FDA sends warning letter to Indian drugmaker after finding glass in injections
Indian generic manufacturer Zydus Lifesciences was hit with an FDA warning letter on Tuesday after it shipped vitamin B injections containing glass particles. An inspection from April 15 to April 23 at...
View ArticleCongress spars over whether the Biosecure Act is an overdue crackdown or a...
After the House of Representatives passed a bill to ban biotech and pharma companies from working with a handful of Chinese contractors, opponents of the legislation are raising new questions about the...
View ArticleGilead partners with AI startup Genesis Therapeutics to make small molecule...
A well-funded California biotech startup using AI to design and improve small molecule drug candidates has just struck its third pharma partnership in four years. Gilead announced a new preclinical...
View ArticleCorrected: Optum’s biosimilar business to go after brand-name Humira, Stelara...
Optum Rx is moving into the biosimilar business with a company it’s calling Nuvaila, and it’s starting out with biosimilars to AbbVie’s blockbuster rheumatoid arthritis drug Humira and J&J’s...
View ArticleAdicet follows other cell therapy biotechs in autoimmune pivot
Adicet Bio is shelving plans to use its lead asset to treat cancer and instead shifting its target to autoimmune diseases. The move, disclosed by the cell therapy-focused biotech in an SEC filing...
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BridgeBio ends development of gene therapy for adrenal gland disorder
BridgeBio said Tuesday night it won’t move forward with a gene therapy for a group of genetic disorders that impair adrenal glands and cause disruptions in producing cortisol. Neil Kumar The California...
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Sanofi, Regeneron to refile Dupixent for skin condition after new study win
The FDA issued a rare rejection for Sanofi and Regeneron’s Dupixent about a year ago, asking for more efficacy data before it would approve the biologic blockbuster to treat a skin condition marked by...
View ArticleGSK discontinues herpes therapeutic vaccine after Phase 2 disappointment
GSK is ending further development of its therapeutic vaccine for herpes after the candidate failed to prevent recurrent symptom flare-ups in infected adults in a mid-phase trial. The vaccine, known as...
View ArticleRadiant Bio snags $35M for antibody platform, with GSK and Regeneron...
A drug developer aiming to create more potent, effective antibodies unveiled a $35 million Series A on Wednesday with the support of the Bill & Melinda Gates Foundation and Canadian VC firm...
View ArticleNovo Nordisk's oral amycretin could lead to more weight loss beyond 12 weeks,...
Novo Nordisk touted more data for its oral amycretin, noting that subjects had not reached a plateau in their weight loss at the end of the early-stage trial. The Danish company previously teased...
View ArticlePanTera raises €93M to ‘radically improve supply’ of actinium for...
A radioisotope producer that has Bayer in its client list has raised €93 million ($103 million) in a Series A raise to build its first commercial manufacturing facility. Isotope manufacturer PanTera’s...
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Sanofi, Regeneron prep another FDA submission for Dupixent, this time for a...
Sanofi and Regeneron’s Dupixent hit all endpoints in a trial evaluating the IL4 and IL13 inhibitor in patients with bullous pemphigoid, a rare skin condition that can cause itching and large blisters....
View ArticleFormer Verily execs launch effort to transform clinical trials
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Two former top Verily execs have started a company that aims to improve clinical trials by advancing new...
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Innovent Biologics highlights subgroup of lung cancer patients in early-stage...
Innovent Biologics reported Monday that 20.8% of advanced lung cancer patients saw their tumors shrink at least 30% after receiving an experimental bispecific antibody that’s meant to boost T cell...
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Sanofi opens ‘world first’ modular vaccines and biologics factory in France
Sanofi has completed construction of a so-called modular facility in France that the company said can quickly switch manufacturing processes that would traditionally take months to complete. The...
View ArticleFDA drafts new strategy to boost the use of advanced manufacturing tech
The FDA on Wednesday unveiled the outline of its plans to support the use of new drug manufacturing technologies, part of the agency’s commitments under the latest user fee program. The seven-page...
View ArticleFDA is poised to pull Ocaliva as adcomm documents question post-approval...
The FDA appeared ready to pull its accelerated approval of Alfasigma and Intercept Pharmaceuticals’ rare liver disease drug Ocaliva, bluntly laying out its rationale in briefing documents ahead of...
View ArticleFDA criticizes AbbVie's 'misleading' ad with Serena Williams
The FDA’s Office of Prescription Drug Promotion sent a letter to AbbVie late last month, calling out the company for what it said was a misleading migraine drug television advertisement, and for using...
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Novo Nordisk's longstanding GLP-1 reduced BMI by 7% in children in Phase 3 trial
Novo Nordisk said children between the ages of 6 and 12 saw a 7.4% reduction in BMI over about a year in a late-stage trial investigating its weight loss drug Saxenda in a pediatric population. The...
View ArticleCVS says it won't correct congressional testimony
The head of CVS Health’s PBM unit won’t correct testimony given to Congress, the company’s lawyers said in a letter to the House Oversight Committee, arguing that the executive’s comments were...
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