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921 stories matching this filter · ← front page

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  • Updated: BlossomHill and Latigo join flourishing IPO queue with cancer, pain drugs
    Last summer, zero biotechs made it onto the public markets as the industry weathered a seven-month dry spell for initial share sales. This time around, it's a summer IPO party as six
    Endpoints · 10d ago↗ source
  • Compounders maintain a firm grip on the GLP-1 market
    <figure><div><img src="https://imgproxy.divecdn.com/lCVH-hvKf5LWLXT4PQ6NchaxlwaNHmtv86eTe3TlyQU/g:nowe:0:107/c:2500:1412/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlc…
    BioPharma Dive · 10d ago↗ source
  • GSK shelves cough drug acquired in $2B deal
    <figure><div><img src="https://imgproxy.divecdn.com/mDk-h3NLB8udDPFuDlI7IPou1i9tJKJYucQXUnhK9vA/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMTc3MzEzMjc4LmpwZ…
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BioPharma Dive · 10d ago
↗ source
  • How well are AI-discovered drugs faring in the clinic?
    <figure><div><img src="https://imgproxy.divecdn.com/FF7gugutgjWeeCEjeDD3aQdzLpVn2Dsf1iRhZmSXUf0/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy02Mzk2MTIwODRfMS5qc…
    BioPharma Dive · 11d ago↗ source
  • GSK culls cough program for drug at the heart of $2B Bellus bet after Phase 3 fail
    Camlipixant, which GSK picked up in its $2 billion buyout of Bellus Health in April 2023, “is unlikely to transform patient care,” the pharma said.
    BioSpace · 11d ago↗ source
  • Insmed moves closer to $6B opportunity as PAH drug shows long-term durability
    Insmed’s inhalable candidate showed “impressive” long-term efficacy in pulmonary arterial hypertension, according to analysts at Guggenheim Partners, with functional and biomarker improvements thro…
    BioSpace · 11d ago↗ source
  • FDA disavows Makary, Prasad’s papers as lawmaker blasts ‘shoot-from-the-hip’ policymaking
    Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Ener…
    BioSpace · 11d ago↗ source
  • GSK drops Phase 3 chronic cough drug in a blow to $2B Bellus Health buyout
    In a major stumble for GSK’s $2 billion acquisition of Bellus Health, the UK pharma said Friday it is ending development of camlipixant in refractory chronic cough (RCC) after the drug ...
    Endpoints · 11d ago↗ source
  • Zealand Pharma gets its US marketing leader from Lilly; Bexorg turns to Biohaven for CSO hire
    → Silvia Luque announced on LinkedIn that she was named head of US marketing at Zealand Pharma after 13 years in various roles at obesity competitor Eli Lilly. She had been ...
    Endpoints · 11d ago↗ source
  • Experts: Ending adequate provision would shut down prescription drug ads
    <p>The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the…
    raps · 11d ago↗ source
  • Industry wants more clarity on NGS for assessing gene therapy safety
    <p>The pharmaceutical industry has largely endorsed the US Food and Drug Administration's (FDA) guidance on next-generation sequencing (NGS) for assessing the safety of human gene therapy products.…
    raps · 11d ago↗ source
  • This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, and more
    <p>Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This…
    raps · 11d ago↗ source
  • Mirador unveils part of pipeline with drug from Kira to rival Tavneos
    Mirador Therapeutics, the secretive immune disease biotech with more than $650 million in VC funding, is finally revealing a piece of its pipeline. The San Diego biotech said Thursday it reached…
    Endpoints · 11d ago↗ source
  • Lilly to buy AtaiBeckley for $2.8B, further validating psychedelics
    <figure><div><img src="https://imgproxy.divecdn.com/tzaRDX3CbhReY4UgPVj2iCgN5MzQ9V_AQf0Jo1lvCvY/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy05OTEzMjk1ODQuanBn.…
    BioPharma Dive · 11d ago↗ source
  • What health system execs are talking about
    Earlier this week, I swung by the American Hospital Association’s Leadership Summit in downtown Denver. When I wasn’t giving out ice cream recommendations, I was trying to get a sense of what hos…
    Endpoints · 11d ago↗ source
  • Veradermics keeps ‘momentum going’ as baldness drug helps women with hair loss
    <figure><div><img src="https://imgproxy.divecdn.com/1t2735bLf2pFiAc5XoslOwKIkl5O8g-p7viDbIw1C94/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMjA2NDE3NzE0LmpwZ…
    BioPharma Dive · 11d ago↗ source
  • Kelun pads efficacy profile of Merck-partnered ADC; Europe will have to wait for Boehringer's Hernexeos
    Plus, news about Vogenx and Orakl Oncology. 🇨🇳 Kelun touts China data for sac-TMT: Kelun-Biotech announced on Tuesday that its Merck-partnered antibody-drug conjugate sacituzumab tirumotecan su…
    Endpoints · 11d ago↗ source
  • Q&A: Betty Tijms wants to stop treating Alzheimer’s as a single disease
    LONDON — For more than a century, scientists studying Alzheimer’s have largely focused their efforts on two proteins — amyloid and tau — that clearly accumulate in the disease. But not everyone wit…
    Endpoints · 11d ago↗ source
  • US drug shortages rise for third straight quarter, hurt by lone suppliers
    The number of drugs in shortage in the US rose for a third straight quarter, a situation complicated by the fact that almost half of the medicines in tight supply rely only on a single ...
    Endpoints · 11d ago↗ source
  • FDA’s first AI-focused cGMP warning letter signals new scrutiny for manufacturers
    The FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversigh…
    BioSpace · 11d ago↗ source
  • Lilly makes up to $3.8B psychedelics play in AtaiBeckley takeover
    With the AtaiBeckley acquisition, Eli Lilly is jumping into psychedelics, a drug class that Jefferies analysts say could herald the “biggest change” for the field of psychiatry.
    BioSpace · 11d ago↗ source
  • Merck wins first approval of a PCSK9 cholesterol pill
    <figure><div><img src="https://imgproxy.divecdn.com/fBH5yVoS6G-IUV5sTGP2zy7wuLAX60VYZCXs0QOEVRo/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9TY3JlZW5zaG90XzIwMjItMDctMjRfMS40M…
    BioPharma Dive · 11d ago↗ source
  • Merck dives into cholesterol with first FDA approval for oral PCSK9 inhibitor
    Merck’s once-daily pill is the first oral PCSK9 inhibitor to hit the market for high cholesterol, beating AstraZeneca in the race to develop more accessible treatment options.
    BioSpace · 11d ago↗ source
  • Braveheart, Attovia, Vogenx keep IPOs ballooning with plans to compete in cardiometabolic, immuno
    Braveheart Bio is looking to take on Bristol Myers Squibb in hypertrophic cardiomyopathy, while Attovia Therapeutics wants to challenge Sanofi and Regeneron’s Dupixent. Vogenx, meanwhile, is lookin…
    BioSpace · 12d ago↗ source
  • The future of pain relief: Exploring opioid alternatives
    In this episode of Denatured, you’ll hear from Lance Alstodt, chairman and CEO at Biorestorative Therapies, and Paul Mieyal, chief business officer at South Rampart Pharma. We explore why pain has…
    BioSpace · 12d ago↗ source