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Regional Coverage

Asia Pacific

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Latest From Asia Pacific

India Government Procurement Preference Norms – Rising Local Flavour

Increasing local content requirements have been stipulated in the public purchase preference norms for medicines in India. Backward-integrated Indian firms stand to gain but progressive localization requirements for drugs not made in India appear to be a tough ask.
India Policy

Singapore Reveals Phase-In Plans For eCTD

The Health Sciences Authority will seek industry’s feedback on the plans it has for introducing in Singapore the electronic format of the common technical document that drug companies use to make their regulatory submission.

Regulation Singapore

Roche Calls For Harmonized Regulations As Subcutaneous Herceptin Declined Trial Waiver In India

Roche has sought a harmonized regulatory approach for approval of innovative medicines and formulations in India, after its request for a trial waiver for subcutaneous Herceptin was turned down by an expert panel.
India Policy

Japan Approvals Include World Firsts For Romosozumab, Spinal Injury Cell Therapy

The latest group of new product approvals in Japan includes the first marketing clearances worldwide for fracture-reducing osteoporosis antibody romosozumab and a stem cell-based therapy for spinal cord injury, as well as two new Daiichi drugs and Pfizer's lung cancer therapy dacomitinib. 

Japan Approvals

Random Checks Now Routine: China To Inspect Your Factories Near And Far

An officially released new regulation in China legalizes overseas inspections of drug and device makers, making the risk-based inspections routine tasks that could also expand to manufacturers' R&D partners and third-party suppliers of ingredients, excipients or packaging materials.

China Manufacturing

Public/Private Cooperation, Tailored Assistance Deemed Key To Enhancing Quality Of US Drug Imports

Public health experts tell committee that much work lies ahead in strengthening the regulatory systems of low-and middle-income countries, and recommend ways to bolster these systems and improve the quality of imports.
Quality Manufacturing
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Europe

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Latest From Europe

Pharmacists To Get New Substitution Powers To Tackle Brexit Shortage Risk

In an effort to address possible serious drug shortages in the event of a no-deal Brexit, the UK government has formally proposed giving pharmacists wide powers to dispense alternative medicines such as different forms, generics, biosimilars, or “therapeutically equivalent” drugs.
Brexit United Kingdom

Financial Penalties Scope Widened Under New EU Regulation

A new EU regulation due to come into effect later this month will amend the rules on the centralized procedure.

Regulation Europe

Irish $1.9bn Tax Bill 'Out Of Nowhere' Perplexes Perrigo, Troubles Analysts

Perrigo appeals tax assessment Ireland levied in late December on Rx ingredient royalty rights firm gained when it became incorporated in Dublin but no longer owns, Analysts allowed President and CEO Murray Kessler. benefit of doubt he'll lead Perrigo out of prolonged slump when he joined firm in November after extensive executive experience with tobacco firms and in other consumer goods markets, but they're more circumspect about its chances of prevailing in Irish tax disagreement.

Consumer OTC Drugs

Perrigo Expanding Consumer Portfolio After Finding Problems Slowing Growth

"Probably the worst offense" among Perrigo's problems is that before appointing President and CEO Murray Kessler in November, it had three CEOs since 2016, making him the fourth chief executive in three years, says Kessler. Perrigo's move to a self-care focus means "a broader emphasis on the wellness component of health and wellness" and opening its portfolio of products and categories to areas including nutraceuticals, oral care, probiotics, therapeutic skin care products and others.

Consumer OTC Drugs

How CAR-Ts Are Changing The Lifecycle Paradigm For ATMPs

CAR T-cell therapies have resulted in the industry and regulators exploring unconventional approaches to collecting real-world safety and efficacy data from existing registries. Can this approach also work for other types of cell and gene therapy products in the future? Delegates at a conference in London explored the topic.
Europe Regulation

NICE Clears Verzenios For Breast Cancer After Lilly Offers UK Discount

Verzenios, Lilly’s new drug for metastatic breast cancer, has been OKd by NICE for use on the national health service in England and Wales. In terms of gaining market share it is some way behind two other competitor drugs, Pfizer’s Ibrance and Novartis’s Kisqali, but it has some clinical advantages that could allow it to gain uptake.

Reimbursement Government Payers
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United States

Set Alert for United States

Latest From United States

CBER's Regulatory Activity in 2018: A Reading List

The US FDA's biologics center invested heavily in preparation for coming waves of advanced therapies. 
Regulation Biologics

US FDA’s Biologics Center Faces Exciting 2019 After Quiet Year For Novel Approvals

CBER’s novel biologic approvals in 2018 were few, long, and with a low level of innovation. But the center’s work to build regulatory framework for emerging technologies is setting the stage for a different story in 2019.
Vaccines Biologics

Medicare Part D Payment Model Gives Health Plans More Incentives To Negotiate Lower Drug Prices

Participating plans to share in savings if they stay below spending target for Part D catastrophic phase and repay 10% of any excess spending; CMS also updates its VBID model.
Medicare Pricing Debate

Scenes From A Shutdown: US FDA Hides It Well

FDA's two recent advisory committee meetings at its White Oak campus offer no obvious clues that agency is struggling due to dwindling carryover balances and furloughed employees.
FDA Leadership

Keeping Track: FDA's Review Actions Carry On During Shutdown

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

Trump’s Big Missed Opportunity: Medicare For All

With control over all branches of government, President Trump and Republicans made a choice to pursue repeal of the ACA and tax cuts over a strategy that could have redefined the party: Medicare For All with competitive private sector principles. 
Pricing Debate Legislation
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