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Process & Production

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).
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Amgen submits BLA of migraine prevention drug to FDA Amgen has submitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for erenumab to prevent migraine.
Production & Manufacturing > Process & Production > News Bayer lymphoma candidate secures FDA priority review designation By PBR Staff Writer
Bayer has secured priority review designation from the US Food and Drug Administration (FDA) for its investigational anti-cancer compound copanlisib to treat follicular lymphoma (FL).
Production & Manufacturing > Process & Production > News
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Russell Finex Specialized Vibrating Graders for the Pharmaceutical Industry
Customized vibrating separator increases productivity and product quality for pharmaceutical filler manufacturer
Production & Manufacturing > Process & Production > Press Releases
XyloCor’s cardiovascular gene therapy gets FDA fast track designation
The US Food and Drug Administration (FDA) has granted Fast Track designation to XyloCor Therapeutics’ lead product candidate XC001 (AdVEGF-All6A+), a cardiovascular angiogenic gene therapy.
Production & Manufacturing > Process & Production > 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).
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AstraZeneca’s bladder cancer drug imfinzi gets accelerated approval from FDA
The US Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca’s Imfinzi (durvalumab) for previously treated patients with advanced bladder cancer.
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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.
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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.
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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 > Process & Production > 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.
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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 > Process & Production > News
Sawai to buy Upsher-Smith’s generic pharmaceuticals business for $1.05bn
By PBR Staff Writer
Japan-based Sawai Pharmaceutical has agreed to acquire Upsher‐Smith’s generic pharmaceuticals business from its parent firm Acova for around $1.05bn.
Production & Manufacturing > Process & Production > News
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