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Process & Production

EMA grants orphan drug status for Tolero's leukemia drug alvocidib By PBR Staff Writer
The European Medicines Agency (EMA) has granted orphan drug designation for Tolero Pharmaceuticals' alvocidib to treat patients with acute myeloid leukemia (AML).
Production & Manufacturing > Process & Production > News
Portola's factor Xa inhibitor antidote andexanet alfa gets FDA orphan drug status By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for Portola Pharmaceuticals' Factor Xa inhibitor antidote andexanet alfa, which reverses the anticoagulant effect of direct or indirect Factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent surgery.
Production & Manufacturing > Process & Production > News EMA accepts MAA for Amgen's myeloma drug Kyprolis By PBR Staff Writer
The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) of Amgen and Onyx Pharmaceuticals' Kyprolis (carfilzomib) for Injection to treat patients with relapsed multiple myeloma who have received at least one prior therapy.
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US FDA accepts Pfizer's sNDA for priority review of Rapamune to treat LAM
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Pfizer's supplemental New Drug Application (sNDA) for priority review of Rapamune (sirolimus) to treat Lymphangioleiomyomatosis (LAM), a progressive lung disease in women of childbearing age.
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Actavis secures final US FDA approval for Buprenorphine sublingual tablets
By EBR Staff Writer
Actavis has secured final approval from the US Food and Drug Administration (FDA) on its Abbreviated New Drug Application for Buprenorphine 2mg and 8mg sublingual tablets, the generic version of Reckitt Benckiser's Subutex.
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Genentech's melanoma drug combination gets FDA priority review
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for review Genentech’s new drug application (NDA) for cobimetinib in combination with Zelboraf (vemurafenib) to treat patients with unresectable or metastatic melanoma harboring a BRAF V600 mutation.
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Humidity
This is the amount of water vapor (kg) contained per unit volume (m3) of the gas mixture. In a gas mixture the water vapor generates a certain partial pressure that is part of the total barometric gas pressure. The vapor pressure can only rise to its saturation limit, which is determined by the temperature. Thereafter water is given off in liquid form (dew). The maximum pressure is called saturation pressure and is temperature dependent. The temperature dependency is, however, not included in the term of absolute humidity.
Production & Manufacturing > Process & Production > Products
FDA grants expanded approval for Eisai's antiepileptic drug Banzel for pediatric patients
By PBR Staff Writer
Japanese pharmaceutical firm Eisai's US subsidiary has secured approval from the Food and Drug Administration (FDA) for an additional pediatric indication for its antiepileptic drug (AED) Banzel (rufinamide) to treat seizures associated with Lennox-Gastaut syndrome (LGS).
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Bexion gets FDA orphan drug status for Saposin C to treat glioblastoma multiforme
By PBR Staff Writer
US-based biotech firm Bexion Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for Saposin C, an active ingredient in its proprietary drug BXQ-350, to treat glioblastoma multiforme.
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FDA accepts for review Pfizer's NDA for pain drug ALO-02
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for review Pfizer's new drug application (NDA) for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride), extended-release capsules, an abuse-deterrent formulation (ADF) opioid for the management of pain.
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Horizon Pharma files IND application for Actimmune to treat Friedreich's Ataxia
By PBR Staff Writer
Irish biopharmaceutical firm Horizon Pharma has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for Actimmune to treat Friedreich's Ataxia (FA).
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FDA grants orphan drug status for Verastem' VS-5584 to treat mesothelioma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for Verastem's orally available compound VS-5584 for use in the treatment of mesothelioma.
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Neuronascent announces expanded patent coverage in US and Russia for NNI-362
The US Patent Office issued an allowance to Neuronascent expanding patent protection of their new therapeutic candidate, NNI-362, beyond composition of matter and pharmaceutical compositions to coverage of its use for patients suffering from neurodegenerative disorders including Alzheimer's, Parkinson's and Huntington's diseases.
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