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.

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

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The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.

The US Court of Appeals for the Fifth Circuit on Tuesday upheld the Federal Trade Commission’s ruling that generic drugmaker Impax Laboratories should be charged with antitrust violations for accepting payments worth about $100 million to delay the entry of a generic opioid for more than two years.

The court’s opinion upheld the FTC’s anticompetitive findings on the deal between Impax (now owned by Amneal Pharmaceuticals) and Endo Pharmaceuticals, under which Endo committed to not market an authorized generic, which increased Impax’s projected profits by $24.5 million. Endo agreed to pay Impax credits for the shrunken market that Impax would inherit if, as expected, Endo made a successful hop to a reformulated Opana ER.

There’s another unicorn in biotech land, as Benchling and its leading R&D cloud platform pull in a $200 million Series E to help scientists accelerate drug development. In doing so, the company hit a lofty $4 billion valuation — nearly five times what it was worth around this time last year, according to Forbes.

Despite the fact that drug development is becoming significantly more complex, the industry continues to run on paper, emails and spreadsheets, co-founder and CEO Sajith Wickramasekara said in a video on Benchling’s website. The MIT grad sought to change that by creating software that allows scientists to better track, model and forecast their work.

Novavax has had a busy month, filled with supply chain issues and manufacturing deals that have affected the rollout of its Covid-19 vaccine. Tuesday, the company announced updates to its leadership team.

CFO Greg Covino will step down from that role after just five months for personal reasons, the release said, but take on a new role as executive advisor. John Trizzino, current chief commercial officer and chief business officer, will take the CFO role over in the interim.

Amylyx is one of several companies looking to break through in the tough ALS field, and Wednesday they announced they’re moving forward with regulatory plans.

The Cambridge, MA-based biotech said they’re submitting a marketing application to the EMA for their AMX0035 program by the end of 2021. Wednesday’s news comes a few weeks after they revealed similar plans to move forward with Canadian health regulators by June 30.