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Regional Coverage

Asia Pacific

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Latest From Asia Pacific

Australia Consults On Adopting EU Extrapolation Paper And Other Guidelines

The Australian regulator has proposed adopting several European Medicines Agency guidelines. For some of these guidelines, the Therapeutic Goods Administration has added its annotations.
Australia Europe

FDA Action Awaits Lupin Sites As Compliance Cloud Lingers

Lupin continues to face the heat for compliance deviations at its manufacturing plants, with the FDA now issuing an official action indicated inspection classification for two of the Indian company's sites. Lingering negative sentiment and remediation costs are some aspects that investors may need to brace for.
Manufacturing Quality

Draft Indian Guide Offers Predictable Regulatory Pathway For Nanopharmaceuticals

While India will continue to apply a case-by-case approach to evaluate nanopharmaceuticals, it has issued draft guidance on the minimum information that sponsors must include in their marketing authorization applications.
India Regulation

Clinical Trial Data Highlight Korean Pharma’s R&D Shift Into Innovation

New clinical trial approval data show that early-stage studies of novel drug candidates by South Korean pharma and biotech firms sharply increased in 2018, underlining the industry’s ongoing shift towards innovation. Trials of oncology drugs continued to dominate, while clinical work in rare disorders such as hemophilia and Crohn’s disease has noticeably increased.

South Korea Clinical Trials

PMDA Chief Defends Japan Spinal Cord Therapy Approval

The head of Japan’s drug and device regulator has defended and supported the country’s recent world-first decision to grant approval to a novel cell-based therapy for spinal cord injuries, saying that patient considerations came first.

Japan Drug Safety

MHRA Reinforces Brexit Road-Map, Indian Firms Expect Tough Transition

The MHRA highlighted at a recent conference in India the key changes that await pharma in the event of a no-deal Brexit, and the agency’s general readiness in that scenario, including putting in place its own IT systems such as a UK national replacement for the EudraGMDP.
Regulation Review Pathway
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Europe

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Latest From Europe

Health Technology Assessments And the Trouble With Rare Disease Treatments

To get their gene or cell therapies through health technology appraisals, companies need to agree to gather longer-term evidence, be upfront about what treatments can really deliver and remember to ask for patient input.

Europe Health Technology Assessment

Only One In Seven PRIME Applications Meet EMA Test

Of the 14 applications for entry onto the European Medicines Agency’s priority medicines scheme during the first two months of 2019, only two – from AstraZeneca and Freeline – made the grade.
Europe Market Access

Danish Agency Claims A First In Raw Data Analysis

The Danish Medicines Agency says it is about time that EU regulators developed US FDA-style capabilities to analyze raw data so that they can make better use of the opportunities provided by big data. Agency chief Thomas Senderovitz tells the Pink Sheet how Denmark is setting up a unique data analytics center for drugs and devices without reinventing the wheel.
Denmark Europe

‘Keep Planning For No-Deal Brexit,’ UK Govt Tells Pharma As Chaos Grows

Amid the growing mayhem in parliament over the Brexit process, life science companies have been advised to continue preparing for the possibility that the UK might leave the EU without a deal at the end of next week. 
United Kingdom Brexit

Italy Moves To Raise Biosimilar Use And Awareness

The use of biosimilars is growing in Italy, but the authorities want their market share to rise further and so the regulator has set up a dedicated webpage to explain the biosimilar concept more clearly to doctors and the general public and to help dispel any remaining doubts about their safety and efficacy. The aim is to increase awareness and use of biosimilars and rationalize state spending on biologic medicines.

Italy Biosimilars

Australia Consults On Adopting EU Extrapolation Paper And Other Guidelines

The Australian regulator has proposed adopting several European Medicines Agency guidelines. For some of these guidelines, the Therapeutic Goods Administration has added its annotations.
Australia Europe
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United States

Set Alert for United States

Latest From United States

Running The Gauntlet: Takeaways From The First Round Of HHS Hearings In 2019

Release of the White House budget proposal kicked off the first round of hearings on HHS with a new Democratic majority in the House and a new HHS budget czar in the Senate. HHS Secretary Azar did his best to set a constructive tone for advancing drug pricing policies – and maintaining his own position – in the year to come.  
Legislation Leadership

Athenex Sues FDA To Get Vasopressin On List Of Drugs That Can Be Compounded

Company argues there is a clinical need for its ready-to-use, preservative-free compounded formulation of vasopressin but agency says Vasostrict is available in a dose without the preservative.

FDA Legal Issues

Woodcock: Concerns About US FDA's Biosimilars Suffix Policy Detached From Reality

In an exclusive interview, Center for Drug Evaluation and Research Director Janet Woodcock contends that industry concerns about FDA's new suffix policy aren't reflective of real-world problems.
Biologics Biosimilars

Zulresso Postmarket Commitment Hints At Easier Dosing In Postpartum Depression

US FDA wants Sage Therapeutics to explore Zulresso use in alternative settings in a postmarketing trial. A successful study could expand access to the new approved brexanolone, whose administration is now long, complicated, and restricted to certified healthcare facilities.
Approvals Neurology

FDA Aims For Greater Role In Pharma Business Continuity Planning

Legislative proposals described in the US FDA’s FY 2020 budget request justification document would give the agency more authority to oversee business continuity planning at pharmaceutical companies with the idea of preventing shortages of essential drugs.

Manufacturing Quality

US FDA “Enriches” Trial Guidance With Recent Examples

Illustrating that principles articulated in 2012 draft are being broadly accepted at FDA, final guidance on enrichment strategies for clinical trials adds new examples from across the agency’s drug review divisions.
Clinical Trials Drug Approval Standards
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