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Featured Stories


Pharma’s ‘No-Show’ At Regulatory Meetings In India: Who Loses?

Regulators in India routinely face flak over lengthy approval timelines, but drug firms failing to show up at pre-scheduled regulatory meetings does little to improve the situation. The reason for the no-shows is open to speculation. Absenteeism appears to be significant in areas such as oncology and hematology.

Regulation Review Pathway BioPharmaceutical

FDA Search For CDER Deputy Emphasizes 'Executive Direction'

An M.D. is preferred for position that would run CDER in director's absence and oversee 'major programs' at the Center.

FDA Leadership Regulation

Anthem In-House PBM Will Draw On CVS But Retain Formulary Control

Hybrid approach to pharmacy benefit management expected to save insurer $4bn annually after Anthem ends its relationship with Express Scripts in 2020. Integration of medical and Rx benefit data could lead to more value-based contracting.

Pharmacy Benefit Management Pricing Strategies Reimbursement

Semaglutide Retinopathy Risk No Bar To Approval, US Panel Says

Novo Nordisk's once-weekly GLP-1 agonist can address diabetic retinopathy complications through labeling, US FDA advisory committee says in endorsing approval; panelists say a postmarketing study on retinopathy would be desirable and could be folded into a larger cardiovascular outcomes trial.

Advisory Committees Drug Review Metabolic Disorders
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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Combo Product Classification Guidance Doesn't Fix All Existing Problems, Experts Say

US FDA's tendency to designate products as drugs over devices may remain despite clarifications offered in final guidance.

Review Pathway FDA Regulation

Latest From Regulation

Rare Diseases: Growing Understanding Will Unlock Accelerated Approval, FDA Says

US FDA officials say they need knowledge of the disease to have the confidence to use accelerated approval.

Rare Diseases Review Pathway

New ICH Guide To Eliminate ‘Discordant Advice’ On Juvenile Animal Studies

Experts at the International Council for Harmonisation have nearly completed the first draft of a guideline that explains in which situations nonclinical juvenile animal testing is considered informative and necessary to support pediatric drug development. The guideline is expected to address the "discordant advice" that different regulatory agencies currently offer companies in relation to such studies.

Safety Clinical Trials

Moscicki's Move From FDA To PhRMA About 'Best' Use Of Leadership Skills

At inconveniently timed NORD conference, the former CDER deputy center director finds himself unable to speak for either FDA or the Pharmaceutical Research and Manufacturers of America.

FDA Leadership

Latest From Policy

Drug Pricing Legislation Appears Nowhere In Sight Following Senate Hearing

Senators and witnesses rehashed years-old arguments and found little common ground on which elements of drug pricing to address.

Pricing Debate Reimbursement

Antibiotic Incentives: Prize Fund Is Focus Of Presidential Report On Incentives

Upcoming White House report on antibiotic incentives will provide a strong endorsement of one-time payments to reward successful development of new therapeutics. That is a mixed blessing for advocates for legislative action for incentives who are focusing on 'wildcard' patents.

Infectious Diseases Intellectual Property

Allergan May Rue Mohawk Tribe Deal As Court Invalidates Restasis Patents

District court questions legitimacy of Allergan's patent transfer tactic, saying it 'could spell the end of the PTO's IPR program.'

Intellectual Property Policy

Clinical / R&D Explore this Topic

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Latest From Research & Development

Chronic Fatigue Syndrome Research Takes Leap Forward With NIH Funding

Research centers are collaborating on projects to find causes of disease; Ampligen, Rituxan and KPAX-002 are only drugs in clinical trials.

Research and Development Strategies Neurology

A Biomarker For Bristol: Mutation Burden Shows Promise In Small Cell Lung Cancer

Phase I/II data from Opdivo/Yervoy combination in SCLC provide more evidence that tumor mutation burden is emerging as a biomarker for immunotherapy, but commercial value is unclear and results don't have implications for the all-important CheckMate 227 non-small cell lung cancer trial, analysts say.

Drug Approval Standards ImmunoOncology

Canada Prepares To Publish Draft Rules On Release Of Clinical Data

Following a public consultation earlier this year, Health Canada has asked for expert advice on its plans to allow the release of clinical data that is currently considered confidential. It expects to publish draft regulations this autumn.

Clinical Trials Canada

Commercial Explore this Topic

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Latest From Commercial

Pfizer Takes On International Reference Pricing

Sam Taylor, Pfizer’s head of global pricing, shares his wisdom on the increasingly complex subject of international reference pricing.

Pricing Strategies Pricing Debate

Pfizer Déjà Vu: Is It Time To Sell The Consumer Health Business?

As Pfizer re-examines a potential sale of its consumer business, analysts expect it would attract suitors for its unit, with $15bn to $17bn a likely price, but also say it might be better off continuing to compete in the sector that accounted for around $3.4bn of its 2016 revenues.

Consumer M & A

PCSK9 Patent Case: Praluent Injunction Vacated, But May Well Return

Appeals court vacates injunction that Repatha marketer Amgen had won against Sanofi/Regeneron's Praluent, but notes 'a reduction in choice of drugs cannot be the sole reason for a district court to deny an injunction.'

Intellectual Property Legal Issues

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA Outlines How Generic Drug Makers Can Reverse Filing Decisions

ANDA sponsors can file a 'request for reconsideration' disputing regulatory decisions and can appeal some – but not all – of the agency's decisions. If manufacturers are still not happy with outcome, they can go through the formal dispute resolution process.

Generic Drugs Manufacturing

PDA Survey Shows Compliance Can Trump Science In Aseptic Processing

PDA leaders weigh in on results of recent aseptic practices survey, saying pharmaceutical manufacturers may be carrying out certain aseptic practices to meet the expectations of regulators rather than the dictates of science. The survey also shows that despite adoption of technologies like RABS and isolators to keep workers away from sterile drug products, half the time they're still the root cause of contamination.

Europe United States

FDA Contract Awards In Brief: Regenerative Medicine, eCTD, Reg Science

Contracts US agency awarded as fiscal year 2017 came to a close include one to Nexight for a regenerative medicine standards development process, another to Lorenz to manage eCTD submissions – and 26 more for regulatory science R&D.

Regenerative Medicine Compliance

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Nicorette, Tylenol Ease J&J's Consumer Pain From Slow Oral Care Sales

J&J’s worldwide OTC drug division sales rose 4.4% to $1bn, driven by the Tylenol and Nicorette brands, the firm reports Oct. 17. Those revenues helped offset softness in the firm’s Listerine and other oral care products due to more competition online from start-ups selling straight to consumers.

Consumer Sales & Earnings

FDA Objects To Amarin Trade Complaint Against Omega-3 Ingredients

FDA Chief Counsel Rebecca Wood says Amarin's request for an ITC investigation necessarily turns on questions of drug and supplements policy, where it is the expert and authorized agency. If successful, Amarin's move could encourage others to similarly seek alternative forums for action.

Consumer Legal Issues

Pfizer Déjà Vu: Is It Time To Sell The Consumer Health Business?

As Pfizer re-examines a potential sale of its consumer business, analysts expect it would attract suitors for its unit, with $15bn to $17bn a likely price, but also say it might be better off continuing to compete in the sector that accounted for around $3.4bn of its 2016 revenues.

Consumer M & A
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