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Process & Production

EMA committee recommends approval Teva’s Cinqaero asthma drug By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Teva Pharmaceutical Industries' Cinqaero (reslizumab) asthma drug.
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Incyte secures FDA breakthrough therapy for ruxolitinib to treat acute GVHD Incyte has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its ruxolitinib (Jakafi) JAK1/JAK2 inhibitor to treat patients with acute graft-versus-host disease (GVHD).
Production & Manufacturing > Process & Production > News FDA grants orphan drug status to Anavex 2-73 to treat infantile spasms By PBR Staff Writer
Biopharmaceutical firm Anavex Life Sciences has secured US orphan drug status for Anavex 2-73 to treat infantile spasms.
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European CHMP grants orphan drug status to Orbus’ eflornithine brain cancer drug
By PBR Staff Writer
Orbus Therapeutics has secured orphan drug designation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its eflornithine brain cancer drug.
Production & Manufacturing > Process & Production > News
Marathon Pharmaceuticals submits deflazacort NDA to treat Duchenne muscular dystrophy
By PBR Staff Writer
Marathon Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA), seeking approval for its deflazacort investigational drug to treat Duchenne muscular dystrophy (DMD).
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FDA advisory committee to review Amgen's BLA for adalimumab biosimilar
The Arthritis Advisory Committee of the US Food and Drug Administration (FDA) will review data supporting Amgen's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).
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FDA committee to review Valeant's NDA for brodalumab
Valeant Pharmaceuticals International has received notification from the US Food and Drug Administration (FDA) that the Dermatologic and Ophthalmic Drugs Advisory Committee will review Valeant's New Drug Application (NDA) for brodalumab on July 19, 2016.
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FDA grants fast track designation to Remedy's CIRARA to treat large hemispheric infarctions
The US Food and Drug Administration (FDA) has granted Fast Track designation to Remedy Pharmaceuticals' investigational drug, CIRARA, for the treatment of Large Hemispheric Infarctions (LHI).
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FDA committee recommends Pfizer's ALO-02 extended-release capsules for approval
The US Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted (9 to 6) in favor of approval of Pfizer's ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for its proposed indication, “management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”
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EC grants orphan medicinal product designation to AGTC's gene therapy to treat X-linked retinitis pigmentosa
The European Commission (EC) has granted an orphan medicinal product designation to Applied Genetic Technologies' (AGTC) investigational gene therapy product candidate for the treatment of X-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene.
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FDA grants orphan drug status to Escend's ES-3000 to treat chronic myeloid leukemia
Escend Pharmaceuticals' lead compound, ES-3000, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of chronic myeloid leukemia (CML).
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EC grants orphan drug status to Alexion's ALXN1210 to treat paroxysmal nocturnal hemoglobinuria
By PBR Staff Writer
Alexion Pharmaceuticals has secured orphan drug designation from the European Commission for ALXN1210 to treat with paroxysmal nocturnal hemoglobinuria (PNH).
Production & Manufacturing > Process & Production > News
Biogen receives positive CHMP opinion for Tysabri use in highly active rrms patients with inadequate response to prior ms therapy
The Committee of Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a variation to the marketing authorization of Biogen's TYSABRI (natalizumab).
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