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Pfizer taps P!nk, Michael Phelps and other celebrities in latest Covid campaign

11 days ago Endpoints News

Now, four more celebri­ties who are at high risk for de­vel­op­ing se­vere Covid-19 symp­toms are get­ting in on Pfiz­er’s Covid-re­lat­ed ad cam­paigns in the new year. For mu­si­cian and film­mak­er Quest­love, be­ing over­weight puts him at high risk, and for ac­tress Jean Smart, it’s di­a­betes. “In fact, you can be one of al­most 200 mil­lion Amer­i­cans with a high risk fac­tor that makes Covid even riski­er,” P!nk says. The lat­est cam­paign aired just a cou­ple weeks af­ter Pfiz­er and BioN­Tech un­veiled a com­mer­cial pro­mot­ing up­dat­ed boost­er shots fea­tur­ing Stew­art. That’s Covid-19,” Stew­art says as she sharp­ens a long sword in the kitchen.
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FDA and EMA accept Pfizer’s regulatory submissions for ulcerative colitis drug

Pfiz­er’s S1P re­cep­tor mod­u­la­tor for treat­ing ul­cer­a­tive col­i­tis, etrasi­mod, which was at the cen­ter of a bil­lion-dol­lar buy­out from Are­na Phar­ma, has now tak­en an­oth­er step for­ward. On Wednes­day, the phar­ma an­nounced that the FDA had ac­cept­ed for re­view the NDA for etrasi­mod in pa­tients with “mod­er­ate­ly-to-se­vere­ly ac­tive” ul­cer­a­tive col­i­tis. Pfiz­er stat­ed that the FDA’s de­ci­sion will be ex­pect­ed in the sec­ond half of next year. At week 52, 32.1% of pa­tients re­ceiv­ing the drug hit re­mis­sion, com­pared to 6.7% on place­bo, show­ing a 25.4% dif­fer­en­tial and a p-val­ue of p=˂.001. Last year, Bris­tol My­ers Squibb had its S1P Zeposia ap­proved by the FDA to treat ul­cer­a­tive col­i­tis, which earned BMS around $134 mil­lion in 2021.

1 month ago Endpoints News
Glyn Edwards takes chairman role at UK oncolytic virus startup emerging out of stealth

On­colyt­ic virus­es — virus­es that can se­lec­tive­ly repli­cate in can­cer cells and kill them — have been steadi­ly at­tract­ing in­vest­ment and cu­rios­i­ty. ” I got in­volved through a mu­tu­al friend who called and said, ‘these guys are try­ing to spin a com­pa­ny out,'” Ed­wards said. Per Ed­wards, ini­tial ef­forts in oth­er com­pa­nies were look­ing at mul­ti­ple cy­tokines as pay­loads to these on­colyt­ic virus­es, or on­ly have one cy­tokine that is ex­tra po­tent. At least in the US, on­ly one on­colyt­ic virus has made it past the FDA: Am­gen’s Im­ly­g­ic for cer­tain types of melanoma. There are a few com­pa­nies that have been look­ing at on­colyt­ic virus­es as well.

3 months ago Endpoints News
Florida judge dismisses Zantac cancer claims against GSK, other pharmas

GSK can breathe a lit­tle eas­i­er af­ter a Flori­da fed­er­al judge dis­missed thou­sands of claims that Zan­tac and re­lat­ed heart­burn prod­ucts caused can­cer, trig­ger­ing a boost in pre­mar­ket trad­ing on Wednes­day. On Tues­day, Judge Robin Rosen­berg tossed the re­main­ing claims in liv­er, blad­der, pan­cre­at­ic, esophageal, and stom­ach can­cers, up­on de­ter­min­ing that the al­le­ga­tions were based on “flawed” and “un­re­li­able” ev­i­dence. GSK’s stock $GSK was down 2% on Wednes­day at $37.16, af­ter re­port­ed­ly jump­ing about 14% in ear­ly trad­ing. Plain­tiffs ar­gued that ran­i­ti­dine can trans­form in­to ND­MA in the body or on the shelf in high tem­per­a­tures, and in 2020, reg­u­la­tors re­quest­ed the re­call of all ran­i­ti­dine prod­ucts. More than 2,450 plain­tiffs filed suits in the MDL, or had cas­es trans­ferred to the Flori­da fed­er­al court.

1 month ago Endpoints News
PD-L1 pioneer Lieping Chen, Rachel Humphrey spin out new biotech to break down the door on cold tumors

Now, Chen is back with a new biotech with the same end goal — to get in­to un­re­spon­sive tu­mors. In­stead, Nor­mu­ni­ty wants to break down the wall that’s stand­ing be­tween the im­mune sys­tem and can­cer cells us­ing an­ti­bod­ies. Once that hap­pens, ei­ther the body’s nor­mal im­mune sys­tem (hence the name) or a dif­fer­ent im­munother­a­py can en­ter the tu­mors and do their job. “We can then use the an­ti­bod­ies to specif­i­cal­ly un­lock this phe­nom­e­non to al­low the im­mune sys­tem to work or en­able the oth­er users to work,” Chen ex­plained. Chen and Humphrey both em­pha­sized the on­go­ing col­lab­o­ra­tion be­tween Nor­mu­ni­ty and Chen’s lab at Yale, not­ing that they were next door to each oth­er.

3 months ago Endpoints News
Biogen's Q3 revenue declines 10% as focus shifts to new Alzheimer's and ALS drug candidates

While Bio­gen’s Q3 rev­enue dipped by 10% ver­sus the pri­or year, the com­pa­ny fo­cused its earn­ings call on two bright prospects — re­cent­ly un­veiled pos­i­tive re­sults for lecanemab, its an­ti-amy­loid Alzheimer’s fol­low-up to Aduhelm, and its po­ten­tial ALS drug tofersen. Even with a full ap­proval, how­ev­er, ques­tions still re­main on whether CMS will cov­er the drug. An FDA de­ci­sion on tofersen, an an­ti­sense drug de­signed to treat a ge­net­ic sub­set of ALS, is com­ing next April. The FDA, how­ev­er, has nev­er ap­proved a drug based on a drug can­di­date’s pur­port­ed neu­ro­fil­a­ment-low­er­ing ef­fect. Bio­gen’s glob­al MS rev­enue, in­clud­ing Ocre­vus roy­al­ties, de­clined 11% for the quar­ter, and Tec­fidera’s rev­enue de­creased 32% due to the en­trance of gener­ics.

3 months ago Endpoints News
Gritstone bio secures PIPE financing as it unveils PhI data for vaccine candidate

Cal­i­for­nia biotech Grit­stone bio was giv­en an $80 mil­lion cred­it fa­cil­i­ty in the sum­mer, fol­low­ing the trend of sev­er­al biotechs ex­tend­ing cash through loans. Now the biotech is mak­ing an­oth­er fi­nan­cial move as it lifts the cov­er on some vac­cine tri­als. While it is work­ing on can­di­dates in the HIV and tu­mor space, Grit­stone is fo­cused on two can­di­dates to counter SARS-CoV-2. The move comes as it gen­tly pulls the cur­tain back on ear­ly Phase I re­sults for its on­go­ing tri­als in­ves­ti­ga­tion of its “self-am­pli­fy­ing” mR­NA (sam­R­NA) vac­cine can­di­dates against SARS-CoV-2. Ear­li­er this year it re­ceived an $80 mil­lion cred­it fa­cil­i­ty from Her­cules Cap­i­tal and Sil­i­con Val­ley Bank, ini­tial­ly draw­ing $20 mil­lion with an­oth­er $10 mil­lion avail­able to with­draw by March 15 of next year.

3 months ago Endpoints News
UT Welcomes Fans for the Kentucky Game

The University of Tennessee, Knoxville, welcomes fans to campus Saturday, Oct. 29, for the football game against the University of Kentucky. Fans are encouraged to visit utsports.com/gameday/football for the latest updates on game information. For more information, including downtown parking options for fans without a football parking permit, visit the Parking and Transit Services football web page. Fans are invited to stay for the watch party and cheer on the Vols throughout the game. Unmanned aircraft systems are prohibited on university property beginning four hours before the scheduled kickoff time of a football game, during the game and for two hours after the conclusion of the game.

3 months ago News
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