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Process & Production

Gilead Sciences receives positive CHMP opinion for Odefsey to treat HIV By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Gilead Sciences' fixed-dose HIV combination pill Odefsey featuring emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide (TAF) 25 mg.
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European CHMP adopts positive opinion for Afinitor to treat select GI and lung neuroendocrine tumors By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Novartis' Afinitor (everolimus) tablets to treat select gastrointestinal (GI) and lung neuroendocrine tumors (NETs).
Production & Manufacturing > Process & Production > News Therabron Therapeutics wins FDA fast track designation for rhCC10 Therabron Therapeutics has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for rhCC10 (recombinant human Club Cell 10 kDa Protein), specifically for the prevention of chronic lung disease related to premature birth.
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Novartis' Ilaris wins three FDA breakthrough designations to treat periodic fever syndromes
By PBR Staff Writer
Novartis has secured three breakthrough therapy designations from the US Food and Drug Administration (FDA) for Ilaris (canakinumab) to treat rare types of periodic fever syndromes.
Production & Manufacturing > Process & Production > News
Arch Biopartners' AB569 receives positive opinion from EMA COMP
By PBR Staff Writer
The European Medicines Authority (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending Arch Biopartners' AB569 for designation as an orphan medicinal product to treat cystic fibrosis (CF).
Production & Manufacturing > Process & Production > News
FDA approves AbbVie's sNDA for VIEKIRA PAK without RBV in genotype 1b chronic hepatitis C patients
The US Food and Drug Administration (FDA) has approved AbbVie's supplemental New Drug Application (sNDA) for the use of VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A).
Production & Manufacturing > Process & Production > News
Bristol-Myers' Opdivo wins FDA breakthrough designation for head and neck cancer
By PBR Staff Writer
Bristol-Myers Squibb has secured the US Food and Drug Administration (FDA)'s breakthrough therapy status for its immunotherapy drug, Opdivo, to treat recurrent or metastatic head and neck cancer after platinum-based chemotherapy.
Production & Manufacturing > Process & Production > News
FDA accepts Lundbeck's resubmitted application for IV form of anti-epileptic drug carbamazepine
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application (NDA) submitted by Lundbeck for intravenous (IV) form of the anti-epileptic drug (AED) carbamazepine.
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GW Pharmaceuticals' cannabis drug gets FDA orphan drug status
By PBR Staff Writer
GW Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for its cannabis-derived treatment for tuberous sclerosis complex (TSC).
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Merck's Keytruda gets FDA breakthrough status for classical Hodgkin lymphoma
By PBR Staff Writer
Merck has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for Keytruda (pembrolizumab) in classical Hodgkin lymphoma (cHL).
Production & Manufacturing > Process & Production > News
FDA grants orphan drug designation for Marinus' Ganaxolone IV to treat status epilepticus
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to the intravenous (IV) formulation of Marinus Pharmaceuticals' CNS-selective GABAA modulator, ganaxolone, for the treatment of status epilepticus.
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UK's NICE recommends PTC Therapeutics' Translarna for Duchenne muscular dystrophy
By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has recommended PTC Therapeutics’ Translarna (ataluren) to treat children aged five and older with nonsense mutation Duchenne muscular dystrophy (nmDMD).
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FDA to review Merck’s Keytruda for head and neck cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Merck's supplemental biologics license application for Keytruda (pembrolizumab) in recurrent or metastatic head and neck cancer.
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