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1026
AZTherapies Strength↕≥∑ens Neuroinflammation-T±♦&argeted Pipeline Through Ac×βquisition of Smith Therapeutics
FRIDAY, OCTOBER 25, 2019AZTheσσrapies, Inc., a biopharmaceutica&>↔l company developing therapeutics to exten÷d brain health, today announced t♦>♦♦he acquisition of Smith Therapeutics, a privatα∑ e biopharmaceutical compa↔$♠ny with a shared goal of ←™✘↑targeting neuroinflamma tion to treat neurodegene≈✘rative disease. Smith Therapeu¶≥∑tics’ Founder and Chief Executi₩γve Officer Philip Ash↓ >↓ton-Rickardt, Ph.D., α©≈♣has joined the senior leadership tea∏πm at AZTherapies as Senior Vice President Ωγσ↑of Immunology. Financial terms of the acquisit Ω&φion were not disclosed.±δ≤✔Smith Therapeutics’ pr♥Ω©≥oprietary research platfo≥₽₩rm focuses on the use of modifie<♠ε↓d T cells to restore a healthy balance ∞★₩of inflammatory and "•↑ regulatory cells in the brain. To date, Sm↔γ±↕ith has successfully σ✔δengineered immunosuppressive ≠©≠T regulatory (Treg) cells with C>♦✘€himeric Antigen Receptors ( ♥♥↕CARs) targeting brain glial cells. Previous reseπ☆arch has demonstrated the ability of Tregs to d←δγ↓ampen microglial activity and reduce neuroinflamm♥¥ation in models of neurodegeneration, suggesting★ ♦₽ their potential utility in t×™he treatment of diseases including Prog₽≥ressive Supranuclear Palsy (PSP), Alzheimer’s ÷β£disease, Parkinson’s disease, Huntingto"φ₽∑n’s disease, Amyotrophic Lateral Sclerosis (ALγγπS), and others.“This acquisition represents a m∞₹eaningful step forward for us as w♣♥∞₹e continue to strengthen our lea≥λ↓dership position in the dφ™evelopment of therapies targeting n←αeuroinflammation to stop or slow the progσ₽ression of neurodegenerative diseaseπα÷ s,” said David R. Elmaleh, Ph.D., Foun<'<∑der, CEO, and Chairman of AZTherap♦ ies. “We are excited"§☆ to be working with Philip as we add this✘→ cutting-edge technology to o±φ™ur portfolio of innovative programs. An es™∞&₽teemed immunologist and inventor of th'∑↓✔e technology, Philip briσ∞ngs unparalleled exp→≠ertise to the company and w♦↕e look forward to advancing this Cσ★©¶AR-Treg program further into IND-enablin♠★g studies and into clinical d±♠evelopment as rapidly as∏"× possible.”Dr. Ashton-Rickardt com"≥♦mented on the acquisition and his appointment: “Our shared rationa✔∞σle of targeting neuroinflammation•∏ as the root cause of neurodegenerative d☆✔÷☆isease makes this acquisiti←™"©on a great strategic δ≈ fit for us. With AZTherapies’ expφσertise in drug develo₽₹∏<pment and clinical trial execution, we beli♥✘♥eve that together, we are well positioned to adva ≤→<nce our CAR-Treg techno•≠logy and fundamentally change neurodegenerative•δ disease progression.”Prior to laπ€←unching Smith Therapeutics in 2017, Dr. Ashton✘σ'×-Rickardt was Chair in " Immunology at Imperial ®'College London, Visi ✘¶$ting Professor, Brig¥®↑ham and Women’s Hospital, H™¥♥arvard Medical School,© ♥ and Associate Professor in the¶♠ε Department of Patholoλgy at the University ↔±of Chicago. His work has been recognized±® by his peers through the award of tenure from≥α The University of Chicago and by× his fellow citizens as a recipient of the Ear™±ly Career Award for Scientists and Engineers fφ>rom President Bill Clinton. He has pubγ ≥♠lished more than 65 peer-reviewed pa€∏pers in more than 30 acad↕↓₩↑emic journals (including Cell, Science §±↔, Immunity, and Natu≈∑ >re Immunology), has serv¶>φed as an editor for several acaλαdemic journals, and has been a member of grant♠≥÷₹ review boards globally. Dr. Ashton-Rickardt ≠≥received a B.Sc. in Bioche≈σ★σmistry from the University of London, Ki♣ελng’s College with honors, a Ph.D. in Moleγ≈☆♣cular Biology from the Universit®y of Edinburgh, and completed post-doc☆β toral work at the University♥§ of Edinburgh and the Massachusetts Institute o<♦f Technology in Molecular Biol∞ ogy and Molecular Immuno®<☆¶logy, respectively.information source>∞:pharma focus AsiaThe original l★£ ink:https:https://www.pharmafocusasia.∏©com/news/aztherapies-strengthens-neuroi'↑↓nflammation-targeted-pipeline-through-β♠δ§acquisition-of-smith-therape¶★♣utics2019 Asia-pacific pharma IP L∏&∑eader Summit: http://en.zenseegrou∑±p.com/p/510934/will be held in Beijing&nb♦↑λ₹sp; on November 14÷←-15, and will attract more than 500 indu¶×stry experts from domestic and f±σoreign pharmaceutical companies,♦& biotechnology companies, govern®≠∑≤ments, associations, law ≈ εfirms, intellectual property agents and other c©§₹✔ompanies to attend.Officia∑ ✔€l registration and co♥™nsultation channels:Contact：AnnPhone: 0↕¶✘21-65650305Email：Marketing@zensee "λgroup.comhttp://en.zenseegroup.com₽ ∏♣/p/510934 -
1025
Pliant Therapeutics Announces ><>>Strategic Collaboration to Develop Novel≥₽" Therapies for NASH and Fibrotic Disea≤ππses
Pliant Therapeutics Announces Strategic Collab★Ω©oration to Develop Noveβ<l Therapies for NASH and₹₹↕ Fibrotic DiseasesTHURSDAY, OCTOBER 24, 2019♦←↔™Pliant Therapeutics, Inc., a clinical stage b α↓ iopharmaceutical company focused o≥✘±εn discovering and developing novel therapies fo< ≠∑r the treatment of fibrosis, today announced it$<≥π has entered into a strateg↔→ic collaboration and license agreement with≥ § Novartis covering the development and commerciβαalization of Pliant's pre☆←φclinical product candidate, PLN-14≥≤74 and up to three additional int↓∑egrin targets. PLN-1474 is an inγπσ ternally discovered small molec→≤✔ule selective inhibitor£ ↑& of integrin αVβ1, currently being develo∞$ped for the treatment o¥≠≥f liver fibrosis associated ∑"♣ with nonalcoholic steatohepati≈₽tis (NASH)."Our researc≤h continues to generate compelling precli₩ββ∑nical evidence that supports the advancement of✘× PLN-1474 as a clinical candidate and validate<♣s our approach of evaluating αVβ1 integr€♠in inhibition to treat >÷★★advanced liver fibrosis associated wiγ th NASH," said Bernard Coulie, M.D., Ph.D., preλ →sident and chief executive o→δ♥fficer of Pliant Therapeutics.σ™•→ "Pairing Pliant's leadinσσ<g integrin biology and drug discovery capab∏•♣πilities with Novartis, a world-leader with one oσ&↔∞f the broadest pipelines investigating ₹∑εmono and combination therapies©ε for liver diseases including NASH, w←§ill support our goal of developing novel therapα ies for fibrotic diseases and po ™∞ tentially bring meanin≠↓λgful treatment options to patients."Pliant will↔±¶∑ initially receive $80 million from Novartis₽<, including an upfront payment in connection •↑♥ with the collaborati✘↔on agreement as well as equity invesπ tment commitments. The collaboration a₽σ¥greement is for a worldwide exclusive lic≤×♥↓ense to PLN-1474 and up to thrαδ¥÷ee additional product cand•←idates generated under the♠☆ < collaboration. In addition, Novartis ♦ πwill fund Pliant's reseaσα§rch and development activities under the collaborβ$ation. Pliant will be respon"¥sible for development of PLN $φ-1474 through Phase 1 after which Nova₩≈÷rtis will assume responsibility for all future↕© development, manufacturing and commercializatiβΩ•on. Pliant is eligible to earn mile" ≠≥stone payments, contingent upon the a$☆↕₽chievement of specified development, re↕€gulatory and commercia♠♥≥εl milestones. The agreement also↕© provides for tiered royalties payabl ₹e to Pliant ranging from the mid-single digi↔®∞ts to low double digits on product€β sales upon commercialization. The transactε€ion is subject to customary closin> ♣♦g conditions, including clearance under th↔λ✔↑e Hart-Scott-Rodino Antitrust Improvements✔≤₹ Act.NASH associated cirrhosis is the fastest gr→☆®owing indication for liv≥→ ®er transplantation in the United States. M¶αany patients with NASH develop associated l♠₹↑iver fibrosis, which can lead to complication>÷∞s such as cirrhosis and λ÷π&ultimately liver failure. Whil€φγ§e several investigational agents↔$β target mechanisms that impac↓©←↑t the earlier stages of t≤≠✘he NASH continuum, Pliant is targeti≠¶ng αvβ1, an integrin that activ₹♠'πates TGF-β, a putative ma☆γ$♥ster regulator of hepatic fibrosis. PLN∑α-1474 has shown significant i nhibition of fibrosis in live human tissue m∑™→odels. Pliant expects to submit an in≈✔☆vestigational new drug (IND) application to ♦< the U.S. Food and Drug Administ£↑ration before the end of 2019.infor✘¶Ωmation source:pharma foc us AsiaThe original link:https://www.pharmafocus∑₽> asia.com/news/pliant-therapeu₹ $÷tics-announces-strategic-col✘&♠σlaboration-to-develop-novel-therapies-for♦§₩-nash-and-fibrotic-diseases2019 Asia-pacific phaε↓☆rma IP Leader Summit: http:/σ±£ /en.zenseegroup.com/p/510934/ w¥£ill be held in Beijing ↓® on Novembe>¶r 14-15, and will attract &§★≠more than 500 industry experts froπ₹m domestic and foreign pharmaceutical ∏₩↑companies, biotechnology companies, gove✘©>rnments, associations, l↔∑¥βaw firms, intellectual property agents and other '¥☆$companies to attend.Official registr☆§λ€ation and consultation channels:Contact：AnnPhone♥γαγ: 021-65650305Email：Marketing@zen± seegroup.comhttp://en.zenseegroup.↑§"com/p/510934 -
1024
PDS Biotechnology Completes Manufa§δ∏cturing of Clinical Batches of <↕→βPDS0101
PDS Biotechnology Completes Manufa✔'♠cturing of Clinical Batches o₩©f PDS0101WEDNESDAY, OCTOBER 23, 2019PDS Biotech¶nology Corporation, a clinical-stage immunαβλo-oncology company pioneeri&β↓ng development of multi-functiona l novel immunotherapies, today announ↔"ced that it has completed manufacturing of c→ε♦linical batches of PDS0101 with its δ™ partner BSP Pharmaceuticals S∞ .p.A, a leading manufacturer of anticancer drugs.φ♦<The clinical batches of PDS01₹£πδ01 will be used in the Company’s two upcoming✘β© Phase 2 studies, which are expec±✔€ted to start in the first quarter of 202♥₽ •0. The trials include a combination s ↔↑tudy with Merck to eval γuate PDS0101 in combination wit♥£§h KEYTRUDA® in first-line treatmeσ<nt of head and neck canc↔≠er and a study to evaluate PDS0101 in co♠↔↕mbination with two novel clinical-stage immunoλ✔therapies in advanced HPV associated §€✘™cancers with the Nationγ§al Cancer Institute.“We are pleased to αΩ₽"have completed the manufacturing of the c∑Ω♠linical batches of PDS'σ∏0101 with our partner BSP Pharmaceuticals₽₩☆♠ and are honored to be collaboratin§ g with two leaders in the field of immuno-on♦↕★cology,” said Dr. Frank Bedu-Add&≈♣πo, CEO of PDS. “Based on our recentl♣♦γy announced Phase 1 clinical outcome data which $δ↑ demonstrated PDS0101’s₩¶$ unique ability to promote the in-vivo ind> σuction of high levels of HPV-specific CD8+ ki€∏•<ller T-cells as well as the regression of pre≈∏-cancerous lesions in 60% of patients, we bel ¥÷₩ieve that PDS0101 could e∏βxpand the clinical efficacy of ∑≠×checkpoint inhibitors such a® ÷s KEYTRUDA®. We are now working diligentlyε"↔ to qualify clinical sit★≠←™es for our combination trial with KEYTRUε DA® in first line treatment of head and neck¥∑<→ cancer and look forwa ¥φ§rd to initiating both our planned combination β♣trials by the first quarter©λ of 2020.”information source:pharma focus ₩γ>AsiaThe original link:https λ≠✘://www.pharmafocusasia.com/n'☆ φews/pds-biotechnology-completes-manufact§✘₹uring-of-clinical-batches-of-pds010σ&✘→12019 Asia-pacific pharma IP Leader Summit✔∞™: http://en.zenseegroup.com/p/404716/ will b ×e held in Beijing on&nλ♠Ωbsp;November 14-15, an×∑÷πd will attract more than 500 i™∞↕ndustry experts from domestic and foreign pharma≥"α☆ceutical companies, "≠§biotechnology companies, governments, §αλassociations, law firms, intellectual pr •↓ operty agents and othε er companies to attend.Offi'cial registration and consultation ✔•channels:Contact：AnnP•δα≈hone: 021-65650305Email：Marketin£♣§™g@zenseegroup.comhttp://en.zense<↓↔★egroup.com/p/510934 -
1023
Moberg Pharma and DongKoo Sign Agreement for ×MOB-015 in the Republic of Korea
Moberg Pharma and DongKoo Sign Agrπ eement for MOB-015 in the Republic of ÷♥KoreaTUESDAY, OCTOBER 22, 2019Moberg Ph≤"arma AB has signed a distribution a €↕€greement with DongKoo Bio & Pharmaσλ Co., Ltd for MOB-015→←☆ in the Republic of Korea. Under the agreemen ≈✘t DongKoo is granted exclusiv<§e rights to market and€Ω sell MOB-015 in the Republic of Korea.®♥§ Moberg Pharma assumes production and βσ₩supply responsibility.Don↔$φ↕gKoo will conduct registra∏<tion activities in the Republic≥±∞ of Korea, and will be marketing, dist≠↓"ributing and selling MOB-015 in theε≠₹↕ Republic of Korea upo& n completion of regi<∑stration."This is the four ¥☆✔th commercial agreement for MOB-015, ÷<this time with the market leader in dermatology₽≈Ω★ in Korea with excelle§↔☆★nt coverage of the dermatology clinics. We lo♦§γok forward to work with DongKoo and m•→≤₽aking MOB-015 available in Korea, contributing toε our vision of making MO♠↕B-015 the leading nail fungus tre&↓♣atment worldwide", says § Anna Ljung, CEO of Moberg Pharma.According to ↓$§Moberg Pharma's market intelligence, the ε™&Korean market for topical drugs for₩₩ onychomycosis amounts to $©'←40 million (rolling 12m ending June 2019).γβ information source:pharma focus A&♦≠siaThe original link:https://www.pharmafocu≤<£sasia.com/news/moberg-pharma-and-dongk€©oo-sign-agreement-for-mob-015-in-the-r♣£epublic-of-korea2019 Asia-pacific pharma IP Lea&"der Summit: http://en ✔'↕.zenseegroup.com/p/510934/ §↑₽;will be held in Beijing α£¥on November 14-15, and will attr<λ act more than 500 indus÷<π try experts from domestic and for"←€♣eign pharmaceutical compani★¥es, biotechnology companies, governments, asγ÷₽sociations, law firms, intellectual property agΩ✔←ents and other compani€•γ<es to attend.Official regist©✘←ration and consultation channels:Contact₹↕σ：AnnPhone: 021-65650305Email：M±δarketing@zenseegroup.co×mhttp://en.zenseegroup.co$λm/p/510934 -
1022
Sanofi to conduct precau¶∞tionary voluntary recall of Zantac✔$↕↕ OTC in U.S. and Canada
Sanofi to conduct pr§©¥λecautionary voluntary recall of Zanta₽®c OTC in U.S. and CanadaSATURDAY, ÷"OCTOBER 19, 2019As a precautionary measure, Sanofγ♣i will conduct a voluntary recall of Zanta♦≤¥c OTC (over-the-counter) i¥÷n the U.S. and Canada. This'× recall is being taken due to possible contam≥>≤ination with a nitrosamine impurity called N-nit ↓€rosodimethylamine (NDMA).δ® The company is workin✘γ∑g with health authorities to determine thγγ→e level and extent of the recall.On Septem↑ ber 13, 2019, the U.S >Food and Drug Admini<≥stration and Health Canada issued public statemeπ₽∑nts alerting that some ranπ≠←®itidine medicines, in∏≤∞¥cluding Zantac OTC, could contain Nαλ₽DMA at low levels and asked manufacturers t★♣∞$o conduct testing.Evaluations are ongoing on boβ✘>✔th drug substance (active ingredient) and finisε$hed drug product. Due to inconε☆sistencies in prelimina<∑ry test results of the active≤γ↕ ingredient used in the U.S. and C€δ∞πanadian products, Sanofi has made the decision to→↕↑ conduct the voluntary recall in the U.S. and ✘ <Canada as the investi£λ<gation continues.Active i☆Ωngredients used in Sanofi's ranitidine €↓>πproducts outside of the U .S. and Canada are sourced from different₹€ suppliers. Sanofi is committed to transparβ₹§<ency and will continue to communicate rπ∞esults with health authorit§♣↓$ies from the ongoing test✘¶ing, and work with them to♥↓ make informed decisions based on available ↔&data and evidence.Sanofi encourages anyone using>♦ Zantac OTC to speak with ©λφtheir health care providers or pharmaci♥ε₩sts if they have any addi ↓★tional questions.inf ®ormation source:phar→δγma focus AsiaThe original lin×∏k:https:https:https://www.pharmafocusasia.c←om/news/sanofi-to-condu±✔©→ct-precautionary-voluδ ₽ntary-recall-of-zantac-otc-in-us-and-•≈∞canada2019 Asia-pacific pharma IP Leader S♥α¶Ωummit: http://en.zenseegroup.comα£≠/p/510934/ will be held in&nbsσ p;Beijing on Novemb∑∞er 14-15, and will attract m>☆ore than 500 industry experts from domest≈±ic and foreign pharmaceutical• companies, biotechnolog★σπy companies, governments, associations ≤σ, law firms, intellectua™≥±☆l property agents and÷★→ other companies to attend.Of"≤↓ficial registration and consultat₩≤ion channels:Contact：AnβnPhone: 021-65650305Email：Marketing@zenseegroup.c ≈™omhttp://en.zenseegroup.com/p₹✔ ∑/510934
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