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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 Biosimilars

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 Regulation

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 Reimbursement

Canada Consults On Disclosing Names Of Generic Drug Applicants

Health Canada currently does not disclose the names of the companies that have filed abbreviated new drug submissions and it wants to know what the possible impacts of doing so are.
Canada Generic Drugs Regulation

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 Drug Review
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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

Set Alert for Policy & Regulation

US FDA Has Model Drug Facts Labels For OTC Naloxone, Needs Switch Proposals

Development of the model DFLs was a first for agency. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.

Prescription To Otc Switch Consumer Advertising, Marketing & Sales

Latest From Regulation

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

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

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

Latest From Policy

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

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

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

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

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

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

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

FDA's OTC Naloxone Model Labels Confirmed In CONFER Study

Participants in US FDA-commissioned CONFER study were scored on following label instructions for checking whether a potential patient has overdosed and administering a naloxone dose before calling for emergency help as well as on a "composite of cognitive walkthrough" of all those steps. Participants were in four groups: adult users of heroin and prescription opioids; those persons' friends and family members 18 years old and up; and separate groups of volunteers, 15- to 17-year-olds and adults.

OTC Drugs Prescription To Otc Switch

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
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