Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug regulator in George Tidmarsh, a handful of new drugs get turned away from the market and pharma companies continue to commit billions to reshoring manufacturing.
Waltham, Massachusetts–based Skyhawk Therapeutics has been collecting collaborations with larger companies in spades since launching in 2018.
Patients who are prescribed Wegovy or Ozempic can now use GoodRx to access the medications at just $499 a month if they skip insurance. This is not the first time Novo has partnered with a pharmacy to offer the blockbuster drugs.
Inclacumab, which Pfizer obtained in its 2022 acquisition of Global Blood Therapeutics, failed to significantly lower pain episodes in patients with sickle cell disease over the 48-week treatment period.
Kriya is advancing a host of gene therapies for a wide variety of chronic diseases, including geographic atrophy, trigeminal neuralgia and type 1 diabetes.
In Phase III studies, Tonmya showed significantly superior analgesic effects in patients with fibromyalgia versus placebo. The sublingual pill also led to better clinical outcomes.
The label expansion could help Novo Nordisk “help shift the momentum” for Wegovy, after a difficult start to 2025, according to analysts at BMO Capital Markets.
FEATURED STORIES
Artificial intelligence won’t replace people in biopharma, but it is infiltrating every step of drug development, including in some ways that aren’t so obvious.
Sanofi looks to follow a deep history of Big Pharma offloading their consumer healthcare businesses.
Analysts expect the partners’ first-mover advantage, clinical data and existing presence in lung disease to translate into significant sales, with GlobalData predicting Dupixent’s COPD revenues will top $6.5 billion within 10 years.
FDA
Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials.
As companies roll out data showing the power and improved safety profile of antibodies that target two antigens, analysts say the class could overtake monoclonal antibody Keytruda as the “immunotherapy backbone” of solid tumor treatment.
Large pharmaceutical companies were out in force at this week’s 2024 Cell & Gene Meeting on the Mesa, as they look to expand their presence in the industry.
FROM BIOSPACE INSIGHTS
BioSpace’s Q3 2025 U.S. Life Sciences Job Market Report reveals a turbulent quarter for biopharma hiring, with record declines in job postings, rising layoffs, and cautious employer sentiment shaping the industry’s employment landscape.
UPCOMING EVENTS
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.
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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
  1. Nearly two decades in the making, the companies expect to close the deal in the first half of 2024, after which Taro Pharmaceutical will become a privately held entity and will no longer trade on the New York Stock Exchange.
  2. The bladder cancer-focused biotech is looking to be one of the first companies out of the gate with an initial public offering in 2024.
  3. Taiwanese contract development and manufacturing organization Bora will purchase Minnesota-based Upsher-Smith Laboratories, expanding operations into the U.S. for the first time.
  4. Alto Neuroscience and Kyverna Therapeutics are following in the footsteps of CG Oncology, Metagenomi and Arrivent in seeking initial public offerings this year.
  5. Following the J.P. Morgan Healthcare Conference and other parallel meetings in San Francisco, it’s time to reflect on some of the significant deals secured last week.
WEIGHT LOSS
  1. Data showed that Eli Lilly’s Zepbound could resolve obstructive sleep apnea in at least 43% of patients, solidifying the pharma’s case for label expansion.
  2. Altimmune’s obesity candidate pemvidutide strongly preserved lean muscle mass, with fat accounting for more than 78% of weight lost by participants in a Phase II study.
  3. Novo Nordisk’s Wegovy elicited greater weight loss in women than in men with heart failure, according to data presented Sunday at the American Diabetes Association’s 2024 Scientific Sessions.
  4. Zealand Pharma’s petrelintide cut body weight by more than 8% on average, with a good overall safety and tolerability profile.
  5. Eli Lilly on Thursday said it is again suing spas and clinics over compounded and counterfeit forms of tirzepatide, the active ingredient in blockbusters Mounjaro and Zepbound, which the pharma says can cause harmful side effects.
POLICY
  1. The selection of controversial TV personality Mehmet Oz to run the agency overseeing Medicare and Medicaid follows Trump’s pick of RFK Jr. to run its parent department, HHS.
  2. While the full impact of the Supreme Court decision remains unknown, the new regulatory landscape could be a net positive for drug developers.
  3. Trump’s HHS pick, Robert F. Kennedy Jr., is an anti-vaccine campaigner who has previously said that he plans to gut the FDA on allegations of corruption and reduce the NIH’s headcount.
  4. Suggestions that the U.S. should emulate other countries on drug price controls or patents obscure how our present policies have allowed drug development to flourish.
  5. Analyst reactions to Donald Trump’s election victory were mixed Wednesday, with potential positives including an FTC that is likely to be more friendly to M&A, and negatives including concerns about what role Robert F. Kennedy, Jr. might play in healthcare.
CAREER HUB
Do you know about the signs you need a new job? If not then you should be aware of them as they can help you get out of a boring job and get a new inspiring job.
Establishing rapport with someone you’ve just met who also may hold your future in their hands is not easy. Continue reading to discover how to establish rapport with your interviewer.
The first few minutes of your job interview are critical, as studies show hiring managers form strong impressions to make their hiring decisions based on these early minutes of the interview.
Here are three tips to help you land a management position when you’ve never been a manager.
It has been said that qualifications are more of a “wish list” for employers, who do not expect to find someone who meets all the requirements.
Simply staying organized will help you make sure you never miss a beat. Here are a few small steps that’ll make a big difference.
When using the STAR Method, be sure to discuss the who, what, where, when and how of an experience.
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
The centerpiece of the deal is orelabrutinib, a BTK inhibitor in late-stage development for multiple sclerosis that Biogen once paid $125 million for but abandoned after less than two years of testing.
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. Despite the disappointing late-stage results in non-small cell lung cancer, Jefferies analyst Stephen Barker contends the likelihood of FDA approval “remains high” for the experimental antibody-drug conjugate, though the regulator is now more likely to convene an advisory committee.
  2. Set to start in 2025, Relay Therapeutics is moving toward a pivotal study of experimental treatment RLY-2608 in heavily pretreated locally advanced or metastatic breast cancer.
  3. In advanced non-small cell lung cancer, Summit Therapeutics’ ivonescimab appears to be 49% more effective at reducing the risk of disease progression or death versus Merck’s Keytruda in a late-stage study. However, analysts contend the caveat is that the trial was conducted in an entirely Chinese patient population.
  4. Follow-up data from the MARIPOSA study show a favorable overall survival trend versus Tagrisso in EGFR-mutated advanced non-small cell lung cancer. The findings come just weeks after the Rybrevant-Lazcluze combination was approved for the first-line treatment.
  5. Using a computational biomarker, the companies say they can identify which patients would derive significant clinical benefit from their experimental antibody-drug conjugate. AstraZeneca and Roche are co-developing and commercializing a companion diagnostic for the biomarker.
NEUROSCIENCE
  1. Disappointed with Phase I/II results for two Ionis-partnered programs, one for amyotrophic lateral sclerosis and another for Angelman syndrome, Biogen has opted to not proceed with their development.
  2. After missing their initial target in March 2024, Eisai and Biogen have initiated a rolling BLA for a subcutaneous maintenance formulation of Leqembi, which could offer a more convenient dosing schedule for Alzheimer’s disease patients.
  3. With Monday’s agreement, AbbVie joins the industry’s growing interest in next-generation psychiatric therapies and looks to leverage Gilgamesh Pharmaceuticals’ research platform to discover novel neuroplastogens.
  4. Takeda on Monday said it is paying AC Immune $100 million upfront for an option on a Phase Ib/II Alzheimer’s disease candidate that could activate the immune system to clear amyloid beta plaques.
  5. With its $525 million investment, Royalty Pharma will acquire the royalties and milestones for ImmuNext’s anti-CD40 therapy frexalimab, which is currently in Phase III trials for multiple sclerosis.
CELL AND GENE THERAPY
  1. Gamida Cell, whose cell therapy for blood cancer was approved last year by the FDA, is being taken private and restructuring due to liquidity constraints.
  2. Nanoscope Therapeutics nabbed a victory on the changed primary endpoint of its Phase IIb vision loss gene therapy trial Tuesday, teeing the biotech up to file for FDA approval of the candidate this year.
  3. FDA
    With several recent approvals in the space and more on the horizon, BioSpace looks at some of the key decisions and their larger significance both for patients and science.
  4. Brazil’s Ministry of Health and nonprofit Caring Cross announced a collaboration Tuesday aimed at local manufacturing of CAR-T cell and stem cell gene therapies at a much lower cost than Europe and the U.S.
  5. Capstan Therapeutics is looking to move its CAR-T cell candidate forward after securing financing from pharma venture arms and VC firms.