China continues to be a source of innovation as Pfizer strikes biggest pact yet; HHS provides more info on Trump’s Most Favored Nation executive order; FDA Commissioner Marty Makary and CBER director Vinay Prasad reveal new COVID-19 vaccine strategy following Novavax approval; ODAC underway after chaotic planning; more.
From a higher bar for regulatory clearance to pricing limitations, drug development is more expensive than ever. This has led firms to make tough pipeline decisions early in the development process. The result may be costly for all of us.
The new framework was well-received by biopharma analysts, who say it “largely formalizes” current COVID-19 vaccination trends.
Drugmakers will be expected to commit to aligning U.S. prices with the lowest price set in a group of peer nations for all brand products across all markets that do not currently have generic or biosimilar competition.
Most of the 15 million children with a rare disease have no FDA-approved treatments available to them. And when it comes to the most-rare conditions, there isn’t even a pipeline.
The partnership with Sirius expands CRISPR Therapeutics’ modality toolkit, especially in the cardiovascular space.
FEATURED STORIES
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.
As the biopharma industry grapples with the uncertain macro environment brought on by the new administration, CEOs, regulators and many others speak out.
Pharma stocks went on a wild ride Wednesday amid whiplashing tariff threats from the U.S. president.
FROM BIOSPACE INSIGHTS
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
LATEST PODCASTS
In this episode of Denatured, Lori and guests from Teva Pharmaceuticals and TOWER Capital review the investment landscape this year and the policies influencing investment heading into 2025.
Yet another therapy with FDA accelerated approval suffers a setback; Sage’s tough year continues; Sanofi drops $326 million in radiopharma while selling its consumer health unit; Novo Nordisk’s positive Rybelsus results in cardiovascular disease; and more.
J&J beat expectations this week to launch the Q3 earnings season; a study about children treated with bluebird bio’s Skysona comes at a bad time for the company; Sen. Warren calls for scrutiny of Novo’s purchase of Catalent; and other news.
Job Trends
The board of directors of AbbVie Inc. (NYSE: ABBV) today declared a quarterly cash dividend of $1.55 per share.
Subscribe to Genepool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
SPECIAL EDITIONS
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
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.
DEALS
-
The Muna partnership will give GSK access to Muna’s MiND-MAP platform, which it will apply to postmortem brain samples to identify potential therapeutic targets for Alzheimer’s disease. -
One year after a potential $1.7 billion deal with Hansoh Pharma, GSK goes back to China to forge another alliance with DualityBio for another deal that could be worth up to $1 billion as it continues to build up its ADC portfolio. -
The Danish startup, whose lead candidate has parallels to Amgen’s MariTide, launches on the heels of Amgen’s Phase II data release for the drug last week. -
Novartis, Gilead, Roche and Takeda commit to new partners in a spate of mid-sized collaborations this week. Meanwhile, Applied Therapeutics’ stock tanks 80% after govorestat is denied approval, Intra-Cellular Therapies seeks to expand Caplyta into major depressive disorder and the FDA investigates the safety of bluebird bio’s Skysona. -
The collaboration will see COUR and Roche’s Genentech leverage the biotech’s antigen-specific immune tolerance platform to develop and commercialize therapies for an undisclosed autoimmune disease.
WEIGHT LOSS
-
Obesity continues to grab attention at the J.P. Morgan Healthcare Conference in San Francisco, with both Pfizer and Kailera Therapeutics outlining their plans in the space moving forward. -
Metsera will use its IPO proceeds to fund the Phase III development of its injectable, ultra-long-acting GLP-1 therapy MET-097i, which last week achieved 11.3% weight loss in a Phase IIa study. -
The company’s lead asset is a potentially first-in-class oral GLP-1 receptor agonist that has the potential to be dosed weekly, which according to CEO Khurem Farooq can help improve accessibility and affordability. -
According to BMO Capital Markets, Medicare coverage of Lilly’s Zepbound opens the door to using secondary indications to secure CMS coverage for obesity drugs. -
The FDA recommended maintaining a minimum of 5% weight-loss for drug developers seeking to establish the efficacy of their investigational obesity candidates.
POLICY
-
The announcement by the Department of Health and Human Services highlighted a flurry of moves, which include the shifting of departments. Also this week, HHS Secretary Robert F. Kennedy Jr. tapped fellow vaccine critic David Geier to investigate vaccine safety within the CDC. -
Donald Trump’s proposed tariffs on the EU would increase manufacturing costs for pharma companies and would stall medical innovation, according to the results of a recent survey by the Biotechnology Innovation Organization. -
Marty Makary earlier this month distanced himself from the recent shake-ups at the FDA, including the cancellation of its vaccines advisory committee meeting and the steep layoffs at the agency. -
President Donald Trump’s tariffs on pharmaceuticals “to come at some point,” per CNBC, as companies promise to build infrastructure in the U.S. -
If confirmed, Susan Monarez will have her work cut out for her, facing a measles outbreak that has already killed two people—the first measles-related deaths in the U.S. since 2015.
Plus, tips for finding biophama job opportunities, and when and how to follow up after a job interview.
Academic and industry jobs are distinguished by their approaches to collaboration and exploratory research, among other factors.
Here are the top companies on BioSpace with internship opportunities for graduate students.
A minority of companies in the industry use personality tests in hiring. Here’s why—and how to approach the assessments.
If it feels like there has never been a tougher time to look for work, you’re not alone—and you’re likely not wrong.
Carina Clingman answers questions about forging professional connections in-person and on LinkedIn.
HOTBEDS
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
-
Exelixis’ next-generation tyrosine kinase inhibitor zanzalintinib is being tested for colorectal cancer, renal cell carcinoma and head-and-neck cancer, with several readouts slated for the second half of 2025. -
Merck’s Keytruda may be the most talked about drug facing loss of exclusivity but it’s far from the only one, as several of the industry’s top-performers are losing key market protections. Some companies are more prepared than others. -
Casdatifan’s progression-free survival benefits could help differentiate it from Merck’s Welireg in the kidney cancer arena, according to analysts at Truist Securities. -
Ono picked up Romvimza—previously known by its active ingredient vimseltinib—from its $2.4 billion acquisition of Deciphera Pharmaceuticals in April 2024. -
The failure in adjuvant melanoma could cause BMS and Opdualag to miss out on a market opportunity that is nearly twice as large as its current approved indication, according to analysts.
NEUROSCIENCE
-
JPM25 is in full swing as several pharma powerhouses—including Merck, Lilly and Amgen—detail their strategies for growth in the coming year. -
The FDA accepted Biogen and Eisai’s BLA for a subcutaneous administration of the anti-amyloid antibody Monday as the partners await the regulator’s decision on a new intravenous regimen following an underwhelming launch riddled with coverage and accessibility barriers. -
Biogen’s proposed acquisition comes after two difficult years of regulatory and clinical challenges, during which shares of Sage Therapeutics have fallen by more than 90%. -
Among Intra-Cellular’s neuropsychiatric assets is Caplyta, a pill approved for schizophrenia and bipolar depression and proposed for major depressive disorder. -
Emraclidine was the centerpiece of AbbVie’s $8.7 billion acquisition of Cerevel in December 2023 but failed two mid-stage trials. Tavapadon, meanwhile, has been a more rewarding asset for the pharma, clearing three Phase III Parkinson’s studies in 2024.
CELL AND GENE THERAPY
-
When hiring job candidates to work on cell and gene therapies, companies look for more than just technical skills. Talent acquisition executives from Bristol Myers Squibb and Intellia Therapeutics offer an inside look at what they want in an employee. -
With nearly 90% of patients showing no detectable cancer cells after treatment, J&J and Legend’s Carvykti could stave off competition from emerging CAR T therapies such as Gilead and Arcellx’s anito-cel. -
In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified Huntington’s Disease Rating Scale, and neurofilament light chain levels to support the accelerated approval of its gene therapy AMT-130. -
Anito-cel has shown no signs of delayed neurotoxicity at around 9 months of follow-up, hinting at a safety profile that could set it apart from J&J and Legend’s Carvykti. -
Vertex unveiled long-term durability data for Casgevy, while Beam presented Phase I/II findings for its investigational base editor BEAM-101, building up to a BLA by late 2026.
