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Food For Thought On US FDA Reforms

An independent review of the US FDA’s food regulatory programs could renew a debate over splitting FDA into two agencies. That could be a distraction for the agency in the coming year – but it could also help keep the medical product review groups out of the political hot seat.

FDA Leadership Politics

Europe’s Unified Patent Court Postpones Opening & Sunshine Period

Patent applicants are being given an extra two months to equip themselves with the tools they will need to use the UPC’s electronic case management system.

Intellectual Property Europe Regulation

Countries To Discuss Pandemic Treaty Next Year Amid Industry Concern

A World Health Organization negotiating body has agreed to develop a “zero draft” of the proposed pandemic treaty for discussion at a meeting of WHO member states in February next year. But the international pharmaceutical industry has reiterated its concerns about some of the proposals being put forward.

Coronavirus COVID-19 Regulation Manufacturing

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Pink Sheet Podcast

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

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Performance Trackers

Keeping Track: Rebyota, Rezlidhia Rev Up US FDA Approvals; New Sponsors Sought For Poziotinib, Brexafemme

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 – October 2022

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

New Zealand To Create New Regulator Under Therapeutic Product Reform Bill

After 10 years in the making, draft legislation for modernizing how medicines and medical devices are regulated in New Zealand has been introduced in parliament for debate.

New Zealand Legislation

Global Pharma Guidance Tracker – November 2022

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

FDA’s Win-Win: More Comprehensive IND Safety Reports With Minimal Effort Due To Harmonization

New proposed rule calls for replacing US FDA’s current annual reporting requirements for INDs with a safety update report that is consistent the format and content of the development safety update report (DSUR) supported by the International Council of Harmonisiation.

Clinical Trials Drug Safety

China Rhetoric Could Be Key To US FDA IT System Upgrade

FDA Commissioner Robert Califf says mentioning China helps increase congressional support.

Cybersecurity China

Finnish Biosimilar Substitution Proposals Get Pushback From Industry

Finnish government proposals to introduce pharmacy-level substitution for biosimilars have been criticized by the country’s generics and biosimilars industry association.

Biosimilars Regulation

Companies Planning UK Investment Cuts Over Repayments Predicted for 2023

Many pharma firms are considering cutting their investment in clinical trials or reducing their supply to the UK market next year, a survey by industry group EMIG found.

Europe United Kingdom

Latest From Policy

CMS Building Rx Price Negotiating Staff Internally; Contracting With Outside Groups ‘Not On Radar’

CMS head Brooks-LaSure says agency is making progress in staffing the drug pricing control programs established by the Inflation Reduction Act. Medicare Center deputy director Cheri Rice will be its acting director under just-unveiled management structure.

Medicare Leadership

As COVID Vaccine Market Goes Private, US Government Can Still Help Firms Boost Sales

Pfizer and Moderna’s ‘endemic’ COVID vaccine market scenarios anticipate much higher booster rates than have been achieved so far, but performance for 2023 may be aided by the Biden Administration campaign to increase shots this winter.

Coronavirus COVID-19 Reimbursement

Regeneron President Booed At Conference Over Comments Urging Focus On Innovation Before Access

Regeneron President George Yancopoulos got in a screaming match at Milken conference, arguing paying for cures is a secondary problem that should be tackled once such products are developed. He also talked about how he believes tech companies are helping to create some of America’s health crises.

Innovation Pricing Debate

Clinical / R&D Explore this Topic

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Latest From Research & Development

FDA’s Win-Win: More Comprehensive IND Safety Reports With Minimal Effort Due To Harmonization

New proposed rule calls for replacing US FDA’s current annual reporting requirements for INDs with a safety update report that is consistent the format and content of the development safety update report (DSUR) supported by the International Council of Harmonisiation.

Clinical Trials Drug Safety

Drug Repurposing: FDA IND Authority Lacks Levers To Better Direct Trial Resources In A Pandemic

Office of New Drug Director Peter Stein says there needs to be a better way to facilitate drug repurposing to avoid wasting time and resources on theories with little scientific probability of success.

Clinical Trials FDA

US FDA Oncology, Device Centers Developing Public Diagnostic Standards

Pilot program would get around the ‘one drug, one test’ policy, which has created intellectual property issues.

Cancer Diagnostics

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Latest From Commercial

As COVID Vaccine Market Goes Private, US Government Can Still Help Firms Boost Sales

Pfizer and Moderna’s ‘endemic’ COVID vaccine market scenarios anticipate much higher booster rates than have been achieved so far, but performance for 2023 may be aided by the Biden Administration campaign to increase shots this winter.

Coronavirus COVID-19 Reimbursement

Regeneron President Booed At Conference Over Comments Urging Focus On Innovation Before Access

Regeneron President George Yancopoulos got in a screaming match at Milken conference, arguing paying for cures is a secondary problem that should be tackled once such products are developed. He also talked about how he believes tech companies are helping to create some of America’s health crises.

Innovation Pricing Debate

Eisai Plots A Meticulous Path To Medicare Coverage For Lecanemab

Ivan Cheung, Eisai’s US CEO, explains the ‘question-by-question’ the company is taking to convince the Centers for Medicare and Medicaid Services that its Phase III Clarity AD results in Alzheimer’s offer the ‘high level of evidence’ needed for smooth reimbursement of lecanemab.

Reimbursement Medicare

Manufacturing Explore this Topic

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Latest From Manufacturing

Novel Vaccines Among Wide-Ranging EU Plans To Boost Health Threat Preparedness

Two documents published by the European Commission outline proposals to prepare for future health emergencies such as pandemics and the impact of antimicrobial resistance, with next-generation vaccines and novel or repurposed therapeutics high on the agenda.

Europe International

To Prevent Shortages, US FDA Wants Sponsor To Provide Notifications Of Demand Spike

Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.

Supply Chain Manufacturing

Pakistan Proposes Risk-Based Inspections Approach ‘Capable Of Revealing Weaknesses’

Regulators in Pakistan are consulting on draft rules that outline their plan to introduce a risk management approach to their inspection activities and the frequency at which manufacturers can expect to undergo an inspection.

Pakistan Manufacturing
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