Filing a new drug with clinical data in 2025? FDA sets fee at $4.3M
The FDA said Tuesday that companies filing new drug and biologics applications next year with clinical data will each have to pay a fee of $4.3 million, which is about $300,000 more than they’re paying...
View ArticleVertex gets January decision date for non-opioid pain medicine
The FDA is expected to make a decision on Vertex’s non-opioid medicine for acute pain by Jan. 30, the company announced on Tuesday. The experimental drug, suzetrigine, showed in two Phase 3 trials...
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FibroGen to shrink US workforce by 75% following more late-stage fails
FibroGen’s two-year rough streak continued on Tuesday as the San Francisco-based biotech said its prostate cancer drug pamrevlumab failed two late-stage trials. As a result, the biotech said it is...
View ArticleExclusive: Myeloid Therapeutics moves second in vivo cell therapy into...
Myeloid Therapeutics brought a second in vivo cell therapy program into the clinic, once again taking aim at hard-to-treat solid tumors, the Cambridge, MA-based biotech exclusively told Endpoints News....
View ArticleBiosecure lawmakers tell trade groups that China studies are a new focus
A congressional committee focused on US-China relations is examining clinical trials run by multinational drugmakers at sites affiliated with the Chinese military and has begun reaching out to trade...
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Umoja to dose first patient with in vivo CAR-T by end of this year
Umoja Biopharma has the FDA’s green light to dose the first patient with what it believes could be a more readily accessible CAR-T therapy. The company has plans to launch a Phase 1 trial this year for...
View ArticleTakeda takes $140M write-down on Phase 3 epilepsy drug amid restructuring
Takeda is registering a JPY $21.5 billion ($140 million) impairment on its Ovid-licensed epilepsy drug in light of negative Phase 3 results, the Japanese drugmaker disclosed in its latest quarterly...
View ArticleUpdated: GSK unintimidated by RSV vaccine uptake challenges, Shingrix US...
In the face of broader rollout challenges that could limit uptake of Arexvy, GSK said it is confident that sales for its blockbuster asset will continue to grow in the forthcoming RSV vaccine season...
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As Amgen pursues GIP antagonism, a Novo Holdings-backed biotech does the...
Amgen’s obesity data are helping more than its own stock and internal R&D efforts. The biotech, which teased Phase 2 data in May, has helped elevate the case for GIP antagonism — rather than...
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MacroGenics stops further dosing in Phase 2 prostate cancer drug trial
MacroGenics said it will no longer dose the remaining patients who could have received more in a Phase 2 trial studying its antibody-drug conjugate in prostate cancer, after a recommendation by an...
View ArticleIdeaya and Biocytogen ink $400M+ deal; Daiichi spends more on superstar ADCs
Plus, news about PepGen, Lilly, Abcellera, CastleVax and Tracon: Ideaya and Biocytogen ink deal worth $400M+: At the center of the deal is a bispecific antibody that targets both B7H3 and PTK7. The...
View ArticleUpdated: Eisai says Alzheimer's drug keeps working after three years. But...
PHILADELPHIA — Ever since Eisai first revealed data from its pivotal Alzheimer’s disease study two years ago, the company has argued that treating patients with Leqembi earlier and longer would likely...
View ArticleFDA questions Zevra’s resubmitted data for rare disease drug ahead of adcomm
Ahead of an advisory meeting Friday, the FDA raised questions about the strength of human, mouse and cell data Zevra Therapeutics generated for its treatment for Niemann-Pick disease type C — a rare,...
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Takeda defends Alzheimer's pact, TYK2 potential as restructuring is in 'full...
In its quarterly update on Wednesday, Takeda executives said the Japan-based pharma giant’s $900 million restructuring is in “full swing” as the pipeline has been reconfigured to focus on late-stage...
View ArticleSanofi sues Sarepta, alleging that Duchenne treatment Elevidys infringes on...
Sanofi is suing Sarepta Therapeutics, alleging that the company’s approved muscular dystrophy treatment infringes on its patents related to the chemical makeup of the product. Sanofi’s rare disease...
View ArticleTeva factored IRA's next round of negotiations into its growth plans
Teva is confident in the next phase of its “pivot to growth” strategy — even in the face of upcoming selections for the next round of Medicare negotiations. CEO Richard Francis announced the company’s...
View ArticleHumana is still struggling with high medical costs as new CEO Jim Rechtin...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Humana said Wednesday that higher-than-expected medical costs haven’t let up and are likely to continue...
View ArticleALX Oncology continues its CD47 quest, revealing Phase 2 gastric cancer data
ALX Oncology released topline results from a Phase 2 gastric cancer trial, building on an interim readout from late last year that left a glimmer of hope alive for the CD47 space. The experimental...
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Judge rejects Novo Nordisk's IRA case as pricing negotiations conclude
A New Jersey federal judge has sided with the federal government in Novo Nordisk’s lawsuit against the Inflation Reduction Act, another in a string of legal victories for the law. Zahid Quraishi Judge...
View ArticleAfter norovirus vaccine's trial failure, HilleVax lays off 40% of staff
Boston biotech HilleVax said Wednesday that it will let go of about 41 employees, or roughly 40% of its staff after its lead vaccine failed a mid-stage test earlier in July. In July, the Takeda...
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