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Policy & Regulation

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EMA Updates Board On Business Continuity And Coronavirus

The European Medicines Agency’s first management board meeting of 2020 was held virtually and was shortened but covered a number of topics including COVID-19.

Europe Regulation Coronavirus COVID-19

Regulation

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Latest From Regulation

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

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dystrophy drug and Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.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

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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

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

Biopharma COVID-19 Collaborations May Avoid Antitrust Hurdles, FTC And DOJ Suggest

FTC and DoJ issue guidance for businesses working together to tackle coronavirus pandemic; BIO is 'pleased' they intend to help facilitate critical partnerships.

Coronavirus COVID-19 Enforcement

US FDA Commissioner Hahn’s Star Turn: Baptism By Fire Turns Perilous

Stephen Hahn’s low visibility period as the newly installed FDA commissioner comes to an abrupt end. Trump offers generous praise amid COVID-19 response – but how quickly might that change to blame?

Coronavirus COVID-19 Leadership
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