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  • House panel calls to ban China data from FDA drug trial applications
    A powerful spending committee in Congress wants the FDA to ban the use of clinical trial data from China in future applications by drugmakers to test new treatments. The language was
    Endpoints · 3mo ago↗ source
  • Court dismisses part of Lilly lawsuit against Empower, some claims can proceed
    A federal judge has dismissed part of Eli Lilly’s lawsuit alleging Empower Pharmacy misled customers about its compounded versions of the obesity drug tirzepatide. But the court said some of Lilly’…
    Endpoints · 3mo ago↗ source
  • Supreme Court questions how far generics makers can go with 'skinny label' drugs
    WASHINGTON — Supreme Court justices gave a few hints about how they intend to rule in a divisive case for the pharmaceutical industry. In its final argument scheduled for this term, the high court…
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Endpoints · 3mo ago
↗ source
  • Merck still sees ‘compelling’ outlook for Terns leukemia drug
    Despite updated study data that suggest Terns’ treatment may be less differentiated, company executives claimed Thursday that it still could be an important step forward in care.
    BioPharma Dive · 3mo ago↗ source
  • UniQure, in ‘symbolic’ win, to seek UK approval of Huntington’s gene therapy
    News of the submission, which would be the first for UniQure’s closely watched treatment, comes as the therapy faces an uncertain future in the U.S.
    BioPharma Dive · 3mo ago↗ source
  • Avalyn's upsized IPO; Alector ends another study in GSK partnership
    🔔 Avalyn Pharma’s $300M IPO: The Boston, MA-based biotech is selling over 16.5 million shares at $18 apiece. The company is set to start trading as {$AVLN} on the Nasdaq Thursday ...
    Endpoints · 3mo ago↗ 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo ago↗ source
  • After Apellis deal, Biogen looks to fill early-stage pipeline
    Biogen is still looking at deals even after earmarking $5.6 billion to buy Apellis Pharmaceuticals earlier this month. “Most of what we're going to be focusing on is early-stage development and res…
    Endpoints · 3mo ago↗ source
  • AstraZeneca rekindles UK relationship, pledges £300M to expand
    AstraZeneca and the UK government are back in each other's good graces. AstraZeneca on Wednesday said it is lifting its UK investment pause, with a £300 million budget to finish construction of a n…
    Endpoints · 3mo ago↗ source
  • Chiesi signs $1.9B deal to acquire KalVista and its approved drug
    Chiesi is buying commercial biotech KalVista Pharmaceuticals for about $1.9 billion in an extension of the industry's vigorous spring shopping spree. The Italian pharma will pay $27 per share {$KAL…
    Endpoints · 3mo ago↗ source