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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 > Process & Production > News
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
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).
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > 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 > Process & Production > 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 > 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
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

PBR Supplier Recommendations

Russell Finex - Fine Mesh Separation Technology
Russell Finex are worldwide leaders in fine mesh separation technology, designing and manufacturing vibratory sieves, separators, self-cleaning in-line filters and ultrasonic systems.... Production & Manufacturing > Process & Production > Suppliers
Vaisala - Supplier of Continuous Monitoring Systems for Controlled Life Science Environments
Vaisala is a world leader in environmental and industrial measurement systems and instrumentation. We offer measurement instrumentation, continuous monitoring systems and validation systems to measure and supervise environmental conditions, within regulated or controlled life science environments.... Production & Manufacturing > Process & Production > Suppliers
Munters - Your Perfect Climate
Munters is the global leader in energy efficient climate control. Munters provide temperature and humidity climate solutions to assist manufacture and storage of products and create comfortable indoor environments. The company was established over 65 years ago and with over 3,000 employees in 30 offices worldwide.... Production & Manufacturing > Process & Production > Suppliers
Bürkert Fluid Control Systems - Manufacturer of Measuring, Control and Regulation Systems for Liquids and Gases
The company group Bürkert Fluid Control Systems, founded in 1946 by Christian Bürkert, is a manufacturer of measuring, control and regulation systems for liquids and gases, with headquarters in the southern German town of Ingelfingen. The company which has been family owned since its foundation has got an export ratio of 80%.... Production & Manufacturing > Process & Production > Suppliers
3R PHARMA CONSULTING - Reducing Regulatory Risk
3R PHARMA CONSULTING provides cost-effective, timely solutions to registration filings and challenges in pharmaceutical development strategies across Europe, the US and the rest of world. ... Production & Manufacturing > Process & Production > Suppliers
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PBR White Paper Recommendations

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 Reliable, Long-range Wireless Sensors for Environmental Monitoring By Vaisala pbr
The Vaisala viewLinc Monitoring System tracks environmental conditions wirelessly using Vaisala’s VaiNet wireless devices based on LoRa™* technology. By using a chirp spread spectrum (CSS)* wireless protocol, VaiNet provides robust communication that is extremely reliable over long distances and under harsh, complex and obstructed conditions.... Production & Manufacturing > Process & Production > White Papers Tip Speed - Establishing Optimal Blending Speed By Custom Powder Systems
Tip speed (angular velocity) is a constant that can be used to establish an initial blending speed for a given bin geometry. The blender speed may need to be adjusted upon further testing but is a good starting point. The tip radius is the distance perpendicular to the blender rotational center measured to the furthest top bin corner.... Production & Manufacturing > Process & Production > White Papers Blender Type Comparison Pedestal Blender (PB) vs. Column Blender (CB) By Custom Powder Systems
A pedestal blender is a single purpose machine that can only blend. A column blender has the additional capability a lifting axis and slew (placing) axis that offers the additional capabilities.... Production & Manufacturing > Process & Production > White Papers See more
1-15 of 2228 results