News & Analysis as of

Biopharmaceutical Life Sciences Pharmaceutical Industry

American Conference Institute (ACI)

[Event] 21st Annual Conference on Paragraph IV Disputes - April 29th - 30th, New York, NY

Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more

Latham & Watkins LLP

Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook

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Stakeholders from across the healthcare and biopharmaceutical industry recently convened in San Francisco for the annual J.P. Morgan Healthcare Conference. In this episode of our Connected With Latham podcast series,...more

American Conference Institute (ACI)

[Event] European Summit For Women Leaders in Life Sciences Law - March 11th - 12th, Brussels, Belgium

Excitement is building as C5’s inaugural European Summit For Women Leaders in Life Sciences Law gets closer. Make plans to join women at the forefront of life sciences law as they address legal, regulatory, and policy...more

Faegre Drinker Biddle & Reath LLP

FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models

On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more

American Conference Institute (ACI)

[Event] 2nd Annual Life Sciences AI Summit - February 20th - 21st, New York, NY

Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more

Latham & Watkins LLP

Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then,...

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In this episode of our Connected With Latham podcast series, Haim Zaltzman, Global Vice Chair of Latham’s Emerging Companies & Growth Practice, sits down with BridgeBio’s Co-Founder and Chief Executive Officer Neil Kumar and...more

Cooley LLP

SEC charges biopharma with misleading investors about status of INDs

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The SEC has announced that it filed settled charges against Kiromic BioPharma and two of its executives for alleged failure to disclose in its public statements and filings, including in its public offering prospectus,...more

Faegre Drinker Biddle & Reath LLP

Biopharma & Medical Device Briefing: PFAS Reporting Requirements; ECHA Substances of Very High Concern List; and MicroRNA...

With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more

Wilson Sonsini Goodrich & Rosati

[Event] Biotech Summit 2024 - October 9th - 10th, Boston, MA

Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more

Perkins Coie

BARDA BioMaP-Consortium Up and Running

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In a previous Update, we reported on the Biomedical Advanced Research and Development Authority’s (BARDA) plans to implement the new Biopharmaceutical Manufacturing Preparedness-Consortium (BioMaP-Consortium or Consortium),...more

Epstein Becker & Green

Sponsored Genetic Testing Programs: Compliance Considerations Following DOJ False Claims Act Settlement

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Manufacturer-sponsored genetic testing programs provide several benefits to patients, including expanding access to genetic testing, providing opportunities for patients to participate in research, empowering patients to make...more

Perkins Coie

BARDA Shares Details About Innovative BioMaP Consortium at BARDA Industry Day 2023

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The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Foley & Lardner LLP

IP Toolbox Is Crucial In AI-Powered Drug Discovery

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Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering. As the cost of developing new drugs...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - May 2023

Supreme Court Hears Argument on Traceability Requirement in Circuit-Split Slack v. Pirani - Key Points - - Before the end of June, the U.S. Supreme Court is expected to issue a decision in a high-profile securities case...more

Smart & Biggar

Top 10 patent and regulatory things you need to know when bringing a biopharma product to Canada

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Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...more

American Conference Institute (ACI)

[Event] The National Forum on IP Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies - March 21st -...

Hosted by American Conference Institute (ACI), the National Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies will highlight leveraging technology, safeguarding IP, and securing...more

Knobbe Martens

BioNTech to Ship Modular mRNA Vaccine Factory to Rwanda

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Biopharmaceutical New Technologies (BioNTech), the global immunotherapy company based in Mainz, Germany, is scheduled to ship its BioNTainer modular mRNA vaccine factory to Rwanda. According to BioNTech’s press release, the...more

McDermott Will & Emery

[Event] 2023 J.P. Morgan Healthcare Conference - January 10th, San Francisco, CA

Come together with key decision-makers, innovators and investors from across the healthcare, life sciences and private equity (PE) industries during the year’s largest healthcare investment symposium....more

Proskauer - The Patent Playbook

In the Orphan Drug Approval Race, Winner Takes All? Ramifications of Catalyst Pharms. v. Becerra

How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for? By way of background, a sponsor can obtain orphan drug...more

Goodwin

Navigating The New Normal: Disruption And Reinvention: The Pivot to Local Supply Chains

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It seems like there is a new article every day about how the COVID-19 pandemic has impacted the supply chain, particularly as economies reopen and we move into the next phase of the “new normal.” The disruptions in the supply...more

Cooley LLP

Blog: Cooley’s 2020 Life Sciences M&A Year in Review

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General Trends in Life Sciences M&A - If 2019 was the year of life sciences mega-deals, 2020 was the year of COVID-19, as the global pandemic permeated every aspect of the dealmaking landscape, with the life sciences...more

Kilpatrick

Industry Insights by Jeremy Levin, Chair and CEO of Ovid Therapeutics and Board Chair of BIO (AdvanSE Life Sciences Conference...

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On November 11, 2020, I had the pleasure of participating in a virtual fireside chat with Dr. Jeremy Levin at the first AdvanSE Life Sciences Conference held by the Southeast Life Sciences Association. Dr. Levin has a long...more

Rothwell, Figg, Ernst & Manbeck, P.C.

The New Exclusive European Licensee of Cenobamate: Angelini Pharma Acquires Emerging Swiss Biotech Company Arvelle Therapeutics

The Italian pharmaceutical company Angelini Pharma announced on January 4, 2021, that it will acquire emerging Swiss biotech company Arvelle Therapeutics for a total aggregate valuation of up to $960 million. Angelini Pharma...more

McDermott Will & Emery

[Virtual Event] 2021 J.P. Morgan Healthcare Conference - Life Sciences Investment Forum - January 11th, 10:00 am - 1:00 pm EST

You won’t want to miss four days of exclusive, virtual events that bring together industry leaders, emerging standouts, innovators and investors from across the industry landscape at the largest healthcare investment...more

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