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21 January 2015 | By Citigate Dewe Rogerson
Pharmalink AB, a specialty pharma company focused on orphan and niche products, announces that its IND for Nefecon® is now open with the US Food & Drug Administration...
6 January 2015 | By Bristol-Myers Squibb
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) injection, for intravenous use...
23 December 2014 | By Dr Tim Sandle, Bio Products Laboratory
This article surveys some of the recent developments in regulatory requirements and standards that have taken place during the past 12 months, highlighting those aspects that are of relevance to pharmaceutical microbiology...
Cocrystals can help to address the manufacturability (flow, compaction, processability) as well as solubility/dissolution,hygroscopicity and stability properties of an active pharmaceutical ingredient (API).
17 December 2014 | By Eli Lilly and Company
Eli Lilly and Company has received its third U.S. Food and Drug Administration (FDA) approval for CYRAMZA(R) (ramucirumab)...
27 November 2014 | By Boehringer Ingelheim
Boehringer Ingelheim announced that the European Commission has granted EU marketing authorisation for Vargatef® (nintedanib*), valid for the 28 countries within the EU...
27 November 2014 | By Bristol-Myers Squibb
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration has issued a Complete Response Letter regarding the New Drug Application for daclatasvir, an NS5A complex inhibitor, in combination with other agents for the treatment of hepatitis C...
25 November 2014 | By Janssen
Janssen-Cilag International NV announced that the European Commission (EC) has approved the use of REZOLSTA® (darunavir/cobicistat) in combination with other antiretroviral (ARV) medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older...
19 November 2014 | By GlobalData
The pharmaceutical market is beginning to show signs of stability, with a review of 30 leading companies highlighting combined revenues of $718.7 billion in 2013, down just 0.2% from 2012, according to research and consulting firm GlobalData...
17 November 2014 | By Roche
Avastin plus chemotherapy reduced the risk of the disease worsening by 62 percent compared to chemotherapy alone in a Phase III study...
14 November 2014 | By Roche
The cobas Strep A test is the first molecular point of care test to provide a result in 15 minutes for this common infection...
The newest GLP-1 receptor agonist treatment option to help improve glycemic control type 2 diabetes in adults is now available in U.S. pharmacies. Eli Lilly and Company's (LLY) Trulicity™ (dulaglutide) is a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) designed with patients in mind. It comes in a single-dose pen…
22 October 2014 | By GlobalData
The recent US Food and Drug Administration approval of Harvoni (ledipasvir/sofosbuvir), Gilead Sciences’ once-daily, single-tablet regimen to treat chronic hepatitis C virus (HCV) genotype 1 (GT1) infection in adults, will enable the company to maintain its dominance in an increasingly competitive market...
16 October 2014 | By Roche
Roche announced that the U.S. Food and Drug Administration has approved Esbriet (pirfenidone) as a treatment for idiopathic pulmonary fibrosis in the United States...
9 October 2014 | By Roche
Roche announced that the U.S. Food and Drug Administration has accepted to file the company's supplemental Biologics License Application and granted Priority Review of Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7 million Americans...
