Mylan expects the product, which is ready to enter Phase IIb, will be submitted to the FDA for approval
Global program marks Sandoz' sixth biosimilar molecule to enter Phase III testing
Judicial Watch Nationwide Search of State Records Reveals Massive Health Insurance Policy Cancellations Resulting From Obamacare Mandates
State Records Show Insurance Company Cancellation Notices Specifically Cite ACA Requirements as Central Factor in Decision
WASHINGTON, DC--(Marketwired - Dec 17, 2013) - Judicial Watch today released state records revealing high numbers of policy cancellations as a direct result of requirements of the Affordable Care Act (ACA), also known as Obamacare. Statements in the records, which include filings by health insurance companies with...
ECRI Institute Helps Hospitals Address Joint Commission's 2014 Alarm Safety Goal
As first deadline draws near, hospitals should consider four key factors to improve alarm management
PLYMOUTH MEETING, Pa., Dec. 17, 2013 /PRNewswire-USNewswire/ -- A nationwide initiative to improve alarm management, spurred into high gear by The Joint Commission's 2014 National Patient Safety Goal, promises to be a big focus over the next few years. Now, with the January 2014 deadline looming for Phase I criteria, time is running out for hospitals to take action.
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AstraZeneca has also agreed to pay various sales-related royalty payments up until 2025
GlaxoSmithKline said launch activities in the US will begin during the first quarter of 2014
The Data Safety Monitoring Board (DSMB) determined that the combination of rigosertib and gemcitabine is unlikely to demonstrate a statistically significant improvement in overall survival compared to gemcitabine alone
Eighteen medical communication companies (MCCs) received about $100 million from 13 pharmaceutical and one device company that released data in 2010
However, the validity of a patent covering the double combination of lamivudine and abacavir (Epzicom) and the triple combination of lamivudine, abacavir and zidovudine (Trizivir) was upheld.
AstraZeneca statement in response to reports of a launch of esomeprazole strontium product in the US
LONDON, 17 December 2013 - AstraZeneca is aware of reports that an 505(b)(2) NDA esomeprazole strontium product has been launched in the US by Hanmi Pharmaceutical and affiliates (“Hanmi”) and its US marketing partner Amneal Pharmaceuticals (“Amneal”).
On 30 September 2013, the US Court of Appeals for the Federal Circuit (“CAFC”) lifted a temporary injunction against Hanmi’s US launch of its 505(b)(2) NDA esomeprazole strontium product (previously granted on 13 September...