NDA for Lundbeck's vortioxetine with US FDA

Singapore: Takeda Pharmaceutical and H. Lundbeck A/S have submitted a new drug application (NDA) to the US Food and Drug...

October 3, 2012 | Wednesday | News
Novartis gets positive regulatory feedback for hive drug

Singapore: Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a po...

January 28, 2014 | Tuesday | Regulatory
FDA green signal for joint GSK-Pfizer HIV drug

Singapore: The US FDA has approved GSK and Pfizer-owned HIV dedicated firm, ViiV Healthcare's, Tivicay (dolutegravir) 50...

August 13, 2013 | Tuesday | News
FibroGen, Astellas start trial of anemia therapeutic agent

Singapore: FibroGen and Japanese company Astellas Pharma have initiated the first clinical study in the phase III clinic...

December 12, 2012 | Wednesday | News
Antisense Therapeutics ties up with China CRO for trial

Singapore: Antisense Therapeutics, an Australian publicly listed biopharmaceutical drug discovery and development compan...

March 19, 2013 | Tuesday | News
Merck resubmits NDA for ezetimibe, atorvastatin

Singapore: US FDA has acknowledged the resubmission of a New Drug Application (NDA) for ezetimibe and atorvastatin table...

January 3, 2013 | Thursday | Regulatory
Eli Lilly pipeline will counter patent cliff in 2014

Singapore: Eli Lilly and Company has outlined its strategies to face patent cliff expected in 2014. In a statement to in...

October 7, 2013 | Monday | News
BioPharma Asia: Is Asia ready to boost global drug pipeline?

Singapore: Asia share of global GDP, measured in purchasing power, has increased from 26.8 percent in 2001 to 33.8 perce...

March 17, 2014 | Monday | Analysis
Novo Nordisk obesity drug trial confirms weight loss

Singapore: Novo Nordisk's 56-week double-blind phase IIIa clinical trial with liraglutide has shown that it has the pote...

May 28, 2013 | Tuesday | News
New TB cocktail drug holds great promise

Singapore: A novel anti-TB drug has generated encouraging results in a recent Phase II trial funded by the non-profit TB...

July 27, 2012 | Friday | Analysis
Singapore univ prepares for trial of glaucoma drug

Singapore: For glaucoma patients, taking daily medication will soon become a thing of the past. With Nanyang Technologic...

February 12, 2013 | Tuesday | News
BioDuro opens discovery lab in Shanghai

Singapore: BioDuro, a PPD Company, has opened a new state-of-the-art laboratory in Shanghai, China, strengthening its ab...

May 16, 2013 | Thursday | News
FDA approves ZALTRAP for colorectal cancer

Singapore: Sanofi and Regeneron Pharmaceuticals have received US Food and Drug Administration (FDA) approval for ZALTRAP...

August 6, 2012 | Monday | Regulatory
Report on strategies to manage patent protection loss

Singapore: Exclusivity is everything in the pharmaceutical brand business. Without it, power over pricing disappears and...

July 6, 2012 | Friday | Analysis
Eisai cancer drug gets orphan drug designation from Japan

Singapore: Eisai has received orphan drug designation from Japan's Ministry of Labour, Health and Welfare for its multi...

August 27, 2012 | Monday | News
QRx Pharma gets FDA inputs on Moxduo

Singapore: Australia-based QRxPharma is proceeding with US FDA to discuss the company's Moxduo new drug application (NDA...

October 9, 2013 | Wednesday | News
Daiichi Sankyo enrolls patients for edoxaban trial

Singapore: Japan-headquartered Daiichi Sankyo has completed patient enrollment in the global Hokusai-VTE phase III study...

October 30, 2012 | Tuesday | News
Daiichi, Amplimmune join hands for protein R&D

Singapore: Daiichi Sankyo and Amplimmune have entered into a strategic collaboration to develop a new therapeutic prote...

January 8, 2013 | Tuesday | News

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