News
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Zhejiang Juhua has announced that the US FDA accepted a drug master file (DMF) for pharmaceutical-grade HFA 134a submitted by its fluorochemicals subsidiary on December 26, 2014 and that the company also received accreditation for… Read more . . .
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The UK’s Prescription Medicines Code of Practice Authority (PMCPA) has reprimanded Chiesi for a misleading and unsubstantiated claim regarding the company’s Fostair beclometasone/formoterol inhaler. The authority has published advertisements in the BMJ, The Pharmaceutical Journal,… Read more . . .
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Adamis Pharmaceuticals has announced that data from a Phase 1 PK study its APC-5000 fluticasone/salmeterol DPI, a generic carrier-free version of Advair Diskus, show less systemic exposure to both components compared to Advair. The open-label… Read more . . .
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In its announcement of fourth quarter and full year financial results for 2014, Insmed has confirmed that it filed an MAA for Arikayce liposomal amikacin inhalation solution. The company said that the EMA’s Pediatric Committee… Read more . . .
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Australia’s Therapeutic Goods Administration (TGA) has issued a warning about devices marketed by a company called Discreet Vape that look nearly identical to metered dose inhalers used for rescue medications for asthma. The PUFFiT and… Read more . . .
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Several months after Retrophin announced that it would divest several of its pipeline products, including Syntocinon intranasal oxytocin and intranasal ketamine, to Turing Pharmaceuticals, the latter company has officially announced its launch. Turing Pharmaceuticals is… Read more . . .
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A Phase 3 trial program of Sunovion Pharmaceutical’s SUN-101 glycopyrrolate inhalation solution for the treatment of moderate-to-very severe COPD has begun enrolling patients, the company announced. The program includes three studies expected to enroll about… Read more . . .
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Prescriptions for Zomig nasal spray increased 23% in 2014 compared to 2013, Impax Laboratories said, helping to offset a major decrease in revenues for the Impax Pharmaceuticals division after the 2013 loss of exclusivity for… Read more . . .
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Boehringer Ingelheim has presented data from five Phase 3 trials of tiotropium Respimat for the treatment of asthma at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The data come from… Read more . . .
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Savara Pharmaceuticals has announced positive results from a Phase 2 trial of its AeroVanc vancomycin DPI for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infections in cystic fibrosis patients. In the 28-day trial, patients… Read more . . .
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