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Foley Hoag LLP
Interchangeable biosimilar products would not be allowed to disclose or explain their interchangeability designations in their products' labels under FDA's new draft guidance.
Ropes & Gray LLP
On September 7, 2023, FDA issued three new draft guidance documents intended to strengthen the 510(k) premarket notification pathway for medical devices.
McGuireWoods LLP
Surge Private Equity has announced it has invested in Elite Clinical Network (ECN) in a transaction valued at around $200 million.
Foley & Lardner
As announced in a September 14, 2023, press release, the FTC has issued a policy statement "warning pharmaceutical companies that make and sell brand-name...
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Means-plus-function ("MPF") claims define an element, in a combination claim, by its function instead of its structure. Under 35 U.S.C. § 112(f)...
Crowley Law LLC
The application and advancement of artificial intelligence is one of the most discussed topics across industry sectors these days. There is no shortage of conversation about what AI holds...
McGuireWoods LLP
TPG has announced it will acquire a majority stake in Crowe Healthcare Consulting from Crowe LLP.
Foley & Lardner
If artificial intelligence (AI) is the vehicle that will revolutionize health care, data is the fuel that will propel the revolution. Health AI startups have recognized an unprecedented opportunity to create...
This marks the first issue of WilmerHale's The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences, a monthly bulletin that will highlight developments in the antitrust and life sciences space.
Goodwin Procter LLP
The Goodwin Propsci team has partnered with several well-known companies for a short video series that explores what's happening in the real estate life sciences industry.
Goodwin Procter LLP
On August 25, 2023, Sandoz announced that the FDA has approved its biosimilar Tyruko® (natalizumab-sztn), developed by Polpharma Biologics. Tyruko® injection is the first and only FDA-approved...
Potter Clarkson
On 30 June 2023 the US District Court for the District of New Jersey ruled in favour of Orexo AB in its patent litigation against Sun Pharmaceutical Industries Limited...
Lowenstein Sandler
In March 2022, President Joe Biden signed the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA) into law...
WIT Legal
The plaintiffs, two major pharmaceutical companies, sued more than 10 generic drug manufacturers for infringing on a patent essential to the creation of their commercially successful schizophrenia medication.
Harness IP
In order to reach their primary goal of improving patient treatment, medical device developers must, among other things, consider the type of patient class and their out-of-pocket costs for receiving treatment.
Harness IP
Harness IP Principal Chris Cauble gives an insightful look at the risks and rewards of seeking foreign intellectual property (IP) protection in "Focusing Solely on U.S. Patents Can Be a Risky Move. Here's Why,".
Reed Smith
As a defense lawyer, one grows accustomed to clear judicial days on which the state court can foresee forever. See Thing v. La Chusa, 48 Cal. 3d 644, 668 (1989).
Goodwin Procter LLP
On August 29, 2023, Formycon AG and its licensing partner, Klinge Biopharma GmbH, announced that the FDA has accepted the aBLA for FYB203, Formycon's candidate biosimilar to Regeneron's EYLEA® (aflibercept).
Reed Smith
Shortly after Connecticut's 2023 legislative session kicked off, Governor Ned Lamont announced a series of policy initiatives aimed at reducing health care costs and undertaken...
Foley Hoag LLP
Jeffrey Lewis and Stuart Knight were published in Life Sciences Intellectual Property Review discussing the shared language and differences between the US, EU and UK standards...
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