Kriya is advancing a host of gene therapies for a wide variety of chronic diseases, including geographic atrophy, trigeminal neuralgia and type 1 diabetes.
The sub-analysis, presented at the European Association for the Study of Diabetes congress, showed improved safety data to counteract past tolerability issues.
Both Novo Nordisk and Eli Lilly are eyeing regulatory advancements for their obesity blockbusters as the European Association for the Study of Diabetes’ annual conference continues this week.
Merck, Eli Lilly and AstraZeneca have similarly suspended or outright canceled investments in the U.K. in the past week after a sizeable increase in a mandatory levy in the region.
Like the first batch of appointees to the CDC’s vaccine advisory committee, several of the new panelists have documented histories of vaccine and COVID-19 skepticism.
Novartis and Monte Rosa first partnered in October 2024 for a molecular glue asset for immune-mediated and autoimmune diseases. This time, the pharma is putting $120 million down upfront for more of the biotech’s AI-discovered degraders.
CDER Director George Tidmarsh said on two separate events last week that he thought advisory committee meetings for specific drug applications were redundant, but then denied having said the agency would abandon them.
FEATURED STORIES
While some of the initial excitement around immunotherapies has waned, companies—particularly smaller biotechs—are developing newer iterations that will take cancer care to the next level.
Lilly CEO Dave Ricks in Wednesday’s third-quarter earnings call acknowledged that the company is at the mercy of wholesaler stocking decisions.
Big-name venture capital firms are raising billions again, though funding a small number of de-risked companies. Meanwhile, smaller VC firms are catching the less flashy companies they think could be future pillars of the sector.
BioSpace has been compiling a list of the most innovative and exciting biotechs for a decade. Here we take a look back at noteworthy companies from each of those lists.
While some analysts say Donald Trump is a wild card when it comes to drug pricing, many argue his presidency would be more positive for the industry overall, as Kamala Harris has her price-cutting sights squarely on Big Pharma.
FDA
As therapies for rare and neurological diseases earn accelerated approval, experts laud the program’s intent while remaining concerned about confirmatory trials and clinical efficacy, especially as products greenlit under this pathway are pulled from the market.
FROM BIOSPACE INSIGHTS
Biotech’s slump may finally be over in 2026. In interviews with BioSpace, Zymeworks’ CEO Ken Galbraith and Zai Lab’s President and COO Josh Smiley explain what’s fueling the comeback.
UPCOMING EVENTS
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
Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 2 clinical study evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class capsid inhibitor.
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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. All assets of the regenerative medicine and cell therapy company are being divested to its research partner to the tune of $2 million in the form of a credit bid.
  2. Following in the footsteps of Novartis, J&J and Merck, GSK jumped into the J.P. Morgan dealmaking frenzy Tuesday, picking up respiratory and inflammation-focused Aiolos Bio.
  3. From the rising trend of royalty financing to other adaptive funding strategies, firms think outside the box in responding to unprecedented challenges.
  4. Harpoon has several antibodies in its pipeline that are engineered to redirect a patient’s T cells to recognize and kill cancer cells.
  5. The pharmaceutical giant will pay $28 a share to acquire Ambrx’s pipeline of ADCs, particularly its lead candidate for prostate cancer.
WEIGHT LOSS
  1. The plethora of genes involved in obesity presents an intriguing opportunity for both gene silencing and ex vivo gene therapy approaches.
  2. Building on last year’s potential $7 billion partnership with Flagship Pioneering, Pfizer and Flagship-founded ProFound Therapeutics will work on discovering new obesity candidates.
  3. Seeking to target the lucrative obesity market, Merck is focusing its R&D efforts on next-generation GLP-1 therapies that offer additional benefits beyond weight loss, according to company executives.
  4. Sen. Bernie Sanders (I-Vt.), chair of the Senate health committee, has proposed issuing a subpoena to Novo Nordisk President Doug Langa forcing him to testify regarding the company’s pricing for Wegovy and Ozempic.
  5. Seeking to carve out its own niche in the obesity space, Syntis Bio launched on Tuesday to develop an oral weight-loss treatment that mimics the effects of gastric bypass surgery.
POLICY
  1. IRA
    The adjusted guidelines will provide drugmakers with more opportunities to engage with the Centers for Medicare and Medicaid Services regarding the initial maximum fair price offers, according to the agency.
  2. Faced with potential monetary fines, Johnson & Johnson said Monday it is abandoning a proposed 340B rebate plan for hospitals involving two of its blockbuster drugs, Stelara and Xarelto.
  3. Women are already underrepresented in clinical trials; the new abortion and IVF laws could make it worse.
  4. Sen. Bernie Sanders’ aggressive targeting of Danish drugmaker Novo Nordisk’s Ozempic and Wegovy pricing, and not Eli Lilly’s rival drugs, is not fair.
  5. Despite the settlement, the Securities and Exchange Commission on Thursday sued Cassava Sciences in the Western District Court of Texas, claiming that the company misled investors regarding the Phase IIb performance of its Alzheimer’s disease drug candidate.
CAREER HUB
Here is how you can land a job at one of the biggest pharmaceuticals in the world.
Regardless of if your motivation is to increase your salary or find a job that is more interesting to you, preparing for a career change can take a lot of time and energy.
Let’s take a trip through the alphabet to pick up 26 tips to optimize your cover letters.
To help you in your job search, we’ve compiled a list of cover letter do’s and don’ts.
No matter how much you justify ghosting, it’s likely to be seen as an unprofessional reputation-killer you may never recover from. Here are some situations in which you might be tempted to ghost and what to do instead.
Most of the interview process is out of your hands, for better or for worse. But what you can control are your actions.
Besides making sure you don’t accidentally reply all to that company-wide notice, here are some words to reserve for your texts with friends.
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 FDA previously placed two clinical studies on hold, including the Phase III trial in which the liver toxicity occurred. Intellia is working with experts to create a risk management program for nex-z.
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. 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.
  2. 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.
  3. 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.
  4. Bispecific antibodies and anti-TIGIT therapies both appear to be writing comeback stories as cancer experts head to Barcelona for the 2024 European Society for Medical Oncology Congress. Radioligand therapies and synthetic lethality assets are also attracting attention.
  5. The company is building a new facility in California, its third U.S.-based radioligand therapy production site, and expanding an Indianapolis site for producing isotopes for cancer treatment.
NEUROSCIENCE
  1. Recent M&A activity indicates a potential resurgence in the appetites of larger companies for psychiatric drug development, but experts say the space may not offer a sufficient risk-reward proposition for R&D.
  2. Otsuka Pharmaceuticals announced Wednesday it is ending development of drug candidate AVP-786 after failing to improve agitation associated with dementia due to Alzheimer’s disease.
  3. Approaches and targets for depression and other mental health illnesses have remained stagnant for decades. With several readouts for novel therapies on the horizon, that could be changing.
  4. Following a series of clinical failures, optimism builds for the first disease-modifying treatment.
  5. 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.
CELL AND GENE THERAPY
  1. BMS and J&J will meet with the Oncologic Drugs Advisory Committee Friday to discuss their CAR-T therapies Abecma and Carvykti as the companies seek their approval as earlier lines of treatment.
  2. 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.
  3. Separate challenges exist for companies developing gene therapies for rare and common cardiovascular conditions, experts told BioSpace.
  4. 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.
  5. 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.