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.
Of the 25 companies receiving tax incentives in Massachusetts, 23 will add jobs outside of Boston and Cambridge. Medtronic, which is receiving the largest award, will create 220 roles in Billerica. Other recipients include AbbVie, Dyne Therapeutics and Viridian Therapeutics.
FDA
In three draft guidance documents, the FDA has laid out pointers to help companies craft better drug development programs and drug applications.
The discontinued CAR T therapy bbT369 came to Regeneron when the pharma bought all of 2seventy bio’s pipeline assets for $5 million upfront in January 2024.
Sales of Sanofi’s COVID-19 and flu vaccines fell 17% in the third quarter amid declining vaccination rates and pricing pressures in Europe.
The antibody-drug conjugate, withdrawn from the market by GSK in 2022 after failing a confirmatory study, was approved Thursday by the FDA for previously treated patients with multiple myeloma. This is despite a negative advisory committee vote in July.
Viking Therapeutics CEO Brian Lian is watching the growth of interest in MASH and obesity but prepared to go it alone.
FEATURED STORIES
Policy uncertainties are impacting biopharma dealmaking from continent to continent, with companies being asked to walk a tightrope on their relations with China.
Major pharmaceutical companies are committing billions to US manufacturing in an effort to avoid steep tariffs threatened by President Donald Trump.
FDA
In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions taken by HHS Secretary Robert F. Kennedy, Jr. and others within the department appear to be at odds with this sentiment.
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
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
Lykos Therapeutics will ask the FDA to reconsider its rejection of the company’s MDMA-assisted PTSD therapy, Pfizer scores positive Phase III results for its RSV vaccine, a roundup of Q2 earnings season and more.
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In this episode, Lori and guests discuss the pursuit of adequate representation and how clinical trials are being shaped by the legal environment they operate within.
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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. Biogen touted strong Q3 sales of its Alzheimer’s drug Leqembi a day after announcing a deal worth up to $1.45 billion with Neomorph to discover and develop molecular glue degraders.
  2. Pfizer, Sanofi and others report Q3 beats; AbbVie, Roche and Novartis strike big deals; the 2024 presidential election looms; and BioSpace takes a look back at 10 years of NextGen, our annual pick of young biotechs to watch.
  3. 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.
  4. Sanofi will sell a 50% controlling stake in consumer healthcare unit Opella to private equity firm CD&R, with the French government taking a stake as well to ensure the business remains in the county.
  5. European CDMO Ardena will buy Catalent’s oral solids manufacturing facility in Somerset, N.J.
WEIGHT LOSS
  1. The San Diego–based company’s molecules avoid the well-trod GLP-1 pathway in favor of an alternate route in the gut.
  2. Biopharma executives shared their thoughts on the potential impacts of the new administration; Annalee Armstrong recaps JPM and her talks with Biogen, Gilead, Novavax and more; Wegovy’s higher dose induces more weight loss; AstraZeneca and Daiichi Sankyo’s Dato-DXd scores its first FDA approval.
  3. Computational research conducted by scientists from Washington University in St. Louis shows that GLP-1 agonists can have mental and cognitive health benefits but may also harm the kidneys and pancreas.
  4. As the year gets underway, analysts and biotech executives highlight cell therapy’s pivot from oncology to autoimmune diseases, a continued appetite for next-generation obesity drugs and an increased focus on neuromuscular, kidney and cardiovascular diseases.
  5. The data suggest the high dose nearly closes the efficacy gap with Zepbound.
POLICY
  1. Twenty attorneys general allege that the recent workforce reduction at the Department of Health and Human Services is unlawful and could have potentially irreversible consequences.
  2. As the Trump administration—including HHS Secretary Robert F. Kennedy Jr.—plays fast and loose with scientific studies and facts, there may be a more sinister force at play: censorship.
  3. In an internal memo, the World Health Organization signaled its support for anti-obesity drugs like Wegovy and Zepbound, which the agency decided against listing in 2023, the last time the Essential Medicines list was updated.
  4. The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and less affordable,” according to vaccine expert Paul Offit. It could also further complicate the picture for companies like Novavax.
  5. When it comes to vaccination, the COVID-19 pandemic divided American society. President Donald Trump and his new Health and Human Services secretary are bringing down the hammer. What happens when there is no middle ground?
CAREER HUB
BioSpace interviewed Marianne Stanford, Ph.D., who shared her thoughts on the immunology field and the career path of an immunologist.
Finding a job in the pharmaceutical industry can be challenging. Find out which skills can help you score your dream pharmaceutical company job.
How can you show employers that your skills are current, despite being out of work for months or years?
Trying to develop a career in pharma may be overwhelming when you think about it. However, this article can help!
Conducting some research before your job interview can help ease your mind. You will feel less stressed once you know what to look forward to during the meeting and which skills will allow you to shine.
Setting yourself apart from other job candidates can be a challenging thing to do - but it doesn’t have to be with these eight important tips!
Your CV can be the ticket that lands you your dream job - as long as you focus on making sure that it’s well-written with the help of these CV writing tips.
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
A source familiar with the matter said the White House initially requested the resignation of Sanjula Jain-Nagpal, a policy and research official at the FDA.
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. The company will push through with an accelerated approval application for odronextamab in follicular lymphoma, leaving diffuse large B cell lymphoma behind.
  2. In the Phase III SERENA-6 trial, camizestrant—in combination with CDK-inhibitors—beat out current standard-of-care treatments in terms of progression-free survival, according to AstraZeneca.
  3. Eikon’s lead candidate, EIK1001, is being tested for advanced melanoma. The candidate is currently in late-stage development, which the biotech will fund using Wednesday’s series D raise.
  4. 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.
  5. The agreement, in which Merck will pay the biotech an undisclosed initial sum to license drugs targeting a solid tumor, could net Epitopea up to $300 million down the line.
NEUROSCIENCE
  1. Cebranopadol, a dual-NMR agonist, reached the primary endpoint in a Phase III trial and matched placebo for safety, a significant concern in the analgesic field.
  2. Spravato’s monotherapy nod on Tuesday comes after a series of setbacks in the depression space.
  3. The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a third-party provider while releasing Amylyx’s investigational ALS therapy from a previous pause.
  4. Biogen’s effort to buy Sage reveals its “desire to expand its pipeline at a discount,” according to analysts from BMO Capital Markets.
  5. Boehringer Ingelheim’s trio of late-stage schizophrenia failures on Thursday came a day after the Department of Health and Human Services hit back on the pharma’s legal challenge to the IRA’s drug price negotiation program.
CELL AND GENE THERAPY
  1. Despite the death, the FDA has allowed Neurogene to forge ahead with the Phase I/II Rett syndrome trial, but using only the lower 1E15 vg dose of its investigational gene therapy NGN-401.
  2. Novartis’ up to $1.1 billion acquisition of gene therapy specialist Kate Therapeutics fits with the pharma’s plan to expand its new modality pipeline to ensure long-term business sustainability.
  3. Investigational CAR T therapies stole the spotlight at the American College of Rheumatology Convergence as data presented by Bristol Myers Squibb, Kyverna Therapeutics and more highlighted their potential to effectively treat lupus.
  4. After failing to receive the RMAT designation from the FDA for its early-stage Batten disease gene therapy, Neurogene tells investors that it’s evaluating options for the program.
  5. Regenxbio is pushing its Duchenne muscular dystrophy gene therapy into pivotal development, with a BLA planned for 2026—potentially posing a threat to Sarepta’s Elevidys.