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1-15 of 2214 results
EMA's CHMP backs Novartis' Zykadia for first-line use in lung cancer
By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval to expand the use of Novartis' Zykadia (ceritinib) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Production & Manufacturing > Manufacturing > News
ReNeuron secures £1.8m grant to optimize cell therapy manufacturing processes
Innovate UK has awarded ReNeuron Group a £1.8m grant to further advance its next generation commercial cell therapy manufacturing capabilities.
Production & Manufacturing > Manufacturing > News
FDA accepts to review Pfizer’s sNDA for XELJANZ to treat adult PsA patients
The US Food and Drug Administration (FDA) has accepted for review Pfizer's supplemental New Drug Application (sNDA) for XELJANZ (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA).
Production & Manufacturing > Manufacturing > News
Takeda’s Alunbrig granted accelerated approval for Metastatic NSCLC
Takeda Pharmaceutical’s Alunbrig (brigatinib) has secured accelerated approval from the US Food and Drug Administration (FDA) for the treatment of anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) in patients whose disease has progressed on or are intolerant to crizotinib.
Production & Manufacturing > Manufacturing > News
FDA grants Pfizer’s Lorlatinib breakthrough designation for NSCLC
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Pfizer’s lorlatinib for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), who were earlier treated with one or more ALK inhibitors.
Production & Manufacturing > Manufacturing > News
uniQure’s gene therapy for severe hemophilia B gets PRIME designation in Europe
uniQure’s AMT-060 investigational gene therapy in patients with severe hemophilia B, has been granted PRIME designation by the European Medicines Agency (EMA).
Production & Manufacturing > Manufacturing > News
EMA's CHMP recommends approval for Kevzara for rheumatoid arthritis
The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi and Regeneron Pharmaceuticals’ Kevzara (sarilumab) for treating adult patients with moderately to severely active rheumatoid arthritis after adopting a positive opinion for its for its marketing authorization.
Production & Manufacturing > Manufacturing > News
Biosimilars to rituximab, etanercept recommended for approval in Europe
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of both Sandoz' biosimilars rituximab and etanercept to treat the same indications as their respective reference medicines.
Production & Manufacturing > Manufacturing > News
FDA grants priority review for Lynparza for maintenance setting in ovarian cancer patients
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for Lynparza (olaparib) tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting.
Production & Manufacturing > Manufacturing > News
Canadian drugmaker Apotex unveils $184m US expansion plan
By PBR Staff Writer
Canada-based pharmaceutical firm Apotex said it will invest $184m to expand its facilities in South Florida, US, and create 150 new jobs.
Production & Manufacturing > Manufacturing > News
BeiGene to construct biologics manufacturing facility in Guangzhou, China
By PBR Staff Writer
BeiGene (Hong Kong) and Guangzhou GET Technology Development are setting up a joint venture to build a $330m commercial-scale biologics manufacturing facility in China.
Production & Manufacturing > Manufacturing > News
Sanofi, Lonza to build EUR270m biologics production facility in Switzerland
By PBR Staff Writer
Sanofi and Lonza have agreed to invest an initial CHF290m (€270m) to construct a mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.
Production & Manufacturing > Manufacturing > News
Abzena signs antibody manufacturing development deal with University College London
Abzena has entered into a manufacturing agreement with University College London (UCL).
Production & Manufacturing > Manufacturing > News
Arix Bioscience raises £100m in IPO
Global healthcare and life science company Arix Bioscience has raised £100m in its Initial Public Offering (IPO) on the main market of the London Stock Exchange.
Production & Manufacturing > Manufacturing > News
Momenta announces FDA warning letter to contracted Glatopa’s fill/finish manufacturer
Momenta Pharmaceuticals has announced that Pfizer, Sandoz’s contracted Glatopa (glatiramer acetate injection) fill/finish manufacturing partner has received a warning letter from the FDA.
Production & Manufacturing > Manufacturing > News
1-15 of 2214 results