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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Pozen’s Yosprala receives complete response letter from the FDA
Pozen Inc, a pharmaceutical company committed to transforming medicine that transforms lives, announced today that their investigational drug candidates Yosprala 81/40 and 325/40 ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves first biosimilar product Zarxio
The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves first generic versions of celecoxib
The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid ...
Posted by Michael Wonder on 05 Aug 2015
US FDA accepts for review a biologics license application for Merck and Sanofi Pasteur’s investigational paediatric hexavalent vaccine
Merck, known as MSD outside the United States and Canada, and Sanofi Pasteur, the vaccines division of Sanofi, announced today ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves additional antibacterial treatment for plague
The U.S. Food and Drug Administration today approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Lymphoseek to help determine the extent of head and neck cancer in the body
The U.S. Food and Drug Administration today approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic ...
Posted by Michael Wonder on 05 Aug 2015
Janssen files four-times-a-year schizophrenia shot
Johnson & Johnson group Janssen has filed an application in the US to market a three-month injectable formulation of paliperidone palmitate for ...
Posted by Michael Wonder on 05 Aug 2015
Galderma receives FDA approval of novel treatment option for rosacea patients
Galderma Laboratories, L.P. today announced that the U.S. Food and Drug Administration approved Soolantra (ivermectin) cream, 1% for the once-daily topical treatment ...
Posted by Michael Wonder on 05 Aug 2015
Novartis' new heart failure medicine LCZ696, now called Entresto, approved by FDA to reduce risk of cardiovascular death and heart failure hospitalization
Novartis announced today that the US Food and Drug Administration (FDA) has approved Entresto (sacubitril/valsartan) tablets, previously known as LCZ696, for ...
Posted by Michael Wonder on 05 Aug 2015
Novartis combination therapy Tafinlar and Mekinist achieves important EU and US regulatory milestones
Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has ...
Posted by Michael Wonder on 05 Aug 2015
First vaccine approved by FDA to prevent serogroup B Meningococcal disease
The U.S. Food and Drug Administration announced today the approval of Trumenba, the first vaccine licensed in the United States ...
Posted by Michael Wonder on 05 Aug 2015
European biotech firms head to Wall Street
Wall Street’s seemingly insatiable appetite for biotechnology stocks has led to a surge in small companies from Europe listing in ...
Posted by Michael Wonder on 05 Aug 2015
Post-market review framework
Minister Ley announced the revised post market review framework. Information about the framework can be found on the PBS website. ...
Posted by Michael Wonder on 05 Aug 2015
Genentech submits new drug application to FDA for investigational cobimetinib used in combination with Zelboraf (vemurafenib) in advanced melanoma
Genentech, a member of the Roche Group, today announced the company has submitted a New Drug Application (NDA) for cobimetinib ...
Posted by Michael Wonder on 05 Aug 2015
Biotech gets a reality check
When short sellers retreat, long investors reap the rewards. But buyers of booming biotechnology stocks should take it as warning. ...