Taysha 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...
View ArticleThree healthcare SPACs reveal their IPO plans
SPACs might never fully go away if the ambitions of three new healthcare-focused shops have any sway. As initial public offerings are far and few between, and even reverse mergers have fallen by the...
View ArticleSamsung Bio and Baxter dial up manufacturing deal to $223M
Baxter Healthcare will pay Samsung Biologics an extra $208 million to manufacture certain drug products until the end of 2034 in a revised manufacturing contract. This is at least the third agreement...
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iOnctura raises €80M in Series B to advance rare eye cancer treatment
iOnctura has collected €80 million ($85.9 million) in a Series B round to support its lead cancer candidate through a Phase 2 test in uveal melanoma and expand its development to other indications. The...
View ArticleEli Lilly sues more compounders over ‘deceptive’ tirzepatide claims
Eli Lilly is filing a fresh round of lawsuits against medspas, wellness centers and other entities that it claims are selling compounded versions of its tirzepatide-based drugs Mounjaro and Zepbound....
View ArticleGilead tested an antibody many times. Āshibio salvages it, with $40M and...
Gilead had tested a humanized antibody called andecaliximab, or GS-5745, in close to 1,000 patients before giving up on it a few years ago. The company had multiple mid- and late-stage attempts in...
View ArticleAphaia targets prediabetes with oral glucose drug
The idea behind Aphaia Pharma is to treat metabolic disease early enough that patients don’t progress to a type 2 diabetes diagnosis. The company is developing an oral glucose treatment targeting...
View ArticleForbion's new €75M fund; Cara Therapeutics to cut workforce after trial failure
Plus, news about Cinclus Pharma, Biophytis and Blanver: Forbion’s new fund: The Dutch VC firm’s BioEconomy Fund I closed €75 million (about $80 million) to invest in sustainable startups across food,...
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Silence’s siRNA candidate for cardiovascular disease continues to deliver in...
Silence Therapeutics has unveiled additional data from a mid-stage trial of its siRNA therapy candidate in certain people at risk of heart episodes, setting the stage for potential registrational...
View ArticleFDA 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 $30 million
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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