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Featured Stories


COVID-19 Vaccines: Ex-FDA Leaders Urge High Bar For Emergency Use Authorization

Eschewing the standard approval mechanisms for COVID-19 vaccines is likely only appropriate in very limited high-risk populations, unless clinical efficacy outcomes are available, former FDA leaders say.

Coronavirus COVID-19 Vaccines Review Pathway

Part B Drugs At Home: Medicare Policy Responds To COVID-Driven Access Concerns

Temporary policy may open door to longer term change as Medicare allows reimbursement of at-home administration of non-hospital drugs covered by Part B under a recently-released regulation aiding at encouraging telehealth during the coronavirus outbreak.

Reimbursement Medicare Coronavirus COVID-19

EMA Set To Discuss Safety Of Ranitidine Drugs Soon

Following the announcement in the US that ranitidine drugs must be withdrawn from the market, the European Medicines Agency told the Pink Sheet it would decide on the fate of these medicines in the EU after wrapping up its own inquiry.

Manufacturing Safety Regulation

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: Oncology Submissions From Blueprint, Y-mAbs, BMS/bluebird; Approvals For BMS’ Reblozyl, LFB’s SevenFact

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

EMA Issues Guidance On Compassionate Use Of Remdesivir For COVID-19

Recommendations from the European Medicines Agency explain the conditions under which early access to remdesivir could be given through compassionate use programs.

Coronavirus COVID-19 Regulation

Belgium Imposes Selective Export Ban As COVID-19 Threatens Stocks

A number of countries are resorting to extreme measures such as export bans to preserve stocks of medicines for the COVID-19 pandemic. Belgium is among the latest to impose an export prohibition, but might it fall foul of the EU’s export regulations? 

Belgium Coronavirus COVID-19

Individualized Therapeutics Could Get Boost From NIH Platform Gene Therapy Pilot

Experience and data from the study, which will use the same vector platform to deliver different transgenes for different diseases, could feed into the US FDA’s efforts to establish a public-private partnership to enable manufacturing of gene therapies for ultra-rare diseases.

Gene Therapy Regenerative Medicine

Pink Sheet Podcast: US FDA’s Chloroquine EUA And Coronavirus Treatment Accelerator, Novartis Receives No Penalty For Zolgensma Problems

Pink Sheet reporters and editors discuss the effects of the chloroquine emergency use authorization, FDA efforts to speed coronavirus treatment development, and the agency decision against penalizing Novartis over Zolgensma’s data integrity problems. 

Coronavirus COVID-19 Gene Therapy

Coronavirus Update: Supercomputing, Regulatory Flexibilities & Coordinating Supply Strategies

In addition to our daily in-depth coverage of key events relating to the COVID-19 pandemic, we’re bringing you a periodic round-up of other developments. This edition covers Europe and other countries.

Europe Asia Pacific

EU Pharma Urges Rethink On Knee-Jerk Trade Policies In Global COVID-19 Fight

EU drug industry federation, EFPIA, is concerned that an increase in protectionist trade measures by some countries could result in tit-for-tat policies that could hamper the global response to contain COVID-19.

Coronavirus COVID-19 Trade

Latest From Policy

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

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

Clinical / R&D Explore this Topic

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Latest From Research & Development

Coronavirus Update: Supercomputing, Regulatory Flexibilities & Coordinating Supply Strategies

In addition to our daily in-depth coverage of key events relating to the COVID-19 pandemic, we’re bringing you a periodic round-up of other developments. This edition covers Europe and other countries.

Europe Asia Pacific

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

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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

Set Alert for Manufacturing

Latest From Manufacturing

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

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
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