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1026
AZTherapies Strengthens Neuroinflammation-Targeteα&∑®d Pipeline Through Acquisition of Smith→★ Therapeutics
FRIDAY, OCTOBER 25, 2019AZTλ♣↑Ωherapies, Inc., a biopharmace✘≥♦ utical company developingδ★¶× therapeutics to ext≥₹end brain health, today announced the acquis₽₹ition of Smith Therapeutics, a private biopha≈↑rmaceutical company with↕¥∑ a shared goal of targeting neuroinflammation to∑↔ treat neurodegenerative disease. Smith Therap÷eutics’ Founder and Chief Executive Officer Phili≤•σp Ashton-Rickardt, Ph.D.,ε∏α has joined the senior leadership te¶α≥ am at AZTherapies as Senior Vice President of Imm₹↑✘Ωunology. Financial terms of the acq≠•♥uisition were not disc¥$₩®losed.Smith Therapeutics’ proφΩprietary research platform focuses on th$ε✔∞e use of modified T cells to restore a healthy b≠₩alance of inflammatory and$↕ regulatory cells in the brain. To date, S∏§"mith has successfull↑ ₽✘y engineered immunosuppress§δφive T regulatory (Treg) cells with Chim₩$✔'eric Antigen Receptors (CARs) targeting brain$∑ glial cells. Previous researcεγ≤∑h has demonstrated the ability of Tregs↑÷ to dampen microglial activity and reduce λσ♣•neuroinflammation in m♥∞odels of neurodegeneration, suggesting their pote∑←✔☆ntial utility in the treatment↕λ of diseases including Progressive S≠↔β✔upranuclear Palsy (PSP), Alzheime€∑≈r’s disease, Parkinson’s disα✘ease, Huntington’s disease, Amyotrophα♥≠ic Lateral Sclerosis &₹(ALS), and others.“This acqu§↑isition represents a meaningful step foε♣rward for us as we continue to strengthe®$n our leadership positio↑n in the development of therapiesβ ≠ targeting neuroinflammation to s✘♥¥top or slow the progression of neurodegenerative α≈diseases,” said David R. Elmaleh, Ph.D., Fou±↓nder, CEO, and Chairman of AZ↕Therapies. “We are excited to be wo←✔∏rking with Philip as we add this cutt®₩¥ing-edge technology ε★to our portfolio of innovative programs. An e↓steemed immunologist and₹α inventor of the technology,✔π↓$ Philip brings unparallel×β☆σed expertise to the company and we loo₩♠k forward to advancing this CAR-Treg program f£urther into IND-enabliα₹←ng studies and into clinical development as rap←₹idly as possible.”Dr. Ashton-Rickardt commented o ¶n the acquisition and his ap≥$δ>pointment: “Our shared rationale of targetingσ>♥ neuroinflammation a♠s the root cause of neurodegen★✘®erative disease makes this acquisition™≠ β a great strategic fit for ∏≠¥us. With AZTherapies’ expertise in drug×&↓ development and clinical trial ≠€±execution, we believe that together, we↔₽∏σ are well positioned to<∞÷ advance our CAR-Treg technology∞≥ and fundamentally change neurodegener®>ative disease progression.”Prior to launchiΩ€ng Smith Therapeutics in 2017, Dr. Ashto±↔♠n-Rickardt was Chair in Immunology at Ω±∑↔Imperial College London, Visiting Professor, Brig÷'ham and Women’s Hospital, Harvard Medi§ ∞♠cal School, and Associate Professor in the Dep×✘artment of Pathology at the Univer₹÷sity of Chicago. His work has bee•π₹n recognized by his peers through the award of te¶§nure from The University ©↕>σof Chicago and by his fellow citi≠¶♥zens as a recipient of the Early C↑<areer Award for Scientists aσ®♥nd Engineers from President Bill Clinton. H∑∑₹e has published more than 65 peer-reviewed papers≈¶ in more than 30 academic journals (incl♦÷δuding Cell, Science, Immunity, and Nature Immuno× φlogy), has served as an editor f$♦✔₩or several academic journals, and has been a memb★§er of grant review boards globally.¶♥•£ Dr. Ashton-Rickardt received a B.Sc. in ≥Biochemistry from the ♣₽σ↔University of London, King’s College with honors,₹↔ a Ph.D. in Molecular Biology from t§♥α♥he University of Edinburgh, and c↕¶₩ompleted post-doctoral work at the Univ£↔ersity of Edinburgh and the Massachusett<s Institute of Technology in Mo$☆lecular Biology and Molecular Immunology, respec←>★¶tively.information so♥♠ urce:pharma focus AsiaThe original linφ•k:https:https://www.pharma ≈₹★focusasia.com/news/aztherapies-s∏δ™trengthens-neuroinflammation-tβ♥± argeted-pipeline-through-acquisition-of-smith-t ©herapeutics2019 Asia-pacific pharma IP Leader S$≠γummit: http://en.zenseegroup.com★δ&Ω/p/510934/will be held i©≈&σn Beijing on No¥♠vember 14-15, and will attract mo>φre than 500 industry experts from ♣πdomestic and foreign pharmaceut↑♣•ical companies, biotechnology &↓÷↕companies, governments, associations, law γ firms, intellectual property agents an₽₽₩d other companies to att¶÷₩end.Official registration and consulta¶δtion channels:Contact：A •nnPhone: 021-65650305Email：Marketing@¶'π✘zenseegroup.comhttp://en.zenseegroup.•→₽com/p/510934 -
1025
Pliant Therapeutics Announces Strategic₹♥€ Collaboration to Develop Novel Th<πerapies for NASH and Fibrotic Diseases
Pliant Therapeutics Announces Strategic₩$♠ Collaboration to Develop Novel Therapi×">es for NASH and Fibrotic DiseasesTHUR€¥←≤SDAY, OCTOBER 24, 2019Pliant Therapeu♥Ωtics, Inc., a clinical stage biopharmaceutical co&♣≤mpany focused on discovering₹♣γ' and developing novel therapies for t ₩he treatment of fibrosis, today β≤announced it has entereα∏ασd into a strategic colla₹σboration and license agreement with Novartis co>♠♣¶vering the development and commπ↓♠ercialization of Plian$♣<t's preclinical product candidate, PLN-1474 ♠•and up to three addi≠×tional integrin targets. PLN-1474 is an iπ±nternally discovered small ™↔&§molecule selective inhibitor of integrin αVβ1≤", currently being developed"< for the treatment of liver fibro∑>sis associated with nonalcoholic s→↔&teatohepatitis (NASH) λ."Our research continues to generate ∏ ♣compelling preclinical evidenc ®≤e that supports the ad≠δ≤vancement of PLN-1474 as a clinical candidα™&✔ate and validates our approach o↕≤₽σf evaluating αVβ1 integrin inhibition©∏π¥ to treat advanced liver fi☆φ✘brosis associated with ¥∞$♣NASH," said Bernard CoulΩ¶ ie, M.D., Ph.D., president and λαchief executive officer of Pliant Therapeutics. "≥×♠®Pairing Pliant's leading integrin biol±↕ogy and drug discovery capabilities with Novartis♠∏, a world-leader with one of the broadest pipelπ&¶ines investigating mono and combina∑γ₹≈tion therapies for liver diseases including NASH×★•, will support our goal of developing nove∞Ω l therapies for fibrotic dise♠♦ ♠ases and potentially br↔§↕ing meaningful treatment options to patients."P$↓∏liant will initially r ®§eceive $80 million from Novartis, including±¶ an upfront payment in c≤≈∞±onnection with the collaboration agreeme£→nt as well as equity investment commitme&♠∑γnts. The collaboration agreement is for a worldw σide exclusive license§ ∏↔ to PLN-1474 and up to three additional product δ"≤candidates generated under the collaboratioφ'♦n. In addition, Novartis will fund Pli™αant's research and d ↕♣βevelopment activities↑£ β under the collaboration. Pliant will be res®πponsible for development of ✔≠$€PLN-1474 through Phase 1 aft✘£er which Novartis will as∑™σ♠sume responsibility for all future ↓÷development, manufacturing and commercializatβ₹ion. Pliant is eligible to earn milestone pay♥✘βεments, contingent upon th e achievement of specified development, ★∑'regulatory and commercial milesσ" ₹tones. The agreement also provides for tierπ☆ed royalties payable to Pliant ranging ♥"from the mid-single digits♣±€ to low double digits on product sales upon com×'₹mercialization. The transaction is subject ↕™to customary closing conditions, includi✘ ≈βng clearance under the Hart-Scott§÷&↔-Rodino Antitrust Impr™Ω¥¶ovements Act.NASH associated cirrhosis is the fas©∑test growing indication for liver ¶✘transplantation in the United Sta↕×ε©tes. Many patients w ★×εith NASH develop associated liver fiε☆πbrosis, which can lead to complications such as ₩cirrhosis and ultimately liver failure.≤±×β While several investigation™al agents target mechanisms that impact← the earlier stages of the NASH continuum↕α☆↔, Pliant is targeting αvβ1, an ₽∏integrin that activates TGF-β, a puta •δtive master regulator of hepatic fi☆≠πλbrosis. PLN-1474 has sho$£wn significant inhibition of fibrosis in ®↑λαlive human tissue models. Pliant expects to subm'♠it an investigational n₩∑ew drug (IND) applicγ®ation to the U.S. Food and Drug Administratio"Ω₹n before the end of 2019.information §®÷☆source:pharma focus AsiaThe original link:ht₹∞♣βtps://www.pharmafocusasia.com/news→✘↑/pliant-therapeutics-ann →ounces-strategic-collaborat¥÷γion-to-develop-novel-¶÷therapies-for-nash-andσβ✘-fibrotic-diseases2019φσ¶ Asia-pacific pharma IP✘φ→ Leader Summit: http://en.zen§≠♥seegroup.com/p/510934/&nbs✘←p;will be held in Beijing •π↑on November 14-15, and will attract ε≤☆≠more than 500 industry expertδ↕≥$s from domestic and foreign pharmaceutical ♦§companies, biotechnology αβ•companies, governments, ∑ ☆associations, law firms, intellectual prop♥₹erty agents and other companies to attend.Offic ®€ial registration and consultation channels:Conta£$₩φct：AnnPhone: 021-65650305Email：Ma↓₽φ✘rketing@zenseegroup.comhttp://en.z§÷'enseegroup.com/p/510934 -
1024
PDS Biotechnology Complete↔∑s Manufacturing of Clinical Batches λ$↑∞of PDS0101
PDS Biotechnology Completeπ ₩¥s Manufacturing of Clinical Batc×→∞hes of PDS0101WEDNESDAY, OCTOBER 23, 2019PDSΩδ Biotechnology Corporation, a c±↕linical-stage immuno-oncology company pio€®→neering development of multiεβ"§-functional novel immunotheraφ↑pies, today announced tha¥δ™t it has completed manufacturing of cli≤←εnical batches of PDS0101 with its partner BSP↕♠₩ Pharmaceuticals S.p.AΩΩ, a leading manufacturer of anticancer dα→®rugs.The clinical batches of PDS0101" $ will be used in the Company’♦±↔s two upcoming Phase 2≠ studies, which are σexpected to start in the first quar±©εter of 2020. The trials include a combin®ation study with Merck to evaluate PDS0101 in coσ♣β↑mbination with KEYTRUDA® in first-lin↓<e treatment of head and ne€✔ck cancer and a study φ¥to evaluate PDS0101 in combination wiσφ₩∞th two novel clinical-sta↕∞ge immunotherapies in advanced HPV as •sociated cancers witφ§€h the National Cancer Institute.“We are pleas&₹ →ed to have completed the m∞ "anufacturing of the clinical batches of PDS0101÷ with our partner BSP Pharmaceut∑icals and are honored to be collaborating w♠$÷₹ith two leaders in the field of i®§Ω→mmuno-oncology,” said Dr.<γ•σ Frank Bedu-Addo, CEO of PDS. “Ba☆♣sed on our recently announc<≠ed Phase 1 clinical outcome daε♥ta which demonstrated PDS0101’s unique abi✔∑££lity to promote the in-vivo induction of high l≥♦εevels of HPV-specific CD8+ killer T-cel£αls as well as the regression of pre-ca γ<ncerous lesions in 60% of patients, we₽¥σ believe that PDS0101 could expand the cl♦< inical efficacy of checkp₩♣oint inhibitors such as KEYTRUDA®. We are¥↓σ now working diligently to qualify clinica÷₹l sites for our combination ✘±₽←trial with KEYTRUDA® in>♣§ first line treatment of head and∞↔ neck cancer and look f∞♥orward to initiating both our planne♦♥δd combination trials by the first quarter of 2✔↑020.”information source:pharma focus AsiaT€ he original link:http♥σs://www.pharmafocusasia.com/new₹✘ §s/pds-biotechnology-complβetes-manufacturing-of-clinical-♦β↑γbatches-of-pds01012019 Asia-pacifiπφ☆↕c pharma IP Leader Summit: http://e€n.zenseegroup.com/p/4047σ>±§16/ will be held in Beijingβ ¶' on November σα14-15, and will attr✘'↑act more than 500 industr∏α y experts from domestic and ✘αforeign pharmaceutical compani↑☆es, biotechnology co×↕φmpanies, governments, assoc§♦iations, law firms, intellectua₽≈≠l property agents an↓✘d other companies to attend.Offi↕♠cial registration and€ consultation channels:Contact：AnnPhone: 021-6♣<✘5650305Email：Marketing₩€€@zenseegroup.comhttp://en.zλ↓φenseegroup.com/p/510934 -
1023
Moberg Pharma and DoβλngKoo Sign Agreement fo>÷↔×r MOB-015 in the Republic × of Korea
Moberg Pharma and DongKoo Sign Agreemenλ ♣t for MOB-015 in the Republic of K♣®¶oreaTUESDAY, OCTOBER 22, 2019Moberg Pharm$®ε£a AB has signed a distribπ >≠ution agreement with D♥±ongKoo Bio & Pharma Co., Ltd¶ for MOB-015 in the Republic of Korea. Under t♦§he agreement DongKoo is gran$ ted exclusive rights to market and sell MO€→↑B-015 in the Republic of Korea. γ¥✘'Moberg Pharma assumes↓♦ production and supply respon×sibility.DongKoo will conduct registration acti"'♣♠vities in the Republic of Korea, and will be m★$♣≠arketing, distributing and se≤>ββlling MOB-015 in the Republic of Korea upon c♠≥ ompletion of registrat☆™♣ion."This is the fourth co↕♦mmercial agreement for MOB-015, this time with th₹ ↕e market leader in dermatology i↔δ∏n Korea with excellent coverage of the derma₩₩εtology clinics. We look ←∏forward to work with DongKoo and making MOB-0₩γ♥15 available in Korea, contributing σ♠to our vision of making MOB-015 the le→♣≈γading nail fungus treatment worldwi£$de", says Anna Ljung, CEO of M↕£oberg Pharma.According to Moberg Pharma's↕™¶♣ market intelligence, thπ©αe Korean market for topi♦≤cal drugs for onychomycosis amounts to $4€φσ♥0 million (rolling 12m ending June 2019).informat±★>↓ion source:pharma focus AsiaThe♣ original link:https:/¶↕/www.pharmafocusasia.com/news/moberg-pharma-and±✔-dongkoo-sign-agreement-for-mob-015-in-the-re♦>≤ public-of-korea2019 Asia-pacif≤δ↓ic pharma IP Leader Summit: http:£✔//en.zenseegroup.com/p/510934/&& ™nbsp;will be held in Bei£φΩjing on November 14-15★∏₽, and will attract more than 500♥>♥ industry experts from domestic and foreign phar•≥maceutical companies, biotechnoλ∏logy companies, governments, associγations, law firms, intellectual property ag☆< δents and other companies to attend.O→ fficial registration and consultation ch£δ annels:Contact：AnnPhone:<∞ 021-65650305Email：Marketing@ze₩δβ©nseegroup.comhttp://en.zenseegroup.com/p σε€/510934 -
1022
Sanofi to conduct preca↓₩utionary voluntary recall ±✔¥δof Zantac OTC in U.S. and Canada
Sanofi to conduct precautionary volu→★ntary recall of Zantac OTC in U.S. and≠↕¥ CanadaSATURDAY, OCTOBER 19, 201 ♠9As a precautionary measure, Sanofi £€will conduct a voluntary recall of Zantac OTC"δ↓↑ (over-the-counter) in the U.S. and Canada. ThiφσΩs recall is being taken due to possible contamin"&®∞ation with a nitrosamine impurity c alled N-nitrosodimethylamine (ND☆∞δMA). The company is wo÷↔↕rking with health auth≈✘∞orities to determine the level and extent o♥♦™f the recall.On September 13, 2019,φ₹÷ the U.S Food and Drug Admini'₹stration and Health '§±&Canada issued public st¥✘atements alerting that some ranitidine medic₹¶ines, including Zantac O±∞®∑TC, could contain NDMA at low levels and a¶'★sked manufacturers to con•σduct testing.Evaluations are ong₹'↓πoing on both drug substance (active ingredient) a'✔±nd finished drug product. Due to inco©•nsistencies in prelimi≈↔nary test results of the active inε®gredient used in the U.S. and Canad>βλian products, Sanofi σ<<has made the decision to conduct th♣↔e voluntary recall in the U.S. and ✘<≠Canada as the investigatio¶πn continues.Active ing♦δredients used in Sanofi's ranitidine pro↕λ↓ducts outside of the U.S. and Canada are s×←© ourced from different supplier>₩∑s. Sanofi is committed to transparency ₽φand will continue to communicate results with hea∏<lth authorities from the ong₹≠ ↓oing testing, and work with them to makeε§ informed decisions based on availableγπ data and evidence.Sanofi encourages anyone ★↕↕using Zantac OTC to speak with their health careγ∏ providers or pharmacist✘∏☆s if they have any additional questions.©εinformation source:pharma÷♣£± focus AsiaThe original link:https:δ★https:https://www.pharmafocusasia.com/news/☆φsanofi-to-conduct-precautionary-voluntary-recall-♥©>of-zantac-otc-in-us-and-canada2019 Asia-pacifi¥α↓c pharma IP Leader Summit: http://en.zenseegro πup.com/p/510934/ will be held×≠ ♣ in Beijing on&nb€★≥sp;November 14-15, and will attract more than₽• 500 industry experts from d¥ ←✘omestic and foreign pharmaceutical companies, bio∏' ±technology companiesσ", governments, associations,βε law firms, intellectual property agents and ot$♥♥her companies to attend.Official'∑ registration and consulta☆¶±↕tion channels:Contact：AnnPhone: 021-→★≥★65650305Email：Marketing@zenseegroup.comhttp:/"≤₽/en.zenseegroup.com/p/5109φ →34
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