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Featured Stories


Real-World Evidence Challenges: Death Among Toughest Data Points To Measure

Death typically is not included in electronic health records, and sources are disparate; Difficulties with endpoint expose potential limitation to real-world evidence use.

Clinical Trials Research and Development Strategies Drug Approval Standards

Trade War Spreads: Trump Rains On China Biotech Investment Parade

The music is ending and the party may be over; Chinese biotech investment could soon face heightened scrutiny from the Trump administration.

China Financing Policy

UK MHRA Spells Out Do's And Don'ts Of Real-World Evidence For Showing Efficacy

A senior UK regulator explains why the MHRA agreed to a complex real-world evidence study instead of an RCT to demonstrate a drug's efficacy, despite the challenges posed by potential for bias.
United Kingdom Clinical Trials Regulation

The Quality Lowdown: A Week Of International Intrigue

Or perhaps it's been a week of intriguing international events in global drug quality, as an international group works to ratchet up global standards, regulators aim to ease the coming UK/EU divorce and the US and China play their hands in a tariff poker match. Meanwhile, US FDA looks to avert labeler code crisis, Quebec API firm comes clean about missing identity testing, and US firm recalls drug product based on FDA’s API supplier inspection findings.

Quality Manufacturing Compliance

Stand-Off: Vertex Refuses NICE Data on CF Drug Symkevi, HTA Body Awaits Next Move

Vertex says it will not file data on its cystic fibrosis drug Symkevi (tezacaftor/ivacaftor) until the UK's NICE changes the way it assesses drugs.

Approvals Commercial Companies
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US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – July 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.
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Generics In The US 2018

Read this eBook and learn more about the West AccelTRA elastomer components program that was designed to help in this effort. Learn how the AccelTRA component program has been helping generic biopharmaceutical manufacturers by providing a number of key features, for those high-volume products and where manufacturers would like to deal mostly with one high-performing elastomer component.

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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Genentech Wins Attorneys' Fees After Phigenix's Aggressive Patent Suit

"Tipping point" occurred when Phigenix changed theory that Genentech's Kadcyla infringed its patent; CEO may be on hook for attorneys' fees.

Legal Issues Intellectual Property Policy

Latest From Regulation

WHO Consults On New Measures To Improve Medicines Access

A draft roadmap lists initiatives to be undertaken between 2019 and 2023 to help improve access to medicines and vaccines. 
International Market Access

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.
European Performance Tracker Drug Review

Insmed's Amikacin Has US FDA Questioning Microbiological Endpoint Vs. Clinical Benefit

Whether converting positive sputum culture to negative will lead to an improvement in how a person feels, functions or survives is at the heart of agency’s review of Insmed’s amikacin liposome inhalation suspension for accelerated approval in mycobacterial lung disease.


Advisory Committees Drug Review

Latest From Policy

ICER’s 2019 Agenda Includes CAR-T Therapy, Drugs For Depression, Arthritis, AMD

Proposed list of topics for review in 2019 by the Institute for Clinical and Economic Review includes a total of 15 drugs but that could change as the year goes on.

Policy Cost Effectiveness

Korea May Adopt Further Cost-Containment Steps Under 'Moon Jae-In Care' – IQVIA

Korea is expected to feel the pressure to introduce more drug cost-containment measures amid rapidly rising National Health Insurance expenditures, IQVIA predicts. In particular, expenses associated with implementation of 'Moon Jae-in Care' could erode NHI financial surpluses in the short-medium term.
Policy Legislation

Biosimilar Litigation Trends: Settlements, Declaratory Judgment Rejections, Congressional Intervention

Of the 27 suits brought so far, four have resulted in patent settlements; restarting patent dance is new trend for ongoing litigation.

Biosimilars Intellectual Property

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Fauci: Concerns About Exclusive Licensing Of Government-Developed Products Are Misguided

NIAID director says granting exclusive licenses to drug companies is necessary for late-stage development and production of government-developed products. 
Vaccines Research & Development

Two Neurodegenerative Disease Drugs Secure EMA's Coveted PRIME Designation

What is claimed to be the first therapy targeting the underlying cause of Huntington’s disease and a gene therapy for Lorenzo’s Oil disease have become the latest investigational products to make it onto the European Medicines Agency’s priority medicines scheme.

Europe Innovation

Celtaxsys To Hash Out Phase III Cystic Fibrosis Endpoints With US FDA

Private start-up's acebilustat failed to improve lung function in Phase II, but the anti-inflammatory showed large numerical reductions in pulmonary exacerbations, which can be fatal.

Rare Diseases Clinical Trials

Commercial Explore this Topic

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Latest From Commercial

Perrigo's OTC Core Could Expand To Include National Brands

Submitting an OTC switch of Nasonex would be a first for Perrigo, as would marketing a national brand OTC if the switch is approved. In tandem with announcing divesture of Perrigo's Rx business, CEO Uwe Rohrhoff says marketing national brands in some OTC categories fits in the company's "value-creation road map."

Prescription To Otc Switch Advertising, Marketing & Sales

Step Therapy For Medicare Part B Drugs Will Lower Costs By 20%, HHS Projects

Beginning in 2019, Medicare Advantage plans may use step therapy in Part B, potentially including “cross management” with Part D drugs, under new guidance from the Centers for Medicare and Medicaid Services.

Pricing Debate Medicare

Reckitt Ups 2018 Guidance On Mucinex 'All-In-One,' China Platform Gains

Max Cold & Flu All-In-One is the first Mucinex product providing an “all-in-one-and-done proposition" and is expected to offset the impact of private label products. Mucinex plus growth and expansion plans for infant formula spark increase in firm’s 2018 forecast.

China Consumer

Manufacturing Explore this Topic

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Latest From Manufacturing

Chinese API Maker Blasted For Failing To Document Equipment Cleaning And Lax Stability Testing Practices

FDA chastised Chinese API maker for inadequate cleaning validation, failing to ensure that products are manufactured in a state of control, and lax stability testing practices. The agency noted that the firm did not learn from observations the agency made of similar mistakes during previous inspections.

United States Manufacturing

Probable Carcinogen Found Haunting More Firms’ Valsartan API

As Zhejiang Huahai works to rid its valsartan API manufacturing process of NDMA impurity, two competitors also have launched recalls after discovering the probable carcinogen in their valsartan API. Meanwhile, US FDA confronts Huahai over handling of impurities that visited chromatograms in the form of ghost peaks.

Manufacturing Quality

FDA's Final Guideline Standardizes Dissolution Testing For Highly Soluble Drugs

FDA guidance aims to establish uniform dissolution testing methods for highly soluble immediate-release solid oral dosage forms.

Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

OTC Private Labelers Recall CVS, Walmart Brand Products

Recalls include one lot of CVS Health Sinus Relief manufactured by Product Quest Manufacturing, Walmart's Equate laxative made by Lupin's US office and 12 cough and cold products marketed under Preferred Plus Pharmacy and other private label brands and made by RIJ Pharmaceutical Corp. Chart provides update on recent US OTC recalls.

Consumer Recalls

Bausch Health Boosts Ad Spending For Expanding OTC Eye Care Lineup

"We're investing more to drive growth as we allocate capital to support the launches of new products in the segment like Lumify, for DTC advertising that continue to drive sales growth of other US consumer products like our eye vitamins," says CEO Joseph Papa.

Consumer Ophthalmic

Perrigo's OTC Core Could Expand To Include National Brands

Submitting an OTC switch of Nasonex would be a first for Perrigo, as would marketing a national brand OTC if the switch is approved. In tandem with announcing divesture of Perrigo's Rx business, CEO Uwe Rohrhoff says marketing national brands in some OTC categories fits in the company's "value-creation road map."

Prescription To Otc Switch Advertising, Marketing & Sales
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