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Featured Stories



An Orange Book By Any Other Name …

One of US FDA’s most important publications ever, the Orange Book celebrates 40 years as the definitive guide to approved drug products and therapeutic equivalents. Even as the color has receded from the book itself, orange still generates appreciation from regulators and outside attorneys.

Generic Drugs Legal Issues Regulation

Brexit: Life Science Firms In An ‘Impossible Position’

As negotiations between the UK and EU enter a crucial phase, the UK life sciences industry has called for more clarity and guidance on what companies can expect to face at the end of the Brexit transition period. 

United Kingdom Europe Brexit

Second-Guessing FDA? Sage Zulresso Denied Add-On Status In Medicare

Medicare’s doubts about trial design for Sage’s postpartum depression therapy suggests even ‘breakthrough’-designated products can struggle with the ‘substantial clinical improvement’ standard for NTAP status. Denial of enhanced payment for Zulresso ends a long winning streak by innovators.

Medicare Reimbursement Neurology

Spotlight On Coronavirus

Vaccine Advisory Cmte. Will Expose Wide Audience To Uncertainties of Drug Development

Meetings have long been touted as a tool to boost public confidence in COVID vaccines, but those looking for clean-cut answers may be unsettled to learn about the unknowns that come with all drug development, particularly that done at speed. Advisors are there to offer an ‘unvarnished’ view, committee member Paul Offit says in an interview with the Pink Sheet in advance of the the VBRAC’s 22 October meeting.

Coronavirus COVID-19 Advisory Committees

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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: Regeneron Ebola Antibody Cocktail Inmazeb Approved; Avenue Feels Pain From CRL; Scynexis Submits Oral Antifungal

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

Approvals Drug Approval Standards Complete Response Letters

Global Pharma Guidance Tracker – September 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 Australia Hong Kong

Policy & Regulation Explore this Topic

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Latest From Regulation

UK Confirms It Will Accept EU Marketing Authorizations For Two Years

New guidance from the UK covers the recognition of EU approvals, accelerated assessment, rolling reviews, and much else besides.

United Kingdom Approvals

EU Framework For Patient Preference Studies Under Review

An EU public-private collaborative project is seeking validation from regulators and health technology assessment bodies regarding its proposed best practice approach to conducting patient preference studies.

Europe Health Technology Assessment

EU Decision Thwarts Novartis's Near-Term Piqray Ambitions

Novartis seems to have accepted the fact that the indication granted for Piqray in the EU means there is little scope for the advanced breast cancer drug to be used in markets such as the UK.

United Kingdom Health Technology Assessment

Bumpy Japan Zolgensma Review Holds Lessons For Applicants

Product review report reveals multiple delays and missteps on route to market, holding valuable lessons for other gene therapy developers but also evidencing an ultimately welcoming environment.

Japan Gene Therapy

US FDA Drug Review Hiring Doing Well Despite Pandemic

CDER has ‘turned the corner’ on hiring during 2020, acting Director tells stakeholders – though the added workload from COVID-19 makes that hard to see.

Leadership FDA

How To Manage Pharmacovigilance Inspections In A Globalized World

As companies undergo pharmacovigilance inspections from a growing multitude of regulatory authorities from around the globe, a senior pharmaceutical industry executive discusses how her company has been handling this complex and challenging task.

International Drug Safety

Latest From Policy

Medicare’s Antibiotic Boost: Six Qualify For Add-On Payment

CMS final rule for hospital payment in 2021 includes enhanced payment for six novel antibiotics – including one that is not yet approved by FDA. New policies to encourage antibiotic innovation are clearly having an impact in the context of Medicare payments.

Medicare Infectious Diseases

Adolescents In COVID-19 Vaccine Trials: As Pfizer Starts Dosing, US FDA Encouraging Other Sponsors

But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.

Coronavirus COVID-19 Vaccines

Biden, Germany And Bringing A National Drug Pricing Negotiation Process To US

Germany uses government facilitated price negotiations between publicly funded insurers and manufacturers that are based on an independent assessment of how much added value a drug provides.

Pricing Debate Elections

Clinical / R&D Explore this Topic

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Latest From Research & Development

Where The COVID Vaccine Trials Stand: A Snapshot Of The Leaders And Rest Of The Field

With some studies about to finish and others on clinical hold, the coronavirus vaccine field approaches an inflection point as the US FDA prepares for its first advisory committee on the topic. Our charts and graphics offer a quick look at what stands where.

Clinical Trials Coronavirus COVID-19

COVID-19 Vaccine Sponsors Want US FDA To Find Alternatives For Control-Arm Data After First EUA

US FDA must rethink guidance on maintaining placebo-control in COVID-19 trials after any vaccine gets an EUA, companies say, arguing current proposal may not be ethical or feasible. Disease organizations who agree with the hurdles to preserving placebo-control maintain this is a reason why any EUA must meet a very high standard.

Coronavirus COVID-19 Advisory Committees

Commercial Explore this Topic

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Latest From Commercial

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

Webinar Recording: India Supply Chain Issues Against The Backdrop Of COVID-19

Join Anju Ghangurde and Vibha Ravi in this recorded session from Informa Pharma Intelligence's recent 24-hour webinar series on COVID-19: Lessons Learned And A Path Forward.

India Coronavirus COVID-19

Manufacturing Explore this Topic

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Latest From Manufacturing

The Golden Winged Warbler And Creating Pharma Supply Chain Immunity

Expert outlines how pharma can create resilient and secure supply chains and some benefits of localization.

Manufacturing Risk Management

US FDA Gives Wholesalers But Not Manufacturers More Time To Begin Verifying Saleable Returns

Wholesalers are given three more years to set up electronic systems to verify saleable returns under another reprieve from the FDA. Yet the reprieve does not extend to manufacturers, who must respond within 24 hours to wholesalers’ requests to manually verify that a returned product is not suspect.

Manufacturing Quality

For Emergency Use, US FDA May Visit Rather Than Inspect COVID-19 Vaccine Manufacturing Sites

Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.

Vaccines Quality
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