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COVID-19: WHO Supports Pooling Of Rights, MPP Includes Drugs and Tests

Intellectual property rights are in the spotlight again, after the World Health Organization and the Medicines Patent Pool announced initiatives to help ensure that all countries will be able to access products being developed for COVID-19.

International Coronavirus COVID-19 Intellectual Property

COVID-19 Economic Fallout May Delay Cell And Gene Therapy Reimbursement Solutions

The economic stress on payers caused by the pandemic will cause a setback in the development of payment approaches for regenerative therapy, Blue Cross Blue Shield executive warns.

Reimbursement Coronavirus COVID-19 Gene Therapy

Vaccine Experts Inject Realism Into US Gov't's COVID-19 Timeline

The Trump administration says a COVID-19 vaccine could be available in as little as 12 months, but most experts think that is overpromising unless safety or efficacy standards are sacrificed. Many are urging pivotal studies that look at clinical outcomes, not surrogates, for US FDA approval. 

Coronavirus COVID-19 Vaccines Clinical Trials

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.

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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

Global Pharma Guidance Tracker – March 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.

International Europe

France Moves To Bolster Drug Supplies Hit By COVID-19

France has announced a number of emergency measures to protect drug supplies threatened by the spread of the coronavirus.

France Coronavirus COVID-19

Coronavirus Notebook: US FDA's Paper Push, Industry Execs/US Officials Emphasize Their Collaboration

Dispatches from a world turned upside down include the US FDA expressing confidence in Chinese manufacturers – to make their GDUFA payments; projections of drug shortages for ventilator patients; and the launch of new hydroxychloroquine studies.

Coronavirus COVID-19 FDA

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

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

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

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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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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

France Moves To Bolster Drug Supplies Hit By COVID-19

France has announced a number of emergency measures to protect drug supplies threatened by the spread of the coronavirus.

France Coronavirus COVID-19

Coronavirus Notebook: US FDA's Paper Push, Industry Execs/US Officials Emphasize Their Collaboration

Dispatches from a world turned upside down include the US FDA expressing confidence in Chinese manufacturers – to make their GDUFA payments; projections of drug shortages for ventilator patients; and the launch of new hydroxychloroquine studies.

Coronavirus COVID-19 FDA

US FDA Requests Frequent Updates On Supply Chain Disruptions In COVID-19 Era

Pharmaceutical companies struggling to keep up with coronavirus-related supply chain havoc asked to keep the US regulator informed as situation unfolds.

Manufacturing Quality
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