Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Arnold & Porter Kaye Scholer LLP
The second issue has been the definition of CCI, and there is a disconnect between what the EMA and what industry considers should be withheld from disclosure.
Arnold & Porter Kaye Scholer LLP
VALUeHEALTH was concerned with ensuring the sustainable interoperability of European eHealth services beyond 2020.
Butler Snow LLP
It's Spring! In this issue of Pro Te, we do a little a "spring cleaning" to brush the dust off some familiar topics that we consider in day-to-day pharmaceutical litigation.
McDermott Will & Emery
Addressing the issue of the proper construction of claims to a trihydrate compound, the US District Court for the District of New Jersey concluded that a person of ordinary skill in the art (POSA)...
Orrick
As surprising as it may be to city dwellers, the deer farming industry generates $3 billion per year for the U.S. economy.
Reed Smith
In In re: Risperdal Litigation: P.D. v. Janssen Pharmaceuticals, Inc., 2017 Phila. Ct. Com. Pl. LEXIS 231 (July 26, 2017), the (male) plaintiff allegedly developed gynecomastia excessive breast tissue...
Morgan Lewis
Agency also launches voluntary pilot program as first step in developing software pre-certification program.
Reed Smith
If not yet dead, the medical monitoring claim itself is hooked up to monitors and the prognosis is not good.
Holland & Knight
In this memorandum, Holland & Knight's Healthcare & Life Sciences Team summarizes recent U.S. Senate action on healthcare legislation and provides an outlook on upcoming issues and possible actions.
Reed Smith
Not even three weeks ago, back on July 28, we discussed the court's rigorous application of Daubert in excluding expert medical causation opinions in Smith v. Terumo Cardiovascular Sys. Corp., a federal case in the district of Utah.
Ropes & Gray LLP
On July 25, 2017, the U.S. Food and Drug Administration issued a guidance document1 announcing its intention not to object to an institutional review board's (IRB) waiving or altering of the informed consent requirements for an FDA-regulated clinical investigation that presents no more than minimal risk and involves adequate human subjects protections.
Akin Gump Strauss Hauer & Feld LLP
President Trump is expected to sign FDARA into law.
Ropes & Gray LLP
As part of an overarching initiative to update its regulatory oversight of digital health technologies, the U.S. Food and Drug Administration has announced new plans to streamline the development...
Reed Smith
About two years ago, in our post "How Does a Bad Idea Get Implanted," we discussed what at the time seemed a California peculiar argument that the "unavoidably unsafe" product doctrine...
Fenwick & West LLP
This report analyzes key aspects of initial public offerings (IPOs) for technology and life sciences companies that went public in the first half of 2017.
Ropes & Gray LLP
As part of an overarching initiative to update its regulatory oversight of digital health technologies, the FDA has announced new plans to streamline the development and availability of high quality digital health products.
Reed Smith
One of the wonders of parenthood is its ability to deliver interludes so sublime in their exquisite simplicity that they provoke smiles long after they end.
Ropes & Gray LLP
The panelists provide lessons learned and perspectives of different stakeholders in the due diligence process.
Foley & Lardner
I've written previously about sequential PTAB challenges to the same patent, but the dispute between Coherus Biosciences Inc. and AbbVie Biotechnology Ltd. has engendered six Inter Partes Review...
Seyfarth Shaw LLP
Finding against the Federal Circuit once again on a patent case, the Supreme Court issued a unanimous decision in Sandoz v. Amgen relating to the interpretation of the Biologics Price Competition...
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Arnold & Porter Kaye Scholer LLP
VALUeHEALTH was concerned with ensuring the sustainable interoperability of European eHealth services beyond 2020.
Ropes & Gray LLP
As part of an overarching initiative to update its regulatory oversight of digital health technologies, the U.S. Food and Drug Administration has announced new plans to streamline the development...
Arnold & Porter Kaye Scholer LLP
The second issue has been the definition of CCI, and there is a disconnect between what the EMA and what industry considers should be withheld from disclosure.
Ropes & Gray LLP
As part of an overarching initiative to update its regulatory oversight of digital health technologies, the FDA has announced new plans to streamline the development and availability of high quality digital health products.
Jones Day
In late 2016, an Interpretive Notice by the European Commission stated that products produced by essentially biological processes should not be patentable.
Ropes & Gray LLP
The panelists provide lessons learned and perspectives of different stakeholders in the due diligence process.
Seyfarth Shaw LLP
Finding against the Federal Circuit once again on a patent case, the Supreme Court issued a unanimous decision in Sandoz v. Amgen relating to the interpretation of the Biologics Price Competition...
Reed Smith
One of the wonders of parenthood is its ability to deliver interludes so sublime in their exquisite simplicity that they provoke smiles long after they end.
Reed Smith
Not even three weeks ago, back on July 28, we discussed the court's rigorous application of Daubert in excluding expert medical causation opinions in Smith v. Terumo Cardiovascular Sys. Corp., a federal case in the district of Utah.
Foley & Lardner
Patent challengers have heavily relied on inter partes review (IPR) ever since its inception under the America Invents Act (AIA).
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