19:08 , May 18, 2018 |  BC Week In Review  |  Company News

FDA names, shames ‘anticompetitive’ drug companies

FDA Commissioner Scott Gottlieb Thursday made public a list of 41 branded drug companies that generics manufacturers have accused of blocking access to drug samples to thwart development of competitive generic drugs. The list includes...
13:30 , May 17, 2018 |  BC Extra  |  Politics & Policy

FDA names, shames ‘anticompetitive’ drug companies

FDA Commissioner Scott Gottlieb Thursday made public a list of 41 branded drug companies that generics manufacturers have accused of blocking access to drug samples to thwart development of competitive generic drugs. The list includes...
07:00 , Apr 13, 2015 |  BC Week In Review  |  Clinical News

Jadenu deferasirox regulatory update

FDA approved Jadenu deferasirox from Novartis to treat chronic iron overload in patients ages >=10 with non-transfusion-dependent thalassemia (NTDT) syndromes and due to blood transfusions in patients ages >=2. The iron chelating agent is a...
08:00 , Feb 23, 2015 |  BioCentury  |  Finance

Catching up in beta thalassemia

Despite impressive data from more advanced therapies in beta thalassemia, investors in Merganser Biotech Inc. think there's still a role for the biotech's hepcidin replacement therapy in patients with less severe disease. The hematology play...
07:00 , Aug 11, 2014 |  BioCentury  |  Regulation

LDT blurred Lines

FDA's release of draft guidance in a congressional notice officially put down a marker on the agency's plans for a risk-based framework for regulating laboratory-developed tests. Some stakeholders think the proposed oversight could better align...
07:00 , Jun 23, 2014 |  BC Week In Review  |  Company News

Novartis A pharmaceuticals news

Novartis said that an ongoing, internal review of adverse event reporting practices in the pharma’s Japanese Novartis Pharma K.K. (NPKK) business unit has revealed about 10,000 previously unreported individual case safety reports. The pharma said...
08:00 , Feb 17, 2014 |  BioCentury  |  Regulation

Sickle cell suffering

There are two key takeaways from FDA 's fifth Patient-Focused Drug Development workshop. The first is that there are opportunities for drugs that treat debilitating chronic effects of the disease, which are not the primary...
08:00 , Jan 27, 2014 |  BC Week In Review  |  Company News

Novartis, BioScrip Inc. hematology news

The U.S. District Court for the Southern District of New York unsealed a complaint filed by the U.S. government alleging that Novartis paid kickbacks to BioScrip to boost sales of iron chelating agent Exjade deferasirox...
07:00 , Oct 28, 2013 |  BioCentury  |  Finance

Paying the iron price

A group of VCs and Novartis AG (NYSE:NVS; SIX:NOVN) are betting that Sideris Pharmaceuticals Inc. 's iron chelator program can better the pharma's iron overload drug Exjade deferasirox , as well as a compound from...
07:00 , May 13, 2013 |  BC Week In Review  |  Clinical News

Exjade deferasirox regulatory update

EMA's CHMP recommended against expanding the label of Exjade deferasirox from Novartis to include first-line treatment of chronic iron overload in patients ages >=6 years with beta thalassemia major who receive infrequent blood transfusions. The...