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Worries About 180-Day Exclusivity Reforms Persist As User Fee Bill Advances

FDA-crafted legislative text emerges that generic industry says could weaken the incentive, but so far no changes are in the draft House and Senate bills.

Generic Drugs Legislation 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 Infectious Diseases

Copay Assistance Can Be Excluded From Medicaid ‘Best Price’ Without Strings Attached – US Court

Decision is a win for the Pharmaceutical Research and Manufacturers of America in lawsuit against the US Health and Human Services Department.

Medicaid Legal Issues Reimbursement

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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: 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

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Latest From Regulation

EU Accelerated Assessment: Lilly Requests Fast-Track Status, EMA Says No To SIFI And Janssen

Eli Lilly has asked the European Medicines Agency to grant accelerated assessment to its planned EU marketing application for pirtobrutinib. Meanwhile, the agency has rejected requests to fast-track SIFI’s Akantior and Janssen’s Zejula plus Zytiga combination therapy. 

European Performance Tracker Review Pathway

EU Biosimilar Filings, Opinions And Approvals

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Europe Approvals

EMA Recommends Dozens Of Suspensions Over Flawed Synchron Studies

The European Medicines Agency's human medicines committee has recommended the suspension of marketing authorizations for around 100 generics after identifying “irregularities” in how bioequivalence studies were conducted by Synchron Research Services.

Regulation Europe

Denmark Finds Sponsors ‘Overburdening’ Study Sites To Support Decentralized Trials

A senior Danish GCP Inspector highlights instances of clinical trial sites facing burdensome procedures to support decentralized trials and discusses other challenges posed by such studies.

Denmark Clinical Trials

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

Latest From Policy

Janssen May Challenge English Funding Rejection For Depression Nasal Spray

Health technology assessment body NICE has now rejected Spravato for the third time, saying it has concerns over the clinical evidence and economic model for the drug, for treating adults with major depression that is resistant to treatment.

Cost Effectiveness Health Technology Assessment

Closed-Loop Inspections? Strict COVID Zero Policy Delays US FDA’s China Field Trips

Chinese biotechs are bracing for lengthy delays as the nation’s unwaveringly stringent restrictions continue to cause barriers to on-site inspections from the US FDA. Hard-hit domestic firms are proposing a ‘quarantine bubble’ like that used during the Beijing Winter Olympics to put back on track the field checks necessary for obtaining biologics approvals.

China Manufacturing

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

Clinical / R&D Explore this Topic

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Latest From Research & Development

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

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

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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

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Latest From Manufacturing

Closed-Loop Inspections? Strict COVID Zero Policy Delays US FDA’s China Field Trips

Chinese biotechs are bracing for lengthy delays as the nation’s unwaveringly stringent restrictions continue to cause barriers to on-site inspections from the US FDA. Hard-hit domestic firms are proposing a ‘quarantine bubble’ like that used during the Beijing Winter Olympics to put back on track the field checks necessary for obtaining biologics approvals.

China 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
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