Article Listing - US FDA approves Alza's IONSYS
Data on Novo Nordisk's Victoza further supporting safety presented at expert workshop
14 June 2013
Danish Insulin giant Novo Nordisk (NOV: N) presented data further supporting the safety of Victoza (liraglutide [rDNA origin] injection) at a scientific workshop in the US arranged by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Cancer Institute (NCI).
Lilly stops Ph II study of Alzheimer's candidate LY2886721 due to abnormal liver tests
14 June 2013
US drug major Eli Lilly (NYSE: LLY) says it has stopped its Phase II study (BACC) for LY2886721, a beta secretase (BACE) inhibitor being investigated as a once daily treatment for its potential to slow the progression of Alzheimer's disease. The decision was due to abnormal liver biochemical tests. The cases of abnormal liver biochemical tests were identified as part of routine monitoring. Lilly will continue to monitor all participants with abnormal liver biochemical tests.
FDA backs Amgen's Xgeva for new use, to treat giant cell tumor of the bone
14 June 2013
The US Food and Drug Administration late yesterday (June 13) expanded the approved use of biotech major Amgen's (Nasdaq: AMGN) Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.
US Supreme Court issues mixed ruling on DNA patents
14 June 2013
The US Supreme Court yesterday (June 13) delivered its unanimous decision regarding the Association for Molecular Pathology versus Myriad Genetics case on patent claims on isolated DNA molecules, stating that companies cannot patent specific DNA, but that synthetically produced genetic material can be patented.
Bionor Pharma leaps on positive trial results of HIV vaccine Vacc-4x with Revlimid
14 June 2013
Norway-based Bionor Pharma (OSE: BIONOR) saw its shares leap 16% to 3.67 kroner on June 13, after the company revealed that the first part of its phase II clinical study combining the HIV vaccine, Vacc-4x, with Celgene's immunomodulator, Revlimid (lenalidomide), has been successfully completed.
NICE says "yes" to Alimera's Iluvien for treatment of diabetic macular edema
14 June 2013
In draft guidance published today (June 14) by UK drugs watch dog the National Institute for Health and Care Excellence (NICE) it is recommending US ophthalmic biopharma specialist Alimira Sciences (Nasdaq: ALIM) Iluvien (fluocinolone acetonide intravitreal implant for the treatment of chronic diabetic macular edema considered insufficiently responsive to available therapies, reversing a prior draft guidance last summer (The Pharma Letter August 8, 2012).
Genetics and genomics industry in the USA has a trillion dollar impact, new Battelle study shows
14 June 2013
A new Battelle study released this week by United for Medical Research illustrates the genetics and genomics industry's impact on the US economy has reached nearly a trillion dollars. The study is based on new data collected over the previous two years, and represents an update to the highly-cited Battelle 2011 report tracking the growth of the industry and its links to the federally funded Human Genome Project (HGP).
EULAR highlights: Celgene's apremilast; AbbVie's Humira; and Lilly's baricitinib
13 June 2013
Among highlights of the ongoing European League Against Rheumatism (EULAR) in Madrid, Spain, US biotech firm Celgene (Nasdaq: CELG) presented positive data from a third Phase III randomized controlled study, dubbed PALACE 3, of apremilast in psoriatic arthritis.
Turkey's NSCLC drug market forecast to expand at 7% a year through 2017
13 June 2013
From 2012 to 2017, the non-small-cell lung cancer (NSCLC) market in Turkey will increase at an annual rate of 7%, reaching a value of $73 million in 2017, according to a new report from health care advisory firm Decision Resources.
Sunesis Pharma's VALOR trial of vosaroxin should continue with no change, says DSMB
13 June 2013
Sunesis Pharmaceuticals (Nasdaq: SNSS) says that the independent Data and Safety Monitoring Board (DSMB) for the VALOR trial has completed its latest periodic safety review and recommended that the trial continue as planned without changes to study conduct.
- US Supreme Court says patent settlement can "sometimes" be illegal
- InSite Vision joins Merck & Co and Pfizer in patent infringement law suit against
- Osteoporosis drug bazedoxifene stops growth of breast cancer cells, even in resistant tumors
- Additional indications in Japan for Roche's Avastin and Astellas' Prograf
- Highlights of EHA meeting: Novartis' Jakavi; Bristol-Myers and AbbVie's elotuzumab; Janssen's ibrutinib
