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Featured Stories


US FDA Wins Big In Shutdown-Averting Approps Bill

Agency would receive more than $268m in additional dollars for medical product and food safety as part of substantial FY 2019 increase.
FDA Legislation Regulation

Collaboration And Pay For Performance Deals – The Way To Pay for One-Off Treatments

New payment models, registries and the Cross Border Healthcare Directive could help determine new ways to pay for potentially one-off treatments such as gene therapies in Europe.

Europe Government Payers Market Access

Immunomedics Dodges Manufacturing Site Specifics In Quest For Cancer Breakthrough Approval

Biotech firm chooses words carefully to wind its way through site inspection findings and CMC review concerns in hopes of winning its first FDA approval for a breakthrough breast cancer treatment.

Quality Manufacturing Complete Response Letters

Pricing Cures For Sickle Cell Disease: Sen. Cassidy Weighs In

Price decisions based on straight calculation of medical costs avoided may overestimate value of a cure, Cassidy warns.

Pricing Strategies Legislation Reimbursement

Generic Sensipar: Cipla Challenges Legality of Amgen/Teva Patent Settlement

Cipla, which previously settled with Amgen, alleges Sensipar's formulation patent is currently unenforceable due to ‘patent misuse,’ and brand sponsor’s deal with Teva following a brief generic launch violates federal antitrust law and California state law.

Generic Drugs Intellectual Property Legal Issues
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US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – January 2019

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 Australia

Pulse Of The Industry 2018: How Medtechs Will Create Value In The New Health Ecosystem

In the 12th edition of EY’s medtech report, The Pulse of the Industry, they examine the annual performance of the medical device industry in the context of the technological advances and rising customer expectations associated with the Fourth Industrial Revolution. To thrive in this transformative age, medtechs must adapt their business models to meet the increased expectations of consumers and other health care stakeholders.

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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Checkpoint Inhibitors: US FDA Wants Consistent Adverse Event Definitions

Label writing is difficult because sponsors are collecting varying adverse reaction data, agency officials say.
Drug Safety Cancer Biologics

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

J.P. Morgan Roundtable: The Regulatory Role In Accelerating Complex Therapies

Companies working on cell and gene therapies and novel approaches to neurological diseases participated in a roundtable discussion during the J.P. Morgan Healthcare Conference about how regulators are supporting novel modalities, which in turn improves investor and partner sentiment.

Regenerative Medicine Research and Development Strategies

Australia Considers Identifying Drugs Filed For Approval

The Therapeutic Goods Administration wants to know whether, and how, it should disclose the fact that a medicine has been accepted for regulatory review. It has put several options to stakeholders, including disclosure for all medicines or only certain kinds, or keeping the current practice of “neither confirm nor deny.”
Approvals Drug Review

Latest From Policy

Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Infectious Diseases Reimbursement

EU Cross-Country Coalition Targets New Products For Joint Pricing Talks

The BeNeLuxAI initiative was among the many topics covered at the DIA Europe 2019 conference in Austria last week. The cross-country coalition has some new drugs in its sights for joint pricing talks and the conference was given an insight into the workings of the collaboration by a Belgian health department advisor close to the initiative.

Health Technology Assessment Pricing Debate

Ways And Means Drug Pricing Hearing Emphasizes Repetitive, Years-Old Questions

There was little on specific legislative proposals and a lot of time discussing broad questions that Congress has been asking for years about drug pricing.

Pricing Debate Legislation

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Infectious Diseases Reimbursement

Real-World Evidence Takes Courage: A Conversation With IQVIA’s Nancy Dreyer

Emerging standards for regulatory use of RWE should resist the temptation to impose the standards and expectations of randomized clinical trials to a fundamentally different kind of evidence, Dreyer cautions.
Digital Health Drug Approval Standards

FDA's Real World Study On Adoption Of PD-1 Dosing Change Aims To Inform Reviewers

Study using US FDA’s Information Exchange and Data Transformation (INFORMED) program will focus on shift from weight-based to flat dosing for Opdivo and Keytruda.

Clinical Trials Research and Development Strategies

Commercial Explore this Topic

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Latest From Commercial

Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Infectious Diseases Reimbursement

Puma Beats Most Of Stock Drop Suit Over Nerlynx Study Statements

Jury finds one comment in an investor call was false or misleading, limits damages award to $4.50 per share, or $64,000 for the lead plaintiff, a fraction of what was sought. Case suggests that sometimes taking a stock drop case to trial may limit liability.

Legal Issues BioPharmaceutical

Poland Kick Starts 2019 With Three Rx-To-OTC Switches

Clotrimazole, pyrantel, and ciclopirox olamine have been switched from prescription-to-OTC status by Poland's national drug regulator.
Poland Prescription To Otc Switch

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA Launches Pilot To Gain Practical Experience With 'Established Conditions' In Quality Assessments

FDA is accepting applications from the pharmaceutical industry to pilot the use of established conditions proposed by sponsors in NDAs, ANDAS, BLAs and supplements. The purpose of the pilot is for FDA to gain practical experience in assessing proposed established conditions and to ensure that assessment decisions do not negatively impact user fee time frames.

Manufacturing Quality

Deal On European SPC Manufacturing Waiver Is An Acceptable Compromise

A deal on the European supplementary protection certificate manufacturing waiver has been agreed by the European Council, Parliament and the European Commission, providing a concrete path for a regulation to move forward, albeit with compromises on several key provisions. Meanwhile, the European off-patent and brand industries remain at odds over the benefits of the waiver.

Europe Intellectual Property

FDA Proposes To Rely On Industry-Driven Consensus Quality Standards In New Drug Reviews

FDA’s drug center has proposed a new program that would allow pharmaceutical manufacturers to attest that drug products submitted for review conform to certain consensus quality standards. The agency said that such a program would improve drug quality, encourage the development of emerging technology and ensure smoother drug reviews.

 

Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Moberg Sells Consumer Health Portfolio To Pay For Rx Research Focus

Moberg had been expanding its OTC portfolio while also continuing trials for Rx ingredients including its MOB-015 formulation of terbinafine indicated for fingernail and toenail fungus. But $155m agreement with two investment groups will complete Moberg's divestment of consumer health brands.
OTC Drugs Consumer

Pfizer Consumer Health True To Form Pending Move To JV With GSK

Pfizer consumer health sales up 4% to $3.6bn in 2018 as it prepares to move business into JV with GSK anticipated to close in the second half of 2019. Following 2% growth in 2017, a flat year in 2016 and a dip in 2015, Pfizer's view is confirmed of consumer health as a reliable revenue stream but not a strong growth driver.

Consumer OTC Drugs

Biotene OTC Dry Mouth Competitor Remains On Market As GSK Litigates

Former Biotene owner Laclede ordered by US federal judge to stop using brand, now owned by GSK, to promote its competing line of Salivea dry mouth products. But judge rejected GSK’s request that the Salivea dry mouth product marketers are subject to a lifetime non-compete agreement.

Consumer Legal Issues
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