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


Mylan Scores IPR Victory, Paving The Way For Follow-On Lantus

US Patent and Trademark Office invalidated two patents covering Sanofi's Lantus vial, clearing the way for Mylan to launch a follow-on product after FDA approval.

Biosimilars Metabolic Disorders Intellectual Property

US FDA May Ask Congress For More Resources After Withdrawing Generic Label Reg

Label updates for older generics are still planned, Commissioner Gottlieb says, but will depend more on sponsor collaboration as well as additional resources and authorities from Congress.
Generic Drugs FDA Regulation

Has R&D Productivity Rebounded? US FDA Officials Think So

Record-setting pace of NME approvals is a cause for celebration. But is it a sign that drug industry R&D productivity has actually improved? The US FDA’s top drug review official thinks so – but the data aren’t yet clear.
Drug Review FDA Regulation

UK Inquiry Into ‘Unfair’ Orkambi Pricing Risks Pricing Confidentiality

The UK government has criticized Vertex for the company’s approach to pricing its cystic fibrosis drug Orkambi. In the meantime, a parliamentary inquiry that could expose sensitive pricing details moves forward.

Europe United Kingdom Cost Effectiveness

EMA Clarifies Sponsor Role In Contracting For Investigator Sites

The European Medicines Agency has made it clear that all clinical trial-related medical activities are the responsibility of the investigator and that a sponsor cannot contract these to a third party. Also, the EMA discourages performing trial procedures at a patient's house, unless duly justified.
Europe Clinical Trials Regulation
Advertisement

US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – November 2018

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 Belgium

Global Generics & Biosimilars Awards 2018

Generics bulletin was able to celebrate the outstanding progress that both teams and individuals achieved in providing greater healthcare access through generic, biosimilar and value-added medicines. Many of these achievements have been documented in Generics bulletin. Click below and enjoy the selection of articles that reflect the wide array of industry activities.

Read more

Pharma Report Store

Have an immediate and specific information need?

Browse and buy from 1000s of analysis and research reports now:

Shop Now

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Cost Concerns May Hinder Naloxone Co-Prescribing Ideas

US FDA estimates mandating naloxone co-prescriptions could dramatically increase spending to more than total estimated cost of opioid crisis itself; joint advisory committee to consider options to increase naloxone availability.
Neurology Pricing Debate Advisory Committees

Latest From Regulation

Warnings Up As US FDA Trims List Of Uninspected OTC Drug Manufacturers

Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.

Consumer Enforcement

EU Drug Filings To Fall Slightly In 2019, But Scientific Advice On The Up

The EMA expects initial applications for drug approvals to decline slightly next year, with the budget also down a little because of Brexit uncertainty. The agency's management board reported on its visit to the agency’s future home in Amsterdam. 
Drug Review Regulation

Two Orphans And An Avastin Biosimilar Among EU Approval Recommendations

Seven new drug applications got the thumbs up this week from the EMA's drug evaluation committee, the CHMP.  Their EU approval should now be a formality. Two new Shionogi treatments are set for approval, as are two orphan products – one from Medac, the other from AOP Orphan Pharmaceuticals. Pfizer got the OK for one biosimilar but has withdrawn its application for another.

Europe Regulation

Latest From Policy

Infectious Diseases Proposed As Focus Of Inter-Korea Health Cooperation

Amid ongoing talks to denuclearize North Korea, the two Koreas are gearing up for bilateral cooperation in various industries including the health and medical sector, if and when international sanctions on the North are lifted. A new report suggests possible ways the two sides can initially work together in the area, with a focus on infectious diseases.

South Korea North Korea

Revamped Cancer Drugs Fund Means More Positive Recommendations, Says NICE

NICE, the health technology appraisal body for England and Wales, has rejected criticism that access to cancer drugs is worsening in the UK. The institute pointed to the revamped Cancer Drugs Fund which it said meant more positive recommendations.

Europe United Kingdom

Older Patents Get Help As Federal Circuit Sides With Novartis In Gilenya, Everolimus Disputes

US court finds no obviousness-type double patenting under statute that changed patent term from 17 years from issuance to 20 years from filing; decisions will impact other cases involving patents issued prior to statute.
Generic Drugs Legal Issues

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Major Depressive Disorder Patients Emphasize Long-Term Nature Of Disease In Feedback Meeting

Externally hosted patient focused drug development meeting in MDD brings timely messages to US FDA during period of active regulatory review of new applications. Patients stress need for fewer side effects to encourage long-term medication use, and also want fast-acting meds that can “jump start” lifestyle changes. 
Neurology Research & Development

A Call To Action On Antibiotic Development

Recent comments by US FDA’s top infectious disease review manager about the need for new ideas to incentive development of antibiotics should be a call to action for biopharma companies and patient advocates who do not normally consider infectious disease as part of the portfolio.
Research & Development Reimbursement

NASH Drug Development Guidance Encourages Sponsors To Adopt Innovative Trial Designs

Although guidance appears to be free of surprises, US FDA once again made a push for sponsors to adopt seamless trial designs.
Clinical Trials Liver & Hepatic

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

Warnings Up As US FDA Trims List Of Uninspected OTC Drug Manufacturers

Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.

Consumer Enforcement

CVS ‘Guaranteed Net Cost’ Program Is Alternative To High Price/High Rebate Model

Program likely to generate fewer rebates so it remains to be seen whether payers will embrace the new model in a big way.

Pharmacy Benefit Management Reimbursement

P&G's Personal Health Sector Has Merck Consumer Chief As International Head

P&G names Merck KGAA consumer chief Uta Kemmerich-Keil to lead international division of personal health business as it closes on $4.2bn acquisition of German firm's consumer business. Deal closes a month after P&G announced biggest changes to organizational structure in 20 years, including combining personal care and health care into personal health and forming six global units, each headed by a CEO.

International Germany

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Warnings Up As US FDA Trims List Of Uninspected OTC Drug Manufacturers

Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.

Consumer Enforcement

New Russian Quality Assurance Rules Could Push Up Costs & Delay Product Launches

New rules aimed at tightening quality control on medicines that are to be introduced in Russia next year are expected to help prevent low-quality drugs getting to the market. However, they will bring some additional costs for pharmaceutical companies. It is also being suggested they could lead to delays in product launches.

Regulation Russian Federation

US FDA Warning Letter Hits Huahai For Failure To Prevent Valsartan Contamination

Zhejiang Huahai should have realized its valsartan API was tainted by the probable carcinogen NDMA, FDA says in warning letter, despite earlier statement from agency leadership to the contrary.

Enforcement Manufacturing

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Warnings Up As US FDA Trims List Of Uninspected OTC Drug Manufacturers

Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.

Consumer Enforcement

Crown Labs Spreads Out, GSK Narrows Focus In OTC Skin Care Brand Deal

GSK further narrows consumer health focus with sale to Crown Labs of North American distribution rights for PanOxyl acne wash, Sarna anti-itch lotion, Zeasorb anti-fungal product, Desenex athlete’s foot treatment and Mineral Ice pain-relieving gel. Deals also helps UK pharma pay for its $5.1bn acquisition of oncology drug firm Tesaro.

Dermatology M & A

P&G's Personal Health Sector Has Merck Consumer Chief As International Head

P&G names Merck KGAA consumer chief Uta Kemmerich-Keil to lead international division of personal health business as it closes on $4.2bn acquisition of German firm's consumer business. Deal closes a month after P&G announced biggest changes to organizational structure in 20 years, including combining personal care and health care into personal health and forming six global units, each headed by a CEO.

International Germany
UsernamePublicRestriction

Register

Advertisement