BioNTech, Regeneron claim Phase 2 win for cancer vaccine, PD-1 combo
One of BioNTech’s first mRNA cancer vaccine candidates has cleared a key mid-stage trial, setting it up for a potential showdown with a closely-watched and more advanced program from Merck and Moderna....
View ArticleDay One's $175M PIPE; Pinetree raises $17M in Series A
Plus, news about LTZ Therapeutics and VBI Vaccines: Day One raises money, cuts drug: The Brisbane, CA-based biotech revealed a $175 million private placement, reeled in $8.2 million in sales from...
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Imunon shares up over 150% as ovarian cancer treatment extends survival in...
Imunon shares skyrocketed Tuesday after the biotech reported positive survival data from a mid-stage trial of its IL-12 boosting immunotherapy on top of standard of care in ovarian cancer. The New...
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Incyte drops four early-stage programs from its pipeline as part of strategic...
Incyte culled four early-stage assets and one mid-stage drug in a bid to stay competitive, particularly in the LAG-3 market. In its second-quarter earnings update, Incyte announced that it discontinued...
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Behind Boehringer’s up to $1.3B Nerio deal is a budding cancer pipeline and...
Boehringer Ingelheim has long been known for its work outside oncology. But since the start of 2019, it’s snapped up more than half a dozen cancer startups, including another this week. “Over the last...
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China corruption crackdown hits Merck’s Gardasil sales, spooking investors
China’s recent effort to crack down on healthcare corruption has spurred a slowdown in Gardasil shipments, according to Merck CEO Rob Davis. On Tuesday, Davis told investors that China’s corruption...
View ArticleFDA shoots down second Novartis petition seeking to halt Entresto generics
Following the FDA’s decision to approve the first Entresto generics in May, the agency has told Novartis that its latest effort to block the copycat pill won’t go forward. The FDA said in its response...
View ArticleAfter a year of tumult, Pfizer manages to pull off a boring quarter
Sometimes no news is good news. On Tuesday, Pfizer delivered an uneventful update to investors with its second-quarter earnings results. It was a welcome reprieve from the New York drugmaker’s volatile...
View ArticleFiling 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 ArticleRNA editing startup AIRNA raises $60M for clinical trial in rare liver disease
One of the latest entrants to the RNA editing field has tripled its funding and plans to start a clinical trial in a rare liver disease as soon as next year. AIRNA, which launched with $30 million last...
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's $140M writedown 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 ArticleGSK unintimidated by RSV vaccine uptake challenges, Shingrix US sales drop
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...
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