Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Reed Smith
Last week we bashed a Ninth Circuit Daubert decision. We feel a little bit bad about that, because we hate contributing to the chorus of defense hacks who bemoan the Ninth Circuit's supposedly liberal, pro-plaintiff bias.
Reed Smith
Earlier this week, we posted on the Ninth Circuit's conversion of the Daubert's gate (that the trial court should keep) into more of a swinging saloon door.
Seyfarth Shaw LLP
Finding against the Federal Circuit once again on a patent case, the Supreme Court this week issued a unanimous decision in Sandoz v. Amgen relating to the interpretation of the Biologics...
Arnold & Porter Kaye Scholer LLP
n June 12, 2017, the United States Supreme Court issued a unanimous opinion, written by Justice Thomas, in Sandoz, Inc. v. Amgen, Inc. ...
Morgan Lewis
AbbVie's arguments raised in a prior IPR were key to the PTAB's finding of no commercial success.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
ASGCC countered that nothing in Massachusetts law prohibits a private organization from engaging in the non-sale distribution of clean needles.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Below, a divided Federal Circuit panel held that: (1) a biosimilar applicant is not required to provide its application and manufacturing information to the Reference Product Sponsor (RPS)
Haug Partners
The Supreme Court yesterday issued its first opinion interpreting the BPCIA, the statute which created a pathway for the approval of abbreviated applications to market biological products.
Thompson Coburn LLP
On May 30, 2017, the FDA's Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals went into effect, placing new compliance requirements on food importers.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
To understand what the latest news means in the ongoing saga over EpiPen Medicaid Drug Rebates, it is important to understand how we got here.
Ropes & Gray LLP
Kim Nemirow, Ropes & Gray government enforcement partner, analyzes new compliance strategies global life sciences companies are facing in an evolving market.
Ropes & Gray LLP
Kim Nemirow, Ropes & Gray government enforcement partner, analyzes new compliance strategies global life sciences companies are facing in an evolving market.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The 21st Century Cures Act includes substantial changes to the FDA's regulation of medical devices.
Mayer Brown
Today, the Supreme Court issued three decisions, described below, of interest to the business community: Class Actions—Appellate Jurisdiction; Biologics Price Competition and Innovation Notice Requirement...
Pryor Cashman LLP
Stephen Goodman, Co-Chair of Pryor Cashman's Life Sciences Group and co-founder of MABA, was quoted in the press announcing the winners of MABA's 1st Pitch Life Science competition...
Day Pitney LLP
In March, as discussed here, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule that delayed the effective date of planned cardiac care bundled payment initiatives and the expansion of the Comprehensive Care for Joint Replacement (CJR) Model from July 2017 to October 2017.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
On that date, FDA will replace all approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for biologics with biologic license applications (BLAs) or abbreviated...
Reed Smith
The plaintiff thought she had a strong summary judgment opposition. She included the deposition testimony of her prescribing doctor, who suggested that Boston Scientific's warnings for the pelvic...
BakerHostetler
Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval...
Baker Sterchi Cowden & Rice LLC.
The old adage "location, location, location" applies as much for medical device preemption as it does for real estate.
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Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Below, a divided Federal Circuit panel held that: (1) a biosimilar applicant is not required to provide its application and manufacturing information to the Reference Product Sponsor (RPS)
Mayer Brown
Today, the Supreme Court issued three decisions, described below, of interest to the business community: Class Actions—Appellate Jurisdiction; Biologics Price Competition and Innovation Notice Requirement...
Haug Partners
The Supreme Court yesterday issued its first opinion interpreting the BPCIA, the statute which created a pathway for the approval of abbreviated applications to market biological products.
Seyfarth Shaw LLP
Finding against the Federal Circuit once again on a patent case, the Supreme Court this week issued a unanimous decision in Sandoz v. Amgen relating to the interpretation of the Biologics...
Arnold & Porter Kaye Scholer LLP
n June 12, 2017, the United States Supreme Court issued a unanimous opinion, written by Justice Thomas, in Sandoz, Inc. v. Amgen, Inc. ...
Reed Smith
The plaintiff thought she had a strong summary judgment opposition. She included the deposition testimony of her prescribing doctor, who suggested that Boston Scientific's warnings for the pelvic...
Ropes & Gray LLP
Kim Nemirow, Ropes & Gray government enforcement partner, analyzes new compliance strategies global life sciences companies are facing in an evolving market.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The 21st Century Cures Act includes substantial changes to the FDA's regulation of medical devices.
BakerHostetler
Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval...
Thompson Coburn LLP
On May 30, 2017, the FDA's Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals went into effect, placing new compliance requirements on food importers.
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