Where thousands of former Health and Human Services employees will work next is unknown, but biopharma companies likely aren’t the main destination. Two biopharma executives discuss potential landing spots.
Drugmakers will be expected to commit to aligning U.S. prices with the lowest price set in a group of peer nations for all brand products across all markets that do not currently have generic or biosimilar competition.
Most of the 15 million children with a rare disease have no FDA-approved treatments available to them. And when it comes to the most-rare conditions, there isn’t even a pipeline.
The partnership with Sirius expands CRISPR Therapeutics’ modality toolkit, especially in the cardiovascular space.
The late-stage results come in advance of pivotal data that Ionis expects to provide for its antisense oligonucleotide Tryngolza in the third quarter, building up toward a regulatory submission in hypertriglyceridemia by year-end.
In an interview on Friday, FDA Commissioner Marty Makary threw his weight behind psychedelic therapies, noting that patients taking these substances experience significant benefits for various neuropsychiatric conditions.
The deal comes three months after Pfizer inked a PD-1/VEGF partnership with Summit Therapeutics, leading BMO Capital Markets to express confusion regarding the pharma’s overall strategy.
FEATURED STORIES
Some analysts say so, and a recent study suggested Lilly’s tirzepatide beat Novo’s semaglutide at inducing weight loss, but there are other factors in the market race. 
Why I advocated on Capitol Hill this month for the renewal of the FDA’s Priority Review Voucher program
After a busy first half of 2024, several companies are expecting key data readouts in the neuropsychiatric and neurodegenerative disease spaces during the next six months.
Halia Therapeutics, NodThera and Gain Therapeutics target neuroinflammatory processes in hopes of modifying the course of Parkinson’s progression.
The Federal Trade Commission criticized the business practices of pharmacy benefit managers this week, but drugmakers are also at fault for the high costs of medicines.
Artificial intelligence is making it faster to get drug candidates to the clinic, but to gain a competitive advantage, companies must have a strong foundation of data.
LATEST PODCASTS
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.
Sarepta’s Elevidys is back on the market for ambulatory patients with Duchenne muscular dystrophy, Health Secretary Robert F. Kennedy Jr. reportedly plans to dissolve the U.S. Preventive Services Task Force and “fix” the vaccine injury compensation program, Merck, AstraZeneca and more report Q2 earnings, Novo names a new leader and Roche’s trontinemab impresses at AAIC25.
Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug regulator in George Tidmarsh, a handful of new drugs get turned away from the market and pharma companies continue to commit billions to reshoring manufacturing.
Job Trends
Merck, known as MSD outside of the United States and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer at high risk of recurrence in adults.
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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. Continued fallout from the IRA, heightened antitrust enforcement and the rise of AI will all shape the first wave of biotech mergers and acquisitions coming this year, experts tell BioSpace.
  2. What needs to happen for funding in biopharma to bounce back? BioSpace’s Lori Ellis discusses the macroeconomic environment and biopharma funding outlook with venture capital guests Ansbert Gadicke, Martin Gershon and Mike Goguen.
  3. After a “reasonably strong year” in 2023, next year will see “similar levels” of M&A activity with increased investor interest in weight loss and cardiovascular diseases, contends professional services firm PwC.
  4. BioSpace and guests from Halia Therapeutics, Triumvira Immunologics and the Alzheimer’s Drug Discovery Foundation will discuss alternative financing strategies to consider for 2024. Watch now.
  5. The companies have received all required regulatory approvals to complete the deal, the largest for the sector in the past three years and the biggest for the hot antibody-drug conjugate market.
WEIGHT LOSS
  1. The clinical-stage biotech emerged from stealth on Thursday with several oral and injectable candidates, including a GLP-1 receptor agonist in Phase I trials, in an effort to challenge Novo Nordisk and Eli Lilly.
  2. Nearly all doses of Eli Lilly’s highly popular weight-loss drug Zepbound and type 2 diabetes medication Mounjaro will have limited availability through the second quarter of 2024, according to the regulator.
  3. With Wednesday’s readout showing symptom improvements in obstructive sleep apnea patients, Eli Lilly is preparing to file for a label expansion for its blockbuster weight-loss drug Zepbound.
  4. The German biopharma company on Tuesday announced ambitious pipeline plans that include starting 10 new Phase II and III trials over the next 12 to 18 months.
  5. 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.
POLICY
  1. With Medicare expenditures on Stelara increasing nearly tenfold, a new report from the HHS Office of Inspector General has found major differences in drug payment amounts under Part B versus Part D.
  2. In the latest setback for the pharma industry and its allies, the United States District Court for the Southern District of Ohio dismissed a U.S. Chamber of Commerce lawsuit on the grounds of improper venue.
  3. Lobbying groups and individuals connected with the industry are supporting candidates from both parties, with a particular focus on the future of the 340B discount program and pharmacy benefit managers.
  4. IRA
    Reiterating his ruling in a prior Inflation Reduction Act case, New Jersey District Court Judge Zahid Quraishi ruled that Novo Nordisk’s participation in the Medicare Drug Price Negotiation Program is of its own free will.
  5. 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.
CAREER HUB
There are many reasons employees elect to remain at a given job: good salary and benefits, a strong sense of mission or duty, convenience, and so on. There are also many reasons that employees decide to leave a job – and one very common reason is management.
Once you do land your next job interview, you’ll want to address your layoff in the right way. Here’s how.
Finding common ground and making small talk are both skills that help you build that rapport with someone.
Of the resumes submitted to employers that use Applicant Tracking Systems (ATS), 75% are never seen by human eyes.
The global COVID-19 pandemic may not seem like the best time to accelerate your career, but some characteristics of this unusual time actually lend themselves to career-boosting activities. Whether you are still working from home or are back in your workplace, this article offers suggestions for pumping up your career.
The most effective job seekers know that standing out from the crowd goes a long way toward job search and career success. Less well-known is exactly how to differentiate oneself and gain that competitive advantage.
Going through a career transition can be stressful and difficult to navigate. Many professionals don’t know how to start the process or begin to explain the reasoning for making a shift.
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 revamped and “more anti-vax skewed ACIP committee” at the CDC “has a bone to pick with mRNA vaccines,” according to Truist Securities analysts. Meanwhile, the FDA moves forward on having Pfizer/BioNTech and Moderna update labels for their COVID vaccines.
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. At this week’s American Academy of Neurology annual meeting, Amylyx provided additional data from its Phase III amyotrophic lateral sclerosis study showing the full extent of Relyvrio’s failure.
  2. Amylyx looks to the future after Relyvrio withdrawal, ADCs continue to attract investment and the drug shortage persists in the U.S.
  3. Already approved in schizophrenia and bipolar depression, Intra-Cellular Therapies reported strong late-stage data Tuesday for its antipsychotic Caplyta in major depressive disorder.
  4. Following cases of convulsions in rabbits in a preclinical study, the FDA has placed a clinical hold on Neumora Therapeutics’ Phase I schizophrenia drug candidate NMRA-266.
  5. Experts are hopeful that objective biomarker measures for amyotrophic lateral sclerosis, such as the ones being developed by EverythingALS, will lead to more targeted, effective treatments.
CELL AND GENE THERAPY
  1. Citing the need for more time to review additional Chemistry, Manufacturing and Controls information, the FDA has extended its target action date for Rocket Pharmaceuticals’ investigational gene therapy by three months.
  2. With last year’s approval of Vertex and CRISPR’s Casgevy, it’s the start of a new era of gene editing. But there are still challenges we must face.
  3. Shares of preclinical genetic medicines company Metagenomi tanked more than 30% on Friday afternoon in a disappointing debut for its initial public offering, bucking the trend of positive IPOs so far this year.
  4. Investors drove up the price of Kyverna Therapeutics’ stock by 59% in its initial public offering on Thursday afternoon, the first day of trading, reaching a peak per-share price of $35.01.
  5. BioNTech will pay $50 million in cash and purchase $200 million of Autolus Therapeutics’ shares to progress the companies’ respective CAR-T candidates to commercialization.