Publicly traded life sciences companies continue to be the primary target of the plaintiffs’ bar, facing far more securities class action lawsuits compared to other sectors. What does this mean for your business, and what practical steps can you take
Life Sciences Perspectives
Life Sciences Perspectives, published by Goodwin Procter, focuses on legal and regulatory developments affecting the life sciences sector. The blog covers topics such as pharmaceutical and biotechnology transactions, regulatory compliance for drugs, biologics, medical devices, diagnostics, and laboratory testing. It also addresses antitrust issues, healthcare fraud enforcement, data privacy regulations like the EU Data Act, and FDA programs impacting drug development and approval. The blog provides updates on policy changes, enforcement trends, and strategic considerations for companies and investors operating in the life sciences and medtech industries.
Latest from Life Sciences Perspectives - Page 10
Seven Tips for Healthcare & Life Sciences Companies Engaging Independent Monitors and Compliance Experts
For a healthcare or life sciences company settling a government enforcement action, the prospect of being subject to an independent monitor, independent review organization (IRO), or other government-mandated compliance expert may become a reality. (We collectively refer to all of…
Antitrust & Competition Life Sciences Quarterly Update Q1 2023
While a number of factors suggest that deal activity, including those with material antitrust issues, will increase throughout 2023, recent enforcement activity could potentially chill the largest transactions from moving forward. But FTC’s filing of a complaint to block Amgen/Horizon…
Supreme Court Affirms Amgen Patents’ Invalidity in Closely Watched Enablement Case
The U.S. Supreme Court has decided a closely watched case regarding patent law’s enablement requirement, Amgen Inc. v. Sanofi. The Supreme Court affirmed the Federal Circuit’s decision that Amgen’s patent claims were invalid, holding that the patents’ disclosures “offer[ed] persons skilled…
The European Commission Proposes First Major Overhaul of the EU Medicines Regulatory Framework in 20 Years: Regulatory Data Protection
We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the major elements of the proposals is…
DEA Publishes Temporary Rule on the Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Substances
Since the declaration of the public health emergency due to the COVID-19 epidemic, Drug Enforcement Administration (DEA) registered practitioners have been able to prescribe controlled substances, without a prior in-person visit with a patient, subject to certain conditions as outlined…
Proposed USPTO Fee Changes Will Make It Much More Expensive to Patent and to Challenge Patents on Therapeutics. You Have an Opportunity to Comment…
The United States Patent & Trademark Office (USPTO or PTO) recently announced proposed changes to certain fees it charges with respect to patent applications, design patents, and America Invents Act (AIA) trials. These changes may significantly increase costs associated with…
The ABCs of DCTs: New FDA Guidance Provides Recommendations for the Conduct of Decentralized Clinical Trials
On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” (the “Draft Guidance”). The Draft Guidance expands on the FDA’s 2020 recommendations issued in…
DEA Announces Temporary Extension of COVID-19 Telehealth Flexibilities for Prescription of Controlled Medications
The Controlled Substances Act, as amended by the Ryan Haight Act, generally prohibits prescribing controlled substances via telehealth without a prior in-person examination, subject to certain very limited exceptions. Those exceptions include prescriptions issued during a public health emergency. Thus,…
The MHRA Proposes to Extend the Period of Acceptance of CE Marked Medical Devices in Great Britain Beyond 30 June 2023
BACKGROUND
On 28 April 2023, the UK’s medical devices regulator, the Medicines & Healthcare products Regulatory Agency (MHRA), announced its intention to extend the acceptance of CE marked medical devices in Great Britain (England, Scotland and Wales) beyond 30 June…