FDA makes it easier for biosimilars to obtain interchangeability designations
The FDA on Thursday began easing the process for biosimilar developers to demonstrate interchangeability with their brand-name biologics. The agency previously required studies to prove that switching...
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PTC touts Phase 2 biomarker data for Huntington’s drug, showing...
PTC Therapeutics presented new biomarker data for a Huntington’s disease drug Thursday morning that it says demonstrates evidence of reducing the mutant huntingtin protein (mHTT) in patients’ systems,...
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Jazz's stock dips after mid-stage fail in essential tremor
Jazz Pharmaceuticals said Thursday that the highest dose of suvecaltamide failed a Phase 2b trial in essential tremor, a neurological condition that causes involuntary shaking. Patients who took a 30...
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Corrected: Emergent sells Baltimore facility for $30M
Emergent BioSolutions is selling off a Baltimore manufacturing site for $30 million to Bora Pharmaceuticals. Joe Papa “The decision to sell our Camden manufacturing facility is aligned with our...
View ArticleAnother fire breaks out at a Novo Nordisk site; Thermo Fisher earmarks $58M...
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. A fire broke out at a Novo Nordisk office building in Bagsværd,...
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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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