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


Clinical Study Disclosures Will Make Drug Reviews More Efficient – Gottlieb

US FDA pilot program linking drug approval documents to sponsors' clinical study reports will improve review efficiency and access to information by medical researchers and drug developers, commissioner says; move also could aid sponsors when it comes to reimbursement decision-making, Foley and Lardner's Rosen predicts.

Drug Review Clinical Trials FDA

Pharma Wants Clarity On Joint Evaluation Of EU Paediatric And Orphan Regulations

The European Commission's plans to evaluate the EU pediatric and orphan drugs regulation in tandem has prompted questions from the pharmaceutical industry on how exactly this critical exercise would proceed and what its ultimate objective would be.

Pediatrics Rare Diseases Regulation

Countermeasures May Need More Incentives Than Vouchers, Gottlieb Says

With priority review voucher values falling, Congress may want to think about additional incentives for medical countermeasure development, Commissioner Gottlieb tells Senate committee.

Legislation FDA Review Pathway

RMAT Designation, Gene Therapies Highlight 2017 CBER Transformation

CBER Director Peter Marks says the center implemented a lot in a short amount of time for the RMAT pathway.

Biologics Drug Review Review Pathway
Advertisement

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

OTC Monograph Reform Momentum Carries Potential Exclusivity Snag

Support was unanimous during House Health Subcommittee markup for draft legislation on streamlining FDA's monograph system by eliminating public rulemakings from the process and allowing the agency to make decisions with administrative orders. Two-year exclusivity for some products didn't go over so well.

United States Consumer Legislation

Latest From Regulation

Planning Ahead In The EU: The Impact Of The GDPR On Clinical Trials And Research

When it becomes effective in the EU in May, the new General Data Protection Regulation will have major implications for the planning and conduct of clinical trials and research. Lawyers David Pountney and Richard Binns discuss how pharmaceutical companies and CROs should plan to ensure they remain compliant.

Clinical Trials Legal Issues

‘We’re Still In The EU!’ UK MHRA Insists As Brexit Talks Move Into Phase 2

The UK MHRA says it plans to continue playing a full part in the EU regulatory network as Brexit negotiations continue, while a task force at the EU industry body EFPIA has discussed contingency planning and other issues.

Brexit United Kingdom

CBER Director Marks: Regenerative Medicine Enforcement Will Be 'Notched Up' In 2018

In an interview with the Pink Sheet, Marks said the guidances on regenerative medicines make clear what the agency will be enforcing.

Regenerative Medicine Safety

Latest From Policy

Joint HTA And Pricing: How To Make Specialized Treatments like Strimvelis Affordable

Joint negotiations and outcome based deals could be key in securing access to advanced therapies like Strimvelis that are available only from specialized centers.

Market Access Rare Diseases

Complete Response Letters: US FDA Trying To Identify Subsets For Public Release

Agency want to identify a 'manageable' subset of letters for release in which drug approval was denied for reasons, such as safety concerns, that can help inform clinical practice and impact public health, Commissioner Gottlieb says, adding: 'I'm not sure that that's doable. I'm inclined to think that it might be.'

Complete Response Letters Drug Review

Next User Fee Cycle Should Focus On Policy Improvements, Gottlieb Says

US FDA commissioner wants to focus on new policies that will improve innovation and move beyond incremental process improvements.

Legislation FDA

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Putting Innovation In The Spotlight

The Clinical and Research Excellence (CARE) Awards are Informa Pharma Intelligence's way of honoring the R&D accomplishments across the biopharmaceutical industry. Nominations are free and open through Jan. 19.

Commercial Research & Development

Target's NASH Study Captures Real World Data, Helps Partners With Trial Design

Longitudinal observational study of NASH patients provides data to companies to help them better understand disease; Target PharmaSolutions conducting similar efforts in primary biliary cholangitis, hepatocellular carcinoma, and inflammatory bowel disease.

Clinical Trials Liver & Hepatic

J.P. Morgan Notebook Day 3: Lilly's CGRP Prospects, Juno On Track, Color From Alnylam's Greene, Shire's New CMO

Daily round-up of news and notes from the 2018 J.P. Morgan Healthcare Conference in San Francisco: Lilly CEO on CGRP reimbursement jitters, Alnylam president on Sanofi deal terms, Juno stakes BCMA myeloma claim, Shire's new CMO.

Commercial Companies

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

Putting Innovation In The Spotlight

The Clinical and Research Excellence (CARE) Awards are Informa Pharma Intelligence's way of honoring the R&D accomplishments across the biopharmaceutical industry. Nominations are free and open through Jan. 19.

Commercial Research & Development

Reflections From J.P. Morgan: Challenges As Always And Reasons For Optimism

Biopharma investors were underwhelmed by the deal-making news, but innovation, corporate tax reform and a relatively positive outlook on drug pricing left attendees at the J.P. Morgan Healthcare Conference with the sense that good things are in store for pharma in 2018.

Pricing Debate Business Strategies

J.P. Morgan Notebook Day 4: CRISPR's Not Worried; Theratechnologies' HIV Niche; And Is Moderna's IPO Coming Soon?

Daily round-up of news and notes from the 2018 J.P. Morgan Healthcare Conference: Alder's Options for CGRP drug; CRISPR's not worried about Cas9 controversy; Theratechnologies seeks more HIV niche products; Moderna is shaping up to have a big 2018; TG Therapeutics and Immunomedics milestones ahead.

Commercial Companies

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Complex Generics Guidance: US FDA Aims To Alert Firms, As GAO Requested

The US FDA says it's working to provide the type of notice generic drug firms told the General Accountability Office they want to receive whenever the agency plans to issue or revise product-specific guidance on complex generics. Surprise issuance causes setbacks for generic drug sponsors who must scramble to revise their applications accordingly, if they can.

Manufacturing Quality

French To Import Czech Version Of Sandoz’ Penicillin For Syphilis Amid Global Shortage

The French regulator has announced that it is importing supplies of Sandoz’ penicillin product benzathine benzylpenicillin as a result of shortages of the product. The French situation reflects a wider problem with supply of the product at the global level due to GMP issues and the shrinking number of API manufacturers.

Manufacturing Quality

Pediatric Provision Moves OTC Monograph Reform To Subcommittee Vote

An updated draft includes a provision requiring FDA to report annually to the Energy and Commerce Committee and to the Senate HELP Committee on the agency's evaluation of the cough and cold monograph to determine whether to impose more stringent limits on formulations allowed for use by children under age 6.

United States Consumer

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Pediatric Provision Moves OTC Monograph Reform To Subcommittee Vote

An updated draft includes a provision requiring FDA to report annually to the Energy and Commerce Committee and to the Senate HELP Committee on the agency's evaluation of the cough and cold monograph to determine whether to impose more stringent limits on formulations allowed for use by children under age 6.

United States Consumer

Athlete's Foot Firm Kicks Back On NAD Finding That Brand Is A Fungal Claim

Kramer Laboratories' claims for Fungi-Nail athlete's foot product referred to FDA and FTC after it refuses to comply with NAD's recommendation to modify the name. The firm, which agreed to modify packaging and commercial claims, was warned by FDA about the brand in 2005.

Consumer Advertising, Marketing & Sales

Dentek Promotes Flossing With Rap Parody By YouTube Performers

Prestige Brands' Dentek oral care brand hires a family who are YouTube performers to promote its floss picks in a 30-second rap parody promoting a 30-day family floss challenge, which will invite consumers to post photos on Facebook, Instagram and Twitter.

United States Consumer
UsernamePublicRestriction

Register

Advertisement