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The Eteplirsen Approval: Former FDA Officials Weigh In On The Science

A former CDER director, office director, division director, and supervisory reviewer agreed to comment for the record on the merits of the science that formed the basis of FDA’s accelerated approval of the Duchenne Muscular Dystrophy therapy Exondys 51.

Drug Review Review Pathway Drug Approval Standards

Duke's McClellan: Changing Drug Development Policy From Outside FDA

In an interview, Margolis Center for Health Policy's Mark McClellan and Gregory Daniel talk about their recent move from Brookings to Duke, the breadth and impact of their work with FDA on drug development issues, and opportunities for potential future collaborations under PDUFA VI.

Policy Drug Approval Standards Drug Safety

As Drug Value Frameworks Gain Traction, Patients Seek More Input

'Patients are ready and willing to have conversations' about trade-offs, National Health Council's Perfetto says.

Comparative Effectiveness Health Technology Assessment Pricing Reimbursement

Zika Vaccine Trials Could Test Multiple Candidates Vs. Common Control Group

FDA and NIH officials propose three strategies for clinical trials, saying it will be challenging to identify the most promising candidates; Sanofi and Walter Reed researchers note challenges in vaccine development, including manufacturing scale up.

BioPharmaceutical Clinical Trials Research and Development
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Policy & Regulation

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Ireland Prepares New Biosimilar Policy To Improve Access, Boost Industry

Ireland is developing a new policy intended to increase the use of biosimilars, taking account of initiatives in other countries. The government says the aim is to help boost competition and access to cheaper biologicals.

Biosimilars Market Access Ireland

Latest From Regulation

Japan Approvals Include Keytruda, First Asia Nod for Iclusig

A large batch of new drugs, indications and formulations just granted approval in Japan includes Keytruda and the first marketing authorization in Asia for Ariad's Iclusig.

Approvals Japan

FDA's Drug Promotion Advisory Reviews Taking Longer

FDA is having trouble meeting its internal goal of 45-day reviews for core launch materials due to complex issues that have required medical review division consultations, Office of Prescription Drug Promotion Director Abrams says.

Regulation Advertising and Marketing

Biosimilars Will Get PDUFA-Style Reviews Under New User Fee Plan

FDA will have a total of 12 months to review 351(k) applications and additional time to schedule certain product development meetings under the Biosimilar User Fee Act II agreement; measures to enhance management of user fee resources and improve hiring will carry over from PDUFA VI.

Regulation Biosimilars

Latest From Policy

13 Ways To Create A Sustainable Biosimilars Market In Europe

More alignment between manufacturers and national payers is needed on issues such as price, competition and the role of payer guidance if the biosimilars market is to be sustainable over the longer term, says a new report.

Biosimilars Market Access

Big Pharma’s Big Debate Win

Sometimes silence is golden. The first Presidential debate had lots of noise – but no discussion of health care, much less drug pricing. And, as an added bonus, both candidates agreed that tax repatriation is a good idea.

US Election 2016 Policy

What's Driving Price Increases For Addiction Treatment Drugs?

At House hearing, PhRMA representative cites introduction of innovative delivery systems while GPhA exec points to manufacturing costs; state attorneys general file Suboxone 'product hopping' suit.

BioPharmaceutical Policy

Clinical / R&D

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Latest From Research and Development

'Right To Try' Or 'Right To Ask'? Hearing Spotlights Adverse Events As Key Barrier To Expanded Access

FDA and the pharmaceutical industry appear to have a shared interest in finding ways to dramatically increase expanded access programs to avoid a potentially difficult fight over 'Right to Try' legislation at the federal level in 2017. A September 22 hearing on a pending Senate bill illustrates why.

Legislation Research and Development

Merck KGaA Previews Cladribine Regulatory Revival Story At ECTRIMS

With the EMA’s review of the latest MAA for cladribine ongoing, Merck KGaA uses ECTRIMS 2016 to showcase longer-term efficacy data and a safety analysis that could lay to rest concerns about the multiple sclerosis therapy's risk of malignancy.

Research and Development Neurology

With VERTIS SITA2 On Board, Merck Eyes Broad Initial Approval For Ertugliflozin

In an interview at the European Association for the Study of Diabetes meeting, Merck exec Sam Engel explains the rationale behind the clinical trial strategy for the SGLT-2 inhibitor ertugliflozin, as it gears up with partner Pfizer for filings by the end of this year.

Metabolic Disorders Clinical Trials

Commercial

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Latest From Commercial

Teva Leads Generic Rivals In First-To-File ANDAs By A Long Shot

Teva has submitted 13 ANDAs with first-to-file opportunities to FDA this year, while rivals Mylan, Endo, Sandoz and Indian firm Hetero each have filed two ANDAs with FTFs, according to public data released by the agency and further analyzed by Teva.

Regulation Commercial

FDA Logo Modernization Aims For Uniform 'Look And Feel'

Changes will eliminate more distinctive graphics for individual centers to help make agency communications more consistent.

Advertising Promotion and Regulation Commercial

Portola Defends AndexXa Antidote Safety, Says Thrombotic Events In Line

Interim analysis of ANNEXA-4 study published in NEJM supports case for AndexXa approval, but 18% thrombosis rate raised some eyebrows.

Cardiovascular Approvals

Manufacturing

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Latest From Manufacturing

FDA Investigators Finding Fewer Deficiencies For Visual Inspection Programs

Experts on visual inspection and patient risk attribute a downward trend in inadequate visual inspection plans for particles to a new USP chapter that offers greater clarity on testing conditions. While there is negligible safety risk posed by visible particles, manufacturers should still conduct particle characterization studies. And no, glass particles are not risker than metal or wood particles.

BioPharmaceutical Manufacturing

Novartis Tests Global Manufacturing Process For CAR-T Therapy

Rather than wait for regulatory approval prior to commercial-scale manufacturing, Novartis is proving out its global commercial manufacturing process for a CAR-T cell therapy in a Phase II clinical trial as questions remain on how to translate the manufacturing process from the research laboratory to the factory.

Manufacturing Advanced Therapies

GDUFA II: ANDAs, Not Facilities Will Govern Revenue

Since applications comprise most of the workload, they will be the focus in the next generic drug user fee cycle.

Application Process Drug Review

Consumer / OTC Drugs

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Latest From Consumer

Perrigo Deal Makes Extraction-Resistant PSE A Two-Player Competition

Via Highland Pharmaceuticals agreement, Perrigo snaps up the only tamper-resistant pseudoephedrine formulation still available for licensing. It now goes up against Bayer – but will beat the pharma giant to market.

Consumer Drug Safety

Pfizer Keeps Hands On Consumer Product Wheel In Opting Against Split

Pfizer didn't cite its consumer health business in announcing it will retain current structure, but best-selling Lipitor's cholesterol treatment indication is the most coveted indication yet to be available OTC.

Consumer Prescription To Otc Switch

UK Recommends Double Emergency Contraceptive Dose To Counter Enzyme Inducers

Women taking CYP3A4 enzyme inducers or St. John's wort should use double the standard dose of levonorgestrel, if using it as an emergency contraceptive, to compensate for reduced plasma levels of the ingredient, UK agency says.

Consumer Drug Safety
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