FDA hands Chinese drug manufacturer a Form 483 noting employees destroyed...
Employees of Chinese drugmaker Jiangsu Hengrui Pharmaceuticals “diverted” FDA inspectors as colleagues tore up and threw away documents in a “rapid-like manner” at a manufacturing facility, according...
View ArticleOregon jury says J&J owes talc claimant $260M
An Oregon jury awarded a talc claimant $260 million in a verdict against Johnson & Johnson on Monday. The case was brought by a 49-year-old mother of three named Kyung Lee, who claimed J&J’s...
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Amgen's Uplizna succeeds in Phase 3 trial for rare autoimmune disease
Amgen released new Phase 3 data Wednesday for its rare disease drug Uplizna in an autoimmune condition, bringing it potentially closer to another FDA approval. The results may put additional pressure...
View ArticleSenate Finance Chair presses HHS to crack down on cybersecurity in wake of...
Senate Finance Committee Chair Ron Wyden (D-OR) is urging HHS to take a stronger stance on healthcare companies’ cybersecurity practices as the healthcare system is still piecing together what happened...
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Amarin names new CEO as Patrick Holt departs
Amarin has its third new CEO since 2021 following the resignation of Patrick Holt. The company announced Wednesday that the board of directors promoted Aaron Berg, EVP and president of the US business,...
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Lilly exec says developing new therapies for lupus is 'in scope'
Despite prior setbacks, Lilly executives said they’re pressing ahead with new research in lupus at a time when other companies are taking to cell therapy to crack the hard-to-treat disease. Paul...
View ArticleFormer Sanofi R&D leader Frank Nestle to lead Deerfield’s growing drug...
The healthcare investment firm Deerfield Management recruited a top pharma scientist to lead its growing research arm, which has sprawling connections to many of the nation’s top academic centers,...
View ArticleITM nabs €188M to boost isotope manufacturing, advance cancer pipeline
Radiopharma company and radioisotope supplier ITM, or Isotopen Technologien München, raised €188 million ($204 million) to boost in-house manufacturing of lutetium-177 as well as to push its Phase 3...
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Virtual physical therapy programs can be just as good as in-person care,...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Many virtual programs used to treat common musculoskeletal problems improve pain and function, while...
View ArticleWho are the women making a mark in biopharma R&D? Nominate them for...
It’s one of our favorite times of the year: You can now nominate someone to be spotlighted in Endpoints News’ annual Women in Biopharma R&D special report. Last year, we passed the 100 mark on the...
View ArticleSeres will sell microbiome pill to partner Nestlé to pay off debt and stay open
Seres Therapeutics has signed an agreement with its commercialization partner Nestlé Health Science to sell the remaining rights to its microbiome pill and focus on developing a second drug for...
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Moderna’s mRNA candidate picked for FDA’s Operation Warp Speed for rare diseases
Moderna is joining another Operation Warp Speed initiative — this time, for rare diseases. The biotech’s mRNA candidate for a protein and lipid metabolism disorder was selected by the Center for...
View ArticleBoehringer Ingelheim, Zealand’s positive Phase 2 MASH fibrosis data...
Boehringer Ingelheim and Zealand Pharma’s survodutide has improved liver scarring in a Phase 2 test in patients with metabolic dysfunction-associated steatohepatitis, or MASH, according to an...
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GSK acquires tiny RNA startup Elsie, boosting its grand plans for developing...
GSK is boosting its RNA ambitions, announcing Thursday it has acquired a small, privately held San Diego startup called Elsie Biotechnologies that the British drugmaker has been collaborating with for...
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Exclusive: Walmart shut down its healthcare clinics after losses reached...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Walmart’s efforts to build a new kind of primary care service in rural communities — and to create a...
View ArticleReplimune aims for accelerated approval of melanoma therapy; Structure's...
Replimune aims for accelerated approval of melanoma therapy: The company announced Thursday that one-third of melanoma patients who received its genetically engineered herpes virus therapy plus Bristol...
View ArticleMerck KGaA’s South Korean partnership; Sanofi’s supply chain alliance with DHL
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. South Korean CDMO Lotte Biologics and Merck KGaA’s life science arm...
View ArticleJ&J’s dealmaker: Plenty of ‘firepower,’ but mostly focused on tuck-in M&A
SAN DIEGO — The head of dealmaking at Johnson & Johnson said that biotech valuations have come back down to more reasonable levels that make it easier to get transactions done, although the company...
View ArticleAbbVie's newly-acquired ADC hits Phase 2 goal in ovarian cancer
AbbVie’s $10.1 billion purchase of ImmunoGen and accompanying antibody-drug conjugate Elahere is already paying off, with the drug scoring a new mid-stage victory. The Chicago-area pharma said...
View ArticleNine years and four generics later, the HIV drug at the center of the Shkreli...
Years after Martin Shkreli kicked off a drug pricing controversy around the HIV drug Daraprim, the price of the drug has not fallen to pre-Shkreli figures despite several generic competitors. There are...
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