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Featured Stories


COVID-19 Partnerships Without Formal Contracts Pose Risks, From Potential Liability To IP Issues

Companies are racing to co-develop coronavirus treatments before finalizing deal teams. These team-ups raise questions about what happens after the pandemic subsides.

Coronavirus COVID-19 Deals Research and Development Strategies

US FDA User Fee Renewals Remain On Schedule Despite Coronavirus

Virtual kick-off meetings may be necessary, but preparations continue in anticipation of the formal talks to reauthorize the prescription drug, generic drug and biosimilar user fee programs.

User Fees Drug Review Coronavirus COVID-19

Why The US FDA Requested Ranitidine Withdrawal; How Other Withdrawals Could Follow

Agency worried what might happen beyond expiry or room temperature to generate carcinogenic impurities in ranitidine; will guide assessment of nitrosamine risks in other drugs.

Compliance Manufacturing Quality

Latest News

Coronavirus 2019-nCov novel coronavirus concept resposible for asian flu outbreak and coronaviruses influenza as dangerous flu strain cases as a pandemic 3d rendering

COVID-19 Pipeline Tracker

Product candidates in development worldwide to address the 2019-nCoV pandemic, categorized by treatment and prevention. Subscription required.

View Tracker

Performance Trackers

Keeping Track: US FDA Okays BMS’ Zeposia In MS, Nixes Lilly/BI’s Empagliflozin For Type 1 Diabetes

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.

US FDA Performance Tracker Approvals Drug Review

Global Pharma Guidance Tracker – February 2020

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.

Guidance Documents Regulation International

Policy & Regulation Explore this Topic

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Latest From Regulation

AbbVie Brings In Non-EU Kaletra To Bolster Dwindling French Supplies

The US company is bringing extra supplies of lopinavir/ritonavir into France but stresses that the combination treatment is not authorized for treating patients with the coronavirus.

France Distribution

Neurology At The Forefront Of US FDA Complex Innovative Trial Design Pilot

Wave’s Duchenne muscular dystrophy drug and Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.

Clinical Trials Neurology

US FDA And Sponsors Resolve Disclosure Issues On Complex Trial Design Pilot Projects

Agency officials can now discuss the ideas that have been accepted, though not in great detail.

Clinical Trials Research and Development Strategies

US FDA Exploring Virtual Advisory Cmtes.; Might Sponsors Want To Wait For In-Person Meetings?

Likelihood of webcast-only advisory committee meetings may depend on the extent of the coronavirus outbreak, Office of New Drugs Director Peter Stein tells the Pink Sheet in an interview.

Coronavirus COVID-19 Advisory Committees

Chloroquine ‘Approval’ For COVID-19 And The US FDA’s New Reality

Asking whether FDA’s decision to allow emergency use of two old anti-malarial drugs was ‘political’ misses the point. The issue already was political, and FDA’s action may well be the best way to keep some measure of federal control on supplies of a drug with important other uses.

Coronavirus COVID-19 Leadership

UK MHRA Finds Labs Releasing Unreliable Data Due To Pressure From Pharma

A UK regulator with the MHRA is concerned that bioanalytical laboratories are not being given enough time to do their job properly by drug companies under pressure to ensure their clinical trials remain on schedule. 

Clinical Trials Safety

Latest From Policy

Biopharma, Payers Seek National Guidelines For Prescribing Potential COVID-19 Drugs

Guidelines for US health care providers could help prevent shortages as demand for possible treatments surge, groups say. Stakeholders also argue “Buy America” executive order would hamper drug access.

Coronavirus COVID-19 Market Access

Amarin's Vascepa May Face Generic Competition In US Next Year After Patents Ruled Invalid

Amarin had argued that Vascepa’s sales success showed that its patents were not obvious, but the court found otherwise, even as it concluded that Hikma, Dr. Reddy's and West-Ward has infringed on the fish oil pill's patents.

Legal Issues Intellectual Property

J&J Ramps Up Manufacturing Capacity To Produce 1 Billion Doses Of Candidate COVID-19 Vaccine

Company expects clinical trials to begin by September and says first batches could be available for emergency use authorization in early 2021; J&J pledges vaccine will be available to public on not-for-profit basis.

Coronavirus COVID-19 Vaccines

Clinical / R&D Explore this Topic

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Latest From Research & Development

Neurology At The Forefront Of US FDA Complex Innovative Trial Design Pilot

Wave’s Duchenne muscular dystrophy drug and Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.

Clinical Trials Neurology

Gottlieb’s Rx For Coronavirus

Study everything together and a scale-up manufacturing after preliminary efficacy results, former FDA commissioners Gottlieb and McClellan and their coauthors recommend in a pair of white papers on how the US should respond to the coronavirus pandemic.

Coronavirus COVID-19 Clinical Trials

J&J Ramps Up Manufacturing Capacity To Produce 1 Billion Doses Of Candidate COVID-19 Vaccine

Company expects clinical trials to begin by September and says first batches could be available for emergency use authorization in early 2021; J&J pledges vaccine will be available to public on not-for-profit basis.

Coronavirus COVID-19 Vaccines

Commercial Explore this Topic

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Latest From Commercial

Biopharma, Payers Seek National Guidelines For Prescribing Potential COVID-19 Drugs

Guidelines for US health care providers could help prevent shortages as demand for possible treatments surge, groups say. Stakeholders also argue “Buy America” executive order would hamper drug access.

Coronavirus COVID-19 Market Access

Amarin's Vascepa May Face Generic Competition In US Next Year After Patents Ruled Invalid

Amarin had argued that Vascepa’s sales success showed that its patents were not obvious, but the court found otherwise, even as it concluded that Hikma, Dr. Reddy's and West-Ward has infringed on the fish oil pill's patents.

Legal Issues Intellectual Property

TV Drug Advertising Spend Rising, But Few Brands Provide Pricing Info

DTC spending had shown an uptick in 2020 compared with 2019. Many advertisers are not, however, providing clear drug pricing information in their TV spots, despite some voluntary commitments to do so.

Advertising, Marketing & Sales Ad Campaigns

Manufacturing Explore this Topic

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Latest From Manufacturing

UK MHRA Relaxes GMP Rules For Drugs Imported From Third Countries During COVID-19 Outbreak

The regulatory agency also urges qualified persons at drug companies to let the agency know as soon as possible if they are finding that the new measures are not flexible enough to deal with the current logistical challenges quickly.

Quality United Kingdom

Gottlieb’s Rx For Coronavirus

Study everything together and a scale-up manufacturing after preliminary efficacy results, former FDA commissioners Gottlieb and McClellan and their coauthors recommend in a pair of white papers on how the US should respond to the coronavirus pandemic.

Coronavirus COVID-19 Clinical Trials

US FDA Allows Outsourcers To Compound Hydroxychloroquine As COVID-19 Drives Demand

The US FDA has added hydroxychloroquine sulfate to the list of drugs outsourcing facilities can compound as pharmacy group calls for more such approvals with COVID-19 driving demand for additional prescription and over-the-counter drugs.

BioPharmaceutical Manufacturing
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