The FDA had given Pfizer and Moderna until May 17 to propose changes to the labels of their COVID-19 vaccines or challenge the agency’s directive. The products’ labels already include myocarditis warnings, albeit for different age groups.
The CMS last month declined to include anti-obesity medications in its Medicare coverage for Part D, a move that Lilly says could interfere with patients getting the appropriate medical care.
The deal helps revitalize the TREM2 target after the high-profile failure of AbbVie and Alector’s candidate last year.
After discussions with the FDA, Moderna has withdrawn its application for a combination shot, which had demonstrated efficacy in eliciting antibodies in data announced earlier this month.
BioSpace sits down with four NextGen companies that are thriving despite a multi-year down period. You will hear about ways they are defying the odds to churn out clinical data that may finally provide the industry with a ladder out. Watch now.
Roche, along with Bristol Myers Squibb, Novo Nordisk, AbbVie, Eli Lilly and others, is making inroads into molecular glues to use in cancer, immunology and other applications.
FEATURED STORIES
Donanemab, which will be marketed as Kisunla, will compete with Biogen and Eisai’s Leqembi.
In 2023, the ADC market exceeded $10 billion, and this momentum is persisting into 2024, as evidenced by several strategic deals and a robust pipeline of candidate drugs.
When moving to a new role at the same company, it’s important to create a transition plan, understand your responsibilities and expectations and get to know your new team.
After winning expanded approval for its gene therapy for Duchenne muscular dystrophy, Sarepta’s leadership and analysts see a sizeable commercial opportunity on the horizon.
If approved, ensifentrine would be the first non-steroidal, anti-inflammatory drug for patients with chronic obstructive pulmonary disease, offering an option with potentially fewer side effects.
Exsilio Therapeutics emerged from stealth on Tuesday with a platform that leverages mRNA technology to develop redosable genomic medicines for a range of complex diseases.
FROM BIOSPACE INSIGHTS
While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience that would make change possible.
LATEST PODCASTS
In this episode presented by Cresset, BioSpace’s head of insights Lori Ellis discusses the emerging geopolitical battle for AI supremacy and global AI governance with Mutlu Dogruel, VP of AI and Mark Mackey, CSO of Cresset.
George Tidmarsh takes over temporarily at CBER following Vinay Prasad’s abrupt departure; Replimmune trial leaders protest rejection reportedly driven by FDA’s top cancer regulator Richard Pazdur; Merck’s $3 billion savings push claims 6,000 jobs; and Pfizer CEO Albert Bourla addresses President Donald Trump’s new threats around Most Favored Nation drug pricing.
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the concerns and opportunities of patient data driving AI tasks with Louise Molloy, associate director medical information and pharmacovigilance.
Job Trends
Forge Biologics today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA), the healthcare regulatory body of the United Kingdom (UK), granted Innovation Passport designation to the Company’s novel AAV gene therapy program, FBX-101.
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SPECIAL EDITIONS
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
DEALS
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The Japanese biotechnology and food company has bought into the gene therapy space with its $620 million acquisition of Ohio-based CDMO and clinical-stage biotech Forge Biologics. -
The cell therapy-focused biotech will use most of the net proceeds from its initial public offering to fund Phase II clinical trials for its lead program, a novel CAR T-cell candidate. -
The New York-based genetic medicine company, which expects gross proceeds of approximately $100 million, joins a small group of biotechs that have launched initial public offerings this year. -
The Swiss drugmaker gains rights to RVT-3101 in the U.S. and Japan. Telavant was formed in late 2022 by Roivant and Pfizer, which had a 25% stake in the venture and retains rights to the antibody in other countries. -
While Merck lost out to Pfizer earlier this year in snapping up Seagen, this week the company closed a deal worth a potential $22 billion with Daiichi Sankyo—further evidence of the industry’s insatiable appetite for ADC technology.
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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Executives from the three largest pharmacy benefit manager companies testified Tuesday before Congress that rising drug prices in the U.S. are due to pharma companies taking advantage of market exclusivities and excessive charges. -
Allarity Therapeutics announced Monday that the Securities and Exchange Commission has made a preliminary determination recommending an enforcement action against the company for alleged violations of federal securities laws. -
The Department of Health and Human Services’ Office of the Inspector General found that bluebird bio’s fertility support program for its gene therapies could potentially violate federal anti-kickback statutes. -
Eli Lilly’s tirzepatide, which has previously been approved in China for diabetes, can now also be used for chronic weight management in the world’s second most populated country. -
As scrutiny of pharmacy benefit managers mounts, a House committee will hold a hearing on the alleged anticompetitive business practices of these middlemen.
Going into an interview knowing that it’s OK to be yourself and perfection isn’t the goal can help alleviate that self-imposed pressure.
In order to play the “cat and mouse” game with poise, we’ve provided a breakdown of the steps to take to negotiate properly. Read on for tips to help you successfully negotiate a job offer.
Once you’ve determined where you want to reside, the next step is hunting for a premier job in your field in that location.
Before you even begin researching, prioritize which aspects of the job offer are most important to you.
First, prioritize these criteria according to your own desires and needs. Which aspects of the offer do you most value?
When you’re ready for a new job, contacting employers is a no-brainer. But the same kind of clear-cut call to action doesn’t necessarily apply to contacting recruiters.
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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Incyte announced Tuesday it is realigning its research and development priorities to focus on dermatology and inflammatory assets obtained from the $750 million acquisition of Escient Pharmaceuticals. -
BioNTech and Regeneron will face off against Merck and Moderna, which are advancing their investigational cancer vaccine mRNA-4157/V940 in combination with Keytruda, in advanced melanoma. -
AstraZeneca is seeking a fixed-duration approval for Calquence, which will allow patients with chronic lymphocytic leukemia to take breaks from the therapy and prevent excessive toxicities and drug resistance. -
Under the deal announced Monday with the California biotech, German pharma Boehringer Ingelheim is gaining access to novel immune checkpoint inhibitors designed to activate the immune system to fight cancer cells. -
The combination therapy is one step closer to becoming a potential new first-line standard of care for patients with unresectable or metastatic urothelial carcinoma in Europe.
NEUROSCIENCE
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Heather, Greg and Tyler discuss a busy news week including Wegovy’s label expansion, biosimilars, surprise donanemab delays for Eli Lilly and speculate on election impact. -
The FDA plans to convene an advisory committee meeting to discuss the safety profile and efficacy of Eli Lilly’s Alzheimer’s candidate, the company announced Friday. -
The regulator’s new draft guidance, released on Monday, provides additional details regarding the use of surrogate and biomarker endpoints to support accelerated approvals. -
In Monday’s neurology update for investors, Roche touted data from a small Ib/IIa trial for trontinemab, an investigational therapy for Alzheimer’s disease which demonstrated “rapid and robust” amyloid plaque reduction.
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Acadia Pharmaceuticals is terminating development of its antipsychotic drug pimavanserin, which did not demonstrate a statistically significant improvement over placebo in the late-stage study’s primary endpoint.
CELL AND GENE THERAPY
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Sarepta did not hold an investor call for its second-quarter earnings report or provide an updated full-year revenue outlook. -
From innovation in manufacturing to more-flexible regulation and better communication with payers, much needs to happen to make CGTs commercially viable. But it is possible, experts agreed at a recent panel. -
The primary focus in scaling up production should first be the adoption of lean manufacturing principles used in virtually every other industry. -
The pivotal Phase II trial is testing Allogene’s CAR T candidate cemacabtagene ansegedleucel for large B-cell lymphoma. ALLO-647 was being used as a preparative lymphodepletion therapy. -
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.
