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BioWorld Insider Podcast
One-on-one with medical innovators
Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.
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.
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.
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.
In this episode, BioWorld Staff Writer Lee Landenberger spoke with Howard Fillit, founding executive director and chief science officer at the Alzheimer’s Drug Discovery Foundation, which was created to accelerate the discovery of drugs to prevent, treat and cure Alzheimer's disease. The geriatrician, neuroscientist and Mount Sinai School of Medicine professor has led the foundation since it was formed in 1998. He’s seen a lot of change in the R&D of dementia treatments and shared his insights about the importance of biomarkers, the controversy surrounding Biogen Inc.'s recently approved Aduhelm (aducanumab) and the impact of financial investments that drive the development of these therapies compared to other indications.
Biopharma deal-making activity, a closely-watched marker of industry health, remained alive and well in Q2. But whither M&A? And what’s with all those $1 billion-plus deals? Join News Editor Michael Fitzhugh and BioWorld Senior Analyst Karen Carey as they chat about the latest currents in combinations, partnerships amid the pandemic, and the rising values of up-front payments – at least for those clinical-stage companies lucky enough to make lucrative deals ahead of commercialization.
BioWorld subscribers looking for an even deeper dive on the numbers can read Karen’s Q2 Deals and M&A overview, including overviews M&A value and volume by year, a list of the year’s top M&A deals to date – led by Jazz Pharmaceuticals plc’s takeout of GW Pharmaceuticals plc – and even more details about the world of biopharma deals in BioWorld Snapshots.
Iteos Therapeutics Inc. has come a long way in the past year. The company went public in July 2020 and this week inked a deal with Glaxosmithkline plc (GSK) that could top $2 billion. Iteos brings GSK a human monoclonal antibody targeting TIGIT, the third of the known CD226 checkpoints that the company wanted for its cancer therapy program. The two companies plan to split U.S. profits, something that Iteos insisted upon as part of the deal. Iteos is receiving $625 million as an up-front payment and up to $1.45 billion in potential milestone payments.
In this episode, BioWorld Staff Writer Lee Landenberger caught up with Michel Detheux, president and CEO of Iteos, who said the company was in a strong financial position and didn’t need a deal this size, but the cash infusion will significantly boost its PD-1 development programs.
The FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s disease therapy, Aduhelm (aducanumab), is the first real beacon of hope in 18 years for the 50 million people living with the disease. But the approval was met with controversy over the drug’s efficacy and pricing. Even as Biogen readies to launch in just two weeks with more than 900 sites lined up to start treating patients, a required confirmatory study could sink everything.
BioWorld has been reporting on the development of Aduhelm since its discovery, by way of Neurimmune AG’s reverse translational medicine technology. Later licensed to Biogen, it was co-developed with Eisai Co. Ltd.
In this episode, News Editor Michael Fitzhugh talks with Ivana Rubino, Biogen’s VP of global and U.S. medical affairs for Alzheimer’s disease, about the approval, the controversies and what it all means for Biogen’s future.