News
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AstraZeneca gets temporary injunction to stop Actavis sales of generic version of Pulmicort Respules
The United States Court of Appeals for the Federal Circuit has granted AstraZeneca’s request for a temporary injunction stopping Actavis from further sales of its budesonide inhalation suspension, according to Actavis. AstraZeneca has appealed the… Read more . . .
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The FDA has granted Adapt Pharma Fast Track designation for its intranasal naloxone for the treatment of opioid overdose, the company said. Adapt Pharma licensed the product from Lightlake Therapeutics in December 2014. In the… Read more . . .
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Lupin Limited and Polish biopharmaceutical company Celon Pharma have announced that they will co-develop a generic version of GSK’s Advair Diskus. Celon, which currently markets a fluticasone/salmeterol DPI called Salmex in Poland, will supply the… Read more . . .
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Actavis has announced that after the United States District Court for the District of New Jersey denied AstraZeneca’s request for a permanent injunction and ruled that US Patent No. 7,524,834 is invalid, Actavis launched its… Read more . . .
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Since 2000, developers of immediate-release oral drugs have been able to request waivers of in vivo bioequivalence studies based on the FDA’s Biopharmaceutics Classification System (BCS). Now a workshop sponsored by the AAPS Inhalation and… Read more . . .
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GSK has relied heavily on social media to get out the word that its Flonase fluticasone propionate nasal spray is now available over the counter in the United States. The FDA approved Flonase OTC in… Read more . . .
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PARI has announced that it has begun supplying nebulizer compressors to patients using its new Kitabis Pak through a program called PARI Provide. Kitabis Pak, which includes generic tobramycin inhalation solution packaged with a PARI… Read more . . .
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Dance Biopharm has announced the appointment of former Dynavax chief medical officer and president J. Tyler Martin as President, a newly created position. Martin has also been appointed a member of the board of directors.… Read more . . .
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Hosokawa Micron has introduced the Mini Cyclomix lab mixer for use in development of dry powder formulations for inhalation, the company announced. According to the company, the lab-sized blender is designed to disperse API in… Read more . . .
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Theravance has announced that the the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug Safety and Risk Management Advisory Committee will meet jointly on March 19, 2015 to discuss whether the Breo Ellipta fluticasone/vilanterol DPI… Read more . . .
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