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Pharma industry news

Roche logo

Roche’s Avastin plus chemotherapy receives positive recommendation from CHMP for EU approval in advanced cervical cancer

Posted on: 2 March 2015 | Source: Roche

Combination of Avastin and chemotherapy would be the first new treatment in advanced cervical cancer to extend life in nearly a decade...

Bristol Myers Squibb logo

U.S. Food and Drug Administration accepts Biologics Licensing Application for Opdivo (nivolumab) for the treatment of advanced squamous non-small cell lung cancer

Posted on: 2 March 2015 | Source: 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...

Roche logo

Roche extends tender offer for FMI

Posted on: 2 March 2015 | Source: 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...

Amgen

EMA accepts marketing authorisation application of Amgen’s kyprolis® (carfilzomib) for the treatment of relapsed multiple myeloma

Posted on: 2 March 2015 | Source: Amgen

Amgen and its subsidiary Onyx Pharmaceuticals, Inc., today announced that the European Medicines Agency has accepted the Marketing Authorization Application (MAA) of Kyprolis® (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy...

Otsuka

CHMP recommends JINARC® (tolvaptan) for approval in EU for treatment of autosomal dominant polycystic kidney disease

Posted on: 2 March 2015 | Source: 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

Amgen receives positive CHMP opinion for use of Vectibix® (panitumumab) as first-line treatment for advanced colorectal cancer

Posted on: 2 March 2015 | Source: 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 Sciences logo

Gilead announces SVR12 rates from Phase 3 study evaluating Harvoni® for the treatment of chronic hepatitis C in patients co-infected with HIV

Posted on: 27 February 2015 | Source: Gilead Sciences

96 percent SVR12 rate for hepatitis C genotypes 1 and 4 among HIV-infected patients on antiretroviral therapy...

Gilead logo

Gilead announces Phase 3 results for investigational once-daily single tablet HIV regimen containing tenofovir alafenamide (TAF)

Posted on: 27 February 2015 | Source: Gilead Sciences

First TAF-based regimen found to be non-inferior with improved renal and bone parameters compared to stribild®...

Novartis

Novartis lung cancer drug Zykadia® recommended for EU approval in patients with ALK+ NSCLC previously treated with crizotinib

Posted on: 27 February 2015 | Source: 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...

Moberg Pharma

Moberg Pharma AB (Publ) year-end report 2014

Posted on: 27 February 2015 | Source: Moberg Pharma

Successful fourth quarter and the first profitable full year...

UCB Logo

UCB Full Year Report 2014: Core medicines grow by 24% while next wave of new potential solutions for patients advances

Posted on: 27 February 2015 | Source: UCB

"UCB continues its growth path with Cimzia®, Vimpat® and Neupro®, now accounting for 50% of our net sales. We continue to advance and prepare the launches of our next wave of potential new patient solutions: brivaracetam, epratuzumab and romosozumab..."

Bristol Myers Squibb logo

ALLY trial demonstrates 97% hepatitis C cure rates among patients coinfected with HIV after ribavirin-free investigational 12-week regimen of daclatasvir and sofosbuvir

Posted on: 27 February 2015 | Source: Bristol-Myers Squibb Company

Bristol-Myers Squibb Company announced results from ALLY-2, a Phase III clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) coinfected with HIV – a patient population that historically has been challenging to treat in large part due to potential drug-drug interactions between the therapy regimens used to treat each infection...