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1022
Sanofi to conduct precautionary volu♦¥ntary recall of Zantac OTC in U.S. an•π d Canada
Sanofi to conduct precautionary voluntary &© recall of Zantac OTC in U.S. and C"αanadaSATURDAY, OCTOBER 19, 2019As a prσα↓γecautionary measure, Sanofi ≤ will conduct a voluntary recaΩll of Zantac OTC (over-the-counter) in the U✔✘.S. and Canada. This recall is being taken du§×∑e to possible contaminat×σδγion with a nitrosamin♠¶e impurity called N-nitrosodimethylam→←ine (NDMA). The company is wo↔≈♣rking with health authoriti §λes to determine the level and ext¶Ωent of the recall.On Sep₹™≤♠tember 13, 2019, the U.S Food and Drug Adminε∞istration and Health Cana₹"↕da issued public statements alertin∑g that some ranitidine medicines, including ≈$αZantac OTC, could contain NDMA at low<$ levels and asked manufacture>©<λrs to conduct testing.Evalu®↔ations are ongoing on both drug su★♣εbstance (active ingredient) ¶✘and finished drug prod><←∞uct. Due to inconsistencies i✔σn preliminary test results of the active ing≤"×redient used in the U.S. an♠>d Canadian products, Sanofi has m£←ade the decision to co☆↕γ>nduct the voluntary recall in the U.S. ₽♠₩and Canada as the investiga×≥α↑tion continues.Active ingredie$♦nts used in Sanofi's ranitidineα$€ products outside of the U.S. and Canada a±↑re sourced from different suppliers.±≥α₩ Sanofi is committed to transparenε§cy and will continue to communicate results wit™"h health authorities from the ongoing testing, an≈δ¥φd work with them to mak&e informed decisions b÷♦₽ased on available data and evidence.Sanof$♦φi encourages anyone using Zantac OT★φC to speak with their health ∑ care providers or pharm✘ ₹acists if they have any additional questiσ♦εons.information source:pharma fo≤β§cus AsiaThe original link:https:h♠÷ttps:https://www.pharmafocusasia.com/news →/sanofi-to-conduct-prec ÷±∏autionary-voluntary-recall-of-zantac-otc-in-us-↔✘and-canada2019 Asia-pacific pharma✘ ' IP Leader Summit: http://en★★≥₩.zenseegroup.com/p/510934/ will be heπ™ld in Beijing on&£↕≠nbsp;November 14-15, and will attraεε₽•ct more than 500 industry e 'xperts from domestic and foreign pharmace↓"✔utical companies, biotechnoΩ•★¶logy companies, governments, aα'ssociations, law firms, intellectual property ™$agents and other companies to attend.Off₩♣♣®icial registration and consultat★>↓↔ion channels:Contact：AnnPhone: 021-65650305Em≠®♠ail：Marketing@zenseegroup.comhttp://en.zenseeg→≈roup.com/p/510934 -
1023
Moberg Pharma and DongKoo Sign Agree'€←ment for MOB-015 in the Republic of Korea
Moberg Pharma and Dong<♠©Koo Sign Agreement for MOB-015 in the Republic σ•of KoreaTUESDAY, OCTOBER 22, 2019Moberg Pharma A ≠B has signed a distribution agreeme ♥nt with DongKoo Bio & Pharma Co., ±★α Ltd for MOB-015 in the Republic of→₽₽¥ Korea. Under the agreement DongKo×π∑o is granted exclusive∞Ω•< rights to market and sell MOB-015 in the±∞£ Republic of Korea. Moberg Ph>×φ£arma assumes production and supply resp₽ >σonsibility.DongKoo will conduct r≠≠γegistration activities in the Repu$α×★blic of Korea, and will be marke↕™×ting, distributing and selling MOB-015 i≤↑™n the Republic of Korea upon compl₹♣≤®etion of registration."This is the fourth commerc₹₹>ial agreement for MOB-015, this time with the mar₩αket leader in dermatology in Korea w☆β ↓ith excellent coverage of the dermatology clin→♦¶ ics. We look forward to woα↔rk with DongKoo and making MOB-015 availabl€♣e in Korea, contributing to our vision ofε♣ making MOB-015 the leading nail fungu§"≤s treatment worldwide", says An∏βγna Ljung, CEO of Moberg ←∑₩÷Pharma.According to Moberg Pharma's maε♥¥Ωrket intelligence, the Korean market for t↔βopical drugs for onychomycosis amounts to $×♥± 40 million (rolling 12m ending June 2019).inform★≤ation source:pharma focus AsiaThe origi ≤∑nal link:https://www.pharmafocusasi>♦"a.com/news/moberg-pharma-a✔¥♣¥nd-dongkoo-sign-agreement-for-mob-015-in-theγ∑ε-republic-of-korea2019 Asia-pac®αφific pharma IP Leader Summit: http://en.ze≤↓×≈nseegroup.com/p/510934/ will be held in&nbs€∞×εp;Beijing on N€↕ovember 14-15, and will attract more th♥✘an 500 industry expert©₩s from domestic and foreign ph€δ×armaceutical companies, biotechnology cσγompanies, governments, asso¥÷₽δciations, law firms, intellec∏→λ£tual property agents and other companies to a±↕ttend.Official registratβ♠ion and consultation chan←®$"nels:Contact：AnnPhone: 0€↕21-65650305Email：Marketing@zensee<'∑group.comhttp://en.zenseegroup.com/p/510934 -
1024
PDS Biotechnology Completes M♣≤₩anufacturing of Clini♥>$cal Batches of PDS0101
PDS Biotechnology Completes Manufac®πturing of Clinical Batγ£®↕ches of PDS0101WEDNESDAY♠£γ, OCTOBER 23, 2019PDS Biotechnology Corporatα÷ion, a clinical-stage immuno-oncolγ>♥↓ogy company pioneering develop"πment of multi-function✔∑al novel immunotherapies,≥ ♥ today announced that it has completedΩ™ manufacturing of clinical batches of ÷PDS0101 with its partner BSP Pharmaceuticals S.p↕↓.A, a leading manufacturer of →$"anticancer drugs.The clinical batches of PDS→±$0101 will be used in the Com<φ↕pany’s two upcoming Phase 2 studies, which ∏¥® are expected to start in δ™≤the first quarter of 2020. The trials incl✘£γude a combination studyε< with Merck to evaluate PDS0101 in c÷₽ombination with KEYTRUDA® in first-lπ∞φ&ine treatment of head and neck canc∑α♣er and a study to evalu ate PDS0101 in combination with two noΩ•∞vel clinical-stage immγ'unotherapies in advanced HPV associa¶ ted cancers with the National Cancer Institu ☆γte.“We are pleased to ha™₽'☆ve completed the manufa¥σcturing of the clinical b↑<§atches of PDS0101 with our partner B↑α✔SP Pharmaceuticals and are honored to be collab≤ βorating with two leaders in the field of immuno-oφ ∑ ncology,” said Dr. Frank Bedu-Addo₹♠, CEO of PDS. “Based on our recent ∏ly announced Phase 1 clinical outcome data whic∞βh demonstrated PDS0101’s u↕♠§nique ability to pro₽δ≤>mote the in-vivo induction of high levels of✘α© HPV-specific CD8+ killer Tδε-cells as well as the regression of pre¥ ©↔-cancerous lesions in 60% of pat"εients, we believe that PDS0101 could expand →$↕the clinical efficacy≥φ of checkpoint inhibitors such as KE×♥YTRUDA®. We are now ®• working diligently to qualify clini↔ελcal sites for our combination trial with KEYTRUDΩ¥↕A® in first line trea ↕tment of head and neck cancer and look for× ward to initiating both our planned combination t↔>rials by the first quarter of 2020.”infor → mation source:pharma focus AsiaThe oα♥≠riginal link:https://www.p∑©>∏harmafocusasia.com/news/pds-biotechnoloσ↕£÷gy-completes-manufacturing-of-clin☆δical-batches-of-pds01012019©✘ < Asia-pacific pharma IP Leader Summit: http:/♣$∑/en.zenseegroup.com/p/404716/§&♥ will be held in&'≥™↓nbsp;Beijing o∞£♥n November 14-15, and will attract ♣♣more than 500 industry experts from domes≠∞←tic and foreign pharma•φceutical companies, bioγ&technology companies, governme↕↕₹nts, associations, law firms, i ₹→ntellectual property agents and other ¥♠ companies to attend.Official registratε↕£→ion and consultation channels:Contact：↓×₹♦AnnPhone: 021-65650305Email：Marketinα&≈±g@zenseegroup.comhttp://en.zenseegroup.com/p/✘↔510934 -
1025
Pliant Therapeutics Announces$σ✘♠ Strategic Collaboration to Dev£≤♥¥elop Novel Therapies for NASH and₩β× Fibrotic Diseases
Pliant Therapeutics Announc₽©es Strategic Collaboration t→'•£o Develop Novel Therapie♦∏s for NASH and Fibrotic DiseasesTH"φ©URSDAY, OCTOBER 24, 2019Pliant Therapeutics♦ •, Inc., a clinical stage biopha↓"'×rmaceutical company focused on dis↑>covering and developing novel the÷↑rapies for the treatment oδ&→$f fibrosis, today announced it has ✔→$entered into a strategic collaborati¥γon and license agree★☆ment with Novartis covering the development and c<®★↓ommercialization of Pliant's preclinic∞ ₹al product candidate, PLN-1474 and up to thr↔✘♣ee additional integrin targets. PLN-1474 i→✔φ€s an internally discovered small molecule sε★"elective inhibitor of integrin αVβ1, currently bein↔ λg developed for the treatment of liver ♣βfibrosis associated with ↕ ≠•nonalcoholic steatohepatitis (NASH)."Our r♦<esearch continues to generate compel'↑ling preclinical evidence¥&← that supports the advancement of P ☆®≤LN-1474 as a clinical candidate and validates↑• our approach of evalu↔¶↓≠ating αVβ1 integrin inβhibition to treat advanced li'$ ver fibrosis associated with NASH," said ÷<Bernard Coulie, M.D.,$' Ph.D., president and chief ex ←ecutive officer of Pliant Therapeutics. "P♣€airing Pliant's leading integrin biology a™✘™✘nd drug discovery capabilities with Novartis, §©£a world-leader with oΩne of the broadest pipelines investigating mon↕₩ ₹o and combination therapies for liver diseases in♥εσcluding NASH, will support ou±✘¥®r goal of developing novel th∞σ♠erapies for fibrotic diseases anφ₹d potentially bring m♥φλeaningful treatment op$↔'tions to patients."Pliant will initially ♣δ §receive $80 million fro∏♠m Novartis, including an upfront payment in conneγ ction with the collaboration agreement asγ>♣≤ well as equity investment commitmenΩ¥®ts. The collaboration agreement is fo≤<r a worldwide exclusive lic® ense to PLN-1474 and up to thre×π∏e additional product candidates generated uπnder the collaboration. In additi→ on, Novartis will fund Pliant's resea★€$rch and development activities≈¶ under the collaboration. Pliant will be resp↓↓&onsible for development of PLN-1474 th¥¥rough Phase 1 after which Novartis will assume÷Ω responsibility for all♠׶ future development, manuf₽≈acturing and commercialization♦™★. Pliant is eligible to earn'ε δ milestone payments, contingent upon the achi♠εevement of specified development, regula★®•tory and commercial milestones. The aγ₩×₩greement also provides for tiered royalties p☆δayable to Pliant ranging from the mid-single ¶digits to low double digits on pro¶×"duct sales upon commerc↕→£←ialization. The transaction is subject to c₹≥ ustomary closing conditions, in™★cluding clearance under the Hart-Scot∏↔≤±t-Rodino Antitrust Improvements Act.<₩NASH associated cirrhosis is ♦↓$the fastest growing in÷>"dication for liver transplantation in t™>he United States. Many patients with NASH dev€σ₩elop associated liver fibrosis, whi™• ch can lead to complications such as cirr<≈☆hosis and ultimately liver failure. Whλ↔ ile several investigaπ✔tional agents target m✔☆echanisms that impact ≈↕the earlier stages of the NASH conti★©γεnuum, Pliant is targeting αvβ1, an •£γ♠integrin that activates TGF-β, a putatiΩ≥ve master regulator of hepatic fiφ₽★brosis. PLN-1474 has shown significant inhibitionπ÷γ☆ of fibrosis in live human tissue model✔©♦s. Pliant expects to submi≠↕<≤t an investigational new drug (IND) applicati¶on to the U.S. Food and Drug Administration be'☆±₽fore the end of 2019σ∏±.information sour∑<®↑ce:pharma focus AsiaThe original link:https://www✔₹$.pharmafocusasia.com/news/pliant-therapeut↕∑¶≤ics-announces-strategic-collaboration-to-develoσ←p-novel-therapies-for-nβ∞ash-and-fibrotic-diseases2019←•> Asia-pacific pharma IP Leader Summ™•★it: http://en.zenseegroup.com/p/510934/✘φ will be held in Beijing o±$•n November 14-15, and will attract moΩΩ★♠re than 500 industry experts from dome•÷☆₹stic and foreign pharm€ aceutical companies, biotechnology compani→≈es, governments, associations, law firm←>πs, intellectual property agents and ot↕∞↔₽her companies to attend.Officia↓δ$l registration and consu♠$♦ltation channels:Contact：AnnPhone≥π§✔: 021-65650305Email：↔™∞Marketing@zenseegroup.comht£ tp://en.zenseegroup.com/p/510934 -
1026
AZTherapies Strengthens Neuroinflammation-Tar★ ♥geted Pipeline Through Acquisition of Smi↔≤th Therapeutics
FRIDAY, OCTOBER 25, 201 9AZTherapies, Inc., a biopharmaceutδ'ical company developing theδ♠♣rapeutics to extend brain hσealth, today announced the a₹'cquisition of Smith Therapeutics÷≠≥≠, a private biopharmaceutical compan& y with a shared goal of targeting n¶÷✘euroinflammation to treat neurodegenerativ←¶→≈e disease. Smith Therapeuti∞↓ αcs’ Founder and Chief Executive Officer Philip ™σΩ Ashton-Rickardt, Ph.D., has joined the senφ<ior leadership team at AZTherapies as Se≥§nior Vice President of Immunology. Fina±™®ncial terms of the acquisition were ∑∞≠not disclosed.Smith Therapeutics’ proprieta↓☆β∑ry research platform focuses on the use of modif Ω ¶ied T cells to restore a healthy balance of infla<$↔mmatory and regulatory cells in the bβ€rain. To date, Smith has successfully Ω↔≠engineered immunosuppressive T rα€egulatory (Treg) cells with C¥★ ✔himeric Antigen Receptors (CARs) tar'πgeting brain glial c☆≠∑>ells. Previous research✔π™σ has demonstrated the abil¶'ity of Tregs to dampe≤¥n microglial activity and reduce neu✘Ωroinflammation in mod®λels of neurodegenera↓≠tion, suggesting their potent∞£®±ial utility in the treatment σ≈ ≠of diseases including Progressive S↑<π≤upranuclear Palsy (PSP), ÷≠®Alzheimer’s disease, &♦Parkinson’s disease, Huntington’s diseasε♥e, Amyotrophic Lateral Sc§$←αlerosis (ALS), and others.“This acquisition repr ∏βesents a meaningful s₹δ™÷tep forward for us as ≤♦'<we continue to strengthen our leadership pos≤βπ±ition in the development of tδγherapies targeting neuroinλδflammation to stop or slow th©∑≤e progression of neurodegeneratε"€ive diseases,” said David R. Elmaleh≤∏©, Ph.D., Founder, CEO, and Chairman of AZTherapieα€s. “We are excited to be working w♦§ith Philip as we add this ≈♥€≠cutting-edge technolo£§↔★gy to our portfolio of innovative programs. An eβ§>steemed immunologist and inventor of the te÷ chnology, Philip brings unparalleled≈↓÷ expertise to the company ±Ωand we look forward to advanc±ing this CAR-Treg program further iπγΩnto IND-enabling studies ≈£★and into clinical develop≈£ment as rapidly as possible.”Dr. Ash↕✘ton-Rickardt commented on the acqui↕>♦$sition and his appointment: “Our shared ratioφ✔nale of targeting neuroinflammation as the root ¥λcause of neurodegenerative disease δmakes this acquisition a gr¥eat strategic fit for us. With AZTherap×←ies’ expertise in drug developmentγΩ and clinical trial execution, we b¶±elieve that together, we are well pos←×₹itioned to advance our CAR-Treg te←¥β∑chnology and fundament₩σally change neurodegener>↓∞ ative disease progression.←₩φ”Prior to launching Smith Therapeutics in♦€λ 2017, Dr. Ashton-Ricka ♥←δrdt was Chair in Immunology at •γ☆♠Imperial College London, Visiting >'€Professor, Brigham and Women’s Hoβ®≤✔spital, Harvard Medical School♥Ω, and Associate Professor in the Department of Pa¶©£thology at the University of Ch♠↓ Ωicago. His work has been recognized by hi±÷s peers through the award of tenure from The¶ University of Chicago and δ₹'by his fellow citizens as a r↕→>ecipient of the Early Career Award for Scient→★₹ists and Engineers from↑∑ President Bill Clinton. He has publ±₩✘÷ished more than 65 peer-reviewed papers iσn more than 30 academ<&ic journals (including Cell, Science, Immuni↓✘λty, and Nature Immunε©ology), has served as an edit€ 'or for several academic journals, a•÷nd has been a member of gδ÷π♣rant review boards globally. Dr. Ashton-Rickar¥<€Ωdt received a B.Sc. in Biochemistry fσ↓πrom the University of London, King’s Coll →ege with honors, a Ph.D. in Molecul∏©λ∞ar Biology from the Universiλ ↑ty of Edinburgh, and completed post-d¥πoctoral work at the University of Edinbu✔↕rgh and the Massachus δ↑etts Institute of Technology in Mol €ecular Biology and Molecular Immunology, respecti∑ vely.information source:pharma focus AsiaTheβ•€↑ original link:https:https://www.pharmaf© ocusasia.com/news/az∞₩therapies-strengthens-neuroinflamm> ¥ation-targeted-pipeline-through-acquisition-of-s€¥¥mith-therapeutics2019 Asγ₹ia-pacific pharma IP Leader Summit: h↔$$<ttp://en.zenseegroup.com/p/5©≤↕10934/will be held in π£&δBeijing on November§πβ 14-15, and will attract more than 500 ind↑ε↓≥ustry experts from domestic and✘ foreign pharmaceutical compa•∞↕nies, biotechnology companies, governments, ©&₩associations, law firms, intellectua©♠↔l property agents and other companies to attend.∏↑Official registration ∑Ω↑and consultation channels:Contact：AnnPhone: 021↕↑-65650305Email：Marketing@zenseegroup.comhttp://≠₩£↔en.zenseegroup.com/p/510÷"934
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