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

Italy Moves To Raise Biosimilar Use And Awareness

The use of biosimilars is growing in Italy, but the authorities want their market share to rise further and so the regulator has set up a dedicated webpage to explain the biosimilar concept more clearly to doctors and the general public and to help dispel any remaining doubts about their safety and efficacy. The aim is to increase awareness and use of biosimilars and rationalize state spending on biologic medicines.

Italy Biosimilars Regulation

Generics Firms Improved Chances Of Winning Pre-ANDA Meetings For Complex Drugs Last Year

FDA officials said manufacturers of complex generic drugs submitted more approvable requests for pre-submission meetings for FY 2018. Official also clarifies at recent meeting when it's best to request a pre-ANDA meeting and when to submit a controlled correspondence.

Manufacturing Quality Policy

‘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

Latin America Notebook: Advancing Adaptive Trial Designs, Translating ICH Guidelines, Sharing Confidential Information

Brazil's drug regulator ANVISA will require more experience in dealing with adaptive trial designs before issuing guidance; translating older ICH guidelines remains a barrier to their implementation; and industry is asked to be more transparent in sharing their confidential information among drug regulators to facilitate convergence.

South America Clinical Trials Regulation
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

The Quality Lowdown: Valsartan Options, Supply Chain Warnings, Button Cameras

Yet another valsartan approved as quality/shortage crisis unfolds, while warning letters hit firms on poor root cause investigations and supply chain issues, and FDA investigators procure shirt-button candid cameras.

Manufacturing Quality Enforcement

Latest From Regulation

Opioids, Old Initiatives Dominate FY 2020 US FDA Funding Increase

The agency requested a funding increase in part to implement 2018 legislation intended to combat the opioid crisis, but also to support many initiatives in last year's budget request.
FDA Legislation

Australia Consults On Adopting EU Extrapolation Paper And Other Guidelines

The Australian regulator has proposed adopting several European Medicines Agency guidelines. For some of these guidelines, the Therapeutic Goods Administration has added its annotations.
Australia Europe

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

Latest From Policy

Measles Hearings Offer Counterpoint To Pricing Spotlight: Vaccines Touted As Cost-Effective Solution To Outbreaks

Congressional hearings on the recent outbreaks of measles and other vaccine-preventable diseases offered a positive theme for the industry during the ongoing drug pricing debate.

Legislation Drug Safety

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

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

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

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

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

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

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

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
UsernamePublicRestriction

Register

Advertisement