In an opinion piece in the Wall Street Journal, Health Secretary Robert F. Kennedy Jr. said he will roll chronic disease programs into a new Administration for a Healthy America.
Novartis and Argo Biopharma go back to January 2024, when the pharma first bet up to $4.165 billion across two RNAi agreements targeting cardiovascular diseases.
Aside from lowering triglyceride levels, Ionis’ olezarsen reduced acute pancreatitis events, an outcome that BMO Capital Markets said could help the asset deliver a “significant first-in-class commercial launch.”
Data from the late-stage MAPLE-HCM study position Cytokinetics’ cardiac myosin inhibitor aficamten as a potential first-line therapy for patients with obstructive hypertrophic cardiomyopathy.
Health Secretary Robert F. Kennedy Jr. will appear before the Senate Finance Committee Thursday, ahead of a vaccine advisory committee meeting later in September. Meanwhile, deal-making appetite appears healthy, and the weight loss space continues generating clinical data and other news.
Paul Offit, longtime member of the FDA’s vaccine advisory committee and an outspoken critic of Health Secretary Robert F. Kennedy Jr., was recently informed by the Department of Health and Human Services that his services are no longer required.
FEATURED STORIES
The intellectual property landscape for newer gene-editing technologies, like that for CRISPR-Cas9, remains unclear and hard to navigate.
Analysts expect the companies’ Vabysmo and Eylea HD to generate a combined $13.2 billion by 2030 in the vascular endothelial growth A therapy market, as healthcare providers and patients switch from older products.
With promising early results, cell and gene therapies are making headway against both rare and common ocular and auditory diseases.
The FDA has three regulatory milestones in the next two weeks, including a decision on a subcutaneous formulation of an effective multiple sclerosis therapy.
With gene therapies by REGENXBIO and AbbVie, Adverum and others in mid- or late-stage trials, this therapeutic class could soon be an option for this common cause of blindness in the elderly.
Eli Lilly this week announced plans to sell single-dose vials of its weight loss drug Zepbound directly to consumers. Novo Nordisk could adopt a similar strategy for Wegovy as its CEO is set to testify Sept. 24 before the Senate health committee.
LATEST PODCASTS
In this episode of Denatured, Jennifer Smith-Parker speaks to Kenneth Galbraith, CEO of Zymeworks and Josh Smiley, president and COO of Zai Lab, about how renewed confidence is driving biotech entering 2026.
Eli Lilly’s retatrutide exceeds expectations in Phase III, capping off a sparkling 2025 for the obesity titan; an internal FDA safety review finds no confirmed pediatric deaths caused by COVID-19 vaccines, and Commissioner Marty Makary says no black box warning will be attached to the shots; and BioSpace looks at six biotechs that could be pharma’s next buy.
In this episode of Denatured presented by AnaptysBio, Jennifer Smith-Parker speaks to Dr. Joe Murray, Mayo Clinic; Marilyn Geller, the Celiac Disease Foundation; and Dr. Paul Lizzul, AnaptysBio, about the challenges and opportunities facing celiac disease treatment.
Job Trends
Bristol Myers Squibb announced that it recently became aware of an unsolicited “mini-tender” offer by Tutanota LLC to purchase up to five hundred thousand shares of Bristol Myers Squibb’s common stock, representing significantly less than one percent of Bristol Myers Squibb’s common stock outstanding, at an offer price of $55 per share.
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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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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. -
Despite a sharp downturn in initial public offering activity, New York-based gene therapy company Lexeo Therapeutics and French biotech Abivax are seeking funding for their lead candidate programs.
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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At a private event held amid the fallout from the CrowdStrike incident, cybersecurity issues took a front seat, with the consequences of the evolving EU AI Act and the Loper Bright and Corner Post decisions also raising concerns for quality assurance and regulatory affairs professionals. -
With Medicare expenditures on Stelara increasing nearly tenfold, a new report from the HHS Office of Inspector General has found major differences in drug payment amounts under Part B versus Part D. -
In the latest setback for the pharma industry and its allies, the United States District Court for the Southern District of Ohio dismissed a U.S. Chamber of Commerce lawsuit on the grounds of improper venue. -
Lobbying groups and individuals connected with the industry are supporting candidates from both parties, with a particular focus on the future of the 340B discount program and pharmacy benefit managers. -
Reiterating his ruling in a prior Inflation Reduction Act case, New Jersey District Court Judge Zahid Quraishi ruled that Novo Nordisk’s participation in the Medicare Drug Price Negotiation Program is of its own free will.
According to a BioSpace poll, over half (56%) of respondents are not happy with their current life sciences position. Are you one of the 56%? You deserve to be happy! Start working towards your happiness and check out job opportunities at these top companies!
You want to take every opportunity you can find to incorporate resume action verbs. The main way to do that is to replace any weak verbs you’ve written.
As a valued member of our BioSpace community, we are eager to hear more from you and other readers in 2019. We want to know your if you have ‘work-life balance’ with your job.
Attempting to customize your resume yourself can be a time-consuming process, which might not lead to more interview requests. Here’s how to effectively tweak your resume for a job!
According to a BioSpace survey, almost 70% of respondents are likely to look for a new job in the 12 months. The question is, why? Of those planning to look for a new job, 54% said they wanted new challenges and 42% said they wanted more rewarding opportunities. How about you? Are you ready to look for a job with more challenges and rewarding opportunities?
Expending countless hours of time and energy usually leads to frustration and burnout during a job search. Here are some tips to understanding what a company is really looking for in a job description.
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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While its investigational regimen fell short of the primary efficacy endpoint, AVEO dug into data from its control group and touted a “clinically meaningful” improvement in progression-free survival in patients receiving Fotivda monotherapy. -
Agenus is now looking for alternative pathways to initiate a Phase III trial for BOT/BAL, including potential partnerships. -
Fresh off its $13-billion acquisition of medical devices developer Shockwave Medical, Johnson & Johnson is expecting greater business growth in the future. -
The last few months have been difficult for Gilead, with several late-stage failures and development discontinuations. Amid these problems, Merdad Parsey will be stepping down from his CMO role early next year. -
Immutep shares jumped nearly 20% on Friday after data showed its LAG-3 therapy—plus Keytruda—elicited strong response rates in head and neck squamous cell carcinoma patients in the front-line setting.
NEUROSCIENCE
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With Monday’s FDA rejection of their long-acting glatiramer acetate formulation, Viatris and Mapi Pharma continue the biopharma industry’s recent losing streak in multiple sclerosis. -
In this deep dive, BioSpace examines what’s next for Leqembi, the true cost of anti-amyloid antibodies, and what other Alzheimer’s treatments are coming down the pipeline. -
The FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss Eli Lilly’s application for its Alzheimer’s disease antibody donanemab, the company announced Friday.
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Friday’s topline data from the Phase III PHOENIX trial of Relyvrio, which won approval in 2022, showed no significant difference on either the primary or secondary endpoints, according to Amylyx. -
After oncology and neuroscience headlined biopharma investment in 2023, experts anticipate increased interest in the autoimmune and obesity spaces this year.
CELL AND GENE THERAPY
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A report from analysts at Jefferies suggested that new screenings for metachromatic leukodystrophy and Duchenne muscular dystrophy could bump sales of the gene therapy Libmeldy by more than $100 million. -
Addition joins a growing list of launches this year, following in the footsteps of startups like Crystalys Therapeutics and Ollin Biosciences. -
Eli Lilly’s retatrutide exceeds expectations in Phase III, capping off a sparkling 2025 for the obesity titan; an internal FDA safety review finds no confirmed pediatric deaths caused by COVID-19 vaccines, and Commissioner Marty Makary says no black box warning will be attached to the shots; and BioSpace looks at six biotechs that could be pharma’s next buy. -
These deals radically reshaped the biopharma world, either by one vaccine rival absorbing another, a Big Pharma doubling down after another failed acquisition or, in the case of Pfizer and Novo, two heavyweights duking it out over a hot obesity biotech. -
Backed by Italy-based Fondazione Telethon ETS, Waskyra, for Wiskott-Aldrich syndrome, is the first gene therapy from a non-profit sponsor to win FDA approval.
