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Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

India’s E-Plan To Map Drug Sales – Turning Point For Better Traceability?

A government plan aimed at putting in place an e-platform to regulate the sale of medicines in India, is expected to bolster end-to-end traceability and help lower the risk of fake drugs in the supply chain. But the platform’s proposed revenue model appears to be a sticking point, at least for now, among other tricky areas.

Policy & Regulation Regulation

New Korea Fund To Nurture Early Stage Biotech Start-Ups

South Korea is broadening its state support for the biotech industry, which it sees as a new growth engine, this time by focusing on early stage biotech start-ups, amid industry views that such support and investment in the country has so far been lacking.

South Korea Policy

Singapore Eye Wash Maker Blinks At US FDA's OTC Monograph, GMPs

A warning FDA submitted March 16 says Opto-Pharm's "Buffered Eye & Skin" product – distributed in the US by Cintas under the Xpect and First Aid Direct brands – are not labeled or formulated in accordance with the agency's ophthalmic drug products monograph.

Singapore Asia Pacific

India’s Micro Therapeutic says EMA’s ‘Sweep’ Suspension Will Hurt; CRO Industry Shuns ‘Bad Eggs’

Data integrity concerns continue to cloud outlook for India’s contract research sector. The European Medicines Agency’s latest action against Micro Therapeutic Research Labs suspends more than 300 products in the EU over “unreliable” data and the firm tells Pink Sheet this will result in a “considerable dent” in its operations.

Policy & Regulation Regulation

Japan Price Reforms Will Be Pro-Innovation, Inclusive - Official

A Japanese official provides reassurances at BIO Asia that the government intends to abide by drug pricing policies that support innovation, although the research-based pharma industry remains concerned that sweeping reforms now under discussion may hamper R&D and investment in the country.

Japan Policy

Black Triangle Scheme And Formal Inspections On the Cards In Australia

New pharmacovigilance-enhancing proposals from Australia’s Therapeutic Goods Administration signal the agency’s intention to become more proactive when it comes to monitoring drug sponsors.

Drug Safety Post Market Regulation & Studies
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Europe

Set Alert for Europe

Latest From Europe

EMA Expanding Use Of Early Background Summaries To Support Initial Drug Evaluations

The European Medicines Agency is expanding an initiative in which its product team summarizes critical background information about new drugs to help the agency’s scientific committees assess initial marketing authorization application.

Regulation Europe

CHMP’s March Recommendations Include Dinutuximab, Nonacog Beta Pegol And Trumenba

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) meets monthly to review applications for centralized EU marketing authorization. Here’s a summary of their March 2017 recommendations.

Approvals Europe

India’s Micro Therapeutic says EMA’s ‘Sweep’ Suspension Will Hurt; CRO Industry Shuns ‘Bad Eggs’

Data integrity concerns continue to cloud outlook for India’s contract research sector. The European Medicines Agency’s latest action against Micro Therapeutic Research Labs suspends more than 300 products in the EU over “unreliable” data and the firm tells Pink Sheet this will result in a “considerable dent” in its operations.

Policy & Regulation Regulation

EC To Consult On Ways To Boost Generics & Biosimilars Industry, Introduce EU-wide SPC

A new package of measures from the European Commission will introduce an SPC export manufacturing waiver to help improve the competitiveness of Europe’s generics and biosimilars industry, while originator companies should benefit from steps to smooth out the rules on the “Bolar” research exemption and implement an EU-wide SPC.

Manufacturing Legal Issues

EMA To Improve Dialogue With Registry Holders To Support Drug Evaluation

The European Medicines Agency is looking at ways to promote the systematic use of patient registries to support the evaluation of the benefits and risks of medicines.

Regulation Europe

Court Decision Means Longer Wait For Clarity On EMA’s Access To Documents Policy

The EU court’s dismissal of appeals filed by the European Medicines Agency in cases relating to its access to documents policy means stakeholders will have to wait even longer to get legal clarity on the policy. One lawyer believes that the case could result in a broader definition of what constitutes commercially confidential information.

Regulation Clinical Trials
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United States

Set Alert for United States

Latest From United States

Cost Sharing Fight: PhRMA Says Insurance Design Is Real Pricing Culprit

New report finds increase in use of deductibles and coinsurance charging members list prices.

Policy Pricing Debate

User Fee Bill Could Become Ensnared In US Abortion Politics

Amendment defunding Planned Parenthood is one ACA repeal refugee that could hitch a ride with user fee bill, which would be 'problematic,' to say the least, for Democrats.

FDA Legislation

Mylan’s Generic Advair Delay Gives Leverage To Rivals

Mylan received a “complete response” letter from FDA on its application for a generic version of GSK’s blockbuster Advair, offering scarce details on the reason why or possible length of the delay.

Generic Drugs Drug Approval Standards

Ocrevus Launching Quickly Even After Manufacturing Worries Delayed US Approval

Genentech’s ocrelizumab, a CD20-directed antibody, becomes first US-approved treatment for primary progressive multiple sclerosis and is also indicated for relapsing disease. Labeling includes warnings about infusion reactions, infections and malignancy but lacks a boxed warning or REMS.

Approvals Biologics

Genentech's Subcutaneous Rituximab Breezes Through US FDA Advisory Committee

Lack of concerns about reformulation of product among either Oncologic Drugs Advisory Committee members or FDA reviewers and the decades-long existence of the molecules raises questions as to why the meeting was needed.

Advisory Committees Drug Review

US FDA And OMB Should ‘Pause’ Billion-Dollar Quality Metrics Program, Industry Groups Say

High projected cost and low perceived benefit merits further dialogue on US FDA's quality metrics initiative, industry coalition says. One group might tap into Trump administration's anti-regulatory view in advising budget office that compliance could cost industry $1bn per year. Groups question whether initiative could wind up causing drug shortages instead of preventing them.

United States Manufacturing
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