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Process & Production

Orexigen expands NB32 intellectual property portfolio with new US patent Orexigen Therapeutics has announced that the US Patent and Trademark Office (PTO) has issued a patent related to NB32, the company's investigational medication being evaluated for weight loss.
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Takeda completes post-marketing commitment to submit data for pioglitazone containing medicines Takeda Pharmaceutical (Takeda) has completed the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Ministry of Health, Labour and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA) for pioglitazone containing medicines, including ACTOS (pioglitazone HCl).
Production & Manufacturing > Process & Production > News Momenta's ANDA for generic Copaxone accepted for review by FDA By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for review the abbreviated new drug application (ANDA) of Momenta Pharmaceuticals's three-times-a-week generic Copaxone (glatiramer acetate injection, 40mg/mL), submitted by Sandoz,
Production & Manufacturing > Process & Production > News
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Pfizer gets FDA fast track status for C. difficile vaccine candidate
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation to Pfizer's investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090).
Production & Manufacturing > Process & Production > News
Fujifilm Diosynth Biotechnologies Expands Cell Culture Manufacturing Capacity
Fujifilm Diosynth Biotechnologies has announced continued expansion of its cell culture manufacturing capabilities with the addition of two 2,000L single-use bioreactors. One each of these is being installed at the company's sites in Research Triangle Park (RTP), NC, USA and Billingham, UK.
Production & Manufacturing > Process & Production > Press Releases
Amgen's NDA for heart failure drug ivabradine gets FDA priority review status
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review designation for Amgen's new drug application (NDA) of its oral drug ivabradine to treat chronic heart failure (HF).
Production & Manufacturing > Process & Production > News
USPTO issues notice of allowance for claims in Alnylam's Tuschl patent application
Alnylam Pharmaceuticals (ALNY), a leading RNAi therapeutics company, has announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for claims in the Tuschl et al. patent application 12/591,829.
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FDA approves ViiV Healthcare's Triumeq to treat HIV-1 infection
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for ViiV Healthcare's Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets to treat patients with HIV-1 infection.
Production & Manufacturing > Process & Production > News
EMA accepts to review Cubist's MAA for ceftolozane/tazobactam
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted review of US-based Cubist Pharmaceuticals' marketing authorization application (MAA) for its investigational antibiotic ceftolozane/tazobactam to treat complicated urinary tract Infections and complicated intra-abdominal infections.
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VIVUS acquires topiramate-related patents from Janssen Pharmaceuticals
VIVUS has announced the acquisition of a group of patents from Janssen Pharmaceuticals covering uses of topiramate as monotherapy and in combination with other pharmaceutical agents to treat a variety of medical conditions.
Production & Manufacturing > Process & Production > News
BioLineRx Receives Notice of Allowance for US Patent on BL-7010 for Gluten Toxicity
By PBR Staff Writer
BioLineRx Ltd., a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced receipt of a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent claiming the use of BL-7010, a novel polymer in preventing or decreasing gluten’s deleterious effects on the gastrointestinal mucosa.
Production & Manufacturing > Process & Production > News
Dicerna issues multiple patents covering claims for dicer substrate siRNAs
By PBR Staff Writer
Dicerna Pharmaceuticals announced a series of recently issued patents providing broad composition and method of use claims covering double stranded RNA molecules, called dicer substrate siRNAs (DsiRNAs).
Production & Manufacturing > Process & Production > News
ABB Consulting – Global Technical & Engineering Specialists
ABB Consulting provides technical and engineering services to help companies in the global process industries achieve operational excellence.
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