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Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

Foreign Pharma Takes Simmering Price Concerns To New Korea Govt

Amid an escalating tussle with the health ministry over the level of South Korean drug prices, foreign pharma firms operating in the country are now proposing the launch of a new joint study on the issue with the incoming government.

South Korea Pricing Debate

Tweaked ‘New Drugs’ Flouted Price Approval Norms In India

Pharmaceutical firms face more flak in India for allegedly flouting pricing norms – this time more than 200 formulations were allegedly launched in the country without seeking price approvals, though some companies claim they are fully compliant with the norms.

Regulation India

Consumer Health Weekly Trademark Review May 9, 2017

Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled from the Official Gazette of the U.S. Patent and Trademark Office.

China India

India Pushing Ahead With Rare Disease Policy Plan

India appears to be on course to developing a national rare disease policy, with the adoption of a specific definition for rare diseases and the initiation of a rare disease registry in the country.

Policy Rare Diseases

China FDA Proposes Sweeping Reforms To Incentivize Innovation

The China FDA releases a raft of new regulatory proposals outlining fundamental changes in areas including patent linkage and data exclusivity, which look set to profoundly impact decision makers looking at bringing new drugs and devices to the world’s second-largest pharma market.

China Intellectual Property

Stability At Last For Drug Innovators And Pricing In Australia

The Australian government has promised not to implement any new therapeutic groups under the Pharmaceutical Benefits Scheme for the next five years, nor will it introduce any new pricing reforms without consulting the innovative drug industry first.

Pricing Strategies Market Access
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Set Alert for Europe

Latest From Europe

AB Science Asks For Re-examination After EMA Rejects Masitinib For Mastocytosis

The EMA’s main scientific committee, the CHMP, has rejected AB Science’s potential mastocytosis drug masitinib, but the company has asked for a re-examination of the decision on a number of grounds, including the fact that it has implemented GCP corrective actions and that updated information shows the product to have “acceptable” long-term safety.

Drug Review Compliance

Accelerated Assessment Decision ‘Imminent’ For Two Products In EMA’s PRIME Scheme

The sponsors of two products in the European Medicines Agency’s popular PRIME scheme for speeding patient access to drugs for unmet medical needs appear to be close to filing their applications for marketing authorization. Five more products were accepted on the scheme this week.

Europe Drug Review

Decade-Old Advanced Therapy Set For EU Approval

German company CO.DON is celebrating the fact that it probably won’t be long before it can start selling across Europe its key product – an advanced therapy for the repair of certain cartilage defects of the knee that’s been in use in Germany for ten years.

Germany Europe

High Rejection Rate of Proposed Brand Names On EMA Radar

In March, the number of proposed new drug brand names rejected by the European Medicines Agency exceeded those that were accepted. A dedicated group at the agency is to look into the problem at a meeting with stakeholders on June 1.

Trademarks Europe

Rejigging The Benefit-Risk Balance For Advanced Therapies In The EU

The European Medicines Agency’s Committee for Advanced Therapies has revealed its priorities for addressing the challenges manufacturers face in the fast-growing field of advanced therapies.

Research & Development Regulation

On The Rise In The EU: New Drug Applications, Conditional Approval Recommendations

Applications to the European Medicines Agency are continuing to rise, with orphan drugs playing a part in the increase, but the numbers of drugs for new pediatric indications and those for use outside the EU are still lamentably low. For the first time in five years, the CHMP issued no negative opinions, but more applications for accelerated assessment were rejected than accepted.

Approvals Drug Review
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United States

Set Alert for United States

Latest From United States

Amgen Migraine Antibody, Bayer Oncologic, Spark Gene Therapy Join NME Review Queue

US FDA received several applications for new molecular entities last week, including a BLA for Alphaeon's Botulinum toxin that came just three years after number trails began.

Approvals Drug Review

Kalydeco Expands Indication Without Clinical Data; Keytruda Is Latest Bladder Cancer Approval

Keeping track of US FDA approvals last week included watching the creative and the familiar.

Approvals Review Pathway

Sarepta Protocol Changes Could Impact Future Duchenne Trials

If US FDA Commissioner Gottlieb allows use of in-dwelling ports in ESSENCE study, Office of Pediatric Therapeutics will assess whether the determination could serve as precedent for placebo-controlled trials of other exon-skipping compounds in Duchenne muscular dystrophy.

Advisory Committees Clinical Trials

Biosimilar Litigation: Janssen Vs. Samsung Anticipates Supreme Court Decision

Hoping to hold off a biosimilar to Remicade, Janssen challenges Samsung's decision not to participate in patent dance as it claims infringement of three manufacturing patents.

Biosimilars Legal Issues

OTC Monograph User Fees Totaling $22m To $34m Floated In Senate Discussion Draft

Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.

Consumer Consumer

Two-Tier OTC Monograph Approach Could Come With User Fee Revamp

One tier could provide two-year exclusivity, should FDA request clinical trials for new conditions or ingredients, under a US Senate discussion draft. Essentially stalled monograph process would be replaced by deadlines for FDA action in under two years.

Consumer Legislation
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