An oft-ma­ligned rare bone dis­ease pro­gram at Ipsen is go­ing to get a clos­er look from reg­u­la­tors on a day that’s proven to be mighty spooky.

The FDA has sched­uled an ad­vi­so­ry com­mit­tee to ex­am­ine Ipsen’s palo­varotene on Oct. 31, ac­cord­ing to a no­tice post­ed in the Fed­er­al Reg­is­ter, set­ting up a show­down for a drug that once failed a Phase III test. The hear­ing will come about two months ahead of palo­varotene’s de­ci­sion date, which is slat­ed for Dec. 29.

An Ipsen spokesper­son con­firmed the ad­comm date, telling End­points News that it is “com­mon” for the FDA to con­vene a pan­el of out­side ex­perts in ar­eas with no treat­ment op­tions, par­tic­u­lar­ly in rare dis­eases.

Re­searchers had been de­vel­op­ing the can­di­date to try to pre­vent new bone growth as­so­ci­at­ed with fi­brodys­pla­sia os­si­f­i­cans pro­gres­si­va (FOP) and mul­ti­ple os­teo­chon­dro­mas. Ipsen took on the drug fol­low­ing a $1 bil­lion-plus ac­qui­si­tion of Cana­di­an biotech Clemen­tia Phar­ma­ceu­ti­cals in Feb­ru­ary 2019, which had re­pur­posed it af­ter Roche punt­ed on em­phy­se­ma tri­als.

In De­cem­ber 2019, reg­u­la­tors slapped Ipsen with a par­tial hold on dos­ing pa­tients 14 and un­der in a Phase II and Phase III study af­ter re­ports of “ear­ly growth plate clo­sure,” a con­di­tion that can se­vere­ly stunt a child’s growth. The next month, the drug failed a Phase III fu­til­i­ty test and Ipsen de­cid­ed to pause dos­ing in all re­main­ing pe­di­atric pa­tients from that study.

Ipsen ap­peared to turn things around in short or­der, re­sum­ing dos­ing a few months lat­er af­ter amend­ing tri­al pro­to­cols. The com­pa­ny even won pri­or­i­ty re­view in May 2021. But things took a turn af­ter Ipsen with­drew its ap­pli­ca­tion in Au­gust 2021, cit­ing the FDA’s re­quest for ad­di­tion­al da­ta from its two piv­otal stud­ies.

The move came as a sur­prise to an­a­lysts but didn’t seem to dent their ex­pec­ta­tions. Jef­feries’ Pe­ter Welford said at the time that the with­draw­al wouldn’t change his pro­jec­tion of $180 mil­lion in peak sales, which had as­sumed a 2021 US ap­proval.

But Ipsen re­sub­mit­ted its ap­pli­ca­tion this June, once again win­ning pri­or­i­ty re­view. The com­pa­ny ap­plied for ap­proval in FOP in adults and chil­dren, in­clud­ing girls old­er than eight and boys old­er than 10. The drug has al­so been ap­proved in Cana­da, win­ning an OK this past Jan­u­ary.

Ed­i­tor’s note: This ar­ti­cle has been up­dat­ed with com­ment from an Ipsen spokesper­son.

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.