News
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The FDA has made the approval packages for Boehringer Ingelheim’s Stiolto Respimat and Spiriva Respimat available on its website. The Stiolto Respimat tiotropium bromide/olodaterol SMI, which is marketed as Spiolto Respimat in Europe, was approved… Read more . . .
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Teva has announced the FDA’s acceptance of the company’s NDAs for fluticasone propionate (FP)/salmeterol and FP monotherapy DPIs for the treatment of asthma. Both products are delivered using the breath-activated RespiClick inhaler. In late 2015,… Read more . . .
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The Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) has recommended against the use of MedImmune’s FluMist Quadrivalent Live Attenuated Influenza Vaccine (FluMist Quadrivalent) for the 2016-2017… Read more . . .
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AeroVanc developer Savara Pharmaceuticals has acquired Serendex Pharmaceuticals, which is developing Molgradex inhaled granulocyte-macrophage colony-stimulating factor (molgramostim) for the treatment of autoimmune pulmonary alveolar proteinosis (PAP). Serendex announced in September 2015 that it was initiating… Read more . . .
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In May 2016, Grupo Ferrer announced that it would acquire inhaled drug company Alexza Pharmaceuticals; as of June 21, 2016, the company says, Ferrer Pharma has merged into Alexza Pharmaceuticals, with Alexza now a wholly… Read more . . .
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GlaxoSmithKline and Innoviva have presented data from the FULFIL study of its fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI versus Symbicort for COPD, reiterating that the data support the company’s plans to file an NDA for the product… Read more . . .
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Adherium has announced that AstraZeneca will use Adherium’s SmartTouch Symbicort device in an upcoming 12-month clinical study of adherence in patients with COPD that is expected to enroll almost 400 US COPD patients. In July… Read more . . .
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In its annual report for the fiscal year ended 30 April 2016, Consort Medical reports that its subsidiary Bespak experienced revenue growth of almost 11%, and CDMO Aesica, which Consort acquired in November 2014, experienced… Read more . . .
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Hovione has announced that the official groundbreaking for the expansion of its facility in New Jersey took place on June 8, 2016. The expansion will double the capacity of the facility by adding 30,600 sq… Read more . . .
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US generic inhalation solutions manufacturer Nephron Pharmaceuticals has licensed Apotex’s generic budesonide inhalation suspension, a generic version of AstraZeneca’s Pulmicort Respules, and subsequently launched the product in the US, the company said. Nephron will manufacture,… Read more . . .
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