Eli Lilly drops a second Phase III readout for orforglipron; AbbVie committed to the psychedelic therapeutics space with the $1.2 billion acquisition of Gilgamesh’s depression asset; the CDC taps vaccine skeptic Retsef Levi to lead its COVID-19 immunization working group; and the FDA prioritizes overall survival in cancer drug development.
In another blow to Prothena’s neurodegenerative disease portfolio, anti-amyloid candidate PRX012 has run into the same problem that larger peers Biogen and Eli Lilly have battled: high rates of swelling in the brain.
Exelixis is looking at the possibility of relocating some of the eliminated Pennsylvania roles to its headquarters in Alameda, California, according to a company spokesperson.
The American Academy of Pediatrics called the decision to limit children’s access to COVID-19 vaccines “deeply troubling.”
Novo Nordisk has brought on other cardiometabolic collaborators this year, including United Laboratories International and Deep Apple Therapeutics.
The CDC director—the first to be confirmed by the Senate under new legislation—has been ousted after less than a month following internal unrest regarding new, more restrictive approvals for updated COVID-19 vaccines, according to multiple sources.
Looking for a biopharma job in San Francisco or South San Francisco? Check out the BioSpace list of eight companies hiring life sciences professionals like you.
FEATURED STORIES
When talking to some of the most impressive women in biopharma, the conversation inevitably turned to what these women wanted other entrepreneurs to know. Here’s the best of the best of that advice.
Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the regulator considers more drastic action.
What will Boston Pharmaceuticals CEO Sophie Kornowski do now that the company is selling off its pipeline and winding down operations? Whatever it is, data will take her there.
Amid a season of regulatory and scientific advances, experts reveal a culture of data hoarding among cell and gene therapy developers that is reinforcing fragmentation, stalling innovation and delaying access to treatments.
Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based combination shot that targets both influenza and COVID-19. Now, the entire vaccine sector is sizing up a new regulatory world, companies’ next steps uncertain.
Participants in trials of BrainStorm Cell Therapeutics’ NurOwn filed a Citizens’ Petition with the FDA earlier this month seeking a new review of the stem cell therapy that was rejected in 2022 based on real-world data and 90% survival in an expanded access program.
FROM BIOSPACE INSIGHTS
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.
LATEST PODCASTS
Sanofi and BMS paid big money for rare disease and cancer assets, while Regeneron got in the obesity game; AstraZeneca, Gilead and Amgen shone at ASCO; RFK Jr. and the CDC appeared to disagree over COVID-19 vaccine recommendations and several news outlets are questioning the validity of the White House’s Make America Healthy Again report.
HHS Secretary RFK Jr. removes the COVID-19 vaccine recommendation for healthy kids and pregnant women—the latest in a string of changes to vaccine policies; judge issues an order to halt HHS’ reorganization and mass layoff plans; Rocket Pharmaceuticals’ pivotal Danon disease trial is on hold after a patient death; and President Trump has named Mehmet Oz to spearhead his Most Favored Nation drug pricing policy.
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the importance of target product profiles, particularly when navigating funding challenges, with Ian Fisher, head of development analytics.
Job Trends
French biotech Inventiva’s layoffs and pipeline shift are expected to help keep the company operational into the second half of 2026.
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 biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
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.
DEALS
-
Blueprint has a next-generation systemic mastocytosis treatment, called elenestinib, that Sanofi CEO Paul Hudson told analysts provides an “opportunity to grow through the ‘30s.” -
Bristol Myers Squibb is dropping at least $3.5 billion to jointly develop the bispecific antibody, which will race with Summit Therapeutics, Merck and Pfizer in the crowded PD-1/PD-L1xVEGF space. -
AstraZeneca has put hundreds of millions of dollars into AI deals, with an eye toward not just accelerating the development of drugs that treat cancer after it appears but also in creating diagnostics that can catch cancer earlier than current methods allow. -
The acquisition of SiteOne provides a bit of diversification for Lilly, which has burrowed into the obesity and diabetes space with mega-blockbuster tirzepatide and several follow-on molecules. -
In addition to a $140 million series D, GRIN Therapeutics has signed a global licensing deal for the epilepsy disorder drug radiprodil worth $50 million upfront.
WEIGHT LOSS
-
Analysts at William Blair say dapiglutide’s 11.6% weight reduction at 28 weeks could still be better, given that Zealand’s study predominantly included men and enrolled patients with lower BMI at baseline. -
In combination with Eli Lilly’s tirzepatide, marketed as Zepbound for obesity, Scholar Rock’s monolonal antibody helped patients lose the same amount of weight as patients on tirzepatide alone while preserving more muscle mass. -
Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the year, M&A is back with one deal for a gene editing biotech reinvigorating that sector; and RFK Jr. installs a suite of new vaccine board members who share his skeptical views on vaccines. -
At 12 weeks, weight loss ranged from 2.6% to 11.3%, compared to a gain of 0.2% in the placebo group. Guggenheim analysts were also impressed by the tolerability profile. -
For $812 million, Novo Nordisk will enlist Deep Apple to discover and develop a non-incretin therapy for obesity, months after the Danish pharma’s amylin efforts underwhelmed investors.
POLICY
-
The Department of Health and Human Services is terminating around $500 million in BARDA contracts associated with mRNA vaccine development, a move that will affect several pharma companies, including Moderna, Pfizer, Sanofi and AstraZeneca. -
The regulatory environment is placing extreme pricing pressure on pharmaceutical manufacturers. Their success in the market depends on mounting an agile response. -
Albert Bourla confirmed that he called President Donald Trump after receiving a letter asking Pfizer and a clutch of other pharmaceutical companies to lower drug prices or face consequences. -
Earlier this year, the Centers for Medicare and Medicaid Services scrapped a previous proposal, from the Biden administration, to include anti-obesity medications in Medicare Part D coverage. -
Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy families have turned to the news for answers. Meanwhile, the FDA insists it remains committed to notifying companies of any regulatory action before sharing information with the media or public.
For reasons including downsizing, avoiding retirement and a tight labor market, senior-level biopharma professionals are increasingly turning to fractional roles, according to two recruitment experts.
Massachusetts’ biopharma jobs increased 2.6% in 2023, according to the MassBio Industry Snapshot. Whether the state’s jobs grow in 2024 remains to be seen based on this year’s layoffs and seemingly slowed hiring based on BioSpace data.
The federal judge’s decision Tuesday said the Federal Trade Commission exceeded its statutory authority in implementing a final rule aimed at restricting noncompete clauses.
Massachusetts’ new salary range transparency law can be a tool for companies looking to attract biopharma professionals while also helping candidates and current employees improve their job searches and salaries, according to two experts.
A BioSpace LinkedIn poll showed that just 19% of respondents believe biopharma professionals need Ph.D.s for scientist roles.
Employers have adjusted to higher salaries. That also means they’ve become adamant they get specific skill sets, according to Greg Clouse, BioSpace recruitment manager.
HOTBEDS
REPORTS
How does age affect employees’ experiences in the workplace? This report examines the intersection of age along with gender and other demographics.
In the final instalment of our Diversity in Life Sciences series, BioSpace provides life sciences organizations with practical solutions and benchmarking data to strengthen their DEI initiatives.
BioSpace surveyed industry employers and professionals to understand what to expect from the recruitment market in 2022. What do professionals want? How difficult will it be to recruit new talent?
CANCER
-
While it trails Johnson & Johnson’s Tecvayli, Regeneron still hopes Lynozyfic can differentiate in terms of dosing convenience and efficacy. -
Pfizer insists that the discontinuation of the Phase II study was due to recruitment difficulties and was not linked to maplirpacept’s safety or efficacy. -
In a detail-thin announcement, Amgen said that adding bemarituzumab to chemotherapy improved overall survival, though analysts pledged to wait for more data on safety and tolerability before assessing the drug. -
The FDA delivered two notable approvals for RSV immunization, UroGen overcame a negative advisory committee vote to secure an approval in bladder cancer, and more key regulatory nods from the past month. -
Gilead is betting up to $750 million on Kymera’s anti-CDK2 molecular glue for solid tumors, while Sanofi elected to move forward with another protein degrader from the biotech, designed to target immune-mediated diseases.
NEUROSCIENCE
-
Armed with the latest biological knowledge and cutting-edge computational techniques—and, of course, investor dollars—these six biotechs are playing in the largely underappreciated longevity space, developing therapies that may improve the quality of aging. -
BrainStorm Cell Therapeutics issued a statement Tuesday supporting a Citizens’ Petition submitted to the FDA requesting the approval of its cell therapy NurOwn, whose BLA was withdrawn in 2023. A Phase IIIb trial was scheduled to begin last month. -
After a season of regulatory upheaval, obesity and rare genetic diseases will likely remain major themes for biopharma in 2025, according to Jefferies. -
The high court sides with HHS on HIV PrEP drugs; Health Secretary RFK Jr.’s newly appointed CDC vaccine advisors discuss thimerosal in flu vaccines, skip vote on Moderna’s mRNA-based RSV vaccine; FDA removes CAR T guardrails; AbbVie snaps up Capstan for $1.2B to end first half; and psychedelics take off again with data from Compass and Beckley.
-
BPL-003 showed “robust” efficacy data in treatment-resistant depression, according to analysts from Jefferies, who noted that the asset could hit peak market sales of $1 billion. The results clear the way for the asset’s late-stage development and for the completion of a proposed merger with atai Life Sciences.
CELL AND GENE THERAPY
-
Sarepta’s shares crashed 41% in premarket trading Monday morning to $21.01 after the biotech reported a second death from acute liver failure, a known side effect of adeno-associated virus-based gene therapies. -
The company’s intein-based technology is initially aimed at Stargardt disease, a type of macular degeneration. -
The layoffs will heavily affect Vertex’s operations in Rhode Island, where the biotech will consolidate three facilities into one. -
HHS Secretary Robert F. Kennedy Jr. made waves this week, firing the remaining members of the CDC’s Advisory Committee on Immunization Practices; Metsera’s amylin drug produced weight loss of 8.4% at 36 days; and FDA leaders gathered last week to discuss the future of cell and gene therapy, a sector that has been in turmoil since the ousting of CBER Chief Peter Marks.
-
Gene therapies have ridden investor mania to huge valuations but commercialization challenges have pushed market caps to the floor. At a roundtable last week, FDA leaders promised faster approvals and broad support to the industry.
