Pharma News

Adamis Pharmaceuticals Corporation announced that after the close of the stock markets on June 3, 2016 it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe (PFS) product.  PFS is for the emergency treatment of acute anaphylaxis, which is a severe allergic reaction.   A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has

Eli Lilly and Company announced that clinical study data from two of its ongoing immuno-oncology clinical collaborations with Merck were presented this weekend at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO). Specifically, data were presented from two early-phase trials evaluating ALIMTA® (pemetrexed)-plus-carboplatin and CYRAMZA® (ramucirumab), respectively, in combination with Merck's KEYTRUDA® (pembrolizumab), in patients with non-small cell lung cancer (NSCLC).

Mylan N.V. announced the U.S. launch of Clindamycin Palmitate Hydrochloride for Oral Solution USP, 75 mg/5 mL, which is a generic version of Pharmacia and Upjohn's Cleocin® Solution. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria and susceptible strains of streptococci, pneumococci and staphylococci when less toxic alternatives are inappropriate.

Mylan N.V. and Biocon Ltd. announced the presentation of data from the HERITAGE study at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 3-7. The study confirmed the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by Biocon and Mylan, in comparison to branded trastuzumab.

Regeneron Pharmaceuticals, Inc. and Sanofi announced that a one-year phase 3 study, known as LIBERTY AD CHRONOS, evaluating investigational dupilumab met its primary and key secondary endpoints. In the study, dupilumab with topical corticosteroids (TCS) was compared to TCS alone in moderate-to-severe atopic dermatitis (AD) adult patients. Patients in the study were inadequately controlled by topical corticosteroids (TCS) with or without topical calcineurin inhibitors (TCI). Dupilumab with TCS significantly improved measures of overall disease severity at 16 and 52 weeks, when compared to placebo with TCS.

Roche announced that the European Commission (EC) has approved the subcutaneous (SC) formulation of MabThera® (rituximab) for people with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL). The approved dose for CLL is 1600mg. Following the approval of MabThera SC (1400 mg) for common forms of non-Hodgkin lymphoma in March 2014, this is the second European approval for the formulation.

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. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.

Mylan NV, a global pharmaceutical company, announced the US launch of Propafenone hydrochloride extended-release capsules USP, 225 mg, 325 mg, 425 mg, a generic version of GlaxoSmithKline's Rythmol SR.

Supernus Pharmaceuticals, Inc., announced the issuance of a sixth patent (number 9,351,975) by the United States Patent and Trademark Office (USPTO) covering Oxtellar XR, its novel once-daily extended-release oxcarbazepine product. The patent provides protection for the product with expiration that is no earlier than 2027.

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