Hospira hopes to get back on track with its infusion pump business this year. The latest bit of good news for the company is FDA clearance for the Plum 360 Infusion System, which adds the capability to wirelessly stream data to an electronic medical record and access an expanded drug library for information to maintain patient safety.
In 2013, U.K. and European regulators banned most products from a Wockhardt plant in India that was found faking data, but the U.K. allowed it to continue shipping a few that were required for essential medicines. This week, the U.K. stiffened the action to include all active ingredients from Wockhardt's plant in Chikalthana, a facility the FDA has also banned from shipping to the U.S.
Celator Pharmaceuticals received fast-track designation for its candidate for the treatment of secondary acute myeloid leukemia in elderly patients. CPX-351 is designed to achieve sustained release of the anticancer drugs cytarabine and daunorubicin in a precise ratio.
Johnson & Johnson's antipsychotic med Invega Sustenna is already bringing in blockbuster-plus sales for J&J, and if the company has its way, a new, even longer acting formula will give the franchise an even bigger boost.
Novartis picked up FDA and European approvals to sell its secukinumab as a treatment for psoriasis, the first steps in the company's plot to build a global anti-inflammatory contender and outpace its rivals.
Apple has growing med tech ambitions, but those gnarly healthcare regulations have left a sour taste in its mouth. As a result, the Silicon Valley bigwig has stepped up its engagement with the feds, seeking not only to learn by meeting with the FDA but also to change the rules via a lobbying effort that cost nearly $3 million last year.
The hepatitis C market is breaking new ground all over the place. As payers put the squeeze on Gilead Sciences and AbbVie for discounts in the U.S., England's National Health Service is delaying a broad rollout of Gilead's blockbuster Sovaldi till July, citing the drug's high cost--an unprecedented move on a treatment already blessed by the country's cost-effectiveness watchdogs.
The FDA said in a draft guidance issued last week that it does not intend to regulate general wellness products, which include an array of consumer-oriented wearables like Fitbit's exercise trackers.
Shares of CytRx bounced up 10% this morning as investors responded to the news that the FDA had lifted its partial hold on its late-stage cancer drug aldoxorubicin.
An Apotex plant in Brantford, Ontario, was cited in a November inspection for equipment that was not properly cleaned and was found to be contaminated, according to a report in The Star. The plant was also cited for not having password-protected computers that could prevent employees from altering or deleting testing data.