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Process & Production

FDA accepts to review Pfizer's NDA for rheumatoid arthritis drug Xeljanz By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted to review Pfizer’s new drug application (NDA) for Xeljanz (tofacitinib citrate) 11mg once daily modified release tablets to treat moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX).
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Boehringer's Spiolto Respimat approved in European countries to treat COPD By PBR Staff Writer
Boehringer Ingelheim has received regulatory authority approvals for Spiolto Respimat (tiotropium/olodaterol) in European countries as a once-daily maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Production & Manufacturing > Process & Production > News Clovis begins rolling NDA submission to FDA for rociletinib to treat advanced EGFR-mutant NSCLC Clovis Oncology (CLVS) announced that it has commenced the submission of a New Drug Application (NDA) regulatory filing to the US Food and Drug Administration (FDA) for rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test.
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Breckenridge gets final ANDA approval for desvenlafaxine XR tablets
Breckenridge Pharmaceutical announced that Breckenridge and Alembic Pharmaceuticals Limited were granted final approval for their ANDA desvenlafaxine succinate extended-release tablets 50mg and 100mg, a generic version of Pristiq by Pfizer.
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RedHill gets two notices of allowance from USPTO covering RHB-104
By PBR Staff Writer
Israeli biopharmaceutical firm RedHill Biopharma has received two notices of allowance from the US Patent and Trademark Office (USPTO) regarding its patent application numbers 13/722,395 and 14/271,758 covering RHB-104.
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EMA validates Biogen and Sobi's MAA for Alprolix to treat hemophilia B
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for Biogen and Swedish Orphan Biovitrum's (Sobi) Alprolix (rFIXFc), a recombinant factor IX Fc fusion protein product candidate for the treatment of hemophilia B.
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EMA committee issues positive opinions for Alexion's Strensiq and Kanuma
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending marketing authorization of Alexion Pharmaceuticals' Strensiq (asfotase alfa) and Kanuma (sebelipase alfa).
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EMA committee grants positive opinion for Abbvie's Humira to treat hidradenitis suppurativa
By PBR Staff Writer
US-based biopharmaceutical firm AbbVie has received positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for Humira (adalimumab) to treat adults with moderate to severe hidradenitis suppurativa (HS).
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EMA committee recommends approval of Novartis's multiple myeloma drug Farydak
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Swiss drugmaker Novartis's Farydak (panobinostat) to treat patients with multiple myeloma.
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EMA committee issues positive opinion for Newron's Sarizotan to treat Rett syndrome
By PBR Staff Writer
Italy-based Newron Pharmaceuticals has received a positive opinion from the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) for its new chemical entity Sarizotan to treat Rett Syndrome (RTT), a severe neurodevelopmental disorder.
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EMA validates Amicus' MAA for Galafold to treat Fabry patients
By PBR Staff Writer
The European Medicines Agency (EMA) has validated Amicus Therapeutics' marketing authorization application (MAA) and started centralized procedure for the oral small molecule pharmacological chaperone, Galafold (migalastat HCl), designed to treat Fabry patients who have amenable genetic mutations.
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InVivo gets notice of allowance on patent covering broader compositions to treat open and closed wound spinal cord injuries
InVivo Therapeutics Holdings Corp. announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent Application No. 14/496,742, titled “Methods and Compositions for the Treatment of Open and Closed Wound Spinal Cord Injuries”.
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AOP Orphan seeks approval for tetrabenazine in European countries for tardive dyskinesia
By PBR Staff Writer
AOP Orphan Pharmaceuticals is strengthening its core CNS specialty business with regulatory submissions in several European countries for tetrabenazine to treat tardive dyskinesia (TD), a chronic movement disorder, in a decentralized procedure (DCP).
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