Monarez is the first CDC director to be confirmed by the Senate under a new 2023 law and will be the first person without a medical degree to assume leadership of the agency in more than 70 years.
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.
CEO Emma Walmsley maintained that continued investment in the U.S. is a priority for the pharma to ensure its medicines for the country are supplied domestically.
Under the Inflation Reduction Act, medications with the same active ingredient will be treated as the same drug for price negotiation purposes—even if approved by the FDA under a separate application—disincentivizing companies from investing time and money in gaining approval for new formulations and indications.
The FDA’s dramatic summer continues to unfold as news broke late Tuesday evening that Vinay Prasad will depart the agency, where he had been the head of the Center for Biologics Evaluation and Research for less than three months.
Pascal Soriot’s comments came during AstraZeneca’s Q2 earnings call in regard to President Donald Trump’s newly announced European pharma tariffs. The company also announced estimate-beating earnings, with its cancer portfolio driving earnings despite clinical roadblocks.
FEATURED STORIES
The EPIC Act has been proposed with bipartisan and industry support to give small molecule drugs the same protection against price negotiation as biologics, but concerns over how to balance the federal budget could prevent a short-term fix to the IRA.
Around 25 companies have gone public this year, most of them in the early months. Most have tumbled from their original offer price.
By far, the largest acquisition of 2024 was Novo Holdings’ yet-to-be-closed buyout of manufacturer Catalent at $16.5 billion. Outside of that, the leading pharmaceutical companies kept to less than $5 billion per deal.
By speeding lifesaving drugs’ way to market and focusing on the underlying causes of disease, the pathway has helped save many lives.
The darlings of the weight loss and diabetes spaces, GLP-1 receptor agonists have shown promise against Alzheimer’s in recent studies—with Phase III results expected next year from Novo Nordisk.
President-elect Donald Trump and his incoming administration are unlikely to attempt a wholesale restructuring of U.S. healthcare and could promote M&A activity, but controversial picks like Robert F. Kennedy could impact vaccine sales, experts say.
LATEST PODCASTS
This week Lori, Greg and Tyler discuss drug pricing reforms. CMS sent offers to manufacturers of the 10 drugs that have been selected for Medicare price negotiations. What’s the best way forward that benefits patients while still supporting the innovation that makes these drugs possible? How will the election impact negotia
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?
BioSpace’s Lori Ellis and Chantal Dresner discuss anticipated job market trends for 2024 including unemployment, anticipated job search activity and hiring trends.
Job Trends
BioMed X, a German biomedical research institute, announces the start of a new research project in partnership with Merck at its site in Heidelberg, Germany.
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SPECIAL EDITIONS
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.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
DEALS
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Avalo Therapeutics rolled the dice on a big pivot Wednesday, acquiring AlmataBio and focusing on the biotech’s ex-Eli Lilly hidradenitis suppurativa candidate over its existing assets. -
Gamida Cell, whose cell therapy for blood cancer was approved last year by the FDA, is being taken private and restructuring due to liquidity constraints. -
The Swiss contract manufacturer’s cash deal for Roche’s facility in Vacaville, California, is one of the world’s largest manufacturing sites for biologics—a major growth driver for Lonza and other CDMOs. -
Continuing 2024’s biotech initial public offering rally, Boundless Bio will debut Thursday on the Nasdaq with the proceeds used to advance its pipeline of extrachromosomal DNA cancer assets. -
Big Pharma’s appetite for safe and effective oral IBD drugs with novel mechanisms of action continues to grow, with my former company just the latest in a string of acquisitions in the space.
WEIGHT LOSS
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Under a multi-year agreement announced Wednesday, Eli Lilly will leverage Haya Therapeutics’ proprietary RNA-guided genome platform to identify drug targets to address the chronic conditions. -
BioAge will use the proceeds from the initial public offering to move its oral apelin receptor agonist azelaprag past its Phase III STRIDES study and into a registrational Phase III trial. -
Eli Lilly offers weight loss drug Zepbound directly to consumers while Novo Nordisk continues to struggle with supply challenges for its own GLP-1s. Meanwhile, gene therapies for retinal diseases target competitive market, and layoffs persist. -
Novo Nordisk’s continuing supply problems for semaglutide come as the pharma tries to expand the drug’s indication, opening it up to more patients—and potentially to heavier production pressures. -
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.
POLICY
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In the five weeks since Donald Trump returned as U.S. president, the FDA, NIH and CDC have been thrown into disarray, with meetings regarding vaccines and rare diseases canceled or indefinitely postponed—all without a clear reason why. -
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. -
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. -
The Outsourcing Facilities Association, a trade group representing compounders, filed a similar lawsuit in October last year after the FDA formally ended the tirzepaptide shortage. -
Samsung Bioepis allegedly entered into an agreement with a third-party health company, allowing it to market its own private label of a Stelara biosimilar.
Regardless of the field that you work in, mentioning top skills in your resume is a crucial step. Here are some tips to prepare the best leadership skills resume.
While you’re starting your job search and before you go into any interviews, think about how you want to talk about your job loss.
Reasons for investing in leadership development program in the biotech industry are divided into need and opportunity. Read the proper opportunity divisions here.
No matter in which industry you are, clear communication is very important. Follow these tips for clear communications to be prepared to fit in the work environment.
Virtual meetings might have enhanced the ways we connect with each other but it can be really hard to communicate with someone who doesn’t know the basic Zoom meeting etiquette.
Learn these important leadership qualities. The first five on the list are emotional and attitudinal. The other five concern intellectual abilities and learned skills.
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 agreement will give Kura enough capital to support the development and launch of its menin inhibitor ziftomenib. -
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. -
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. -
Despite recent enthusiasm around the PD-1/VEGF space, BMO Capital Markets analyst Evan Seigerman noted that Merck’s pact with LaNova Medicines is more “conservativism” on the pharma’s part than confirmatory of recent data in the drug class. -
GSK is carving out a niche for Blenrep in the second-line multiple myeloma setting, for which it projects multi-blockbuster potential for the antibody-drug conjugate.
NEUROSCIENCE
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Launched in 2020 to more quickly bring to market an effective medicine for amyotrophic lateral sclerosis, the HEALEY Platform Trial has generated disappointing results for many but also continuing programs from Clene and Prilenia. -
The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions. -
BMO Capital Markets analyst Evan Seigerman said luvadaxistat’s inconsistencies between mid-stage trials raise questions about Neurocrine Biosciences’ developmental efforts moving forward. -
The next generation of Alzheimer’s therapeutics is moving away from amyloid plaques and tau tangles, offering multiple approaches to slow cognitive decline. -
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.
CELL AND GENE THERAPY
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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. -
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. -
The plethora of genes involved in obesity presents an intriguing opportunity for both gene silencing and ex vivo gene therapy approaches. -
Results of a large Stanford Medicine study, published Wednesday in The New England Journal of Medicine, finds CAR-T therapies carry a low risk of secondary malignancies not related to the T cells. -
Pfizer’s investigational Duchenne muscular dystrophy gene therapy, fordadistrogene movaparvovec, failed in a late-stage study to significantly improve motor function in patients versus placebo.
