Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
Dr. Jayanta (Jay) Bhattacharya, nominated to be Director of the National Institutes of Health (NIH), and Dr. Martin Makary, nominated to be the Commissioner of the U.S. Food and Drug Administration (FDA), appeared before the...more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more
Swedish biotechnology company Xbrane Biopharma reports that, despite the difficulties posed by the Covid-19 pandemic, it will continue to recruit patients for the ongoing Phase III trial of its Xlucane® (ranibizumab)...more
The COVID-19 pandemic has introduced new challenges for the pharmaceutical industry, including makers of biosimilars. In response, the FDA has asked pharmaceutical makers to closely monitor their supply chains and...more