Specialty Pharmacy

It has been announced by the United States subsidiary of Dr.Reddy’s Laboratories, that the company has reached a settlement with the U.S. Government in a case involving packaging for five blister-packed prescription products.

In a joint filing, both parties have agreed to a settlement of the action without any adjudication or issue of fact or law. The matter has been settled for $5 million dollars, and the product in question has not been distributed in the packaging at issue since June 2012, the company said.

The Food and Drug Administration recently approved Pfizer’s Ixifi (infliximab-qbtx), the company’s second approved biosimilar of Janssen’s Remicade. The biosimilar was approved for all of Remicade’s indications, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis and plaque psoriasis, among others.

The approval follows the April 2016 launch of its first Remicade biosimilar Inflectra. According to reports, Pfizer has said it has no plans to launch Ixifi in the United States.

The Food and Drug Administration has given full approval to Sanofi’s Admelog short-acting insulin lispro — a follow-on of Eli Lilly’s Humalog. The product received tentative approval from the FDA earlier this year, and now it is the first short-acting follow-on product to get the FDA’s stamp of approval.

Investment firm KKR and minority investor Walgreens Boots Alliance, based in Deerfield, Ill., on Thursday closed its acquisition of PharMerica, a provider of specialty pharmacy services.

The deal, first announced in August, was closed ahead of schedule. The all-cash transaction is valued at roughly $1.4 billion and will make PharMerica a private company. In connection with the completion of the acquisition, shares of PharMerica’s common stock will cease trading on the NYSE prior to the opening of the NYSE on Dec. 8, 2017.

GlaxoSmithKline on Wednesday announced that new data from a Phase III clinical study supports the safety and efficacy of Shingrix ((Zoster Vaccine Recombinant, Adjuvanted) in preventing shingles (herpes zoster) when given to adults 18 years and above shortly after undergoing autologous haematopoietic stem cell transplant (auHSCT).

In its third quarter, Fred’s reported a $51.8 million loss — an increase over the $38.4 million loss it reported in Q3 2016. As it works to pay off its debt, the company canceled its quarterly dividend and said it is exploring strategic alternatives for non-core businesses, including its specialty pharmacy business and real estate. It’s also updating its share repurchase program.

On the eve of World AIDS Day (Dec. 1), Johnson & Johnson announced that its Janssen Pharmaceutical Companies together with a consortium of global partners have initiated the first efficacy study for an investigational mosaic HIV-1 preventive vaccine.

The Bill & Melinda Gates Foundation and National Institutes of Health are joining forces with Johnson & Johnson to advance the potential prevention option, which is designed to be a “global vaccine” that could prevent a wide range of viral strains responsible for the HIV pandemic.

The Food and Drug Administration has approved the first biosmilar to treat HER2-positive breast cancer and certain gastric cancers, the agency announced Friday. Ogivri (trastuzumab-dkst), from Pittsburgh-based Mylan and Bengaluru, India-based Biocon, is a biosimilar of Genentech’s Herceptin, and the second biosimilar approved to treat cancer.