Corrected: 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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Roche says its Carmot-acquired obesity pill is effective in early study
Roche’s once-daily oral weight loss pill helped Phase 1 subjects lose up to 7.3% of their body weight within one month, which is less than competitors who measured the performance of their oral options...
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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J&J expands Tremfya into IBD with new FDA approval
The FDA has approved Johnson & Johnson’s IL-23 blocker Tremfya to treat ulcerative colitis, a boost to the pharma’s hopes that the drug will serve as a worthy follow-up to the blockbuster Stelara....
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Sanofi buys into radiopharmaceutical field with $110M upfront, going after...
While it’s put more emphasis on becoming an “immunology powerhouse” in recent quarters, Sanofi still shows signs of interest in oncology. On Thursday it announced licensing deals with the radiopharma...
View ArticleModerna plans $1.1B in R&D and program cuts, delays break-even point to 2028
Stéphane Bancel has relented to Wall Street’s desire for cost-cutting and reining in Moderna’s pipeline. To kick off its annual R&D day in New York, Moderna said Thursday that it will slash its...
View ArticleAura's infrared light-activated drug stops tumor growth and preserves vision...
Aura Biosciences said eight of 10 patients with a rare eye cancer who received a therapeutic dose of its experimental virus-like drug conjugate saw their tumors stop growing at one year. Of the 10...
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