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COVID Vaccines: Is Expanded Access A Better Option Than Emergency Use Authorization?

Given concerns about completing Phase III trials, advisory committee member asks whether US FDA has considered ‘the possibility of an expanded access protocol,’ but agency official points to added complexity that comes with the pathway; bioethics experts talk to the Pink Sheet about pros and cons of expanded access vs. EUA pathways.

Coronavirus COVID-19 Vaccines Advisory Committees

Tom Abrams’ Steady Leadership Guided US FDA Through Dramatic Changes In Rx Promotion

From the rise of DTC to the shadow of Caronia, Abrams, the long-time head of the Office of Prescription Drug Promotion, monitored dramatic changes in the pharmaceutical marketplace and regulatory environment. He retired from FDA on 23 October after a tenure marked as much by careful research projects and copious guidances as it was by promotional and legal upheavals.

Advertising, Marketing & Sales Leadership FDA

The Future Of Purdue: Will The ‘Public Benefit Corporation’ Model Take Off?

Purdue’s opioid settlement is making headlines for the size of the financial penalty. But the plan to re-imagine Purdue as a public benefit company could have far-reaching significance for the industry – if it ever gets off the ground.

Pricing Debate Legal Issues 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.

View Tracker

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 NICE Advice On Patient Preference Studies Draws High Enthusiasm, Low Uptake

More than a year after the UK health technology assessment body NICE started offering scientific advice on designing patient preference studies, only two companies have sought guidance on this front. The HTA body has also contributed to related projects that it hopes will increase the relevance of such studies in the context of a NICE appraisal.

United Kingdom Health Technology Assessment

Access And Affordability Are Key, Says New EMA Head

Ensuring patients have access to approved medicines is a key priority for Emer Cooke, the soon-to-be new head of the European Medicines Agency. Cooke says she will probably be a very different type of “captain” of the “wonderful ship” that is the EMA.

Market Access Europe

PDUFA VII: US FDA Wants Dedicated RMAT Program Funding

Cell and gene therapy product activities also have increased CBER’s workload significantly and strained staff, the agency tells industry representatives.

User Fees Gene Therapy

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

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

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

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

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

Access And Affordability Are Key, Says New EMA Head

Ensuring patients have access to approved medicines is a key priority for Emer Cooke, the soon-to-be new head of the European Medicines Agency. Cooke says she will probably be a very different type of “captain” of the “wonderful ship” that is the EMA.

Market Access Europe

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
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