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Policy & Regulation

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Brexit: Scenario Planning Well Under Way At EMA

The EMA has outlined some of the planning that has been going on in preparation for its relocation from the UK to another EU member state as a result of Brexit, including ongoing relations with the UK regulator, the MHRA.

Brexit Regulation Europe

Gottlieb Promotes 'Bottom-Up' Review To Increase FDA Efficiency, Consistency

US FDA commissioner nominee suggests breakthrough concepts should be more widely adopted within the review divisions and that staff should find and distribute best practices.

Drug Review FDA Regulation
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Regulation

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Latest From Regulation

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

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

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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Policy

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Latest From Policy

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

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

Coherus Knocks Out One Humira Patent But Others Block Biosimilars

Patent Trial and Appeal Board invalidates patent on method to treat rheumatoid arthritis; next hurdle is overcoming formulation patents that do not expire until 2022.

Biosimilars Intellectual Property

Ontario Introduces Canada’s First Universal Youth Drug Program

Health authorities in Ontario, Canada, have become the first to offer a universal drug program offering younger patients access to free medicines. The move could be a small step towards eventually establishing a National Pharmacare Program across Canada.

Policy Reimbursement

Generic Drug Sponsors Seek Advance Notice Of Approvals From US FDA

Pre-launch communication from agency would allow sponsors to ramp up commercial activities and could head off some innovator company legal challenges to ANDA approvals, attorneys say; CDER’s Moscicki suggests GDUFA goal dates now provide sponsors some level of predictability.

Generic Drugs Drug Approval Standards

The Latest Furor Over Trump’s Drug Pricing Plan

Did the head of the Office and Management & Budget really endorse Part D rebates? Like so much about the Trump Administration’s response to drug pricing, there is probably a lot less to the story than it sounds.

Pricing Debate Medicare
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