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Featured Stories



Oxford/AstraZeneca Vaccine Shows 70% Efficacy As Company Prepares Approval Filings

Topline results with AZD1222 have shown a lower efficacy rate than the Pfizer and Moderna vaccines, but a subgroup receiving a half-dose in their first injection showed a 90% efficacy result.

United Kingdom International Coronavirus COVID-19

US FDA’s Unapproved Drug Initiative Nixed, But Without Agency Buy-In Demise May Be Short-Lived

Trump administration effort to reduce drug prices by curtailing agency program requiring new approvals for some old products undermines FDA’s role in policing the safety of prescription drugs, experts say.

FDA Pricing Debate Drug Safety

An Oversupply Of COVID Antibody Treatments? Multiple Monoclonal Products Raise Potential For Errors

As distribution of Regeneron’s monoclonal antibody treatment for coronavirus begins, OWS officials worry about provider confusion with Lilly’s product due to differences in preparation and administration.

Coronavirus COVID-19 Safety Regulation

Spotlight On Coronavirus

Biden's COVID-19 Advisory Board Bodes Well For Science-Driven FDA

Two prominent former US FDA officials are a part of the president-elect’s new COVID-19 advisory board. Biden’s emphasis on scientific independence, including a commitment to publicly release vaccine trial data, could help restore public confidence in the agency and coming COVID-19 vaccines.

Coronavirus COVID-19 FDA

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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: Keytruda Adds TNBC Claim; Finerenone, Brincidofovir, HTX-011 Submitted; CRL For Supernus’ ADHD Drug

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

US FDA Performance Tracker Drug Review Approvals

Global Pharma Guidance Tracker – October 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

EU Clinical Trial Portal Requires Rethink On Balancing Business Interests & Transparency

In the first of a two-part article on transparency provisions for the new EU clinical trial portal, the Pink Sheet reports on aspects that sponsors must consider to protect commercially confidential information in their clinical trial applications. The second article will look at the approach taken by Merck and discuss outstanding hot topics in relation to transparency and CTIS.

Clinical Trials Regulation

Coronavirus Notebook: An Accidental Oxford Half Dose, And EU Finally Seals Moderna Vaccine Deal

EU and UK regulators are vying for vaccine filings, and the EMA will consider changing the terms of the marketing authorization for remdesivir after a WHO panel advised against its use in COVID-19. An Austrian biotech firm is investigating the prophylactic potential of a carrageenan-based spray.

Europe United Kingdom

Transparency On COVID Vaccine Clinical Holds Needed, Sharfstein Says; US FDA Advisory Cmtes Offer Venue

Former acting Commissioner Josh Sharfstein argues that while agency officials have done a commendable job in overall communication on COVID vaccine development, more information is needed on the clinical holds.

Advisory Committees Clinical Trials

Alzheimer’s Drug & Dermatitis JAK inhibitor Among New EU Filings

Pfizer’s abrocitinib and Biogen/Eisai’s aducanumab are among a host of new investigational products that are under review by the European Medicines Agency.

Europe Approvals

US FDA’s COVID Whirlwind: Pfizer Vaccine Adcom Set; Monoclonal EUAs Cleared; Trump Aggrieved

Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.

Coronavirus COVID-19 Approvals

Medicare Part D Drug Rebate Rule Finally Sees Light Of Day: Now What?

Assurances from HHS Secretary Azar that rule will not significantly raise premiums and federal spending amount to a request to ‘just trust me.’

Pricing Debate Regulation

Latest From Policy

COVID-19 Vaccines: ACIP’s Allocation Proposal Prioritizes Long-Term Care Residents, Essential Workers

First group to receive vaccine would comprise health care personnel and residents of long-term care facilities; next in line are non-health care essential workers, who would take priority over adults with high-risk medical conditions and those ages 65 years and older, according to the CDC advisory committee’s proposed allocation framework.

Advisory Committees Coronavirus COVID-19

Vaccine Distribution Priorities To Rely On Governors, Not ACIP, HHS Secretary Azar Says

Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated.

Coronavirus COVID-19 Vaccines

Innovation-Friendly? Cases Indicate How Far China's Willing To Protect Patents

Increasingly looking to China to commercialize their latest therapies, multinationals may be leaping into unknown waters to navigate an intellectual property judiciary and administrative maze, in a country where some copy drugs have been approved before patent expiry. With a government trying to balance innovation and access, two recent rulings involving AstraZeneca shed rare light onto China’s protections for innovation, with advisors pointing to challenges and success factors.

China Intellectual Property

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Latest From Research & Development

Trump’s Big Bet On COVID-19 Vaccines May Have Shortchanged Therapeutics. Should Biden Rectify The Difference?

Incoming US President may be wise to up government investment in COVID-19 therapeutics, including both research and manufacturing, experts say. Additional government funding should target a larger variety of treatment types and prioritize better study designs.

Coronavirus COVID-19 Elections

New EMA Head To Bolster Regulatory Collaboration In The EU & Beyond

Strengthening regulatory partnerships and being ready to support the translation of disruptive innovations into the treatments of tomorrow are on the to-do list of incoming European Medicines Agency chief Emer Cooke.

Europe Regulation

Coronavirus Notebook: MHRA Begins Rolling Review Of Moderna Vaccine, Sanofi/GSK Hook Up To COVAX

Russia seeks WHO endorsement of its Sputnik V vaccine, a UK BioIndustry Association taskforce identifies potential new antibody cocktails, and the European Centre for Disease Prevention and Control considers the best strategies for targeted vaccination programs.

Europe United Kingdom

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Latest From Commercial

Lilly's US Bamlanivimab Contract Raises Difficult Allocation Considerations

The price of the antibody monotherapy for COVID-19 will be $1,250 per vial for wealthy countries. CEO David Ricks outlined the company's guidelines for pricing and distributing a limited supply.

Coronavirus COVID-19 Pricing Debate

Gilead’s Immunomedics Buy: Five Things To Worry About

Acquisition is based on the prospects for Immunomedics’ Trodelvy, but regulatory changes, manufacturing challenges, and research dynamics could upset even the best-laid plans.

Clinical Trials Commercial

Novavax Push For COVID-19 Vaccine Manufacturing Capacity Delays Flu Vaccine Application

As CEO Erck touts that its COVID vaccine has the 'best data,' Novavax prepares to enter Phase III trials and inks deal with Serum Institute to boost production even as its 'almost a perfect flu vaccine' remains on hold.

Vaccines Manufacturing

Manufacturing Explore this Topic

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Latest From Manufacturing

Vaccine Distribution Priorities To Rely On Governors, Not ACIP, HHS Secretary Azar Says

Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated.

Coronavirus COVID-19 Vaccines

Manufacturers Want Delay In Conducting US Nitrosamine Risk Assessments

Perrigo, Pfizer want the US FDA to postpone its March 1 deadline for conducting nitrosamine risk assessments. Generics exec cites“serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.

Manufacturing Quality

COVID-19 Prompts WHO To Propose Revisions To GMPs For Investigational Drugs Guideline

Accelerated development of COVID-19 products prompts World Health Organization to revise a guideline on good manufacturing practices for investigational drugs and propose a new guideline applying GMP principles to R&D facilities.

Manufacturing Quality
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