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Innovation Pharmaceutical Industry

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in...

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This episode, Matthew and Heather chat with Paul Testa, an Executive Vice President of Kyowa Kirin, a pharma group that develops innovative specialty drugs to raise the health and well being of people across the globe. Paul...more

McDermott Will & Emery

Pharma and MedTech Services Investment Summit 2024

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The inaugural Pharma and MedTech Services Investment Summit brought together C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

Womble Bond Dickinson

[Webinar] Innovation Interchange Summit: The Power Of Cross-Industry Insight - May 16th, 11:00 am - 4:00 pm ET

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Powerful ideas emerge when you look at something through a completely different lens. And when two parties come together to share those unique perspectives? That’s when the magic happens. Womble Bond Dickinson’s virtual...more

McDermott Will & Emery

[Event] Pharma and MedTech Services Investment Summit 2024 - May 2nd, San Francisco, CA

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YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING - Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more

Smart & Biggar

Update on biosimilars in Canada – March 2024

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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

Polsinelli

Revisiting Government March-In Rights Under Bayh-Dole: The FTC Weighs In

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On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute...more

Cornerstone Research

Potential Unintended Economic Impacts of the Inflation Reduction Act on the Pharmaceutical Industry

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The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

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President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI

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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

Foley & Lardner LLP

Strengthening the Flow of the Biotech Sector’s M&A Pipeline

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Originally published in Genetic Engineering News on October 10, 2023. Reprinted with permission. The biotechnology sector has long been characterized by its constant innovation, rapid technological progress, and unyielding...more

Nelson Mullins Riley & Scarborough LLP

New FDA Draft Guidance Updates Recommendations for Good Clinical Practices

The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from...more

Hogan Lovells

French decree regarding the “direct access”: a half-hearted step forward for pharmaceutical innovations

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Publication of the French decree regarding the experimentation of the "direct access" to pharmaceutical products with anticipated reimbursement: a half-hearted step forward for pharmaceutical innovations....more

Hogan Lovells

Décret relatif à l’accès direct : une avancée en demi-teinte pour les innovations pharmaceutiques

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Publication du décret relatif à l’expérimentation du dispositif d’accès direct des médicaments à un financement anticipé : une avancée en demi-teinte s’agissant de l’accès au marché des innovations pharmaceutiques en France....more

Manatt, Phelps & Phillips, LLP

[Webinar] The NCATS Alliance: Speeding the Process of Bringing New Treatments to Patients - March 15th, 1:00 pm - 2:00 pm ET

Featuring Francis Collins, M.D., Ph.D., Senior Advisor to President Biden and Former Director of the National Institutes of Health, and Joni Rutter, Ph.D., NCATS Director, Plus a Panel of Health Care Leaders From Pfizer,...more

Manatt, Phelps & Phillips, LLP

[Webinar] Reimagining Medicine: Can Policy Keep Pace With Scientific Advances? - February 1st, 1:00 pm - 2:00 pm ET

Speakers From AbbVie, National Institutes of Health, National Organization for Rare Disorders, NYU Grossman School of Medicine and Verily Share Insights on How Medical Innovation Is Disrupting Policy—and What Needs to Come...more

Epstein Becker & Green

Video: Health Care's Past, Present, and Future - Diagnosing Health Care Podcast

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In celebration of the 50th episode of our Diagnosing Health Care podcast, we’re looking at how the past 50 years of health law will impact health care in the next 50 years. On this episode, Epstein Becker Green attorneys...more

Goodwin

Executive Order for Advancing Biotechnology and Biomanufacturing Innovation Signed by President Biden

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​​​​​​​On September 12, 2022, President Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The objective of the Executive Order...more

A&O Shearman

Market access for innovations made easier in Slovakia

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On 1 August 2022, a crucial amendment to Act No. 363/2011 Coll. on the scope and conditions of the reimbursement of medicinal products, medical devices and dietetic foods under public health insurance (the Reimbursement Act)...more

American Conference Institute (ACI)

[Event] 13th Summit on Biosimilars & Innovator Biologics - June 28th - 29th, Boston, MA

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

Knobbe Martens

Baxter Acquires Hillrom in the Largest Medical Device Acquisition of the Year

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Baxter International Inc. (“Baxter”) has agreed to acquire Hillrom for $10.5 billion ($156 per share) in a deal expected to close in 2022.  After assumption of debt, the total enterprise value of the deal is approximately...more

Haug Partners LLP

Next-Generation Antibodies: Antibody-Drug Conjugates

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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

Knobbe Martens

UCLA Biodesign Launches Study to Help Advance MedTech and Digital Health Innovation Forward Into a New Decade

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What does it require to bring a transformational innovation to patients? To address this question, the UCLA Biodesign Hub for MedTech and Digital Health has launched an industry-wide study to uncover the cost and time to...more

White & Case LLP

President Biden Signs Legislation Boosting Generic and Biosimilar Drugs to Help Foster Price Competition

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On April 23, 2021, President Biden signed into law two bipartisan bills aimed at reducing prescription drug prices by supporting generic and biosimilar alternatives to branded drugs. The Ensuring Innovation Act supports...more

Locke Lord LLP

Ensuring Innovation Act Alters Eligibility for New Chemical Exclusivity

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On April 23, 2021, President Biden signed into law The Ensuring Innovation Act (S. 415), which amends the requirements for New Chemical Entity (NCE) and Orphan Drug (ODE) exclusivities under the Federal Food, Drug, and...more

Proskauer - Health Care Law Brief

Three Health Care Investment Trends That We Are Currently Following

The COVID-19 pandemic has had well-documented transformative effects on the delivery of health care. Investors, providers, payors and other stakeholders have often been at the forefront of the industry shifts in the trailing...more

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