As part of a post-merger plan, DowDuPont, the combined company of The Dow Chemical Company and DuPont, has announced the corporate brand names that each of its divisions plans to assume once they are separated as independent companies, which is expected in 2019. Read More

Fresenius Kabi, a specialty and generic pharmaceuticals company, may face issues with its pending $4.3-billion acquisition of Akorn, a specialty generic pharmaceutical company, following Akorn’s alleged breaches of FDA data-integrity requirements relating to product development. The companies are conducting investigations before the close of the transaction. Read More

AstraZeneca’s global biologics R&D arm, MedImmune, is spinning out six molecules from its early-stage inflammation and autoimmunity programs into an independent biotech company, Viela Bio. Viela Bio will be funded with up to $250 million from a consortium of investors. Read More

Mylan has received a favorable ruling from the US Patent Trial and Appeal Board, which denied a motion by the St. Regis Mohawk Tribe to terminate Mylan’s patent challenge regarding Allergan's Restasis (cyclosporine ophthalmic emulsion), an eye-care drug and one of its top-selling drugs. Read More

Amgen has suffered a setback in seeking pediatric exclusivity for its blockbuster drug, Sensipar (cinacalcet hydrochloride), as it faces generic-drug competition. A federal district court ruled in favor of the FDA, which denied Amgen’s request for pediatric exclusivity, which would have given the company six added months of market exclusivity. Read More

The FDA has issued two draft guidances to further the agency’s implementation of the Drug Supply Chain Security Act, which outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs distributed in the US. Read More

FDA Commissioner Scott Gottlieb has outlined the agency’s plans to address ways to increase the effectiveness of influenza vaccines, including evaluating the selection of the vaccine-manufacturing process (egg-based versus cell-based). Read More

Hospira, a Pfizer company, is voluntarily recalling three lots of labetalol hydrochloride injection, a blood-pressure drug, and one lot of labetalol hydrochloride injection (Novaplus) to the hospital/institution level, due to cracks on the rim surface of vials for the lots. Read More

The FDA has cited an insulin manufacturing facility in Malaysia of Biocon, a Bangalore, India-based pharmaceutical company, following a pre-approval inspection. Biocon and Mylan are advancing a biosimilar to Sanofi’s diabetes drug, Lantus (insulin glargine), one of its top-selling drugs. Read More

The FDA has cited a drug manufacturing facility in Gujarat, India of Sun Pharmaceutical Industries, a Mumbai, India-based company, with three observations. In the last two years, the site has received a Complete Response Letter and Warning Letter from the FDA for manufacturing issues. Read More