Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Keeping Track: Pharming’s Joenja, Cidara’s Rezzayo And Incyte’s Zynyz Headline US FDA Approval Bonanza

Executive Summary

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

You may also be interested in...



Industry Refuses To Let Congress Forget PASTEUR Act

Melinta CEO and a representative of the Infectious Diseases Society of America call on a Senate HELP subcommittee to push for passage of PASTEUR Act. Introduced in the Senate and House for the third time this year, the measure would establish a subscription model to pay drug developers upfront for certain antimicrobials.

US FDA Rejects Melinta Effort To Go Beyond Court Order In FedEx-Driven ANDA Dispute

Court found FDA erred in finding Melinta received notice of Paragraph IV certification for generic Minocin on date specified by Nexus. Agency will not require Nexus to send a new notice or give Melinta heads up of final approval of the ANDA.

The Quality Lowdown: CMC Challenges Include Pfizer Unit's Quest For Injectable Acetaminophen

Pfizer’s InnoPharma unit finally overcame US FDA’s concerns about injectable acetaminophen GMPs and leachables. Meanwhile, Azurity resolved zonisamide manufacturing issues, Amphastar overcame doubts about naloxone’s nasal spray device, Incyte reused Zynyz CMC data, Cidara showed Rezzayo vials had enough powder, Pharming showed equivalence between Joenja tablets and capsules, and Orphalan avoided half-tablet stability testing of its functionally scored Cuvrior tablets.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147950

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel