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news.Mylan blood pressure drug approval delayed
Mylan Bertek was notified by the FDA that the regulator has extended the original ten month Prescription Drug User Fee Act (PDUFA) deadline for the completion of its
Mylan Bertek was notified by the FDA that the regulator has extended the original ten month Prescription Drug User Fee Act (PDUFA) deadline for the completion of its
Both companies share a common focus on priority R&D categories including cardiovascular, antibacterial, glucose metabolic, bone disorders, immune disorders and anti-allergy. Integration will enable increased concentration of R&D
Idun is focused on the discovery and development of therapies to control apoptosis, a process of cell death that occurs in a broad range of diseases. The company
Under the terms of the agreement, FDC will develop and manufacture the ophthalmic product and Spectrum Pharmaceuticals will be responsible for all regulatory, marketing and distribution matters in
Medicine Shoppe International, a Cardinal Health Company, is the largest franchisor of independent community pharmacies in the US with nearly 1,000 Medicine Shoppe pharmacies domestically and nearly 300
The study included three dose levels of Progenta as well as placebo and positive control arms. The positive control was Abbott’s Lucrin, an approved gonadotropin releasing agonist (GnRHa),
Vicuron’s investigational agent, dalbavancin, is a novel once-weekly antibiotic for the treatment of complicated skin and soft tissue infections (cSSTIs) including the most difficult to treat strain of
The company is currently testing alagebrium in patients with systolic hypertension, heart failure and erectile dysfunction. Patients already enrolled in the clinical trials are continuing treatment. In December
The verdict came at the close of the first phase, the damages phase, of this bifurcated (two-phase) trial. This ruling completes the litigation associated with the two cases.
Orchid’s responsibilities will include development of active pharmaceutical ingredients, development of final formulations, and manufacture of finished products for exclusive sale by Alpharma in the US and Europe.