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Policy & Regulation

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Biosimilars In 2017: Crowded US FDA Review Queue, Key Legal Decisions

At least five biosimilars could gain US licensure in the coming year on first-cycle review, including subsequent competitors to Remicade and Humira; however, patent litigation is expected to increase and will continue to slow the march of products from FDA approval to commercialization.

Biosimilars Regulation Legal Issues

Carrots and Stick: Biopharma At The White House

Drug industry executives discuss drug pricing and tax and regulatory reform in a high-profile meeting with President Trump at the White House.

Pricing Debate US Election 2016 Medicare
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Regulation

Set Alert for Regulation

Latest From Regulation

Survival Benefit For Hypotension Shock Drug Nice But Not Needed By FDA, La Jolla Says

La Jolla Pharmaceutical's angiotensin II drug LJPC-501 is on track for NDA via SPA this year, after meeting blood pressure increase primary endpoint in ATHOS-3, but also showing a trend toward an overall survival benefit.

Cardiovascular Clinical Trials

Off-Label Promotion Decisions Likely Made Case-by-Case, US FDA Official Says

OPDP chief Abrams did not give many general tips for complying with guidance on off-label promotion 'consistent with' FDA-approved labeling, leaving sponsors to make own interpretations.

Advertising, Marketing & Sales FDA

EMA’s Post-Brexit Home ‘Could Be Decided This Year’

The leader of Denmark’s bid to host the European Medicines Agency after the UK leaves the EU says that a rapid decision-making process on the agency’s new location is needed in order to avoid entanglements with the wider Brexit negotiations, and that a decision could be taken sometime in the second half of this year.

Brexit Regulation

Mexico's COFEPRIS: A Friend Or Foe To Industry?

'We have a lot of red tape, but we have a clear red tape,' attorney José Alberto Campos-Vargas says in an interview.

Drug Review Regulation

Keeping Track: US FDA Files Another Pfizer Cancer Biologic And TMC's New Antibiotic

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

Performance Tracker Approvals

Adverse Event Assessment In India Gets Harvard-Built Tool; Will Increased Trial Activity Follow?

Against backdrop of subdued trial activity in the country and concerns about injury compensation, Indian Society for Clinical Research and Harvard's MRCT Centre offer a portal to facilitate a more objective assessment of causality of serious adverse events.

Drug Safety Clinical Trials
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Policy

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Latest From Policy

Rival For Opdivo As Keytruda Launches For NSCLC In Japan At Same Daily Price

Opdivo has a new rival in the lung cancer setting in Japan following the reimbursement and launch of Keytruda at the same daily price.

Japan Policy

Abuse-Deterrent Opioids: US FDA Follows The ‘Route Of Abuse’ To Exclusivity

Inspirion’s MorphaBond win suggests agency’s thinking on three-year exclusivity for abuse-deterrent formulations has ‘evolved’ from a formulation-specific approach to one based on route of abuse.

Policy Approvals

FluMist May Not Get CDC Seal Of Approval For Several Years

CDC advisory committee wants vaccine effectiveness data for H1N1 component but that is not the predominant strain this season; AstraZeneca is not giving up.

Vaccines Policy

Bayer CEO On Europe's 'Identity Crisis'

The UK's decision to leave the European Union and a change in global politics that has prompted emotions to get in the way of facts are the catalysts for Europe's current identity crisis, says Bayer chief Werner Baumann. During the company's annual financial results presentation in Leverkusen, Germany, the CEO also called on European regulators to better protect innovation during times of political uncertainty.

Brexit Policy

ICER Revising Drug Review Criteria, Will Use Net Prices, Broad Evidence Base

Proposed updates to group’s cost effectiveness evaluations will guide reviews during 2017-2019. Ultra-orphan drug will be assessed with different standards.

Cost Effectiveness Pricing Strategies

Ovarian Cancer Drugs Will Get ICER Review As Olaparib's Maintenance Indication Looms

PARP inhibitors from Tesaro, Clovis, and AstraZeneca have been tentatively chosen for the evaluation.

Pricing Strategies Reimbursement
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