Scrip Approvals

Pink Sheet Podcast: New Acting US FDA Biologics Center Director, SCOTUS Eyes Generic Drug Policy

Derrick Gingery|Nielsen Hobbs|Maaisha Osman|Dave Wallace — Fri, 01 May 2026 17:19:56 +0000

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter, Editor-in-Chief Nielsen Hobbs and Generics Bulletin Executive Editor Dave Wallace discuss US Fo

The Mouse Roars: Vanda Suit Argues US FDA Requires Unnecessary Animal Studies

Nielsen Hobbs — Fri, 01 May 2026 17:04:01 +0000

Vanda ’s most recent lawsuit against the US Food and Drug Administration touches on animal testing alternatives, one of the agency’s biggest policy initiatives at the moment. And while the firm faces

Alternate Leadership Strategy: Deputy Director Szarama Is Acting US FDA Biologics Center Chief

Derrick Gingery — Fri, 01 May 2026 01:04:33 +0000

A relative newcomer to the US Food and Drug Administration will take over temporarily for outgoing Center for Biologics Evaluation and Research Director Vinay Prasad. A Health and Human Services Depar

US FDA AdComm Says Camizestrant Novel Trial Design Provocative, But Not Paradigm-Shifting

Bridget Silverman — Fri, 01 May 2026 00:55:54 +0000

The novel design of the pivotal SERENA-6 trial overshadowed its new molecular entity subject when the US Food and Drug Administration’s Oncologic Drugs Advisory Committee reviewed AstraZeneca ’s cami

US FDA Panel Backs AstraZeneca’s Truqap In Prostate Cancer Despite Toxicities

Sue Sutter — Fri, 01 May 2026 00:16:12 +0000

The 7.5-month radiographic progression-free survival benefit with AstraZeneca ’s Truqap (capivasertib) will be clinically meaningful to some metastatic hormone-sensitive prostate cancer patients desp

Amgen Updates Tavneos Label While US FDA Weighs Withdrawal Proposal

Maaisha Osman — Thu, 30 Apr 2026 21:29:12 +0000

Amgen has submitted a labeling update to strengthen hepatotoxicity warnings for its complement 5a receptor inhibitor Tavneos (avacopan), even as the US Food and Drug Administration considers withdraw

EMA’s Vaccine Hesitancy Group Draws On Former US FDA Experts Califf And Offit

Eliza Slawther — Thu, 30 Apr 2026 15:39:52 +0000

Former experts at the US Food and Drug Administration are among the 21 members of the European Medicines Agency’s new vaccine confidence advisory group, which will advise the EU drug regulator on vacc

New EU Approvals

Neena Brizmohun — Thu, 30 Apr 2026 13:06:53 +0000

The Pink Sheet’s regularly updated list of products containing new active substances that have been approved for marketing in the EU under the centralized authorization procedure now includes eight

French HTA Body Slams Pharma Companies For Increasing ‘Unacceptable’ Behavior

Francesca Bruce — Thu, 30 Apr 2026 12:10:57 +0000

HAS, the French health technology assessment (HTA) agency, has called on pharmaceutical companies to stop trying to undermine its evaluations and put pressure on the organization using “unacceptable m

PBM Regulation May Bolster Big Three Market Position Versus Smaller Competitors

Cathy Kelly — Wed, 29 Apr 2026 21:36:12 +0000

Federal regulation of the pharmacy benefit manager market likely will disadvantage smaller pharmacy benefit managers, will be manageable for the three leading PBMs, and probably will not lead to addit

Skinny Label At SCOTUS: Could Generics Maintain Carve-Out Authority No Matter The Decision?

Dave Wallace — Wed, 29 Apr 2026 21:12:04 +0000

Hikma could lose the monumental skinny label carve out case against Amarin at the US Supreme Court, but maintain its and other generic drug sponsors’ ability to market products with patented indica

US FDA’s Makary Expects To Name Permanent CBER Director Within Weeks As Prasad Departs

Maaisha Osman — Wed, 29 Apr 2026 17:36:10 +0000

US Food and Drug Administration Commissioner Martin Makary expects to name a permanent director for the Center for Biologics Evaluation and Research in the coming weeks, as current Director Vinay Pras

England Reimburses Rystiggo For gMG After NHS Strikes Improved Deal With UCB

Neena Brizmohun — Wed, 29 Apr 2026 15:47:35 +0000

England’s health technology assessment institute, NICE, has reversed its rejection of UCB’s Rystiggo (rozanolixizumab), for treating generalized myasthenia gravis (gMG), after the company and the coun

EU Shift On Patient-Facing Documents: What Goes Where And When In CTIS

Vibha Sharma — Wed, 29 Apr 2026 13:43:57 +0000

Clinical trial sponsors not yet ready to adopt the new EU approach for patient‑facing documents in the Clinical Trials Information System (CTIS) will be required to explain their reasons in the study

US FDA’s Deep Skepticism Of AZ’s Novel Camizestrant Trial Design Signals AdComm Trouble

Bridget Silverman — Tue, 28 Apr 2026 22:42:54 +0000

AstraZeneca hoped to define a new model for addressing drug resistance with the SERENA-6 trial of its next-generation selective estrogen receptor degrader camizestrant, but the US Food and Drug Admin

US FDA Questions Clinical Meaningfulness Of AstraZeneca’s Truqap Benefit In Prostate Cancer

Sue Sutter — Tue, 28 Apr 2026 21:41:47 +0000

The US Food and Drug Administration questioned the clinical meaningfulness of radiographic progression-free survival improvement with AstraZeneca ’s Truqap (capivasertib) absent a survival benefit in

US FDA Details Data Manipulation, False Statements In Tavneos Withdrawal Request

Derrick Gingery — Tue, 28 Apr 2026 21:34:41 +0000

A US Food and Drug Administration proposal to withdraw Amgen ’s vasculitis drug Tavneos (avacopan) states the new drug application contained manipulated clinical data and untrue statements that impac

US FDA’s Real-Time Clinical Trial Pilot To Run Alongside Traditional Reviews, Test Oversight

Maaisha Osman — Tue, 28 Apr 2026 17:30:00 +0000

The US Food and Drug Administration has launched two proof-of-concept “real-time clinical trials” with AstraZeneca and Amgen and is seeking input on a broader pilot program, which could support co

UK Must Tackle ‘Variation’ In Clinical Trial Set Up Times, Says O’Shaughnessy

Eliza Slawther — Tue, 28 Apr 2026 13:08:43 +0000

While the UK has made significant strides in speeding up clinical trial set-up, as reflected in new data released earlier this month, lower median set-up times alone are not enough, according to Lord

EU CHMP Opinions And MAA Updates

Neena Brizmohun — Tue, 28 Apr 2026 13:06:07 +0000

The European Medicines Agency’s key scientific panel, the Committee for Medicinal Products for Human Use (CHMP), meets once a month and among other things adopts positive or negative opinions on EU ma