The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research into one entity.
In its first commercial quarter for ATTR-cardiomyopathy, Alnylam’s Amvuttra reached roughly 1,400 patients and made more than $490 million.
Merck has characterized its cost-cutting initiative as more of a reallocation of resources to support other, higher-growth areas of its business.
In 17 identical letters posted to his Truth Social account, the president said companies must lower their prices or the government ‘will deploy every tool in our arsenal to protect American families from continued drug pricing practices.’
The FDA greenlit multiple new drugs this month and issued some notable label expansions, including for Eli Lilly’s Kisunla. Meanwhile, the regulator turned away a cell therapy for Duchenne muscular dystrophy and a gene therapy for the rare disease Sanfilippo syndrome.
Bristol Myers Squibb tested Cobenfy as an adjunctive treatment with atypical antipsychotics for schizophrenia in the Phase III ARISE study, which earlier this year failed to demonstrate significant symptom improvement.
FEATURED STORIES
Hundreds of companies are currently running clinical trials in the increasingly lucrative obesity space. BioSpace looks at five candidates with data expected before the end of the year.
Clinical trial concerns and a negative advisory committee vote ultimately sunk the treatment.
This week, Q2 earnings from Novo Nordisk and Eli Lilly revealed that the competition between the pharma giants’ weight-loss drugs Wegovy and Zepbound is getting closer.
After Merck noted the issue in its Q2 earnings call without providing specifics, analysts are left in the dark about the HPV vaccine’s future in China.
Experts say the time is now to develop and provide widespread access to genetic medicines for the rarest diseases. What’s more, they say it is a moral imperative.
Longeveron and Lexeo Therapeutics are working on CGT therapies to treat Alzheimer’s disease, but it’s not clear whether they have a better chance of success than traditional approaches.
LATEST PODCASTS
In this episode presented by PII, BioSpace’s head of insights discusses how to relieve clinical trial patients of technological burden to improve compliance with guests Oliver Eden and Travis Webb.
Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study.
In this episode presented by Element Materials Technology, BioSpace’s head of insights discusses how China, historically focused on manufacturing, is increasingly becoming an innovation leader, particularly in pharmaceuticals, with guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney. Ultimately, balanced strategies involve domestic capacity investments coupled with global collaboration.
Job Trends
Bristol Myers Squibb (NYSE: BMY) today announced that the company will participate in the TD Cowen 44th Annual Health Care Conference in Boston, Massachusetts, on Monday, March 4, 2024.
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SPECIAL EDITIONS
In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.
In this deep dive, BioSpace explores the next big thing in obesity.
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
DEALS
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After finally getting the green light from the Federal Trade Commission last month, Amgen has completed the buyout and expects to provide updated fiscal year 2023 guidance during its third-quarter earnings call. -
The Japan-based pharma is acquiring Orchard Therapeutics for approximately $477.6 million, if all conditions are met. Orchard’s pediatric gene therapy has a PDUFA date set for March 2024. -
AbbVie, Amgen, Gilead, Merck and Novartis are among the 31 members that have formed the Partnership for the U.S. Life Science Ecosystem to push back against federal antitrust reforms. -
Here’s how some biopharmas have managed to gain funding despite a falloff in investment in the sector. Hint: Positive late-stage data is a key factor. -
Eli Lilly on Tuesday continued its buying spree with a $1.4 billion acquisition of the radiopharma company’s pipeline of clinical and preclinical radioligand therapies.
WEIGHT LOSS
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As part of its ongoing review, the European Medicines Agency this week is slated to examine the potential risks of suicidal ideation and self-harm associated with diabetes and weight-loss treatments. -
The FTC and the U.S. Department of Justice’s antitrust division will have another 30 days to examine Novo Nordisk Foundation’s acquisition of contract manufacturer Catalent, according to an SEC filing. -
The four highest doses of Eli Lilly’s blockbuster diabetes treatment Mounjaro will be in short supply through the rest of the month due to strong demand, according to the regulator. -
Fresh from its IPO, Fractyl Health got an Investigational Device Exemption from the FDA, clearing a pivotal study of its Revita system to help maintain weight loss following the discontinuation of GLP-1 drugs. -
Despite strong demand for weight-loss drugs, the lack of Medicare coverage is potentially interfering with prescription and dispensing rates of anti-obesity medications for elderly adults, according to a new study.
POLICY
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Two months after winning FDA approval in the same indication, AbbVie and Genmab on Monday secured the European Commission’s nod for its bispecific antibody Tepkinly for the most common type of low-grade non-Hodgkin lymphoma. -
Amgen’s Enbrel, Bristol Myers Squibb’s Eliquis and Johnson & Johnson’s Stelara will account for 51.4% of the Inflation Reduction Act’s drug price negotiation savings in 2026, according to the Brookings Institution. -
In June, the regulator placed a partial clinical hold on a Phase I trial of the companies’ antibody-drug conjugate after three patient deaths were reported. -
For the Biden-Harris administration to compare the newly announced negotiated Medicare prices to the list prices for these drugs is, at best, not very meaningful. At worst, it’s disingenuous. -
Just months after a jury ordered payment to Pfizer in the patent infringement case, a Delaware judge has nullified the award and invalidated the patents behind the lawsuit involving AstraZeneca’s blockbuster lung cancer drug.
Do you know about the hidden job market and how to tap into it to find jobs? For years, career gurus have claimed that 75-95% of job vacancies are “hidden” in that they are not advertised or publicized.
Frustrated by your job search? Does your dream employer rarely have openings? A little-known technique – the job proposal approach – can open doors for you.
Learn about the top resume buzzwords you need to include in your resume. Includes tips for branding yourself, positioning yourself as a leader, and more!
Curious to know how you can tailor your resume? This blog post will give you some tips on tailoring your resume so it stands out from the rest of the pile!
Here are the keys to a smooth long distance job search. Follow these simple guidelines to avoid many of the stresses of job hunting from a distance.
Are you worried about your first phone interview? Don’t worry, everyone gets through that phase. Follow these phone interview tips to nail your telephonic interview.
HOTBEDS
REPORTS
In this Employment Outlook report, BioSpace explores current workforce sentiment, job activity trends and the prospective job and hiring outlook for 2025, particularly as it compares to the previous year.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
CANCER
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Kazia Therapeutics is eyeing an FDA accelerated approval pathway for its investigational glioblastoma drug paxalisib, with Wednesday’s release of secondary overall survival data from a Phase II/III trial.
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Amgen has quietly discontinued the development of its Phase I bispecific T-cell engager AMG 794, which the company had been studying for several malignant solid tumors. -
GLP-1 receptor agonists could reduce the risk of 10 obesity-associated cancers, such as meningioma, multiple myeloma and colorectal cancer, according to an analysis of electronic health records. -
With the antibody drug conjugate market projected to hit $28 billion by 2028, some companies are looking to harness the drugs for immunotherapy. -
Eli Lilly is expanding its radiopharmaceutical portfolio with a $140 million upfront payment to Radionetics Oncology and the exclusive future right to acquire the biotech for $1 billion.
NEUROSCIENCE
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The FDA has rejected Minerva Neurosciences’ treatment for negative symptoms in schizophrenia, noting a lack of data and other factors that led to the Complete Response Letter. -
In a Phase II study, Sanofi and Denali’s RIPK1 inhibitor SAR443820/DNL788 failed to meet the primary endpoint of improved functional performance in amyotrophic lateral sclerosis patients. -
Novo Nordisk seems to believe it can do a better job managing troubled Catalent than the contract manufacturer. However, the Danish drugmaker has its work cut out for it. -
The French drugmaker Thursday touted trial results in The New England Journal of Medicine showing frexalimab significantly slowed disease activity in people with relapsing multiple sclerosis.
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A longer-acting formulation of Otsuka Pharmaceuticals’ aripiprazole could help soften the blow of Abilify Maintena’s loss of exclusivity coming later this year, according to a new report from GlobalData.
CELL AND GENE THERAPY
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MeiraGTx Holdings is licensing a genetic eye disease medicine to Eli Lilly in a deal worth up to $475 million. -
The FDA previously placed two clinical studies on hold, including the Phase III trial in which the liver toxicity occurred. Intellia is working with experts to create a risk management program for nex-z. -
Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study. -
The potential approval of Vertex’s IgAN therapy povetacicept in 2026 comes amid launch headwinds for the company’s non-opioid pain medicine Journavx and gene therapy Casgevy. -
With a 100% response rate in a Phase II study, KYV-101 sets a new efficacy bar in generalized myasthenia gravis, according to analysts at William Blair.
