FDA
The UCSF professor and frequent YouTube poster has criticized COVID-19 vaccine mandates as well as the accelerated approval pathway and other FDA practices. Predictions of what his tenure might achieve are scattershot.
Lexeo wants to more quickly move investigational gene therapy LX2006 into a registrational study and hopes for a potential efficacy readout in 2027.
The package revives President Donald Trump’s much-maligned Most Favored Nation rule but goes further into the private markets and beyond, leveraging the patent system, drug importation and more.
In addition to eliciting greater weight loss than Novo Nordisk’s Wegovy, Eli Lilly’s Zepbound does not come at the expense of safety, according to newly released comprehensive tolerability data—findings that Leerink analysts say confirm the GLP-1 drug’s edge in the closely watched market race.
Last month, Roche committed $50 billion in U.S. manufacturing funds, with which it will construct at least four new facilities.
The Plavix lawsuit dates back to 2014, when Hawaii first sued BMS and Sanofi, alleging that they failed to properly inform patients in the state that the drug is likely to be less effective for them.
The FDA and CDC have also recommended pausing the use of Ixchiq in seniors 60 years and older while safety investigations are ongoing.
FEATURED STORIES
FDA
As tariffs, HHS workforce cuts and the ouster of CBER Director Peter Marks threaten the “lifeblood” of the cell and gene therapy space, experts express wariness over the unknowns and optimism that Marks’ legacy will carry on.
FDA
As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering statements that alternatively contradict and jibe with reported events.
Presentations at this year’s American Association for Cancer Research meeting could have a broad impact on the treatment landscape for head and neck and lung cancer, and implications for specific drug modalities like TIGIT and VEGF.
FROM BIOSPACE INSIGHTS
The first annual BioTechX USA, held in Santa Clara in September, bridged the communication gap by bringing together life sciences leaders in all areas of the industry.
LATEST PODCASTS
In the first podcast in a special series focused on BioSpace’s NextGen Class of 2025, Senior Editor Annalee Armstrong speaks with Dannielle Appelhans, CEO of COUR.
In this episode, presented by the Genscript Biotech Global Forum 2025, BioSpace’s Head of Insights Lori Ellis and Tom Whitehead continue to discuss the patient and caregiver experience, where Tom gives his insights to the future of CGTs.
Novartis, Eli Lilly and more put on their deal-making caps, Bristol Myers Squibb targets $2 billion in savings through 2027, sales continue to soar for Lilly and Novo Nordisk’s GLP-1s and Regeneron sues Sanofi over an alleged failure to provide adequate information about Dupixent sales.
Job Trends
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SPECIAL EDITIONS
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.
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
Year-over-year BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the first quarter of 2025.
DEALS
  1. With just one asset in weight loss moving through the clinic, Pfizer targets the space for potential dealmaking, as well as bringing assets over from China.
  2. Biogen’s effort to buy Sage against the board’s wishes and a long-time effort by investor Alcorn to scuttle Aurion’s IPO underscore the cutthroat nature of biopharma dealmaking.
  3. Novartis was among the most prolific pharma dealmakers in 2024, a trend that it expects to continue with more bolt-on deals this year to set up for sustainable long-term growth.
  4. Sanofi’s jump in earnings comes with an increased emphasis on R&D and vaccines, plus an eye cast toward M&A to shore up its pipeline.
  5. The J.P. Morgan Healthcare Conference started off with a flurry of deals that reinvigorated excitement across the biopharma industry. Johnson & Johnson moved to acquire Intra-Cellular Therapies for $14.6 billion, breaking a dealmaking barrier that kept Big Pharma’s 2024 biotech buyouts to under $5 billion.
WEIGHT LOSS
  1. Roche and Zealand plan to study petrelintide as a monotherapy and in combination with CT-388, a dual agonist of the GLP-1 and GIP receptors that Roche picked up in its recent acquisition of Carmot Therapeutics.
  2. BioSpace remembers COVID-19 five years after the pandemic was declared, Novo Nordisk’s CagriSema again misses expectations as the company joins a lawsuit filed by drug compounders against the FDA, Viking secures ample supply of its investigational obesity medication, J&J strikes out in depression, and Makary and Bhattacharya near confirmation.
  3. Analysts acknowledged the long-term manufacturing deal could dull Viking’s takeout prospects but hailed it as a smart move to ensure supply.
  4. The latest data showed 15.7% weight loss in patients with diabetes after 68 weeks. In December 2024, CagriSema returned another disappointing readout for Novo, eliciting weight-loss of 22.7% in patients without diabetes, below the pharma’s prior projection of 25%.
  5. While drug developers work to mitigate the side effects associated with GLP-1–based obesity drugs, recent studies reveal that myriad variables are causing patients to stop treatment.
POLICY
  1. FDA
    After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with regulatory experts predicting delays in drug approvals and greater influence of political appointees.
  2. As the biopharma industry grapples with the uncertain macro environment brought on by the new administration, CEOs, regulators and many others speak out.
  3. According to analysts at Jefferies, legislation such as the newly proposed bills that aim to streamline regulatory processes would be a positive for the biotech industry.
  4. Biotech companies are already seeing regulatory delays and plenty of uncertainty after around 3,500 FDA employees were cut by the Trump administration.
  5. Pharma stocks went on a wild ride Wednesday amid whiplashing tariff threats from the U.S. president.
CAREER HUB
Looking for a biotech job in San Diego? Check out these seven top companies hiring life sciences professionals like you.
Massachusetts’ new salary range transparency law can be a tool for companies looking to attract biopharma professionals while also helping candidates and current employees improve their job searches and salaries, according to two experts.
By building and nurturing a strong personal brand, you can benefit in multiple ways, including enhancing your credibility, attracting opportunities and inspiring investor confidence.
To avoid being laid off, a third of biopharma professionals would take a pay cut and nearly a quarter would take a demotion, according to BioSpace LinkedIn polls. We spoke to several professionals about their layoff experiences and what they would—and wouldn’t—have done to keep their jobs.
Plus, learn how to handle vacation time in a new job and navigate the stress of a recent promotion to leadership.
A BioSpace LinkedIn poll showed that just 19% of respondents believe biopharma professionals need Ph.D.s for scientist roles.
Employers have adjusted to higher salaries. That also means they’ve become adamant they get specific skill sets, according to Greg Clouse, BioSpace recruitment manager.
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 Most Favored Nation directive would allow drugmakers to directly sell their products to patients at a lower cost, cutting out what President Donald Trump called “the middlemen.”
REPORTS
How does age affect employees’ experiences in the workplace? This report examines the intersection of age along with gender and other demographics.
In the final instalment of our Diversity in Life Sciences series, BioSpace provides life sciences organizations with practical solutions and benchmarking data to strengthen their DEI initiatives.
BioSpace surveyed industry employers and professionals to understand what to expect from the recruitment market in 2022. What do professionals want? How difficult will it be to recruit new talent?
CANCER
  1. Adaptimmune is rolling out its T cell therapy Tecelra for synovial sarcoma, recording $1.2 million in sales since its approval in August 2024. Nevertheless, it is pausing development of two oncology assets to save money.
  2. With Keytruda, the best-selling drug in the world, facing the end of exclusivity in 2028, BioSpace looks at five drugs that have taken the leap off the patent cliff.
  3. The French pharma is getting Black Diamond’s de-prioritized molecule for non-small cell lung cancers with specific mutations whose development had been paused to save money.
  4. Roche’s up to $1 billion investment will provide access to Oxford BioTherapeutics’ antibody-drug conjugate platform for undisclosed cancer targets.
  5. Monday was a busy day for AstraZeneca, which also paid up to $1 billion to acquire Belgian biotech EsoBiotec and its cell therapy pipeline and technology.
NEUROSCIENCE
  1. Mission Therapeutics is down to its clinical assets MTX652 and MTX325, which work by disabling a key enzyme that interferes with the cell’s normal process of removing faulty or dysfunctional mitochondria.
  2. The licensing deal follows years of controversy for Cassava, as well as the high-profile late-stage failure of its Alzheimer’s disease drug simufilam.
  3. ITF, IntraBio and Orchard are among the companies that have won FDA nods in the past year for Duchenne muscular dystrophy, Niemann-Pick disease type C, metachromatic leukodystrophy and more.
  4. Emalex is gearing up for a New Drug Application for ecopipam in Tourette syndrome later this year.
  5. BridGene strikes another partnership with Takeda as the latter company continues its dealmaking streak, following high-ticket agreements with Keros Therapeutics, AC Immune and Degron Therapeutics in the past nine months.
CELL AND GENE THERAPY
  1. At the 2025 National Biotechnology Conference, gene therapies, bispecific antibodies and other novel modalities—relative newcomers to medicine—will be much discussed. In this curtain raiser, BioSpace speaks with conference chair Prathap Nagaraja Shastri of J&J about these highly anticipated topics.
  2. The treatment, called DB-OTO, is one of several early-stage gene therapies being developed to treat relatively straight-forward causes of genetic deafness.
  3. The proposed acquisition by global investment firms Carlyle and SK Capital Partners could net shareholders $3 per share plus potential CVR dollars and provide bluebird bio with primary capital to expand the commercial reach of its gene therapies.
  4. The move comes weeks after Pfizer terminated its partnership with Sangamo Therapeutics for another hemophilia gene therapy.
  5. The Philadelphia market has gained recognition not only for its cell and gene therapy sector but also its real estate scene and talent pool. Vittoria Biotherapeutics, Interius BioTherapeutics and Chamber of Commerce for Greater Philadelphia executives share why the area is a life sciences hot spot.