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UK Govt Issues Brexit Wish List For Pharma Regulation; Wants Lots To Stay The Same

A position paper from the UK government has laid out some ideas for ensuring a smooth transition to a post-Brexit world in the area of regulation, with a focus on issues such as marketing authorization validity, continued regulatory oversight, inspections, and adverse drug reaction reporting.

Brexit United Kingdom Regulation

Indian Policy Shifts Could Force Firms To Abandon 'Second Brand' Strategies

India’s new draft pharmaceutical policy proposes a raft of radical changes that have left industry jittery and could force a significant realignment in the operations of foreign and local firms. Second brand strategies and widespread licensing-out of manufacturing are no longer favored, and a 'one company – one drug – one brand name – one price' thrust are among the key changes proposed.

Generic Drugs Pricing Strategies Policy

EMA Multinational Assessment Teams Move Into Post-Authorization After Delay

The scope of the European Medicines Agency’s multinational assessment team initiative was originally due to expand in April from the pre-authorization to the post-authorization phase. It will happen next month instead.


Once More Unto The Breach: PTC's Duchenne Drug Translarna Gets Advisory Cmte.

US FDA's Peripheral and Central Nervous System Drugs Advisory Committee to consider application, which PTC Therapeutics filed over protest.

Advisory Committees Rare Diseases Regulation

Policy & Regulation Explore this Topic

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Should A Biosimilar Sponsor Do The 'Patent Dance?' It Depends On Many Things

The amount of exclusivity remaining for a reference product, strength of an innovator's patents and risk of a preliminary injunction are factors that biosimilar sponsors should consider in deciding whether to follow the BPCIA's patent information and exchange procedures, one legal expert suggests.

Biosimilars Biologics Legal Issues

Latest From Regulation

Another Feather In Cap For Orchard’s Gene Therapy Product Following UK PIM designation

Orchard Therapeutics’ gene therapy product for treating the rare, so called “bubble baby” disease has been granted a “promising innovative medicine” designation under the UK’s early access to medicine scheme. The product already has orphan drug, breakthrough therapy and rare pediatric disease designations in the US.

Market Access Regulation

Opioid Cough Medicines Might Face Complete Ban In Pediatric Patients

US FDA's Pediatric Advisory Committee sets meeting for meeting Sept. 11 to discuss the use of opioids with hydrocodone and codeine for treating pediatric cough.

Pediatrics Advisory Committees

Gottlieb Adds A No. 2: Sherman Is US FDA Principal Deputy Commissioner

Rachel Sherman takes over a position that has not been filled permanently since Josh Sharfstein left in 2011.

FDA Leadership

Latest From Policy

FDARA Takes Effect With Under-The-Radar Presidential Signature

Key FDA legislation moves to implementation phase with presidential signature but little fanfare.

FDA Legislation

FDARA: The Forgotten Health Care Bill

The White House missed an opportunity to tout a major legislative accomplishment in the first year of President Trump’s term.

United States FDA

Multiple Sclerosis Drug Price Increases Probed By House Oversight Panel Democrats

Reps. Cummings and Welch contact seven manufacturers of multiple sclerosis drugs with inquiries about persistent and significant annual price increases. The members suggest some firms are boosting prices in "lockstep."

Pricing Debate Policy

Clinical / R&D Explore this Topic

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Latest From Research & Development

Keeping Track: Oncology Stays Hot With Besponsa And Lynparza Approvals; New Uses Of Adcetris, Cabometyx Submitted

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

Performance Tracker Approvals

FDA Policy Says Right-to-Try Talks Are Between Providers, Sponsors

New internal policy says the US agency cannot force a drug maker to supply an unapproved drug to a patient for expanded access and that the provider must seek company approval to provide the product.

FDA Research & Development

Clinical Data Forgers Face Harsh Punishment In China

China FDA now has more solid ground to enforce GCP norms. A legal explanation from the nation's highest People's Supreme Court clarifies responsibilities of study sponsors and CROs involving in data falsification.

Clinical Trials Research & Development

Commercial Explore this Topic

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Latest From Commercial

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

Policy People In The News: Patrick Conway Departs CMS

Conway, a champion of the US agency's move into value-based care, will take the helm at Blue Cross/Blue Shield of North Carolina; Biogen, Astellas, Myovant make executive changes in policy operations.

Appointments Companies

Commercial Capsules: Autoimmune Positioning; Sanofi In China; Migraine Race; BMS Deal; Clinical Advances

AbbVie outlines how it will stay top dog in autoimmune therapy; Dermira licenses lebrikizumab, threatening pressure on Sanofi/Regeneron's Dupixent; Sanofi has driven up vaccine sales in China after responding to new government distribution rules; Lilly plans a migraine filing; FibroGen, Myokardia and Hansa Medical advance in the clinic and Bristol-Myers shells out up to $2.3bn to turn cold tumors hot. Commercial Capsules rounds up key commercial news reported recently by sister publication Scrip.

Clinical Trials Deals

Manufacturing Explore this Topic

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Latest From Manufacturing

South Africa Has Compulsory Licensing, Parallel Imports In Its Sights

The draft South African national intellectual property policy proposes a number of measures that will be of keen interest to R&D-based and generic industries alike. Part one of this article looked at patent matters including patentability criteria and opposition procedures. In part two, we examine proposals in areas like voluntary and compulsory licensing, parallel importation, and boosting local drug manufacturing capacity.

Intellectual Property South Africa

More Questions As Biocon Pulls EU Filings For Two Biosimilars

Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical questions on how soon things can be set right in an increasingly competitive scenario.

Biosimilars Manufacturing

EU Member States Taking New Steps To Tackle Drug Shortages

The EU Heads of Medicines Agencies has outlined some of the recent initiatives taken by the member states to deal with medicines shortages, including a new Dutch center and a member state coordinating initiative by the Irish regulator.

Distribution Manufacturing

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Perrigo Draws On OTC Strength For Private Label Nexium 24HR Launch

Perrigo plans late September launch of a store brand OTC of Nexium 24HR after FDA’s ANDA approval and settlement of patent litigation with AstraZeneca. But it faces competition from Aurobindo's generic OTC esomeprazole 20 mg delayed-release capsules.

Consumer Prescription To Otc Switch

Consumer Health Weekly Trademark Review Aug. 8, 2017

Ccompiled 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 Trademarks

GMP Problems Stop Canadian Firms’ Topical OTC, Homeopathic Imports

Homeolab USA’s and Cellex-C’s imports were stopped earlier in 2017 following GMP inspections at their facilities, and FDA warns that approvals for marketing of additional products in the US could be withheld until each firm is GMP-complaint. Homeolab trips up by trying to prevent FDA photography inside plant.

Consumer Manufacturing