Branded

SILVER SPRING, Md. — The Food and Drug Administration has approved Biogen and AbbVie’s Zinbryta (daclizumab), the companies announced Tuesday. The drug is a once-daily self-administered injection indicated to treat relapsing forms of multiple sclerosis in patients who have had an inadequate response to two or more MS therapies. 

 

SILVER SPRING, Md. — The Food and Drug Administration has approved Boehringer Ingelheim and Eli Lilly and Co.’s Jentadueto XR (linagliptin and metformin HCl) tablets, the companies announced Tuesday. 

 

The new drug is indicated as a once-daily adjunctive treatment for Type 2 diabetes and works by increasing hormones that stimulate insulin production in the pancreas and that stimulate the liver to produce less glucose. 

 

WOONSOCKET, R.I. — CVS Health on Wednesday announced that its push to curb opioid overdose by providing overdose reversal drug naloxone without a prescription would hit 30 states by August through expansion to seven new states this summer. The initiative works by establishing a standing order with an in-state physician to allow pharmacists to dispense the drug to patients without individual prescriptions. The company has already begun dispensing naloxone in 23 states. 

 

FOSTER CITY, Calif. — Gilead Sciences announced Wednesday that it had named two new executives to its leadership team. Kevin Young has been named the company’s COO and Dr. Martin Silverstein was named EVP strategy. The two will report to Gilead president and CEO John Milligan. Additionally, Gilead’s EVP commercial operations will be leaving the company to pursue other opportunities. 

 

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday approved an expanded indication for Janssen Pharmaceuticals’ diabetes medication Invokamet (canagliflozin and metformin HCl). The drug has been approved as a first-line treatment for adults with type 2 diabetes who aren’t being treated with either canagliflozin or metformin. 

 

SILVER SPRING, Md. — The Food and Drug Administration has approved Seqirus’ Flucelvax Quadrivalent, the first four-strain cell structure-derived inactivated influenza vaccine for adults and children over 4 years of age, the company announced Monday. 

 

The quadrivalent vaccine covers two strains each of influenza A and influenza B and is derived from a cell culture — the same cell culture technology the company used in its first product Flucelvax. 

 

FORTH WORTH, Texas — Galderma Laboratories announced Thursday that it had launched a new pump dispenser system for its Mirvaso (brimonidine) topical gel. The gel treats facial redness associated with rosacea and the new pump dispenses a consistent dose with each use. 

 

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday issued a safety alert about the diabetes medicine canagliflozin (Invokana, Invokamet). An ongoing clinical trial has found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the drug.

 

Although the FDA has not determined whether canagliflozin increases the risk of leg and foot amputations, it is currently investigating the issue and will update the public when it has more information.