UK ad­vis­es against cov­er­ing No­var­tis' Kym­ri­ah for adults; Ex-Mast chief Bri­an Cul­ley ap­point­ed CEO at Bi­o­Time

→ Right on the heels of en­dors­ing the use of No­var­tis’ CAR-T Kym­ri­ah in chil­dren, the UK drug price watch­dog NICE is turn­ing its thumbs down for ex­tend­ing its wel­come to adults. “How­ev­er, NICE does recog­nise that No­var­tis’ ti­s­agen­le­cleu­cel-T, al­so known as Kym­ri­ah, has sig­nif­i­cant clin­i­cal ben­e­fits, and would wel­come fur­ther dis­cus­sions on its cost-ef­fec­tive­ness.”

→ De­gen­er­a­tive dis­ease spe­cial­ist Bi­o­Time $BTX has tapped Bri­an Cul­ley as its new CEO, tak­ing up a role pre­vi­ous­ly shared by Adi Mo­han­ty and Michael West. Cul­ley helmed Mast Ther­a­peu­tics for sev­en years be­fore a failed lead pro­gram dragged it down and left it with lit­tle op­tion oth­er than serv­ing as a shell for Savara’s re­verse merg­er. West will now move on­to the chief ex­ec­u­tive role at AgeX, a Bi­o­Time af­fil­i­ate fo­cused on age-re­lat­ed de­gen­er­a­tive ail­ments.

→ Next-gen CAR-T com­pa­ny Tmu­ni­ty has turned to the UK’s Abzena $ABZA for hu­man­iz­ing an­ti­bod­ies it needs for its pro­grams.

Pharm­ing’s ap­pli­ca­tion to ex­pand the la­bel for its hered­i­tary an­gioede­ma drug has been spurned by reg­u­la­tors. The FDA is ask­ing for an ad­di­tion­al tri­al be­fore it can con­sid­er Ru­con­est as a pro­phy­lac­tic treat­ment.

Roche is rolling out new apps de­signed to help sup­port the way med­ical teams treat can­cer pa­tients.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Can South Dako­ta's trans­genic cows help treat the flu?; A speedy re­view for Mer­ck­'s Pre­vnar ri­val in kids

Wednesday brought another win for South Dakota’s biggest transgenic cow so far.

SAB Biotherapeutics, which develops treatments by collecting and distilling antibodies from cows with humanized immune systems, announced that its antibody treatment for flu passed an early-stage challenge study.

Volunteers were intentionally exposed to the flu virus and then given infusions of the SAB antibody treatment or placebo. Those who received the antibody treatment saw a significantly greater reduction in viral load and symptoms than those who received placebo. The company didn’t release numbers but said the p-value was 0.026.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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