FDA revises guidance on biosimilar promotional labels and advertising
Following a recent move to ask Congress to eliminate the interchangeability designation for biosimilars, the FDA on Wednesday proposed updated guidance on the labeling and advertising of biologics and...
View ArticleEsteve to acquire Perrigo's rare disease pharma business for up to $295M
Perrigo announced Thursday that Barcelona-based pharma company Esteve Healthcare has agreed to purchase its three rare disease drug assets for as much as €275 million ($295 million). The marketed...
View ArticleIn rare move, Colombia issues compulsory license for HIV medicine in effort...
The Colombian government on Wednesday issued a compulsory license for a commonly used drug to treat HIV, the first time the government there has stepped in to manufacture a drug without the drugmaker’s...
View ArticleGilead leans on CymaBay liver drug, Trodelvy readouts and long-active PrEP...
Gilead Sciences notched “fine” sales for the first quarter but the biopharma promised more to come. Gilead reported sales of $6.6 billion, a 5% increase year-over-year, prompting Mizhuo analysts to...
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UCB makes major management changes; Bristol Myers’ ADC partner tops list of...
Iris Loew-Friedrich → UCB is shaking up its leadership team “to better align with its commitment to growth and innovation, and to better address the dynamic external landscape of the healthcare...
View ArticleFDA approves Pfizer’s hemophilia B gene therapy
Pfizer announced Friday morning that the FDA approved its gene therapy for the rare genetic bleeding disorder hemophilia B. The one-time treatment, known generically as fidanacogene elaparvovec, is...
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Cigna’s Evernorth just made a move to boost Humira biosimilar use
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Cigna’s health services arm Evernorth said on Thursday that it plans to offer a cheaper copycat of...
View ArticleOphthalmic biotech raises $16.5M; Pfizer’s AI collaboration bears fruit
Plus, news about Biodexa Pharmaceuticals: RevOpsis Therapeutics secures $16.5M seed round: The San Carlos, CA-based biotech will use the funds to complete IND-enabling studies for its lead candidate,...
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The next generation of AI biotechs is here. Can they deliver on the hype?
“We’re in a frothy time,” acknowledges Alexandra Snyder, the head of R&D at Generate:Biomedicines. Generate is one of the AI-driven biotechs that make up a new generation of companies with huge...
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AbbVie beats first-quarter expectations, but Humira guidance leaves analysts...
AbbVie’s effort to protect Humira’s market share is getting expensive. On Friday, the company announced a 40% decline in the megablockbuster drug’s US sales for the first quarter. While it managed to...
View ArticleBristol Myers to shutter Bay Area cell therapy facility as it eliminates jobs...
Bristol Myers Squibb is closing a cell therapy manufacturing site in California as the company implements a $1.5 billion cost-cutting program that was announced this week, according to a company...
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Ipsen matches rare disease and TikTok influencers to create connections
Ipsen’s new sponsored TikTok features the popular “Of course” trend and two social influencers, but with a rare disease twist. The short video shows two young women, Carli and Erin, using the familiar...
View ArticleSanders presses pharma leaders to change stance on Pandemic Accord proposals
Sen. Bernie Sanders (I-VT) is calling on global pharmaceutical leaders to get behind proposals laid out in a World Health Organization-led global pandemic preparedness agreement that’s nearing...
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FDA greenlights label update to Gilead's Biktarvy to include more data in...
The FDA on Friday approved a label update on Biktarvy, Gilead’s blockbuster HIV drug, to include more data on the drug’s safety and efficacy for pregnant people with HIV. The additional data reflected...
View ArticleCHMP recommends eight new drug approvals, six label expansions
It was a positive week for the European Medicines Agency’s human medicines committee (CHMP), which recommended the approval of eight new drugs including Takeda’s Fruzaqla and AstraZeneca’s Truqap. The...
View ArticleBristol Myers eyes major cuts; That $1B AI startup; Pharma reacts to China...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
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Sanofi and Regeneron debut next generation in Dupixent's asthma campaign
The leading TV ad-spending drug brand is getting a campaign refresh for one of its indications. Sanofi and Regeneron renewed the effort for Dupixent in asthma with light-hearted humor around everyday...
View ArticlePharma reputation slips among patient advocacy groups, according to annual...
Patient advocacy groups’ perception of pharma companies fell for the first time since beginning a steady rise five years ago, a sign that the industry may not be able to fully hang on to the improved...
View ArticleMerck touts updated 21-valent pneumococcal data weeks ahead of FDA decision:...
Merck bolstered its pneumococcal vaccine data on Monday, as the company looks to one-up Pfizer’s Prevnar 20 shot. Merck said that its new conjugate vaccine, called V116, proved noninferior to its much...
View ArticleNovo Nordisk's once-weekly insulin will face FDA adcomm in May, following...
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet on May 24 to discuss Novo Nordisk’s application for a once-weekly insulin. The drug candidate, insulin icodec, is designed to...
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