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Puerto Rican Pharma Plants Prepare For Hurricane Maria

Pharmaceutical companies race to prepare manufacturing facilities in Puerto Rico, many of which date back to the 1980s and 1990s, for the arrival of Hurricane Maria.

Manufacturing Puerto Rico United States

US FDA's Benefit/Risk Framework Gets High Marks But Could Be Improved

Agency summaries contained in reviews of novel drugs and biologics are useful and informative but difficult to find, and their use should be expanded to other types of applications, industry sponsors and other external stakeholders say.

Drug Review Drug Safety Drug Approval Standards

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 Neurology

Pfizer's Sutent Expanded Indication: 'Hope' Or 'False Hope'?

US FDA Oncologic Drugs Advisory Committee casts tie vote on proposed expansion of Sutent's renal cell carcinoma indication, mirroring debate FDA having internally.

Advisory Committees Cancer Drug Review
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Policy & Regulation Explore this Topic

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Problems With Alternative Levothyroxine In France Force Merck To Switch Back To Original

French patients who have experienced adverse reactions to a new formulation of Merck KGaA’s hyperthyroidism drug Levothyrox are to be given temporary access to the original formulation, pending the availability of other brands of levothyroxine. Merck says the vast majority of patients have had no problems with the new version.

Drug Safety France Regulation

Latest From Regulation

ICH Consults On Revised Approaches To Assess Risk Of Reproductive Toxicity Of Drugs

Changes have been proposed to the international guideline on the methodologies that drug companies should use to test medicinal products to assess the risk of reproductive toxicity. The revised guideline takes into account new testing paradigms that allow enhanced human risk assessment and reduced animal use.

Safety Regulation

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

EU Finalizes GMP Rules, Inspection Procedures For Investigational And Finished Drugs

Two new legal acts have been adopted by the European Commission specifying updated good manufacturing practice requirements for investigational medicinal products and finished medicines. The legislation take into account recent updates to the EU rules on the safety of medicines.

Manufacturing Clinical Trials

Latest From Policy

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

The Flaws With IPR Patent Review: Acorda CEO Weighs In On Allergan Move

Allergan’s unusual arrangement to try to avoid IPR proceedings on Restasis made headlines last week. Our article suggesting the move is potentially damaging for the image of the biopharma sector as a whole prompted a response from Acorda CEO Ron Cohen.

Intellectual Property Legal Issues

Medicare Coding Change For Biosimilars Could Save $65bn, Firms Say

Biopharma manufacturers, payers and other stakeholders strongly support changing an Obama-era policy for reimbursing biosimilars under Medicare Part B in comments to the Centers for Medicare and Medicaid Services.

Biosimilars 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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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

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

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

EU Finalizes GMP Rules, Inspection Procedures For Investigational And Finished Drugs

Two new legal acts have been adopted by the European Commission specifying updated good manufacturing practice requirements for investigational medicinal products and finished medicines. The legislation take into account recent updates to the EU rules on the safety of medicines.

Manufacturing Clinical Trials

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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