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Pfizer/BioNTech’s COVID-19 Vaccine Moves Into Adolescents; Adcomm To Weigh Broader Pediatric Issues

Emergency use authorization in 12-15 year-olds follows announcement of a June advisory committee meeting on pediatric data requirements, including the FDA’s criteria for younger children. Authorization for US adolescents has raised ethical questions about prioritizing this lower-risk group over hard-hit populations overseas.

Coronavirus COVID-19 Vaccines Review Pathway

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 China

Product Accepted Twice On PRIME Marks A First For EMA

Vertex and CRISPR can now get access to the advantages afforded by the European Medicines Agency’s priority medicines scheme for both of the indications they are targeting with their investigational gene therapy, CTX001.

Regulation Europe Market Access

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

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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

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

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

COVID-19 Vaccine Regulatory Strategy Evolving With The Pandemic

AstraZeneca and Novavax have not filed EUAs for their vaccines, and they never might. The pathway remains viable in the short-term, but as BLAs are approved and supplies are no longer short, the window may close.

Coronavirus COVID-19 Vaccines

Coronavirus Notebook: EMA Reviews Safety Of All Four Approved Vaccines, EU Buys Big On Comirnaty

Calls grow for a relaxation of IP on COVID-19 vaccines as interest groups pile the pressure on the UK government and the Pope gives his blessing to the proposed waiver.

Europe United Kingdom

Pediatric Cancer Trials: US FDA Panel To Weigh Use Of Real-World Data, Patient-Reported Outcomes

Advisory committee will discuss ways to encourage inclusion of the Pediatric PRO-CTCAE tool in cancer trials on 11 May, followed the next day by a discussion on real-world data sources that could inform the efficacy and long-term safety of pediatric cancer treatments.

Advisory Committees Pediatrics

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

Latest From Policy

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

Fixed Combinations Of ‘Old Antibiotic’ Plus New Moiety Eligible For NCE Exclusivity, US FDA Says

A 2008 law that limited exclusivity for certain antibiotics to three years does not apply to Allergan’s Avycaz, which combines an approved old antibiotic active moiety and a new active moiety, CDER exclusivity board concludes.

Intellectual Property Legal Issues

Medicare More Than Doubles Payment Rate For COVID Monoclonal Antibody Administration At Home

Regeneron and Eli Lilly have seen limited uptake for their COVID treatments; CMS payment increase addresses concerns that inadequate reimbursement has hampered use of the monoclonal antibody drugs.

Medicare Reimbursement

Clinical / R&D Explore this Topic

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Latest From Research & Development

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

Pfizer DMD Gene Therapy Phase III Trial Stalled In US After FDA Questions On Potency Assays

Pfizer disclosed that a Phase III trial for the gene therapy has been unable to start in the US because of questions from the FDA, even while enrollment in 15 sites outside the US is under way.

Gene Therapy Drug Approval Standards

ChemoCentryx’s Avacopan May Need Another Trial After Tepid Advisory Committee Vote

Near tie goes to the US FDA? While almost every member of the Arthritis Advisory Committee agreed with agency’s assessment that ChemoCentryx’s trial of avacopan for ANCA vasculitis was poorly designed, making it hard to tease out the drug’s benefit-risk profile, about half were in favor of approval due to the potential to spare patients from the adverse effects of steroids. Others said the sponsor didn’t meet the agency’s standard for approval off just one pivotal study.

Advisory Committees Rare Diseases

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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

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Latest From Manufacturing

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

Pressure Mounts On EU To Follow US In Backing COVID-19 Vaccine IP Waiver

The pharmaceutical industry in Europe has attacked the US decision to come out in support of a relaxation of IP rights that is designed to boost global production of COVID-19 vaccines. But the move by the Biden administration could well cause other countries to rethink their opposition to the move.

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