Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
The Force is Strong with this One – Success and Paying it Forward with Co-Founder of ChannelAdvisor and Spiffy Scot Wingo
No Password Required: President at Constellation Cyber, Former FBI Translator, and Finder of Non-Magical Mushrooms
Hosted Payload Episode 10: Jeanine Poltronieri/For All Mankind (Season 1)
Hosted Payload Episode 9: Danielle Pineres/First Man
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Hosted Payload Episode 8: Priya Venkat / A Million Miles Away
Leading the Lead Revolution With the Consortium for Battery Innovation — Battery + Storage Podcast
Market Leader's Podcast Episode 84: “Change Agent: Establishing True Innovation Goals Within a Law Firm,” with Roberto Pont
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 159: Bob Quinn, Executive Director, and Adrianne Grimes, Director of Marketing and Comms, SCRA
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Is Quiet Quitting the New Workplace Phenomenon?
Remaining Innovative in the Battery Storage Space With Electrovaya CEO Dr. Raj Dasgupta - Battery + Storage Podcast
Video: Health Care's Past, Present, and Future - Diagnosing Health Care Podcast
Innovation in Compliance - Innovation as a Process with Stephen Shapiro
Taking the Pulse, A Health Care & Life Sciences Video Podcast | Episode 109: Kelly Calabria, President and CEO of Foundation for Health Leadership & Innovation
Innovation in the Business of Law | Rocky Dhir | Texas Appellate Law Podcast
Guidepost in Motion: Off The Chain Part 2 Innovations and Best Practices in Crypto and Blockchain
In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update....more
Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Lauren welcome Dr. Ehsan Samei and Dr. Susan Halabi, leaders of the new Triangle CERSI, which stands for the Center of Excellence in Regulatory...more
This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather in Boston for ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics....more
Antibodies are part of the body’s adaptive immune response to defend itself against toxins and pathogens, such as bacteria and viruses. When the body identifies a foreign entity, it mounts a cascading response that culminates...more
Cancer is a horribly painful and debilitating illness, but would you ever call it “diabolical”? What about “conniving”? You might after you hear about the latest research out of Vanderbilt University showing that cancer cells...more
Innovative technologies are being deployed to address the Western world’s major killer: cancer. Traditionally, cancer treatment has included surgery, chemotherapy, and radiation, but recently, the development of targeted...more
This year, the BPCIA turns 10! As we prepare to enter the next decade of this revolutionary law, we cordially invite you to join us for ACI’s 11th Annual Biosimilars & Innovator Biologics Summit, in a fully virtual,...more
On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and last-minute revisions that implicate biologic medicines and patent obligations. ...more
Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more
Late on September 30, an agreement (USMCA) was reached between the United States, Mexico and Canada which modernizes the 24 year old North American Free Trade Agreement (NAFTA)....more
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more
The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more
Earlier this month, a final agreement was reached on the Trans-Pacific Partnership that could provide for as little as five years of exclusivity for biologics. In recent months, it was reported that the biologics exclusivity...more
Last month, in a letter to the Senate and House Committees on the Judiciary, 101 patient organizations expressed "concern[] that, as currently written, H.R. 9 [the Innovation Act] falls short of preserving important patent...more
On the third day, the Center for Biologics Evaluation and Research (CBER) conducted its own Town Hall. CBER Director, Karen Midthun, explained how CBER works proactively to help develop new biological therapies. For example,...more