Af­ter re­ject­ing it twice, the FDA has fi­nal­ly ap­proved a new drug for low­er­ing the risk of hear­ing loss among chil­dren be­ing treat­ed for can­cer with chemother­a­py.

Ped­mark, as Fen­nec Phar­ma calls its drug, is a for­mu­la­tion of sodi­um thio­sul­fate. Giv­en that oto­tox­i­c­i­ty is a ma­jor dose-lim­it­ing side ef­fect of cis­platin chemother­a­py and there were no avail­able treat­ments for it, the FDA grant­ed North Car­oli­na-based Fen­nec both fast track and break­through ther­a­py des­ig­na­tions back in 2018, and put the drug on pri­or­i­ty re­view two years lat­er.

But man­u­fac­tur­ing is­sues that turned up at a pre-ap­proval in­spec­tion and were doc­u­ment­ed in a Form 483 ul­ti­mate­ly led to a com­plete re­sponse let­ter from the FDA. A re­sub­mis­sion one year lat­er failed to change the FDA’s minds.

Then this April, Fen­nec filed for ap­proval a third time.

In its re­cent quar­ter­ly re­port, the com­pa­ny not­ed that it’s built out the com­mer­cial or­ga­ni­za­tion over the past months with key hires in sales, mar­ket ac­cess and field-based med­ical teams.

Ped­mark is in­di­cat­ed for pe­di­atric pa­tients be­tween 1 month to 18 years old who have lo­cal­ized, non-metasta­t­ic sol­id tu­mors and have been treat­ed with cis­platin in­fu­sions for no longer than six hours. For this group of pa­tients, hear­ing loss stem­ming from such chemother­a­pies is of­ten long-last­ing and per­ma­nent, and cur­rent­ly they would need to re­sort to cochlear im­plants.

Com­mon side ef­fects in­clude hy­per­sen­si­tiv­i­ty, hy­per­na­trem­ia (hav­ing too much sodi­um in the blood), hy­pokalemia (hav­ing too lit­tle potas­si­um), nau­sea and vom­it­ing.

Shares $FENC rose al­most 16% to $7.63.

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

We now know where Roche’s ex-pharma chief Bill Anderson is going.

German pharma giant Bayer announced Wednesday that Anderson will be taking on the role as CEO, less than six weeks after Anderson stepped down from his perch at Roche as head of the group’s pharmaceutical division.

Roche announced back in December that Anderson would depart on Dec. 31 to “pursue opportunities outside of Roche.” His replacement, Genentech vet and Roche’s current head of global product strategy, Teresa Graham, will start her role in March.