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Process & Production

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 > Process & Production > 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 > 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.
Production & Manufacturing > Process & Production > News
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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
Novartis gets FDA breakthrough therapy status for CTL019 to treat r/r DLBCL
By PBR Staff Writer
Novartis has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its investigational chimeric antigen receptor T cell (CAR-T) therapy, CTL019, to treat adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies.
Production & Manufacturing > Process & Production > News
FDA advisory committee to review Puma’s NDA for neratinib
The US Food and Drug Administration (FDA) has scheduled Puma Biotechnology’s New Drug Application (NDA) for neratinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on 24 May 2017.
Production & Manufacturing > Process & Production > News
Icon Bioscience submits NDA to FDA for anti-inflammatory drug Dexycu
Icon Bioscience has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its lead pipeline product Dexycu (IBI-10090).
Production & Manufacturing > Process & Production > News
Active Biotech’s tasquinimod gets FDA orphan drug status for multiple myeloma treatment
The US Food and Drug Administration (FDA) has granted orphan drug designation to Active Biotech’s investigational novel agent, tasquinimod, for multiple myeloma treatment.
Production & Manufacturing > Process & Production > News
FlexyPlant – Scale-Up Application Example from the Pharmaceutical Industry
| By SYSTAG
Scale-up by a factor of 300; from 70ml reactor into 25lt pilot plant. A scale-up step by factor 300 takes place in different laboratories, in fully diversified plants mostly. A great deal of information may be lost, and the knowledge of development Chemists can not be implemented optimally.
Production & Manufacturing > Process & Production > White Papers
Optimizing Development Resources for Efficient Product Development
| By SYSTAG
Nowadays, efficient process research and development are, more than ever, an absolute must for contract manufacturers and API manufacturers. New products/processes need to be pushed through to market readiness faster and faster.
Production & Manufacturing > Process & Production > White Papers
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 > Process & Production > News
FlexyCUBE - for parallel process optimisation
The Modular Tool Tailored to Suit any Laboratory Automation Needs
Production & Manufacturing > Process & Production > Products
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