Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the FDA’s attitude toward mRNA and COVID-19 vaccines that have investors worried.
Looking for a biopharma job in San Diego? Check out the BioSpace list of eight companies hiring life sciences professionals like you.
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.
Harliku is the only FDA-approved drug for alkaptonuria, a rare condition characterized by skin discoloration, arthritis and heightened risks of heart failure and stroke.
Exemptions to new export control policies have allowed companies to ship patients’ biological materials to foreign laboratories, including those in China and other adversarial nations, according to the FDA.
California’s life sciences jobs led the nation last year, according to a new California Life Sciences (CLS) report. However, employment growth slowed and could continue slowing. CLS President and CEO Mike Guerra discusses the critical factors influencing California’s success.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis discusses key themes from BIO and DIA, including the funding environment, with Rich Daly, CEO of Catalyst Pharmaceuticals, Peter Ronco, CEO of Emmes Corporation, and Phil Vanek, founder of Redline Bio Advisors.
FEATURED STORIES
The past four years have brought disappointment for the Huntington’s community, but optimism is growing as companies including Prilenia and Wave Life Sciences eye paths to approval of therapies that could address the underlying cause of the disease.
A fatal, highly hereditary illness with no disease-modifying treatments, Huntington’s is long overdue for a therapeutic win. Here, BioSpace looks at five candidates that could change the trajectory for patients.
With Eisai and Biogen’s Leqembi and Eli Lilly’s Kisunla launching onto the market, the 2024 Clinical Trials of Alzheimer’s Disease conference focused on the role these drugs might play, as well as combination therapies and innovative new treatment options.
With Novo Holdings’ $16.5 billion buyout of Catalent being reviewed by regulators, what work the contract drug manufacturer may or may not be performing for Eli Lilly remains a point of contention.
With climbing biotech M&A and IPO activity following the post-pandemic slump, experts offer insights on maximizing value and otherwise capitalizing on exit opportunities.
In a tough fundraising space, cell therapy biotechs pursuing autoimmune indications review staffing to ensure the right expertise is in place to tackle the new disease area.
FROM BIOSPACE INSIGHTS
Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. Learn how strategic insights and targeted outreach can turn awareness into high-converting leads.
LATEST PODCASTS
This week Lori, Greg and Tyler discuss AbbVie: how longtime CEO Richard Gonzalez ⁠navigated Humira’s LOE⁠, his victorious retirement ⁠announcement⁠, and the future of biosimilars.
This week Lori, Greg and Tyler discuss the ⁠Accelerated Approval of Amtagvi⁠, the first one-time cell therapy for solid tumors and the first TIL therapy; the ⁠FTC and HHS probe⁠ into generic drug shortages and some recent ADC-focused raises from ⁠ProfoundBio⁠ and ⁠Firefly Bio⁠.
This week, Greg, Heather and Tyler discuss reaction to ⁠Novo Nordisk’s purchase of Catalent⁠ and speculate on what that means for existing manufacturing contracts, customers and consequences with ⁠regulators⁠.
Job Trends
Omega Therapeutics, Inc. announced financial results for the first quarter ended March 31, 2024, and highlighted recent Company progress.
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SPECIAL EDITIONS
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.
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.
DEALS
  1. Is there a connection between Bristol Myers Squibb’s announcement that it will reduce its headcount by 6% and the company’s recent acquisitions of Karuna, Mirati and RayzeBio?
  2. Here’s how to assess whether to develop a new therapy by building a proprietary platform, acquiring another company or asset or partnering with an established entity.
  3. CEO Hervé Hoppenot said Tuesday on an investor call that Escient Pharmaceuticals’ two lead assets “address large populations with a clear medical need” with a potential multibillion-dollar market opportunity.
  4. Novartis on Thursday announced that it is making $150 million in upfront payments to protein degradation biotech Arvinas, while separately revealing that its tender offer for MorphoSys has begun.
  5. Vertex Pharmaceuticals on Wednesday announced it is acquiring clinical-stage immunotherapy company Alpine Immune Sciences for $4.9 billion in cash, the largest acquisition so far this year.
WEIGHT LOSS
  1. Eli Lilly released topline Phase III data on Tuesday showing that after more than three years of follow-up, pre-diabetic patients treated with tirzepatide were less likely to progress to type 2 diabetes.
  2. Eli Lilly’s new research and development facility in Boston’s Seaport district will focus on DNA- and RNA-based therapies, as well as other priority areas such as diabetes and obesity.
  3. Rivus Pharmaceuticals will push HU6 into Phase III development and is looking to engage with regulatory authorities and launch a late-stage study next year in obesity-related heart failure with preserved ejection fraction.
  4. 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.
  5. While some biopharma companies beat expectations, others fell short for various reasons, with some deciding to return or axe assets.
POLICY
  1. 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.
  2. 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.
  3. Drugmakers will have until the end of February to decide whether they want to participate in the second round of Medicare negotiations or not. CMS has until June 1 to send an initial offer for the adjusted prices.
  4. Novartis is locked in a legal back-and-forth with MSN Pharma over alleged patent infringement of its heart failure drug Entresto.
  5. Along with its gene editing therapy Casgevy, Vertex is offering fertility preservation support for its patients—a program that the HHS claims violates anti-kickback statutes.
CAREER HUB
Behavioral interviewing is touted as providing a more objective set of facts to make employment decisions than other interviewing methods. Read to learn more.
The salary expectation question is one of the most difficult questions asked during a job interview. Here’s how you can answer the question perfectly.
The coronavirus disease (COVID-19) pandemic that has ravaged across the globe has demanded more experts in microbiology, particularly jobs in virology.
BioSpace’s Pharm Country Hotbed ranges from Connecticut, New York, New Jersey, Pennsylvania and Rhode Island.
“The Great Resignation” is a term that’s been coined to describe the wave of people leaving their jobs for other opportunities or exiting the workforce altogether.
A resume is your introduction to a potential employer, and as the saying goes, “You only get one chance to make a good first impression.” Follow these resume writing tips today.
Being confident about your skills and learning new things are some of the best career advice and tips a professional should know to become better at your workplace.
HOTBEDS
Where are the Best Places to Work in life sciences? BioSpace’s annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace - find out who made the list this year.
IN CASE YOU MISSED IT
The strategic reprioritization comes after the company hit two major hurdles in the past year, including a clinical hold for an investigational gene therapy and an FDA rejection for its lead asset.
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
  1. Truqap’s positive clinical data comes after it failed a late-stage study in metastatic triple-negative breast cancer. It helps AstraZeneca position itself as a top player in the prostate cancer space, alongside its Big Pharma colleagues.
  2. ADC Therapeutics, Sutro Biopharma and Zai Lab are among those developing antibody-drug conjugates to address payload and toxicity challenges of current ADCs—and rapidly grow the multibillion-dollar market.
  3. The agreement will give Kura enough capital to support the development and launch of its menin inhibitor ziftomenib.
  4. Analysts are split on whether the positive trial results will help Merck stem future Keytruda losses as the mega-blockbuster goes off patent in 2028.
  5. The deal has secured Novartis the chance to work with Ratio Therapeutics on a novel drug candidate that could fortify the Big Pharma against competition from would-be radiopharmaceutical rivals such as BMS and Lilly.
NEUROSCIENCE
  1. Roche’s fenebrutinib this week scored a mid-stage win in relapsing multiple sclerosis, while Sanofi’s tolebrutinib met the primary endpoint in a Phase III trial for progressive MS but flopped in two late-stage relapsing MS studies.
  2. Days after Sanofi reported back-to-back failures for its BTK inhibitor, Roche’s fenebrutinib on Wednesday scored a mid-stage win in relapsing multiple sclerosis, demonstrating near-total elimination of disease activity.
  3. The investigational injection fosgonimeton appeared to have better efficacy in patients with more severe disease, according to post-hoc subgroup analyses, though none resulted in statistically significant effects.
  4. Recursion’s oral drug candidate for cerebral cavernous malformation showed no improvements in patient- or physician-reported outcomes at 12 months. The biotech will engage with the FDA to determine the need for an additional study.
  5. The BTK inhibitor showed promise in non-relapsing secondary progressive multiple sclerosis but not relapsing MS. The company said it plans to apply for approval for the former “as soon as possible.”
CELL AND GENE THERAPY
  1. Exsilio Therapeutics emerged from stealth on Tuesday with a platform that leverages mRNA technology to develop redosable genomic medicines for a range of complex diseases.
  2. FDA
    While Thursday’s label expansion and traditional approval for the gene therapy is an important milestone, many challenges still face the Duchenne muscular dystrophy community.
  3. FDA
    On the heels of a Phase III flop for Pfizer’s Duchenne muscular dystrophy gene therapy candidate, the FDA has green lighted the expanded use of Sarepta Therapeutics’ Elevidys.
  4. 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.
  5. FDA
    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.