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FDA grants accelerated approval to first drug for Duchenne muscular dystrophy
Tuesday, September 20, 2016The US Food and Drug Administration today approved Exondys eteplirsen injection the first drug approved to treat patients with Duchenne muscular dystrophy DMD Exondys is specifically indicated for patients who have a confirmed mutation of the dystr...
Novartis intensifies Entresto push with new analysis
Tuesday, September 20, 2016Novartis on Monday intensified its bid to convince doctors to prescribe its heart failure drug Entresto releasing an analysis that concluded the medicine contributed to higher quality of life scores compared with an older drug The decline in healthr...
ICON Completes the Acquisition of Clinical Research Management, Inc.
Tuesday, September 20, 2016ICON plc a global provider of drug development solutions and services to the pharmaceutical biotechnology and medical device industries today announced that it has completed the previously announced acquisition of Clinical Research Management Inc Cli...
TWi Confirms Patent Challenge Relating to Its Paragraph IV ANDA Filing for a Generic Equivalent to Androgel 1.62%
Monday, September 19, 2016TWi Pharmaceuticals Inc confirmed today that it has filed an Abbreviated New Drug Application ANDA containing a Paragraph IV certification with US FDA seeking approval to market a generic version of Androgel which the patents are owned by Unimed Pha...
GE brings off-the-shelf biotech drug factories to Ireland
Monday, September 19, 2016General Electric is digging deeper into biotechnology with plans to build four prefabricated drug factories in Ireland bringing to Europe a lowcost manufacturing concept it first pioneered in China The US conglomerate better known for making jet eng...
Themis Medicare inks pact with Nevakar for injectable products
Saturday, September 17, 2016Drug firm Themis Medicare has signed an agreement with Nevakar LLC to further develop manufacture and market latters injectable products in the US and some other select countries Under the agreement Themis will develop a selected number of innovativ...
EMA panel recommends nod for Pfizer's breast cancer drug
Saturday, September 17, 2016US drugmaker Pfizer Incs breast cancer drug Ibrance should be given marketing approval an advisory committee at the European Medicines Agency recommended The Committee for Medicinal Products for Human Use CHMP gave a positive opinion for Ibrance to...
AcelRx's opioid painkiller succeeds in key study
Friday, September 16, 2016AcelRx Pharmaceuticals Inc said its experimental opioid painkiller was well tolerated in postoperative patients including those with organ impairment and the elderly in a latestage study The Redwood City Californiabased drugmakers stock was up about...
Novo Nordisk says diabetes drug semaglutide cuts heart risk by 26 percent
Friday, September 16, 2016Novo Nordisks experimental injectable diabetes drug semaglutide reduced cardiovascular risk by percent in a keenly awaited clinical according to results released on Friday Semaglutide is the third diabetes drug to show such heart benefits after Nov...
Allergan to Buy Vitae Pharmaceuticals for $639 Million
Friday, September 16, 2016Allergan PLC agreed to acquire clinicalstage biotechnology company Vitae Pharmaceuticals Inc for million more than double its market value in a move aimed at strengthening the drugmakers skincare pipeline The price values Vitae at a share compared...
