The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
340B Drug Pricing Program Compliance
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series
Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series
Drug Pricing Initiatives During the Trump Presidency
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
As we have previously reported, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. On November 10, 2023, the PMPRB published its Scoping Paper...more
After reports were made regarding the presence of nitrosamines in certain pharmaceutical products in 2018 and 2019, and subsequent precautionary regulatory action was taken, an avalanche of litigation commenced in Canada and...more
On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more
On September 24, 2020, FDA announced that it was taking action to help lower prescription drug prices by issuing a final rule and a final guidance aimed at facilitating the safe importation of certain prescription drugs....more
This article was last updated on July 10, 2020. In view of COVID-19, we have compiled a list of important updates as it relates to the pandemic and its impact on Life Sciences. We will continue to update this page as new...more
In Washington: The Trump administration continues to pressure local officials to open its schools for children to return to class, as the Department of Education Secretary Betsy DeVos threatened to cut federal funding to...more
UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more
In November 2019, we highlighted the key proposed amendments to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). The proposed amendments aim to reduce...more
In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more
On October 28, 2019, the Ontario Ministry of Health and Long-Term Care (the Ministry) published proposed changes to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee...more
This year, Florida Governor Ron DeSantis signed into law a bill that creates Florida Statute Section 381.02035, which establishes the Canadian Prescription Drug Importation Program within the Agency for Health Care...more
Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more
On February 1, 2019, the Ontario Ministry of Health and Long-Term Care (“Ministry”) announced that CWC Pharmacies (Ontario) Ltd. (“Costco Pharmacies”), a subsidiary of Costco, was ordered to pay an Administrative Monetary...more
In October 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) issued an interesting Environmental Scan on International Policies on the Appropriate Use of Biosimilar Drugs (Report). This Report outlines...more
In this special mid-year edition, we take a look at the major highlights in Canadian life sciences and intellectual property law that we have reported on over the last six months, starting with one of the most closely-watched...more
An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more
No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding - What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC)...more
On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more
Supreme Court of Canada News - SCC denies Apotex leave to appeal omeprazole infringement decision. On June 1, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal (docket no. 37478) the Federal Court...more
The Superior Court of Québec (Court), presided by Justice M. Monast, recently ruled on an important point of contention for franchise pharmacies, by confirming the validity of a percentage royalty clause contained in a...more