NHS England will provide certain children and young adults with Kymriah (tisagenlecleucel), Novartis’ CAR-T cell therapy. The NHS says this decision is “the first in what is expected to be a rapidly expanding class of personalized cancer therapies.” Kymriah was approved by the European Commission last month and by the U.S. FDA last year, and is…
FDA Issues More Warnings to Online Networks Selling Illegal Opioids
The FDA has issued four more warnings to online networks—CoinRX, MedInc.biz, PharmacyAffiliates.org, and PharmaMedics—operating a total of 21 illegal websites marketing potentially generous, unapproved, and misbranded versions of opioid medications. “The illegal online sale of opioids represents a serious risk to Americans and is helping to fuel the opioid crisis. Cutting off this flow of…
FDA Expands Indication of Vertex’s Cystic Fibrosis Drug
FDA expanded approval of Vertex Pharmaceuticals’ cystic fibrosis (CF) therapy Kalydeco (ivacaftor) to include use in children aged at least 12 months, but younger than 24 months who carry at least one responsive CFTR mutation, making it the only medicine to treat CF in this age group. Kalydeco’s new approval was supported by data from the ongoing late-stage…
Medical Marijuana Track-and-Trace Still a Hazy Concept
As medical marijuana becomes a more popular option for patients seeking treatment for a variety of illnesses, and as some states struggle to effectively track their product, questions regarding cannabis regulation are starting to increase. Track-and-trace is a hot topic in the pharmaceutical industry, made all the more urgent as the next phase of deadlines…
China Names 48 Critical Foreign Drugs To Expedite Approvals
In a move consistent with policy changes in China to ease up on drug approval regulations, the country’s Center for Drug Evaluation (CDE) released a list of 48 drugs—already approved outside of China—that it hopes to make eligible for expedited clearance. The drugs, most of which are treatments for rare diseases or for the prevention…
AstraZeneca To Pay Millions To Settle Seroquel, Crestor Lawsuits
AstraZeneca agreed to pay $110 million to settle two U.S. lawsuits claiming that the company fraudulently marketed Seroquel and Crestor, agreeing to pay $110 million. The drugmaker denies the allegations, but says, “it is in the best interests of the company to resolve these matters […] while avoiding the delay, uncertainty, and expense of protracted litigation.” Settling with…
Ironwood Pharmaceuticals Returns U.S. Rights To Zurampic To AstraZeneca
In a second quarter 2018 investor update, Ironwood Pharmaceuticals revealed that is has terminated its agreement with AstraZeneca regarding the U.S. rights to Zurampic (lesinurad), the gout therapy. The deal, which out-licensed exclusive U.S right for the therapy to Ironwood, was finalized in 2016 and worth potentially $265 million, plus royalties. Additionally, the deal included exclusive U.S.…
Microsoft Delves Into Using Blockchain As Part Of A Process Flow
At the Adents Serialization Innovation Summit in Philadelphia, Tianna Umann, Microsoft software architect, gave a talk explaining that when used within an already existing end-to-end solution, blockchain can improve communication by storing and sharing product transaction and check-point status during the manufacturing process and along supply chain in a single, fixed ledger. Using a sequence…
U.S. Court Rejects Allergan’s Attempt To Use Tribal Immunity To Shield Restasis Patents
In September 2017, Allergan agreed to pay the Saint Regis Mohawk Tribe of Upstate New York $15 million a year to take ownership of the company’s Restasis patents. As a sovereign entity, the tribe claimed immunity from civil patent challenges. Following this move, Mylan NV, Teva Pharmaceutical Industries Ltd., and Akorn Inc all filed challenges against Allergan, who maintained tribal immunity. On…
FDA Releases Biosimilars Action Plan Along With Some Harsh Words For Drug Manufacturers
The FDA released the Biosimilars Action Plan (BAP) on Wednesday, which details the key actions the agency is taking to encourage innovation and competition among biologics and the development of biosimilars. According to the FDA, the BAP focuses on four key areas: Improving the efficiency of the biosimilar and interchangeable product development and approval process Maximizing…