FDA's ad enforcer critiques Brittany Mahomes' paid Instagram post for Kaléo
Brittany Mahomes’ Instagram is the subject of a recent letter the FDA sent to Kaléo regarding a misleading direct-to-consumer ad for its epinephrine injection. The FDA called the Instagram post and...
View ArticlePfizer cuts 210 North Carolina workers after it officially discontinues...
Pfizer will end development on its experimental Duchenne muscular dystrophy gene therapy after a Phase 3 failure last month, and plans to eliminate roles at a North Carolina site that was working on...
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Roivant's dealmaker lands $81M cash bonus following drug sale to Roche
One of the best pharma deals in recent history has now led to one of the industry’s biggest-ever executive paydays. Roivant awarded its top dealmaker Mayukh Sukhatme an $80.55 million cash bonus,...
View ArticleIndivior reaches $86M settlement over its alleged role in the opioid epidemic
Indivior will pay $86 million over five years as part of a settlement with 17 states over it’s alleged role in the opioid epidemic, New York Attorney General Letitia James announced last week....
View ArticleAstraZeneca and Daiichi Sankyo fail to win NICE recommendation for Enhertu,...
The United Kingdom’s drug pricing watchdog has officially declined to recommend AstraZeneca and Daiichi Sankyo’s Enhertu for HER2-low breast cancer in the UK, noting that the companies were “unwilling”...
View ArticleBessemer VC Morgan Cheatham shares how AI healthcare startups can win in a...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Among what seems like a gazillion startups using AI to solve administrative problems for healthcare...
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Roche begins Phase 2 obesity trial for GLP-1/GIP agonist CT-388
Roche said it would step on the gas pedal to catch up to Novo Nordisk and Eli Lilly (plus many other hopefuls) in obesity. And it has. The Swiss pharma conglomerate has kicked off a Phase 2 trial of...
View ArticleKeytruda tops $7B quarterly sales for the first time
Merck’s Keytruda has a new line on its long list of accomplishments: topping $7 billion in quarterly sales for the first time. On Tuesday, the New Jersey drugmaker said the cancer drug’s quarterly...
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Montara Therapeutics, co-founded by UCSF's Kevan Shokat, to develop new neuro...
A year after selling their first neuro startup to AbbVie, Kevan Shokat and the former PhD student he co-founded that company with are back with a new idea. Montara Therapeutics is starting small with...
View ArticleCelldex says barzolvolimab scores in Phase 2 test in chronic inducible urticaria
Celldex said its monoclonal antibody has shown encouraging efficacy in a mid-stage trial in patients with an inflammatory skin condition that features hives and swelling, setting the stage for...
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Pfizer ups 2024 guidance by $1B after multiple rounds of cost cuts
Pfizer beat Wall Street’s expectations on revenue in the second quarter and raised its full-year revenue guidance by $1 billion, it said Tuesday morning. The large drugmaker pulled in $13.3 billion...
View ArticleBioNTech, 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...
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