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151-165 of 1845 results
EC grants orphan drug status to Mereo's BPS-804 for osteogenesis imperfecta
By PBR Staff Writer
Mereo BioPharma Group announced that its drug BPS-804 has been granted orphan drug designation by the European Commission (EC) in the treatment of osteogenesis imperfecta (OI).
Production & Manufacturing > Process & Production > News
FDA grants Imbruvica breakthrough therapy designation for cGVHD
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted a fourth Breakthrough Therapy designation (BTD) and an orphan drug designation for ibrutinib (Imbruvica) for the potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.
Production & Manufacturing > Process & Production > News
EMA and FDA accept for review Roche’s Ocrevus for two forms of multiple sclerosis
By PBR Staff Writer
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted to review Roche’s marketing applications for Ocrevus (ocrelizumab) to treat two forms of multiple sclerosis.
Production & Manufacturing > Process & Production > News
Bristol-Myers Squibb’s Opdivo gets FDA breakthrough therapy designation for advanced form of bladder cancer
Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Opdivo for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen.
Production & Manufacturing > Process & Production > News
EMA committee recommends approval of Merck’s Keytruda for advanced NSCLC
By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Merck’s Keytruda (pembrolizumab) to treat advanced or metastatic non-small cell lung cancer (NSCLC).
Production & Manufacturing > Process & Production > News
EMA committee recommends approval of 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.
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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.”
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
151-165 of 1845 results