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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...
View ArticleSafety, efficacy and dosing questions linger for Lilly's Alzheimer's drug...
The FDA detailed its biggest concerns about Eli Lilly’s experimental Alzheimer’s therapy donanemab ahead of a last-minute advisory committee meeting to convene Monday about the drug. In documents...
View ArticleFDA explains why it rejected Vanda's insomnia application as company faces...
In a rare move, the FDA’s Center for Drug Evaluation and Research publicly disclosed more information about why it rejected a new indication for Vanda Pharmaceuticals’ sleep disorder drug. The company...
View ArticleSenate fails to pass bill codifying access to contraception
The Senate on Wednesday rejected a bill that would codify the right to contraception, with all but two Republicans voting against it. The vote comes at nearly the two-year mark since the Supreme Court...
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Google's parent company Alphabet poaches Eli Lilly CFO; More changes at...
Anat Ashkenazi → It’s been nearly a year since Google’s parent company Alphabet announced that its CFO Ruth Porat would move into the newly created role of president and chief investment officer,...
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Biomea’s early-stage diabetes drug put on full clinical hold, stock crashes
Biomea Fusion’s Phase 1/2 covalent menin inhibitor program in diabetes has been placed on full clinical hold due to “possible” drug-related hepatotoxicity. Liver enzyme elevations were flagged in the...
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#EASL24: Boehringer Ingelheim, Zealand tout key fibrosis data from mid-stage...
Boehringer Ingelheim officially unveiled fibrosis data from a mid-stage trial of its Zealand Pharma-partnered drug in MASH on Friday, after its liver congress abstract was “unintentionally and...
View ArticleIpsen returns to Marengo Therapeutics for new trispecific deal
Ipsen and Marengo Therapeutics are expanding a deal to include two trispecific antibody assets that tackle so-called cold tumors, which do not typically respond well to immunotherapies. The companies...
View Article#EASL24: Aligos, Arbutus, Atea, Barinthus and Bluejay unveil hepatitis results
At this year’s EASL International Liver Congress, Vir took center stage Wednesday to report early Phase 2 data for its hepatitis D approach, and then saw its stock $VIR jump as much as 15% upon data...
View ArticleNeuroscience company Rapport Therapeutics lists on Nasdaq
Rapport Therapeutics expects to raise $154 million from its initial public offering and a concurrent stock sale to private investors, the company announced Thursday evening. Rapport, a neuroscience...
View ArticleAbbVie and Alphabet's Calico added to Operation Warp Speed for rare diseases
AbbVie and Alphabet’s Calico announced Friday that their potential treatment for the rare neurological disease known as vanishing white matter disease will be part of the FDA’s new Operation Warp Speed...
View ArticleItalian antitrust agency investigates Novartis, Biogen and others over...
Italian antitrust authorities are investigating four companies over alleged collusion to delay the introduction of a new biosimilar to Roche’s blockbuster eye drug Lucentis. The Italian Competition...
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