Av­enue Ther­a­peu­tics lands an FDA ad­comm for trou­bled flag­ship drug; FDA ap­proves eye in­jec­tion treat­ment for flu­id buildup

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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

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.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

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.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

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.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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