While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience that would make change possible.
The decision follows last month’s vote of the CDC’s revamped vaccine advisory committee. Thimerosal, mostly removed from vaccines decades ago, has long been a target of anti-vaccine advocates for unfounded links to autism and adverse health outcomes.
Looking for a biopharma job in California? Check out the BioSpace list of 11 companies hiring life sciences professionals like you.
Dispatch seeks to address two main challenges of immunotherapies in solid tumors: the lack of a target and the immunosuppressive tumor environment.
The FDA will select at most five companies that align with national priorities, including lower drug prices and increased domestic investment.
The voluntary pauses follow two patient deaths associated with the Duchenne muscular dystrophy gene therapy.
FEATURED STORIES
Launched in 2021, the public-private consortium on Wednesday updated ASGCT attendees on its efforts to bring adeno-associated virus gene therapies to more rare disease patients.
A new BioSpace report finds that life science professionals are prioritizing diversity less when job hunting. Still, DEIB programs don’t appear to be going anywhere.
Amylyx’s recent decision to withdraw its ALS drug Relyvrio from the market highlights an important business decision for companies: when to continue marketing or investigating a drug that has failed a pivotal or confirmatory study.
As Sarepta Therapeutics moves closer to full approval and an expanded label for its gene therapy, some experts push back on clinical efficacy and cost while others note the hope it provides patients with Duchenne muscular dystrophy.
It wasn’t calls from lawmakers but market competition with Eli Lilly’s Zepbound that prompted Novo Nordisk to lower the prices of its blockbuster weight-loss drug.
Since the 2022 launch of ChatGPT, biopharma has poured money into this new form of artificial intelligence, but companies remain cautious with unproven technology.
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
Cognizant announced an expanded agreement with Takeda, a global biopharmaceutical company, to support the company’s digital transformation strategy by reinforcing and supporting its technology efforts.
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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
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Pfizer will acquire the Seattle-based antibody-drug conjugate leader in a $43 billion deal expected to close late in 2023 or early 2024. -
The California Department of Financial Protection and Innovation shut down the Silicon Valley Bank Friday, a top financial institution for the life sciences industry, leaving biopharmas scrambling. -
As life sciences companies feel the burn of the current economy, one Bay Area biotech, CODA Biotherapeutics, quietly shut its doors. -
As the macro pressures of higher rates and fear of recession build, today’s investor is increasingly risk averse. With zero-risk options offering decent returns, only the highest-quality programs will get funding. -
Seagen and Pfizer are in early-stage talks over a potential acquisition that could exceed $30 billion.
WEIGHT LOSS
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Using electronic health records, healthcare analytics firm Truveta contends that Eli Lilly’s Mounjaro (tirzepatide) could achieve stronger and faster weight loss than Novo Nordisk’s Ozempic (semaglutide). -
To help cope with the high demand for weight-loss treatments, Eli Lilly is investing $2.5 billion in a German manufacturing facility after last week’s FDA approval of Zepbound for chronic weight management. -
Just a week after it secured FDA approval, Eli Lilly’s Zepbound now faces a challenge from Novo Nordisk’s investigational next-generation weight-loss candidate CagriSema in a Phase III trial. -
In this episode BioSpace’s Greg Slabodkin, Tyler Patchen and Lori Ellis discuss Zepbound, Wegovy, the weight loss race and the future of this drug class.
POLICY
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National Institutes of Health researchers in a Phase Ib/II study found a five-drug combination elicits strong remission rates in diffuse large B-cell lymphoma patients without using chemotherapeutic agents. -
The next six months for the FDA are primed to be as groundbreaking as the first six, with Eli Lilly’s donanemab and Lykos Therapeutics’ MDMA-assisted PTSD therapy on the docket, among others. -
Following two deaths due to presumed sepsis, the FDA has placed a partial clinical hold on three trials for Zentalis’ azenosertib including a Phase I in solid tumors, Phase II in platinum-resistant ovarian cancer and Phase II in uterine serous carcinoma. -
Merck on Monday secured the FDA’s green light for its 21-valent pneumococcal vaccine Capvaxive, which covers serotypes responsible for around 84% of invasive pneumococcal disease cases. -
The FDA is facing four big target action dates in the final week of June, including one label expansion for a bispecific antibody and another for an investigational gene therapy.
A new year calls for a renewed sense of focus, direction, and motivation in your career. It’s a time to let go of the bad habits that have been holding you back professionally, and replace them with newer, better strategies that will help you to have a year of growth and success in 2019.
California’s life science sector is a major player in the state’s job creation and economic development. In 2016, life science companies in California employed more than 360,000 professionals.
Holidays mean a lot of opportunity to socialize with people both within and outside of your field, and if you happen to be on the job market or considering making a career switch in 2019, it can also be a great opportunity to make organic connections with people who may end up helping you out in the future.
Here are 7 self reflection questions to ask yourself during the New Year to find out if you’re on the right path to achieving your career goals in the coming year.
Flexible hours. More vacation time. Work from home. Free gym memberships. Free snacks. Company-sponsored outings. Student loan payment assistance. These are some of the perks that companies dangle in order to attract top talent to their ranks.
Need help writing your career change cover letter? Here are some tips that will get you started on the right path by making you the best candidate for the job.
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
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The Chinese biotechs are broadening their collaboration. Hansoh Pharma is licensing Biotheus’ anti-EGFR/cMet bispecific antibody to develop antibody-drug conjugates. -
The PD-1 inhibitor Keytruda significantly improved overall survival in a late-stage trial when used with chemoradiotherapy to treat patients with newly diagnosed advanced cervical cancer. -
After several delays, BeiGene on Thursday finally secured the FDA’s approval for its PD-1 inhibitor Tevimbra for the treatment of unresectable or metastatic esophageal squamous cell carcinoma. -
Antibody-drug conjugate Adcetris, when used with rituximab or lenalidomide, improved overall survival in patients with relapsed or refractory diffuse large B-cell lymphoma. Pfizer secured access to Seagen’s ADC in March 2023. -
BeiGene’s Brukinsa becomes the first BTK inhibitor approved for follicular lymphoma, the most common type of low-grade non-Hodgkin lymphoma.
NEUROSCIENCE
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Cassava Sciences reported Phase II data from its Alzheimer’s candidate simufilam Tuesday. The company’s stock dropped 17% following the reveal. -
Research hasn’t shown that removing amyloid plaques alone improves function in Alzheimer’s patients, said Sharon L. Rogers, CEO of AmyriAD. -
The FDA issued a complete response letter Thursday refusing accelerated approval for Eli Lilly’s Alzheimer’s disease candidate donanemab. -
The neurodegenerative drug development space saw incremental victories in 2022. Leaders from Eisai, Voyager and QurAlis discuss upcoming milestones. -
The FDA approved Eisai and Biogen’s lecanemab (Leqembi) Friday afternoon. It is the second anti-amyloid antibody to be approved for Alzheimer’s disease in two years.
CELL AND GENE THERAPY
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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.
