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Regional Coverage

Asia Pacific

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Latest From Asia Pacific

Global Pharma Guidance Tracker – November 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

The Quality Lowdown: Spanish Falsification, Czech Mold And Dutch Contamination Cited After EU Lull Ends

Barcelona’s Union Quimico, Czech Republic’s Vakos and The Netherlands’ Pharma Essentials among those cited as the EMA ramps up in Amsterdam.

Enforcement Manufacturing

Hello NMPA: China Approval For Astellas's Xtandi, Keytruda Set For Fourth Indication

Astellas’s Xtandi gets its latest approval in China, where Merck’s Keytruda is set for another win.

China Regulation

Zydus Cadila’s New Injectables Plant Could Help Blunt US Drug Shortages

Site switch also could trigger ANDA approvals sidelined as Moraiya plant recovers from US FDA warning letter.

Manufacturing Quality

Cadila Shifts US Injectables Production From Plant After Tough FDA Inspection

Expert investigators found many problems at Ahmedabad plant, warning letter and Form 483 report show.

Enforcement Manufacturing

Vaccine Maker Bankruptcy Shows Regulatory Perils Of Business In China

China's Changchun Changsheng Biotech has been officially declared bankrupt, ending long-running speculation. The major vaccine maker’s dramatic fall has several take-away lessons for health companies operating in China, where several new regulations are taking effect.

China Business Strategies
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Europe

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Latest From Europe

EMA Prepares Approval Verdict On Beovu, Idhifa, Recarbrio

Products from Novartis, Celgene and Merck could get an EU approval recommendation at this week's CHMP meeting.

Drug Review Europe

New EU Commissioner Outlines Plans To Tackle Shortages

The EU’s new health commissioner, Stella Kyriakides, has outlined the commission’s plans for dealing with medicines access issues in the EU member states. They include completing the review of the EU pediatric and orphan legislation and developing a new strategic plan to tackle shortages and affordability problems next year.

Europe Market Access

Sticking To Nitrosamine Evaluations Deadline Is Priority For EU Regulators

EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.

Europe Manufacturing

Scottish HTA body OKs Lynparza For Earlier Use In Ovarian Cancer

AstraZeneca’s Lynparza can now be used on the Scottish National Health Service for newly diagnosed advanced ovarian cancer.

United Kingdom Health Technology Assessment

Orchard’s Gene Therapy Under Fast-Track Review At EMA

A handful of new products are under review at the European Medicines Agency. Orchard Therapeutics' gene therapy application will be fast-tracked; Roche's filing for its new flu treatment will not.
Drug Review Europe

Patient Voice Makes Impact In Scientific Advice From EU HTA Network

The EU network of health technology assessment bodies says it is seeing the benefit of systematically involving patients when companies approach it for early scientific advice on evidence generation.

Health Technology Assessment Regulation
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United States

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Latest From United States

Keeping Track, Oncology Edition: Biologic Breakthroughs And BLAs

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

US FDA Performance Tracker Cancer

Brinavess Rejected By Advisory Cmte., Leaving US FDA To Mull Lifting Clinical Hold On Correvio's AFib Drug

Cardiovascular and Renal Drugs Advisory Committee voted 11-2 against approval for Correvio's atrial fibrillation drug Brinavess over cardiovascular safety concerns; the agency would have to lift the long-standing  clinical hold on the drug before the company can do any further study in humans.
Advisory Committees Cardiovascular

Biologic Exclusivity Provision In USMCA Is Boon To Generics Industry; BIO Is 'Tremendously Worried'

Revised North American trade deal touted as enabling Congress to address crisis of high drug prices; requirement for 10 years biologic exclusivity is removed and language to allow incentives for generics added.

Trade Intellectual Property

US FDA Could Use More Foreign Investigators If It Could Find Them, Woodcock Says

Hiring travails, inspection pre-announcement, lack of translators highlighted in congressional hearing on FDA foreign inspections.

Enforcement Manufacturing

US FDA Pushes Back Against Critics: Breakthrough Is Not A Drug 'Beauty Contest'

Richard Pazdur, FDA's oncology chief, reiterates the breakthrough therapy designation is for agency-sponsor communication and not an investor tool.

Drug Review FDA

US FDA's Office Of New Drug Leaders Listen To Stakeholders

Twenty-five officials of FDA's Office of New Drugs gather to hear recommendations from stakeholders on what they can do to improve drug development programs.
FDA Drug Review
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