Novartis follows Lilly and J&J in announcing multibillion-dollar US...
With US tariffs on pharmaceuticals likely to come "very soon," another of the world's largest drugmakers is announcing plans to beef up their American manufacturing. On Thursday, Swiss-based Novartis...
View ArticleFDA is reversing return-to-office mandate for some workers
Less than a month after the Trump administration ordered all FDA employees to come back to their offices full-time, agency leaders have told some staff that remote work will return, multiple FDA ...
View ArticleIra Mellman joins PICI; ViiV Healthcare CMO replaces Chris Corsico at GSK
After 17 years at Genentech, Ira Mellman is joining the Parker Institute for Cancer Immunotherapy as president of research. The PICI, founded by tech entrepreneur Sean Parker, is a key funder ...
View ArticleTome Bio founders wrangle ‘jumping genes’ for new gene insertion tool
Two Boston scientists say they have developed a new gene editing tool based on mysterious "jumping genes" known as retrotransposons, which can copy and paste themselves to hop around the genome. While...
View ArticleCDMOs anticipate inspection bottlenecks after FDA firings
CDMOs fear that FDA site inspections might slow down due to the mass staffing cuts at the federal health agencies. While President Donald Trump's potential pharma tariffs have all drugmakers on alert ...
View ArticleArgenx’s Vyvgart Hytrulo syringe is approved in the US; Opthea to cut 65% of...
Plus, news about Protagonist Therapeutics, Pfizer and Keros Therapeutics: Argenx wins FDA approval for Vyvgart Hytrulo syringe: The subcutaneous injection, which comes in a more convenient prefilled...
View ArticleRecruiters say some biopharmas pause hiring as they struggle to make sense of...
An already bleak biotech market has become more daunting for job seekers, particularly executives. It’s a gut punch for those who have been holding out hope for brighter days since 2022, when the...
View ArticleBristol 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...
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