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


EMA Set For More Staff Losses & Activity Cuts Next Year

The latest EMA management board meeting heard an update on the situation regarding Brexit-related staff losses and recruitment, and was told that an additional set of temporary suspensions or reductions in its activities might be necessary from the beginning of 2019.
Brexit Regulation Europe

US FDA's Gottlieb Shuts The Door On Exclusivity For 'Transition' Biologics

With an eye toward interchangeable insulins, FDA commissioner says existing protein products that will be 'deemed to be licensed' as biologics in March 2020 will not gain any additional exclusivity; coupled with the loss of existing unexpired exclusivity, the decision may spur innovator lawsuits against the agency for an unconstitutional 'taking.'

Biosimilars Biologics Regulation

Brexit Delays Key ATMP Guideline Update – EMA Says Perhaps Not So Bad

The European Medicines Agency's proposal to revise its decade-old guideline on safety and efficacy follow-up and risk management of advanced therapies has generated keen interest among stakeholders. The update of this key guideline, however, is on hold due to Brexit. 
Europe Brexit Regenerative Medicine

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 Cancer

Counter-Intuitive Thinking To Combat Drug Shortages

Search for solutions to chronic drug shortages may require policymakers to push for payment policies that run counter to the current drug pricing themes, like retrofitting US Medicare’s New Technology Add-On Payments to apply to old, off-patent therapies.
Generic Drugs Manufacturing Reimbursement
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

When Drugs Become Biologics: US FDA Guidances Explain 'Transition Provisions'

With two new guidance documents, agency is trying to bring order to the potentially chaotic regulatory process that insulins and other currently approved protein products will face in March 2020; FDA also issues two more Q&A guidance documents on scientific and regulatory considerations for biosimilars.

Biosimilars Biologics Regulation

Latest From Regulation

Medicare Part D ‘Enhanced MTM Model’ Saves $325m In First Year

US Centers for Medicare and Medicaid Services announces first-year results from its medication therapy management model, intended to optimize prescription drug use among Medicare beneficiaries.

Medicare Reimbursement

CHMP Meeting Under Way: Who Will Pass Muster This Month?

With its final meeting of the year under way, the EMA's medicines evaluation committee, the CHMP, will bring seasonal cheer for some companies if it decides their products merit EU approval. New treatments from Shionogi and Medac are up for an opinion. Portola is due to appear before the panel to answers questions relating to its marketing application for AndexXa but will the CHMP decide this week or not? 
Europe BioPharmaceutical

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

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

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

Biosimilar Litigation Settlement Score Card: Genentech-Pfizer Herceptin Agreement Is 10th Deal

Genentech inks second settlement of trastuzumab biosimilar litigation; suits ongoing against Amgen, Celltrion/Teva, and Samsung with joint claim construction proceedings.

United States BioPharmaceutical

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

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

Pfizer Decides Not To Challenge AbbVie's Humira Biosimilar Patents

Pfizer is the seventh company to enter licensing agreement with AbbVie; it has completed development program for its adalimumab candidate.
Biosimilars Commercial

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Industry Advised To ‘Lawyer Up’ If Serialization Systems Don’t Comply With DSCSA

Drug makers must comply with draft FDA guidance on Drug Supply Chain Security Act serialization requirements that took effect Nov. 27 or else “lawyer up” to explain to the agency why their products are not serialized in accordance with it, pharmaceutical lawyer advises.
United States Manufacturing

US FDA To Rely On Inspections From More European Countries

The US Food and Drug Administration can now rely on the results of GMP inspections from 20 EU member states after confirming that five more countries have been deemed suitable for inclusion in its mutual recognition agreement with the EU.

Europe US States

Beefed-Up SPC Manufacturing Waiver Gains Traction In European Parliament

A proposal to allow generics firms to manufacture versions of supplementary protection certificate-protected medicines in preparation for EU launch immediately on SPC expiry is making progress through the European parliamentary process, to the delight of the generics industry – and the dismay of originator companies.
Europe Intellectual Property

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

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

Coppertone, Dr. Scholl’s On The Block As Bayer Narrows Consumer Health Focus

Bayer will sell Coppertone sunscreen and Dr. Scholl’s foot care brands to focus on growing its core consumer health brands. Although the plan represents ‘failure” in turning around sales for both brands, it is a ‘sensible’ move, say analysts.

Commercial M & A
UsernamePublicRestriction

Register

Advertisement