The back-to-back high-level disruptions in vaccine policy under Robert F. Kennedy Jr. comes as the U.S. records its first death from measles since 2015.
Our CEO accidentally started a book club. Now we’re all dreaming of mega pharma mergers.
In the Phase III SERENA-6 trial, camizestrant—in combination with CDK-inhibitors—beat out current standard-of-care treatments in terms of progression-free survival, according to AstraZeneca.
Eikon’s lead candidate, EIK1001, is being tested for advanced melanoma. The candidate is currently in late-stage development, which the biotech will fund using Wednesday’s series D raise.
As FDA seeks to rehire some fired employees, Donald Trump threatens to enact tariffs on pharma companies unless they reshore manufacturing; another lawsuit hits the complex GLP-1 compounding space as Eli Lilly offers expanded Zepbound options; and struggling gene therapy biotech bluebird bio goes private in an attempt to stay solvent.
While many industry players and observers have high hopes for the EPIC Act, some say budgetary headwinds could make it difficult for the current administration to make meaningful repeals or amendments to the IRA.
FEATURED STORIES
BioSpace has been compiling a list of the most innovative and exciting biotechs for a decade. Here we take a look back at noteworthy companies from each of those lists.
While some analysts say Donald Trump is a wild card when it comes to drug pricing, many argue his presidency would be more positive for the industry overall, as Kamala Harris has her price-cutting sights squarely on Big Pharma.
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.
FROM BIOSPACE INSIGHTS
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
LATEST PODCASTS
President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.
In this episode of Denatured BioSpace’s head of insights Lori Ellis discusses the public health consequences of vaccine hesitancy and the critical distinction between skepticism and cynicism with Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
A new executive order aims to smooth the path for getting U.S. manufacturing facilities up and running; HHS says it will require placebo-controlled trials for all vaccine approvals; tariff threats hit BioNTech; Novo Nordisk’s FDA application for an oral version of Wegovy is accepted; and more.
Job Trends
Merck (NYSE: MRK) announced today that Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, is scheduled to participate in a fireside chat at the Leerink Partners Global Biopharma Conference 2024 on Monday, March 11, 2024, at 12:40 p.m. ET.
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SPECIAL EDITIONS
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.
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.
DEALS
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The Federal Trade Commission’s lawsuit takes an unusual strategy, according to legal experts, raising concerns and uncertainties in the biopharma industry. -
Roger Perlmutter’s company announced the addition Thursday of myriad early- to mid-stage assets in the cancer and neurodegenerative disease spaces. -
Data from a Phase III trial of apraglutide for a type of short bowel syndrome with intestinal failure is expected by the end of the year. It is also in a Phase II study for acute graft-versus-host disease. -
The Federal Trade Commission filed a lawsuit Tuesday seeking an injunction to prevent Amgen’s buyout of Horizon Therapeutics, which the agency says would “entrench monopoly drugs.” -
The Chapter 11 bankruptcy was driven by increasing generic competition, declining profits and the unrelenting legal woes of its head Martin Shkreli, dubbed “Pharma Bro” in the media.
WEIGHT LOSS
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While Pfizer’s oral GLP-1 candidate met its primary endpoint in a Phase IIb obesity trial, twice-daily dosing of danuglipron resulted in high rates of adverse events including nausea, vomiting and diarrhea. -
Patients treated with Altimmune’s investigational GLP-1/glucagon dual receptor agonist saw up to 15.6% weight loss, and nearly a third of those taking the highest dose lost at least 20% of their body weight. -
This week on The Weekly we talk struggles with GLP-1 drug shortages and what that might mean for Novo and Lilly competitors; Regeneron and Sanofi positive results for Dupixent in COPD. Plus, Merck buys Caraway, Beigene’s deal with Ensem, ups and downs for Flagship. -
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.
POLICY
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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 interest in psychedelic therapies ramp up, Lykos Therapeutics will go in front of the FDA’s Psychopharmacologic Drugs Advisory Committee on June 4 to present its investigational treatment for post-traumatic stress disorder. -
With appeals and additional cases still pending, it remains to be seen if any of the arguments being brought by biopharma companies against the U.S. government will hold up in court. -
The FDA is looking at four decision deadlines in the coming three weeks, including two for a CAR-T therapy and another for a hepatitis B vaccine. -
The Federal Trade Commission has asked for an additional 30 days for its review of Novo Nordisk’s $16.5 billion acquisition of Catalent, with the companies expecting to complete the merger by the end of 2024.
While many job seekers are unnerved by the “Tell me about yourself” request, it’s actually an opportunity to shine and take control of the interview.
What will it take to motivate the employer to hire you, or at least invite you back for a second interview?
Experts differ on how direct job seekers should be in closing the sale. Some say candidates miss opportunities if they don’t come right out and ask for the job. Others say a hard sell doesn’t work in this situation.
Here are a few ways to amplify your job search that can help you make significant progress.
Be ready by anticipating and countering objections the employer might raise.
This smooth 24 hours of preparation for your job interview should ensure a long run when you get that job offer. Here are last minute interview tips to hone your skills.
HOTBEDS
IN CASE YOU MISSED IT
In this bonus episode, BioSpace’s vice president of marketing Chantal Dresner and careers editor Angela Gabriel take a look at Q1 job market performance, layoffs and administration decisions impacting the workforce.
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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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. -
Despite its overall survival and disease progression benefits, the U.K.’s drug cost watchdog has declined to recommend AstraZeneca and Daiichi Sankyo’s Enhertu due to a lack of cost-effectiveness. -
Rybrevant has been approved for use with carboplatin and pemetrexed in the first-line treatment of locally advanced or metastatic non-small cell lung cancer with exon 20 insertion mutations in the EGFR gene. -
Retaining the full rights to Trodelvy, Gilead now has access to $210 million in financing from venture capital firm Abingworth to help push the antibody-drug conjugate into non-small cell lung cancer studies.
NEUROSCIENCE
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Biogen’s 2022 fourth-quarter and full-year report comes the day after an additional warning on the company’s first Alzheimer’s drug came to light. -
The discovery of novel Alzheimer’s biomarkers is enabling better trial selection, earlier pipeline decision making and new targets for therapeutics. -
Phase I/II data showed AC Immune’s anti-amyloid-beta vaccine candidate could safely elicit an antibody response in patients with Alzheimer’s disease. Now, it will expand to Down Syndrome patients.
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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.
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Research hasn’t shown that removing amyloid plaques alone improves function in Alzheimer’s patients, said Sharon L. Rogers, CEO of AmyriAD.
CELL AND GENE THERAPY
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Taking center stage at the American Society of Gene and Cell Therapy meeting was the first-ever reported case of a personalized in vivo CRISPR editing therapy, which substantially eased the symptom burden in an infant. -
Since Elevidys’ accelerated approval in 2023, experts have been clamoring for more data, particularly in older and non-ambulatory children. New results, presented Friday, show mobility improvements in 8- to 9-year-old patients after one year of follow-up. -
Lilly will use Rznomics’ proprietary ribozyme technology to develop RNA editing therapies for congenital hearing loss. -
After warnings that the dragged-out process was putting the cell therapy company at risk of bankruptcy, bluebird bio now has a new deal to offer shareholders. -
It’s another wild twist in the story of Galapagos, a company that has been around for more than 25 years but has yet to get a therapy approved.
