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

Featured Stories



FTC And PBMs: Support For Investigation Building But Outcome May Ultimately Disappoint Critics

Federal Trade Commission’s ‘pro-competitive’ perspective could support conclusion that pharmacy benefit managers serve useful role in lowering drug costs, health policy expert suggests. FTC will get an earful about PBM practices, but ‘those complaints could be an indication that competition is working.’

Reimbursement Market Access M & A

PK Evaluation In Pregnancy: Can HIV Show A Way Forward?

US FDA workshop on efforts to advance pharmacokinetic data collection in pregnant women highlights the (slow-moving) antiretroviral experience, but COVID therapies show that regulatory receptiveness is a poor match for recruitment and liability concerns.

Regulation Research & Development Gynecology & Urology

At Solicitor General’s Urging, Supreme Court May Take Up Patent Eligibility Dispute Riling Biopharma

Federal Circuit’s rulings on subject matter patent eligibility have fractured the court, the US government says in advising the high court to review American Axle v. Neapco to provide clarity. BIO, former PTO director Kappos and Sen. Tillis also urge Supreme Court to hear the case.

Intellectual Property Legal Issues Policy

Pink Sheet Podcast

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

More Podcasts

Performance Trackers

Keeping Track: Lilly’s Mounjaro Enters Diabetes Market; Biogen/Eisai Lecanemab Leads Neuroscience News

CDER turned in its 13th novel approval of 2022 on Friday the 13th, and other drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals Drug Review


Global Pharma Guidance Tracker – April 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

Set Alert for Policy & Regulation

Latest From Regulation

UK Prepares To Vaccinate Against Monkeypox

The UK Health Security Agency says it took a number of factors into account when deciding to use Bavarian Nordic’s smallpox vaccine Imvanex, including high European manufacturing standards, the US approval for monkeypox, and the lack of an alternative UK-licensed vaccine.

Europe United Kingdom

Global Pandemic Treaty: Working Draft To Be Discussed In July

The World Health Organization’s plan to have a global pandemic treaty in place by 2024 is drawing a lot of attention as work continues to produce a working draft by the middle of the year.

Coronavirus COVID-19 Market Access

WHO Member States Agree To Strengthen Global Clinical Trial Ecosystem

World Health Assembly delegates have given the thumbs up to a resolution that draws on lessons learnt during the COVID-19 pandemic to improve global coordination on how clinical trials are designed, evaluated and reported.

International Clinical Trials

EU Tracking CTR Impact On Clinical Trials Environment

The European medicines regulatory network has started publishing monthly metrics to offer insight into how the Clinical Trial Regulation is affecting the EU research space.

Europe Clinical Trials

EU CHMP Opinions and MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Drug Review Europe

Are Trial Sponsors Treading On Investigators’ Toes In Decentralized Trials?

The Danish regulator’s experience with reviewing and inspecting decentralized elements in clinical trials highlights concerns around the blurring of lines that divide the roles and responsibilities of sponsors and trial investigators.

Denmark Clinical Trials

Latest From Policy

MSD Removes ‘Key Barrier’ To English Funding For Keytruda In Triple-Negative Breast Cancer

MSD has agreed to restrict the use of its Keytruda combination therapy in a manner that means that Roche’s Tecentriq combination is no longer a direct comparator.

Cost Effectiveness Reimbursement

Inter-Agency User Fees? US FDA/ARPA-H Relationship Could Get Interesting

The Biden Administration’s signature health research agency ARPA-H is still in the formative stages. Authorizing legislation moving through Congress could set up a very interesting dynamic when it comes to working with the US FDA.

FDA Research & Development

Ukraine War Could Spur Changes In The Clinical Trial Paradigm

Decentralized trials are way to help displaced Ukrainians remain in studies and could encourage greater participation from individuals in other countries, those overseeing sites in Ukraine say.

Clinical Trials Policy

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Inter-Agency User Fees? US FDA/ARPA-H Relationship Could Get Interesting

The Biden Administration’s signature health research agency ARPA-H is still in the formative stages. Authorizing legislation moving through Congress could set up a very interesting dynamic when it comes to working with the US FDA.

FDA Research & Development

House GOP Targets US FDA Applications With China-Only Data, Cites General Oversight Concerns

While industry concern with FDA’s policy shift on clinical data from China has focused on the disruption in business plans, Republican lawmakers appear to feel that the agency has not gone far enough and are seeking a GAO review of FDA’s entire bioresearch monitoring program.

Clinical Trials China

US FDA and ARPA-H: Woodcock Has Questions

The FDA’s principal deputy commissioner wonders how the agency will work with ARPA-H to help get its projects to patients and the health care system given its other responsibilities.

Research & Development Legislation

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

Gene Therapy Development Should Involve Fewer Surprises, Says US FDA’s Marks

Regulators want to help smooth the process of bringing a gene therapy to market, hoping to iron out ‘surprises’ and even address reimbursement issues for the sake of patients.

Commercial Clinical Trials

Aduhelm Label Update Includes Seizure Risk And Recommends More MRIs

New safety information may help defense of CMS's coverage restrictions. FDA updated the prescribing information for Biogen’s Alzheimer's therapy after four cases of seizures were reported in a trial.

Neurology Drug Safety

FTC’s Take On Two Pharma Mergers Shows Deals Can Clear Higher Hurdle

Pfizer’s acquisition of Arena without FTC intervention and Hikma’s acquisition of Custopharm with one product divestiture shows the commission is bound by anticompetitive facts of a deal. A more controversial merger may not get through, former FTC attorney says.

M & A Commercial

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Surprise US FDA Facility Inspections Resume In India

Unannounced facility visits also were to start again in China, but FDA Commissioner Robert Califf said they have been delayed by the COVID-19 outbreak in the country.

Manufacturing India

US FDA Supply Chain Guidance Includes More Stakeholders, More Risks Than CARES Act

Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.

Supply Chain Quality

More Change With Less Hoopla To FDA Out-Of-Specification Investigations Policy

Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.

Manufacturing Quality
UsernamePublicRestriction

Register