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Process & Production

Mylan confirms first-to-file patent challenge relating to BREVIBLOC Mylan confirmed that it and several subsidiaries have been sued by Baxter International, Baxter Healthcare Corporation and Baxter Healthcare S.A., in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Esmolol HCl in Sodium Chloride Injection, 10mg/ml (250 ml) and 20 mg/ml (100 ml).
Production & Manufacturing > Process & Production > News
Orexigen gets allowance from USPTO for new US patent for Contrave Orexigen Therapeutics has received a notice of allowance from the U.S. Patent and Trademark Office (PTO) for U.S. Patent Application No. 11/757,773, which covers use of Orexigen's sustained release formulation of naltrexone, which was designed to improve drug tolerability for Contrave (naltrexone HCl / bupropion HCl extended release), in a method for treating obesity.
Production & Manufacturing > Process & Production > News Highland Therapeutics receives second notice of allowance for patent on Lead product Highland Therapeutics, a pharmaceutical company, announced that the US Patent and Trademark Office has issued a Notice of Allowance for a patent application for HLD-200, a novel formulation of methylphenidate designed to be taken once-daily in the evening with the objective of controlling symptoms of ADHD immediately upon awakening and throughout the day.
Production & Manufacturing > Process & Production > News
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Sanofi and Regeneron's atopic dermatitis drug receives FDA breakthrough therapy status
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Sanofi and Regeneron Pharmaceuticals' dupilumab to treat adults with moderate-to-severe atopic dermatitis (AD).
Production & Manufacturing > Process & Production > News
FDA grants orphan drug status for BerGenBio's BGB324 to treat acute myeloid leukaemia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan-drug designation for Norwegian biopharmaceutical firm BerGenBio's BGB324 to treat acute myeloid leukaemia (AML).
Production & Manufacturing > Process & Production > News
Janssen submits NDA for three-month paliperidone palmitate to treat schizophrenia in US
By PBR Staff Writer
Janssen Research & Development has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for three-month atypical antipsychotic paliperidone palmitate to treat adults with schizophrenia, a complex and chronic brain disorder.
Production & Manufacturing > Process & Production > News
OXiGENE gets European patent for OXi4503 in AML and other myeloid malignancies
OXiGENE, a biopharmaceutical company developing novel cancer therapeutics, announced that the company has been granted a patent by the European Patent Office related to its current clinical product candidate, OXi4503.
Production & Manufacturing > Process & Production > News
Dehumidified Automated Warehouse at Novo Nordisk A/S Awarded
Novo Nordisk is world leader in diabetes care with insulin products as well as systems for dosing of insulin.With 26,000 employees, whereof almost 50% are working in Novo’s homecountry, Denmark, Novos products are represented in appr. 180 countries with affiliates and offices in 80 countries.
Production & Manufacturing > Process & Production > Case Studies
GMP Compliance With Help From Munters Air Treatment Systems
At Xellia Pharmaceuticals Munters create a strictly controlled and GMP compliant climate.
Production & Manufacturing > Process & Production > Case Studies
Klocke uses NA and ML for Quality Storage
The KLOCKE Group manufactures and packages pharmaceutical products, food supplements and cosmetic products. In Appenweier, Germany, fixed pharmaceutical forms are developed and manufactured. The product range consists of granules, tablets, film tablets, sugar-coated tablets and hard capsules.
Production & Manufacturing > Process & Production > Case Studies
Munters Helps Fulfilling FDA Requirements
Strict climate control in weighing room is elegantly performed by a Munters ML Plus system.
Production & Manufacturing > Process & Production > Case Studies
ML Plus Brochure
| By Munters
Introducing the ML Plus systems that is specifically designed to control both temperature and relative humidity in demanding production processes.
Production & Manufacturing > Process & Production > White Papers
Munters Quantum™ Desiccant Rotor - A Break Through Within Product Drying and Cooling Processes
As the world leader of energy efficient desiccant dehumidifiers Munters is constantly refining the desiccant wheel technique, materials and capacity. With more than 50 years experience and more than 300,000 desiccant systems produced Munters has an extraordinary operational experience that stands out in the air treatment business.
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