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Featured Stories


Triangulation Or The Bermuda Triangle: Can Trump Work With House Dems On Drug Prices?

President Trump is highlighting drug pricing as an area where he may be able to work with the new Democratic majority in the House. The political wisdom of building common ground on the topic is hard to ignore – but the tempestuous personality of the President is still the overriding factor. Instead, focus on whether HHS can win some breathing room to keep going with administrative changes.
Elections Pricing Debate Legislation

FDA Launches Protocol For Inspections Of Sterile Drug Manufacturing Facilities

US FDA expects the New Inspection Protocol Project (NIPP) it launched Nov. 9 to increase the consistency of its sterile manufacturing inspections – and the ability of those inspections to catch quality problems before they could lead to drug shortages.

Quality Compliance Manufacturing

Mallinckrodt's Abuse-Deterrent Oxycodone IR May Face Hurdle At US FDA Panel

FDA finds no benefit in deterring intranasal abuse; final data not yet submitted to determine IV abuse deterrence.
Advisory Committees Neurology Regulation

Mexico and Argentina To Cut Burden for Pharma By Swapping GMP Reports

Medicines regulators in Mexico and Argentina have agreed to exchange good manufacturing practices inspection certificates.

South America Argentina North America

Good News For Australian Sponsors Sourcing APIs From Canada

Australian and Canadian drug regulators have extended their mutual recognition agreement on good manufacturing practice inspection and certification to include active pharmaceutical ingredients.

Australia Canada Manufacturing
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European Performance Tracker

Global Pharma Guidance Tracker – October 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.

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Case Study: Broad Thinking Yields Big Results

There are numerous details when considering product packaging that require both creative thinking and feature prioritization. Rather than developing a standard solution for the current need, it’s imperative to think broadly and design options that are cost-effective, simplify operations and save time and/or resources.

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Generics In The US 2018

Read this eBook and learn more about the West AccelTRA elastomer components program that was designed to help in this effort. Learn how the AccelTRA component program has been helping generic biopharmaceutical manufacturers by providing a number of key features, for those high-volume products and where manufacturers would like to deal mostly with one high-performing elastomer component.

Read the eBook and discover more

Policy & Regulation Explore this Topic

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OTC Primatene Mist Returns: Market Future Bright After Cloudy NDA History

Amphastar has initial inventory on hand of epinephrine inhalation aerosol reformulated with hydrofluoroalkane as a propellant, and expects "almost no costs" for sales of first several hundred thousand units. After two NDAs and two CRLs, firm convinces US FDA consumers can use the product without doctor or pharmacist guidance and understand it is not for ongoing asthma treatment.

Consumer Approvals Drug Approval Standards

Latest From Regulation

Big Share Of EU Decentralized Procedures Still Seeking Post-Brexit Home

Progress is being made with redistributing UK rapporteurships for non-centrally approved medicines, but companies need to keep up the momentum if all procedures are to be reallocated to other EU countries by the Brexit date of March 29, 2019.

Brexit Life Cycle Management

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Keeping Track: Yupelri Is Latest Novel Drug Approved, But Bad News For Biosimilars

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

Latest From Policy

AbbVie Inks Sixth Humira Biosimilar Settlement, Battles Boehringer's 'Unclean Hands' Claim

Boehringer stands out in its decision to litigate rather than settle, and the firm has obtained AbbVie's settlement agreements with other biosimilar makers.

Legal Issues Biosimilars

US FDA May Largely Avoid House Democrats' Investigation Agenda

Drug pricing hearings likely will involve FDA, but most pressing issue facing agency following midterms may be whether Commissioner Gottlieb will depart.
Elections Legislation

Democrat-Controlled House Will Turn Up The Volume On Drug Pricing

With US House of Representatives now controlled by Democrats, lower chamber of Congress will likely increase hearings and investigations into industry pricing practices, but any legislation will likely need to dovetail with President Trump’s agenda to advance.
Legislation Pricing Debate

Clinical / R&D Explore this Topic

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Latest From Research & Development

Expanded Access: US FDA Told To Increase Regulatory Clarity, Early Interactions With Sponsors

Independent assessment finds positive perceptions of expanded access program but calls on agency to do more to correct manufacturer misperceptions about adverse events and clarify when data from expanded access would support labeling extensions.

Research & Development Clinical Trials

Regulatory Lessons For Advanced Therapy Makers: A Case Study

Developing advanced therapy medicinal products is not easy, but the head of regulatory affairs at Swedish cell therapy company Immunicum has some useful tips for SMEs that could help them navigate their development more easily.

Research & Development Clinical Trials

ICER Is Weighing Early Research Consulting Work With Pharma

The drug value assessment organization said it is considering whether or not to move forward with a program to consult pharmaceutical manufacturers on early research, a move that could raise questions about the group's independence.

Clinical Trials Health Technology Assessment

Commercial Explore this Topic

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Latest From Commercial

Prestige Consumer's First Quarter Exclusively In OTCs Is Prelude To Growth

Prestige Consumer's sales in its latest quarter were lifted by gas relief and ear wax products, but the gains were offset "revenue recognition" accounting changes and slower sales of BC and Goody's as supplies of the analgesics transitioned to new packaging.

Consumer Commercial

Potassium Lowering Therapies Hit NICE Hurdle In UK

AstraZeneca’s Lokelma and Vifor’s Veltassa will be subject to a final review by the England and Wales health technology appraisal body in December following draft guidance not recommending their use in the National Health Service to treat hyperkalemia.

Health Technology Assessment Reimbursement

Amgen Drops Repatha List Price 60% To Cut Medicare Co-Pays And Boost Use

Company says 75% of Medicare Part D patients who aren't eligible for low income subsidies abandon the PCSK9 inhibitor at the pharmacy counter due to $370 co-pay, which may now range from $25-$150 per dose.

Pricing Strategies Market Access

Manufacturing Explore this Topic

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Latest From Manufacturing

Mylan’s Fulphila: First Neulasta Biosimilar’s Road To US Market Slowed Only By Product Quality, GMP Deficiencies

Mylan demonstrated analytical similarity, including for the PEG moiety, and the absence of clinically meaningful differences between MYL-1401H and Amgen’s pegfilgrastim during first review cycle, but it had to resubmit the application after FDA flagged concerns about the biosimilar’s manufacturing process and ongoing facility deficiencies.

Drug Review Profile Biosimilars

Firms Face New Australian Rules On Autologous HCTs From Mid-2019

Companies in Australia are being urged to make sure their autologous human cell and tissue products will meet new regulatory requirements starting in July next year.
Australia Regulation

PIC/S To Guide Member Inspectorates On Harmonizing GMP Deficiency Classifications

Draft guidance soon will help the world’s leading pharmaceutical inspectorates align views on which drug GMP deficiencies are considered major – and which are truly critical.

Compliance Manufacturing

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Perrigo Moves From Health Care To 'Self Care'

Providing self-care products "opens this organization up to massive opportunity" which Perrigo will identify in early 2019, says new CEO Murray Kessler. It remains committed to selling or spinning off its Rx unit, though it's "just a few FDA approvals away from significantly" growing, he says as firm reports $68m net loss in its latest quarter.

Consumer Sales & Earnings

Glaxo, Sanofi Look Far Afield For Consumer Health Growth

Big pharmas' recent third-quarter results and commentaries point to sales drivers for consumer health divisions coming from markets outside their established primary markets of US and Europe. Consumer unit lines include oral care and topicals as well as nutritional products.

Consumer Sales & Earnings

Amarin Says REDUCE-IT Results Are Off Limits To Omega-3 Supplement Claims

REDUCE-IT results are limited to Amarin's Vascepa "and cannot be extrapolated to omega-3 products that are materially different based on, for example, composition, dosage, and regulatory status," pharma firm says in complaints against Coromega and Omax. Amarin seeks to stifle the omega-3 supplement firms despite First Amendment argument it made in successful litigation against FDA to make truthful statements about its products even though the information is not approved by the agency.
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