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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 Drug Safety

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 Regulation

EU Extends Pilot Of New Drug Safety Reporting System

Testing of the enhanced EU drug safety reporting system, EudraVigilance, is to be extended beyond February in an effort to gain more information on how stakeholders are finding the new requirements.

Drug Safety Regulation Europe

Japan Approvals Include World Firsts For Romosozumab, Spinal Injury Cell Therapy

The latest group of new product approvals in Japan includes the first marketing clearances worldwide for fracture-reducing osteoporosis antibody romosozumab, a stem cell-based therapy for spinal cord injury, two new Daiichi drugs, and Pfizer's lung cancer therapy dacomitinib. 

Japan Approvals Regenerative Medicine

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 Regulation
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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.

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Policy & Regulation Explore this Topic

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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 Regulation

Latest From Regulation

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

EMA To Bring Anticancer Drugs Guide Up To Speed With Biomarker Development

Although biomarkers are increasingly being used in oncology to define malignant diseases and develop new treatment strategies, the European Medicines Agency's current guideline on evaluating anticancer drugs does not adequately address these aspects.
Europe Clinical Trials

After MPs Reject Brexit Deal, UK ABPI Wants Solution 'Quickly'

Following the government’s defeat over the Brexit withdrawal deal, the life sciences industry wants the UK parliament to find a solution quickly to avoid a “no-deal” scenario.

Brexit United Kingdom

Latest From 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

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

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

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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

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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

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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

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

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

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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
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