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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 United States

FDA-Industry Relations Faulted As 'Revolving Door' In BMJ Report

Academic authors say that more than half of FDA medical reviewers leave to either work or consult to industry; experts chime in with mixed reactions to the findings.

Advisory Committees Regulation United States

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 BioPharmaceutical

A Tale Of Two Committees: Which Probed EpiPen Better?

If you were an FDA official, would you prefer to be a sideshow at a contentious House committee hearing or the focus of a cordial Senate one?

Drug Review Pricing Debate Product Approvals
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Policy & Regulation

Set Alert for Policy & Regulation

FDA Hiring Campaign Continues; Goal Is Addressing Pending ANDAs

GDUFA funding will bring 50 additional people to the Office of Pharmaceutical Quality for generic drug review purposes.

Pricing Debate Drug Review People

Latest From Regulation

FDA Encourages Pediatric Master Protocols With Bayesian Approach

Most trials currently use of frequentist statistics, but agency argues that Bayesian methods allow for better extrapolation.

Clinical R and D Regulation

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

Lilly’s Sarcoma Drug Lartruvo Latest To Test EU Conditional Approval System

Lartruvo, Lilly’s new drug for the rare condition soft tissue sarcoma, has been recommended for conditional marketing authorization in the EU pending the results of an ongoing Phase III study. The conditional approval system itself is under scrutiny regarding the fulfilment of obligations.

Approvals Regulation

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

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

'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

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

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

Investigation Failures, Root Cause Problems Continue To Bedevil Manufacturers

FDA and industry experts discuss avoiding old pitfalls and exploring new investigation models at FDA/PDA conference, as pharmaceutical manufacturers continue to struggle with failure investigations and discerning the root cause of quality defects.

Manufacturing BioPharmaceutical

Excipient Database Should Help Take Mystery Out Of ICH Q3D Risk Assessments

The pharmaceutical industry is developing an excipient database to better enable industry to conduct risk assessments set out in the ICH Q3D guideline.

Manufacturing BioPharmaceutical

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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