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Featured Stories


Medicare Coverage For CAR-T Will Require Additional Patient Data Collection

National coverage decision does not limit Medicare payments to labeled indications or site of care. CMS expects to “leverage” existing FDA post-market data collection requirements but seeks additional data on patient-reported outcomes in some cases.

Medicare Reimbursement Cancer

UK Industry Skeptical Of Govt’s No-Deal Brexit Filing Expectations

The BioIndustry Association’s latest Brexit webinar looked at issues such as companies’ drug filing strategies in a no-deal scenario as well as the costs that industry is likely to incur as a result of changes to regulatory processes.

United Kingdom Brexit Regulation

Heart Rhythm Concerns Prompt EU-Wide Suspension For Fenspiride Cough Medicines

Fenspiride medicines are being suspended while the European Medicines Agency's pharmacovigilance committee carries out an urgent safety review to address concerns that these drugs can cause sudden serious heart rhythm problems.
Drug Safety Respiratory Europe

ANDA Sponsors In Drivers Seat For Competitive Generic Therapy Exclusivity

Draft guidance says US FDA will not assume a product has launched, the final requirement to receive the promised 180-day exclusivity, unless notified by the sponsor.
Generic Drugs Review Pathway Regulation

Wait For Benefits Of EudraVigilance Pilot Before Expanding To More EU Products, Says Pharma

Drug companies say that any decision on taking the EudraVigilance monitoring requirements into the next phase should only be made when there is clear evidence that it has improved patient safety.
Europe Regulation Safety
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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

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 Manufacturing

Latest From Regulation

France Invites Advanced Therapy Makers To Use Fast-Track Trial Approval Pathway

Updated guidance on France’s experimental fast-track procedure for approving clinical trials shows that the pathway has entered a new phase.

France Clinical Trials

EU ‘Big Data’ Report: Big Opportunities – And Big Challenges

EU regulators have produced the first fruits of their ambitious “big data” project aimed at ensuring that the EU drug regulatory system can make full use of the rapidly increasing volume and complexity of data being gathered across multiple settings in the healthcare area.

Europe Regulation

Keeping Track: Rebuff Of Iclaprim Creates Early Pileup Of CRLs For Novel Drugs

The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA Performance Tracker 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

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

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

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

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

Manufacturing Explore this Topic

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Latest From Manufacturing

How One Biotech Venture Is Breaking The Cost Barrier In Manufacturing MAbs For Infectious Diseases

Biotech official explains how creating partnerships with NGOs, using innovative cell cloning technology and cutting costs is allowing startup to develop new monoclonal antibody treatments for infectious diseases in developing countries, including a new MAb for Ebola.
Manufacturing Quality

Regenerative Medicine Therapies: Manufacturing Changes May Not Impact RMAT Designation

Final guidance notes that preliminary clinical evidence may come from studies conducted outside the US, says historical controls may be considered in clinical trial designs.

Clinical Trials 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

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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