Pharma News

AstraZeneca and its global biologics research and development arm, MedImmune,  announced that the US Food and Drug Administration (FDA) has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human monoclonal antibody (mAb), and granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for the second quarter of 2017.

Exact Imaging, the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, has received FDA 510(k) clearance for its ExactVu micro-ultrasound system.

Biotage, a leading global supplier of solutions and technology for analytical, medicinal and peptide chemistry, is pleased to announce the launch of Biotage SNAP Bio C18 and Biotage SNAP Bio C4 cartridges - a new range of high performance flash cartridges with wide pore media (300 Å) for reversed phase purification of peptides and other larger molecules.

AstraZeneca and Eli Lilly and Company announced a worldwide agreement to co-develop MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42), which is currently in Phase I trials as a potential disease-modifying treatment for Alzheimer’s disease (AD). This agreement builds on the existing collaboration related to AZD3293, a BACE inhibitor in two pivotal Phase III trials.

Roche announced that the US Food and Drug Administration (FDA) has approved Avastin (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Women are said to have a ‘platinum-sensitive’ form of the disease if a relapse occurs six months or longer following the last treatment with a platinum-based chemotherapy.

Novartis today announced that the European Commission (EC) has granted an additional indication for Lucentis® (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) associated with causes other than neovascular age-related macular degeneration (nAMD), or secondary to pathologic myopia (PM). With this approval, Lucentis is the first retinal treatment approved for these conditions, addressing an important unmet medical need.

Gilead Sciences, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients. The data submitted in the NDA support the use of the regimen for 12 weeks in DAA-experienced patients with genotype 1 to 6 HCV infection without cirrhosis or with compensated cirrhosis.

Novartis announced positive results from the first large-scale study exploring the effects of directly switching symptomatic, non-frequently exacerbating patients with moderate COPD from their current treatments, including steroid-containing combinations and long-acting bronchodilators, to the dual bronchodilator Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg.

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Viking Therapeutics, Inc. (Viking), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to VK0214 for the treatment of X-linked adrenoleukodystrophy (X-ALD).

Novartis announced results from its phase III open-label, randomized, active-controlled, multi-center ASCEND-4 study, which found that patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) treated with first-line Zykadia (ceritinib) had a median progression-free survival (PFS) of 16.6 months (95% confidence interval [CI]: 12.6, 27.2), compared to 8.1 months (95% CI: 5.8, 11.1) in patients treated with standard first-line chemotherapy with maintenance. This equated to a 45% reduction in the risk of disease progression (hazard ratio [HR] = 0.55, P<0.001).