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  • Mammalian hair, roof leaks: Novo Nordisk's site in Indiana under FDA scrutiny once again
    Novo Nordisk’s troubled factory in Indiana that it got from Catalent continues to face contamination issues, with a re-inspection in April finding mammalian hair in finished drugs and water leaks t…
    Endpoints · 2mo ago↗ source
  • Hikma to funnel $267M to Ohio; Cingulate gets CRL for ADHD drug
    Plus, news about West Pharmaceutical, Stallergenes Greer and Curium: 🏭 Hikma’s US expansion: The generic drugmaker is investing $267 million in Ohio. Its existing factory in Columbus will get $216…
    Endpoints · 2mo ago↗ source
  • Lilly, Boehringer retrench in Germany on proposed health spending cuts
    Backlash is brewing against a sweeping overhaul of Germany’s health insurance system as Eli Lilly and Boehringer Ingelheim slash investment in the country. The drugmakers' cuts come after the Germa…
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Endpoints · 2mo ago↗ source
  • Supreme Court sides with Hikma in 'skinny label' case
    The Supreme Court unanimously sided with Hikma Pharmaceuticals and its “skinny label” version of a prescription-strength fish oil pill in a case that was closely watched by the generics industry. T…
    Endpoints · 2mo ago↗ source
  • Novo Holdings backs European fund; Alnylam sends second obesity drug into clinic
    Plus news about IMU Biosciences, Autobahn and Jade Biosciences. 💸 Novo Holdings invests in Europe-focused fund: The investment manager of the Novo Nordisk Foundation's fortunes is backing the Scal…
    Endpoints · 2mo ago↗ source
  • Alnylam, Inceptive ink AI deal potentially worth $2B
    The RNA-focused drugmaker says Inceptive's tools will help prioritize the best development options as well as speed up the research process.
    BioPharma Dive · 2mo ago↗ source
  • An ADC specialist sinks on safety concerns for blood cancer drug
    Shares for ADC Therapeutics fell more than 50% after a Phase 3 trial observed a death rate that at least one analyst believes “may be difficult to accept for physicians, patients and regulators.”
    BioPharma Dive · 2mo ago↗ source
  • Otsuka showcases kidney drug data; Pfizer cuts an AI deal
    Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
    BioPharma Dive · 2mo ago↗ source
  • Parabilis Medicines charts $413M IPO to back peptide pipeline
    Parabilis Medicines, the peptide biotech led by former Johnson & Johnson R&D head Mathai Mammen, is seeking more than $400 million in its Nasdaq debut. If the drug developer follows through with it…
    Endpoints · 2mo ago↗ source
  • ADC Therapeutics' confirmatory data for Zynlonta muddied by death rates
    ADC Therapeutics’ bid to secure full approval for Zynlonta in relapsed or refractory diffuse large B-cell lymphoma has been complicated by death rates in its confirmatory trial. The company said ...
    Endpoints · 2mo ago↗ source
  • ADC biotech Ona Therapeutics secures $86.6M in Series B raise
    Barcelona-based Ona Therapeutics has raised $86.6 million in a Series B round to advance two ADC candidates into the clinic. CEO Valerie Vanhooren told Endpoints News in an interview that the cash…
    Endpoints · 2mo ago↗ source
  • A Spanish biotech banks $87M to make differentiated ADCs
    Ona Therapeutics, a Barcelona-based drugmaker, is developing next-generation drugs it says could help patients with advanced forms of breast and colorectal cancers.
    BioPharma Dive · 2mo ago↗ source
  • Alnylam to pay $30M upfront to AI startup Inceptive in RNA R&D deal
    Alnylam Pharmaceuticals announced its first discovery-focused AI deal Wednesday, tapping a Silicon Valley biotech startup to see if AI can boost its R&D efforts. Alnylam and Inceptive signed a coll…
    Endpoints · 2mo ago↗ source
  • Bristol Myers turns focus to AI costs after broad rollout to workers
    PALO ALTO, CA — After giving artificial intelligence tools to thousands of employees, Bristol Myers Squibb is now working to get a handle on the costs of the technology and where it’s actually crea…
    Endpoints · 2mo ago↗ source
  • Axsome pushes back generic entry for narcolepsy drug until 2040
    Axsome Therapeutics has successfully delayed generic competition for its narcolepsy drug Sunosi until 2040. The company announced on Wednesday that it has reached a settlement with the last applica…
    Endpoints · 2mo ago↗ source
  • FDA guides pharma on explaining unapproved drugs to payors
    Biopharma companies preparing to launch the next practice-changing blockbusters want payors to know what's coming before they ultimately land an FDA approval. The trick is to do that without stretc…
    Endpoints · 2mo ago↗ source
  • Legend surges on early data for ‘in vivo’ lymphoma cell therapy
    Initial findings show that the therapy reduced or eliminated disease signs in all recipients, sparking hopes that the treatment might be competitive with “ex vivo” medicines like Novartis’ Kymriah.
    BioPharma Dive · 2mo ago↗ source
  • What it will take for more employer GLP-1 coverage
    Last week, Eli Lilly proclaimed that its weight loss shot and pill are now “covered for millions of Americans,” now that all three major pharmacy benefit managers have put the ...
    Endpoints · 2mo ago↗ source
  • House bill aims to crack down on China biotech deals
    A proposal to add biotechnology to the COINS Act follows two big deals involving Pfizer and Bristol Myers, and comes amid U.S. fears that China’s drugmaking progress may threaten national security.
    BioPharma Dive · 2mo ago↗ source
  • NewLimit’s $435M megaround; Lilly’s busy dealmaking week
    The anti-aging biotech has secured one of the year’s biggest venture fundings to bring its first drug into testing. Elsewhere, Lilly nabbed a “GLP-2” obesity drug and Praxis shares tumbled.
    BioPharma Dive · 2mo ago↗ source
  • Regeneron doubles down on CytomX after other pharmas walked away
    After losing a couple of pharma alliances in recent quarters, CytomX Therapeutics is getting a major lift from a key collaborator. Regeneron is doubling down on its partnership with the Bay Area bi…
    Endpoints · 2mo ago↗ source
  • Mineralys makes money moves before looming hypertension approval
    Mineralys Therapeutics first drew attention in 2021 with a bold bet on a new type of hypertension drug called lorundrostat. It came with a tiny $1 million upfront fee to the medicine's originator,…
    Endpoints · 2mo ago↗ source
  • Lilly strikes Ascidian deal worth up to $1.9B for RNA editing in kidney diseases
    Last month, Ascidian Therapeutics presented the first data suggesting a new way to fix broken genes may be safe in people. Now Eli Lilly has struck a deal with the startup. Ascidian’s ...
    Endpoints · 2mo ago↗ source
  • Lilly, Ascidian link up in RNA exon editing pact
    Worth as much as $1.9 billion, the deal directs Ascidian to help Lilly find potential drugs for genetically driven kidney diseases.
    BioPharma Dive · 2mo ago↗ source
  • Celcuity breast cancer drug misses ‘lofty’ expectations in ASCO-spotlighted trial
    Gedatolisib could “establish a new standard of care” for PIK3CA-mutated breast cancer, an investigator said, but the results nonetheless appeared to disappoint investors.
    BioPharma Dive · 2mo ago↗ source