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Sanofi's Sotagliflozin: Risk Of Ketoacidosis Divides US FDA Advisory Committee

Some Endocrinologic and Metabolic Drugs Advisory Committee members said a REMS is sufficient, but others worried that proposed risk management plans were not proven effective.
Metabolic Disorders Advisory Committees Regulation

Uloric U-Turn: Gout Therapy Likely To Stay On Market Despite CV Safety Concern

US FDA would not have approved Takeda’s Uloric but for a post-market safety study commitment. Now that the study is complete and suggests a potential increased risk of mortality, however, FDA doesn’t seem inclined to pull the product.
Drug Safety Post Market Regulation & Studies Advisory Committees

Mexican Pharma Industry Joins Anti-Corruption Crackdown

The Mexican research-based pharmaceutical industry has pledged to crack down on corruption as the country’s new president says the vice must be eliminated to deliver better health system.

Mexico Government Payers Market Access

CVS Medicare Part D Plan With Pass-Through Rebates Has Limited Uptake

Low enrollment indicates that beneficiaries have trouble figuring out whether reductions in cost sharing would offset a much higher premium.

Medicare Pharmacy Benefit Management Policy

European Council Move Brings SPC Manufacturing Waiver A Step Closer

A proposed SPC manufacturing waiver – which would allow generic and biosimilar manufacturing within Europe during the SPC period – has taken a step closer to being realized after the European Council approved a mandate for negotiations with the European Parliament. However, it remains uncertain whether key elements desired by the off-patent industry will fall into place.

Europe Manufacturing Generic Drugs
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US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – December 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
International Europe Australia

Global Generics & Biosimilars Awards 2018

Generics bulletin was able to celebrate the outstanding progress that both teams and individuals achieved in providing greater healthcare access through generic, biosimilar and value-added medicines. Many of these achievements have been documented in Generics bulletin. Click below and enjoy the selection of articles that reflect the wide array of industry activities.

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Policy & Regulation Explore this Topic

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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 Review Pathway

Latest From Regulation

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

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

UK NICE OKs Melanoma Combo Treatment From Array/Pierre Fabre

Array BioPharma/Pierre Fabre’s combination treatment for metastatic melanoma has received NICE's go-ahead for funding under the national health service in England and Wales.
Health Technology Assessment Reimbursement

Latest From Policy

PhRMA Adds Genentech, Gilead To Its Ranks Ahead Of House Democrats’ Drug Pricing Scrutiny

Roche, through Genentech, returns to the PhRMA fold after leaving the trade group in 2009; Gilead is a first-time member; both are retaining their BIO memberships as well.

Pricing Debate Research and Development Strategies

ICER’s ‘Unsupported Price Increase’ Report Due This Fall

Report by the Institute for Clinical and Economic Review will seek to inform the public policy debate on price increases for prescription drugs.

Pricing Debate Policy

Bio Industry Warns UK Orkambi Inquiry Against Publishing Confidential Price Information

Vertex and bioindustry groups have called on a UK inquiry investigating the availability of the cystic fibrosis drug Orkambi on the National Health Service not to publish confidential information.

Europe United Kingdom

Clinical / R&D Explore this Topic

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Latest From Research & Development

External Control Arms: Better Than Single-Arm Studies But No Replacement For Randomization

Synthetic control group derived from historical clinical trial data could augment smaller randomized trials and yield better information than single-arm studies, but this approach should not be viewed as a substitute for randomized trials where feasible, US FDA officials said at a Friends of Cancer Research meeting.

Clinical Trials Drug Approval Standards

Opioid Sponsors Enter 2019 At A Crossroads

Recent regulatory trends at US FDA offer no clear path to success for sponsors developing opioids. As 2018 concludes with only one approval and at least five rejections, firms will need new strategies if they hope to bring the analgesics to market. 
Research & Development Neurology

What’s The Plan? US FDA Drug Development Tool Qualification Process Requires “Cultural Change”

FDA sees negotiating formal “qualification plan” as key process improvement that should ultimately accelerate pace for construction of biomarkers and other drug development tools. But it will take some getting used to.
Clinical Trials Drug Approval Standards

Commercial Explore this Topic

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Latest From Commercial

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

J.P. Morgan Notebook Day 4: US Generics Steady, UroGen, REGENXBIO, Dr. Reddy's In China, And Investor Sentiment Shifts

Daily round-up of news and notes from the 2019 J.P. Morgan Healthcare Conference in San Francisco: US generics see gains, researcher calls for more tech transfer, and biotech investor sentiment rises as big deals bring optimism – among other items from the last day of this year's JPM. 

Business Strategies Regenerative Medicine

Manufacturing Explore this Topic

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Latest From Manufacturing

Pharmaceutical Groups Urge FDA To Upgrade From NDC To GTIN To Avoid Conflicts With DSCSA

Pharmaceutical manufacturers and distributors complain that FDA’s plan to add digits to the NDC would be a mistake and could potentially conflict with global standards as well as the bar code technology systems put into place under the Drug Supply Chain Security Act. They suggest embedding the NDC into the GS1 Global Trade Identification number (GTIN) to avoid these conflicts.
Manufacturing Distribution

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

US FDA Brings Back Furloughed Workers To Inspect High-Risk Facilities

Though they remain unpaid, hundreds of furloughed FDA employees will return to duty to conduct routine surveillance inspections of high-risk manufacturing facilities.

Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

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

House Maintains Momentum For US OTC Monograph Reform, But Senate Remains A Question Mark

With a new US Congress just convening, OTC monograph reform advocates face an old problem: the need for Senate action. The House has already cleared an OTC reform measure, as part of a pandemic preparedness bill, in the first days of the legislative session.

Consumer Legislation
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