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GSK Adds £50m Per Year To Brexit Cost Estimates

Brexit is likely to cost GSK around £50m a year in the form of customs duties and transaction and administration costs. It is one of a handful of companies to have made its cost estimates public.

Brexit Regulation Compliance

IND Safety Reporting: Stakeholders Tussle Over Which Adverse Events To Report, Proper Oversight Body

US FDA officials, drug sponsors discussing creation of library of adverse event rates.

Drug Safety Regulation Clinical Trials

One-Third Of Payers Preferred Biosimilars Over Reference Drug in 2017

As biosimilar uptake remains modest, rebate amounts trend upward for medical benefit drugs, according to latest MagellanRx drug trend report.

Biosimilars Pricing Strategies Policy

The Sarepta Precedent: The Good, The Bad, And The Ugly

Podcast discussion of three broader precedents stemming from US FDA's original Exondys 51 approval.

Drug Approval Standards FDA Neurology

FDA Performance Tracker

Keeping Track: A Burst Of Breakthroughs, A Priority Review For Keytruda, And Some Supplemental Submissions

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

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

New MHRA Guideline Could Be Global Pharma's Go-To Standard For GxP Data Integrity

The UK regulator has done a good job of aligning its final data integrity guideline with those of other international bodies, which means global drug companies will not have to balance competing requirements to achieve compliance, says consultancy firm Rammell. However, some aspects of the guideline, such as following a risk-based approach, could pose some challenges.

Regulation United Kingdom Quality

Latest From Regulation

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

Swayed By Industry Opposition To 'Intended Use' Rule, FDA Definitively Delays Implementation

US FDA is considering calls to drop 'totality of circumstances' test and to clarify that mere knowledge of unapproved use does not constitute evidence the use was intended.

Advertising, Marketing & Sales Legal Issues

Korea Revises Rules To Curb Rebate Activities, Improve Ethics

South Korea continues efforts to root out illegal rebate payments for drugs and to step up the pharma industry's ethics and social responsibility by revising relevant rules, but in a way that doesn't harm patients' health.

Regulation Reimbursement

Latest From Policy

Shire, Microsoft and Eurordis Partner To Improve Diagnosis And Treatments For Rare Disease

An alliance between Shire, Eurordis and Microsoft to speed up diagnosis of rare diseases in children could lead to better access to treatments and the development of new medicines.

Market Access Policy

340B Hospitals May Be Losing Transparency Debate In Congress

Biopharma industry's arguments on rebate pass-through to patients appear to carry the day at Senate HELP Committee hearing.

Pricing Debate Legislation

Oncologists Charge More Than Other Specialties For Same Drugs, Study Finds

Oncologists charge at least 50% more for Lupron and Aranesp than do urologists or nephrologists, researchers with Johns Hopkins and Memorial Sloan Kettering found.

Pricing Debate Policy

Clinical / R&D Explore this Topic

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Latest From Research & Development

Right-To-Try Bill In House Limits Process To Patients Facing 'Severely Premature Death'

Vote slated for Tuesday; legislation is somewhat narrower than Senate-passed bill, which applies to patients with a 'life-threatening disease or condition.'

Legislation Clinical Trials

CTI's Approval Prospects For Pacritinib In Myelofibrosis Look To Be Improving

Firm publishes final data from a Phase III study showing the safety-troubled JAK2/FLT3 inhibitor performs better than Jakafi in reducing spleen size. Ongoing dose-finding study will determine the regulatory path forward.

Drug Review Clinical Trials

Tie-Ups, Chronic Diseases Influence Korea Generic Regulatory Patterns

South Korean pharma firms are still heavily dependent on generics for revenues, but approvals for required bioequivalence tests continue to drop, indicating that more developers are opting for joint studies and co-development. By therapeutic area, chronic disease drugs led generic development in the country in 2017 amid an aging population and increasingly Westernized eating habits.

Research & Development Drug Review

Commercial Explore this Topic

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Latest From Commercial

Praluent’s Price Cut: Testing The Tech Model For Drug Pricing

It may be more accident than design, but Sanofi and Regeneron are applying a tried and true pricing model to Praluent. Just ask tech companies. 
Pricing Strategies Cardiovascular

Praluent Pricing: Collaboration With ICER Sets A New Standard

Sanofi/Regeneron reveal plans to lower price of PCSK9 blocker Praluent to match ICER's updated recommendation, following assessment based on new outcomes data. Decision sparks debate across industry and raises questions about setting precedent on pricing for the future.

Pricing Debate Pricing Strategies

Express Scripts Combination With Cigna's PBM Could Reverse Deficit From Losing Anthem

Merger could restore number of covered lives PBM will lose once its contract with Anthem expires, but there is also risk of alienating current health plan clients who don't want to contract with a competitor.

Pharmacy Benefit Management M & A

Manufacturing Explore this Topic

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Latest From Manufacturing

Why Most Firms Still Don't Use RABS Or Isolators To Better Protect Filling Lines From Contamination

Despite the reduced risk of contaminating sterile drug products, most manufacturers are still not using advanced technologies such as RABS and isolators in the cleanroom. High costs and lack of regulatory pressure were cited in survey responses as reasons for the slow uptake. 
United States Manufacturing

Industry Groups Seek Clarity From FDA On Exception Handling Under DSCSA

As supply chain partners drill down into implementing the last phase of Drug Supply Chain Security Act serialization, they ask FDA for more clarity, and some relief, on exception handling for products with no serial numbers after full track-and-trace goes into effect.
Manufacturing Quality

Proposed Legislation Would Help FDA Stop Illicit Opioids At Border -- And More

US FDA would gain more of the ability it seeks to interdict illicit opioids at the border under legislation proposed by House Energy & Commerce Committee's top Democrat. But would there be collateral damage to the legitimate pharmaceutical industry?

Distribution Compliance

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Alka-Seltzer Plus Labeling Error Prompts Recall From Some US Stores

Recall is second in a year for products marketed under the iconic Alka-Seltzer brand. Alka-Seltzer Plus line comprises products indicated for cold alone or for cough/cold; cold and flu and symptoms including sinus pressure, and are available in regular and extra-strength and day and night formulations.
United States Consumer

Gottlieb An Anchor For OTC Drug Industry On Stormy Congressional Seas

Commissioner Gottlieb has been a “very strong champion” of FDA and his interest in improving the OTC monograph and switch processes provides hope to the industry during a tumultuous legislative era, say CHPA executives at their annual meeting in Florida. They expect monograph reform will happen this year but doubt much else will happen before mid-term elections in November.

Prescription To Otc Switch Drug Approval Standards

For Successful OTC Switch Proposals, A Good Offense Defends Against Doubters

OTC switch sponsors should identify adversaries early in the application switch process so they can counter arguments that could derail their switch, s consultant advises. Some switches fail because firms target regulatory approval and do little on marketplace performance.

Consumer Prescription To Otc Switch