Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Featured Stories


Sanofi's Sotagliflozin: Risk Of Ketoacidosis Divides US FDA Advisory Committee

Some Endocrinologic and Metabolic Drugs Advisory Committee members said a REMS is sufficient, but others worried that proposed risk management plans were not proven effective.
Metabolic Disorders Advisory Committees Regulation

Uloric U-Turn: Gout Therapy Likely To Stay On Market Despite CV Safety Concern

US FDA would not have approved Takeda’s Uloric but for a post-market safety study commitment. Now that the study is complete and suggests a potential increased risk of mortality, however, FDA doesn’t seem inclined to pull the product.
Drug Safety Post Market Regulation & Studies Advisory Committees

Mexican Pharma Industry Joins Anti-Corruption Crackdown

The Mexican research-based pharmaceutical industry has pledged to crack down on corruption as the country’s new president says the vice must be eliminated to deliver better health system.

Mexico Government Payers Market Access

CVS Medicare Part D Plan With Pass-Through Rebates Has Limited Uptake

Low enrollment indicates that beneficiaries have trouble figuring out whether reductions in cost sharing would offset a much higher premium.

Medicare Pharmacy Benefit Management Policy

European Council Move Brings SPC Manufacturing Waiver A Step Closer

A proposed SPC manufacturing waiver – which would allow generic and biosimilar manufacturing within Europe during the SPC period – has taken a step closer to being realized after the European Council approved a mandate for negotiations with the European Parliament. However, it remains uncertain whether key elements desired by the off-patent industry will fall into place.

Europe Manufacturing Generic Drugs
Advertisement

US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – December 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.
International Europe Australia

Global Generics & Biosimilars Awards 2018

Generics bulletin was able to celebrate the outstanding progress that both teams and individuals achieved in providing greater healthcare access through generic, biosimilar and value-added medicines. Many of these achievements have been documented in Generics bulletin. Click below and enjoy the selection of articles that reflect the wide array of industry activities.

Read more

Pharma Report Store

Have an immediate and specific information need?

Browse and buy from 1000s of analysis and research reports now:

Shop Now

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Roche Calls For Harmonized Regulations As Subcutaneous Herceptin Declined Trial Waiver In India

Roche has sought a harmonized regulatory approach for approval of innovative medicines and formulations in India, after its request for a trial waiver for subcutaneous Herceptin was turned down by an expert panel.
India Policy Review Pathway

Latest From Regulation

FDA’s Sentinel Strategy: Starting Slow Move Toward “Active” Surveillance

US FDA’s strategic plan for Sentinel includes pilot projects to move towards the vision of active surveillance. However, FDA is also making clear that it won’t be a quick or easy transformation. 
Drug Safety Post Market Regulation & Studies

Insulin Makers May Be First In Crosshairs Of DeGette Rx Pricing Investigation

Rep. Diana DeGette, new chair of US House Energy and Commerce Committee's Subcommittee on Oversight and Investigations, said insulin is a good example of problems with drug pricing and promised to call drug company CEOs to hearings.
Metabolic Disorders Pricing Debate

Evenity Likely Headed For Approval With Amgen's Proposed Indication, But Postmarketing Requirements Remain Unclear

US FDA advisory committee splits on whether Amgen's osteoporosis drug romosozumab needs observational study or randomized controlled trial to assess cardiovascular risks. 
Advisory Committees Orthopedics

Latest From Policy

ICER’s ‘Unsupported Price Increase’ Report Due This Fall

Report by the Institute for Clinical and Economic Review will seek to inform the public policy debate on price increases for prescription drugs.

Pricing Debate Policy

Bio Industry Warns UK Orkambi Inquiry Against Publishing Confidential Price Information

Vertex and bioindustry groups have called on a UK inquiry investigating the availability of the cystic fibrosis drug Orkambi on the National Health Service not to publish confidential information.

Europe United Kingdom

US Federal Courts Can Operate Until Jan. 25; Patent Office Faces Eminent Closure Under Shutdown

Federal courts and USPTO will soon run out of funds that have allowed them to continue normal operations; pending ANDAs to get same filing date, which could lead to FDA legal challenges.
Legal Issues Intellectual Property

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

External Control Arms: Better Than Single-Arm Studies But No Replacement For Randomization

Synthetic control group derived from historical clinical trial data could augment smaller randomized trials and yield better information than single-arm studies, but this approach should not be viewed as a substitute for randomized trials where feasible, US FDA officials said at a Friends of Cancer Research meeting.

Clinical Trials Drug Approval Standards

Opioid Sponsors Enter 2019 At A Crossroads

Recent regulatory trends at US FDA offer no clear path to success for sponsors developing opioids. As 2018 concludes with only one approval and at least five rejections, firms will need new strategies if they hope to bring the analgesics to market. 
Research & Development Neurology

What’s The Plan? US FDA Drug Development Tool Qualification Process Requires “Cultural Change”

FDA sees negotiating formal “qualification plan” as key process improvement that should ultimately accelerate pace for construction of biomarkers and other drug development tools. But it will take some getting used to.
Clinical Trials Drug Approval Standards

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

J.P. Morgan Notebook Day 4: US Generics Steady, UroGen, REGENXBIO, Dr. Reddy's In China, And Investor Sentiment Shifts

Daily round-up of news and notes from the 2019 J.P. Morgan Healthcare Conference in San Francisco: US generics see gains, researcher calls for more tech transfer, and biotech investor sentiment rises as big deals bring optimism – among other items from the last day of this year's JPM. 

Business Strategies Regenerative Medicine

House Maintains Momentum For US OTC Monograph Reform, But Senate Remains A Question Mark

With a new US Congress just convening, OTC monograph reform advocates face an old problem: the need for Senate action. The House has already cleared an OTC reform measure, as part of a pandemic preparedness bill, in the first days of the legislative session.

Consumer Legislation

J.P. Morgan Notebook Day 3: Biotech Feeling Government Shutdown, AstraZeneca, Denali, Allergan, Aptinyx, Sangamo

Daily round-up of news and notes from the 2019 J.P. Morgan Healthcare Conference in San Francisco: AstraZeneca's net prices set to slide in 2019; biotechs ponder disasters from government shutdown; Denali moves into gene therapy; Sangamo clarifies partnering strategy; and Scrip talks to Allergan and Aptinyx about upcoming NMDA data releases.

Business Strategies Pricing Debate

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Pharmaceutical Groups Urge FDA To Upgrade From NDC To GTIN To Avoid Conflicts With DSCSA

Pharmaceutical manufacturers and distributors complain that FDA’s plan to add digits to the NDC would be a mistake and could potentially conflict with global standards as well as the bar code technology systems put into place under the Drug Supply Chain Security Act. They suggest embedding the NDC into the GS1 Global Trade Identification number (GTIN) to avoid these conflicts.
Manufacturing Distribution

Random Checks Now Routine: China To Inspect Your Factories Near And Far

An officially released new regulation in China legalizes overseas inspections of drug and device makers, making the risk-based inspections routine tasks that could also expand to manufacturers' R&D partners and third-party suppliers of ingredients, excipients or packaging materials.

China Manufacturing

US FDA Brings Back Furloughed Workers To Inspect High-Risk Facilities

Though they remain unpaid, hundreds of furloughed FDA employees will return to duty to conduct routine surveillance inspections of high-risk manufacturing facilities.

Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

House Maintains Momentum For US OTC Monograph Reform, But Senate Remains A Question Mark

With a new US Congress just convening, OTC monograph reform advocates face an old problem: the need for Senate action. The House has already cleared an OTC reform measure, as part of a pandemic preparedness bill, in the first days of the legislative session.

Consumer Legislation

EllaOne Firm Endorses UK Reproductive Rights Group's Push For OTC Sales Of Emergency Contraceptives

EllaOne manufacturer HRA Pharma supports British Pregnancy Advisory Service's call to scrap mandatory consultations for emergency contraceptives by switching the medicines from pharmacy-only sales to OTC. BPAS says there are “no risks which outweigh its use and it is considerably safer than many medicines sold straight from the shelf in the UK."

Consumer Prescription To Otc Switch

Burt’s Bees Hopes Third Time’s A Charm In Oral Care With P&G As Provider

Clorox and Procter & Gamble embarked on a strategic licensing partnership to market Burt’s Bees toothpastes, available now in mass retail doors. Billed as simple formulas for adults and kids, with or without fluoride, the line marks the third swing at toothpaste for the iconic natural brand.

Consumer Deals
UsernamePublicRestriction

Register

Advertisement