President Barack Obama said in Tuesday’s State of the Union Address that personalized medicine is a pharma front that deserves financial support. Bloomberg notes in its recap that the details are vague but that the fiscal 2016 budget will outline what exactly the Precision Medicine Initiative will include. The president said his goal is to “bring us closer to curing diseases like cancer and diabetes—and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”
Giovanni Caforio is Bristol-Myers Squibb’s new CEO. Bloomberg reports that 50-year-old Caforio will officially take the title on May 5, when Lamberto Adreotti steps down. Suntrust analyst John Boris told Bloomberg that Caforio, who worked at the pre-AbbVie Abbott Laboratories, “is ideally positioned to pick up the immuno-oncology strategy,” the company has laid out for itself.
Salix is rebounding from its failed 2014 tax inversion move with a new proposal—to be the acquiree instead of the acquirer. Sources tell Reuters that the North Carolina drugmaker has signed on with Centerview Partners Holdings “to explore its options, including a potential sale to a larger drugmaker.” The company had a double-run of bad luck last year, which included new tax rules that unwound its proposed takeover of Cosmo Pharmaceuticals, and a foiled Allergan merger over surprisingly high drug inventory.
Interest groups PhRMA and BIO want the FDA to pull generics of painkillers that lack abuse-deterrent properties. Regulatory Focus reports that the companies laid out their case in a January 7 letter to the regulator in which they argue that pulling the drugs has two benefits: It would encourage innovation and help patients. RF also notes the letter’s limited focus, writing that this same note does not “call for the removal of branded versions containing the same active ingredient without similar abuse-deterrent qualities.” Prescription opioid abuse has been a hot local and national topic, with lawmakers urging the FDA to crack down on approvals and municipalities going so far as to sue painkiller manufacturers. Although efforts to curtail prescription opioid use appear to have a positive impact, research also indicates that lower prescription numbers appear to be offset by higher rates of heroin use.
Want to see an FDA-issued Warning Letter from before 2005? Fat chance—the regulator has removed online access to those letters, according to the Wall Street Journal. An FDA spokesperson told the Journal that after reviewing the page’s traffic statistics—and seeing very low numbers—the regulator decided to pull the page, citing the need “to make room on its server to accommodate newer letters getting posted.” An expert cited by the Journal estimates 5,000 to 6,000 of these Warning Letters must be accessed through special request.
