Sanders 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...
View ArticleBristol Myers buys into Repertoire's autoimmune vaccines, giving new life to...
Flagship-incubated Repertoire Immune Medicines has lined up an autoimmune disease pact with Bristol Myers Squibb, marking the first major update from the well-funded startup in about two years. Bristol...
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Addex's J&J-partnered drug fails Phase 2 epilepsy study
The top experimental drug stemming from Johnson & Johnson’s long-running alliance with Addex Therapeutics has failed a Phase 2 epilepsy study, casting a shadow over its future. The candidate,...
View ArticleAstraZeneca, Daiichi Sankyo’s Enhertu claims another Phase 3 victory in...
Enhertu notched another win for AstraZeneca and Daiichi Sankyo that could see uptake moved slightly earlier in a specific subset of breast cancer patients. The Phase 3 DESTINY-Breast06 study set...
View ArticleFDA approves X4 Pharmaceuticals' pill for ultra-rare immune disease WHIM...
X4 Pharmaceuticals announced Monday morning that the FDA approved its daily pill for WHIM syndrome — an ultra-rare immune disease named after its symptoms. The pill, mavorixafor, was approved for...
View ArticleOno Pharmaceutical acquires Deciphera for $2.4B after biotech's Phase 3 win
Japanese drugmaker Ono Pharmaceutical is acquiring cancer-focused biotech Deciphera Pharmaceuticals for $2.4 billion, the companies announced Monday morning. The deal will see Ono acquire all...
View Article4P-Pharma raises €15M; Oncotelic Therapeutics sells rights to cancer assets
Plus, news about Adaptilens: 4P-Pharma secures €15M in second closing: The fundraise, which was backed by private investors, will be used to support the French biotech as it uses its “startup studio’s...
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WuXi wants to regain client confidence amid claims of IP transfer to Chinese...
WuXi AppTec said it has “unwavering commitment” to protecting its customer’s intellectual property, in the face of allegations it passed a US client’s information to Chinese authorities. Although the...
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Prime Medicine receives FDA clearance to run first prime editing clinical trial
The FDA has OK’d the first-ever human trial of prime editing, Prime Medicine announced Monday, opening the door for testing a new technology that backers hope will widen the array of diseases that can...
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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...
View ArticleFDA finalizes long-awaited rule to bring lab tests under its purview
The FDA on Monday finalized a long-awaited rule that outlines how it will regulate laboratory-developed tests (LDTs) as medical devices, even though some critics say the FDA is overstepping its...
View ArticleFDA converts Pfizer's Tivdak to full approval in cervical cancer
Pfizer’s new cervical cancer drug Tivdak has been converted from an accelerated to a full approval. The Seagen and Genmab-parterned drug, also known as tisotumab vedotin-tftv, was first approved via...
View ArticleFederal judge throws out two drugmaker IRA lawsuits in win for government
A New Jersey federal judge on Monday tossed cases brought by Johnson & Johnson and Bristol Myers Squibb against the Inflation Reduction Act, another victory for the law while Medicare works through...
View ArticleDNA sequencing firm PacBio to lay off workers and shutter San Diego office
Pacific Biosciences is letting go of 190 employees, according to the company, as part of cost-cutting measures after disappointing sales of its DNA sequencers. The company employed just under 800...
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