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Life Sciences

Epstein Becker & Green

The VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to Fruition

Epstein Becker & Green on

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. During that time, FDA has also asserted that it...more

Wilson Sonsini Goodrich & Rosati

CDER Launches the ARC Program to Expedite Treatment Options for Rare Diseases

In May 2022, the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) announced the launch of a new program for expediting the development of new treatment options for rare...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sigma-Aldrich Files Reply to Broad’s Opposition to Sigma's Substantive Preliminary Motion No. 1 to Deny Priority Benefit in...

On December 3rd, Senior Party Sigma-Aldrich filed its Preliminary Motion No. 1 that asked the Board to deny the Broad Institute, Harvard University, and MIT (collectively, Broad) benefit of its U.S. Provisional Application...more

Hogan Lovells

Cell and gene therapy transactions carry unique risks for both licensor and licensee

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Cell and gene therapy transactions have increased dramatically over the last few years, in both number and complexity, and have given rise to a number of issues that merit further attention. In the article below, we outline a...more

TransPerfect Legal Solutions

What’s Trending: Milestone Disputes in Life Sciences Litigation

Earlier this month, the ACC hosted an illuminating panel presentation on Life Sciences Litigation: A Look at Milestone Disputes & Recent Trends. Panelists included Lauri Mims and Jennifer Huber, both Partners at Keker Van...more

Knobbe Martens

Medtronic acquires Intersect ENT, sells Fiagon to Hemostasis LLC as required by FTC

Knobbe Martens on

On May 13, 2022, Medtronic, Inc. announced that it completed the acquisition of Intersect ENT, Inc. The transaction was only able to gain approval of the Federal Trade Commission (FTC) upon the agreement that Medtronic sell...more

Manatt, Phelps & Phillips, LLP

A Focal Point for FDA’s Rare Diseases Efforts: CDER’s New ARC Program

Last week, the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) launched a new program to coordinate and centralize CDER’s rare disease activities. The mission of the Accelerating Rare...more

Proskauer - Life Sciences

BridgeBio Transaction Reflects Healthy Market for FDA Priority Review Vouchers

BridgeBio’s recently announced sale of an FDA Priority Review Voucher for $110 million reflects a robust secondary market for these regulatory fast passes. Prices for Priority Review Voucher (“PRVs”) reflect the high stakes...more

McDonnell Boehnen Hulbert & Berghoff LLP

CVC Files Reply to Sigma-Aldrich Opposition to CVC's Responsive Motion No. 1

Pursuant to the Patent Trial and Appeal Board Order issued November 29, 2021, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") on December 17,...more

Hogan Lovells

China's draft implementation rules on human genetic resources: potential changes on HGR Supervision?

Hogan Lovells on

The Ministry of Science and Technology of China has finally issued the draft of Implementation Rules for the Regulations of Human Genetic Resources Administration for public comments on March 21, 2022, which gives more...more

Quarles & Brady LLP

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think

Quarles & Brady LLP on

On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more

Hogan Lovells

Brazil requires drug makers to add QR codes in package inserts and implement traceability systems

Hogan Lovells on

A new law was enacted in Brazil on May 12, 2022 (Law No. 14,338/2022) requiring that medicine package inserts will have to be provided in digital format, in addition to the existing written format. The law will require that a...more

McDonnell Boehnen Hulbert & Berghoff LLP

Junior Party CVC Files Reply to Sigma-Aldrich's Opposition to Its Preliminary Motion No. 4

On November 19th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed Substantive Preliminary Motion No. 4* in Interference No. 106,132,...more

Wilson Sonsini Goodrich & Rosati

FDA Warns Companies Illegally Selling CBD and Delta-8 THC Products

On May 4, 2022, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food,...more

McDonnell Boehnen Hulbert & Berghoff LLP

CVC Files Reply to Senior Party Sigma-Aldrich's Opposition to CVC's Substantive Preliminary Motion No. 3 in Interference No....

On November 19th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its Substantive Preliminary Motion No. 3 in Interference No. 106,132...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - May 2022

Latham & Watkins LLP on

Drug Pricing Initiatives: In advance of the midterm elections in November, discussion continues in Congress and among stakeholders of drug pricing reform measures, including those that were originally part of H.R. 5376 (the...more

Knobbe Martens

FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program

Knobbe Martens on

On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA...more

MoFo Life Sciences

The “Big Bang” For Sequence Listings: New Requirements In Place July 1, 2022

MoFo Life Sciences on

Life sciences patent applications often contain DNA, RNA, and amino acid sequences in the specification, claims, or figures that are required to be provided in the form of a sequence listing. The inclusion of sequences in...more

American Conference Institute (ACI)

[Event] 20th Advanced Summit on Life Sciences Patents - June 2nd - 3rd, New York, NY

ACI’s Advanced Summit on Life Sciences Patents is back in person on June 2–3 in New York City. Our reimagined 2022 conference will provide practical insights on how to implement bullet-proof patent prosecution tactics,...more

Woodruff Sawyer

Securities Class Action Trends for Life Sciences, 2021: REPORT

Woodruff Sawyer on

Insights Priya Cherian Huskins, Esq.Senior Vice President, Management LiabilityEditor, Management Liability/D&O May 10, 2022 /Management Liability/D&O While the life sciences sector has experienced a slowdown in IPO activity...more

McDonnell Boehnen Hulbert & Berghoff LLP

Treasury Department Issues General License Authorizing Certain Transactions Related to Patents, Trademarks, and Copyrights

On March 2, 2022, the Office of Foreign Assets Control ("OFAC") of the U.S. Department of the Treasury issued General License No. 13, which authorized "U.S. persons . . . to pay taxes, fees, or import duties, and purchase or...more

McDonnell Boehnen Hulbert & Berghoff LLP

CVC Files Reply to Sigma-Aldrich Opposition to CVC Substantive Preliminary Motion No. 1 to be Accorded Priority Benefit

On November 19th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its Substantive Preliminary Motion No. 1 in Interference No. 106,132...more

Allen Matkins

Life Sciences Real Estate Update - May 2022

Allen Matkins on

Developers look to office-to-lab conversions to meet life sciences demand Bullet GlobeSt.com – April 29 As demand for lab space among life sciences companies continues to skyrocket, developers are increasingly looking to a...more

American Conference Institute (ACI)

[Event] 2nd Annual Summit on Women Leaders in IP Law - May 24th - 25th, Washington, DC

Showcasing Powerful Women in Intellectual Property! ACI’s Summit on Women Leaders in IP Law will bring together women in Intellectual Property roles to explore industry trends and other important factors impacting today’s...more

McDonnell Boehnen Hulbert & Berghoff LLP

Senior Party Sigma-Aldrich Files Reply to Junior Party CVC'S Opposition to Its Substantive Preliminary Motion No. 1 to Change...

On November 19th, Senior Party Sigma-Aldrich filed its Substantive Preliminary Motion No. 1 in CRISPR Interference No. 106,132, asking the Board to substitute the Count pursuant to 37 C.F.R. §§ 41.121(a)(1)(iii) and...more

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JD Supra Privacy Policy

Updated: Dec 28, 2021:

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Information for EU and Swiss Residents

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Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

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Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

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Changes in Our Privacy Policy

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Contacting JD Supra

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Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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