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ENDPOINTS NEWS
Subscriptions. ENDPOINTS NEWS by John Carroll & team — all the news at 11:30am ET. EARLY EDITION by Arsalan Arif — news and links at 7:15am ET. ENDPOINTS MANUFACTURING Weekly biopharma NOVARTIS PLOTS ‘NEXT FRONTIER’ OF MS TREATMENT A couÂple of months afÂter getÂting its self-adÂminÂisÂtered mulÂtiÂple scleÂroÂsis drug KesÂimpÂta cleared by EU regÂuÂlaÂtors, NoÂvarÂtis has found what it beÂlieves is “the EXCLUSIVE: HELSINN CHIEF RICCARDO BRAGLIA SPELLS OUT A Late on Friday, as the biopharma industry in the US was making a rush to the exits for a 3-day weekend, BridgeBio put out word that the FDAhad come through on
EXCLUSIVE: CARL JUNE’S TMUNITY ENCOUNTERS A LETHAL The multifaceted campaign to create a CAR-T for solid tumors has run into a lethal problem. In exclusive interviews, Tmunity founders Carl June and Oz Azam tell me that they have had to scrap BIDEN HHS SEEKS TO DISMISS PHRMA’S LAWSUIT TO STOP As the FDA has yet to authorize any state plans to import prescription drugs from Canada, the Biden administration called on the US DistrictCourt
TEVA CEO KÃ…RE SCHULTZ SEES A 35% RAISE DESPITE THE COMPANY The new awards helped boost Schultz’s pay by nearÂly 36% year over year, when he reÂceived $11.6 milÂlion in 2019. His 2020 packÂage is still a far cry from his first year steerÂing TeÂva ASTELLAS OUTLINES ANOTHER FIVE-YEAR PLAN; BAYER’S VC ARM Three years after Astellas unveiled its last five-year plan, the Japanese pharma is unveiling another. The new blueprint, announced Wednesday, is less sweeping or EDUARDO BRAVO RETURNS TO BRING EUROPEAN BIOTECH IN ON THEAUTHOR: JASONMAST
The last year's SPAC boom has been dominated so far by US-based VCs. Now a prominent European biotech executive and a couple investors aregetting
SAY GOODBYE TO TOCAGEN, STRUGGLING BRAIN CANCER BIOTECH TO In fact, paÂtients on the conÂtrol arm lived a month longer on avÂerÂage than paÂtients on the drug arm, 12.2 vs 11.1. That comÂputÂed to a hazÂard raÂtio of 1.06 and a p-valÂue of 0.62.KYLE BLANKENSHIP
kyle@endpointsnews.com @ka_blankenship. Kyle Blankenship on LinkedIn. A native of Austin, Kyle previously worked as an associate editor at another leading biopharma publication and has held editorENDPOINTS NEWS
Subscriptions. ENDPOINTS NEWS by John Carroll & team — all the news at 11:30am ET. EARLY EDITION by Arsalan Arif — news and links at 7:15am ET. ENDPOINTS MANUFACTURING Weekly biopharma NOVARTIS PLOTS ‘NEXT FRONTIER’ OF MS TREATMENT A couÂple of months afÂter getÂting its self-adÂminÂisÂtered mulÂtiÂple scleÂroÂsis drug KesÂimpÂta cleared by EU regÂuÂlaÂtors, NoÂvarÂtis has found what it beÂlieves is “the EXCLUSIVE: HELSINN CHIEF RICCARDO BRAGLIA SPELLS OUT A Late on Friday, as the biopharma industry in the US was making a rush to the exits for a 3-day weekend, BridgeBio put out word that the FDAhad come through on
EXCLUSIVE: CARL JUNE’S TMUNITY ENCOUNTERS A LETHAL The multifaceted campaign to create a CAR-T for solid tumors has run into a lethal problem. In exclusive interviews, Tmunity founders Carl June and Oz Azam tell me that they have had to scrap BIDEN HHS SEEKS TO DISMISS PHRMA’S LAWSUIT TO STOP As the FDA has yet to authorize any state plans to import prescription drugs from Canada, the Biden administration called on the US DistrictCourt
TEVA CEO KÃ…RE SCHULTZ SEES A 35% RAISE DESPITE THE COMPANY The new awards helped boost Schultz’s pay by nearÂly 36% year over year, when he reÂceived $11.6 milÂlion in 2019. His 2020 packÂage is still a far cry from his first year steerÂing TeÂva ASTELLAS OUTLINES ANOTHER FIVE-YEAR PLAN; BAYER’S VC ARM Three years after Astellas unveiled its last five-year plan, the Japanese pharma is unveiling another. The new blueprint, announced Wednesday, is less sweeping or EDUARDO BRAVO RETURNS TO BRING EUROPEAN BIOTECH IN ON THEAUTHOR: JASONMAST
The last year's SPAC boom has been dominated so far by US-based VCs. Now a prominent European biotech executive and a couple investors aregetting
SAY GOODBYE TO TOCAGEN, STRUGGLING BRAIN CANCER BIOTECH TO In fact, paÂtients on the conÂtrol arm lived a month longer on avÂerÂage than paÂtients on the drug arm, 12.2 vs 11.1. That comÂputÂed to a hazÂard raÂtio of 1.06 and a p-valÂue of 0.62.KYLE BLANKENSHIP
kyle@endpointsnews.com @ka_blankenship. Kyle Blankenship on LinkedIn. A native of Austin, Kyle previously worked as an associate editor at another leading biopharma publication and has held editor AGC ADDS ANOTHER MAJOR COVID-19 VACCINE MAKER TO THE With the demand for contract manufacturers at an all-time high amid Covid-19, German firm AGC hasn't been shy about its open-door policywith major
CLAIMING LEADERSHIP TO COMBAT COVID-19, US PLEDGES TO 3 hours ago · AfÂter beÂing critÂiÂcized for months for hoardÂing Covid-19 vacÂcines, the UnitÂed States is makÂing a grand gesÂture. PresÂiÂdent Joe Biden has anÂnounced plans to buy500 milÂlion
JUBILANT HOLLISTERSTIER PLOTS OUT EXPANSION AT WA STERILE The dire need for manÂuÂfacÂturÂing caÂpacÂiÂty and a pledge of a rapid ramp up of vacÂcines and treatÂments to batÂtle Covid-19 have left comÂpaÂnies scramÂbling to exÂpand inÂter SYNTHEKINE NABS MEGAROUND IN BID TO EDGE OUT MERCK, SANOFI 3 hours ago · Nine months afÂter launchÂing out of StanÂford with $82 milÂlion and a portÂfoÂlio of enÂgiÂneered cyÂtokines, SynÂthekine has landÂed a $107.5 milÂlion SeÂries B fromDeerÂfield Man
A SECOND ADCOMM MEMBER ABANDONS HIS POST IN AFTERMATH OF 39 minutes ago · The FDA lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee on Wednesday, as Mayo Clinic neurologist David Knopman hit the exit over the agency’sdecision
PFIZER ROLLS OUT NEXT-GEN PNEUMOCOCCAL VACCINE WITH FDA 1 day ago · Merck and Pfizer have been locked in a yearslong battle for a next-gen pneumococcal vaccine winner, with the latter looking to one-up — or should we BRISTOL MYERS’ CAR-T BREYANZI BUSTS OUT A WIN IN EARLIER Despite being third to the field in B cell lymphoma, Bristol Myers Squibb has repeatedly argued its CAR-T Breyanzi could have the juice to overtake its older competitors. Going into earlier lines FDA PLANS NEW STUDIES ON ACCELERATED APPROVAL DISCLOSURES When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen's new Alzheimer's drug, do THE FLAGSHIP TRAIN KEEPS CHUGGING WITH ITS ‘INTERSYSTEMS 3 hours ago · Flagship companies like to move quickly these days. Just one day after Valo Health announced a move to Nasdaq via SPAC after its unveiling last SID MUKHERJEE’S VOR TAPS A CAR-T DEVELOPMENT PARTNER TO 3 hours ago · In the buzzy world of onÂcolÂoÂgy, few names shine brighter than CoÂlumÂbia onÂcolÂoÂgist and bestÂselling auÂthor SidÂdhartha MukherÂjee, whose Vor BioÂpharÂma is lookÂing toENDPOINTS NEWS
Subscriptions. ENDPOINTS NEWS by John Carroll & team — all the news at 11:30am ET. EARLY EDITION by Arsalan Arif — news and links at 7:15am ET. ENDPOINTS MANUFACTURING Weekly biopharma EXCLUSIVE: CARL JUNE’S TMUNITY ENCOUNTERS A LETHAL The multifaceted campaign to create a CAR-T for solid tumors has run into a lethal problem. In exclusive interviews, Tmunity founders Carl June and Oz Azam tell me that they have had to scrap BIDEN HHS SEEKS TO DISMISS PHRMA’S LAWSUIT TO STOP As the FDA has yet to authorize any state plans to import prescription drugs from Canada, the Biden administration called on the US DistrictCourt
EXCLUSIVE: HELSINN CHIEF RICCARDO BRAGLIA SPELLS OUT A Late on Friday, as the biopharma industry in the US was making a rush to the exits for a 3-day weekend, BridgeBio put out word that the FDAhad come through on
REGENERON’S GOLDEN GOOSE EYLEA MAY STAVE OFF BIOSIMILAR Almost 10 years have passed since its first FDA approval and Regeneron’s macular degeneration injection Eylea continues to pile up sales to the tune of BOEHRINGER EMBARKS ON A PHIII ODYSSEY FOR A FAILED In the 8 months since researchers at Boehringer Ingelheim laid claim to a Phase II win for their schizophrenia drug BI 425809, the project team has been busily working up an ambitious Phase III CMC HOLDUP DELAYS IOVANCE FILING AGAIN CEO Maria Fardis highÂlightÂed the fact that liÂfileuÂcel, which is iniÂtialÂly beÂing deÂvelÂoped for PD-1 reÂfracÂtoÂry melanoma, repÂreÂsentÂed the first cell therÂaÂpy in solENDPOINTS NEWS
Subscriptions. ENDPOINTS NEWS by John Carroll & team — all the news at 11:30am ET. EARLY EDITION by Arsalan Arif — news and links at 7:15am ET. ENDPOINTS MANUFACTURING Weekly biopharma EXCLUSIVE: CARL JUNE’S TMUNITY ENCOUNTERS A LETHAL The multifaceted campaign to create a CAR-T for solid tumors has run into a lethal problem. In exclusive interviews, Tmunity founders Carl June and Oz Azam tell me that they have had to scrap BIDEN HHS SEEKS TO DISMISS PHRMA’S LAWSUIT TO STOP As the FDA has yet to authorize any state plans to import prescription drugs from Canada, the Biden administration called on the US DistrictCourt
EXCLUSIVE: HELSINN CHIEF RICCARDO BRAGLIA SPELLS OUT A Late on Friday, as the biopharma industry in the US was making a rush to the exits for a 3-day weekend, BridgeBio put out word that the FDAhad come through on
REGENERON’S GOLDEN GOOSE EYLEA MAY STAVE OFF BIOSIMILAR Almost 10 years have passed since its first FDA approval and Regeneron’s macular degeneration injection Eylea continues to pile up sales to the tune of BOEHRINGER EMBARKS ON A PHIII ODYSSEY FOR A FAILED In the 8 months since researchers at Boehringer Ingelheim laid claim to a Phase II win for their schizophrenia drug BI 425809, the project team has been busily working up an ambitious Phase III CMC HOLDUP DELAYS IOVANCE FILING AGAIN CEO Maria Fardis highÂlightÂed the fact that liÂfileuÂcel, which is iniÂtialÂly beÂing deÂvelÂoped for PD-1 reÂfracÂtoÂry melanoma, repÂreÂsentÂed the first cell therÂaÂpy in sol WHITE HOUSE LAYS OUT SPRAWLING NEW PLAN TO SHORE UP PHARMA 22 hours ago · As the US increasingly relies on foreign drug and active pharmaceutical ingredient (API) manufacturing, particularly from China and India, the Biden-Harris Administration early Tuesdaymorning
SPRINGWORKS AND SEAGEN TEAM UP IN MULTIPLE MYELOMA; MERCK 1 day ago · SpringÂWorks has a new colÂlabÂoÂraÂtion, and it’s one with a promiÂnent pharÂma partÂner. The ConÂnectiÂcut biotech is teamÂing up with Seagen on a new clinÂiÂcal triÂal toeval
ENDPOINTS NEWS POLL: LET’S GET YOUR OPINION ON THAT 19 hours ago · The FDA has approved the Biogen drug aducanumab for Alzheimer’s, a stunning decision that caps nearly two years of controversy and hands the large biotech a INCYTE FACES DELAY ON FDA’S JAKAFI DECISION FOR CGVHD 17 hours ago · Just 10 months afÂter InÂcyte postÂed an upÂbeat asÂsessÂment for Jakafi in a Phase III for chronÂic graft-verÂsus-host disÂease, the FDA has optÂed to push back the sNÂDA to latÂer in TRAILING THE BIG PHARMA PLAYERS, A LESSER KNOWN BCMA CAR-T 21 hours ago · Bristol Myers Squibb and bluebird cleared the first BCMA CAR-T therapy for multiple myeloma patients back in March, and J&J and their partners at JUST HOW SADLY MISGUIDED IS THE FDA ON ADUCANUMAB 1 day ago · The FDA has approved the Biogen drug aducanumab for Alzheimer’s, a stunning decision that caps nearly two years of controversy and hands the large biotech a AMID COVID-19 HUNT, PFIZER ADDS LYME DISEASE VACCINE IN In the midst of their $500 million program to build a Covid-19 vaccine with BioNTech, Pfizer has announced a sizable deal to commercialize a vaccine for a far different disease. Pfizer and Valneva NOVO NORDISK SCORES A WIN FOR SEMAGLUTIDE IN OBESITY 1 day ago · Novo Nordisk pulled a highly anticipated win for its GLP-1 therapy semaglutide in obesity on Friday, becoming the first company to get a chronic weight management drug for adults pastregulators
HOPING TO CHALLENGE BLOCKBUSTER BREAST CANCER FRANCHISES 21 hours ago · For the last sevÂerÂal years, an unÂder-the-radar chalÂlenger to Big PharÂma’s breast canÂcer franÂchisÂes has been workÂing on an anÂtiÂbody drug conÂjuÂgate inÂvolvÂing Her FDA LETS BLUEBIRD RESUME TRIALS FOR SICKLE CELL GENE 1 day ago · BlueÂbird bio anÂnounced that the FDA has liftÂed its holds on clinÂiÂcal triÂals for their gene therÂaÂpies for sickÂle disÂease and beÂta-thaÂlassemia, endÂing a 4-month sagathat
ENDPOINTS NEWS
Subscriptions. ENDPOINTS NEWS by John Carroll & team — all the news at 11:30am ET. EARLY EDITION by Arsalan Arif — news and links at 7:15am ET. ENDPOINTS MANUFACTURING Weekly biopharma NOVARTIS PLOTS ‘NEXT FRONTIER’ OF MS TREATMENT A couÂple of months afÂter getÂting its self-adÂminÂisÂtered mulÂtiÂple scleÂroÂsis drug KesÂimpÂta cleared by EU regÂuÂlaÂtors, NoÂvarÂtis has found what it beÂlieves is “the EXCLUSIVE: CARL JUNE’S TMUNITY ENCOUNTERS A LETHAL The multifaceted campaign to create a CAR-T for solid tumors has run into a lethal problem. In exclusive interviews, Tmunity founders Carl June and Oz Azam tell me that they have had to scrap ENDPOINTS WEBINARSENDPOINTS NEWS BIOTECHENDPOINTS NEWS LOGO Endpoints Webinars. Life sciences marketers work with long sales cycles and products that require market education — which make webinars one of the most essential tools in the biopharma demand generation toolbox. Endpoints webinars are a turn-key solution — let us handle the audience generation, content, marketing, and tech. BIDEN HHS SEEKS TO DISMISS PHRMA’S LAWSUIT TO STOP As the FDA has yet to authorize any state plans to import prescription drugs from Canada, the Biden administration called on the US DistrictCourt
MAX GELMAN – ENDPOINTS NEWSMAKSIM GELMANMAKSIM GELMAN CRIME SCENESMAKSIM GELMAN IN PRISONMAKSIM GELMAN NOWMAKSIM GELMAN STABBING SPREEMAKSIM GELMAN WIKIPEDIA Max hails from New Jersey and spent several years of baseball reporting and editing. Over the course of two seasons, Max covered the St. Louis Cardinals, Colorado Rockies and Chicago White Sox for AS FEARS MOUNT OVER J&J AND ASTRAZENECA, NOVAVAX ENTERS A As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax. In theKYLE BLANKENSHIP
kyle@endpointsnews.com @ka_blankenship. Kyle Blankenship on LinkedIn. A native of Austin, Kyle previously worked as an associate editor at another leading biopharma publication and has held editor TONIX CRASHES ON PHIII PTSD FAILURE, SENDING STOCK TO THETONIX PHARMACEUTICALS STOCKTONIX STOCK FORECASTTONIX NEWSTONIX PHARMACEUTICALS HOLDING CORP TNXPTONIX PHARMACEUTICALS MESSAGE BOARD After scoring two promising FDA designations on its lead drug, tiny Tonix Pharmaceuticals is aborting its late-stage study in PTSD due to lousy results — nearly flat-lining the company’s stock AFTER LEAVING WALL STREET TO LAUNCH A GENE THERAPY UPSTART AfÂter leavÂing Wall Street to launch a gene therÂaÂpy upÂstart, Rachel McMinn nabs $115M to driÂve her first canÂdiÂdate to theclinÂic
ENDPOINTS NEWS
Subscriptions. ENDPOINTS NEWS by John Carroll & team — all the news at 11:30am ET. EARLY EDITION by Arsalan Arif — news and links at 7:15am ET. ENDPOINTS MANUFACTURING Weekly biopharma NOVARTIS PLOTS ‘NEXT FRONTIER’ OF MS TREATMENT A couÂple of months afÂter getÂting its self-adÂminÂisÂtered mulÂtiÂple scleÂroÂsis drug KesÂimpÂta cleared by EU regÂuÂlaÂtors, NoÂvarÂtis has found what it beÂlieves is “the EXCLUSIVE: CARL JUNE’S TMUNITY ENCOUNTERS A LETHAL The multifaceted campaign to create a CAR-T for solid tumors has run into a lethal problem. In exclusive interviews, Tmunity founders Carl June and Oz Azam tell me that they have had to scrap ENDPOINTS WEBINARSENDPOINTS NEWS BIOTECHENDPOINTS NEWS LOGO Endpoints Webinars. Life sciences marketers work with long sales cycles and products that require market education — which make webinars one of the most essential tools in the biopharma demand generation toolbox. Endpoints webinars are a turn-key solution — let us handle the audience generation, content, marketing, and tech. BIDEN HHS SEEKS TO DISMISS PHRMA’S LAWSUIT TO STOP As the FDA has yet to authorize any state plans to import prescription drugs from Canada, the Biden administration called on the US DistrictCourt
MAX GELMAN – ENDPOINTS NEWSMAKSIM GELMANMAKSIM GELMAN CRIME SCENESMAKSIM GELMAN IN PRISONMAKSIM GELMAN NOWMAKSIM GELMAN STABBING SPREEMAKSIM GELMAN WIKIPEDIA Max hails from New Jersey and spent several years of baseball reporting and editing. Over the course of two seasons, Max covered the St. Louis Cardinals, Colorado Rockies and Chicago White Sox for AS FEARS MOUNT OVER J&J AND ASTRAZENECA, NOVAVAX ENTERS A As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax. In theKYLE BLANKENSHIP
kyle@endpointsnews.com @ka_blankenship. Kyle Blankenship on LinkedIn. A native of Austin, Kyle previously worked as an associate editor at another leading biopharma publication and has held editor TONIX CRASHES ON PHIII PTSD FAILURE, SENDING STOCK TO THETONIX PHARMACEUTICALS STOCKTONIX STOCK FORECASTTONIX NEWSTONIX PHARMACEUTICALS HOLDING CORP TNXPTONIX PHARMACEUTICALS MESSAGE BOARD After scoring two promising FDA designations on its lead drug, tiny Tonix Pharmaceuticals is aborting its late-stage study in PTSD due to lousy results — nearly flat-lining the company’s stock AFTER LEAVING WALL STREET TO LAUNCH A GENE THERAPY UPSTART AfÂter leavÂing Wall Street to launch a gene therÂaÂpy upÂstart, Rachel McMinn nabs $115M to driÂve her first canÂdiÂdate to theclinÂic
NEWS – ENDPOINTS NEWS FraÂzier reÂloads with $1.4B to bet on 'growth buyÂout' plays — nearÂly douÂble the last fund. 2 days ago. Financing. Eye inÂjecÂtions causÂing blindÂness? FDA’s stem cell clinÂic COVID-19 VACCINE FOR KIDS: FDA SPELLS OUT QUESTIONS ON 5 hours ago · NIÂAID chief AnÂthoÂny FauÂci preÂdictÂed days ago that Covid-19 vacÂcines for younger chilÂdren will be availÂable by the end of the year or earÂly next year. But whatreÂquireÂments
PREMIUM – ENDPOINTS NEWS A closÂer look at the FDA’s more than 700 panÂdemÂic-reÂlatÂed record reÂquests to reÂplace onÂsite inÂspecÂtions. Let’s make that $1B-plus: AbingÂworth gathÂers more cash, this WHITE HOUSE LAYS OUT SPRAWLING NEW PLAN TO SHORE UP PHARMA 10 hours ago · As the US increasingly relies on foreign drug and active pharmaceutical ingredient (API) manufacturing, particularly from China and India, the Biden-Harris Administration early Tuesdaymorning
ENDPOINTS NEWS POLL: LET’S GET YOUR OPINION ON THAT 8 hours ago · The FDA has approved the Biogen drug aducanumab for Alzheimer’s, a stunning decision that caps nearly two years of controversy and hands the large biotech a AMID COVID-19 HUNT, PFIZER ADDS LYME DISEASE VACCINE IN In the midst of their $500 million program to build a Covid-19 vaccine with BioNTech, Pfizer has announced a sizable deal to commercialize a vaccine for a far different disease. Pfizer and Valneva ASTRAZENECA’S NON-PROFIT VACCINE IS, FOR NOW, COSTING THEM Vectura announced Wednesday that the private equity firm Carlyle Group agreed to buy them out for $1.4 billion, or a 32% premium on thecompany’s
INCYTE FACES DELAY ON FDA’S JAKAFI DECISION FOR CGVHD 5 hours ago · Just 10 months afÂter InÂcyte postÂed an upÂbeat asÂsessÂment for Jakafi in a Phase III for chronÂic graft-verÂsus-host disÂease, the FDA has optÂed to push back the sNÂDA to latÂer in JUST HOW SADLY MISGUIDED IS THE FDA ON ADUCANUMAB 1 day ago · The FDA has approved the Biogen drug aducanumab for Alzheimer’s, a stunning decision that caps nearly two years of controversy and hands the large biotech a AFTER A NOOSE WAS FOUND AT NC PLANT, MERCK LAUNCHES 1 day ago · Merck is investigating after it says a noose was found at one of its manufacturing plants in the Durham, NC area, prompting a fierce rebuke from the company, the Raleigh News &* Channels
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ENDPOINTS by John Carroll & team — _all_ the news at 11:30a ET EARLY EDITIONby Arsalan Arif — skimmable links and news at 7:15a ETINSTANT SUBSCRIBE
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