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US FDA approves Aurobindo’s generic anti-infective drug By PBR Staff Writer
The US Food & Drug Administration (USFDA) has issued final approval to produce and market Aurobindo Pharma’s generic version of Amoxicillin for oral suspension to treat infections in the American market.
Drug Research > Drug Delivery > News
Sagent Pharmaceuticals launches Ketorolac Tromethamine Injection, USP By PBR Staff Writer
Sagent Pharmaceuticals announced the launch of Ketorolac Tromethamine Injection, USP, a nonsteroidal anti-inflammatory agent, in three preservative-free glass vials.
Drug Research > Drug Delivery > News Mylan Commences Phase III Clinical Trials for its Generic Version of Advair Diskus and Insulin Analog to Lantus By PBR Staff Writer
Mylan Inc. (Nasdaq: MYL), one of the world's leading global pharmaceutical companies, today announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's Advair Diskus® and its insulin analog to Sanofi's Lantus®.
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Mylan Commences Phase III Clinical Trials for its Generic Version of Advair Diskus and Insulin Analog to Lantus
By PBR Staff Writer
Mylan Inc. (Nasdaq: MYL), one of the world's leading global pharmaceutical companies, today announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's Advair Diskus® and its insulin analog to Sanofi's Lantus®.
Drug Research > Drug Delivery > News
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MJR-nanotechnology
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Merck Serono stops clinical trials of lung cancer vaccine
By PBR Staff Writer
Merck Serono has discontinued all remaining clinical studies of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (L-BLP25) as a monotherapy in Stage III non-small cell lung cancer (NSCLC).
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Our superior MJR technology is suitable for all kinds of application forms (oral, parenteral, subcutaneous, topical, inhalation, chewing gum) and different drug release profiles (immediate release (IR), modified release (ER, SR), depot formulations, inhalative formulations).
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Oxygen Biotherapeutics halts Phase IIb traumatic brain injury trial of Oxycyte
By PBR Staff Writer
Oxygen Biotherapeutics has decided to stop the current Phase IIb trial of its drug candidate Oxycyte indicated for the treatment of patients with traumatic brain injury.
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Genocea begins Phase IIa trial of GEN-004 to treat pneumococcus
By PBR Staff Writer
Genocea Biosciences has started a Phase IIa trial of its universal vaccine candidate GEN-004 to treat patient with Streptococcus pneumonia (pneumococcus).
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Mylan Ireland to buy US rights of Arixtra injection from Aspen
By PBR Staff Writer
Mylan Ireland has entered into an agreement with Aspen Global to acquire the US commercialization, marketing and intellectual property rights relating to Arixtra (fondaparinux sodium) Injection and the authorized generic (AG) of Arixtra.
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Emergent BioSolutions to develop dry formulation of anthrax vaccine NuThrax
By PBR Staff Writer
US-based Emergent BioSolutions has signed a contract with the National Institute of Allergy and Infectious Diseases (NIAID) to develop a dry formulation of NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant).
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Par Pharmaceutical resumes shipment of generic Precedex injection
Par Pharmaceutical Companies has resumed shipping dexmedetomidine hydrochloride (HCl) injection, EQ 100 mcg base/mL, the generic version of Hospira's Precedex Injection. Par immediately resumed shipping after a US District Court lifted a temporary restraining order that was issued in August at Hospira's request.
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