The high court found that members of a task force that determines what preventive drugs must be covered can be removed at will by HHS Secretary Robert F. Kennedy Jr.
The revamped and “more anti-vax skewed ACIP committee” at the CDC “has a bone to pick with mRNA vaccines,” according to Truist Securities analysts. Meanwhile, the FDA moves forward on having Pfizer/BioNTech and Moderna update labels for their COVID vaccines.
The FDA found that data from a single Phase II study were “insufficient” to justify an accelerated approval review for sevasemten in Becker muscular dystrophy.
Altimmune’s pemvidutide failed to significantly improve fibrosis in MASH patients in a Phase IIb study. The biotech crashed 53% in the aftermath of the readout.
Calico will leverage 9MW3811’s anti-inflammatory mechanism to advance its mission of addressing aging-related diseases.
While ALTO-203 missed its depression-related endpoints, improvements in EEG biomarkers, attention and wakefulness point to signals of drug activity, William Blair said, though the analysts pointed to other indications as potentially more promising for future development.
FEATURED STORIES
The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions.
It’s time for Congress to step up and fund America’s supply chain independence from Chinese companies by bolstering our domestic manufacturing capabilities.
Analysts expressed skepticism about plans detailed by Moderna’s R&D chief Stephen Hoge to trim research spending in preparation for the launch of up to 10 new products.
As it nears a crucial FDA action date for its transthyretin amyloid cardiomyopathy candidate, BridgeBio focuses on its late-stage pipeline.
No patients have received Casgevy, CRISPR Therapeutics and Vertex Pharmeceuticals’ recently approved sickle cell gene therapy. Experts weigh in on the path to profit for the treatment and the therapeutic class in general.
Healthcare players are pointing fingers amid regulatory crackdowns on pharmacy benefit managers, but proposed reforms wouldn’t address a dearth of competition in the larger market.
FROM BIOSPACE INSIGHTS
Listen now for a high-level discussion on overcoming pharmaceutical supply chain challenges through end-to-end integration.
LATEST PODCASTS
The White House is clamping down on pharma’s ability to buy new molecules from Chinese biotechs; Sanofi, Merck and others abandon the U.K. after the introduction of a sizeable levy; Novo CEO Maziar Mike Doustdar lays off 9,000 while the company presents new data at EASD; Capsida loses a patient in a gene therapy trial; and CDER Director George Tidmarsh walks back comments on FDA adcomms.
This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
In this episode presented by Taconic Biosciences, BioSpace’s head of insights Lori Ellis discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment with Mike Garrett, CEO.
Job Trends
Blackstone announced a new collaboration with Moderna, Inc. through a development and commercialization funding agreement where funds managed by Blackstone Life Sciences will provide up to $750 million to fund Moderna’s influenza program.
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SPECIAL EDITIONS
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
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.
DEALS
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All three companies closed out the year, which saw significant growth in mergers and acquisitions, with high-value deals that could potentially set the tone for M&A in 2024. -
The acquisition announced on Friday will give Bristol Myers Squibb ownership of Karuna Therapeutics’ investigational antipsychotic KarXT, which is being tested for schizophrenia and Alzheimer’s disease psychosis. -
Continued fallout from the IRA, heightened antitrust enforcement and the rise of AI will all shape the first wave of biotech mergers and acquisitions coming this year, experts tell BioSpace. -
What needs to happen for funding in biopharma to bounce back? BioSpace’s Lori Ellis discusses the macroeconomic environment and biopharma funding outlook with venture capital guests Ansbert Gadicke, Martin Gershon and Mike Goguen. -
After a “reasonably strong year” in 2023, next year will see “similar levels” of M&A activity with increased investor interest in weight loss and cardiovascular diseases, contends professional services firm PwC.
WEIGHT LOSS
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Novo Nordisk will face strong generic competition from at least 15 companies in China for its blockbuster GLP-1 receptor agonist products Wegovy and Ozempic, according to Reuters. -
The U.K.’s National Institute for Health and Care Excellence has endorsed the use of Eli Lilly’s Zepboundfor weight management in patients with BMI of 35 kg/m2 and above and at least one weight-related comorbidity. -
Structure Therapeutics’ GLP-1 receptor agonist GSBR-1290 achieved mean weight loss of 6.2% in overweight or obese patients. The company’s shares jumped to a six-month high on the news Monday. -
Driven by growing market demand and an improving supply chain, the global weight-loss drug market is expected to hit $150 billion in value by the early 2030s, according to analysts cited by Reuters. -
The FDA currently does not recommend using changes in lean mass as an endpoint in clinical trials for weight loss drugs. Should it?
POLICY
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Massachusetts residents voted Tuesday against the Natural Psychedelic Substances Act, which would have seen some psychedelics, including psilocybin and dimethyltryptamine, legalized in the state. -
Senator Elizabeth Warren told the Federal Trade Commission that the acquisition of contract manufacturer Catalent could increase Novo’s dominance over the hot GLP-1 market, reducing competition and increasing prices. -
The U.S. Department of Justice alleged that Teva violated the Anti-Kickback Statute and the False Claims Act. The payment is in addition to the criminal penalty paid by Teva USA under its deferred prosecution agreement. -
WuXi AppTec looks to unload its Philadelphia manufacturing sites and WuXi Biologics slows its rapid expansion in the U.S. as the companies await the Senate’s review of the BIOSECURE Act that threatens to cut them off from U.S. biopharma. -
Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents.
This article offers suggestions for how to be camera-ready for a virtual interview.
Many people are wondering how they can make meaningful connections and grow their professional network in a time when large group meetings are discouraged.
Once you’ve made initial meaningful contact with a hiring manager – through an interview, online or phone inquiry, informational interview or networking experience – the best way to turn that encounter into opportunity is through sustained follow-up.
Here are four ways to improve your productivity while working from home!
You can apply these career-planning and goal-setting techniques to establish career goals that are just as exciting as those you dreamed about as a kid.
The interview goes both ways and in order to choose a perfect workplace, you must analyze a few things. Here are a few interview red flags to watch out for during an 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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NuCana’s chemotherapy replacement has failed to improve progression-free survival in a Phase II test, sending the biotech’s shares down by 50%. -
The pharma continued its clinical losing streak on Thursday with the announcement that it is discontinuing late-stage studies of the anti-PD-1 therapy in non-small cell lung cancer and cutaneous squamous cell carcinoma. -
With the FDA’s rejection of Ordspono in March, Monday’s green light from the European Commission marks the first approval worldwide and the first regulatory victory for Regeneron’s bispecific antibody platform. -
The Oncologic Drugs Advisory Committee in a Sept. 26 meeting will discuss whether the regulator should restrict approval of checkpoint inhibitors based on PD-L1 expression levels. -
The regulator’s Complete Response Letter flagged problems at a third-party fill/finish site, which Regeneron says it has already addressed. The manufacturing facility is currently awaiting reinspection.
NEUROSCIENCE
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Neurocrine Biosciences on Tuesday won the FDA’s approval for a sprinkle capsule formulation of Ingrezza, providing a more convenient route of treatment for Huntington’s disease patients with trouble swallowing. -
On June 10, the FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss the New Drug Application for Lilly’s Alzheimer’s drug. -
After a record low in 2022, the pharma industry in 2023 saw a surprise rebound in productivity following one of its slowest years on record, according to a report from audit firm Deloitte. -
Ketabon is working to develop a medication that harnesses ketamine’s antidepressant effects without the safety issues that currently prohibit its at-home use. -
Biogen on Wednesday exceeded analyst profit estimates for the first quarter of 2024 as the biotech’s cost-cutting measures took hold and sales of its Alzheimer’s disease therapy Leqembi started to pick up.
CELL AND GENE THERAPY
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The FDA’s busy week ahead involves three decision dates for potential industry firsts and a highly anticipated advisory committee meeting for two CAR-T therapies. -
Separate challenges exist for companies developing gene therapies for rare and common cardiovascular conditions, experts told BioSpace. -
Formerly known as Ryne Bio, Kenai Therapeutics emerged on Thursday with backing from several groups and has a cell therapy candidate going after Parkinson’s disease. -
Sarepta Therapeutics on Wednesday called the launch of the gene therapy for Duchenne muscular dystrophy “exceptional” but the company does not expect to see significant growth in the first half of 2024 due to its currently limited patient pool. -
Cell and gene therapy professionals gathered in Miami last month to discuss new manufacturing approaches for these up-and-coming treatments.
