Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Featured Stories



The TRIPS Trap: Industry’s Delicate Challenge Responding To Waiver Push

Biopharma companies are understandably upset by the Biden Administration’s decision to support a waiver of intellectual property protections on COVID vaccines. But over-reacting may only make matters worse.

Intellectual Property Policy Politics

Real World Data In Drug Marketing Applications: Drivers For Success

A study examining 27 drug marketing applications that contained real world data and an idea on how to make it easier for companies to understand which RWD to use were discussed this week at the RAPS EURO Convergence 2021 conference.

Real-World Evidence International Approvals

New Medicare Payment Models Should Not Be All About Saving Money, CMMI’s Fowler Says

CMS’s Innovation director Elizabeth Fowler wants to ‘reignite’ momentum behind health care system transformation. What does that mean for biopharma?

Pricing Debate Medicare Reimbursement

Spotlight On Coronavirus

Read More...

Latest News

Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

More Podcasts
 

 

Click to read Six Themes That Will Shape Biopharma In Transformational 2021

Key Predictions From Industry Leaders

 

 

 

Performance Trackers

Keeping Track: First COVID Vaccine BLA Kicks Off; Oncology Submissions From Hutchmed, Takeda And Shorla

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

US FDA Performance Tracker Approvals Complete Response Letters

Global Pharma Guidance Tracker – March 2021

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

Set Alert for Policy & Regulation

Latest From Regulation

Pink Sheet Podcast: COVID Vaccine In Kids, CMS Drug Pricing Moves, Standard Care In Clinical Trials

Pink Sheet reporters and editors discuss the US FDA decision to lower the eligibility age for the Pfizer/BioNTech COVID-19 vaccine, CMS drug pricing project plans, and mid-stream standard of care changes in drug development.

Coronavirus COVID-19 Pricing Debate

J&J Vaccine: Some CDC Advisors Question Warning’s Strength As Clot Reports Grow, Female Use Drops

Some ACIP members argued woman older than 50 should also be singled out in warning for Johnson & Johnson’s COIVD-19 vaccine and said that people need to be more clearly told they can get alternative vaccines that don’t have this risk.

Coronavirus COVID-19 Vaccines

Patient-Reported Outcomes In Pediatric Cancer Trials Endorsed By US FDA Advisory Committee

Incorporation of the Ped-PRO-CTCAE instrument would help inform short-term tolerability and long-term effects of treatment, particularly newer immunotherapy agents, but there are logistical and operational challenges to overcome, advisory committee members said.

Pediatrics Clinical Trials

Sponsors Fail To Win US FDA Endorsement For Trimming Trials During Pandemic

Agency more interested in switching to remote methods or imputing data than reducing sample size or duration of cell/gene therapy trials, official tells ASGCT.

Clinical Trials Coronavirus COVID-19

Coronavirus Notebook: EMA Hones In On COVID-19 Activities, Russia’s Sputnik V launches in India

A new study shows that the immune response to Pfizer/BioNTech’s Comirnaty in elderly people is 3.5-fold greater when the second dose is given after 12 weeks rather than three. The WHO has OKd the emergency use of a Chinese vaccine.

Europe International

UK Pioneers Tailored Biosimilars Pathway With Fresh Guidance

Updated guidance on the UK’s new licensing pathway for biosimilars – which will typically not require comparative efficacy data – has been published by the MHRA after a stakeholder consultation. It has been warmly welcomed by the off-patent industry both locally and internationally.

Biosimilars Review Pathway

Latest From Policy

No To Five, Yes To Three: NICE Decides On Funding For Drugs In England

Pfizer has been unsuccessful in its appeal against the health technology assessment body’s rejection of the rare heart disease drug, Vyndaqel. Meanwhile, Dr Falk Pharma has received the all-clear to make Jorveza (budesonide) available on the National Health Service for eosinophilic esophagitis.

Health Technology Assessment United Kingdom

CDC Advisors Like Pfizer’s COVID Vaccine For Adolescents But Are Less Sure Of Coadministration

Without giving ACIP a chance to vote on the change or providing additional data, CDC announces new guidance allowing coadministration of COVID-19 vaccines with other immunizations. Needless to say, the decision raised a few eyebrows.

Vaccines Safety

Speed Bumps Ahead For IP Waiver, But Will It Nudge Voluntary Licensing?

IP experts share views on a range of critical issues around the proposed US-backed patent waiver for COVID-19 vaccines. Proprietary materials once public can’t be pulled back, one cautioned, while others indicated the waiver risk may be the stick that pushes companies to toe the tech transfer line.

Coronavirus COVID-19 Vaccines

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

US FDA Preparing For Potential Bolus Of Complex Generic Applications

Increasing number of product development meetings suggests that many complex generics remain in the development stages.

Generic Drugs Research & Development

EU Seeks Suggestions On How To Improve Pediatric & Orphan Drugs Legislation

Companies wanting to get involved in long-running plans to overhaul the EU orphan drugs and pediatric medicine legislation can make their contribution through a public consultation that began on 10 May.

Europe Legislation

Advicenne Hastens EU Approval For Sibnayal By Withdrawing Orphan Designation

 Advicenne withdrew its orphan drug designation application for Sibnayal over concerns that a key study was not designed to compare the product to standard of care.

Europe Rare Diseases

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

Pfizer’s Outlier Quarter, At Both Extremes

Investors are trying to wrap their minds around exactly how big Pfizer’s COVID vaccine business will end up being. But they also have questions about Pfizer’s prospects at the opposite end of the patient-population spectrum.

FDA Gene Therapy

US Gov't Plans To Control COVID Vaccine Distribution At Least Through 2022; Already Authorized Products Have Booster Advantage

Due to need to plan for potential vaccine boosters now, administration is focusing on contracting with the companies whose shots are already being given in the US, David Kessler tells the Senate health committee. Data on whether it is ok to ‘mix and match’ vaccine types with boosters should be available in a few months.

Coronavirus COVID-19 Vaccines

Bladder Cancer Accelerated Approvals: Merck’s Keytruda and Genentech’s Tecentriq Each May Have One Last Lifeline

US FDA will ask advisory committee whether data from the trial supporting full approval of Merck’s Keytruda for second-line setting can be used to confirm clinical benefits for earlier setting of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy following a failed confirmatory study. Genentech’s Tecentriq is also at risk of losing its accelerated approval in that space but it could buy some time as its confirmatory study is not yet complete. New competitor entrant since accelerated approvals also lessens degree of unmet need.

Advisory Committees Cancer

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

US FDA’s Drug Shortage Program On ‘Site Engagement’ To Be Nixed In GDUFA III

Generics industry and FDA also debated inspection policies in lieu of travel and safety restrictions mandated by the pandemic.

Generic Drugs User Fees

US Gov't Plans To Control COVID Vaccine Distribution At Least Through 2022; Already Authorized Products Have Booster Advantage

Due to need to plan for potential vaccine boosters now, administration is focusing on contracting with the companies whose shots are already being given in the US, David Kessler tells the Senate health committee. Data on whether it is ok to ‘mix and match’ vaccine types with boosters should be available in a few months.

Coronavirus COVID-19 Vaccines

Pink Sheet Podcast: COVID-19 Vaccine IP Waivers, Pandemic Delayed Inspections, CAR-T Reimbursement

Pink Sheet reporters and editors discuss the potential for the US and other governments to waive IP protections for COVID-19 vaccines, the FDA’s inspection backlog during the pandemic, and potential reimbursement changes for CAR-T therapies.

Coronavirus COVID-19 Intellectual Property
UsernamePublicRestriction

Register