Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Featured Stories


Pharma Uncertainty Remains As UK Votes To Delay Brexit

UK members of parliament have ruled out a no-deal Brexit and voted to request a delay to the exit date, and they will vote again on the withdrawal deal next week. But all this just serves to exacerbate the uncertainty and frustration felt by businesses working in the pharmaceutical sector.
Brexit Regulation United Kingdom

US FDA 2020 Budget Request Is Parting Gift From Commissioner Gottlieb

The Trump Administration’s request to increase FDA funding by 12% is a reminder of the behind-the-scenes benefits brought to FDA by the outgoing commissioner. The proposed increase for FDA stands in stark contrast to what is otherwise an austerity budget for HHS agencies.
FDA Policy BioPharmaceutical

Achilles On Getting ‘New Wave’ Immunotherapy From Concept To Clinic In Three Years

Clonal neoantigen immunotherapy developer Achilles Therapeutics tells the Pink Sheet how the regulatory landscape for advanced therapies might not be as tricky as it used to be.

Research & Development Clinical Trials United Kingdom

‘Project Facilitate’: US FDA Plans May Meeting On Expanded Access Call Center

Oncology Center of Excellence pilot program is intended to make the single patient IND process easier to navigate and more efficient; regulatory project managers will help walk providers through the process and provide contact information for drug companies and institutional review boards.

Clinical Trials Review Pathway Regulation

FDA Action Awaits Lupin Sites As Compliance Cloud Lingers

Lupin continues to face the heat for compliance deviations at its manufacturing plants, with the FDA now issuing an official action indicated inspection classification for two of the Indian company's sites. Lingering negative sentiment and remediation costs are some aspects that investors may need to brace for.
Manufacturing Quality India
Advertisement

US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – February 2019

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
International Europe Australia
Advertisement

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

EMA Guide To Help Regulators Assess Subgroup Analyses In Confirmatory Trials

A new final guidance by the European Medicines Agency outlines broad principles and strategies that regulatory assessors can use when investigating subgroups in confirmatory clinical trials.
Europe Clinical Trials Regulation

Latest From Regulation

Keeping Track: Two Goal Date Extensions, Another Herceptin Biosimilar Approval, And A BLA Withdrawal

The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA Performance Tracker Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Part D Premiums ‘Won’t Go Up’ With HHS Rebate Proposal, Azar Maintains

US HHS secretary tells Senate Finance Committee he believes pharmacy benefit managers will effectively keep drug costs down in Medicare Part D, even without rebates.

Medicare Reimbursement

Latest From Policy

Fate Of JHL Biotech's Biosimilars Uncertain As Judge Bars Use Of Genentech Trade Secrets

Court denies JHL motion to dismiss trade secret theft suit, bars development or sale of biosimilars that rely on information from Genentech documents; trial scheduled to begin in November 2020.

Intellectual Property Biosimilars

Making The Case For Rebates: UnitedHealth Pushing Expansion Of POS Program

Faced with a proposed regulation that aims to eliminate rebates and an upcoming hearing on Capitol Hill, US pharmacy benefit managers including OptumRx are working to validate the concept of rebates when redirected to patients at the point-of-sale. 

Pharmacy Benefit Management Pricing Debate

Novartis Strikes Kymriah Outcome-Based Deal With German Insurers

Novartis and German insurers have agreed a payment by outcomes deal for its CAR-T therapy Kymriah.

Europe Germany

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Cancer Trials: US FDA Guidances Aim To Expand Eligibility Criteria And Better Inform Labeling

Draft guidances reflect the agency’s thinking on when patients with HIV/hepatitis infection, brain metastasis, organ dysfunction or prior malignancies, as well as pediatric patients, should be enrolled in cancer trials; FDA also finalizes recommendations on adolescent enrollment in adult studies of oncology drugs.

Clinical Trials Regulation

Historic Output Of Disease-Specific Guidances Is Among Gottlieb's Legacies At US FDA

A Pink Sheet analysis illustrates how the outgoing commissioner enhanced FDA's ability to facilitate the further development of innovative drugs. 
Research & Development Drug Approval Standards

China Tightens Clinical Trial Oversight Post Gene-Edited Babies Scandal

New draft regulation will require state-level approval over high-risk and reproductive use of gene and cell technologies.

China Clinical Trials

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

Making The Case For Rebates: UnitedHealth Pushing Expansion Of POS Program

Faced with a proposed regulation that aims to eliminate rebates and an upcoming hearing on Capitol Hill, US pharmacy benefit managers including OptumRx are working to validate the concept of rebates when redirected to patients at the point-of-sale. 

Pharmacy Benefit Management Pricing Debate

Cipla, Piramal Launch Sensipar Generics Amid Growing Antitrust Challenges to Amgen/Teva Settlement

Amgen seeks a preliminary injunction to halt US sales by Cipla and says it will take steps to stop Piramal’s sales; in its antitrust lawsuit, Cipla alleges Amgen paid to license Teva products under the companies’ patent settlement, which resulted in Teva pulling its generic off the market shortly after launch.


Generic Drugs Launches

Australian Competition Watchdog Probes GSK/Pfizer Consumer Health JV Proposal

Assessing how closely GSK's OTC brands including Panadol compete with Pfizer's Robitussin and other OTC brands is the aim of investigation by Australia's Competition and Consumer Commission into the pharma giants' proposed consumer health joint venture. ACCC states particular interest in importance of Panadol, Voltaren and Advil brands, and whether GSK and Pfizer compete closely in supply of pain relief, gastrointestinal and cold and flu relief products.

M & A Regulation

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Guardian Pharmacy Ordered To Stop Making Sterile Drugs Under Terms Of Consent Decree

Drug compounding pharmacy Guardian Pharmacy Services was ordered to stop manufacturing sterile drugs after ignoring quality problems for too long, bringing to two the number of decrees the Justice Department has filed against drug compounding pharmacies so far this year, which at the current rate may exceed the two consent decrees filed in all of calendar year 2018. The action follows reports that patients administered eye injections of a drug compounded by Guardian during cataract surgery developed vision impairment.

United States Manufacturing

US Visa Concerns Led ICH To Choose Canadian Meeting Site

The US, one of ICH’s original three member authorities, was spurned in favor of Canada for the pharmaceutical regulatory harmonization initiative’s next meeting in the region because of some participants’ difficulties obtaining US visas.

Manufacturing Legal Issues

Pfizer Must Correct Data Integrity Problems Seen At India Plant Globally, FDA Says

US FDA warning letter instructed Pfizer to implement a global corrective and preventive action plan to address widespread data integrity problems. While the impact of the warning letter on the site is expected to be minimal due to its closure, the global impact on the company’s sterile drug operations could be significant.

 

Manufacturing Quality
UsernamePublicRestriction

Register

Advertisement