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Mylan NV launches generic version of Celgenes Vidaza injection

Mylan N.V. announced the U.S. launch of Azacitidine for Injection, 100 mg/vial, which is a generic version of Celgene's Vidaza® Injection, 100 mg/vial. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for...

Peregrine Pharmaceuticals Updates Highlighting Latest Developments for Contract Manufacturing and Drug Development Businesses

Contract Manufacturing Revenue Hits All-Time High of $44 Million for Fiscal Year Ended April 2016; Fiscal Year 2017 Contract Manufacturing Revenue Projected Between $50-55 Million; Continued Growth Expected to Lead to Future Sustainable Profitability in 24 Months ...

EU approves Novartis drug Afinitor to treat certain types of advanced GI and lung NET

Novartis announced that the EU has approved Afinitor®(everolimus) tablets for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin in adults with progressive disease. ...

Bayer collaborates with U.S. National Surgical Adjuvant Breast and Bowel Project to Investigate Stivarga as Adjuvant Therapy in Colon Cancer

Study will include patients with Stage IIIB and IIIC colon cancer who have undergone complete surgical resection of primary tumor and received standard adjuvant chemotherapy / Indication-seeking trial will be conducted by NSABP with the support from Bayer. ...

Allergan receives US FDA marketing approval for Juvederm Volbella XC for use in lips & perioral rhytids

Allergan plc a leading global pharmaceutical company announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market JUVÉDERM VOLBELLA®XC, for use in the lips for lip augmentation and for correction of perioral...

Alexion Pharma (ALXN) Granted Ophand Drug Status in Europe for ALXN1210

Alexion Pharmaceuticals Inc announced that the EC as granted orphan drug designation (ODD) to ALXN1210, a highly innovative, longer-acting C5 antibody being evaluated in patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a debihlitating, ultra-rare, life-threatening...

EC Approves the AbbVies IMBRUVICA for First-Line Treatment of Patients with Chronic Lymphocytic Leukemia

AbbVie a global biopharmaceutical company announced that the EC approved IMBRUVICA® (ibrutinib) as a first-line treatment option for adult patients with chronic lymphocytic leukemia (CLL), expanding upon the initial EC approval in October 2014 for certain patients with CLL....

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