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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.

 

SILVER SPRING, Md. — The Food and Drug Administration on Friday approved a new indication for Eisai’s Lenvima (lenvatinib). The multiple receptor tyrosine kinase inhibitor has been approved to treat advanced renal cell carcinoma (RCC) in combination with everolimus in patients previously treated with an anti-angiogenic therapy. 

 

SILVER SPRING, Md. — The Food and Drug Administration issued a safety message late last week concerning the potential for serious side effects associated with fluoroquinolone antibiotics.