FDA
As tariffs, HHS workforce cuts and the ouster of CBER Director Peter Marks threaten the “lifeblood” of the cell and gene therapy space, experts express wariness over the unknowns and optimism that Marks’ legacy will carry on.
A BioSpace survey found that 56% of employed and 81% of unemployed respondents are considering jobs outside biopharma. Some are also seriously thinking about leaving the U.S. to find employment in the field.
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.
Looking for a manufacturing job? Check out the BioSpace list of 11 companies hiring life sciences professionals like you.
Nine states in the Southeast showed growth in bioscience employment and establishments from 2019 to 2023, according to 2024 data from BIO and TEConomy Partners. NCBiotech and Bexion executives discuss the area and the pros and cons of setting up shop far from major hubs.
Canada’s health agency says it has been “taking all necessary action safeguard the drug supply and ensure Canadians have access to the prescription drugs they need.”
The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in patients with prostate cancer who do not carry HRR mutations.
FEATURED STORIES
FDA
The groundwork being done in 2024 is building the foundation for global collaboration in the future.
With the antibody drug conjugate market projected to hit $28 billion by 2028, some companies are looking to harness the drugs for immunotherapy.
Patient assistance programs may actually be a two-way street, providing patients with drugs and companies with data.
Eli Lilly, Rivus Pharmaceuticals and more target different biological processes in hopes of generating higher-quality weight loss and avoiding metabolic issues.
FDA
Donanemab, which will be marketed as Kisunla, will compete with Biogen and Eisai’s Leqembi.
In 2023, the ADC market exceeded $10 billion, and this momentum is persisting into 2024, as evidenced by several strategic deals and a robust pipeline of candidate drugs.
LATEST PODCASTS
In this episode presented by Cresset, BioSpace’s head of insights Lori Ellis discusses the emerging geopolitical battle for AI supremacy and global AI governance with Mutlu Dogruel, VP of AI and Mark Mackey, CSO of Cresset.
George Tidmarsh takes over temporarily at CBER following Vinay Prasad’s abrupt departure; Replimmune trial leaders protest rejection reportedly driven by FDA’s top cancer regulator Richard Pazdur; Merck’s $3 billion savings push claims 6,000 jobs; and Pfizer CEO Albert Bourla addresses President Donald Trump’s new threats around Most Favored Nation drug pricing.
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the concerns and opportunities of patient data driving AI tasks with Louise Molloy, associate director medical information and pharmacovigilance.
Job Trends
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted approval to Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
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SPECIAL EDITIONS
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.
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.
DEALS
  1. AbbVie’s $10.1 billion ImmunoGen buy and Altimmune’s Phase II win demonstrate that the antibody-drug conjugate market is red hot in cancer and GLP-1 drugs for weight loss are an absolute craze.
  2. Facing the loss of Humira revenues from biosimilar competition, AbbVie is looking to grow its pipeline by acquiring ImmunoGen and its antibody-drug conjugate Elahere, which was granted FDA accelerated approval last year.
  3. 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.
  4. The buy brings three small molecules in preclinical development for Parkinson’s disease, amyotrophic lateral sclerosis and lysosomal storage diseases into Merck’s pipeline.
  5. Armed with a pipeline of obesity and diabetes hopefuls, Carmot Therapeutics joins the small group of biotechs to attempt a Nasdaq debut this year.
WEIGHT LOSS
  1. The European Medicines Agency on Friday said it found no evidence linking GLP-1 receptor agonists with suicidal thoughts and actions, following a review of patients taking Novo Nordisk’s semaglutide and liraglutide, and Eli Lilly’s dulaglutide and AstraZeneca’s exenatide.
  2. Florida District Judge Roy Altman earlier this week ruled against Eli Lilly, finding that the drugmaker cannot use state law to block reformulated versions of its blockbuster weight-loss and diabetes medication tirzepatide.
  3. The American Society of Health-System Pharmacists has released statistics showing the number of active and ongoing U.S. drug shortages has reached 323, the highest number since it began tracking the data.
  4. GLP-1 treatments are all the rage in this space, but they aren’t the only approach in development. The pipeline assets highlighted here offer a differentiated approach, potentially increasing efficacy or reducing side effects.
  5. A new Scandinavian study published Wednesday found no conclusive evidence to support the link between GLP-1 receptor agonists and an increased risk of thyroid cancer.
POLICY
  1. The BIOSECURE Act’s prohibition on doing business with China-based companies may have implications for biotech and biopharma markets on both sides of the Pacific.
  2. With the BIOSECURE Act likely to be voted on in Congress this year, WuXi AppTec’s U.S. revenue dropped 1.2% in the first half of 2024 while the Chinese company increased its lobbying efforts.
  3. The combination therapy is one step closer to becoming a potential new first-line standard of care for patients with unresectable or metastatic urothelial carcinoma in Europe.
  4. Despite their initial kicking and screaming, drugmakers seem confident the Inflation Reduction Act’s Medicare Drug Price Negotiation Program will not greatly impact their bottom lines.
  5. Executives from the three largest pharmacy benefit manager companies testified Tuesday before Congress that rising drug prices in the U.S. are due to pharma companies taking advantage of market exclusivities and excessive charges.
CAREER HUB
Whether you’re a recent graduate about to embark on your career or a seasoned professional navigating the difficult waters of professional development and career pathing, a mentor can be an invaluable resource for career advice, support, connections, and encouragement.
Here are four ways to improve your productivity while working from home!
You can apply these career-planning and goal-setting techniques to establish career goals that are just as exciting as those you dreamed about as a kid.
The interview goes both ways and in order to choose a perfect workplace, you must analyze a few things. Here are a few interview red flags to watch out for during an interview.
Questions about the future are not uncommon in job interviews and represent an opportunity for careful preparation.
It’s common to feel overwhelmed or stressed about a major career change. There are a few things you can do to position yourself as the right person for the job.
Once you have your job search spreadsheet organized and the hunt is officially underway, complete the tasks that come up with this method in mind.
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 women’s health focused company acquired the drug for up to $954 million in 2021 through the acquisition of Forendo Pharma.
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. BioNTech on Monday reported nearly $885 million in losses in the second quarter of 2024, compared to $208.5 million during the same period last year.
  2. Despite having an impressive roster of high-profile supporters, including AbbVie, BMS, J&J, Novartis and Pfizer, PARP-focused Ribon has called it quits after nearly a decade in business.
  3. Approved under the regulator’s accelerated pathway, Tecelra is also the first new synovial sarcoma therapy in more than a decade, according to Adaptimmune Therapeutics.
  4. In pursuit of Merck’s blockbuster Keytruda, GSK’s Jemperli scored its own broad FDA label expansion, allowing its use in first-line endometrial cancer regardless of biomarker status.
  5. As part of a major reorganization, Vir Biotechnology has discontinued the bulk of its virology work and pivoted to cancer in an exclusive licensing deal with Sanofi.
NEUROSCIENCE
  1. Acorda Therapeutics becomes the latest biotechnology company in 2024 to go bankrupt and shutter its business, following years of financial difficulty. Merz Therapeutics will acquire two commercial medicines from Acorda for $185 million.
  2. A federal appeals court Monday backed Teva and Viatris’ challenge to a lower court ruling, finding that the companies can again make their case against Johnson & Johnson’s patent covering its schizophrenia drug Invega Sustenna.
  3. The filing of a Biologics License Application for a subcutaneous version of Biogen and Eisai’s Leqembi (lecanemab) has been delayed due to procedural reasons, the companies announced Monday.
  4. While disease-modifying therapies largely steal the spotlight in Alzheimer’s drug development, several companies are working to solve this less-discussed but disruptive facet of the illness.
  5. Imagine testing a really good drug for HER2+ breast cancer in someone with liver cancer. Would it be any surprise when that drug fails?
CELL AND GENE THERAPY
  1. The FDA’s Oncologic Drugs Advisory Committee will meet on March 15 to discuss BMS and J&J applications for their CAR T-cell therapies Abecma and Carvykti, respectively.
  2. Lori, Greg and Tyler discuss last week’s ⁠call for a class-wide box warning⁠ on all commercial CAR T therapies, while investigations are ongoing into ⁠cases of secondary malignancies⁠. How do we approach this ⁠balancing act⁠ of treatment and side effects?
  3. This week, Lori, Greg and Tyler discuss the first ⁠surge of IPO activity⁠ this year plus gene therapy pricing,
  4. CRISPR gene-editing has had its first ever approval in the UK. Will the FDA follow suit? What can patients expect the price tag to be?