In a Phase Ib/IIa trial, 91% of patients receiving the highest dose of trontinemab were amyloid negative after seven months of treatment, representing what B. Riley Securities called a “paradigm shift” to first-generation FDA-approved antibodies.
The German giant is looking to develop new drugs for undisclosed eye diseases using Re-Vana’s extended-release injectable platform to supply drugs to the eye for months at a time.
The star of GSK’s Hengrui partnership is the COPD candidate HRS-9821, which will complement the pharma’s respiratory pipeline that’s anchored by the anti-asthma drug Nucala.
Health Secretary Robert F. Kennedy Jr. wants to remove all members of the USPSTF for being too “woke,” according to reporting by the Wall Street Journal. An HHS spokesperson, however, says no final decision has been made about the panel.
Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe infection exacerbated by immunosuppression.
Despite the failure of its Recognify-partnered inidascamine, Jefferies analysts do not expect a definitively negative stock impact on atai, given the company’s promising psychedelic pipeline.
FEATURED STORIES
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.
As we near the end of second quarter of 2024, the initial public offerings among biotechs have slowed, but the market is still going strong.
CEO Pascal Soriot on Tuesday heralded a “new era of growth” for AstraZeneca with plans to launch 20 new medicines in six years. He’s delivered before but can he do it again?
UPCOMING EVENTS
-
Tuesday, November 18, 2025 11–11:45am EST·Virtual
-
Wednesday, November 26, 2025 9–9:45am EST·Virtual
-
Monday, December 1, 2025 8am–5pm EST·Munich, Germany
-
Tuesday, December 2, 2025 8am–5pm EST·Munich, Germany
-
December 6, 2025 2pm - December 13, 2025 6pm EST·Brooklyn, New York
LATEST PODCASTS
In this episode presented by Slone Partners, Leslie Loveless, Co-CEO and Managing Partner discusses how hiring and the building of executive teams has responded to the current biotech environment.
Pfizer seals the deal with Metsera for $10 billion after Novo Nordisk bowed out; President Donald Trump welcomes executives from Novo and Eli Lilly to the White House to announce that the companies’ GLP-1 medicines would be sold at a reduced cost; and the FDA grants the second round of priority review vouchers—primarily to already marketed drugs.
In this episode presented by PII, BioSpace’s head of insights discusses how to relieve clinical trial patients of technological burden to improve compliance with guests Oliver Eden and Travis Webb.
Job Trends
Gilead Sciences, Inc. announced that Ted Love, MD, has been appointed to the company’s Board of Directors.
Subscribe to GenePool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
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
-
The acquisition provides the Swedish company with an approved JAK inhibitor for myelofibrosis, a rare bone marrow cancer that disrupts the body’s normal production of blood cells. -
The biopharma company scored two major wins on Tuesday: a court victory over HIV patent claims and an acquisition deal to expand its pipeline in cancer and inflammatory diseases. -
Novel therapies often pass through several owners on their way to the market. Here’s a look at some of the drugs that got dropped before they hit primetime. -
Japanese biopharma scoops up Iveric’s investigational drug for age-related blindness disease. The drug, which trails Apellis’ Syfovre, is awaiting FDA approval with a decision expected by August. -
The acquisition of Bellus Health will give GSK access to camlipixant, a potentially best-in-class P2X3 antagonist for chronic cough.
WEIGHT LOSS
-
The team comes together to discuss the dominant themes of what was an incredibly busy week of events in San Francisco during JPM 2024. -
The agency nevertheless said that it could not definitively rule out a small risk of suicidal ideation associated with GLP-1 receptor agonists, and that it will continue evaluating the evidence. -
Eli Lilly on Thursday announced the rollout of a new digital healthcare platform to streamline consumer access to its weight-loss drug Zepbound and other medications. -
The regulator is launching an investigation of Novo Nordisk’s Wegovy, Eli Lilly’s Zepbound and other GLP-1 receptor agonists following patient reports of suicidal ideation, alopecia and aspiration.
-
Novo Nordisk’s partnerships with Flagship Pioneering-backed Omega and Cellarity, each worth up to $532 million, will explore novel treatment approaches to obesity and metabolic dysfunction-associated steatohepatitis.
POLICY
-
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. -
New recommendations from the Centers for Disease Control and Prevention call for the use of respiratory syncytial virus vaccines in adults aged 75 and older, but limited its use in 60- to 74-year-olds. -
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. -
Verona Pharma on Wednesday secured the FDA’s approval for Ohtuvayre, which the company contends is the first inhaled chronic obstructive pulmonary disease medicine with a new mechanism of action in over 20 years. -
Teva Pharmaceuticals has settled years of tax litigation with the Israel Tax Authority for $750 million, which the company will pay in installments starting in 2024 to 2029.
Being fired, while discouraging in the moment, is not a career killer. In fact, sometimes the jolt of getting that proverbial “pink slip” can actually inspire you take stock of your wider career path and goals as you put yourself back on the job market.
Perhaps you sense something just isn’t quite right, but you’re not sure what. Or, maybe you have a pretty good idea that your organization is slimming down and your role will be one of the first ones to go.
Final round interviews can be difficult, especially for those working in a competitive field. To help, here are five impressive final-round interview questions for life science professionals.
In essence, a good interview often comes down to “likeability” and if you’re able to establish a friendly rapport with the interviewer(s). Keep these 5 highly effective rapport-building techniques in mind as you interview.
An new innovative approach to the job interview, and one that could catch on in industries outside of tech.
Crafting a well-organized, powerful resume is important to leave a great impact on recruiters. But all your hard work can go in vain if you make these resume mistakes.
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
-
2024 began with several biopharma players posting positive Phase III data that could mean new market share for the companies and longer survival times and quality of life for patients. -
Following disappointing Phase III results in less aggressive non-small cell lung cancer, AstraZeneca on Friday announced that Imfinzi improved progression-free and overall survival in patients with limited-stage small cell lung cancer. -
Seeking a potential slice of the challenging KRAS market, Merck has launched a Phase III NSCLC trial of its oral G12C inhibitor MK-1084, in combination with Keytruda, in pursuit of Amgen and Bristol Myers Squibb. -
Following clearer overall survival data from the PSMAfore trial, Novartis on Thursday affirmed plans to file for a prostate cancer label expansion for its targeted radioligand therapy Pluvicto later this year. -
Genmab announced Wednesday it is buying ProfoundBio and its pipeline of next-generation antibody-drug conjugates being developed for gynecologic cancers and other solid tumors.
NEUROSCIENCE
-
Neurologist David Weisman, with financial ties to the companies, was removed from the FDA’s upcoming advisory committee meeting slated to consider Leqembi’s traditional approval. -
The FDA has three high-profile events this week, including one target action date and two advisory committee meetings—one to discuss potential traditional approval for Alzheimer’s drug Leqembi. -
While donanemab showed impressive results in Phase III TRAILBLAZER-ALZ 2, concerns regarding its safety remain compared with Biogen’s and Eisai’s Leqembi. -
The amyloid plaque targeting therapy met primary endpoint and all secondary endpoints, which Lilly will use in its submission to the FDA this quarter. -
Clinical results for experimental treatments in Alzheimer’s, ALS and more are expected over the coming months. BioSpace highlights a few of the more highly anticipated datasets.
CELL AND GENE THERAPY
-
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation. -
The plausible mechanism pathway “could accelerate gene therapy/editing development,” analysts at William Blair said Thursday, while adding that additional clarity is needed. -
MeiraGTx Holdings is licensing a genetic eye disease medicine to Eli Lilly in a deal worth up to $475 million. -
The FDA previously placed two clinical studies on hold, including the Phase III trial in which the liver toxicity occurred. Intellia is working with experts to create a risk management program for nex-z. -
Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study.
