Gene therapies have ridden investor mania to huge valuations but commercialization challenges have pushed market caps to the floor. At a roundtable last week, FDA leaders promised faster approvals and broad support to the industry.
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.
Susan Monarez, already acting director of the CDC, said during her confirmation hearing that she sees no causal link between vaccines and autism.
Jefferies analysts called the proxy filing, which is a standard disclosure after a merger agreement, “much more intriguing than normal” given the regulatory turmoil it revealed.
Minovia’s lead product is MNV-201, an autologous hematopoietic stem cell product that is enriched with allogeneic mitochondria.
Flagship Pioneering’s ProFound Therapeutics will use its proprietary technology to mine the expanded proteome for novel cardiovascular therapeutics. Novartis has promised to pay up to $750 million per target, though it has not specified how many targets it will go after.
FEATURED STORIES
The EPIC Act has been proposed with bipartisan and industry support to give small molecule drugs the same protection against price negotiation as biologics, but concerns over how to balance the federal budget could prevent a short-term fix to the IRA.
IPO
Around 25 companies have gone public this year, most of them in the early months. Most have tumbled from their original offer price.
By far, the largest acquisition of 2024 was Novo Holdings’ yet-to-be-closed buyout of manufacturer Catalent at $16.5 billion. Outside of that, the leading pharmaceutical companies kept to less than $5 billion per deal.
By speeding lifesaving drugs’ way to market and focusing on the underlying causes of disease, the pathway has helped save many lives.
The darlings of the weight loss and diabetes spaces, GLP-1 receptor agonists have shown promise against Alzheimer’s in recent studies—with Phase III results expected next year from Novo Nordisk.
President-elect Donald Trump and his incoming administration are unlikely to attempt a wholesale restructuring of U.S. healthcare and could promote M&A activity, but controversial picks like Robert F. Kennedy could impact vaccine sales, experts say.
FROM BIOSPACE INSIGHTS
Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. Learn how strategic insights and targeted outreach can turn awareness into high-converting leads.
LATEST PODCASTS
FDA
J&J and BMS’ challenges to Medicare drug price negotiations shut down in federal court less than a week after BMS announced it was laying off more than 2,000 employees.
DEI
In the second episode of our series on women’s health, we discuss what may happen to future generations if women, the custodians of generational health, are not comfortable sharing complete medical histories.
While Sanofi restructures and parts with employees from U.S. and Belgian sites, a new company in the GLP-1 space emerges from stealth.
Job Trends
Arvinas, Inc. and Pfizer Inc. announced updated clinical data from a Phase 1b combination cohort evaluating vepdegestrant, an investigational oral PROteolysis TArgeting Chimera estrogen receptor degrader, in combination with palbociclib.
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SPECIAL EDITIONS
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
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
  1. Biogen recently bolstered its pipeline with a potential $1.8 billion acquisition of Human Immunology Biosciences, following other big players looking to cash in on a global immunology market estimated to grow to $257 billion by 2032.
  2. In an SEC filing on Friday, Alumis said it aims to start late-stage trials of a TYK2 inhibitor in plaque psoriasis this year and is seeking public funding for the studies.
  3. After rejecting a previous takeover offer from Future Pak, Vanda Pharmaceuticals is now fielding another acquisition proposal from Cycle Pharmaceuticals, which values the biotech at $8 per share.
  4. Telix Pharmaceuticals is looking to cash in on radiopharmaceuticals, which have emerged as one of the hottest spaces in oncology, with an initial public offering to help support its pipeline of targeted radiation products.
  5. Illumina on Monday announced that its board of directors is spinning off Grail and has applied to list the cancer diagnostics company on the Nasdaq.
WEIGHT LOSS
  1. Novo Nordisk and Eli Lilly are expected to rule the obesity market for a few more years without much challenge. To ensure they stay there as competition enters, the companies are spending billions in licensing and M&A deals.
  2. Amid a flurry of weight loss readouts, a fresh-on-the-scene startup has come out with Phase I results showing weight loss at day 36 on par with or better than competitors, with few gastrointestinal side effects.
  3. In a high-profile showdown Tuesday with Sen. Bernie Sanders’ Senate health committee, Novo Nordisk CEO Lars Fruergaard Jørgensen will be asked to defend the drugs’ U.S. monthly list prices of $969 and $1,349, respectively.
  4. Novo Nodrisk’s cannabinoid receptor–targeting obesity pill was picked up in the $1.1 billion acquisition of Inversago Pharmaceuticals last year.
  5. With Thursday’s positive opinion from the Committee for Medicinal Products for Human Use, the matter now heads to the European Commission which will have the final say on whether Wegovy’s label will be updated.
POLICY
  1. Around 300 FDA staffers laid off last week are being asked to return. So far, the Trump administration has terminated some 1,000 employees from the agency.
  2. The postponed ACIP meeting comes barely a week after Robert F. Kennedy, Jr. was confirmed as Secretary of Health and Human Services, despite controversy regarding his anti-vaccine history.
  3. FDA
    Morale is low at the FDA, which was hit with layoffs this week following RFK Jr.’s confirmation. Biopharma leaders and agency insiders fear further workforce cuts could delay new medicines.
  4. Despite expectations of dealmaking leniency, new FTC chairman Andrew Ferguson told staff that he will retain the current 2023 FTC and DOJ guidelines on mergers, upholding stricter anti-trust scrutiny on deals.
  5. Recently appointed HHS Secretary Robert F. Kennedy Jr. in 2018 helped bring several cases against vaccine maker Merck, alleging injury linked to its HPV shot Gardasil.
CAREER HUB
Maryland has become a key part of the strategy for Kite, a Gilead company, and its mission to find a cure for cancer.
The pharmaceutical industry is full of job opportunities for people in various fields. Read on to find out more information about high-paying pharma industry jobs.
Are you looking for doctor careers in the pharma sector? Here is everything you need to know about how you can choose a reputable and growing pharma career.
Before going for pharmaceutical jobs interviews, you should be prepared to give the best answers possible. Here are six questions you should be ready for.
Finding a job in the pharmaceutical industry can be challenging. Find out which skills can help you score your dream pharmaceutical company job.
How can you show employers that your skills are current, despite being out of work for months or years?
Trying to develop a career in pharma may be overwhelming when you think about it. However, this article can help!
HOTBEDS
Where are the Best Places to Work in life sciences? BioSpace’s annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace - find out who made the list this year.
IN CASE YOU MISSED IT
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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
  1. FDA
    Regulators squeezed in two final approvals before the calendar change with the UK approval of Merck’s Winrevair and the FDA’s greenlight for an injectable formulation of BMS’s cancer blockbuster.
  2. Madrigal Pharmaceuticals, X4 Pharmaceuticals and Day One Biopharmaceuticals secured their maiden approvals this year in metabolic dysfunction-associated steatohepatitis, WHIM syndrome and pediatric low-grade glioma. Geron Corporation and ImmunityBio also notched wins.
  3. First approved in 2021, Jemperli has now become a cornerstone of GSK’s cancer business, earning more than $160 million in the third quarter.
  4. Both vibostolimab and favezelimab have had disappointing runs leading up to their termination, sustaining several late-stage failures.
  5. The FDA cited issues with a manufacturing facility as the reason for the rejection. J&J is currently “working closely” with the regulator to resolve these problems.
NEUROSCIENCE
  1. Roche drops a third Alzheimer’s candidate this year, terminating a partnership with UCB just four years after agreeing to work together on new treatments for the neurological disease.
  2. Seaport Therapeutics, kick started by the former leaders of Karuna Therapeutics, has raised $225 million in an oversubscribed Series B to fund a pipeline of neuropsychiatric medicines.
  3. BMO Capital Markets analyst Evan Seigerman in a note to investors said the late-stage data for Vertex’s experimental non-opioid pain medication “reaffirms our confidence in the strength of suzetrigine’s profile.” However, William Blair analysts view these data as “an incremental positive” as the company faces challenges in targeting the acute pain market.
  4. Wave Life Sciences in a Tuesday filing with the SEC said Takeda has elected to terminate its option to continue work on Wave’s WVE-003 clinical-stage Huntington’s disease program—a potential $5 billion commercial opportunity, according to the biotech.
  5. Johnson & Johnson is cutting several programs—most of which are in neurology and psychiatry—as the company also pulls back from the infectious diseases market.
CELL AND GENE THERAPY
  1. Regeneron, Akouos and Mass Eye and Ear are testing therapies that can reverse genetic protein deficiency to restore hearing, with promising early results.
  2. Likely to miss its initiation target, bluebird bio has renegotiated the loan deals of its agreement with Hercules Capital, giving it until June 30 next year—at the latest.
  3. Eli Lilly’s new research and development facility in Boston’s Seaport district will focus on DNA- and RNA-based therapies, as well as other priority areas such as diabetes and obesity.
  4. Patients in the U.K. with transfusion-dependent beta-thalassemia will have access to Vertex Pharmaceuticals’ gene editing therapy Casgevy, thanks to an agreement with the National Health Service on the price.
  5. 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.