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Latest News & Analysis

Coppertone ‘Assurance Assessment’ Anticipates Criticism From Sunscreen Reviews

Bayer shares results from a consulting firm's assessment of its operations, procedures and testing at the root of Coppertone SPF claims and other labeling aspects. The firm could get in front of a conversation that tends to arise this time of year regarding sunscreen safety, effectiveness and truthfulness in marketing.

Commercial Business Strategies

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

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

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

Manufacturing Regulatory Updates In Brief

FDA's “Wayback” archive; EMA's whistleblower policy; IPRF's drug ID plan; reprieve for DMF holders; investigational compounding; PK/PD for kids; ISPE on quality culture; PDA on quality risks.

Quality Manufacturing

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

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
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