News & Analysis as of

Biopharmaceutical

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

Latham & Watkins LLP on

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On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more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

Latham & Watkins LLP on

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

Cooley LLP on

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

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

Foley Hoag LLP - Public Companies & the Law

Biotech Public Markets Finally Thawing(?): Two Massachusetts Biotechs file S-1s

In an encouraging sign that the equity capital markets may be improving for biotechnology companies, Bicara Therapeutics Inc. and Zenas Biopharma, Inc. filed S-1 registration statements yesterday, signaling their intention to...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

Rivkin Radler LLP

NJ Biopharma Company Settles FCA/AKS Case for $5M+

Rivkin Radler LLP on

The U.S. Department of Justice announced on July 24 that Admera Health LLC, a New Jersey-based biopharmaceutical research and clinical laboratory testing company, agreed to pay $5,389,648 to resolve kickback allegations...more

McDermott Will & Emery

Key Takeaways | Contract Research Organizations (CROs)

McDermott Will & Emery on

During this session, the panelists discussed the current market outlook for CROs and the key differentiators making them attractive to private equity investors, such as therapeutic area (TA) specialization, their ability to...more

McDermott Will & Emery

Pharma and MedTech Services Investment Summit 2024

McDermott Will & Emery on

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

Cadwalader, Wickersham & Taft LLP

Delaware Court of Chancery Clarifies “Commercially Reasonable Efforts” in Earn-Out Provisions

On April 30, 2024, in Himawan, et al. v. Cephalon, Inc., et al., the Delaware Court of Chancery held that the defendant acquiror complied with its contractual obligations to use commercially reasonable efforts to achieve...more

Perkins Coie

BioMaP-Consortium Hosts Inaugural Industry Day

Perkins Coie on

In previous Updates, we discussed the formation and growth of the Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium), which was started by the Biomedical Advanced Research and Development Authority...more

McDermott Will & Emery

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

McDermott Will & Emery on

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

Fenwick & West LLP

The BIOSECURE Act: Too Early to Call?

Fenwick & West LLP on

A congressional proposal to sever ties between United States and Chinese biopharmaceutical companies is far from a done deal, but its bipartisan support is a concrete reminder to consider options for supply chain...more

Perkins Coie

BARDA BioMaP-Consortium Up and Running

Perkins Coie on

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

Epstein Becker & Green on

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

Goodwin

German Court Invalidates CureVac Patent in Ongoing BioNTech Lawsuit

Goodwin on

On December 19, a German court invalidated CureVac’s messenger RNA technology patent, EP 1 857 122 B1, in a lawsuit brought by CureVac against its rival BioNTech...more

Perkins Coie

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

Perkins Coie on

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

Goodwin

Recent FDA Initiatives to Support Development of Individualized Cell and Gene Therapies and Rare Disease Therapies

Goodwin on

​​​​​​​Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Lauren are joined by Emily Chee, the US General Manager of Novartis Gene Therapies, a biotech company specializing in gene therapies for rare...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

141 Results
 / 
View per page
Page: of 6

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide