Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser
Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Podcast: Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
A changing competitive landscape: the role of the ITC in the biosimilars space
For autologous cell and gene therapies (CGTs), the collection of patients‘ cells is the first step in the manufacture of the medicinal product. In Germany, this step is usually conducted by specialized treatment centers that...more
The U.S. Food and Drug Administration (FDA) issued new draft guidance on October 29, 2025, proposing what it said were “major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.” ...more
In the last few weeks, Health Canada issued several decisions concerning biologics. On October 17, Health Canada approved, via a Notice of Compliance, Biocon Biologics Ltd.’s YESINTEK (ustekinumab injection) and YESINTEK...more
On July 1, 2025, Florida’s new “Stem Cell Therapy” legislation became effective, adding Fla.Stat. § 458.3245 to Florida’s Medical Practices statutes and § 459.0127 to Florida’s Osteopathic Medicine statutes. Florida’s new...more
On Wednesday, the FDA issued a new draft guidance proposing to reduce the need for sponsors to conduct a comparative efficacy study (CES) to demonstrate biosimilarity in an abbreviated biologics license application (aBLA). ...more
On October 2, 2025, Celltrion launched Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab). ...more
On September 23, 2025, the FDA published three new draft guidances that give insight into a regulatory framework for cell and gene therapies (CGTs) that is now coming into focus. By releasing these guidances together, FDA is...more
The U.S. Food and Drug Administration (FDA) announced in June 2025 the establishment of a new Commissioner's National Priority Voucher (CNPV) program and began accepting applications, promising those selected an accelerated...more
Intellectual property (IP) strategy in the life sciences evolves as rapidly as the scientific breakthroughs driving the industry. Since the America Invents Act reshaped the U.S. patent system more than a decade ago, courts...more
On October 2, 2025, Celltrion, Inc. (“Celltrion”) announced the commercial launch of AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA® in the United States. AVTOZMA® is supplied as an intravenous formulation in...more
On September 30, 2025, the Centers for Medicare & Medicaid Services (CMS) issued final guidance (Final Guidance) for initial price applicability year (IPAY) 2028 of the Inflation Reduction Act (IRA) Drug Price Negotiation...more
Pharmaceutical companies are increasingly concerned about the prospect that the Food and Drug Administration (FDA) will be delayed in its consideration of pending New Drug Applications (NDAs) and Biologics Licensing...more
Though every new presidential administration creates new challenges—and opportunities—for businesses, the second Trump administration has proven to be particularly eventful for the life sciences industry. ...more
The regulatory landscape for biosimilars is undergoing significant change on both sides of the Atlantic. Recent developments signal a potential shift away from the requirement for a clinical efficacy study as an approval...more
Japan continues to position itself as a global leader in regenerative medicine through its progressive regulatory framework tailored to the unique characteristics of cell, tissue, and gene therapy (CTGT) products....more
On September 17, 2025, Alvotech USA Inc. and Alvotech hf. (“Alvotech”) filed a Petition for Post Grant Review of U.S. Patent No. 12,168,036 (“the ‘036 patent”), assigned to Regeneron Pharmaceuticals, Inc. (“Regeneron”). ...more
Welcome to our inaugural Life sciences and healthcare insights report, where our global team share their insights on the most important commercial, legal, and regulatory issues facing life sciences and healthcare companies...more
Clients & Friends, Welcome to the second edition of our newsletter. The response to our inaugural issue reinforced what we already knew to be true: the life sciences community thrives on active dialogue. As we move deeper...more
On September 4, 2025, the U.S. Food and Drug Administration (“FDA”) announced plans to begin releasing complete response letters (“CRLs”) “promptly” after it issues them to sponsors, rather than waiting until after approval....more
Since taking the reins as FDA Commissioner, Dr. Martin Makary has repeatedly expressed an interest in new regulatory pathways, or new options for evidence generation, that would enable more flexible FDA review of...more
The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known genetic defects will...more
The U.S. Food and Drug Administration (FDA) has unveiled a sweeping transparency initiative that will fundamentally change how innovative drug and biologic developers interface with the Agency and the market. ...more
The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications. ...more
On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental...more
On August 18, 2025, Accord and Dong-A ST announced the U.S. launch of Imuldosa® (ustekinumab-srlf), a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Imuldosa® is approved for all the reference product’s...more