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Featured Stories


FDA Panel Rejects Intellipharmaceutics' Opioid For Missing Data, Blue Dye Safety Concern

Panel members question why company pursued filing for its oxycodone ER given lack of data; agrees with FDA that blue Gatorade consumption does not show safety of dye excipient used to deter abuse.

Advisory Committees FDA Regulation

Revised EMA Guideline On First-In-Human Trials Addresses Dosing And Complex Protocols

The European Medicines Agency has updated its 2007 guideline on the strategies drug sponsors should apply to identify and mitigate risks in first-in-human trials to provide additional advice on dosing issues and the use of integrated protocols, among other things. The revised guideline will apply from February 2018.

Clinical Trials Regulation Europe

China Cybersecurity Law Catches Pharma Firms Unawares

China’s first cyber security law came into effect in June, but some pharma companies do not realize they need to comply.

China BioPharmaceutical Compliance

Heplisav Vaccine Postmarketing Study Might Overcome FDA Safety Worries At Panel

Dynavax has already received two complete response letters for its hepatitis B vaccine; more patients who received Heplisav died or experienced cardiovascular events compared with the competitor arm.

Advisory Committees Drug Safety Infectious Diseases
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Policy & Regulation Explore this Topic

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Medicare Part D Rebate Pass-Throughs To Beneficiaries Is 'On The Table'

Lilly CEO David Ricks reflects on the state of play on drug pricing issues on Capitol Hill and in the Administration and the challenges he sees ahead.

Pricing Debate Medicare Legislation

Latest From Regulation

Asia Policy People In The News: South Korean Top Health Regulators Take Office

Expanding risk management will be increasingly important to ensure drug safety, says Ryu Young-jin, new Minister of Korean Food and Drug Safety(MFDS).

South Korea BioPharmaceutical

FDA Gives Congress Reprieve On Deadline For Passing User Fee Bill

Commissioner Gottlieb says agency won't issue layoff notices 'unless and until Sept. 30 passes without reauthorization.'

FDA Legislation

Mapping US FDA's Biosimilar Pathway With Pink Sheet Drug Review Profiles

First four 351(k) BLA approvals highlight emerging FDA positions on issues from naming to the role of biosimilar-specific data, as detailed in Pink Sheet's Drug Review Profile series.

Drug Review Profile Biosimilars

Latest From Policy

Merck and Pfizer Pull PR Coup With Corning Glass Partnership

This time, when Donald Trump hosted an event with two Big Pharma CEOs, the topic wasn’t drug pricing: it was jobs in American manufacturing, tied to a new, stronger glass vial. But it also looks like an early case study in effective engagement with an unpredictable White House.

Manufacturing Pricing Debate

UK’s NICE Updates Policy For Preventing Bias In Advisors

Health technology assessment body NICE wants feedback on its revised policy on declaring and managing any conflicts of interest of its advisory committees.

United Kingdom Health Technology Assessment

India’s Stem Cell Guidelines Mandate Additional Checks

Draft update to national guidelines factors in additional safeguards and makes it mandatory to establish institutional panels to review stem cell research. Gene editing would be an area of "restrictive" research.

Policy Review Pathway

Clinical / R&D Explore this Topic

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Latest From Research & Development

Keeping Track Of Novel Agents: US FDA Approves Nerlynx And Vosevi, Turns Down Evenity; Macrilen Returns

News and highlights about novel agents from our FDA Performance Tracker.

Approvals Complete Response Letters

Keeping Track: Tremfya Clears FDA; Dextenza Amendment Is Too Late; Emicizumab, Abemaciclib Filed

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

Regulation Research & Development

Master Protocols Are Both Welcome And Inevitable – US FDA's Woodcock

Center for Drug Evaluation and Research Director Janet Woodcock continues to promote innovation in clinical trial design with a review of master protocols in the New England Journal of Medicine.

Clinical Trials Personalized Medicine

Commercial Explore this Topic

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Latest From Commercial

Commercial Capsules: Q2 Reporters, Mitsubishi Buy, Celltrion IPO, Renflexis Launch, Keytruda Fail, Ironwood and Vertex Trial Results

Q2 reporting is on a roll as GSK unveils a major shake-up under new CEO Walmsley; the prospect of a simplified route to approval may have helped Neuroderm secure Mitsubishi take-out; biosimilar developments include Celltrion Healthcare's IPO and Merck & Co's launch of Renflexis in the US; clinical trial updates were reported for Keytruda, Ironwood's GERD candidate and Vertex's next generation of cystic fibrosis candidates. Commercial Capsules rounds up key commercial news reported recently by sister publication Scrip.

Commercial Biosimilars

Activist Investor 'Buzz' Annoys Colgate CEO As Earnings Sting Shareholders

Colgate CEO Ian Cook says speculation that recent organic sales misses and competitive pressure make company an activist investor target is “noise” and the firm will combat competitive pressure through increasing advertising, growing e-commerce and expanding its natural product lines.

Consumer Advertising, Marketing & Sales

Emerging Dialysis Drugs Will Face Medicare Reimbursement Challenges

Navigating Medicare's complicated bundled payment system could be tricky for new class of anemia drugs, the HIF prolyl hydroxylase inhibitors, which may start to reach the market for dialysis patients in 2019.

Medicare Reimbursement

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA Will Soon Begin Alerting Generics Firms To Facility Compliance Status

US FDA's GDUFA II commitment to alert generics firms within 90 days regarding inspection results will put additional pressure on Form 483 responses, possibly starting later this year.

Manufacturing Quality

Merck and Pfizer Pull PR Coup With Corning Glass Partnership

This time, when Donald Trump hosted an event with two Big Pharma CEOs, the topic wasn’t drug pricing: it was jobs in American manufacturing, tied to a new, stronger glass vial. But it also looks like an early case study in effective engagement with an unpredictable White House.

Manufacturing Pricing Debate

CMC Regulatory Updates In Brief: CSL's Haegarda Specs; CMC Data Elements; ICH Q3C Maintenance

US FDA explains why it requested CSL Behring to reinstate non-critical manufacturing process controls and tighten container specs in line with process capability. FDA also proposes CMC data elements and posts ICH Q3C updates.

Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

GSK Trims Nutritional Drink Lines, Wants All Of Its Consumer JV Pie

With its July 26 earnings report, the UK firm made clear it's ready to become sole owner of its consumer health JV with Novartis, and that divesting UK brands Horlicks and MaxiNutrition are among its steps toward cutting manufacturing costs.

Consumer Business Strategies

Consumer Health Weekly Trademark Review July 18, 2017

Compiled from the Official Gazette of the U.S. Patent and Trademark Office] for [Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) trademarks registered and published for opposition.

Consumer Trademarks

Activist Investor 'Buzz' Annoys Colgate CEO As Earnings Sting Shareholders

Colgate CEO Ian Cook says speculation that recent organic sales misses and competitive pressure make company an activist investor target is “noise” and the firm will combat competitive pressure through increasing advertising, growing e-commerce and expanding its natural product lines.

Consumer Advertising, Marketing & Sales
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