Amid industry’s ongoing drive to speed drug discovery, clinical development and commercial success, government regulation can sometimes seem slow moving. But even a quick look at regulatory highlights from 2021 shows nothing could be further from the truth. From COVID-19 and cancer to Aduhelm and the broader health care ecosystem, so much has changed – and not just in the U.S. Join us for perspective on this fast-changing landscape from Peter Pitts, president of the Center for Medicine in the Public Interest, among other roles. “All of a sudden, everybody is a regulatory expert,” he said. Will free beer get us where we need to go? Listen to find out.

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The COVID-19 pandemic is so all encompassing and complex, with dramatic details shifting almost hourly, that it can be easy to lose track of the big picture. And there are so many questions. Has industry pushed out vaccines too fast? Was there adequate testing? Did they take shortcuts? Why were governments pushing for boosters before the scientific data was available? We asked BioWorld’s regulatory editor Mari Serebrov, who has covered the pandemic since the beginning, to help put it all into perspective. She has strong insights into vaccine development, including the handful of winners and quite a few failures in the more than 1,000 vaccines and therapeutics in the pipeline. Listen to the discussion on how industry has pushed out vaccines and drugs in this turbo-charged timeline.

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A new pill, molnupiravir, from Ridgeback Biotherapeutics, and partner Merck & Co. Inc., could cut hospitalizations and deaths from COVID-19 in half. The companies are already seeking emergency use authorization in the U.S. and global governments are pledging to buy big lots of the medicine, pending regulatory approvals.

But some people are already crying foul over the proposed price, $712 for a treatment, which includes twice daily doses for five days – because the U.S. government helped pay for the research. Molnupiravir was invented at Emory University and had partial funding and support from the U.S. government.

Joseph Allen, executive director of the Bayh-Dole Coalition, joined the BioWorld Insider Podcast this week to explain how this scientific discovery may have never had a chance to move out of the university onto pharmacy shelves without the government’s support of innovation. The cost of health care, including drugs, is an entirely separate topic and should be treated as such, he said.

Allen explained that the Bayh-Dole Act, which then-Senator Joe Biden voted for in 1980, also has something called a march-in provision. In the absence of good-faith efforts being made to commercialize an invention discovered with government support, it enables the government to force licensing of the technology to another party. While some have argued the same mechanism could be used to set the price of federally funded medicines, Allen said that’s never been the law’s intention.

However the pricing saga plays out, the pill would be a far more convenient alternative to other currently used therapies which are injected.

Listen to BioWorld Insider podcast to better understand the controversial story behind the story.

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Cervical cancer is one of the leading causes of cancer morbidity and mortality in women worldwide. While widespread use of HPV vaccination is dramatically reducing the number of women developing the disease where vaccination is common, the global number of new cases is projected to climb over the next decade.

Treatment options until now have been limited to surgery, chemotherapy, radiation, and immunotherapy. Recent data showed adding Keytruda to standard first-line chemotherapy improved survival, but there's still substantial need for new treatments. This week, one arrived: The Danish firm Genmab and its U.S. partner, Seagen, won accelerated FDA approval for the antibody-drug conjugate Tivdak (tisotumab vedotin). Join us as we talk about the approval and the future of Genmab with the company's president and CEO, Jan van de Winkel.

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Rapid development of mRNA-based COVID-19 vaccines has drawn global attention. But could DNA-based vaccines work better in the long run?

Recent emergency use authorization for Zydus Cadila’s DNA-based COVID-19 vaccine made headlines worldwide, previewing what’s possible. Now, join BioWorld Insider as we take a closer look at this type of vaccine with Lucio Rovati, CEO and chief scientific officer of Italy’s Rottapharm Biotech. Together with another Italian firm, Takis Biotech, they recently announced phase I results of the first DNA vaccine candidate against COVID-19 to enter clinical development in Europe. The vaccine has potential as both an initial vaccine and as a third dose when the antibody response from other available vaccines decreases.

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COVID-19's impact on clinical trials has been broad and varied. Recruiting disruptions, protocol changes and logistical challenges have forced both investigators and regulators to adapt. As the pandemic continues to shape how trials are run, key stakeholders are responding with new ideas to keep drug candidates on track. Join us as we talk to Laurie Halloran, president and CEO of Boston-based Halloran Consulting, about the way trial sponsors and regulators have managed through this time. Working with more than 750 clients, from startups to global drug developers over 23 years, Halloran has seen it all and shares some of the strategies companies are using to succeed.

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About a third of all human cancers are driven by mutations in RAS genes. Many RAS mutations make cells resistant to a lot of approved cancer therapies. Some members of the RAS gene family encode proteins that have a key role in cell signaling. When those genes are mutated, cells grow uncontrollably and evade death signals. So far, blocking RAS gene function has not worked. Despite that, there’s a highly competitive drug development landscape.

Though Revolution Medicines Inc.’s RAS companion/SHP2 inhibitor RMC-4630 failed to show efficacy in two early stage combination trials, the company is moving forward with the candidate, its lead asset, partnered with Sanofi SA as part of a potential $550 million deal.

Mark Goldsmith, Revolution’s president, CEO and chairman joined the BioWorld Insider Podcast to discuss the challenges and progress in other experiments.

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