Cobenfy’s late-stage flop is BMS’ second high-profile failure in as many weeks. The pharma announced last week that Camzyos was unable to improve disease burden in non-obstructive hypertrophic cardiomyopathy.
Bausch Health has launched a shareholder rights plan—also known as a poison pill defense—designed to prevent any one entity from taking control of the company to the detriment of other shareholders.
Such a change would put the U.S. more in line with guidance in other countries and with the World Health Organization, which recommends one dose for children and adolescents only if they have comorbidities.
In December 2024, the FDA affirmed that the shortage of tirzepatide, marketed as Zepbound for weight loss, had ended, formally barring compounders from producing their knockoff versions of the drug.
FDA Commissioner Marty Makary talks about his plans to revamp drug development and reduce ‘conflicts of interest’ between the agency and pharma industry; Roche and Regeneron jump on the U.S. manufacturing train as Trump’s tariffs loom; and Eli Lilly scores a big win for orforglipron while Novo Nordisk reveals it has applied for FDA approval of its oral semaglutide.
Paul Stoffels left his perch as J&J’s chief scientific officer in 2022 to replace Galapagos’ founding CEO Onno van de Stolpe, inheriting a company that had suffered a series of clinical failures since its 1999 creation.
FEATURED STORIES
The FDA’s Oncologic Drugs Advisory Committee recently voted to narrow the label for checkpoint inhibitors Keytruda and Opdivo in stomach and esophageal cancers based on PD-L1 expression levels—but the high unmet need in these patient populations should also be considered.
Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to lead continues to be rocked by sweeping changes and about-faces.
A BioSpace analysis of all 80 priority review vouchers that have been handed out across the three FDA programs that offer them found that 2024 was the busiest year yet. Companies have disclosed spending $513 million on vouchers that were earned in 2024 so far.
FROM BIOSPACE INSIGHTS
While Quantum computing has been reported to be five years away for many years now, companies are preparing for it by setting foundations with AI in development.
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
Amgen (NASDAQ:AMGN) today announced the presentation of data across its diverse portfolio and pipeline at the European Alliance of Associations for Rheumatology’s (EULAR) 2024 Congress, June 12-15 in Vienna.
Subscribe to Genepool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
SPECIAL EDITIONS
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.
Year-over-year BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the first quarter of 2025.
In this deep dive, BioSpace explores the diverse therapeutic modalities now in development, as well as the opportunities and battles for market dominance in this emerging space.
DEALS
-
The sale of Dermavant clears the way for Roivant to focus on autoimmune-focused Immunovant and a slate of upcoming pivotal trials.
-
Bicara Therapeutics, Zenas BioPharma and MBX Biosciences are seeking a combined $700 million-plus in IPO filings this week.
-
Sanofi will join Big Pharma peers Novartis, BMS and Eli Lilly in radioligands, striking a $110 million licensing deal with RadioMedix and Orano Med to develop AlphaMedix for neuroendocrine tumors.
-
Under a multi-year agreement announced Wednesday, Eli Lilly will leverage Haya Therapeutics’ proprietary RNA-guided genome platform to identify drug targets to address the chronic conditions.
-
Not all licensing deals are successful. Here, BioSpace examines a few noteworthy assets that Big Pharma returned in the last 12 months.
WEIGHT LOSS
-
SURMOUNT-5’s results reflect those of multiple real-world studies, which have found that tirzepatide treatment results in stronger weight loss than semaglutide.
-
Amylin analogs present a strong alternative or complement to GLP-1 receptor agonists, potentially eliciting higher-quality weight loss with a cleaner tolerability profile.
-
With Amgen’s MariTide results at the lower end of investors’ expectation of 20% to 25% weight loss, the much-anticipated readout sent the company’s shares tumbling.
-
While taldefgrobep alfa failed to show improved motor function in spinal muscular atrophy, treated patients saw a marked reduction in body fat. Biohaven plans to launch a Phase II trial in obesity by the end of the year.
-
Eli Lilly will provide the funding and expertise to advance Laekna’s LAE102, a first-in-class monoclonal antibody targeting the activin type IIA receptor to induce weight loss and boost muscle mass.
POLICY
-
The settlement is the largest deal to date with the people primarily who played an “instrumental role” in driving the opioid crisis, according to the office of Massachusetts Attorney General Andrea Joy Campbell.
-
Robert F. Kennedy, Jr.’s recent disclosures have revealed several potential conflicts of interest, including investments in two biopharma companies.
-
The U.S. Court of Federal Claims ruled that Vanda cannot claim a breach of confidentiality for specifications that it did not develop itself.
-
At J.P. Morgan, most biopharma executives expressed a neutral stance on the incoming administration, but just days later, President Trump issued multiple executive orders that concern the industry.
-
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.
With 88% of life sciences organizations using or planning to use AI in recruitment and/or hiring, AI regulation is a priority for the industry.
Despite a government report showing that hiring slowed over the month of June, job postings on BioSpace’s life sciences-focused job board saw a marked increase.
Here are 10 career paths to consider that don’t include bench work, along with role descriptions and links to jobs available now on BioSpace’s job board.
Here are the top biotech companies in California hiring now on BioSpace’s life sciences–focused job board.
To be self-employed in the life sciences, you must have a strong network and background and experience in a relevant area.
While MBAs can reflect positively on job applicants, work experience can often be more valuable, depending on the area.
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
-
Biopharma executives were busy Monday, striking high-value deals and providing updates on cancer, obesity and vaccine pipelines.
-
The positive trial results could help Regeneron cushion the blow of its disappointing fourth-quarter sales for Eylea, which exceeded the consensus by a modest 1% and are bogged down by the slow conversion of patients to the high-dose formulation.
-
The multi-billion deal, in which Eli Lilly will acquire Scorpion Therapeutics’ STX-478 program, is a shot in the arm for PI3K treatments, which have had a mixed history over the past few years.
-
On the heels of an FDA approval for its monoclonal antibody Bizengri, Merus will generate three novel cancer-targeting antibodies that it will pass over to Biohaven to link into antibody drug-conjugates.
-
The first major deal of JPM 2025 will give GSK a promising small molecule drug for gastrointestinal stromal tumors.
NEUROSCIENCE
-
Despite the “unfortunate” failure, William Blair analysts do not believe that the utreloxastat readout will heavily affect PTC, instead postulating that the upcoming FDA decision on its phenylketonuria candidate sepiapterin will be a stronger driver of the biotech’s stock.
-
Alector is kicking off a resource realignment effort that will include a workforce reduction. The biotech expects its current cash position to last it through 2026.
-
Cassava Sciences has revealed the late-stage clinical failure of controversial Alzheimer’s drug simulfilam. The company had pledged to share the results whether “good, bad or ambiguous.”
-
Sage Therapeutics discontinued development of its lead candidate dalzanemdor after a third clinical failure, leading analysts to question the biotech’s future profitability.
-
After previously failing studies in Parkinson’s and Alzheimer’s, dalzanemdor’s latest stumble in Huntington’s disease has pushed Sage Therapeutics to pull the plug on the NMDA receptor modulator.
CELL AND GENE THERAPY
-
While some of the initial excitement around immunotherapies has waned, companies—particularly smaller biotechs—are developing newer iterations that will take cancer care to the next level.
-
The biotech beat Wall Street’s third-quarter revenue forecast by 6%, driven by increased uptake of its achondroplasia drug Voxzogo. However, William Blair downgraded BioMarin’s shares to market perform due to a “lack of near-term catalysts” and uncertainty around Voxzogo’s potential revenue growth.
-
With Sarepta’s gene therapy Elevidys now available to a majority of Duchenne muscular dystrophy patients, experts express cautious optimism while emphasizing the need for further data.
-
With an upfront payment of $50 million from Roche, the partnership will leverage Dyno Therapeutics’ in vivo gene therapy delivery technology, which synthesizes virus capsids with better functionality and manufacturability.
-
While ex vivo genome editing results in highly effective cell therapies, it can lead to off-target effects. Caribou Biosciences has come up with a novel approach for potentially more precise gene editing compared to all-RNA guides.