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Latest From Akorn, Inc.
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.
iPLEDGE REMS: US FDA Advisory Cmte. Supports Relaxing Restrictions But Wants More Data
Panel favors elimination of 19-day lockout after patients who can become pregnant miss the first prescription pickup and continuation of at-home pregnancy tests. Members call for more data from isotretinoin sponsors on why acne patients are not participating in pregnancy registry and on disparities by race and ethnicity.
iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Counseling Requirements
Advisory committee to discuss proposed changes to isotretinoin REMS to minimize burden and treatment delays while preventing risk of fetal exposure. Agency recommends against at-home pregnancy tests.
Finance Watch: VC Mega-Rounds Make A Comeback In March
Private Company Edition: After just seven venture capital rounds of $100m or more in January and February, five have been announced already in March, including a $200m series A round for Cargo Therapeutics, Chroma Medicine’s $135m series B financing and $112m for Noema’s series B.
- Medical Devices
- Generic Drugs
- OTC, Consumer
- Specialty Pharmaceuticals
- Other Names / Subsidiaries
- Hi-Tech Pharmacal
- Oak Pharmaceuticals, Inc., VersaPharm
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