August 2012
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OINDP testing experts Copley Scientific have announced the launch of the FRS bi-directional flow sensor, which is designed for use in inhaler testing. According to Copley, the device can be integrated with the company’s Breath Actuation Controller… Read more . . .
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According to Lupin, the FDA has approved the company’s ANDA for a generic version of Par Pharmaceutical’s Nascobal single dose cyanocobalamin nasal spray. Lupin said that it will manufacture the nasal spray at its plant… Read more . . .
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Krystal Biotech has announced the initiation of the Phase 1 CORAL-1/US dose escalation trial of its KB407 inhaled gene therapy for the treatment of cystic fibrosis. The Phase 1 study, which is being conducted at the… Read more . . .
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MannKind Corporation has filed a notice with the US Securities and Exchange Commission (SEC) stating that manufacturing of clinical trial supplies for its planned Phase 2/3 study of MNKD-101 clofazimine inhalation suspension in patients with… Read more . . .
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Liquidia Corporation will pay Pharmosa Biopharm $10 million up front plus development and sales milestones worth up to $215 million and royalties on potential sales for North American development and commercialization rights to Pharmosa’s L606 liposomal… Read more . . .
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Orion Pharmaceuticals has announced plans for a €30 million expansion of its production facility in Espoo, Finland, including a new filling line for its Easyhaler dry powder inhalers. The company said that it is responding… Read more . . .
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Verona Pharma announced that it has submitted an NDA to the FDA for the nebulized formulation of ensifentrine (RPL554), a PDE3/PDE4 inhibitor, for the treatment of COPD. The company said that the submission is supported… Read more . . .
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According to TFF Pharmaceuticals, the company has received a 3-year Direct to Phase 2 Small Business Innovation Research (SBIR) grant worth ~$2.97 million from the National Institute of Allergy and Infectious Diseases (NIAID) for further… Read more . . .
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US-based start-up Cystetic Medicines has announced the initiation of a Phase 1 SAD/MAD trial of its CM001 dry powder “molecular prosthetic” in healthy volunteers. The company is developing CM001 for the treatment of cystic fibrosis… Read more . . .
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Tonix Pharmaceuticals announced that it will acquire the US rights to Tosymra sumatriptan nasal spray from Upsher-Smith along with Zembrace SymTouch sumatriptan injection, both for the treatment of migraines. Dr. Reddy’s subsidiary Promius Pharma submitted… Read more . . .
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