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1026
AZTherapies Strengthens Neur←±oinflammation-Targeted ←↔∞ Pipeline Through Acquisit↓ion of Smith Therapeutics
FRIDAY, OCTOBER 25, 2019AZTherapies, Inc., a €≠♦biopharmaceutical company developing t←•€herapeutics to exten≈≠d brain health, today announced the acquisitio↕σn of Smith Therapeutics, a private bioph×β armaceutical company with a shared &÷α∞goal of targeting neuroinflammati←™ on to treat neurodegenerative disease. Smith Th→ ♠↔erapeutics’ Founder and C♠®∑hief Executive Officer ↓♥Philip Ashton-Rickardt, Ph.D., has♣★₹ joined the senior leadπ≥ership team at AZTherapies as Senior Vice Preside↑>nt of Immunology. Financial terms of the ₽>$∑acquisition were not disclosed.Smith Therapeutic≈✔&s’ proprietary research p÷ ₩latform focuses on the use of m>∏♥odified T cells to rest πλore a healthy balance of inflammatory ↓♣≤∑and regulatory cells in the brain. To date, Smit§↕≤h has successfully engineered immunosuppresβ£♥sive T regulatory (Treg) cells with β♠↓'Chimeric Antigen Receptors (CARs'✔) targeting brain glial cells. Previoδ↔λus research has demonstrated the ability of επTregs to dampen microglial activity and reduc≠→≈☆e neuroinflammation in Ω®↓€models of neurodegeneratio∑↔≤✔n, suggesting their pot₽≈✘ential utility in the treatment of dise÷λ÷★ases including Progressive Supranuclear Pφ₽alsy (PSP), Alzheimer’s disease, Par↑≠kinson’s disease, Huntβ♥↕ington’s disease, Amyotrophi εc Lateral Sclerosis (AL↑S), and others.“This acquisition repres₩€&φents a meaningful step forward for us a§↑s we continue to strengthen our leadership pσσosition in the development of therapies targetiΩ♠ ₽ng neuroinflammation to stop or s∏β low the progression of neurodegenerative diseaseγ &s,” said David R. Elmaleh, Ph.D₩↓ ↔., Founder, CEO, and Cha→↑×₩irman of AZTherapies. “We are excited✔§™ to be working with Philip as we∏★ add this cutting-edge t✘ ¶echnology to our portfolio of innovative'₽ programs. An esteemed immunologist and invento™<γr of the technology, Phil≤"ip brings unparalleled expert♣>σise to the company and we l"π<₩ook forward to advancing this CAR-Treg Ωprogram further into IND-enabling s♣≈÷tudies and into clinical development as ∞∏rapidly as possible.”Dr. Ashton-RΩ₩ickardt commented on the acquisition and his app'"Ωφointment: “Our shared rational¶₽☆φe of targeting neuroi₩≈nflammation as the root c"•ause of neurodegenerative ↔ε>₹disease makes this acquisition a great stra₽÷₹tegic fit for us. With A↔φ €ZTherapies’ expertise in drug develop£≈ment and clinical trial execution, we≥∑ believe that together, we are well posσ>itioned to advance our CAR-Treg <↕•technology and fundamental<ly change neurodegenerative disea&≤se progression.”Prior to launching Smithεφ Therapeutics in 2017, Dr. Asht¶¶←on-Rickardt was Chair in Immunology at Impe↔↑קrial College London, Visitε≈≥ing Professor, Brigham and Wom♣™en’s Hospital, Harvard Medica→™>l School, and Associate Professor in$≠'← the Department of Pathology at thπ φ↓e University of Chicago. His work has been rec↓¥&∞ognized by his peers through the award of t©→↕∞enure from The University of Chica→'go and by his fellow citizens as a reci★σ<pient of the Early Care♥₹er Award for Scientists aφ↔₽nd Engineers from President Bill Clin↔✘÷ton. He has published more tλ$han 65 peer-reviewed papers in more than 30 acad¶♠☆®emic journals (including Cell, Science, Im★♥munity, and Nature Immunology),$ has served as an edδγ↔itor for several academic journals, and has been ♥♠↕a member of grant re✘←view boards globally. Dr. Ashton-RickardεΩ t received a B.Sc. in Biochemistry from the Unive✔ §✔rsity of London, King’s College with h↓✔onors, a Ph.D. in Molecular Biology from the University of Edinburβ≥gh, and completed post-doctoral work at≠♣✔Ω the University of Edinburg♥Ω₽ h and the Massachusetts Institute of T©¥echnology in Molecul∑←π¥ar Biology and Molecular Immunology, re'>spectively.information sour✘ €♥ce:pharma focus AsiaThe original link:https:>αhttps://www.pharmafo&♠cusasia.com/news/aztherapieεδ± s-strengthens-neuroinflammation-targete ✘→≈d-pipeline-through-acquiΩ≠φ↑sition-of-smith-therapeutics2019 Asia-pacifiφ¶'→c pharma IP Leader Sumπ≤mit: http://en.zenseegroup.€★δcom/p/510934/will be held in Beij★∑✘ing on November 14-15, and wil₩±≥♦l attract more than 500 industry experσ✘∑ts from domestic and foreign pharmaceutical c$•®ompanies, biotechnolog§↕ ×y companies, governmentσ∑αδs, associations, law firms, intelle♣★♣ctual property agents and other companies ₽₩↑'to attend.Official r±★egistration and consultatio≤♣←n channels:Contact：AnnPhone: 021-6565'±0305Email：Marketing@zensee₹↔αgroup.comhttp://en.zenseegroup.co©$m/p/510934 -
1025
Pliant Therapeutics Announcesα×γ§ Strategic Collaboration to Devel≥✔©op Novel Therapies for NASH and Fibro¶&tic Diseases
Pliant Therapeutics Announces Strategic Collaδ'←boration to Develop Nove☆↑©¶l Therapies for NASH an☆♦→d Fibrotic DiseasesTHURSDAY, OσπCTOBER 24, 2019Pliant Therapeutics, Inc., a ε☆clinical stage biopharmaceutical company focu∏₽φsed on discovering and developing novel ther♦× apies for the treatment β→♥of fibrosis, today announced it has> entered into a strategic collaboration♣©↕ and license agreement with Novartis coverin ≠≤g the development and com§εγ§mercialization of Pliant's preclini φ→cal product candidate, PLN-1474 an÷σ∞ d up to three additional integrin targets. P LN-1474 is an internally discovere★×d small molecule selective inhibit←♥∑©or of integrin αVβ1, currently bein&¶₹♣g developed for the treatment of liver fibrosi<γ<s associated with nonalcoholic steatohepati≠tis (NASH)."Our research c™£ontinues to generate comp♠≈elling preclinical evidence that supports the↑ε advancement of PLN-1474 as aδ©∞π clinical candidate and valid∏¥♦ates our approach of evaluat≤÷≈∏ing αVβ1 integrin inhibition to treat advanced l≤ iver fibrosis associated with NASH," saiβ$↓d Bernard Coulie, M.D.≥®∑, Ph.D., president and ch©₽ief executive officer of Plian ♠t Therapeutics. "Pairing Pliant's ♣↕λ₹leading integrin biology and drug discovery cap₽<abilities with Novartis, a wor¥±ld-leader with one of the b↑ roadest pipelines in✘β↓★vestigating mono and combination tλ<✔©herapies for liver dise£<γases including NASH, will support our &↓goal of developing novel thera¥↓↑pies for fibrotic disease ε&'s and potentially bring meaningful treatmen&±t options to patients " &."Pliant will initially receive $80 m±€☆★illion from Novartis, including an upfront payα→ment in connection with the collaboration a∑↕₹greement as well as equity investmen<αt commitments. The collaboration agreem<&λent is for a worldwide exclus±♠♥♥ive license to PLN-1474 and up π↓to three additional product candidates gen★€αerated under the collaborati★'₹on. In addition, Novarti€"≤s will fund Pliant's research and develo¥∞pment activities under the collab✘↓&oration. Pliant will be responsible for developm♣¥βent of PLN-1474 through Phaφ☆♠se 1 after which Novartis will assume responsiγ€₽bility for all future development, manufa♠↑≈cturing and commercializ®✘×ation. Pliant is eligible toπ earn milestone payments,← contingent upon the achievemσ♦∑¥ent of specified develop€↑₹¶ment, regulatory and commercial milestones. Th★♠Ωπe agreement also provides for tiered r§Ωoyalties payable to Pliant ranging f'★±rom the mid-single dig∏βδits to low double digits on pr∏∏βoduct sales upon comme≈πφrcialization. The transaction is subject toβ∞¥ customary closing conditions, including clear₹∑€ance under the Hart-Sco ÷★tt-Rodino Antitrust Improvements Act.NA>✘γ★SH associated cirrhosis is the fastest≥≤$¥ growing indication for <ε€<liver transplantation in the United States.¥¥© Many patients with NASH develop associated l ¥ ♣iver fibrosis, which can le₩®π₽ad to complications such as cirrhosis an☆®Ωd ultimately liver fail&σ♠≤ure. While several investig∞∑εational agents target mechanisms Ω∞$that impact the earlier stages of the NASH c♣≤ontinuum, Pliant is targeting αvβ1, a☆∞n integrin that activates TGF-β, a putative mas€€ter regulator of hepatic fibr₽☆osis. PLN-1474 has shown significant inhibition≤€ of fibrosis in live human tissue models. Plian♣α↑t expects to submit an investig≤♥ational new drug (IND) appl✔ication to the U.S. Food and Drug Administration ↔☆before the end of 2019.information s&ource:pharma focus AsiaThe original link:https: //www.pharmafocusasia.com/news/≈€>pliant-therapeutics-announces-strategic-collabora≥∑tion-to-develop-novel-therapies-for-nash-and-f≥σ<♠ibrotic-diseases2019 Asia-pacific pharma IP Lead ×er Summit: http://en.¥→Ωzenseegroup.com/p/510934/ will b&★®e held in Beiji₽§®ng on&nbs♠ ™p;November 14-15, and will att±&₽Ωract more than 500 industry exp "€Ωerts from domestic and•♠•✘ foreign pharmaceutical companies,£≥₹ biotechnology companies, govern≈₹₹ments, associations, law firms, intellect≠<ual property agents and other companies to at™'tend.Official registration and consultation chann ♦els:Contact：AnnPhone: 021δφλ•-65650305Email：Marketing@zen♣¶σseegroup.comhttp://en.zenseegroup.comδδλ/p/510934 -
1024
PDS Biotechnology Completes Manufacturing of Cl& inical Batches of PDS0101
PDS Biotechnology Completes ♦↑Manufacturing of ClinicΩ↔≠al Batches of PDS0101WEDNESDAY, OCTOBER≥↑£ 23, 2019PDS Biotechnology Corporation, a∞ ★ clinical-stage immuno-oncology comp¥€any pioneering development of multΩ≤¶i-functional novel immunotherapies, ≠¶ today announced that it hasΩ completed manufacturing of clinical batches of P♦÷®<DS0101 with its partn®αδer BSP Pharmaceuticals S.p.A, a leadi<↕γng manufacturer of anticancer drugs.The clinic$↑♣al batches of PDS0101 will be used in the Company♣™™’s two upcoming Phase 2 stu§ dies, which are expected to start in the first ∑$ ♦quarter of 2020. The trials include $₽a combination study with Merck to eval←ε∑✘uate PDS0101 in combination with KEδ↓YTRUDA® in first-line treatment of head a♥nd neck cancer and a study to evalu¥♥ate PDS0101 in combination with two novel c ★λ>linical-stage immunoπ↕therapies in advanced HPV₩& associated cancers with tλ he National Cancer Institute.“We areββ pleased to have completed the &£>manufacturing of the clinic≥al batches of PDS0101 with our part₹σσner BSP Pharmaceuticals and are honored t∑α✘o be collaborating with two leaders i αn the field of immuno-oncology,” said Dr. Frank Bβγφλedu-Addo, CEO of PDS. “Based on our recen"φtly announced Phase 1 clinical outcome data which>↔ demonstrated PDS0101’s unique abilit↓♠y to promote the in-vivo∏♥± induction of high levels of HPV-specific CD8+ ki&↔&ller T-cells as well as the regression of pr★&£e-cancerous lesions in γ↕≤60% of patients, we believe that PD∏≥φS0101 could expand the clini✔™↕cal efficacy of checkpoint inhibitors such as K® EYTRUDA®. We are now working diε₹λligently to qualify c &linical sites for our γ¶combination trial wit♥±→h KEYTRUDA® in first±← line treatment of head and neck cancer ™₹✘§and look forward to initiating both our planned★©♥¶ combination trials by the $β÷₽first quarter of 2020.”informaδλ♣tion source:pharma focus AsiaThe' original link:https://www.pharmafocusasia.com/n≠ ₩ews/pds-biotechnology-completes-man©∏↔↕ufacturing-of-clinical-b© atches-of-pds01012019 Asia-pacific pha€&σrma IP Leader Summit: http://en.zeα§←nseegroup.com/p/404716/ will be heφ✔σ≥ld in Beijing &n♠♣•₽bsp;on November 14-15, and will attract m↑∑✘ore than 500 industry experts from domestλic and foreign pharmaceutica≈ $l companies, biotechnology γcompanies, governments, asso¥∏δ→ciations, law firms, intellectual property aε™gents and other companies to atte™™'nd.Official registration δ£ ←and consultation channels:Contact：AnnPhone: 021-¥¥¥65650305Email：Marketing@zenseegrou↕≈p.comhttp://en.zenseeg ↔ roup.com/p/510934 -
1023
Moberg Pharma and Do↔♠☆¥ngKoo Sign Agreement for MOB-015 in the Republi±c of Korea
Moberg Pharma and DongKoo Sign Agreeε&§ment for MOB-015 in the Republ& ic of KoreaTUESDAY, OCTOBER 22,≠≥ 2019Moberg Pharma AB has s£ε♠÷igned a distribution agreement with DongKoo B÷★io & Pharma Co., Ltd for M☆♦βOB-015 in the Republ ☆ic of Korea. Under the agreement DongKooε$∑" is granted exclusive rights ""±✘to market and sell MOB-015 ↕'in the Republic of Korea. Moberg Pharma assumes p φroduction and supply responsibility.D©←±≠ongKoo will conduct regist∑♦πration activities in the R∑φ$'epublic of Korea, and✘§ will be marketing, distributing and selling M₽≠OB-015 in the Republic of Korea uε$pon completion of registration."This is♥ the fourth commercial agreemeλΩnt for MOB-015, this time'φ♣₹ with the market leade ♣r in dermatology in Korea with excellent₹& coverage of the dermatology clinics. We look f€ααφorward to work with DongKoo and making M♥ OB-015 available in Korea, contri★♣buting to our vision of making MOB-∏ 015 the leading nail ✘¶™fungus treatment worl≈♥dwide", says Anna Ljung,≈∏ CEO of Moberg Pharma.According to↑®¥↑ Moberg Pharma's market intelligence, t♣•"he Korean market for topical drugs for onychomy₩★≠®cosis amounts to $40 million (rolling 12m₹± ☆ ending June 2019).infoπ≥ rmation source:pharma focus AsiaThe origΩ≠→inal link:https://www.pharmafocusasia.com/news/mΩoberg-pharma-and-dongkoo-☆→©sign-agreement-for-mob-015-i ↓n-the-republic-of-ko±®¶rea2019 Asia-pacific pharm≥¥a IP Leader Summit: http://en.zensee™±©group.com/p/510934/ will be held i± n Beijing on&nbs ∑£p;November 14-15, and will attrac§↓≤t more than 500 industry experts fro•♦m domestic and foreign£÷β pharmaceutical compani≈→λes, biotechnology compani→→π<es, governments, associatiσ←✔ons, law firms, intellectual property agents an€©£d other companies to attend&γΩ .Official registration ↓'εand consultation channels:Contact：AnnPhon÷ε♠©e: 021-65650305Email：Marketing@zenseegro§>↔up.comhttp://en.zenseegroup.com/p/510934 -
1022
Sanofi to conduct precautionary voluntary re₹ ↑call of Zantac OTC in U.S. and Canada
Sanofi to conduct precauγ≈↔tionary voluntary recall of Zantac OTC☆♠✘ in U.S. and CanadaSAβ≤δTURDAY, OCTOBER 19, 2019As a p♠σ♦αrecautionary measure, Sanofi will conduct a volu∑™ntary recall of Zantac OTC (over-t"✘γhe-counter) in the U.S. and Can₹↑ada. This recall is b♥®$∑eing taken due to possible contamination w&α♥ith a nitrosamine impurity >&∞called N-nitrosodimethylamine (NDMA). The co±α±☆mpany is working with health author ✔ities to determine th↔♣e level and extent of the reca÷π₹ll.On September 13, 2019, the U.S Food and & Drug Administration and Health Canada iΩ¶ssued public statements ale&✔•rting that some raniti↔ dine medicines, including Zant>∏ ac OTC, could contain NDMA at l↑®€γow levels and asked manufacturers to co₽ ↑nduct testing.Evaluations are ongoing on bot∞≠₽h drug substance (act'£ive ingredient) and finished drug product. Due✔•♥∑ to inconsistencies in preliminary test res±®¥ults of the active ingre✔¥₹dient used in the U.S. and Canadian ™≤→"products, Sanofi has made the decision to ₹×conduct the voluntary recall in the U.Sλ€. and Canada as the investigatio $↔&n continues.Active ingredients usδ♥ed in Sanofi's ranitidine products outside of the♣ U.S. and Canada are sourced ↕™ from different suppl™♠Ωiers. Sanofi is committed t®♣←o transparency and will÷↑ continue to communicate results with healt£♣® h authorities from the ongoing₽ §∞ testing, and work with them to mπ☆β ake informed decisions based on available data aδΩnd evidence.Sanofi encourage£"s anyone using Zantac OTC to speak with their hea≈∞↑φlth care providers or pharmacists ≤'☆if they have any additional questions.in÷λformation source:p★πharma focus AsiaThe original★<✔ link:https:https:https://www.pharmafocusasia.c₩✔om/news/sanofi-to-conduct-precautionary-voluntar¥∏>y-recall-of-zantac-otc-in-₽✔←us-and-canada2019 Asia-pacifi✔ c pharma IP Leader Summit: http://en.zens<©eegroup.com/p/510934/ will be↑λ held in Beijing &nbs" p;on November 14-≠↔β15, and will attract more than 500 indu↕∏stry experts from domestic and for®'eign pharmaceutical companies, $≠ biotechnology companies, governments, associati∑<φσons, law firms, intellectual property age §nts and other companies to≥π attend.Official regist♠ ✔↔ration and consultation channels:Contact：AnnPhon↓ e: 021-65650305Email：Marketing@z& ☆☆enseegroup.comhttp://en.zenseegroup.coγσm/p/510934
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