Though Deci­bel Ther­a­peu­tics has large­ly piv­ot­ed to­ward gene ther­a­pies for the in­ner ear, its lead clin­i­cal can­di­date sim­ply aims to pro­tect can­cer pa­tients from chemother­a­py-in­duced hear­ing loss. On Tues­day, the biotech pre­sent­ed its first ef­fi­ca­cy da­ta for the pro­gram, and ex­ecs like what they see.

Deci­bel re­port­ed in­ter­im re­sults from a Phase Ib study show­ing the ex­per­i­men­tal drug, dubbed DB-020, large­ly pro­tect­ed a small group of pa­tients from los­ing their hear­ing. Re­searchers used a par­tic­u­lar­ly unique study de­sign, ad­min­is­ter­ing the com­pound in one of each pa­tients’ ears be­fore they re­ceived cis­platin chemother­a­py and place­bo in the oth­er.

The biotech had 17 evalu­able pa­tients as of the Feb. 4 cut­off date who had nev­er be­fore re­ceived cis­platin. Fol­low­ing the most re­cent chemo cy­cle, 15 of the 17 pa­tients ex­pe­ri­enced on av­er­age a 30 deci­bel-loss from base­line in the place­bo ear. Of those 15, eight pa­tients did not lose their hear­ing in the DB-020-treat­ed ear, and an­oth­er five were par­tial­ly pro­tect­ed from hear­ing loss.

All ears treat­ed with DB-020 lost ap­prox­i­mate­ly eight deci­bels on av­er­age from base­line, Deci­bel said.

DB-020 is a for­mu­la­tion of sodi­um thio­sul­fate in­ject­ed through the eardrum be­fore pa­tients re­ceive cis­platin-based chemother­a­py. The pro­ce­dure can be done in an ENT’s of­fice with­out the need for in­va­sive meth­ods, the com­pa­ny touts.

A Phase Ia study in healthy vol­un­teers had been com­plet­ed in 2019 and the com­pa­ny sub­se­quent­ly moved for­ward with the Phase Ib tri­al. The re­sults had been de­layed due to the Covid-19 pan­dem­ic, Deci­bel said in a press re­lease ear­ly last year. Af­ter kick­ing off the Phase Ib tri­al in Feb­ru­ary 2020, the com­pa­ny an­tic­i­pat­ed col­lect­ing fi­nal pri­ma­ry out­come mea­sures in April 2021 and com­plet­ing the study that Oc­to­ber. The biotech re­vised those time­lines dur­ing the pan­dem­ic, with the tar­get dates now De­cem­ber 2022 and De­cem­ber 2023, ac­cord­ing to changes to the tri­al’s reg­istry on clin­i­cal­tri­als.gov.

Deci­bel’s gene ther­a­py pro­grams still re­main in the pre­clin­i­cal phase, but the com­pa­ny is hop­ing to have an IND for its first such can­di­date sub­mit­ted by the end of the year. The fo­cus on gene ther­a­pies for re­gen­er­a­tion and bal­ance came af­ter a piv­ot away from ear-re­lat­ed con­di­tions such as tin­ni­tus and hear­ing loss a few years ago. Deci­bel is part­nered with Re­gen­eron on some of the pro­grams, and se­cured an ex­ten­sion to its re­search col­lab­o­ra­tion with the bio­phar­ma last No­vem­ber.

The shift was enough to gar­ner a Se­ries D in No­vem­ber 2020 and a quick jump to Nas­daq a few months lat­er. Like many com­pa­nies, Deci­bel has seen its stock price $DBTX sink in this year’s bear mar­ket, as it’s down 55% since the start of the year as of Mon­day’s close.

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.