The FDA’s June 2021 approval of Aduhelm (aducanumab), the first plaque-targeting therapy, rattled the company, regulators and the market. BioWorld brought together two experts to get their thoughts as each is involved in developing vaccines or treatments for Alzheimer’s or Parkinson’s disease. Michael Agadjanyan is the president of Nuravax Inc., which is developing antibodies for preventing Alzheimer’s and Parkinson’s disease. We also spoke with Robert Glanzman, who is chief medical officer...

Complex manufacturing processes and supply chains have always been part of the biopharma industry story, with many people in more than a few nations typically involved along the way. While that observation applies to plenty of other areas of business, Paul Testa, executive vice president for operations and supply chain at Tokyo-based Kyowa Kirin, tells us about the crucial difference with medicine: “We can wait for toilet paper or building materials, but the patient cannot wait because their...

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...

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...

A new pill, molnupiravir, from Ridgeback Biotherapeutics. and partner Merck & Co. 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...

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...

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...

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....

Though Revolution Medicines Inc.’s RAS 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. Mark Goldsmith, Revolution’s president, CEO and chairman joined the BioWorld Insider Podcast to discuss the challenges and progress in other experiments. See acast.com/privacy for privacy and opt-out information.

As researchers from more than 110 countries gathered for the Alzheimer’s Association International Conference, new data estimate the number of people with dementia globally will triple to more than 152 million by 2050. 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...

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...

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...

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...

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. 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. See acast.com/privacy for...