BioSpace

12 billion dollars : one of the boldest women’s health research moves an administration has made for women’s health research. On a global scale, this has caused countries and sovereign states to start investing in women’s health. But in the United States, the funding is not guaranteed. It depends on congressional approval, which is complicated during an election year. As the United States continue...

In this edition of The Weekly , Managing Editor Jef Akst and News Editor Greg Slabodkin share their insights from the American Society of Gene & Cell Therapy’s 27th annual conference, including advances around adeno-associated viruses and the ongoing discussion about the FDA’s accelerated approval program and how it relates to rare diseases. Also, on Tuesday, Eli Lilly announced that an adviso...

In this special edition of The Weekly , we discuss the much-anticipated annual meeting of the American Society of Gene & Cell Therapy in Baltimore. It starts Tuesday and will hit on wide-ranging issues facing the cell and gene therapy (CGT) space, from new therapeutic advances to safety concerns and regulatory considerations to manufacturing and commercialization. Big hitters in the CGT space...

J&J and BMS’ challenges to Medicare drug price negotiations shut down in federal court less than a week after BMS announced it was laying off more than 2,000 employees.    Earlier this week, a federal judge in New Jersey added fuel to the ongoing legal battle between Big Pharma and the government over the Inflation Reduction Act. The judge on Monday dismissed claims from Johnson & Johnson...

The potential impacts on clinical trial outcomes warrant a discussion surrounding the current definition of women’s health. In the second episode on our series on women's health, we discuss what may happen to future generations if women, the custodians of generational health, are not comfortable sharing complete medical histories. Additionally, we discuss how broadening the definition will open fu...

Sanofi will cut an undisclosed number of jobs as it revamps its U.S. vaccines commercial operations , as well as 99 employees from its Belgian sites —moves that are part of a full pipeline reprioritization. Meanwhile, the company got a win this week, with its investigational BTK inhibitor rilzabrutinib generating positive results in a Phase III study for adult patients with persistent or chronic i...

The past two weeks have seen Amylyx lose its only marketed product but receive numerous accolades for its decision to voluntarily withdraw Relyvrio after a failed Phase III trial in amyotrophic lateral sclerosis. Analysts and insiders spoke with BioSpace this week about the company's future and a possible regulatory precedent for other drugs approved based on a single trial. Elsewhere, antibody-dr...

Last month, President Biden signed an Executive Order on Advancing Women’s Health Research and Innovation, signalling the significance of women's health to the government and consequently investors. While women’s clinical trial participation has increased, clinical trials still largely are not designed for women. In this episode, our guests discuss the many areas where trials can be improved, such...

Conference season is in full swing, with the American Association for Cancer Research and American College of Cardiology concurrently holding their annual meetings in San Diego and Atlanta, respectively. From opposite coasts, biopharma companies are presenting their latest data in the cancer and cardiology spaces, both hits and misses alike. Oncology continues to be a hot area for investment , wit...

WuXi AppTec was once again in the news this week, with speculation that the China-based biotech allegedly handed a U.S. client’s intellectual property over to the Chinese government without consent. Meanwhile, Lonza’s $1.2 billion buy of a Roche biologics plant in California—one of the world’s largest biologics manufacturing facilities by volume—bodes well for the CDMO market, and BMS pulls ahead...

The pharmaceutical industry is facing critical attention, particularly around drug pricing and development costs. Drug development cost is about 10% of the total healthcare spend in the United State. Broader issues such as local monopolies, utilization, unit, and costs and local monopolies, politics and a fragmented payer system contribute to the increasingly high costs to patient. Challenging as...

It was another busy week! Bayer reduced its executive suite from 14 to 8 as part of a major restructuring. Meanwhile, the government announced it will pay for Wegovy for patients with heart disease after the Novo Nordisk therapy was approved earlier this month for the cardiovascular indication. Plus, Mirador’s emergence from stealth and the FDA’s approval of the third therapy for Duchenne muscular...

This week, we're talking money! Following the release of BioSpace's 2024 Salary Report , we discuss salary trends and how they are impacting the biopharma workforce. Considering growth rates, we also discuss asking for raises vs looking for a new job and what salary trends may spell out for the rest of the year. Guest Chantal Dresner , VP of Marketing,  BioSpace Angela Gabriel , Content Manager -...

Phew, what a week! One of the most anticipated FDA decisions of the year dropped last week when the regulator approved Madrigal’s Rezdiffra as the first therapy for MASH ( formerly known as NASH ).   Then on Friday, BioSpace kept a close eye on an advisory committee discussing J&J’s Carvykti and BMS’s Abecma, two CAR-T therapies seeking label expansions as earlier lines of treatment in multipl...

Continuing on from our previous episode "The gap is where the pain is", this episode focuses on a healthy discussion regarding the IRA, particularly the unintended consequences to small molecule development within the industry and for patients. Topics explored in this discussion are potential reasons behind the small molecule negotiation timeline decision, the antibody drug conjugates (ADC) boom,...

The weight loss market is the gift that keeps on giving—at least for Novo Nordisk—as Wegovy continues to demonstrate its prowess with label expansion . Also discussed: biosimilar approvals for Fresenius Kabi , and Sandoz . More news at the forefront of Alzheimer's treatment : Eli Lilly's donanemab decision date got pushed and now the FDA wants to discuss the drug’s safety and efficacy at an upcomi...

These days you can hardly move without figuratively bumping into antibody-drug conjugates (ADCs). This week we discuss Pfizer's strategic priorities for oncology - focused on ADCs and less on small molecules - and how the market is being influenced by the IRA.

When it comes to drug pricing, there have been (and are) bad actors in the industry, but the conversation usually ends there. Five KOLs from different parts of the industry come together to discuss the complexities surrounding drug spend and pricing, innovation, funding, and the overall healthcare system. This episode explores the drug pricing gap between consumer experience and industry norms. Jo...

This week Lori, Greg and Tyler discuss AbbVie: how longtime CEO Richard Gonzalez navigated Humira's LOE , his victorious retirement announcement , and the future of biosimilars. Also discussed: Earlybird Health's $186m VC fund ; and definitely not the IRA.

This week Lori, Greg and Tyler discuss the Accelerated Approval of Amtagvi , the first one-time cell therapy for solid tumors and the first TIL therapy; the FTC and HHS probe into generic drug shortages and some recent ADC-focused raises from ProfoundBio and Firefly Bio .

This week, Greg, Heather and Tyler discuss reaction to Novo Nordisk's purchase of Catalent and speculate on what that means for existing manufacturing contracts, customers and consequences with regulators ; as well as discussion around the ongoing issues with drug shortages and manufacturing challenges and whether it the move will help accelerate manufacturing for Wegovy and Ozempic. Plus, what's...

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 negotiations? Also discussed earnings including Novo Nordisk , who beat analyst e...

Almost 30,000 patients have now been treated with CAR-T cell therapies since it was the first approval in 2017. In November 2023, the FDA launched a probe into malignancies caused by CAR T therapies, and just last week the agency called for a class-wide box warning on all commercial CAR-T therapies with ongoing investigations into cases of secondary malignancies . How do we approach this balancing...

Following a challenging year of layoffs and limited funding, Chantal Dresner, VP of Marketing at BioSpace, discusses the findings of our most recent Employment Outlook Report including unemployment, anticipated job search activity, hiring trends and current workforce sentiment.

The first surge of IPO activity this year sees Alto Neuroscience, ArriVent Biopharma , CG Oncology , Kyverna Therapeutics and Metagenomi making announcements. Lori, Greg and Tyler also discuss gene therapy pricing including Vertex/CRISPR's Casgevy .