Bristol Myers' immunotherapy combo nets two new approvals
Bristol Myers Squibb’s combined immunotherapies Opdivo and Yervoy won approval this week as a first-line treatment for metastatic liver cancer and certain forms of colorectal cancer. Both approvals...
View ArticleFDA unveils plan to replace animal testing with organoids
Newly-installed FDA Commissioner Marty Makary announced a plan to begin phasing out animal testing in drug development, particularly for monoclonal antibodies. How long that takes remains to be seen....
View ArticleBiotech’s survival guide; What tariffs could mean for pharma; Congress pushes...
Welcome back to Endpoints Weekly! This week's recap kicks off with Andrew Dunn's examination of the biotech playbook for surviving market turmoil. As former Alnylam CEO John Maraganore put it, recent...
View ArticleSandoz sues Amgen over nearly decadelong launch delay for Enbrel biosimilar
Amgen has enjoyed a monopoly on its blockbuster inflammatory disease drug Enbrel for almost 27 years now. After accumulating $86 billion in global sales, the company is still trying to keep biosimilars...
View ArticleFDA's union readies negotiations with HHS over some fired staff
A union that represents more than 11,000 FDA employees nationwide — the National Treasury Employees Union — said HHS is willing to negotiate over some fired workers, although the schedule for those...
View ArticleAMA asks UnitedHealth to relax cyberattack loan recoupment
The American Medical Association is urging Optum, a unit of UnitedHealth Group, to ease up on recouping the loans it provided to doctors’ medical practices after a cyberattack on the company’s...
View ArticleAbbVie and Sandoz resolve court spat over Rinvoq patents
AbbVie and Sandoz have resolved their patent dispute over AbbVie’s blockbuster immunology drug Rinvoq. Sandoz admitted the Rinvoq patents asserted against it are “enforceable, valid, and would be...
View ArticleBioNTech-backed ADC maker DualityBio plans Hong Kong IPO
Antibody-drug conjugates startup Duality Biologics will join the public markets on Tuesday via an initial public offering on the Hong Kong Stock Exchange. The Shanghai biotech, which has lined up...
View ArticleCDC vaccine advisors set to meet this week after two-month delay
A panel of experts who decide the national immunization schedule will meet on Tuesday for the first time in 2025, providing an opportunity for the nation’s top vaccine scientists to publicly discuss...
View ArticleBristol Myers says Camzyos fails Phase 3 study in genetic heart condition
The centerpiece of Bristol Myers Squibb’s $13 billion MyoKardia acquisition failed a Phase 3 study meant to expand the product's usage, BMS said Monday post-market, a development that could...
View ArticleTrump drug tariffs inch closer as Commerce Department launches 232 investigation
Tariffs on pharmaceutical products that President Donald Trump has teased for weeks moved one step closer on Monday, after the Commerce Department confirmed that it's launched an investigation into the...
View ArticleCell therapy startup Myeloid narrows focus as staff shrinks
Myeloid Therapeutics, a company developing in vivo cell therapies for cancer as well as a novel gene editing technology, has restructured to focus on its two clinical-stage programs, the company's CEO...
View ArticleMerck taps Cyprumed’s drug delivery platform for oral peptides
Merck is looking for ways to make its drugs easier to administer. The large pharma is licensing a drug delivery platform from Austrian biotech Cyprumed in a pact worth $493 million in upfront and...
View ArticleSmall biotech Oak Hill will bring Roche's Angelman drug back to life
Roche devastated the Angelman syndrome community in 2023, when it ended clinical development of rugonersen, a treatment candidate for the rare neurodevelopmental condition. But after
View ArticleJ&J maintains EPS, raises sales outlook under shadow of looming pharma tariffs
Johnson & Johnson is maintaining its 2025 financial guidance and raising its sales forecast despite President Donald Trump’s efforts to tariff pharmaceuticals. The growth projection for its...
View ArticleAttovia collects another $90M for I&I biologics in third funding round in two...
Attovia Therapeutics is turning fundraising announcements into an annual tradition. In June 2023, the San Carlos, CA-based startup launched with $60 million. Then in May 2024, it announced a
View ArticleFDA clears clinical trial of gene-edited pig liver used outside of body
The FDA has permitted eGenesis to begin a clinical trial of a dialysis-like system that involves using a gene-edited pig liver outside of the body. It’s the second formal study of a gene-edited pig...
View ArticleSanofi’s Kymab-originated inflammatory drug flunks mid-stage asthma trial
Sanofi’s efforts to explore its OX40-ligand targeting drug for inflammatory diseases other than eczema have hit a roadblock as the drug failed a Phase 2 trial in patients with asthma. The French...
View ArticleMural Oncology ends clinical development, lays off most workers
Boston and Dublin biotech Mural Oncology is laying off nearly all of its employees and ending clinical development of its IL-2 drug nemvaleukin alfa. The biotech flashed the red lights on Tuesday...
View ArticleBoehringer's bispecific pact with Cue Biopharma; HepaRegeniX raises €21.5M
Plus, news about MetaVia, NAYA Biosciences, Spruce Biosciences and Orion: Boehringer Ingelheim licenses bispecific for autoimmune diseases: The private pharma company will pay Cue Biopharma $12 million...
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