The FDA approved a 1st-of-its-kind treatment for Type 2 diabetes, Johnson & Johnson‘s (NYSE:JNJ) Invokana, with the federal watchdog agency citing it as a pioneer in a new class of diabetes drug.
Pharmaceutical
Becton Dickinson touts closed-doors acquisition of Cato’s pharmacy software solutions
New Jersey healthcare giant Becton Dickinson & Co. (NYSE:BDX) acquired pharmaceutical management systems maker Cato Software Solutions in a closed-doors deal this week.
FDA warns on arrhythmia risk with ‘Z-Packs’
The FDA warned consumers today about a potentially lethal risk of deadly irregular heartbeats for some patients who take the commonly prescribed antibiotic drug azithromycin, sold under the brand names Zithromax and Zmax – giving rise to the drug’s moniker, “Z-Pack.”
Patients with "known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms," according to a warning posted on the FDA’s website.
Covidien updates on medical device, pharma split
Allergan drops $958M on migraine drug maker MAP Pharma
Abbott’s board approves AbbVie pharma spinout | Wall Street Beat
Abbott (NYSE:ABT) said its board of directors approved the spinout of its branded pharmaceuticals business as AbbVie Inc. in which Abbott’s shareholders will receive an AbbVie share for each ABT share they own.
The distribution is slated for Jan. 1, 2013, for shareholders of record as of Dec. 12, according to a press release.
Covidien updates on pharma spinout
With strong fiscal 2012 numbers under its belt, Covidien (NYSE:COV) updated investors today on its expected financials after it spins out its pharmaceuticals business next year.
The Mansfield, Mass.-based medical device company said late last year that it planned to ditch the no-or-low-growth pharma unit, which will become a stand-alone operation.
Delcath’s cancer-treating system lands U.S., Australian regulatory wins
Medical device company Delcath Systems (NSDQ:DCTH) is on a roll, notching a couple new regulatory milestones this month for its organ-isolating ChemoSat chemotherapy treatment systems.
Abbott’s new pharma spin-out chief’s college credentials “misstated”
Contrary to previous company statements, longtime Abbott executive and new pharmaceutical spin-off chief Richard Gonzalez never finished college, the company confirmed today.
An administrative error resulted in regulatory filings stating that Gonzalez had earned a bachelor’s degree from the University of Houston and master’s degree from the University of Miami. Although Gonzalez attended both institutions, he didn’t graduate from either. Abbott has since updated the information on its corporate website to address the error.
Devices vs. drugs: New research puts pressure on stent makers, may hinder Medicare coverage
Proponents of drug-based stroke therapy have launched a campaign against expanded Medicare coverage for preventative carotid stenting, arguing that the devices are no better than drug therapy alone.
The movement may put pressure on medical device makers who were hoping to win Medicare reimbursement for stenting in patients with arterial blockage but no stroke symptoms.