The FDA Adverse Event Reporting System, which Commissioner Marty Makary called “clunky,” previously published updates on a quarterly basis.
A draft executive order obtained by The New York Times purports to clamp down on the pharmaceutical industry’s ability to buy new molecules from biotechs based in China, along with a number of other proposed reforms.
The biopharma job market remains challenging, based on BioSpace data. In August, job postings live on the website dropped 32% year over year. In addition, during the first eight months of 2025, over 26,000 people were laid off or projected to be laid off.
New York City has seen increased life sciences employment during the past decade as public funding and key projects like JLABS @ NYC have given the area a boost. A Partnership Fund for New York City executive discusses the city’s strengths and a notable challenge facing businesses.
Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy.
New draft guidelines suggest the FDA is open to exercising regulatory flexibility for non-opioid drugs being developed for chronic pain.
Analysts at BMO Capital Markets expect the lack of other exon-44-skiping therapies to facilitate a “smooth” approval process for Avidity’s del-zota.
FEATURED STORIES
Continuing our SCOPE 2025 coverage, Rohit Nambisan, CEO at Lokavant addresses not only current challenges, but the life sciences industry’s responsibility to maintain scientific integrity.
After the rejection of Lykos Therapeutics’ MDMA-based PTSD treatment tempered excitement for psychedelic therapeutics, a recent approval and positive data are generating new momentum, which experts expect to continue throughout 2025 and 2026.
Biopharma doubles down on immunology and inflammation as companies target new pathways and seek to improve on current options in inflammatory bowel disease, atopic dermatitis, myasthenia gravis and more.
Jay Ferro, EVP, CIO, CPO & CTO at Clario discusses safety, trust and what keeps him up at night.
Just a few months after Vir Biotechnology lost an emergency authorization for its COVID-19 antibody, Marianne de Backer stepped in as CEO to answer a critical question: What’s next?
As the Q4 2024 pharma earnings period rolls on through the first month of President Donald Trump’s second term, executives find themselves faced with policy questions ranging from the Inflation Reduction Act to RFK Jr.
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
AAVs and accelerated approval are just two of the topics being discussed at ASGCT. Meanwhile, the race between Vertex and bluebird bio’s gene therapies Casgevy and Lyfgenia is heating up.
Follow News Editor Greg Slabodkin and Managing Editor Jef Akst as they travel with some 8,000 others for discussions of cell and gene therapy advances, challenges, regulations and more.
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.
Job Trends
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced the publication of its 2023 Corporate Responsibility Report.
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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. GSK on Wednesday restructured its contract with CureVac to gain access to the biotech’s influenza and COVID-19 programs for $430 million upfront and up to $1.13 billion in future payments.
  2. Eli Lilly is expanding its radiopharmaceutical portfolio with a $140 million upfront payment to Radionetics Oncology and the exclusive future right to acquire the biotech for $1 billion.
  3. Samsung Biologics announced Tuesday it has signed its largest contract ever—a $1.06 billion manufacturing deal with an unnamed pharmaceutical company headquartered in the U.S.
  4. Cartesian Therapeutics’ mRNA CAR-T therapy met its primary endpoint in a mid-stage trial for the chronic autoimmune disorder and expects to raise $130 million via private placement equity financing.
  5. In 2023, the ADC market exceeded $10 billion, and this momentum is persisting into 2024, as evidenced by several strategic deals and a robust pipeline of candidate drugs.
WEIGHT LOSS
  1. Wednesday’s update to the regulator’s drug shortage database is good news for Novo Nordisk, which has struggled to keep up with demand for the blockbuster GLP-1 drugs.
  2. Eli Lilly’s blockbuster weight loss and diabetes drugs missed analysts’ expectations by 18% in the third quarter, which were negatively impacted by inventory stocking in the wholesaler channel. The company’s shares fell more than 13% in trading on Wednesday morning.
  3. The group of like-named companies that include Novo Holdings and Novo Nordisk—the two tied to a multibillion-dollar buyout of Catalent currently under FTC review—ultimately send proceeds to the Novo Nordisk Foundation, one of the world’s largest charitable foundations.
  4. Following an end-of-Phase II meeting with the FDA in the fourth quarter, Viking Therapeutics plans to push its subcutaneous obesity therapy VK2735 into late-stage development and to start a Phase II trial for an oral formulation.
  5. Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which includes drugs that are too complicated to produce and could pose substantial safety risks to patients if manufactured incorrectly.
POLICY
  1. Under Friday’s final ruling anti-obesity medications for weight-loss will remain ineligible for Medicare coverage.
  2. Kennedy, a long-time opponent of vaccines, stated that the MMR vaccine is “the most effective way” to combat the measles outbreak, which has already claimed the lives of two children in the U.S.
  3. Pharma’s reprieve from Donald Trump’s tariffs is expected to be temporary, with Leerink analysts anticipating possible sector-specific duties “in the next month or so.”
  4. FDA
    With the recently announced layoffs of 3,500 FDA staffers and exits of branch directors Patrizia Cavazzoni and Peter Marks, there could be a wealth of talent available to biopharma companies. Does this pose an ethical quandary? It depends on who you ask.
  5. Trump has repeatedly called April 2 “Liberation Day,” alluding to a more sweeping and aggressive set of tariffs. Leerink Partners analysts said that the risks from Trump’s tariffs on the biopharma industry are “underappreciated.”
CAREER HUB
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.
When dealing with a large group of people, the possibility of handling a disgruntled employee is very likely. Here’s how you can handle them efficiently.
Most people don’t know that asking questions can help with an application. Here are some unique questions for interviewer that you should remember to ask next time.
If you’re questioning which types of leaders you get along with the best, or you’re just wondering what types of leaders exist, you’re in the right place. Here’s a quick breakdown.
Just like first impressions, the first 30 days at your new job can set the tone for a new position.
Providing interview feedback to the candidate after an interview is very crucial if you want to pick out only the best. This article will help you do that efficiently.
Are you feeling that your productivity is decreasing at work? Here are some beneficial time management strategies to be mindful of to get work done efficiently.
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
CMS Administrator Mehmet Oz clarified that a deal has not yet been sealed with the manufacturer of semaglutide, Novo Nordisk, or any other GLP-1 drugmaker.
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. An FDA committee’s September 2024 vote to limit the use of Merck’s Keytruda and BMS’ Opdivo in stomach and esophageal cancers based on PD-L1 expression levels reflects an emerging trend that leverages ever-maturing datasets.
  2. In this short teaser, BioSpace’s Head of Insights Lori Ellis talks to CBER Director Peter Marks and Tom Whitehead, Co-Founder of the Emily Whitehead Foundation about anticipated discussions at the upcoming GenScript Biotech Forum.
  3. Staff cuts will leave IGM Biosciences with 37 employees. The company is also halting development of two bispecific antibody T cell engagers for autoimmune diseases.
  4. If approved, Pfizer’s sasanlimab will distinguish itself from Merck’s blockbuster Keytruda as the first PD-1 inhibitor indicated in combination with BCG for high-risk non-muscle invasive bladder cancer patients who had not previously undergone BCG treatment.
  5. On Thursday, Boehringer Ingelheim announced a partnership with Synaffix to advance antibody-drug conjugates and exercised its fourth license option under a 2013 collaboration with Oxford BioTherapeutics.
NEUROSCIENCE
  1. The shocking failure of AbbVie’s emraclidine has investors questioning the Big Pharma’s long-term neuroscience strategy, which put the drug at the center of expectations.
  2. The past four years have brought disappointment for the Huntington’s community, but optimism is growing as companies including Prilenia and Wave Life Sciences eye paths to approval of therapies that could address the underlying cause of the disease.
  3. A fatal, highly hereditary illness with no disease-modifying treatments, Huntington’s is long overdue for a therapeutic win. Here, BioSpace looks at five candidates that could change the trajectory for patients.
  4. With Eisai and Biogen’s Leqembi and Eli Lilly’s Kisunla launching onto the market, the 2024 Clinical Trials of Alzheimer’s Disease conference focused on the role these drugs might play, as well as combination therapies and innovative new treatment options.
  5. Leqembi’s sales continue to be underwhelming, according to analysts, who contend the companies’ Alzheimer’s disease therapy is being held back by barriers such as coverage, infusion centers and time to diagnosis.
CELL AND GENE THERAPY
  1. As it nears a crucial FDA action date for its transthyretin amyloid cardiomyopathy candidate, BridgeBio focuses on its late-stage pipeline.
  2. No patients have received Casgevy, CRISPR Therapeutics and Vertex Pharmeceuticals’ recently approved sickle cell gene therapy. Experts weigh in on the path to profit for the treatment and the therapeutic class in general.
  3. BioMarin executives sought to calm an anxious investor base Wednesday with a public address and pledge to achieve a nearly 50% bump in annual revenue by 2027. But analysts were left wanting.
  4. Proceeds from the oversubscribed financing will be used to advance ArsenalBio’s lead programs, which include a handful of solid tumor cell therapy candidates.
  5. Eli Lilly offers weight loss drug Zepbound directly to consumers while Novo Nordisk continues to struggle with supply challenges for its own GLP-1s. Meanwhile, gene therapies for retinal diseases target competitive market, and layoffs persist.