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Asia Pacific

Set Alert for Asia Pacific

Latest From Asia Pacific

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

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

Is Takeda's Consumer Unit 'Agile' Enough To Stretch Outside Japan?

Takeda says spinning off its consumer product portfolio into a wholly owned and independent subsidiary will boost its profile in the sector, but all signs continue to point to the firm's Rx operations as its predominant revenue drivers.

Consumer Japan

Australia To Make Access To Unauthorized Products Faster And Less Bothersome

New proposals by Australia’s Therapeutic Goods Administration include developing a list of unauthorized drugs that could be made available to patients faster and more easily. A decision to include a product on the list would not be appealable, the TGA says.

Market Access Australia

Reckitt Expands 'OTC' Business, China Presence With Mead Johnson

Marketing Enfamil and other Mead Johnson formula and nutritional brands, says RB CEO Rakesh Kapoor, is "very much in the core of what consumer health stands for," and also immediately doubles the size of the firm's consumer business.

Consumer China

BMS Label Issue Adds To China Drug Shortage Woes

While shortages of some drugs in China are not new, a recent case of a patient scrambling to locate a potentially life-saving chemotherapy to complete their treatment has shone new light on the problem, which the government is taking various steps to combat.

Manufacturing Cancer
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Europe

Set Alert for Europe

Latest From Europe

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

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

Redacting Personal Data/CCI In EU Clinical Trial Inspection Reports On The Agenda

Work is expected to start this year on developing guidance for the EU member states on how to redact clinical trial Inspection reports to protect personal data and commercially confidential information under the new Clinical Trials Regulation.

Europe Clinical Trials

Busy In-Tray Awaits New EFPIA Boss Nathalie Moll

Nathalie Moll, secretary general of biotech industry body EuropaBio, is to be the next director general of EFPIA, the federation that represents the R&D-based pharmaceutical industry in Europe. With issues such as the forthcoming Brexit negotiations, the EU’s inquiry into medicines access and pricing, and the implementation of the new Clinical Trials Regulation, EFPIA’s new leader will have a lot of weighty dossiers to deal with.

Leadership Regulation

How EMA’s Adaptive Pathways Fits Into The Complex Drug Pricing Puzzle

The European Medicines Agency’s adaptive pathways concept may have a role to play in reducing the prices of medicines. But early market access initiatives such as these are just one piece in the complex drug reimbursement puzzle.

Regulation Reimbursement

‘Non-Medical Switching’ Claim Riles Europe’s Biosimilars Industry

Two patient advocacy groups have said that a number of issues surrounding biosimilar switching, patient consent and traceability remain to be addressed in Europe, despite growing support for biosimilar use from physician bodies and clinical studies. But the European biosimilars industry has dismissed these concerns, saying that biosimilar medicines will significantly improve access to biologics patients while contributing to the sustainability of pharmaceutical budgets.

Biosimilars Drug Safety
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United States

Set Alert for United States

Latest From United States

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

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

Direct OTC Purchases With Pre-Tax Accounts Swing On ACA Change, Not Repeal

Sens. Pat Roberts, R-KS, and Heidi Heitkamp, D-ND, and Reps. Lynn Jenkins, R-KS and Ron Kind, D-WI, once again introduce the Restoring Access to Medications Act, proposing amending rather than repealing ACA.

United States Dietary Supplements

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

FDA Urges Full Participation In Quality Metrics Program

Despite the voluntary nature of US FDA’s program, an agency official urges full participation. Without data from such participation, FDA will not be able to predict drug shortages and industry will not see the benefits of reduced inspections and streamlined change control.

Manufacturing Quality
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