A team of Norton Rose Fulbright pharma and medical-device litigators recently presented to the Life Sciences and Healthcare Spring Webinar Series on “Pharma Delivers: Now What?” Pharmaceutical companies delivered pandemic-ending vaccines, and are rewarded with an increasingly positive public reputation.
On February 2, 2017, the Government published a White Paper on its plan for exiting and achieving a new partnership with the EU. The White Paper expands upon Prime Minister Theresa May’s speech on January 17, 2017. We have previously
On May 5, 2016, the United States Patent and Trademark Office issued six new examples that provide guidance to Examiners and patent applicants prosecuting claims directed to life sciences subject matter (Subject Matter Eligibility Examples: Life Sciences). These examples analyze claims that are directed to several of the most contentious areas of patentable subject matter under 35 U.S.C. § 101, including vaccines, methods for diagnosing and treating, nature-based products including mixtures, methods for genetic screening, and machines and processes that are alleged to be founded on a natural law.
On June 26, the Third Circuit ruled that so-called “reverse payment” settlement agreements of patent infringement litigation between branded and generic pharmaceutical companies can face antitrust scrutiny under the Supreme Court’s decision in FTC v. Actavis, even when the
On schedule, CMS released the 2014 Sunshine Act data, which shows $6.49 billion in transfers of value by pharmaceutical and medical-device manufacturers to physicians and teaching hospitals. The data covers 11.4 million financial transactions attributed to over 600,000 physicians
On June 29, 2015, FDA released 44 new and 4 revised product-specific bioequivalence recommendations for the development of generic drugs. FDA has now published a total of 1321 bioequivalence recommendations, listed by the active ingredient, on its website.
Under
This week at an enforcement panel, government representatives discussed using the Sunshine Act data to delve into allegations of kickbacks to doctors and detect industry trends of improper behavior.
During the American Conference Institute’s 7th Annual Forum on Sunshine Act
We recently released our 2015 litigation trends annual survey, the 11th overall and the most extensive in its history. More than 800 corporate counsel representing companies across 26 countries were polled on disputes-related issues and concerns. Click here to read
Beyond the United States’ Physician Payments Sunshine Act reporting requirements, international pharmaceutical and device companies must account for a growing number of transparency requirements related to their interactions with healthcare professionals.
For example, in France, the Bertrand Act requires transparency
Earlier this week, the U.S. Food and Drug Administration (FDA) released guidance on the definition and processing of submissions for modifications and revisions to approved pharmaceutical risk evaluation and mitigation strategies (REMS). REMS are strategies to manage a known or