BC Extra | Apr 10, 2015
Top Story

FDA committee to discuss CV risks of DPP-4s

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on April 14 to discuss results from two CV outcomes trials of dipeptidyl peptidase-4 ( DPP-4 ) inhibitors marketed by AstraZeneca plc (LSE:AZN; NYSE:AZN) and Takeda Pharmaceutical Co....
BioCentury | Jan 13, 2014
Finance

Buyside View XXII: 'Grown up' means growth

Stephen Hansen Senior Writer  An increase in regulatory approvals and new breakthrough therapies has money managers buying into the concept that biotech has entered a new product cycle that provides a strong fundamental basis for...
BioCentury | Dec 16, 2013
Strategy

Out in the cold

New excluded drugs lists devised by pharmacy benefits managers are raising the hurdle for reimbursement of drugs the PBMs' pharmacy and therapeutics committees consider to be clinically equivalent to cheaper drugs. Drugs that are not...
BioCentury | Oct 7, 2013
Finance

3Q Stock Wrap-Up: Make it a double

For the second time this year, all market cap segments closed the quarter in the black. Large caps valued at $5 billion and above gained ground for the fifth consecutive quarter. They added 12%, and...
BC Week In Review | Sep 30, 2013
Clinical News

Incresync alogliptin/pioglitazone regulatory update

In January, FDA approved the fixed-dose combination of alogliptin and Actos pioglitazone as Oseni as an adjunct to diet and exercise to improve blood sugar control in adult Type II diabetics (see BioCentury, Jan. 28)....
BC Week In Review | Sep 30, 2013
Clinical News

Vipdomet alogliptin/metformin regulatory update

In January, FDA approved the fixed-dose combination of alogliptin and metformin as Kazano as an adjunct to diet and exercise to improve blood sugar control in adult Type II diabetics (see BioCentury, Jan. 28). Furiex...
BC Week In Review | Sep 30, 2013
Clinical News

Vipidia alogliptin regulatory update

In January, FDA approved alogliptin as Nesina as an adjunct to diet and exercise to improve blood sugar control in adult Type II diabetics (see BioCentury, Jan. 28). The product is also approved in Japan...
BioCentury | Sep 30, 2013
Finance

Regulatory milestones

Regulatory milestones AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) lost $3.74 (14%) to $22.42 on Wednesday after disclosing that FDA identified "deficiencies" in an sNDA for anemia drug Feraheme ferumoxytol that prevented the agency from discussing potential labeling...
BC Extra | Sep 25, 2013
Company News

EC approves three Takeda diabetes products

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and partner Furiex Pharmaceuticals Inc. (NASDAQ:FURX) said the European Commission approved three Type II diabetes products from Takeda. EC approved Vipidia alogliptin in patients who are uncontrolled on existing therapies....
BC Week In Review | Sep 9, 2013
Clinical News

Nesina alogliptin: Phase III data

The double-blind, international Phase III EXAMINE cardiovascular outcomes trial in 5,380 Type II diabetics with acute coronary syndrome (ACS) showed that once-daily oral alogliptin in combination with patients' existing anti-hyperglycemic and cardiovascular therapy met the...
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