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  • 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 · 12d 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…
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BioSpace · 12d ago↗ source
  • J&J sees Spravato sales surge as psychedelic competitors loom
    Psychedelics, chiefly Compass Pathways' COMP360, are unlikely to make an immediate dent in the sales of Johnson & Johnson’s depression drug Spravato, H.C. Wainwright’s Patrick Trucchio told BioSpace.
    BioSpace · 12d ago↗ source
  • Updated: Sanofi, Arbutus file separate suits against mRNA vaccine makers over LNP tech patents
    Sanofi and Arbutus are each going to court over alleged violations of their respective mRNA delivery patents, adding to a growing list of companies making similar complaints. The French pharma is s…
    Endpoints · 12d ago↗ source
  • Lilly bets $2.8B upfront on psychedelics in deal to buy AtaiBeckley
    Eli Lilly said on Thursday it will buy psychedelic drug developer AtaiBeckley for $2.8 billion upfront, in a move that further spotlights big pharma’s increasing interest in the space after years o…
    Endpoints · 12d ago↗ source
  • Updated: Merck beats AstraZeneca to approval for first PCSK9 pill
    As in football, so in pharmaceuticals: The English have been beaten. Merck has outpaced AstraZeneca in the race to get the first US approval for an oral form of a particular kind of cholesterol-low…
    Endpoints · 12d ago↗ source
  • Takeda’s zasocitinib proves ‘top-notch’ for difficult-to-treat psoriasis in phase 3 update
    Takeda has unveiled more data from its phase 3 trials of zasocitinib, demonstrating that the once-daily pill was able to clear or almost clear scalp psoriasis in 75% of patients.
    Fierce Biotech · 12d ago↗ source
  • Racing Takeda, InnoCare reports TYK2 inhibitor win in phase 2 vitiligo trial
    A phase 2 trial of InnoCare Pharma’s TYK2 inhibitor soficitinib in nonsegmental vitiligo has hit its primary endpoint, clearing the Chinese biotech to advance into the phase 3 part of the study.
    Fierce Biotech · 12d ago↗ source
  • Spurred by deep cuts and M&A activity, H1 layoffs could oust 14,000+ in biopharma
    Takeda’s cuts will go the deepest, affecting over 4,700 employees. Layoffs tied to M&A activity include BioNTech letting go of around 800 people at CureVac.
    BioSpace · 12d ago↗ source
  • FDA acting chief walks back Makary's practice of policymaking through journals
    The FDA is continuing to rewind actions by former Commissioner Marty Makary, saying that two medical journal articles published over the last year did not constitute agency policy. The about-face f…
    Endpoints · 13d ago↗ source
  • Senate committee questions CDC pick on political interference over vaccines
    Lawmakers in the Senate pressed the Trump administration’s nominee for CDC director on whether she will cave to political pressure during a confirmation hearing on Wednesday. The CDC has been witho…
    Endpoints · 13d ago↗ source
  • Amid $55B US manufacturing push, J&J turns to streamlining its pharma supply chain
    After committing $55 billion last year to bolster U.S. manufacturing capabilities, Johnson & Johnson is making changes to its pharmaceutical supply chain.
    BioSpace · 13d ago↗ source
  • J&J restructures pharma manufacturing footprint at cost of up to $750M
    Johnson & Johnson is anticipating as much as $750 million in costs to restructure its pharmaceutical supply chain and exit factories, moves that are coming as it pushes ahead with its $55 billion p…
    Endpoints · 13d ago↗ source
  • Eli Lilly invests in Oura to support patients on GLP-1 drugs
    Eli Lilly on Wednesday made an equity investment in wearable ring startup Oura as the drugmaker looks for ways to support patients taking its GLP-1 medications. An Oura spokesperson declined to sha…
    Endpoints · 13d ago↗ source
  • Celcuity gains FDA approval for closely watched breast cancer drug
    Still, shares fell by nearly 20% after the company revealed a delay in the coming launch of Revtorpyk. Details in the drug’s prescribing information surprised some analysts, too.
    BioPharma Dive · 13d ago↗ source
  • Merck ADC, in China study, shows potential to replace chemo in lung cancer
    The results were seen by Wall Street analysts as “direct proof-of-concept” that sac-TMT, a drug Merck views as a “cornerstone,” could be part of a future treatment standard for front-line lung cancer.
    BioPharma Dive · 13d ago↗ source
  • Braveheart, Attovia join next wave of biotech IPOs
    The two startups are the third and fourth, respectively, to outline offerings this month and aim to capitalize on momentum that’s already yielded several big-ticket IPOs.
    BioPharma Dive · 13d ago↗ source
  • Nobel Laureate Jennifer Doudna enters AI protein design arena
    Jennifer Doudna, Ph.D., the Nobel Laureate best known for co-inventing the CRISPR system that has become the foundation for gene-editing, is dipping her toes into a new, buzzy field: AI-powered pro…
    Fierce Biotech · 13d ago↗ source
  • Why early de-risking is redefining the path to IND
    Lonza explains why early de-risking has become a strategic imperative for biotech teams working to reach IND with confidence.
    Fierce Biotech · 13d ago↗ source
  • Radiopharma maker AdvanCell hauls in $315M for Pluvicto challenger
    AdvanCell raised a $315 million Series D to study a lead-based prostate cancer agent and shore up its US manufacturing of the radioactive treatment. The round marks one of the largest yet for a rad…
    Endpoints · 13d ago↗ source
  • Understanding Agentic AI in Clinical Development
    Earlier this year, my colleague Matt Harrington suggested that clinical leaders should stop asking whether their organizations have an “AI strategy”, not because strategy doesn’t matter, but becaus…
    Fierce Biotech · 13d ago↗ source
  • Kelun’s Merck-partnered ADC notches late-stage NSCLC win alongside Keytruda
    The Phase 3 results are the first direct proof-of-concept for an ADC replacing platinum-based chemo in a first-line standard-of-care regimen for non-small cell lung cancer, according to Leerink Par…
    BioSpace · 13d ago↗ source
  • J&J touts Icotyde prescriptions, but not sales, in first full quarter
    Johnson & Johnson teased some details on Wednesday morning about how the launch of its expected blockbuster Icotyde performed in the second quarter. Without disclosing how much revenue the plaque p…
    Endpoints · 13d ago↗ source
  • J&J dips despite upbeat outlook; AstraZeneca, Spero cut China deals
    J&J’s shares ticked down as oncology sales missed expectations. Elsewhere, AstraZeneca bet $600 million on a lung cancer drug and a pair of biotechs snagged two of the year’s top venture rounds.
    BioPharma Dive · 13d ago↗ source