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Regulatory and compendial news FDA: One-year extension for serialization SILVER SPRING, MD—The United States Food and Drug A d m i n i s t r a t i o n ( F D A ) h a s announced a one-year extension of the November 2017 deadline for product serialization. e serialized identifiers can facilitate supply chain tracing and better detect illegitimate products. On June 30, 2017, the agency issued a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Secu- rity Act (DSCSA)—Compliance Pol- icy. It informs manufacturers and other supply chain stakeholders that although manufacturers are to begin including a product identifier on prescription drug packages and cases on November 27, 2017, the FDA will delay enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions. e policy applies solely to products without an identifier introduced into commerce between November 27, 2017 and November 26, 2018. While manufacturers work to meet product identifier requirements, they must comply with other DSCSA requirements. industRy news Iconovo raises €2.3 million LUND, SWEDEN—The SmiLe Incubator company Iconovo AB has raised €2.3 million, through a share issue that was over-subscribed. In a company news release, Iconovo indicated it will use the funding to offer development of a complete pharmaceutical product consisting of both inhaler and drug formula- tion, based on their proprietary and patented inhalers. Iconovo's prod- ucts are primarily designed for drugs to treat asthma and COPD, as well as vaccines and biologics. e company has already signed an agreement for licensing and prod- uct development with Amneal Pharmaceuticals, New Jersey, US. They have also moved into larger premises and customized laborato- ries and are investing in equipment and hiring. Vectura and Novartis' Sandoz to develop generic CHIPPENHAM, UK—Pharma- Times Online reports that Vectura has signed an exclusive agreement with Novartis unit Sandoz to develop a generic version of an exist- ing, major, inhaled combination therapy for asthma and COPD in the United States. Vectura will be responsible for development of the formulation and manufacture of clinical batches for use in pilot clini- cal studies. Sandoz will be account- able for clinical development, man- ufacture and commercialization of the drug, which is currently known as VR2081. e agreement extends Vectura's existing relationship with Sandoz. After Vectura's merger with SkyePharma in 2016, the group said it would prioritize up to five generic projects utilizing its newly combined pMDI and DPI continued on page 26 Inhalation August 2017 7