Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Jones Day
On April 27, 2017, the EMA held a meeting with the heads of the National Competent Authorities of the EU/European Economic Area Member States to discuss the consequences of Brexit...
Reed Smith
Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues.
Baker Sterchi Cowden & Rice LLC.
The old adage "location, location, location" applies as much for medical device preemption as it does for real estate.
WilmerHale
clash over access to and use of genetic sequence data (GSD) is currently brewing on several international fronts. To date, GSD has been routinely deposited in open-source databases such as GenBank of the National Center for Biotechnology Information ..
WilmerHale
Last year's contentious U.S. presidential election is often blamed for the slowdown in dealmaking activity in the life sciences space.
Haug Partners
For many companies that compete in competitive markets, innovation and product improvement fuels competitive success: create a better product than your competitors, and over time, make it better.
Reed Smith
On May 11, 2017, the Senate on Health, Education, Labor, and Pensions (HELP) Committee approved S 934, a bill extend Food and Drug Administration user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products.
Jones Day
On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting...
Akin Gump Strauss Hauer & Feld LLP
Pharmaceutical waste management is a critical issue for hospitals and health care facilities.
Jones Day
A federal district court in Connecticut held that an online auction service for the purchase of medical supplies violates the Anti-Kickback Statute.
Morrison & Foerster LLP
As many privately held companies choose to remain private longer and defer their initial public offerings, these companies are increasingly reliant on raising capital in successive private placements.
Dentons
Due to potential inconsistencies in CMS's cap-setting calculation methodologies, new teaching hospitals that first started training residents after the 1996 cap-setting base year...
Ropes & Gray LLP
The U.S. health care system is in the midst of a fundamental shift, away from traditional fee-for-service models that reward providers based upon the volume of services provided to patients, and toward value-based care programs designed to reward the quality and efficiency of health care services.
Fish & Richardson PC
In January, 2017, the FDA released a final guidance document outlining its rules for giving nonproprietary names to biological products.
Arnold & Porter Kaye Scholer LLP
The U.S. Food and Drug Administration (FDA) issued a Warning Letter on April 12, 2017 requiring an explanation of how St. Jude Medical plans to correct and prevent cybersecurity concerns identified ...
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
On April 26, 2017, the U.S. Supreme Court heard oral arguments in Sandoz Inc. v. Amgen Inc., Nos. 15-1039, 15-1195, concerning Sandoz's petition and Amgen's cross-petition from the Federal Circuit's...
Foley & Lardner
Although the Solicitor General of the United States filed an amicus brief that sided with Sandoz on both issues, the Justices seemed inclined to affirm the Federal Circuit on both issues.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Yesterday, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The Court's decision, which should issue in June, will be closely watched by participants in the pharmaceutical, biotech, and health care sectors.
Reed Smith
Next week, we are traveling to Budapest, with a side trip to Vienna. We are visiting the Drug and Device Law Rock Climber, who is spending this semester abroad studying computer science (in Budapest) and climbing rocks (in Majorca, etc.).
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Ropes & Gray LLP
The U.S. health care system is in the midst of a fundamental shift, away from traditional fee-for-service models that reward providers based upon the volume of services provided to patients, and toward value-based care programs designed to reward the quality and efficiency of health care services.
Reed Smith
On May 11, 2017, the Senate on Health, Education, Labor, and Pensions (HELP) Committee approved S 934, a bill extend Food and Drug Administration user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products.
Jones Day
On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting...
Morrison & Foerster LLP
As many privately held companies choose to remain private longer and defer their initial public offerings, these companies are increasingly reliant on raising capital in successive private placements.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The Court's decision, which should issue in June, will be closely watched by participants in the pharmaceutical, biotech, and health care sectors.
Baker Sterchi Cowden & Rice LLC.
The old adage "location, location, location" applies as much for medical device preemption as it does for real estate.
Haug Partners
For many companies that compete in competitive markets, innovation and product improvement fuels competitive success: create a better product than your competitors, and over time, make it better.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
On April 26, 2017, the U.S. Supreme Court heard oral arguments in Sandoz Inc. v. Amgen Inc., Nos. 15-1039, 15-1195, concerning Sandoz's petition and Amgen's cross-petition from the Federal Circuit's...
Thompson Coburn LLP
One of the authors of this piece uses a medical device that is wirelessly networked to the device's vendor.
Jones Day
On April 27, 2017, the EMA held a meeting with the heads of the National Competent Authorities of the EU/European Economic Area Member States to discuss the consequences of Brexit...
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