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Featured Stories


Apotex Bags First Biosimilar Neulasta, Plans To Undercut Amgen In Canada By 25%

Apotex is hoping to sell its biosimilar version of Amgen’s Neulasta at a 25% discount in Canada after gaining approval there in what seems to be a world first. Might the Canadian OK help unblock the path to approval in the US and the EU?

Biosimilars Canada Approvals

US FDA Commissioner Gottlieb Sees His Job As A Race Against The Clock

'You have much less time in these jobs than you think you’re going to have,' Gottlieb says.

FDA Leadership Regulation

Gene Therapy 'Cassettes' Could Speed, Cheapen Manufacturing, Gottlieb Says

US FDA Commissioner teases endpoints, suggests accelerated approval plan and post-marketing considerations for gene therapies targeting hemophilia.
Blood & Coagulation Disorders Regenerative Medicine Regulation

EU Proposal To Address Impact Of Duplicate Marketing Authorizations On Biosimilars Availability

The European Commission has proposed updating its guidance on duplicate marketing authorizations to address concerns regarding the availability of biosimilars.
Europe Biosimilars Regulation
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FDA Performance Tracker

Keeping Track: A Diverse Array Of Approvals, A CRL For Evolus' Botox Competitor, And Coherus Refiles Neulasta Biosimilar

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

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Generics, OTC AND API Groups Object To Proposed US Tariffs On Goods From China

AAM, CHPA, SOCMA and BPTF agree that proposed 25% tariffs on pharmaceuticals and APIs from China is a bad idea, unless perhaps it’s just a negotiating ploy.

Manufacturing Trade China

Latest From Regulation

Systemic Exposure Data A MUsT For OTC Monograph Sunscreens, Other Topical Drugs In FDA Draft Guidance

Challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors recently, but a draft guidance from the agency signals that those trials will be expected generally from companies looking to add topical ingredients to OTC drug monographs. CDER details its expectations for studies of ingredients’ absorption potential to inform systemic exposure and overall safety and efficacy conclusions.

Consumer Dermatology

Spray Sunscreens Stay In FDA Enforcement Discretion Shade

CDER's enforcement policy guidance for OTC monograph sunscreens clarifies that spray sunscreens are included in the agency's enforcement discretion. But CDER closes the door on other dosage forms that it also identified in its 2011 ANPR for whether delivery formats other than lotions, creams or other traditional forms would be eligible for the monograph.

Consumer Dermatology

Pharma Firms Alarmed By Australian Plans To Raise GMP Fees

Medicines Australia says that none of the options for recovering GMP costs set out in its consultation earlier this year are suitable, although views among individual pharmaceutical companies differ.

Australia Asia Pacific

Latest From Policy

Impax Defeats FTC Pay-For-Delay Complaint, Helped By Status As Sole Marketer Of Generic Opana ER

FTC Chief Administrative Law Judge finds procompetitive benefit of Endo-Impax patent settlement agreement outweighs unjustified no-authorized generic provision.

Generic Drugs Legal Issues

DTC And The Art Of Selling An Establishment Pricing Plan To A Populist President

The most surprising proposal coming out the Rose Garden drug pricing event was a call for disclosure of prices in DTC ads. As a policy idea, it may be a dud – but that doesn’t mean it isn’t a critical element of the plan.

Advertising, Marketing & Sales Pricing Debate

US Drug Pricing Reform: No More Medicare 'Gravy Train,' Azar Tells Pharma

HHS secretary urges serious proposals from biopharma on enhancing price negotiation in Medicare Parts D and B, promising action from the Administration whether the industry cooperates or not.

Pricing Debate Medicare

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Pharmas Join To Build Inflammation Biomarkers In Alzheimer's, Depression

Drug firms exploring link between inflammation and central nervous system disorders are now sharing resources through public/private Biomarkers Consortium project.
Clinical Trials Research & Development

Keytruda, Tecentriq Face Efficacy Questions In Urothelial Cancer

Monotherapy patients with tumors that have low PD-L1 expression experienced decrease survival in two confirmatory trials; however, the immune checkpoint inhibitors’ accelerated approvals are unlikely to be affected pending final results comparing use in combination with chemotherapy to chemo alone.


ImmunoOncology Clinical Trials

Takeda/Shire Merger: Five Things To Worry About

From 'breakthrough' designations to manufacturing hiccups, numerous review and development challenges await the combined entity.

Drug Review Research & Development

Commercial Explore this Topic

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Latest From Commercial

You Work In The Pharmaceutical Industry; Here's Why You Should Care About The Novartis Payments

There's a lot of finger-pointing in the industry when it comes to why pharma has a bad reputation. Maybe it's time everyone who works in pharmaceuticals takes responsibility for it.

Legal Issues Policy

Sarepta Will Challenge Expected No From EMA On Exondys 51

Sarepta is expecting the European Medicines Agency to recommend against EU approval of its Duchenne muscular dystrophy treatment eteplirsen. Persuading the agency to change its mind during the appeal will be an uphill task for the company.

Drug Review Business Strategies

Rebates And Discounts Have A Big Impact On US Drug Prices, IQVIA Report Shows

A new US drug spending report from IQVIA parses out how rebates impact drug spending and explores affordability for patients. The data show drug makers offset about 28% of drug spending and provide some support to industry's arguments on drug pricing. 

Pricing Strategies Pricing Debate

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

PhRMA, BIO Mum On Trump’s Tariffs

While pressing the US trade representative for stronger IP protection, groups representing the brand biopharma sector remain silent on the Trump administration’s plan to hit China with 25% tariffs.

Manufacturing Trade

Pharmaceutical Industry Not 'Reaping the Benefits' Of Quality Risk Management Tools, Expert Says

Despite the benefits in improving product quality and reducing product defects, the pharmaceutical industry is still struggling to incorporate ICH Q9 quality risk management principles into quality operations, and even more dispiriting, there is still lingering uncertainty on what constitutes quality risk management.

Manufacturing Quality

New PIC/S Guide Offers Framework For Voluntary Reliance On Foreign GMP Inspections

A new guideline has been adopted by PIC/S, the group representing international pharmaceutical inspectorates, to help regulators assess whether GMP compliance at foreign sites has been established by the hosting competent authority, without the need for an on-site visit.
Manufacturing Regulation

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Systemic Exposure Data A MUsT For OTC Monograph Sunscreens, Other Topical Drugs In FDA Draft Guidance

Challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors recently, but a draft guidance from the agency signals that those trials will be expected generally from companies looking to add topical ingredients to OTC drug monographs. CDER details its expectations for studies of ingredients’ absorption potential to inform systemic exposure and overall safety and efficacy conclusions.

Consumer Dermatology

Spray Sunscreens Stay In FDA Enforcement Discretion Shade

CDER's enforcement policy guidance for OTC monograph sunscreens clarifies that spray sunscreens are included in the agency's enforcement discretion. But CDER closes the door on other dosage forms that it also identified in its 2011 ANPR for whether delivery formats other than lotions, creams or other traditional forms would be eligible for the monograph.

Consumer Dermatology

FDA Busy Sorting OTC Monograph Ingredients Anticipating System Overhaul

FDA has yet to finalize about one-third of its OTC monographs and several hundred ingredients do not have a final GRASE determination. Sorting will help the agency determine which of the 800 active OTC monograph ingredients are designated as needing more information to establish GRASE under a faster system based on administrative orders.

Consumer Drug Approval Standards
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