In­tra­venous tra­madol-fo­cused Av­enue Ther­a­peu­tics may not be out of the game just yet.

Af­ter re­ceiv­ing two CRLs for their drug, Av­enue an­nounced to­day that it has re­ceived a writ­ten in­ter­im re­sponse from the FDA’s Of­fice of New Drugs that reg­u­la­tors will hold an ad­comm to reach a de­ci­sion on a for­mal dis­pute res­o­lu­tion re­quest filed by Av­enue back in Ju­ly.

This oc­curred af­ter the FDA sent Av­enue the sec­ond CRL for their drug, an in­tra­venous form of syn­thet­ic opi­oid tra­madol.

The biotech said back in June that the FDA had de­nied its ap­pli­ca­tion as the “de­layed and un­pre­dictable on­set” of pain re­duc­tion from tra­madol didn’t sug­gest a ben­e­fit as a monother­a­py. And at the time, there was not enough in­for­ma­tion to know whether it worked in com­bi­na­tion with oth­er ther­a­pies.

Av­enue dis­agreed at the time, and said they would keep push­ing for reg­u­la­to­ry ap­proval.

The FDA hasn’t yet an­nounced when the ad­comm will con­vene.  The OND will re­spond to the FDRR with­in 30 days af­ter meet­ing.

FDA ap­proves Xipere for flu­id buildup in reti­na

Bausch + Lomb and Clear­side Bio­med­ical an­nounced this morn­ing that the FDA ap­proved Xipere, a tri­am­ci­nolone ace­tonide in­jectable sus­pen­sion, for supra­choroidal use to treat mac­u­lar ede­ma as­so­ci­at­ed with uveitis, a form of eye in­flam­ma­tion.

Mac­u­lar ede­ma is the buildup of flu­id in the mac­u­la, lo­cat­ed in the reti­na at the back of the eye. This buildup can cause reti­nal swelling and dis­tort­ed vi­sion — and can lead to per­ma­nent vi­sion loss if left un­treat­ed, ac­cord­ing to Bausch + Lomb.

The method of choice is unique. The treat­ment us­es a mi­croin­jec­tor — de­vel­oped by Clear­side — to in­ject Xipere in­to the supra­choroidal space of the eye. That space, which is be­tween the scle­ra and choroid, may turn out to be a more ef­fec­tive method to im­prove tar­get­ed drug de­liv­ery.

Ac­cord­ing to Bausch Health chair­man and CEO Joseph Pa­pa, the com­pa­ny ex­pects to make Xipere avail­able in Q1 of next year.

“With this ap­proval, we be­gin a new era in de­liv­er­ing ther­a­pies to the back of the eye,” said Clear­side’s pres­i­dent and CEO George Lasezkay. “Xipere is the first com­mer­cial prod­uct de­vel­oped by Clear­side, the first prod­uct ap­proved for in­jec­tion in­to the supra­choroidal space and the first ther­a­py ap­proved for mac­u­lar ede­ma as­so­ci­at­ed with uveitis.”

Cedil­la Ther­a­peu­tics in­creas­es Se­ries B size with fresh $25 mil­lion

Third-Rock backed Cedil­la Ther­a­peu­tics ex­pand­ed its Se­ries B from last year with an ad­di­tion­al $25 mil­lion, bring­ing the to­tal amount raised to $82.6 mil­lion.

The Se­ries B ex­pan­sion an­nounced to­day in­cludes new in­vestors RA Cap­i­tal Man­age­ment, Janus Hen­der­son In­vestors, Wood­line Part­ners and Lo­gos Cap­i­tal, along­side Third Rock.

The funds will sup­port Cedil­la’s con­tin­u­ing de­vel­op­ment of its two lead pro­grams: a TEAD in­hibitor for sol­id tu­mor treat­ment such as mesothe­lioma and cer­tain squa­mous cell car­ci­no­mas, along with a high­ly se­lec­tive CDK2/Cy­clin E in­hibitor for mul­ti­ple tu­mor types, in­clud­ing CDK4/6-re­sis­tant breast can­cer.

The com­pa­ny plans to ini­ti­ate IND-en­abling stud­ies for its TEAD pro­gram by next June and for the CDK2 pro­gram by the end of 2022.

“With this fi­nanc­ing, we plan to ac­cel­er­ate and ex­pand our de­vel­op­ment ef­forts by pro­gress­ing our most ad­vanced pro­grams to­ward the clin­ic while con­tin­u­ing to in­vest in on­go­ing dis­cov­ery ef­forts against ad­di­tion­al high val­ue can­cer tar­gets,” said Cedil­la pres­i­dent and CEO San­dra Glucks­mann.

Jake Sim­son, a part­ner with RA Cap­i­tal Man­age­ment, will join Cedil­la’s Board of Di­rec­tors as part of the fi­nanc­ing.

Ju­ven­tas Cell Ther­a­py rais­es $63 mil­lion in Se­ries C

Chi­nese biotech Ju­ven­tas Cell Ther­a­py com­plet­ed a Se­ries C fi­nanc­ing round, bring­ing in close to $63 mil­lion.

Ac­cord­ing to a state­ment, Ju­ven­tas will use the funds to pur­sue an NDA in Chi­na and launch im­ple­men­ta­tion of a com­mer­cial­iza­tion and in­ter­na­tion­al re­search and de­vel­op­ment plan for part­ner CASI’s CAR-T treat­ment CNCT19.

CASI shares glob­al co-com­mer­cial and prof­it-shar­ing rights with Ju­ven­tas, and in­di­rect­ly owns just over 12% of the com­pa­ny’s shares fol­low­ing com­ple­tion of the Se­ries C round.

Ju­ven­tas’ fi­nanc­ing was led by CI­CC Cap­i­tal.

“The col­lab­o­ra­tion be­tween CASI and Ju­ven­tas will speed up the adop­tion of CAR-T ther­a­py in Chi­na,” CASI CEO and chair­man Wei-Wu He said in a state­ment.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.