Two biotechs are shuf­fling their C-suites as the cal­en­dar turns to the new year: On­copep­tides and Zymeworks.

Jakob Lind­berg

On­copep­tides an­nounced Wednes­day that it’s re­plac­ing CEO Jakob Lind­berg with Mon­i­ca Shaw as Lind­berg re­turns to the chief sci­ence po­si­tion. Zymeworks, mean­while, re­moved chief med­ical of­fi­cer Neil Joseph­son with­out nam­ing a re­place­ment. The biotech said Jef­frey Smith, the Alder Bio­Phar­ma­ceu­ti­cals founder who en­gi­neered a $2 bil­lion sale to Lund­beck in 2019, will take over ear­ly R&D.

Nei­ther stock re­act­ed much to the news. On­copep­tides shares fell a lit­tle over 1% on Wednes­day, while Zymeworks $ZYME — which an­nounced a large help­ing of oth­er new-year up­dates — was up about 1%.

For On­copep­tides, the move comes af­ter a back-and-forth with the FDA over a dan­gling ac­cel­er­at­ed ap­proval for its can­cer drug Pepax­to. US reg­u­la­tors pulled the drug’s in­di­ca­tion in a late-line mul­ti­ple myelo­ma set­ting af­ter a fiery ad­vi­so­ry com­mit­tee hear­ing at which the agency crit­i­cized oth­er com­pa­nies amid a broad­er push for ac­cel­er­at­ed ap­proval re­form.

Mon­i­ca Shaw

Lind­berg, in an in­ter­view with End­points News af­ter the in­di­ca­tion was yanked, said the com­pa­ny was lean­ing to­ward giv­ing up the fight to keep it ap­proved, em­pha­siz­ing a le­gal bat­tle like­ly wouldn’t be worth it. He al­so lament­ed the “piss­ing con­test” that en­sued be­tween On­copep­tides and the FDA over Pepax­to’s ap­proval.

Neil Joseph­son

Shaw now takes over af­ter Lind­berg spent a lit­tle over a year at the helm. She is a GSK and Leo Phar­ma vet, with On­copep­tides tout­ing her ex­pe­ri­ence in bring­ing 15 drugs through Phase III stud­ies to the mar­ket in a press re­lease.

Zymeworks’ shake­up comes just a few weeks af­ter the com­pa­ny se­cured an opt-in from a deal with Jazz Phar­ma­ceu­ti­cals to col­lab­o­rate on zanidatam­ab, a drug be­ing de­vel­oped for mul­ti­ple HER2-ex­press­ing can­cers. Jazz forked over $325 mil­lion up­front and promised up to $1.76 bil­lion in mile­stones, plus roy­al­ties po­ten­tial­ly reach­ing up to 20%.

It’s the sec­ond zanidatam­ab bench­mark Zymeworks and Jazz reached in the fourth quar­ter of 2022, fol­low­ing an ini­tial $50 mil­lion up­front deal reached last Oc­to­ber.

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

The FDA has found a brand new director of the Digital Health Center of Excellence in Troy Tazbaz, a former senior vice president at Oracle.

According to Tazbaz’s LinkedIn, he took a five-month break after leaving an 11-year career at Oracle before joining the FDA in January. Stat News first reported the hire. Tazbaz also said on his LinkedIn that he biked all the way from Chesapeake Bay to the San Francisco Bay over 58 days during his career break.