The FDA is planning to deliver a suite of disease-specific guidance documents next year on developing targeted gene therapies, starting with hemophilia and then more common single-gene disorders, Commissioner Scott…
Janssen Biotech and Samsung Bioepis jointly requested that Janssen’s patent infringement case be dismissed following the Supreme Court’s ruling earlier this year on the biosimilar approval process. The New Jersey…
The chief administrative law judge of the PTO’s Patent Trial and Appeal Board issued guidance to holders on how to amend their patents after being challenged with an inter partes…
A Philadelphia jury found Bayer and Johnson & Johnson liable for the injuries of a woman prescribed their prescription blood thinner Xarelto, following three consecutive victories for the drugmakers in…
For more efficient development of treatments for pediatric rare diseases, sponsors can implement controlled, multi-arm, multi-company clinical trials, according to a new draft guidance that the FDA says could help…
The FDA’s chief counsel said the agency is examining the legal circumstances where a company’s senior personnel and management could be held not only civilly responsible, but also criminally responsible…
A Florida federal judge ruled Monday that the federal government’s False Claims Act complaint against a compounding pharmacy can proceed. Source: Drug Industry Daily
Drugmakers have improved at clinical trial transparency compared to 2015, with Sanofi and Johnson & Johnson sharing first place in a transparency ranking sponsored by Bioethics International. Source: Drug Industry…
Admission to the FDA’s expedited programs can shave years off clinical development times, according to a new analysis. Source: Drug Industry Daily
Testifying before a UK House of Commons committee Tuesday, international pharmaceutical companies said they are already hedging their bets when it comes to the real-world consequences of Brexit, making preparations…