Limited attention span? Focus on these market shake-ups in 2015
14 January 2015
It has been a whirlwind of a year for pharma, with pricing battles, regulatory showdowns and all-but-legendary M&A. And on the ground, it's Rock-em-Sock-em Robots in some of the industry's biggest markets. A steady flow of new drugs in 2014--and a slate of anticipated launches in 2015--have established brands defending their titles and newcomers looking to land a gut-punch or two, if not a knockout. Here are the match-ups to watch in the coming year.
FDA launches project to cut quality control lapses at drugmakers
14 January 2015
The U.S. Food and Drug Administration launched an initiative on Monday aimed at reducing lapses in quality control at pharmaceutical manufacturing facilities.
LA BioMed develops promising vaccine to combat MRSA
13 January 2015
Grappling with one of the world’s deadliest contagions for more than a decade without a breakthrough, the country’s leading infectious disease researchers have high hopes for a vaccine developed locally.
Russian government takes steps to prevent further drug price increases
13 January 2015
The Russian government is designing a number of measures aimed at preventing a further increase of drug prices in the domestic market, reports The Pharma Letter's local correspondent. According to Russia’s Prime Minister Dmitry Medvedev, the current situation in the market remains complex, which is reflected by the ever-increasing drug prices, caused by currency fluctuations and other factors.
FDA to publish guidance on social media and clinical trial e-consent in 2015
13 January 2015
The FDA has released a list of almost 100 draft drug guidance documents it plans to introduce or update in 2015. The documents cover a range of biotech IT-related topics, including electronic informed consent in clinical trials, links to third-party sites in social media adverts and statistical approaches to showing biosimilarity.
Medvedev Orders Stockpiles of Medicine as Russia's Ruble Slumps
12 January 2015
Prime Minister Dmitry Medvedev has instructed the Health Ministry to stock up on life-saving medications to ensure medical supplies aren't affected by the drastic devaluation of Russia's ruble currency.
China regulator to strengthen "grim" food, drug safety control
12 January 2015
Food and drug safety in China is "grim" and will get stronger oversight, the food and drug regulator said on Wednesday, after a series of scares last year hit the reputations of global firms such as McDonald's Corp and Wal-Mart Stores Inc.
France and Italy ban products from Indian companies
12 January 2015
While FDA regulatory action against Indian companies has drawn the media spotlight the last couple of years, European regulators also have been finding problems with some Indian plants. Both France and Italy took action against Indian drug manufacturers last month, finding them out of compliance and limiting product sales as a result.
In nanorod we trust: magnetic pulse tech breakthrough for cancer drug delivery
12 January 2015
A magnetic pulse technology that can align and push nanoparticles to points distant to magnet surfaces could finally make magnets attractive for deep tissue drug delivery according to researchers.
Analysts name top stock picks as EU biotechs enter 2015
12 January 2015
Analysts at Jefferies marked the new year by picking out their top trends and companies in European biotech. The analysts named Ablynx (EBR:ABLX), Cosmo Pharmaceuticals (SIX:COPN) and Genmab (CPH:GEN)--all of which are up at least 25% over the past year--as their top stock picks for 2015. Of the group, Genmab has the most significant, near-term data readout for its FDA breakthrough designated treatment, daratumumab.
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