President Donald Trump plans to start with a “small tariff” on pharmaceutical imports before ramping duties up to 250% within a year and a half.
BioNTech also laid off 63 employees in June in conjunction with the discontinuation of its cell therapy manufacturing operations in Gaithersburg, Maryland.
The Department of Health and Human Services is terminating around $500 million in BARDA contracts associated with mRNA vaccine development, a move that will affect several pharma companies, including Moderna, Pfizer, Sanofi and AstraZeneca.
From tariffs to drug pricing to the FDA, biopharma CEOs find themselves pulled into policy discussions on this year’s second quarter earnings calls.
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.
The regulatory environment is placing extreme pricing pressure on pharmaceutical manufacturers. Their success in the market depends on mounting an agile response.
FEATURED STORIES
With gene therapies by REGENXBIO and AbbVie, Adverum and others in mid- or late-stage trials, this therapeutic class could soon be an option for this common cause of blindness in the elderly.
Eli Lilly this week announced plans to sell single-dose vials of its weight loss drug Zepbound directly to consumers. Novo Nordisk could adopt a similar strategy for Wegovy as its CEO is set to testify Sept. 24 before the Senate health committee.
Congress, the Federal Trade Commission and the U.S. Patent and Trademark Office are all targeting Big Pharma’s practice of filing multiple, overlapping patents that stifle generic and biosimilar competition.
The vaccine maker is competing with well-established rivals in markets that have a mix of demand issues as well as commercial and structural headwinds, as the biotech looks to establish new growth drivers.
In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them.
Experts say Novo Nordisk and Eli Lilly’s GLP-1 drugs are unlikely to reach more countries in the near term, but Sanofi’s diabetes treatment has gained ground globally.
LATEST PODCASTS
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.
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.
Job Trends
4D Molecular Therapeutics, a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, reported full year 2023 financial results and provided operational highlights.
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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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Despite increasing antitrust scrutiny across the biopharma industry, the European Commission on Thursday said it found no competitive issues with Pfizer’s buyout of the antibody-drug conjugate company. -
Sail Biomedicines combines Laronde’s circular eRNA platform with Senda’s nanoparticle delivery technology in the pursuit of a new class of programmable medicines across therapeutic areas. -
The Danish pharma announced Monday that it is buying a Phase III hypertension candidate from Singapore-based KBP Biosciences. It is Novo Nordisk’s third high-value purchase in as many months. -
The first two weeks of October saw BMS’s $4.8 billion buyout of Mirati, Lilly’s $1.4 billion purchase of Point, Kyowa Kirin’s $387 million acquisition of Orchard and AbbVie’s $110 million Mitokinin deal. -
An increase in funding share and available lab space helps to keep the Bay State’s biotech and pharma sectors strong.
WEIGHT LOSS
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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. -
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. -
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. -
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. -
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
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The number of patients who will be eligible for Novo Nordisk’s blockbuster GLP-1 under new Medicare Part D plan guidelines will vary depending on how cardiovascular disease is defined, according to researchers. -
Johnson & Johnson’s proposed changes to the hospital drug discount program are inconsistent with the federal statute, according to the Health Resources and Services Administration. -
Project 2025, a blueprint for a potential second Trump term that highlights the IRA as a potential target, took a starring role in this week’s Democratic National Convention. -
In a letter to FDA Commissioner Robert Califf, a House committee flagged several U.S. companies—including Eli Lilly and Pfizer—that have allegedly worked with the People’s Liberation Army on clinical trials in Xinjiang, raising ethical and intellectual property concerns. -
Last week, the Biden administration revealed the first drug prices negotiated under the Inflation Reduction Act; Lykos, Grail and others make substantial staffing cuts, and Pfizer/BioNTech see mixed results for their COVID/flu vaccine.
Case job interviews are aimed at gauging at least some of the skills used in a consulting practice.
No matter where in the process you are, here are the questions you should be asking your interviewer.
Here’s a breakdown of how to talk to a future employer about an employment gap in your resume depending on the situation that caused it. So keep reading.
Transferable skills are skills you’ve used in any sector of your life and career that are transferable and applicable to what you what you want to do next.
In the meantime, here are a few things you can do to fill your resume while you’re in between jobs.
Our recent article describing six prominent careers in the biopharma industry was well-received by both college students and current biopharma professionals. As the first installment in a six-part series, we present an in depth review of a rewarding career as a genetic counselor.
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 FDA’s Oncologic Drugs Advisory Committee on Thursday strongly supported changing clinical trials for non-small cell lung cancer drugs given in the perioperative setting, pointing out the need for a more nuanced approached to treatments before and after surgery. -
Novartis continues its dealmaking spree with a bet on Dren Bio’s Targeted Myeloid Engager and Phagocytosis platform to develop bispecific antibodies in oncology. -
A longtime biopharma exec and Moderna shareholder argues in an anonymous email to the companies’ CFOs that they have a fiduciary responsibility to close the deal. Analysts say the proposal is interesting but “too simplistic.” -
AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns. -
Third Arc Bio, led by three former Johnson & Johnson executives, is advancing a portfolio of multifunctional antibodies for cancer and inflammatory and immune-mediated diseases.
NEUROSCIENCE
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The regulator’s new draft guidance, released on Monday, provides additional details regarding the use of surrogate and biomarker endpoints to support accelerated approvals. -
In Monday’s neurology update for investors, Roche touted data from a small Ib/IIa trial for trontinemab, an investigational therapy for Alzheimer’s disease which demonstrated “rapid and robust” amyloid plaque reduction. -
Acadia Pharmaceuticals is terminating development of its antipsychotic drug pimavanserin, which did not demonstrate a statistically significant improvement over placebo in the late-stage study’s primary endpoint. -
Boehringer Ingelheim has paid $27.3 million upfront to Sosei Heptares to develop a small molecule agonist of GPR52 to treat the positive, negative and cognitive symptoms of schizophrenia.
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With Monday’s FDA rejection of their long-acting glatiramer acetate formulation, Viatris and Mapi Pharma continue the biopharma industry’s recent losing streak in multiple sclerosis.
CELL AND GENE THERAPY
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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.
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The potential approval of Vertex’s IgAN therapy povetacicept in 2026 comes amid launch headwinds for the company’s non-opioid pain medicine Journavx and gene therapy Casgevy. -
With a 100% response rate in a Phase II study, KYV-101 sets a new efficacy bar in generalized myasthenia gravis, according to analysts at William Blair.
