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Policy & Regulation

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From Rare To Real: Pharma Urged To Act As China Preps New Rare Conditions List

Chinese regulatory agency working around the clock in preparation to release another official list of rare diseases, and a push to launch more innovative orphan drugs is underway. But this time pharma firms need to be more proactive, noted an NMPA official.

China Rare Diseases Research and Development Strategies

Regulation

Set Alert for Regulation

Latest From Regulation

FTC Vote On BMS-Celgene Acquisition Splits Over Drug Pricing

Divesting Celgene's psoriasis drug Otezla will remedy anticompetitive harm from acquisition, US Federal Trade Commission votes 3-2. Dissenting Democrat commissioners want broader review of pharma mergers.

M & A Enforcement

Hahn Confirmation Hearing: Pharma May Be Left Parsing Non-Rx Questions For Policy Clues

US FDA commissioner nominee could face a slew of questions about non-drug issues such as e-cigarette regulation, which may mean pharma must read between the lines for insight into his drug-related policy stances.

FDA Leadership

The Most Important Hearing In Washington This Week – For Some Of Us, At Least

Impeachment? That’s nothing compared to the chance to hear publicly from Stephen Hahn about what kind of US FDA Commissioner he might be.

FDA Leadership

EMA Recharges Role In Non-EU Drug Approvals

The EMA’s process for assessing medicines for use in non-EU countries is being beefed up after a review showed the mechanism had several flaws that made it unattractive to many companies.

International Drug Approval Standards

EMA Finalizes Guide To Encourage New Treatments For Gout

The European Medicines Agency says new first- and second-line treatments are needed for gout as most patients cannot tolerate, or respond insufficiently to, existing options.

Europe Guidance Documents

CNS 'Graveyard Of Drug Development' Needs Oncology-Like FDA Regulatory Approach

Lundbeck executive calls for adaptive trial designs, transdiagnostic approach, and more scientific discussions between sponsors and the US Food and Drug Administration.

Neurology Clinical Trials
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Policy

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Latest From Policy

ICER Will Explore Value Pricing For Cures In Context Of ‘Shared’ Health System Savings

Future value assessments will include ‘hypothetical’ scenarios in which downstream medical savings will be shared between the health care system and the treatment developer.

Gene Therapy Reimbursement

Pharma Declares Wishlist As Brexit Heightens UK Election Stakes

The UK pharma industry association has underscored the sector’s importance while outlining its demands for the country’s policy around medicines and R&D.

United Kingdom Brexit

GSK Seeks To Halt Boehringer Promos That 'Denigrate' Effectiveness Of Ellipta, Diskus Inhalers

US FDA's wariness of taking enforcement action against Rx drug promotions may lead to more suits like GSK's. Complaint says healthcare providers are switching COPD patients to BI's Respimat inhaler in response to BI's marketing campaign.

Advertising, Marketing & Sales Legal Issues

How To Make Cross-Country Collaborations On Pricing Work

Francis Arickx from the cross-country coalition BeNeLuxA spoke this month about how the initiative had delivered proof of concept and discussed why uniting across borders is important for delivering access to transformative but expensive medicines.  

Europe Health Technology Assessment

International Horizon Scanning Initiative To Level Pricing Playing Field

Nine countries are joining forces on horizon scanning with the aim of improving their chances of securing lower prices for high-cost drugs.

Europe International

Gottlieb On Pursuing Legislative Reform: Start Small, Build Later

Former US FDA commissioner Scott Gottlieb encouraged stakeholders at the Association for Accessible Medicine's GRxBiosims 2019 meeting to start small in scope when pushing for legislative changes, which makes it easier to build on later.
Generic Drugs Legislation
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