The FDA also changed its tune and is now planning to convene an advisory committee to discuss Biohaven’s application.
At a sometimes-contentious U.S. Senate hearing, the Health and Human Services secretary was evasive on the rationale behind cuts being made to the department and his endorsement of the measles vaccine amid a rapidly growing outbreak.
Sanofi expects to add “a significant number of high-paying jobs” in the U.S. with $20 billion investment through 2030.
AbbVie’s Emrelis is the first non-small cell lung cancer therapy approved for patients with high c-Met expression levels who have received prior lines of treatment.
Looking for a biopharma job in San Francisco? Check out the BioSpace list of 10 companies hiring life sciences professionals like you.
Currently trailing Eli Lilly and Structure Therapeutics in the oral weight loss space, Novo Nordisk strikes a deal with Septerna to put new discovery-stage programs into play.
FEATURED STORIES
While San Diego remains a top biotech hub behind Boston and San Francisco, the city—which hosts this week’s BIO International Convention—has seen employment drop amid economic headwinds.
Experts say approval of Lykos Therapeutics’ MDMA capsules for post-traumatic stress disorder would open the door to further research into psychedelic-assisted therapies.
AstraZeneca last week set another ambitious goal, this time with plans to nearly double its total revenue by the end of the decade. However, it’s easier said than done, according to analysts.
While NK cell therapies can potentially avoid the serious side effects sometimes seen with CAR T cell therapies, experts say durability may stall their path to the market.
As AstraZeneca looks to climb toward the top of biopharma companies by revenue by the end of the decade, smaller companies are looking to join the ranks of the unofficial Big Pharma club.
Recent M&A activity indicates a potential resurgence in the appetites of larger companies for psychiatric drug development, but experts say the space may not offer a sufficient risk-reward proposition for R&D.
FROM BIOSPACE INSIGHTS
While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience that would make change possible.
LATEST PODCASTS
George Tidmarsh takes over temporarily at CBER following Vinay Prasad’s abrupt departure; Replimmune trial leaders protest rejection reportedly driven by FDA’s top cancer regulator Richard Pazdur; Merck’s $3 billion savings push claims 6,000 jobs; and Pfizer CEO Albert Bourla addresses President Donald Trump’s new threats around Most Favored Nation drug pricing.
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the concerns and opportunities of patient data driving AI tasks with Louise Molloy, associate director medical information and pharmacovigilance.
Sarepta’s Elevidys is back on the market for ambulatory patients with Duchenne muscular dystrophy, Health Secretary Robert F. Kennedy Jr. reportedly plans to dissolve the U.S. Preventive Services Task Force and “fix” the vaccine injury compensation program, Merck, AstraZeneca and more report Q2 earnings, Novo names a new leader and Roche’s trontinemab impresses at AAIC25.
Job Trends
For many people living with cancer, hearing about the experiences of others can be helpful.
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 Italian pharma company is acquiring what was once one of the hottest stocks in the biotech sector, just months after the FDA rejected Intercept’s non-alcoholic steatohepatitis candidate. -
After a sluggish start to the year, experts expect an uptick in IPO offerings moving into fall, although it’s unlikely 2023 will fully shrug off its slump. -
In the largest biotech Series C financing so far this year, Generate:Biomedicines raised $273 million, while Neumora and RayzeBio announced IPO pricing valued at more than $560 million combined. -
The two biotech companies announced initial public offering pricing Thursday, respectively, with shares beginning trading Friday and valued at more than $560 million cumulatively. -
Following a Phase II review, Novartis has cut the development of a gene therapy candidate for geographic atrophy. In June, the company sold a dry eye disease drug to Bauch + Lomb for $1.75 billion.
WEIGHT LOSS
-
Viking Therapeutics announced Tuesday that its GLP-1/GIP receptor dual agonist helped patients lose up to nearly 15% of their weight over about three months in a Phase II study. -
Boehringer Ingelheim and Zealand Pharma’s dual glucagon/GLP-1 receptor agonist elicited significant topline Phase II results in metabolic dysfunction-associated steatohepatitis. -
Seeking a slice of the lucrative obesity market, Indian pharma companies are developing their own versions of Novo Nordisk’s blockbuster weight-loss drug Wegovy, Reuters reports. -
Two surprise companies, Vertex Pharmaceuticals and Regeneron Pharmaceuticals, made GlobalData’s list with 41.4% and 21.8% market capitalization growth, respectively. -
A week after Britain’s debut of the four-week Kwikpen, a European Medicines Agency panel is slated to review Eli Lilly’s multi-dose, pre-filled pen injector for diabetes drug Mounjaro.
POLICY
-
The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals after the company allegedly ignored directives to withdraw or amend contentious patent listings on the FDA’s Orange Book. -
The U.S. Supreme Court on Friday overturned the long-standing Chevron doctrine, which required courts to defer to federal agencies and their interpretation of statutes, putting potential limits on the FDA’s regulatory decisions. -
Daiichi Sankyo has secured a victory in its patent arbitration with Seagen, nabbing a $47 million award for attorneys’ fees and other costs, plus interest. However, a larger patent battle with Pfizer remains. -
In a potential challenge to Pfizer’s Prevnar 20, Merck’s Capvaxive has been recommended by the Centers for Disease Control and Protection for use in preventing invasive pneumococcal disease in adults. -
The U.S. Supreme Court on Friday overturned the long-standing Chevron doctrine, which required courts to defer to federal agencies and their interpretation of statutes, putting potential limits on the FDA’s regulatory decisions.
Many principles of an online interview are unknown to everyone and they lack confidence. Here are some virtual interview tips to help enhance your skills.
Consider limiting the use of “manage” on your resume, opting instead for more powerful keywords for your resume that can better indicate you’re a leader.
If you’re having trouble finding your confidence again, try these tips for regaining a (healthy) ego.
The interview process at many organizations is not limited to a single interview. Multiple interviews are common and can occur for numerous reasons.
If you’re planning on looking for a new job at the beginning of the year, now is the time to start your job search prep.
Interview practice will help you reduce interview anxiety, improve your interview skills, and in many cases, gain important feedback about how you interview.
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
-
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. -
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.
-
Gilead Sciences’ blockbuster antibody-drug conjugate Trodelvy has encountered some clinical speed bumps in 2024 in bladder and lung cancer. Still, analysts remain bullish on its prospects in the oncology space. -
The FDA on Thursday rejected Merck and Daiichi Sankyo’s HER3-targeted antibody-drug conjugate patritumab deruxtecan in a Complete Response Letter, citing problems with a third-party manufacturer. -
AbbVie and Genmab on Wednesday announced the FDA has expanded the label of their bispecific antibody Epkinly, allowing it to be used in patients with relapsed or refractory follicular lymphoma.
NEUROSCIENCE
-
Novo Nordisk seems to believe it can do a better job managing troubled Catalent than the contract manufacturer. However, the Danish drugmaker has its work cut out for it. -
The French drugmaker Thursday touted trial results in The New England Journal of Medicine showing frexalimab significantly slowed disease activity in people with relapsing multiple sclerosis. -
A longer-acting formulation of Otsuka Pharmaceuticals’ aripiprazole could help soften the blow of Abilify Maintena’s loss of exclusivity coming later this year, according to a new report from GlobalData. -
In the fourth quarter of 2023, Biogen’s revenue from multiple sclerosis drugs fell 8% due to generics competition and the company paid $60 million in close out costs related to Alzheimer’s treatment Aduhelm. -
AVP-786 was unable to significantly reduce total scores in the Cohen-Mansfield Agitation Inventory versus placebo, Otsuka Pharmaceuticals reported Monday. The company is evaluating the next steps for the drug combination.
CELL AND GENE THERAPY
-
From innovation in manufacturing to more-flexible regulation and better communication with payers, much needs to happen to make CGTs commercially viable. But it is possible, experts agreed at a recent panel. -
The primary focus in scaling up production should first be the adoption of lean manufacturing principles used in virtually every other industry. -
The pivotal Phase II trial is testing Allogene’s CAR T candidate cemacabtagene ansegedleucel for large B-cell lymphoma. ALLO-647 was being used as a preparative lymphodepletion therapy. -
The FDA greenlit multiple new drugs this month and issued some notable label expansions, including for Eli Lilly’s Kisunla. Meanwhile, the regulator turned away a cell therapy for Duchenne muscular dystrophy and a gene therapy for the rare disease Sanfilippo syndrome. -
As analysts parsed news of Vinay Prasad’s ouster, worries over drug approval delays, cell and gene therapy impacts and more were top of mind.
