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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
ePAT logging - online trend & data capture
ePAT – for various reactions and processes Quick, easy, inexpensive
Production & Manufacturing > Process & Production > Products
FlexyPAT - Covers all your automation needs
FlexyPAT – Reactors can be automated individually Functional – cost-optimised – user-friendly
Production & Manufacturing > Process & Production > Products
FDA grants orphan drug status to Boehringer's BI 836858 to treat MDS
Boehringer Ingelheim has secured orphan drug designation from the US Food and Drug Administration (FDA) for its anti-CD33 monoclonal antibody, BI 836858, to treat myelodysplastic syndromes (MDS).
Production & Manufacturing > Process & Production > News
FDA grants priority review to Enasidenib for IDH2-Mutant AML
The US Food and Drug Administration (FDA) has accepted under priority review Celgene's new drug application (NDA) seeking approval of enasidenib to treat patients with relapsed/refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation.
Production & Manufacturing > Process & Production > News
FDA grants priority review for EMD Serono's avelumab for metastatic urothelial carcinoma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review for EMD Serono's biologics license application (BLA) of avelumab to treat metastatic urothelial carcinoma (mUC).
Production & Manufacturing > Process & Production > News
EMA's CHMP recommends approval of Novartis’ Tafinlar in combination with Mekinist
The Committee for Medicinal Products for Human Use (CHMP) has recommended approval to the European Medicines Agency (EMA) of Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) as therapy for advanced or metastatic non-small cell lung cancer (NSCLC) patients whose tumors express the BRAF V600 mutation.
Production & Manufacturing > Process & Production > News
AstraZeneca gets positive CHMP recommendation for hyperkalaemia drug
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of AstraZeneca’s ZS-9 (sodium zirconium cyclosilicate) to treat hyperkalaemia.
Production & Manufacturing > Process & Production > 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 > Process & Production > News
FDA plans to not to hold advisory committee meeting for Portola’s betrixaban NDA
The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) is not planning to hold an Advisory Committee meeting for Portola Pharmaceuticals' New Drug Application (NDA) for betrixaban.
Production & Manufacturing > Process & Production > News
Perrigo files for FDA approval for generic version of Valeant's acne gel
Perrigo said it has filed for the US Food and Drug Administration approval for clindamycin, benzoyl peroxide topical gel, the generic version of Onexton gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%).
Production & Manufacturing > Process & Production > News
Ariad seeks European approval for NSCLC drug brigatinib
By PBR Staff Writer
Ariad Pharmaceuticals is seeking approval in Europe for brigatinib to treat adult patients anaplastic lymphoma kinase (ALK+) non-small cell lung cancer (NSCLC) who have been earlier treated with crizotinib.
Production & Manufacturing > Process & Production > News
FDA accepts Intellipharmaceutics’ NDA for Rexista to treat moderate to severe pain
The US Food and Drug Administration has accepted for filing of Intellipharmaceutics International’s New Drug Application ("NDA") seeking authorization to market its Rexista abuse-deterrent oxycodone hydrochloride extended release tablets in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.
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

FlexyCUBE Product Catalog By SYSTAG
SYSTAG - Your Partner in Chemical Development... 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 Custom Powder Systems Announces Dramatic Yield Increase Through use of Anti-Segregation Technologies By Custom Powder Systems
"Our material handling process was very inefficient and we were lucky to yield 50% in-spec product" says the Director of a major generic pharmaceutical company, "and the handling labor was extensive. I can't even begin to tell you how frustrating it was." The Director is discussing the problem his company had with manufacturing one of its key products.... Production & Manufacturing > Process & Production > White Papers See more
1-15 of 2211 results