Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Featured Stories


NICE Says Yes To Akcea’s Tegsedi After ‘Improved’ Commercial Offer

NICE has given the green light to Akcea Therapeutics’ ultra-rare disease treatment Tegsedi (inotersen) after the company offered a better “commercial arrangement.”

Europe United Kingdom Market Access

Filling The Rebate Void: PBMs Versus Wholesalers

The proposal to eliminate rebates in the US raises important follow up questions, including who will be responsible for pharmacy transactions at the point of sale. PBMs say they should stay in that role to assure a smooth transition; independent pharmacies have other ideas.

Reimbursement Pharmacy Benefit Management Pricing Strategies

US PTO's Patent Eligibility Guidance Draws Industry Plaudits, Request For More Specifics

BIO, PhRMA, Novartis, Amgen, and Genentech suggest revisions to guidance on hot-button issue of subject matter patent eligiblity; patent owners group says 'best approach' is to enact legislation to restore patent eligibility law.

Intellectual Property Legal Issues Policy

WHO Consults On Remaining Shelf-Life Policy For Medical Products

The World Health Organization has framed a policy to help suppliers, donors, procurers and distributors manage medical products throughout the supply chain and ensure availability within their remaining shelf-life.
International Regulation Quality

Acting US FDA Chief Sharpless Pledges "Full Speed Ahead" On Agency's Current Agenda

In his first speech to agency staff, Acting Commissioner Norman Sharpless says FDA will continue working on issues including drug pricing and opioids – and he is not approaching the post like a temporary caretaker. 
FDA Leadership Regulation
Advertisement

US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – March 2019

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
International Europe Australia

Embedding Time-Critical Scheduling in Drug Production

Manufacturing is the engine room of the pharmaceutical industry. Ultimately, a medicine has little value if it does not reach patients on schedule, in the required quantity and quality. Download this whitepaper which discusses time-critical scheduling in drug production.

Download Whitepaper
Advertisement

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Pharmakon CEO Convicted Over Life-Threatening Potency Failures

Jury convicts Pharmakon CEO of conspiracy to defraud the FDA and nine counts of adulterating drugs. The firm allegedly ignored and tried to cover up dangerously out-of-specification potency testing results for morphine and other compounded drugs. In one case, providers resorted to naloxone to rescue an overdosed infant.

 

Manufacturing Quality Enforcement

Latest From Regulation

Keeping Track: Approval Of First Intranasal Naloxone Copycat Highlights Otherwise Generic Week

The latest drug development news and highlights from our US FDA Performance Tracker. 
US FDA Performance Tracker Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

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

Advisory Committees Drug Review

Amyloidosis Drug PROs Supported Clinical Meaningfulness Of Objective Measures

In pivotal trials for Alnylam’s Onpattro and Ionis’ Tegsedi, statistically persuasive results on a patient-reported, quality-of-life measure were needed to show the drugs had a meaningful benefit on how hATTR patients with polyneuropathy feel and function, US FDA said.

Drug Review Profile Approvals

Latest From Policy

Life After FDA: Rachel Sherman To Tackle Real World Evidence, Clinical Trial Efficiency

Sherman, who left the No. 2 post at FDA in January, is working part-time at Duke-Margolis and serving as a consultant to Medidata Solutions.

FDA Appointments

The PBM Business Model, As Told To Sen. Cornyn

Execs offer (mostly) consistent responses as congressmen come out of the woodwork to grill the PBMs on their business practices.
Pharmacy Benefit Management Legislation

PBMs On Capitol Hill: Why Pharma Will Miss Them When They Are Gone

Drug pricing “middlemen” had their day in the hot seat during a Senate Finance Committee hearing on drug pricing. But even amid the finger-pointing between industry and PBMs over the high cost of drugs, the PBM execs offered some strong reminders of their real value to industry in fending off more overt price interventions by government.  
Pharmacy Benefit Management Pricing Debate

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Life After FDA: Rachel Sherman To Tackle Real World Evidence, Clinical Trial Efficiency

Sherman, who left the No. 2 post at FDA in January, is working part-time at Duke-Margolis and serving as a consultant to Medidata Solutions.

FDA Appointments

Baby Steps To Real-World Evidence Of Efficacy: External Controls Gain Popularity In Rare Disease Trials

The Pink Sheet takes a closer look at recent clinical announcements showing how rare disease therapy sponsors are already increasingly reliant on natural history studies to guide drug development.

Drug Approval Standards Rare Diseases

Myeloma CAR T-Therapy Among New EMA PRIME Winners

Janssen, Krystal Biotech and Takeda are the latest companies to win a place on the European Medicines Agency’s popular priority medicines scheme for getting drugs for unmet medical needs through the review process faster.

Research & Development Review Pathway

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

US FDA Squashes Sprout's Attempt To Remove Boxed Warning From Addyi Label

In sharp disagreement, FDA says postmarketing trial shows risk of taking alcohol with the female sexual dysfunction drug; Sprout will appeal agency's decision.

Drug Safety Post Market Regulation & Studies

Rebate Reshuffle: Could Pharma Foot The Bill To Offset Higher Premiums?

Bernstein Research analysts said CMS could charge pharmaceutical manufactures a fee to offset increases in insurance premiums anticipated from the elimination of rebates in a "win-win" move.

Pricing Debate Reimbursement

Making The Case For Rebates: UnitedHealth Pushing Expansion Of POS Program

Faced with a proposed regulation that aims to eliminate rebates and an upcoming hearing on Capitol Hill, US pharmacy benefit managers including OptumRx are working to validate the concept of rebates when redirected to patients at the point-of-sale. 

Pharmacy Benefit Management Pricing Debate

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

ICH To Partner For Training Of Regulators, Industry On Key Guidelines

The organization that works to harmonize drug review requirements across a growing number of regulatory authorities aims to partner with non-profit groups to train regulatory authorities and industry on its guidelines, starting with guidelines on stability testing, good clinical practice and good manufacturing practices for active pharmaceutical ingredients.

Manufacturing Quality

The Quality Lowdown: Foreign Burden, Border Destruction, Particles, Sterility

FDA asks about regulating foreign firms more and destroying drugs at the border, and questions firms about particles and aseptic practices.

Manufacturing Quality

FDA Testing Data Exchange Standards For Drug Specifications Under PQ/CMC Pilot

FDA announces the rollout of a pilot program with industry to exchange data on quality specifications for the Common Technical Document’s Module 3. The agency plans to exchange data on other portions of the CTD’s quality section later this year. The data exchange would largely replace the “hunting and pecking” for information in PDFs that reviewers have to do to locate quality information in NDAs and ANDAs.

Manufacturing Quality
UsernamePublicRestriction

Register

Advertisement