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The Issue with Reissue: PTE Edition

The FDA Law Blog

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. FDA has already been there , of course, with respect to 180-day exclusivity.)

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Novo Nordisk moves to strengthen obesity efforts

pharmaphorum

After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. We are excited to join forces with the world-leading pharmaceutical company in the cardiometabolic space and together lead innovation to transform the standard of care.”.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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Pfizer receives EU haemophilia B gene therapy approval

European Pharmaceutical Review

This enables individuals with the rare genetic bleeding disorder to produce factor IX (FIX) themselves, instead of regular intravenous FIX infusions, the company noted. DURVEQTIX was approved by the US Food and Drug Administration (FDA) for haemophilia B as BEQVEZ TM in April this year.

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An Annex 1 and Pharma 4.0 perspective on water quality

European Pharmaceutical Review

The US Food and Drug Administration (FDA) defines eight different types of water: non-potable, potable (drinkable), purified, water for injection (WFI), sterile water for injection, sterile water for inhalation, bacteriostatic water for injection and sterile water for irrigation. 7 also in the scheme of microbial monitoring. References.

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Former Sanofi head Viehbacher to become Biogen CEO

pharmaphorum

Viehbacher led Sanofi between 2008 and 2014 and has decades of experience with both large pharmaceutical companies and small biotechs. A veritable ‘industry veteran’, he spent 20 years at GSK before Sanofi, where he helped reshape the company’s drug portfolio. — Bloomberg (@business) November 10, 2022. to $289.01

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Case Study 5 – Regulatory Affairs Strategy and Project Team Lead

Impact Pharmaceutical Services

IMPACT (now part of Syner-G BioPharma Group) has been providing Regulatory Affairs support to a mid-size pharmaceutical company since 2009. Even though this company has a Regulatory Affairs Department, their rapid growth over the years has made “in-sourcing” of help a necessity. Regulatory Affairs Strategy and Project Team Lead.