Pink Sheet is part 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

Regional Coverage

Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

Gene And Cell Therapies In Asia: Pricing, Manufacturing Stand-Out Issues in Supportive Japan Ecosystem

The Japanese environment for cell and gene therapies and regenerative medicine in general continues to be highly supportive. But will pricing pressures under the NHI scheme move to the fore as more expensive products come to market?

Japan Gene Therapy

China Coronavirus Outbreak Response Critical As First US Case Confirmed

A quickly spreading coronavirus outbreak in China could upend the country’s healthcare priorities as the health regulators and reimbursement agency officials gear up to “control and prevent” the worst public health emergency since the deadly SARS outbreak in 2003.

China Infectious Diseases

India Rare Disease Policy Proposes Crowdfunding But Patients Feel Let Down

Draft policy moots crowdfunding for high-cost rare diseases alongside financial support for those "amenable to one-time treatment" but falls way short of some patient groups' expectations.

India Policy

Australian Fees To Rise As Drug Registrations Decline

The Therapeutic Goods Administration says that its cost-recovery fees need to go up, mainly because of a fall in the number of medicines on the therapeutic products register. It is also seeing a rise in the cost of the fee-free services it provides.

Australia Regulation

China Commits To Patent Linkage And Extensions In US Trade Deal

The first phase of a major trade agreement just signed by the US and China obliges the latter to implement a system linking pharma patent enforcement to marketing authorization procedures as well as to offer patent-term extensions. 

 
Intellectual Property Trade

India 2019 – R&D Highs, Compliance Woes And Other Lows

2019 saw Indian companies advance innovation efforts and build and expand their specialty portfolios and biosimilars businesses. But manufacturing compliance issues weighed down several firms while on another front charges against the Singh brothers of Ranbaxy escalated.

India Regulation
See All

Europe

Set Alert for Europe

Latest From Europe

Big Win For EMA On Transparency

The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.

Europe Clinical Trials

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

Drug Review Europe

England’s NICE Future Proofs Approach To Using Data

UK HTA body NICE is looking to the future and rethinking its approach to data and how they inform its guidance.

Europe United Kingdom

EU Countries Test Offering Simultaneous Scientific Advice

An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.

Innovation Regulation

EMA Suspends Leo’s Actinic Keratosis Drug Picato

The latest drug safety actions by the European Medicines Agency affect products for dermatological use and vaginal atrophy.

Europe Drug Safety

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with seven new products including Roche's Polivy for treating diffuse large B-cell lymphoma. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

Approvals Europe
See All

United States

Set Alert for United States

Latest From United States

‘Real World’ Opioid Abuse Data On OxyContin Again Under Review At US FDA

Resubmission comes more than four years after Purdue pulled an sNDA seeking to demonstrate ‘real-world’ abuse prevention.

Real-World Evidence Neurology

Vaccines Boost Priority Profile Of US FDA’s Biologic Center 2019 Approvals

Tropical diseases were not neglected by the Center for Biologics Evaluation and Research in 2019, producing three novel vaccines (which earned three priority review vouchers) and tilting the approval class toward expedited review programs.

Vaccines Pink Sheet Perspectives

US FDA ‘Public Health’ Approach To Opioids May Open Up Pricing Debates

Latest effort by FDA to re-set reviews for novel opioid analgesics is off to a rocky start after three advisory committee reviews. One unintended consequences may already be apparent: by taking a broad, public health perspective on new formulations, the agency may be inviting arguments based on price.

Neurology Pricing Debate

Postmarketing Trial For Horizon Thyroid Eye Drug Tepezza To Be Larger Than Expected

Horizon CEO says safety trial will be conducted in a larger patient population following discussions during the US FDA advisory committee meeting.

Post Market Regulation & Studies Approvals

Price Inflation Rebates And The Spectre Of 100% Discounts In Medicare Part D

Medicaid programs are essentially getting Humira for free, in large part because of price inflation rebates, according to estimates by Bernstein analysts. Legislation pending in the US Senate wants to bring that dynamic to Medicare.

Pricing Strategies Legislation

Complex Generic Approval Delays Getting Congressional Attention

US Energy and Commerce Committee leaders request data on complex generic approvals, guidances, saying additional changes may be needed for faster approvals.

Generic Drugs Legislation
See All
UsernamePublicRestriction

Register