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  • Premium subscribers invited to exclusive post-hoc Q1 earnings recap live event
    A live, post‑hoc session will be held for premium subscribers that reviews first‑quarter earnings across the pharmaceutical sector, with a particular focus on the deal activity reported in the call…
    Endpoints · 4mo agoNeutral↗ source
  • BMS's Krazati fails confirmatory colorectal cancer trial, jeopardizing its accelerated approval
    Bristol Myers Squibb said its drug Krazati did not meet the primary endpoint in a confirmatory study for second‑line colorectal cancer. The trial was required to verify the benefit that earned the…
    Endpoints · 4mo agoNegative readoutNegative↗ source
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  • House panel urges FDA to bar Chinese clinical trial data from drug applications
    A House spending committee introduced language urging the FDA to prohibit the use of clinical trial data generated in China when reviewing new drug applications. The proposal reflects concerns abo…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Merck remains optimistic on Terns leukemia drug despite new data
    Merck said Thursday that it still sees a compelling outlook for Terns' leukemia drug even after updated study data suggested it may be less differentiated. The updated data came from a trial of TE…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • UniQure to submit UK marketing application for Huntington's gene therapy AMT-130
    UniQure announced it will file a marketing application in the United Kingdom later this year for its gene therapy AMT-130 aimed at Huntington's disease. The filing follows a positive meeting with…
    BioPharma Dive · 4mo agoRegulatoryPositive↗ source
  • FDA oncology panel votes against AstraZeneca's camizestrant trial, citing lack of meaningful benefit
    The FDA's oncology advisory committee convened for the first time in about nine months and evaluated AstraZeneca's late-stage trial of its oral selective estrogen receptor degrader, camizestrant.…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Supreme Court hints at ruling in case over generics' use of skinny-label drugs
    Supreme Court justices have offered preliminary signals about how they may decide a contentious lawsuit that could reshape the way generic drug makers market products with "skinny labels". The cas…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Avalyn Pharma launches $300M IPO, selling 16.5 million shares at $18 each
    Avalyn Pharma, a Boston-based biotech, announced an initial public offering that aims to raise roughly $300 million. The company will sell more than 16.5 million shares at $18 per share and is set…
    Endpoints · 4mo agoDealNeutral↗ source
  • Court dismisses portion of Eli Lilly lawsuit against Empower Pharmacy, leaves some claims alive
    A federal judge ruled that part of Eli Lilly's lawsuit against Empower Pharmacy is dismissed. The suit alleged that Empower misled patients about its compounded versions of tirzepatide, an obesity…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Analysts focus on three programs in big year for Bristol Myers
    Wall Street’s expectations for Bristol Myers Squibb’s upcoming slate of data readouts are reaching a fever pitch. Analysts lobbed questions regarding at least half a dozen trial results expected by…
    Endpoints · 4mo ago↗ source
  • Lilly posts another ‘blowout quarter’ as focus turns to Foundayo launch
    A strong performance from Mounjaro overseas boosted Lilly’s results, and the company raised its guidance for the year for both profit and revenue.
    BioPharma Dive · 4mo ago↗ source
  • XTL Bio to acquire psychedelic biotech; WuXi AppTec’s Q1 revenue rise
    Plus, news about PCI Pharma: 🏭 XTL Bio steps into psychedelics: XTL Biopharmaceuticals is acquiring 100% of the outstanding shares of psychedelic-focused biotech Psyga Bio. XTL will gain Psyga’s m…
    Endpoints · 4mo ago↗ source
  • What we heard at a health tech conference in Boston
    I just came back from the Digital Healthcare Innovation Summit in Boston earlier this week, where I got a good look into what investors are thinking about. A few impressions: Investors see a ...
    Endpoints · 4mo ago↗ source
  • CVS' healthcare delivery chief eyes potential in clinical AI
    CVS Health has been testing AI tools that deliver healthcare, though it sees too many barriers to using them more widely for now. CVS' President of Health Care Delivery Sree Chaguturu told Endpoint…
    Endpoints · 4mo ago↗ source
  • Updated: Early sales of Lilly’s obesity pill appear to trail Novo’s
    About 20,000 people are taking Eli Lilly’s obesity pill Foundayo after its first 20 days on the market, according to the company’s CEO David Ricks. This points to a markedly slower launch of the dr…
    Endpoints · 4mo ago↗ source
  • The R&D 15: How pharma's top companies spent, won and lost on drug research
    Talking over pharma pipelines with a major drugmaker's development chief, he noted that if you looked at the biggest 50 drugs by revenue, the final one on the list brought in about $4 billion last ...
    Endpoints · 4mo ago↗ source
  • Novartis unveils North Carolina factory as final new build in $23B US expansion
    Novartis on Thursday revealed its plans to build another factory in the US, with the Swiss drugmaker noting that it has now allocated every dollar of its $23 billion promise to expand ...
    Endpoints · 4mo ago↗ source
  • Avalyn, in pursuit of better lung drugs, banks $300M in an IPO
    The biotech will use the proceeds to develop inhalable versions of therapies already on the market for the “idiopathic” and “progressive” forms of pulmonary fibrosis.
    BioPharma Dive · 4mo ago↗ source
  • AbbVie faces questions about Skyrizi competition from J&J
    Threats to AbbVie's immunology dominance took center stage on the company's first-quarter earnings call Wednesday morning, as analysts pressed executives on their defense strategy. The heart of the…
    Endpoints · 4mo ago↗ source
  • FDA, AstraZeneca prep for oncology adcomm
    The FDA is set to convene its first advisory meeting of oncology experts in about nine months, with a couple of AstraZeneca drugs as the focus of the discussion. Details about the meeting of the ...
    Endpoints · 4mo ago↗ source
  • Teva nabs experimental Tourette drug in $700M Emalex buyout
    A Jefferies analyst argued the deal — Teva’s largest in a decade — “makes sense” given the synergies between Emalex and the pharmaceutical giant’s neurology business.
    BioPharma Dive · 4mo ago↗ source
  • Chiesi to buy KalVista in $1.9B deal for rare disease drug
    The acquisition is the fifth of a biotech company so far this week and, according to some Wall Street analysts, proves pharma’s interest in new and emerging oral therapies for hereditary angioedema.
    BioPharma Dive · 4mo ago↗ source
  • Bristol Myers reaches a crossroads as a make-or-break year takes shape
    Bristol Myers Squibb is facing a bit of an identity crisis. CEO Chris Boerner is nearly two and a half years into his tenure, with most of his time defined by
    Endpoints · 4mo ago↗ source
  • Pfizer earns positive Phase 3 in multiple myeloma; ICON overstated revenue
    Pfizer’s positive Phase 3 data in multiple myeloma: The company’s Elrexfio produced a “statistically significant and clinically meaningful improvement” in progression-free survival in patients with…
    Endpoints · 4mo ago↗ source
  • FDA tests out ‘real-time’ clinical trials; AbbVie closes in on a KRAS biotech
    Through two pioneering studies, Amgen and AstraZeneca will share study data with FDA scientists as it’s accrued. Elsewhere, Lilly inked a gene editing deal and Pfizer reported success for a multipl…
    BioPharma Dive · 4mo ago↗ source