Issue link: https://www.e-digitaleditions.com/i/292644
EC approves GSK's once-weekly diabetes tablet LONDON, UK—The European Commission granted marketing authorization to GlaxoSmithKline for its once-weekly diabetes treat- ment, Eperzan (albiglutide). The tablet is indicated for the treatment of type-2 diabetes mellitus in adults. GSK expects to launch Eperzan in several European countries in 2014. The product is under review at the FDA. Aegis' tablet formulation boosts bioavailability of phenylephrine by more than 50 percent SAN DIEGO, CA—Aegis Thera - peutics used its Intravail technology to formulate phenylephrine into compressed tablets, improving oral bioavailability by more than 50 per- cent. It is the company's first applica- tion of Intravail in a solid dosage form. The formulation is compatible with current tabletting processes and does not change the tablet's size or appearance. The technology can deliver a range of protein, peptide, and non-peptide drugs that are cur- rently only administered by injection via the oral, buccal, and intranasal routes. FDA approves Celegne's arthritis tablet WASHINGTON, DC—The FDA approved Otezla (apremilast) to treat adults with active psoriatic arthritis. The tablet comes in 10-, 20-, and 30- milligram doses and is manufactured by Celgene, Summit, NJ. AMRI to acquire Cedarburg WASHINGTON, DC—Albany Molecular Research (AMRI) agreed to acquire Cedarburg Pharmaceu - ticals, a contract manufacturer of pharmaceutical and dietary actives, for $38.2 million. The Grafton, WI, company serves generic and branded customers and specializes in con- trolled substances, steroids, prosta - glandins, vitamin D analogs, conju- gation chemistry, and inorganics. AMRI is a contract research and manufacturing organization based in Albany, NY. FDA issues draft Guidance on bioavailability WASHINGTON, DC—The FDA issued a draft "Guidance for Industry: Bioavailability and Bioequivalence Stu dies Submitted in NDAs or INDs—General Considerations." It pro vides recommendations to ap - plicants planning to include bio - availability and bioequivalence in - f o r m a tion for drug products in in vest iga tional new drug applications, new drug applications (NDAs), and NDA supplements. When finalized, this guidance will revise and replace parts of the FDA's March 2003 Guidance "Bioavailability and Bio - equivalence Studies for Orally Ad - ministered Drug Products—Gen eral Considerations." 10 April 2014 Tablets & Capsules New VAC-U-MAX ® Soft Gel Vacuum Conveyors Provide Gentle, Effective Handling of Your Soft Gel, Gel Cap, or Coated Tablet Here's How Designed specifically for safe, damage-free processing, new Soft Gel Vacuum Conveyors offer an ideal way to link manufacturing stages in the production process and provide highly efficient, dust free delivery of your product to capsule filling, inspection, or packaging machines. 69 William Street • Belleville, NJ 07109 • P: 973-759-4600 • F: 973-759-6449 The Smartest Distance Between Two Points For more information call 1-800-822-8629, E-mail: info@vac-u-max.com, or visit www.vac-u-max.com b-TOCFN_1-11_Masters 4/3/14 2:28 PM Page 10