All News

The European Union’s decentralized procedure is to be used by international regulatory agencies as a model for facilitating generic-drug application assessments, as part of the International Generic Drug Regulations Pilot (IGDRP) project.

PharmaChk, a portable anticounterfeiting device, has received a $2 million transition-to-scale grant from Saving Lives at Birth: A Grand Challenge for Development.

Mexico’s pharmaceutical industry will be worth approximately US$22.5 billion by 2020, according to research and consulting firm GlobalData.

Siegfried Schmitt offers some steps that manufacturing companies can take to ensure data integrity.

In this Applied Clinical Trials article, Kadmon CEO Dr. Sam Waksal talks about the importance of imagination for innovation, current business risks in biopharma, and applying understanding to the concept of Big Data.

Medtech employment remained steady in last year with most medical device makers experiencing an increase in their workforce, according to a new jobs report published by EP Vantage.

With the recent approval of Jardiance in the US, Eli Lilly and partner Boehringer Ingelheim (BI) “have taken another step towards owning the most comprehensive diabetes portfolio in the industry”, according to research and consulting firm GlobalData.

The European Medicines Agency (EMA) has released a consultation on good genomics biomarker practices.

Novartis reports that its KAE609 is the first antimalarial drug candidate with a novel mechanism of action to achieve positive clinical proof-of-concept in over 20 years.

In the media world, it’s easy to see when a market is really taking off - someone starts a magazine or a website about it.

FDA has announced it is taking steps to ensure that certain diagnostic tests are accurate, consistent and reliable.

As Europe departs for its annual holiday-sacrosanct, even amid the continuing economic woes, the multiple crises in the Middle East, and the dark mysteries of Russia’s intentions in its former satellites-the question remains unresolved as to what to expect from the new European Parliament in the new term.

The European Medicines Agency (EMA) has released the second module of a new overarching guideline on influenza vaccines for a six-month public consultation.

The Joint United Nations Programme on HIV/AIDS (UNAIDS) and the African Society for Laboratory Medicine (ASLM) have joined with a number of global partners to launch the Diagnostics Access Initiative.

A new report from Frost & Sullivan forecasts “robust demand” for HCV antivirals, with several strong competitors “maneuvering aggressively” to narrow the market gap by introducing a treatment that can outdo Gilead’s Sovaldi.

GSK announced that it has submitted a regulatory filing to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S.

Over the years, healthcare professionals have needed to adapt to a more highly informed patient population due to improvements in the availability of accessible healthcare information through the internet.

PCMA represents several American managed care entities and has been an active participant in the national debate over the issue of high priced biotech Rx drugs.

The launch of several drugs with “extraordinary blockbuster potential” will more than triple the acute coronary syndrome (ACS) treatment market, from $12.3 billion in 2013 to $43.4 billion by 2023, according to research and consulting firm GlobalData.

With all of the buzz and excitement around risk-based monitoring (RBM), one might expect that the broad adoption of this emerging clinical research paradigm is well underway.

Sanofi Pasteur, the vaccines division of Sanofi, reports that results of an efficacy study is a step closer to making dengue the next vaccine-preventable disease.

After months of speculation about prospects for biosimilar development in the U.S., Novartis announced July 24 that FDA has accepted Sandoz’ biologics license application (BLA) for a similar version of Amgen’s Neupogen (filgrastim).

The European Union’s struggle to bring its data protection rules into the 21st century continues-haltingly-as the EU itself enters its new era, with a new European Parliament, a new President-designate of the European Commission, and a new European Commission due to take office in November.

The steady decline of pharmaceutical sales representative access to physicians is spreading to previously rep-friendly specialties, says the ZS Associates spring 2014 AccessMonitorT report.

Today’s Financial Times (FT) reports that nearly $40bn was wiped from the biotech market’s value last week (a 6 per cent drop in the Nasdaq biotechnology index) following the Federal Reserve’s identification of biotech shares as a cause for concern.

It’s difficult to open an email or an envelope in Brussels these days without yet another agenda falling out of it, carrying the promise of a new start.

A potential treatment for sickle cell disease has come through the “valley of death” of early stage development due to support from a collaborative partnership established by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH).

It is well known that Brazil has an immense biodiversity and that the Amazon is the largest tropical rainforest in the world.

The European Medicines Agency (EMA) has insisted that the concerns raised about its scientific advice given to pharmaceutical companies stem from a flawed understanding of the activities of the agency and its partners in this area.

The medical technology industry has a legacy of creating life-enhancing, life-extending products while rewarding its investors in the process.