Stock flies high on Clear­side’s PhI­II mac­u­lar ede­ma tri­al re­sults as drug im­proves vi­sion

The stock is soar­ing at Clear­side Bio­med­ical $CLSD, a Geor­gia-based bio­phar­ma de­vel­op­ing eye drugs that tack­le blind­ness, fol­low­ing news that one of its treat­ment im­proved vi­sion in pa­tients.

The re­sults are from a Phase III tri­al test­ing the treat­ment against mac­u­lar ede­ma as­so­ci­at­ed with in­flam­ma­tion of a part of the eye known as uveitis. Mac­u­lar ede­ma is the buildup of flu­id in the part of the eye known as mac­u­la, re­sult­ing in dis­tort­ed vi­sion.

Rahul Khu­rana

“Typ­i­cal­ly, uveitic mac­u­lar ede­ma may per­sist de­spite ad­e­quate con­trol of uveitis it­self, and it is chal­leng­ing to treat and may per­sist de­spite mul­ti­ple in­ter­ven­tions,” said Rahul Khu­rana, an in­ves­ti­ga­tor, in a state­ment.

Clear­side’s prod­uct is called supra­choroidal CLS-TA, which is cor­ti­cos­teroid tri­am­ci­nolone ace­tonide for­mu­lat­ed for ad­min­is­tra­tion to the back of the eye.

The com­pa­ny said 47 per­cent of pa­tients be­ing ad­min­is­tered its treat­ment could see at least 15 let­ters, com­pared to 16 per­cent for pa­tients who un­der­went a place­bo pro­ce­dure.

The ran­dom­ized, con­trolled, and masked tri­al in­volv­ing 160 pa­tients met both its pri­ma­ry and sec­ondary end­points.

“While cor­ti­cos­teroids are the most com­mon treat­ment for all com­pli­ca­tions of uveitis, in­clud­ing the as­so­ci­at­ed mac­u­lar ede­ma, sys­tem­at­ic con­trolled stud­ies of this kind are rare,” Khu­rana said. “I be­lieve that based on these pos­i­tive re­sults, and if mar­ket­ing au­tho­riza­tion is ob­tained from the FDA, supra­choroidal CLS-TA has the po­ten­tial to be­come a new par­a­digm for the treat­ment of vi­su­al im­pair­ment as­so­ci­at­ed with mac­u­lar ede­ma as­so­ci­at­ed with non-in­fec­tious uveitis.”

The com­pa­ny plans to sub­mit an NDA for the treat­ment dur­ing the fourth quar­ter of this year. It’s al­so “eval­u­at­ing a num­ber of op­tions” for sub­mis­sions to reg­u­la­to­ry agen­cies out­side the US.

Clear­side’s stock is up 66% in pre-mar­ket trad­ing. As of press time, shares were sell­ing at $13 per share, up from yes­ter­day’s mar­ket close of $7.82.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Pfiz­er, Sarep­ta and two oth­ers sug­gest Duchenne drug safe­ty is­sues tied to "class ef­fect"

Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why.

The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

Lina Khan, FTC chair (Saul Loeb/Pool via AP)

New FTC com­mis­sion­er could turn the tide for an in­ves­ti­ga­tion in­to PBMs

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

Pearl Huang, former Cygnal Therapeutics president and CEO

UP­DAT­ED: Flag­ship builds a new start­up out of pieces from 2 of its biotechs. And a Roche vet leaves to do some­thing new

Flagship has crafted a new startup out of pieces from a pair of fledglings in the VC’s nest. And a prominent Roche veteran who ran one of the biotechs won’t be making the next leg of the journey.

The new company is called Sonata Therapeutics, which is picking up the work that Inzen was doing related to the cellular microenvironment and combining with Flagship’s Cygnal Therapeutics, which came out of stealth more than 3 years ago and put Pearl Huang — the BeiGene founder and former Roche SVP — at the helm.

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Patty Murray (D-WA) (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.