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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 Distribution

UK Steps Up Search For Vaccines Against ‘Variants Of Concern’

As the World Health Organization brands the Indian virus a “variant of concern,” the UK is planning to use a lab-grown virus variant in challenge trials of current and new vaccines, and is also investing in new variant vaccine testing facilities. A new study will use Oxford Immunotec’s T cell test to monitor people’s immunological response to infection or vaccination.

United Kingdom Europe Coronavirus COVID-19

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 Regulation

Spotlight On Coronavirus

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Pink Sheet Podcast

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

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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

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Latest From Regulation

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

‘Imminent’ Generic Approvals Expected Help US FDA Meet On-Time Review Metric Retroactively

ANDA action rate dipped below the 90% mandate in second fiscal quarter, another illustration of the effect the pandemic and other issues have on US FDA’s generic drug assessment system.

Review Pathway Coronavirus COVID-19

PTC Therapeutics' Gene Therapy Plans Hit By Pandemic

PTC Therapeutics is one of many companies in the life sciences sector whose regulatory targets have been adversely affected by the coronavirus pandemic.

Europe Gene Therapy

EU Launches Faster Process For Approving Variant Vaccines

Amid the growing threat posed by variants of the coronavirus, the European Commission has published new rules allowing modified vaccines to be approved more quickly. The UK has identified one version of the B.1.167 virus variant as the most transmissible, although the jury is still out on its ability to evade vaccine protection.

Europe International

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

Changing Standards Of Care Trip Up Companies At US FDA Advisory Committees

Following a memorable cancer drug advisory panel meeting where FDA explained how accelerated approvals may be more at risk due to changing standard of care, ChemoCentryx’s ANCA-vasculitis treatment runs into trouble because of another drug’s changing indication during their Phase III study.

Advisory Committees Clinical Trials

Latest From Policy

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

Senate Finance Panel’s New Legislative Staffer Kaltenboeck Likes QALYs For Valuing Drugs

Anna Kaltenboeck joins the committee from Memorial Sloan Kettering’s health policy group, which has been an active participant in US drug pricing reform policy development and a critic of the biopharma industry, often through public commentary by its director, Peter Bach.

Pricing Debate Legislation

In Moving Tribute, Former Roche CMO Sandra Horning Is Honored As HBA’s Woman Of the Year

Horning describes challenges of moving from tenured professor to industry executive in accepting the award from the Healthcare Businesswomen’s Association. She is recognized for her ‘epic tenacity’ in advancing medicines and commitment to patients. Pfizer’s Rod MacKenzie receives honorable mentor award.

Leadership Business Strategies

Clinical / R&D Explore this Topic

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Latest From Research & Development

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

In Moving Tribute, Former Roche CMO Sandra Horning Is Honored As HBA’s Woman Of the Year

Horning describes challenges of moving from tenured professor to industry executive in accepting the award from the Healthcare Businesswomen’s Association. She is recognized for her ‘epic tenacity’ in advancing medicines and commitment to patients. Pfizer’s Rod MacKenzie receives honorable mentor award.

Leadership Business Strategies

Shanghai Seizes Cell Samples As China Tightens Biosecurity Enforcement

Authorities in China appear to be taking a tough early stance in the enforcement of a new national Biosecurity Law that took effect in mid-April, with an imported human cell shipment in Shanghai being seized. 

Legislation Research & Development

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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

With New Rare Blood Clot Warning, J&J COVID-19 Vaccine Rollout Resumes In EU

Similarities to AstraZeneca blood clots are clear, but more research needed before any ‘class effect’ conclusions can be drawn.

Commercial Companies

Lower Reimbursement For Accelerated Approval Drugs May Get Push From ICER

ICER President Steve Pearson expresses interest in setting drug costs for accelerated approval drugs low with price increases based on confirmatory evidence ahead of upcoming white paper from the group.

Pricing Debate Cost Effectiveness

Manufacturing Explore this Topic

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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

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

EU Reveals Plan To Speed Development Of New COVID-19 Therapies

Regulatory flexibilities such as rolling review, conditional marketing authorizations and possibly an EU emergency use authorization will play a key part in the EU’s plans to identify and approve promising new coronavirus treatments.

Europe Coronavirus COVID-19
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