Ambros Therapeutics’ non-opioid bisphosphonate analgesic, already approved in Italy, will soon begin a pivotal test in the U.S.
Sanofi bought Dren’s DR-0201 program earlier this year for $600 million upfront and is running two Phase I trials in undisclosed inflammatory indications.
Vyvgart, an FcRn inhibitor already approved for generalized myasthenia gravis, is also being tested in myositis, Sjögren’s disease and the “clinically related” Graves disease.
Sanofi’s multiple sclerosis hopeful tolebrutinib faced dual setbacks on Monday, with a late-stage failure in one form of the disease and yet another regulatory setback in another.
The FDA had previously turned back the heart rhythm nasal spray twice, once in late 2023 with a refusal to file letter and again in March this year, when it flagged manufacturing issues.
For $950 million upfront, Sobi will gain ownership to pozdeutinurad, an oral URAT1 inhibitor that performed well in Phase II studies.
FEATURED STORIES
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
Every year in biopharma brings its share of grueling defeats, and 2025 was no different, especially for companies targeting neurological diseases. Some failures split up partners, and one particularly egregious case even led to the demise of an entire company.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The FDA is becoming deeply compromised and increasingly at risk of being permanently transformed in ways contrary to its mission, history and culture.
With $6 billion left in firepower, Pfizer is planning transactions in the hundreds of millions to the low-billions range, particularly in internal medicine and immunology and inflammation, Guggenheim reported.
Long a quieter, locally focused industry, Japanese pharma giants are increasingly looking to the rest of the world for deals.
LATEST PODCASTS
Experts unpack the implications of CBER Director Vinay Prasad’s claim that COVID vaccines have caused 10+ child deaths; the 2025 Clinical Trials on Alzheimer’s Disease conference continues following two disappointing readouts; and Novo Nordisk’s amycretin yields promising weight loss results.
Merck has made a $9.2 billion play for Cidara, and there’s another bidding war afoot, this one for sleep biotech Avadel. Meanwhile, Rick Pazdur has taken the helm at CDER while tensions run high between FDA Commissioner Marty Makary and Health Secretary RFK Jr.
In this episode presented by Slone Partners, Leslie Loveless, Co-CEO and Managing Partner discusses how hiring and the building of executive teams has responded to the current biotech environment.
Job Trends
BioSpace has named 50 life sciences companies to its 2026 Best Places to Work list. AbbVie, Amneal Pharmaceuticals and BridgeBio executives share what makes their organizations special.
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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.
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.
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.
DEALS
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Pfizer apparently had more in the tank after the high-profile battle to acquire Metsera earlier this fall. The company has licensed a new GLP-1 from YaoPharma. -
What China is accomplishing in R&D “has implications for everyone playing in the R&D or innovation world,” McKinsey’s Fangning Zhang says. -
The centerpiece of the deal is the in vivo editor TSRA-196, which in preclinical studies has shown robust editing at SERPINA1, the locus linked to alpha-1 antitrypsin deficiency. -
At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise. -
Drug candidates don’t usually move among Big Pharma, but these five biotechs helped facilitate such hand-offs, scooping up assets from one pharma on the cheap before being bought out for billions by another.
WEIGHT LOSS
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Structure’s aleniglipron elicited over 11% weight loss in a Phase II trial, sending the biotech’s stock up nearly 103% as markets closed on Monday. -
Although still in Phase I, Wave Life Sciences’ injectable RNA weight loss treatment achieved results that impressed analysts, with 4% fat reduction after three months, beating Novo Nordisk’s semaglutide at a similar time point. -
Experts unpack the implications of CBER Director Vinay Prasad’s claim that COVID vaccines have caused 10+ child deaths; the 2025 Clinical Trials on Alzheimer’s Disease conference continues following two disappointing readouts; and Novo Nordisk’s amycretin yields promising weight loss results. -
While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook. -
Following Novo Nordisk’s price cuts for its own GLP-1 medicines, Eli Lilly is offering discounts for the obesity drug purchased through LillyDirect. Both pharmas recently struck a deal with the White House for cheaper prices via the yet-to-be-launched TrumpRx.
POLICY
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In this episode of Denatured, Jennifer C. Smith-Parker speaks to Stacey Adam, PhD, Vice President of Science Partnerships at the Foundation for the National Institutes of Health and Patrick Smith, Senior Vice President, Translational Science at Certara, to discuss the latest regulatory news and the future for new approach methologies (NAMs) development. -
With new UK clinical trial rules landing in 2026, the EU Biotech Act on the horizon and China and Australia gaining ground, CROs are zeroing in on study timelines, AI/ML and data privacy as the industry’s next pressure points. -
This week’s meeting of the Advisory Committee on Immunization Practices will be led by Kirk Milhoan, a physician and pastor who recently claimed that COVID-19 vaccines contained a contamination that causes cancer. -
U.K.-based pharmas will not face tariffs as long as Donald Trump is president, according to the agreement. -
The discounts should be compared against the drugs’ “ultimate net price” rather than their indicated list price to gauge the true impact of the negotiations, BMO Capital Markets analysts said.
In a volatile industry, staying put might seem like a smart bet, but job hugging can quietly erode your visibility, growth and future opportunities.
Transparency doesn’t drive people away. It attracts the right ones and keeps them committed. Leadership coach Angela Justice discusses the problem with leaders only selling the upside and the value of setting accurate expectations from the start.
Media coverage can help biopharma executives connect with, inform and inspire the public. In this column, Kaye/Bassman’s Michael Pietrack and three communications experts share how to make the most of these opportunities.
What if loyalty is holding you back? While it’s a sign of character, consistency and belief in a mission bigger than yourself, it can also keep you stuck in a job when you should be moving on.
It’s easy to get caught up in defending yourself against critique that feels unfair. Leadership coach Angela Justice recommends a different approach that can help you better align how you want to be seen with how you’re showing up.
Tapping into the hidden job market can be challenging but is important in today’s employer-driven market. Three talent acquisition experts share tips for accessing hard-to-find roles.
HOTBEDS
REPORTS
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.
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.
The life sciences job market continues to shift. BioSpace’s Q2 2025 U.S. Life Sciences Job Market Report is now available, offering exclusive insights into the latest hiring trends, layoffs, and workforce dynamics across the life sciences industry.
CANCER
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While overall survival remains immature, results so far show a clear trend in favor of Roche’s giredestrant. -
TERN-701 more than doubled the response rate of Novartis’ rival approved therapy in an early-stage trial, sending the biotech’s shares flying.
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The 2025 meeting of the American Society of Hematology features some of the newest developments in blood cancers and rare diseases. -
GSK and Ideaya first linked up in 2020 to advance novel therapies for solid tumors. It is unclear why the pharma terminated the partnership. -
The partnership will focus on Crescent’s PD-1/VEGF inhibitor CR-001 and Kelun-Biotech’s SKB105, both of which the companies plan to push into Phase I/II development for solid tumors early next year.
NEUROSCIENCE
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The R&D pipeline for depression therapies faced a demoralizing 2025 as five high-profile candidates, including KOR antagonists by Johnson & Johnson and Neumora Therapeutics, flunked late-stage clinical trials, underscoring the persistent challenges of CNS drug development. -
Innovative outcome measures coupled with a focus on patient-centered clinical differentiation can help the biopharma industry make meaningful progress in the highly complex area of neuroscience. -
Praxis Precision Medicines has also announced a “successful” pre-NDA meeting with the FDA for its essential tremor drug candidate ulixacaltamide, for which an approval application is slated for early 2026. -
Days after Johnson & Johnson’s posdinemab failed to slow clinical decline in patients with Alzheimer’s disease, Eisai Chief Clinical Officer Lynn Kramer expressed unwavering conviction in his company’s own anti-tau asset, while others suggest the Alzheimer’s field is heading in a completely different direction. -
Investor optimism has waned as final minutes from uniQure’s pre-BLA meeting with the FDA convey that data from the company’s Phase I/II studies of AMT-130 are “unlikely” to provide the primary evidence to support a biologics license application.
CELL AND GENE THERAPY
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Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies. -
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential. -
After revoking Sarepta’s award in July and awarding one to Krystal last month, the FDA’s platform technology designation program appears to be back on track. These six biotechs could be on the regulator’s radar. -
Sarepta must also run a post-marketing study for Elevidys to better assess the risk of serious liver injury in patients dosed with the gene therapy. -
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
