Targeted lung cancer therapies are supplanting conventional treatments
3 March 2015 | By Frost & Sullivan
Close competition encourages established manufacturers to broaden the drug pipeline for targeted therapies, finds Frost & Sullivan...
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Taiho submits TAS-102 Marketing Authorisation Application to the European Medicines Agency for the treatment of refractory metastatic colorectal cancer
2 March 2015 | By Taiho Pharma Europe Ltd
Taiho Pharma Europe Ltd., a subsidiary of Japan based Taiho Pharmaceutical Co., Ltd., announced that it has submitted a Marketing Authorisation Application to the European Medicines Agency for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug intended for use in the treatment of refractory metastatic colorectal…
NICE publishes bladder cancer guideline, recommending photodynamic diagnosis to improve detection
2 March 2015 | By Photocure ASA
Photocure ASA, a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, is pleased to announce that the National Institute for Health and Care Excellence (NICE) in the UK has published its first guidelines on bladder cancer, recommending photodynamic diagnosis for improved detection of bladder cancer...
Alizé Pharma launches Phase II clinical trial of AZP-531 in Prader-Willi syndrome
2 March 2015 | By Alizé Pharma
Alizé Pharma, a company specialized in the development of drugs for the treatment of metabolic disorders and rare diseases, today announces the launch of a Phase II clinical trial of AZP-531, its unacylated ghrelin analog, in patients with Prader-Willi syndrome...
Phase 3 head-to-head ENDEAVOR study demonstrates superiority of Kyprolis® (carfilzomib) over Velcade® (bortezomib) in patients with relapsed multiple myeloma
2 March 2015 | By Amgen
Study met primary endpoint of progression-free survival patients receiving Kyprolis lived twice as long without disease progression...
EMA accepts Santen’s Marketing Application filing for intravitreal sirolimus for the treatment of noninfectious uveitis of the posterior segment
2 March 2015 | By Santen
Santen Pharmaceutical Co., Ltd. announced that the European Medicines Agency has accepted the company’s Marketing Authorization Application filing for the use of intravitreal sirolimus, an investigational mTOR inhibitor, for the treatment of noninfectious uveitis (NIU) of the posterior segment...
Roche’s Avastin plus chemotherapy receives positive recommendation from CHMP for EU approval in advanced cervical cancer
2 March 2015 | By Roche
Combination of Avastin and chemotherapy would be the first new treatment in advanced cervical cancer to extend life in nearly a decade...
U.S. Food and Drug Administration accepts Biologics Licensing Application for Opdivo (nivolumab) for the treatment of advanced squamous non-small cell lung cancer
2 March 2015 | By Bristol-Myers Squibb Company
Opdivo has the potential to be the first Immuno-Oncology agent approved for the treatment of advanced squamous non-small cell lung cancer...
Sartorius reviews fiscal 2014 results
Sartorius, a leading international laboratory and pharmaceutical equipment supplier, closed fiscal 2014 with significant gains in sales revenue and earnings.
Roche extends tender offer for Foundation Medicine, Inc.
2 March 2015 | By Roche
Roche announced that it has extended the expiration of its tender offer to purchase up to 15,604,288 of the outstanding common shares of Foundation Medicine, Inc...
CHMP recommends JINARC® (tolvaptan) for approval in EU for treatment of autosomal dominant polycystic kidney disease
2 March 2015 | By Otsuka Pharmaceutical Co. Ltd
Otsuka Pharmaceutical Co., Ltd. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended JINARC® (tolvaptan) for approval...
Amgen receives positive CHMP opinion for use of Vectibix® (panitumumab) as first-line treatment for advanced colorectal cancer
2 March 2015 | By Amgen
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to extend the marketing authorization for Vectibix® (panitumumab) to include combination with FOLFIRI (an irinotecan-based chemotherapy) as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer (mCRC)...
Gilead announces SVR12 rates from Phase 3 study evaluating Harvoni® for the treatment of chronic hepatitis C in patients co-infected with HIV
27 February 2015 | By Gilead Sciences
96 percent SVR12 rate for hepatitis C genotypes 1 and 4 among HIV-infected patients on antiretroviral therapy...
Gilead announces Phase 3 results for investigational once-daily single tablet HIV regimen containing tenofovir alafenamide (TAF)
27 February 2015 | By Gilead Sciences
First TAF-based regimen found to be non-inferior with improved renal and bone parameters compared to stribild®...
Novartis lung cancer drug Zykadia® recommended for EU approval in patients with ALK+ NSCLC previously treated with crizotinib
27 February 2015 | By Novartis
Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Zykadia® (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib...
