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Gilead Lowering HCV Drug List Prices With Authorized Generics
Approach has been endorsed by Express Scripts as more workable solution than trying to cut list prices for drugs already on the market.
Brazil Takes Steps Towards Harmonization On Pharmacovigilance
Brazil wants to update its pharmacovigilance rules and bring them into line with international standards.
New Patents Database To Help Countries Improve Medicines Procurement
The international drug industry group, IFPMA, the World Intellectual Property Organization and 20 big pharmas have launched Pat-INFORMED, a new patent database that can be used by governments to improve their medicines procurement programs. The R&D-based industry says it clearly links public patent information to registered medicines in a new, user-friendly online gateway. However, the European generics industry body Medicines For Europe says the move amounts to "patent linkage" and will have anti-competitive effects for generics firms.
US FDA’s Opaque Galafold Review: A Rare Misstep In The Trump Era
Voucher Bargain: US FDA Lowers Redemption Fee; NDA And BLA Review Costs Decrease
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Case Study: Broad Thinking Yields Big Results
There are numerous details when considering product packaging that require both creative thinking and feature prioritization. Rather than developing a standard solution for the current need, it’s imperative to think broadly and design options that are cost-effective, simplify operations and save time and/or resources.
Generics In The US 2018
Read this eBook and learn more about the West AccelTRA elastomer components program that was designed to help in this effort. Learn how the AccelTRA component program has been helping generic biopharmaceutical manufacturers by providing a number of key features, for those high-volume products and where manufacturers would like to deal mostly with one high-performing elastomer component.
Policy & Regulation Explore this Topic
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European CHMP Opinions And MAA Updates
This is a monthly update listing recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
Latest From Regulation
Brexit: Number Of Drugs At Risk Of Shortage Cut From 108 to 39
The European Medicines Agency plans to work directly with the marketing authorization holders of products that are still at risk of supply shortages to address the outstanding issues.
Stress Test For WHO’s Quality Certificate Scheme In The Americas
EMA Targets Sponsors That Post Trial Results Too Late
Too many clinical trial sponsors are late in to reporting their study results on the publicly available EU Clinical Trials Register, and the European Medicines Agency is planning to chase up the laggards.
Latest From Policy
India Rolls Out Modicare - Can It Redefine Healthcare Access, Market Potential?
AstraZeneca FluMist Supply Jumps With CDC's Seal Of Approval
Trump's Chinese Import Tariff Hike Could Take Toll On Consumer Health Sector
Low margins, limited supplier alternatives leave little room for OTC drug marketers in the US to maneuver as ingredients continue to be subject to Chinese import tariffs.
Clinical / R&D Explore this Topic
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Latest From Research & Development
Opioids Could Become Bioterror Weapons, US Fears; BARDA Funds Countermeasures
Opiant could get $4.6m to accelerate development of nasal nalmefene for treatment of opioid overdose.
Pivotal Trials Are Cheaper For Unmet Needs And Orphan Drugs, JAMA Study Finds
Repeated Questions Prompt EMA To Reconsider Guidance On Neonates
Commercial Explore this Topic
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Latest From Commercial
AstraZeneca FluMist Supply Jumps With CDC's Seal Of Approval
Novo Nordisk CEO Says Group Doubling Medical Supplies in UK Ahead Of Brexit
Novo Nordisk's chief says the Danish company is stockpiling medicines in case of "no deal" hard Brexit
AbbVie Deployed Nurses As 'Runners And Cappers' In Humira Kickback Scheme, Suit Alleges
California Insurance Commissioner claims AbbVie gave kickbacks for healthcare providers to prescribe Humira and had nurse 'ambassadors' insert themselves between patients and physicians.
Manufacturing Explore this Topic
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Latest From Manufacturing
API Makers Must Control Dangerous Impurities Better, FDA Compliance Official Says
The compliance chief for FDA’s center for drugs said API makers need to do a better job of testing their products for impurities to avoid exposing patients to safety risks, as has occurred with at least one supplier’s valsartan API.
Trump's Chinese Import Tariff Hike Could Take Toll On Consumer Health Sector
Low margins, limited supplier alternatives leave little room for OTC drug marketers in the US to maneuver as ingredients continue to be subject to Chinese import tariffs.
The Quality Lowdown: The More Things Change …
US FDA inspection offers hints that Zhejiang Huahai’s genotoxic valsartan impurity could have been caught earlier, while EMA expands its quality review to other sartans that contain the same trouble-prone tetrazole ring. A micro lab will have to jettison its microbrewery, and compounding supplier Fagron must ID its API sources.
Consumer / OTC Drugs Explore this Topic
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Latest From Consumer
Trump's Chinese Import Tariff Hike Could Take Toll On Consumer Health Sector
Low margins, limited supplier alternatives leave little room for OTC drug marketers in the US to maneuver as ingredients continue to be subject to Chinese import tariffs.
The Quality Lowdown: The More Things Change …
US FDA inspection offers hints that Zhejiang Huahai’s genotoxic valsartan impurity could have been caught earlier, while EMA expands its quality review to other sartans that contain the same trouble-prone tetrazole ring. A micro lab will have to jettison its microbrewery, and compounding supplier Fagron must ID its API sources.
Freshkote Buy Narrows Eyevance's Focus
Agreement with Focus Laboratories includes all Freshkote formulations in multi-dose bottles and single-unit vials to market and commercialize the line worldwide.
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