genetic clue for delaying Alzheimer’s...
Research on one of the most famous families in neurology has shed new light on the interplay between Alzheimer’s disease and a rare gene that protects against it, as well as how that learning might one...
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Gilead's twice-a-year injection fully prevented HIV in Phase 3 study with...
There were no cases of HIV in over 2,000 cisgender women who received a twice-a-year preventive HIV injection developed by Gilead as part of a Phase 3 clinical trial. The data, announced Thursday...
View ArticleTectonic enters public markets in one of few biotech reverse mergers this year
Tectonic Therapeutic, a biotech from renowned entrepreneur and researcher Tim Springer, completed its reverse merger with gene therapy company Avrobio on Thursday and will begin trading as $TECX on...
View ArticleFDA widens Sarepta’s Duchenne gene therapy label to older boys in significant...
The FDA has broadened the label for Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy to patients ages 4 and older. The approval goes beyond the patient population in which the company...
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Moncef Slaoui joins board at mRNA biotech; Gamida Cell retools with ex-Amryt...
Moncef Slaoui → Moncef Slaoui has reemerged this week with another board appointment, making his way to mRNA drug developer Arcturus Therapeutics. Endpoints News scooped you last September on Slaoui’s...
View ArticleUS, EU pledge $2B+ to help boost vaccine manufacturing in Africa
Eyes were on Paris with the official launch of the African Vaccine Manufacturing Accelerator (AVMA) on Thursday. The EU is contributing €750 million to the accelerator, while the US is pledging $1.58...
View ArticleObesity care startup knownwell buys an AI weight loss platform
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) As more startups get into the business of treating obesity, one weight loss startup acquired another to...
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The Endpoints Slack interview: Saji Wickramasekara on where AI misses the...
As a 22-year-old undergraduate, Saji Wickramasekara followed a well-worn tech world script that remains nearly unheard of in biotech — he dropped out of MIT and co-founded a startup. Twelve years...
View ArticleLexicon resubmits type 1 diabetes drug to FDA five years after rejection
Lexicon’s type 1 diabetes drug is finally getting another shot at the FDA. The biotech announced Friday morning that it had officially resubmitted a new drug application for sotagliflozin following a...
View ArticleLayoffs at Ginkgo and Xellia; Melodia and Alivexis ink $275M partnership
Plus, news about Rapafusyn Pharmaceuticals: Ginkgo Bioworks lays off 158 employees: The cuts come after the Boston, MA-based biotech said last month it would ax its labor costs by at least a quarter....
View ArticleFDA ships two Form 483s to Dr. Reddy’s for two separate sites in India
Dr. Reddy’s Laboratories has received two FDA Form 483s in the past month for two different facilities, making a total of at least seven forms sent to the company in the past year. The two open Form...
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Bristol Myers wins approval for KRAS drug Krazati in colorectal cancer
Bristol Myers Squibb won accelerated approval on Friday to take its KRAS inhibitor to colorectal cancer patients. Krazati will now be available for use with Eli Lilly’s Erbitux (cetuximab) for certain...
View Article#ADA24: Lilly’s Zepbound resolves sleep apnea in some obese patients
ORLANDO — Eli Lilly said Zepbound helped at least 43% of patients with obstructive sleep apnea and obesity resolve symptoms of the breathing disorder in late-stage trials. At the American Diabetes...
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#ADA24: Three of Vertex’s islet cell therapy patients go insulin-independent
ORLANDO — Vertex Pharmaceuticals said a third patient in a Phase 1/2 trial assessing its islet cell therapy as a treatment for type 1 diabetes has been fully insulin-independent for at least a year....
View ArticleFDA's Peter Marks single-handedly approved Sarepta’s gene therapy — what does...
Is Sarepta special? Or has the FDA set a new precedent for how it approaches treatments for devastating diseases with few options? On Thursday, the FDA announced it was expanding the allowed use of...
View ArticleArgenx wins second FDA approval for Vyvgart in another autoimmune nerve disease
After a string of clinical failures, the Dutch biotech argenx landed a much-needed win on Friday when the FDA approved its autoimmune disease drug, Vyvgart, for a second rare condition. The disease,...
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