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FDA Pipeline Preview, July 2011 (Pfizer, Pain Therapeutics, Regeneron Pharmaceuticals, Alexion, Tioga Pharmaceuticals, Emergent BioSolutions, Synageva BioPharma, Aradigm, Mobius Therapeutics, Morphotek)
Recent FDA action (through June 2011) related to oxycodone, aflibercept opthalmic solution, icatibant, eculizumab, asimadoline, anthrax vaccine, SBC-102 enzyme replacement therapy, ciprofloxacin, mitosol, MORAb-004 and MORAb-066, levofloxacin.
Complete response
• Oxycodone (Remoxy, Pfizer and Pain Therapeutics) extended-release capsules CII for the relief of moderate-to-severe pain requiring continuous, around-the-clock opioid treatment.
Recommended for approval
• Icatibant (Firazyr, Shire) for the treatment of acute attacks of hereditary angioedema in patients aged 18 years and older.
Priority review
• Eculizumab (Soliris, Alexion) for the treatment of atypical hemolytic uremic syndrome.
Fast-track designations
• Asimadoline (Tioga Pharmaceuticals) for the treatment of irritable bowel syndrome.
• Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant (NuThrax, Emergent BioSolutions) for the treatment of anthrax.
• SBC-102 enzyme replacement therapy (Synageva BioPharma) for the treatment of lysosomal acid lipase deficiency.
Orphan drug designations
• Ciprofloxacin for inhalation (Aradigm) for the management of bronchiectasis.
• Mitosol (Mobius Therapeutics) for the prevention of corneal haze following surface ablation laser keratectomy.
• MORAb-004 and MORAb-066 (Morphotek) for the treatment of soft-tissue sarcoma and pancreatic cancer, respectively.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
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David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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FDA Approves Stelara Biosimilar, Selarsdi
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