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Novel US FDA Approvals Could Rebound In 2017: 40+ Candidates Already Under Review

Novel approvals by US FDA in 2017 could easily surpass the 28 agents approved by the agency's drug and biologics centers in 2016. The big question is whether last year's spike in complete response letters was an anomaly or the start of a trend.

Approvals Review Pathway Regulation

Cyclacel CEO Explains How Sapacitabine Might Get Cleared For AML, Despite Phase III Failure

The company will talk to regulators in the US and Europe to see if the drug could be considered in elderly patients with low baseline peripheral white blood cells, who fared better than others in the failed SEAMLESS study.

Clinical Trials Regulation Cancer

ICER Revising Drug Review Criteria, Will Use Net Prices, Broad Evidence Base

Proposed updates to group’s cost effectiveness evaluations will guide reviews during 2017-2019. Ultra-orphan drug will be assessed with different standards.

Cost Effectiveness Pricing Strategies Reimbursement

Busy In-Tray Awaits New EFPIA Boss Nathalie Moll

Nathalie Moll, secretary general of biotech industry body EuropaBio, is to be the next director general of EFPIA, the federation that represents the R&D-based pharmaceutical industry in Europe. With issues such as the forthcoming Brexit negotiations, the EU’s inquiry into medicines access and pricing, and the implementation of the new Clinical Trials Regulation, EFPIA’s new leader will have a lot of weighty dossiers to deal with.

Leadership Regulation Market Access
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FDA Performance Tracker
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Policy & Regulation Explore this Topic

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Pfizer Warning Letter Trips Up Sandoz/Momenta’s Expected Glatopa Launch

Sandoz/Momenta’s generic of Teva’s 40 mg Copaxone appeared imminent – until apparently unrelated FDA warning letter regarding contract manufacturer Pfizer’s McPherson, Kan., plant put review on hold.

Manufacturing Quality Approvals

Latest From Regulation

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Regulation Advisory Committees

Redacting Personal Data/CCI In EU Clinical Trial Inspection Reports On The Agenda

Work is expected to start this year on developing guidance for the EU member states on how to redact clinical trial Inspection reports to protect personal data and commercially confidential information under the new Clinical Trials Regulation.

Europe Clinical Trials

On Tap: Novel Agents Awaiting US FDA Action In 2017

New molecular entities and novel biologics on US FDA's user fee calendar for 2017.

Approvals Regulation

Latest From Policy

Ovarian Cancer Drugs Will Get ICER Review As Olaparib's Maintenance Indication Looms

PARP inhibitors from Tesaro, Clovis, and AstraZeneca have been tentatively chosen for the evaluation.

Pricing Strategies Reimbursement

Rx Spending Stands Out In CMS Projections – As Slowing Down

Pharmaceutical industry’s message on overall drug spending trends is getting some timely support from the Center for Medicare and Medicaid Services’ annual national health expenditure projections.

Pricing Debate Policy

US FDA's Authority Over CRISPR Is Adequate, NASEM Finds, But Off-Label Challenge May Emerge

National Academies’ report on the fast-advancing genome-editing technologies points out that ways to improve musculature in dystrophy patients will almost certainly raise issues about treatment use in narrow population versus enhancement use in broader population. In most cases, however, specificity of genome-edited products will help limit use of the new therapies to targeted populations.

FDA Policy

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Belgium To Test Parallel Review Of Clinical Trial Dossiers Ahead Of New Regulation

Belgium is following the footsteps of Germany and France by launching a pilot to develop and test procedures for the coming EU Clinical Trial Regulation, which requires national competent authorities and ethics committees to evaluate trial dossiers in parallel and to issue a consolidated single decision within short timelines.

Regulation Clinical Trials

Intercept's Revised NASH Trial Improves Prospects

The pivotal REGENERATE study of Ocaliva now can succeed if either of two co-primary endpoints is achieved. Intercept also will use a new "objective" definition of NASH resolution in the study.

Clinical Trials Research & Development

Catabasis Refutes MRI T2 Biomarker In Duchenne Study

Catabasis says biomarker MRI T2 doesn't work after all in boys with Duchenne's, plans to stick with four-step climb test or 10-meter walk/run test from now on.

Clinical Trials Research & Development

Commercial Explore this Topic

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Latest From Commercial

Cost Versus Value: Earnings Calls Spotlight US Pricing Reforms

Pink Sheet has scoured big pharma annual results presentations to gauge the industry's reactions and concerns around the increasingly tough US drug pricing environment and proposed changes to the Affordable Care Act under the new Trump administration.

Pricing Debate Pricing Strategies

J&J Outlines Pricing Transparency Plan, Will Others Follow?

CEO Gorsky describes J&J’s approach to drug pricing and pledges to provide more detail in an annual transparency report. Investor pressure regarding the pricing debate continued during the Novartis earnings call. Value arguments expected to dominate pharma’s message.

Pricing Debate Sales & Earnings

New Policy Fund Reflects Korea’s Commitment To Health Biotech

South Korea's plan to create a policy fund to support new growth engine industries seems to reaffirm the government's unwavering commitment to nurture the biotech and health care sectors despite the ongoing political chaos in the country.

South Korea Financing

Manufacturing Explore this Topic

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Latest From Manufacturing

Quality Regulatory Updates In Brief: ICH, EMA, MHRA and FDA

ICH updates progress made on quality guidelines; EMA talks combination products; UK MHRA report sheds light on GMP deficiencies; MHRA official describes compliance escalation; FDA guides microbiology reviewers through Common Technical Document; FDA OKs reliance on non-USP compendia in applications.

Quality Manufacturing

A Drag On Drugs? Trump’s Tariffs Could Raise Costs, Particularly For Generics

Drug makers remain mum on Trump tariffs despite worries that older generics could get squeezed. Landmark WHO study is adamant that tariffs should never be imposed on medicines.

Manufacturing Policy

How US Tax Plan Could Affect Global Pharma Manufacturing Networks

Allergan, Pfizer, Bristol-Myers Squibb, AbbVie, GSK, Sanofi and Roche showed glimpses in recent earnings calls of potential impacts on their global manufacturing networks from a US plan to legislate border-adjusted tax cuts. But there was not a word about President Trump’s threat of tariffs.

Manufacturing Policy

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Bayer Plans 19 Consumer Product Launches To Revive Sluggish Sales

Bayer consumer readies 19-product pipeline for 2017 as it works to increase sales of brands including Coppertone and Dr. Scholl’s brands that have been sluggish since being acquired from Merck & Co.

Consumer Advertising, Marketing & Sales

Is Takeda's Consumer Unit 'Agile' Enough To Stretch Outside Japan?

Takeda says spinning off its consumer product portfolio into a wholly owned and independent subsidiary will boost its profile in the sector, but all signs continue to point to the firm's Rx operations as its predominant revenue drivers.

Consumer Japan

Consumer Health Weekly Trademark Review Feb. 14, 2017

OTC drug, personal care product and nutritional supplement trademark filings compiled from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.

Consumer Trademarks
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