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.
Newly appointed Center for Drug Evaluation and Research director Richard Pazdur has filed retirement papers with the agency—three weeks after accepting the role—amid clashes with Commissioner Marty Makary over certain FDA programs.
With no evidence to support the claim that 10 children died due to COVID-19 vaccines, experts unpack the impact of CBER chief Vinay Prasad’s leaked vaccine memo.
While Imvax’s autologous immunotherapy IGV-001 missed the primary endpoint of progression-free survival in a Phase IIb trial, the company will request a meeting with the FDA to discuss next steps for “synergistic” treatment.
Trontinemab lowered amyloid levels below the threshold of positivity in 92% of treated patients.
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.
FEATURED STORIES
While a new facility setup program aimed at encouraging onshoring received a positive reception at a recent meeting, industry representatives said the current rules on existing production plants are the main regulatory issues facing manufacturing teams.
To drive true innovation in drug development, executives must not let excitement about the latest shiny object obscure ultimate outcomes.
Heading into the final quarter of a year that has seen dramatic upheaval at the FDA—from the exodus of numerous senior leaders to unclear policy changes and a safety saga that engulfed the gene therapy space—drug approvals appear roughly on par with recent years.
Therapies from industry leaders BioMarin and Ascendis Pharma supply a key hormone that promotes bone growth. In order to move the field forward, challengers are looking to address the underlying cause of the rare, genetic disease.
New analysis from Jefferies shows that rare disease and cancer drugs granted the status are especially likely to be approved.
Takeda wanted to create something new in the cell therapy world by combining the technology with T cell engagers. A series of acquisitions in 2021 started the process.
LATEST PODCASTS
Sarepta’s Elevidys is back on the market for ambulatory patients with Duchenne muscular dystrophy, Health Secretary Robert F. Kennedy Jr. reportedly plans to dissolve the U.S. Preventive Services Task Force and “fix” the vaccine injury compensation program, Merck, AstraZeneca and more report Q2 earnings, Novo names a new leader and Roche’s trontinemab impresses at AAIC25.
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.
In this episode presented by Eclipsebio, BioSpace’s head of insights Lori Ellis continues the discussion on mRNA and srRNA with Andy Geall of Replicate Bioscience and Alliance for mRNA Medicines and Pad Chivukula of Arcturus Therapeutics.
Job Trends
French biotech Inventiva’s layoffs and pipeline shift are expected to help keep the company operational into the second half of 2026.
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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
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Blank check deals dwindled after a crazy 2021. Now, biotechs are starting to turn to special purpose acquisition companies again as an easy route to the public markets. -
After spinning out of BridgeBio in May 2024, BBOT had an eye on another round of fundraising in 2025. A SPAC quickly emerged as the best option. -
Vertex Pharmaceuticals commits $45 million upfront to leverage Enlaza Therapeutics’ War-Lock platform to create drug conjugates and T cell engagers for autoimmune diseases and gentler conditioning for sickle cell/beta thalassemia gene-editing therapy Casgevy. -
Novartis is licensing ARO-SNCA, a preclinical siRNA therapy for synucleinopathies, a group of neurodegenerative disorders including Parkinson’s disease. -
If the trend holds, IQVIA expects 2025 deal volume between Chinese and multinational companies to easily eclipse the 100 agreements signed in 2024.
WEIGHT LOSS
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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. -
While Eli Lilly’s orforglipron is top of mind heading into the European Association for the Study of Diabetes meeting this week, experts told BioSpace the conference will also provide important insights into the therapeutic benefits of incretin therapies beyond weight loss. -
As Novo Nordisk cuts 9,000 people from its organization in a restructuring effort, BioSpace looks back on the Danish pharma company’s rise. -
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.
POLICY
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The World Health Organization’s Essential Medicines list guides high-level procurement and coverage decisions for over 150 countries. -
Robert F. Kennedy Jr. repeated a series of anti-vaccine talking points during his appearance in front of the Senate finance committee on Thursday, as Democratic and Republican senators alike hammered the Health Secretary on recent COVID-19 vaccine restrictions and his views on Operation Warp Speed. -
Ousted CDC Director Susan Monarez claimed in an op-ed published in The Wall Street Journal Thursday that she was fired for refusing to rubber-stamp COVID-19 recommendations to be made by an advisory panel that has expressed “antivaccine rhetoric.” -
In coordination with the United States President’s Emergency Plan for AIDS Relief, Gilead will make its twice-yearly HIV prophylactic Yeztugo available to resource-limited countries “at no profit.” -
Perhaps the most interesting of the pile of FDA rejection letters was for Lykos Therapeutics’ MDMA therapy. Letters sent to Stealth BioTherapeutics, Regeneron and more were also released as the agency also promised future CRLs “promptly after they are issued to sponsors.”
Companies will look at job candidates’ LinkedIn profiles, so make sure yours is strong, from the summary of your expertise and qualifications to testimonials from colleagues.
After more than 20 years at Eli Lilly, Leslie Sam moved into independent consulting. To prepare for the transition, she focused on becoming technically deep and earning industry recognition.
Employed and unemployed biotech and pharma professionals are thinking about job hunting in other fields amidst a challenging labor market.
When you don’t get the promotion you wanted, it’s important to assess your company and yourself so you can improve your odds in the future.
Looking for an automation engineer job? Check out these seven companies hiring life sciences professionals like you.
Career support is the No. 2 driver of employee engagement while learning and development is No. 3, according to a new Right Management report. A recent BioSpace survey supports those findings.
HOTBEDS
REPORTS
The 2021 Salary Report is significant in more ways than one. This year, BioSpace analyzed salary data through two key lenses: the impact of the pandemic, and for the first time, race and ethnicity.
BioSpace’s 2022 Salary Report explores the average salaries and salary trends of life sciences professionals. Though movement in the labor market slowed during the pandemic, recovery has been swift and employers are once again having to cope with a highly competitive talent market.
BioSpace has created guidelines on how biopharma organizations, large and small, can effectively support employee resource groups (ERGs), encouraging both their creation and ongoing participation.
CANCER
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The French giant is gaining access to darovasertib, a small molecule protein kinase C inhibitor already in Phase II/III trials, with rights for the whole world besides the U.S. -
Exelixis is looking at the possibility of relocating some of the eliminated Pennsylvania roles to its headquarters in Alameda, California, according to a company spokesperson. -
Krystal Biotech’s decision follows the FDA’s rejection last month of Replimune’s RP1, which works similarly to Krystal Biotech’s KB707. The biotech said this has introduced “heightened uncertainty” regarding a potential accelerated pathway for the candidate. -
The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new guidance follows the surprising return of CBER Head Vinay Prasad, who has previously argued for prioritizing OS. -
The platform strategy of using one molecule to target an underlying biological pathway to address many different diseases can be a goldmine for smaller companies. But it also has a unique set of challenges.
NEUROSCIENCE
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Shares of Rapport Therapeutics popped Monday morning after Phase IIa data for RAP-219 exceeded analyst and Wall Street expectations, reducing seizures by almost 78% in patients with drug-resistant focal onset seizures. -
KER-0193 is a modulator of ion channels connected to autism spectrum disorder. The FDA bestowed orphan drug and rare pediatric drug designations on the candidate earlier this year. -
New FDA expert panels, such as recent meetings on SSRI use during pregnancy and on hormone replacement therapy during menopause, are drawing criticism for being one-sided. One leader says such panels are designed to reach a specific conclusion. -
Rick Doblin, the founder of the Multidisciplinary Association for Psychedelic Studies, which founded Lykos, bemoaned a “moving of the goal posts” in Lykos’ rejection but looked for positives in the newly released complete response letter. -
The reprioritization effort will help AC Immune extend its cash runway through the third quarter of 2027.
CELL AND GENE THERAPY
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The FDA has postponed its decision date for Regenxbio’s Hunter syndrome gene therapy to review additional longer-term clinical data for the asset. -
Kriya is advancing a host of gene therapies for a wide variety of chronic diseases, including geographic atrophy, trigeminal neuralgia and type 1 diabetes. -
Prasad Returns, Delany Departs, Lilly’s Weight Loss Pill Disappoints and Sarepta’s Fallout ContinuesCBER Chief Vinay Prasad reclaimed his job less than two weeks after his mysterious exit; MAHA implementor Gray Delany is out after reportedly sparring with other agency officials over communications strategy; Eli Lilly’s first Phase III readout for oral obesity drug orforglipron missed analyst expectations; and Arrowhead Pharmaceuticals addresses the recent woes of its of partner Sarepta.
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Jefferies analysts said these detailed safety outcomes confirm the gene therapy’s positive risk/benefit profile in ambulatory patients with Duchenne muscular dystrophy. -
Skysona can now only be used in patients with cerebral adrenoleukodystrophy who have no available treatment alternatives or stem cell donors.
