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Regional Coverage

Asia Pacific

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Latest From Asia Pacific

COVID-19 Lesson: India Earmarks $1.3bn To Reduce Dependence On China

In a bid to ensure long-term medicines security, the Indian government has earmarked $1.32bn to promote domestic production of 53 APIs, including lopinavir and ritonavir currently being evaluated to treat COVID-19 cases, as well as antibiotics, for which India is highly dependent on China.

Coronavirus COVID-19 Risk Management

India Bars Exports Of Hydroxychloroquine With Some Exceptions

India has prohibited exports of hydroxychloroquine, though with concessions in specific instances, days after a national task force recommended the drug for the prophylaxis of SARS-CoV-2 infections. Home market supplies of the drug also appear strained for now.

Regulation Coronavirus COVID-19

API In Ducts And Filters Led To Cipla’s First Drug GMP Warning Letter

Despite the stain on Cipla’s compliance record, the company leads on drug quality in India, with major concerns raised in only 3% of FDA inspections, compared to 11% generally.

Manufacturing Quality

Price Freezes And Postponed Inspections: Philippines Responds To Coronavirus

Postponed foreign inspections and a price freeze on essential emergency medicines are among the measures the Philippines FDA has implemented in response to the COVID-19 outbreak. 

Philippines Coronavirus COVID-19

Korea Moves To Stabilize Drug Supplies, Works With WHO On Coronavirus

South Korea moves to maintain stability of drug supply and demand amid the coronavirus pandemic, while the WHO participates in the country’s clinical epidemiology research that could potentially be used to revise and complement international guidance on COVID-19 disease.

South Korea Coronavirus COVID-19

Trump Counts On China To Deliver In The Day Of The Coronavirus

President dismisses fears of drug shortages as White House prepares to deliver US from dependence on China’s pharmaceutical manufacturing complex.

Coronavirus COVID-19 Manufacturing
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Europe

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Latest From Europe

AbbVie Brings In Non-EU Kaletra To Bolster Dwindling French Supplies

The US company is bringing extra supplies of lopinavir/ritonavir into France but stresses that the combination treatment is not authorized for treating patients with the coronavirus.

France Distribution

UK MHRA Finds Labs Releasing Unreliable Data Due To Pressure From Pharma

A UK regulator with the MHRA is concerned that bioanalytical laboratories are not being given enough time to do their job properly by drug companies under pressure to ensure their clinical trials remain on schedule. 

Clinical Trials Safety

UK MHRA Relaxes GMP Rules For Drugs Imported From Third Countries During COVID-19 Outbreak

The regulatory agency also urges qualified persons at drug companies to let the agency know as soon as possible if they are finding that the new measures are not flexible enough to deal with the current logistical challenges quickly.

Quality United Kingdom

Russia May Cap Drug Prices In Fight Against COVID-19

As part of its efforts to preserve patient access to medicines amid the COVID-19 pandemic, Russia is planning to cap drug prices if increases of more than 30% are detected. It will also allow online sales of non-prescription drugs and may also tighten the rules on fake and substandard products. 

Russian Federation Pricing Debate

European 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

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated to include two new products, including Alnylam Pharmaceuticals' Givlaari for treating acute hepatic porphyria. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

Europe Approvals
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United States

Set Alert for United States

Latest From United States

Colorectal, Bladder Cancer Therapies Are Top Prospects For April US FDA Approvals

Sanofi’s next-generation meningococcal vaccine, broader use of Bristol-Myers Squibb’s Reblozyl move toward approval; United Therapeutics foreshadows Trevyent regulatory difficulties.

US FDA Performance Tracker Drug Approval Standards

Rapid Biopharma Response To COVID-19 Enabled By Decades Of R&D Investment, Firms Say

Biopharma is working on a reputation renaissance as the public looks to industry for treatments and vaccines for the COVID-19 epidemic and drug pricing concerns take a back seat.

Coronavirus COVID-19 Innovation

Why The US FDA Requested Ranitidine Withdrawal; How Other Withdrawals Could Follow

Agency worried what might happen beyond expiry or room temperature to generate carcinogenic impurities in ranitidine; will guide assessment of nitrosamine risks in other drugs.

Compliance Manufacturing

US FDA User Fee Renewals Remain On Schedule Despite Coronavirus

Virtual kick-off meetings may be necessary, but preparations continue in anticipation of the formal talks to reauthorize the prescription drug, generic drug and biosimilar user fee programs.

User Fees Drug Review

Neurology At The Forefront Of US FDA Complex Innovative Trial Design Pilot

Wave’s Duchenne muscular dystrophy drug and Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.

Clinical Trials Neurology

US FDA And Sponsors Resolve Disclosure Issues On Complex Trial Design Pilot Projects

Agency officials can now discuss the ideas that have been accepted, though not in great detail.

Clinical Trials Research and Development Strategies
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