Tim­o­thy Bax­ter, who was sen­tenced last De­cem­ber to six months home de­ten­tion and fined $100,000 for send­ing false and mis­lead­ing in­for­ma­tion on the opi­oid ad­dic­tion drug Sub­ox­one, is now seek­ing to de­bate the FDA’s pro­pos­al to de­bar him.

Bax­ter, the for­mer med­ical di­rec­tor of In­di­v­ior, pre­vi­ous­ly ad­mit­ted that he failed to pre­vent In­di­v­ior from send­ing false and mis­lead­ing in­for­ma­tion to the Mass­a­chu­setts Med­ic­aid pro­gram on the rel­a­tive safe­ty of a film ver­sion of Sub­ox­one for chil­dren.

But now in re­sponse to the FDA’s pro­pos­al to de­bar Bax­ter for five years from work­ing in the in­dus­try, Bax­ter’s lawyers are re­quest­ing a hear­ing on “dis­put­ed is­sues of ma­te­r­i­al fact.”

For in­stance, Bax­ter’s lawyers say Bax­ter didn’t send the mis­lead­ing in­for­ma­tion but was su­per­vis­ing some­one who re­layed the mis­lead­ing in­for­ma­tion to the Mass­a­chu­setts Med­ic­aid pro­gram.

“Dr. Bax­ter’s con­vic­tion was not premised on the pro­vi­sion of mis­lead­ing in­for­ma­tion about the ‘rate of un­in­tend­ed pe­di­atric ex­po­sures to Sub­ox­one Film’ – the mis­lead­ing in­for­ma­tion per­tained to oth­er med­ica­tions,” the lawyers wrote.

They al­so claim that the FDA and CDC have con­clud­ed that Sub­ox­one Film is as­so­ci­at­ed with a low­er rate of pe­di­atric ex­po­sure than com­pa­ra­ble drugs.

But El­ton Mal­one, as­sis­tant in­spec­tor gen­er­al for in­ves­ti­ga­tions with­in HHS, said at the time of his sen­tenc­ing, “Bax­ter’s know­ing false and mis­lead­ing rep­re­sen­ta­tion of Sub­ox­one is no small is­sue— es­pe­cial­ly at a time when our coun­try bat­tles the on­go­ing opi­oid cri­sis.”

In ad­di­tion to the $1.4 bil­lion res­o­lu­tion with In­di­v­ior’s for­mer par­ent com­pa­ny, Reckitt Benckiser, from 2019, and a plea agree­ment with In­di­v­ior for­mer CEO Shaun Thax­ter, the to­tal res­o­lu­tion re­lat­ing to the mar­ket­ing of Sub­ox­one is more than $2 bil­lion — the largest-ever res­o­lu­tion in a case brought by the De­part­ment of Jus­tice in­volv­ing an opi­oid drug.

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

After a four-year battle over a cancer drug patent, Novartis has been ordered by a California judge to pay a Daiichi Sankyo subsidiary $177.8 million.

Plexxikon filed a lawsuit against the pharma giant in 2017, alledging that Tafinlar, a rival to its melanoma drug Zelboraf that was brought to market in collaboration with Roche, has stepped on its intellectual property. The jury ruled in its favor, adding that the infringement is in fact willful.

As Biogen execs bemoaned the negative media coverage around Aduhelm’s approval a month ago, the biotech isn’t gaining much traction yet in using its new drug, largely due to a lack of insurance coverage, according to an earnings call Thursday.

Management indicated that of the nearly 900 sites that were prepped and ready following Aduhelm’s approval, 325 of those, or about 35%, have completed a positive pharmacy and therapeutics (P&T) review or won’t require one. The review is a step some hospitals or health systems take prior to using a new drug. Some major sites, however, have said they won’t participate.