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Featured Stories


Clinical Trial System 'Broken,' But Modernization Long Way Away – Woodcock

CDER Director says current system is stifles innovation, calls for integration of health care and trial process.

Clinical Trials Regulation Research and Development Strategies

Drug Payment Experiments Coming To Medicare, Medicaid

Centers For Medicare and Medicaid Services releases 'request for information' on how to approach development of new payment models for prescription drugs in government-sponsored insurance.

Government Payers Reimbursement Market Access

Diagnosing A Healthy US FDA: The MRI Drug Safety Review

Do MRI contrast agents cause debilitating chronic illnesses in some patients who receive them? A group of patient advocates firmly believes they do. FDA’s approach to addressing the risk via a public advisory committee shows the agency has found an effective way to handle the type of safety scare that could have paralyzed it a decade ago.

Drug Safety FDA Risk Management

Pfizer v. J&J Sets Stage For Biosimilar Showdown Over Exclusive Contracts

Pfizer's suit claims J&J coerced payers by vowing to withhold all Remicade rebates if any of Pfizer's biosimilar Inflectra is reimbursed, but J&J says Pfizer has failed to show the value of Inflectra.

Biosimilars Legal Issues Reimbursement
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Policy & Regulation Explore this Topic

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Disease-Free Survival In Renal Cancer Raises Questions, But Still Acceptable, ODAC Says

Whether the endpoint can predict overall survival remains unknown, but there is no evidence not to accept it, US FDA advisory committee says.

Advisory Committees Clinical Trials Drug Approval Standards

Latest From Regulation

Hispanic Market OTCs Caught In Recalls Of PharmaTech-Made Drugs

FDA's Sept. 20 update to its recalls database includes listings for Doctor Manzanilla Allergy & Decongestant Relief and Cough & Cold oral solutions made by PharmaTech. Also recalled is a mis-labeled Medline Industries ointment.

Consumer Recalls

EMA Argues Pre-Submission Activities Under Ombudsman's Radar Are A Legal Requirement

The European Medicines Agency maintains it is fulfilling a legal obligation by organizing early interaction meetings with drug developers. The regulator is meeting with the EU Ombudsman, who is investigating whether such interactions can influence the agency’s decisions on marketing authorization applications.

Regulation Europe

EMA’s Future Home: Assessment Of Bids Nears Completion Amid Growing Staff Concerns

Sept. 30 is the date by which the European Commission must complete its assessment of member states’ bids to host the European Medicines Agency after Brexit. The agency has again highlighted the pressures it is under as a result of the relocation, and the situation has worsened after some LGBT staff members expressed concern about their rights in certain potential host countries in eastern Europe.

Brexit Regulation

Latest From Policy

Turkey Finds Permanent Solution To Tamoxifen Shortage

The Turkish government plans to fix the country’s tamoxifen drug shortage problem by allowing by a local company to manufacture the product.

Market Access Pricing Debate

Opioid Industry's 'Superstructure' Targeted By State Attorneys General

Janssen, Teva, Allergan, Endo, and Purdue – as well as several distributors – pursued in multistate investigation that follows individual AG inquiries and flurry of state, city, and county suits.

Legal Issues Advertising, Marketing & Sales

Could Medicare 340B Payment Cuts Lead Hospitals To Buy At List Price?

Pew Charitable Trusts' Allan Coukell warns the Centers for Medicare and Medicaid Services that its proposal to reduce Medicare Part B drug payments to 340B hospitals may have 'unintended consequences.'

Pricing Strategies Medicare

Clinical / R&D Explore this Topic

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Latest From Research & Development

Real-World Evidence Requires 'Leap Of Faith' For Industry, FDA – Gottlieb

US FDA Commissioner says agency will soon offer more clarity on using real-world evidence in drug development, but notes industry needs to take risks of its own.

Research & Development Review Pathway

The Cost Of Drug Development: Can We All Just Agree It’s Expensive?

A new study has re-opened the debate over whether drug development is really as expensive as Big Pharma says it is. Here’s why industry should embrace the study despite its flaws.

Research & Development Cancer

Alzheimer's Guidance Coming From US FDA, Part Of Broader OND Reform

'Believe it or not, we don't have as many disease-specific guidances as you would suspect on the new drug side,' Commissioner Gottlieb says.

Clinical Trials Research & Development

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Latest From Commercial

UK’s NICE Backs BMS's Opdivo In Lung Cancer, But Only Via CDF With Price Cut

UK HTA body NICE has decided to make Bristol-Myers Squibb's PD-1 inhibitor Opdivo available for non-small-cell lung cancer, but only through the UK's revamped Cancer Drugs Fund, and at a discounted price.

Commercial Companies

Switches, Pediatric Products Highlight OTC Outlook In Independent Pharmacies

OTC cold and allergy product sales lead the health, wellness and beauty segment in 16,000 US independent pharmacies, says Hamacher Resource Group. Vitamins and supplements, which lead other categories in chain retail pharmacies, are the No. 2 category in independent pharmacies.

Consumer Advertising, Marketing & Sales

Commercial Capsules: BMS's Opdivo Knock; Novo Nordisk Vs Eli Lilly; Roivant Raises; Sun Plunges; Other R&D Stumbles

Bristol-Myers Squibb faces a second clinical disappointment with Opdivo/Yervoy, allowing Exelixis to take advantage; Novo Nordisk claims a victory over Eli Lilly in the GLP-1 space; Roivant Sciences closed a $1.1bn equity financing; India’s biggest drug firm, Sun Pharma, slid into the red; Regeneron drops out of RSV; and Zynerba's cannabidiol gel misses again. Commercial Capsules rounds up key commercial news reported recently by sister publication Scrip.

Clinical Trials Commercial

Manufacturing Explore this Topic

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Latest From Manufacturing

Hispanic Market OTCs Caught In Recalls Of PharmaTech-Made Drugs

FDA's Sept. 20 update to its recalls database includes listings for Doctor Manzanilla Allergy & Decongestant Relief and Cough & Cold oral solutions made by PharmaTech. Also recalled is a mis-labeled Medline Industries ointment.

Consumer Recalls

Turkey Finds Permanent Solution To Tamoxifen Shortage

The Turkish government plans to fix the country’s tamoxifen drug shortage problem by allowing by a local company to manufacture the product.

Market Access Pricing Debate

FDA Hits Two More Asian Firms With Drug GMP Warning Letters

The spate of recent warning letters going to foreign pharmaceutical manufacturers continues as two Asian firms get into trouble for GMP violations: Firson Co. in South Korea and Wuxi Medical Instrument Factory in China.

Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Perrigo Positioned To Prosper From Potential Amazon OTC Product Play

CEO John Hendrickson says Perrigo would work with Amazon to develop its own private label OTC line and would not expect to lose existing customers. At a recent investor conference, he said Amazon’s commitment to the OTC category would help grow the market, not take market share from other firms.

Consumer Business Strategies

Consumer Health Weekly Trademark Review Sept. 12, 2017

Compiled from the Official Gazette of the US Patent and Trademark Office, Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) marks registered and published for opposition.

Consumer Dietary Supplements

Perrigo Glows From Mucinex Private Label Plan, Starboard Plug

Perrigo plans to introduce two more Mucinex store brand products within six months after a series of manufacturing stumbles, CEO John Hendrickson says. The firm's private label prowess, says activist investor Jeffrey Smith, is insurance that it will grow as e-commerce grows.

Consumer Consumer
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