Smarter design through targeted delivery and human-relevant testing can save the industry from costly safety failures.
This represents Alector’s second failed neurodegenerative asset in a year, after an AbbVie-partnered asset missed in Alzheimer’s last November. On latozinemab for frontotemporal dementia, Alector was working with GSK, which fronted $700 million in 2021 to collaborate on two programs.
Novo Nordisk’s leadership gets another shake-up as President Trump promises to significantly slash prices for its GLP-1 drugs; Summit/Akeso, Exelixis and more present new data at ESMO 2025; Replimune pops as FDA accepts resubmitted BLA; FDA names first winners of Commissioner’s National Priority Voucher program; and more.
The company is dropping its social anxiety disorder program but will still test the molecule in post-traumatic stress disorder.
FDA
The company’s technology, a modified herpes simplex virus used to deliver gene therapies, was given the FDA’s new designation based on its approved topical skin cream. What this will mean for Krystal’s still-in-development eye drop is unclear.
In this episode presented by Element Materials Technology, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney will explore how healthcare and pharmaceutical players are rethinking their strategies amid global supply chain disruption.
Galapagos at the start of the year had planned to split into two businesses, with one resulting entity focused on cell therapies. The biotech nixed these plans a few months later, instead choosing to put up for sale multiple cell therapy assets.
FEATURED STORIES
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.
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?
What a CEO makes can be staggering from the seat of a rank-and-file employee, whose pay is typically in the five-to-six digit range.
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.
FROM BIOSPACE INSIGHTS
The agency’s sweeping rollout and staff challenge underscore rising momentum behind agentic AI: advanced, multiagent systems now fueling early pilots in medical writing, patient engagement and regulatory workflows across the industry.
UPCOMING EVENTS
LATEST PODCASTS
Lori and guests address clinical trial design, which if done without careful consideration of the patient population can exclude patients from clinical trials instead of being inclusive.
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.
With U.S. election season now in full swing, BioSpace looks at pharmaceutical-associated campaign contributions. Plus, Q2 earnings, Adaptimmune’s big approval, an anticipated FDA decision on an MDMA-assisted treatment and more.
Job Trends
Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, taking place May 28-31, 2024 in Miami, FL.
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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. 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.
  2. European CDMO Ardena will buy Catalent’s oral solids manufacturing facility in Somerset, N.J.
  3. Senator Elizabeth Warren told the Federal Trade Commission that the acquisition of contract manufacturer Catalent could increase Novo’s dominance over the hot GLP-1 market, reducing competition and increasing prices.
  4. M&A
    After four patient deaths, Kezar’s lupus trial is officially on hold, sparking investor Kevin Tang’s interest for acquisition.
  5. Big Pharma can’t seem to get enough radiopharmaceutical biotechs. With Lilly, Sanofi and BMS chasing Novartis into the complex space, all eyes are on these specialty biotechs.
WEIGHT LOSS
  1. Patients taking Novo Nordisk’s Wegovy plus Veru’s enobosarm saw 71% lower lean mass loss than those who were taking Wegovy alone but investors await more data.
  2. The readout comes on the heels of CagriSema’s disappointing Phase III performance, where it missed Novo’s projection of 25% weight reduction.
  3. The San Diego–based company’s molecules avoid the well-trod GLP-1 pathway in favor of an alternate route in the gut.
  4. 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.
  5. 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.
POLICY
  1. Yes, according to leading vaccine physician Paul Offit, who denounced the new placebo-controlled trial requirements for vaccines and sought greater clarity: “I don’t know what they’re talking about.”
  2. A new executive order from President Donald Trump aims to cut down the 5-to-10-year timeline to build new facilities while stepping up the rigor of inspections on foreign plants.
  3. 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.
  4. 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.
  5. 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.
CAREER HUB
While you’ve likely answered many of these before, it never hurts to brush up on solid answers and think of new or recent anecdotes to illustrate your point.
Following up after an interview can be essential to help you gain peace of mind and reinforce your interest. Here’s how to improve follow up after interview.
Instead of letting LinkedIn slide to the bottom of your to-do list day after day, dedicate some time to it. Here’s what you need to add to your LinkedIn post.
Deciding on when to switch your job can be a difficult decision to make.
The pharmaceutical industry is full of job opportunities for people in various fields. Read on to find out more information about high-paying pharma industry jobs.
Are you looking for doctor careers in the pharma sector? Here is everything you need to know about how you can choose a reputable and growing pharma career.
Before going for pharmaceutical jobs interviews, you should be prepared to give the best answers possible. Here are six questions you should be ready for.
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
Biopharma professionals will probably find decreasing employment opportunities this month and next even as layoffs continue, based on BioSpace data. However, hundreds of open roles are expected this year in Massachusetts, and a job market turnaround could start late next year.
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. More than a decade after Merck’s Keytruda and BMS’ Yervoy ushered in the immuno-oncology revolution, the space is at a crossroads, with experts highlighting novel targets, combinations and pre-emptive immunization as the next wave for IO.
  2. The company will push through with an accelerated approval application for odronextamab in follicular lymphoma, leaving diffuse large B cell lymphoma behind.
  3. 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.
  4. 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.
  5. 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.
NEUROSCIENCE
  1. Spravato’s monotherapy nod on Tuesday comes after a series of setbacks in the depression space.
  2. 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.
  3. Biogen’s effort to buy Sage reveals its “desire to expand its pipeline at a discount,” according to analysts from BMO Capital Markets.
  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. 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. The cancers were diagnosed 19 to 92 months after Skysona treatment.
  2. Emboldened by technological advances and a deeper knowledge of glioblastoma, Merck, Kazia Therapeutics, CorriXR Therapeutics and others are targeting the often-fatal brain tumor.
  3. 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.
  4. 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.
  5. 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.