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1025
Pliant Therapeutics Announces Strategic Collabo♠∞∑♠ration to Develop Novel Therapies for NASH and <Ω€Fibrotic Diseases
Pliant Therapeutics Announces Strategic Collabora♣tion to Develop Novel Therapies for NASH and'☆< Fibrotic DiseasesTHURSDAY, OCTOB<₽←ER 24, 2019Pliant Therapeutics, Inc., a ✔γ₩clinical stage biopharma≤β≥★ceutical company focused on discovering and"✘¶ developing novel therap'∏ ies for the treatment of fibrosis,¥↓ ↑ today announced it ≈✘≥≥has entered into a strategic ←¶collaboration and licen€'® se agreement with Novartis covering the dev<✘&elopment and commerc•♠σialization of Pliant's precliniγ≤cal product candidate,≈✔ PLN-1474 and up to three additional inte↑£grin targets. PLN-1474 is a✘n internally discove∞δred small molecule selective inhibi ®tor of integrin αVβ1, currently being developed ¥↑♦for the treatment of liver fibrosis associated wβ∏ith nonalcoholic steatohepatitis (NASH)."♥✔↑>Our research continues to generate compell ₩&™ing preclinical evid←™γΩence that supports the adva €ncement of PLN-1474 as a clinical candidate and ∑±φvalidates our approach of evaluating αVβ1 inteδ&☆εgrin inhibition to treat advanced li★₽₹ver fibrosis associated with NASH," said Bernard ☆β Coulie, M.D., Ph.D., president and chief executiv✔γ≈e officer of Pliant The®₩₹↑rapeutics. "Pairing "→Pliant's leading integrin biology and drug disc€↑& overy capabilities with Nov artis, a world-leader with onπe of the broadest piβ↑↓pelines investigating mono and combi£→nation therapies for liver diseases incσ₹luding NASH, will suppor✘•€¥t our goal of developing novel therapies for fi♥' λbrotic diseases and potentially bring me≤♣aningful treatment options to patients.™¥"Pliant will initially←₩ receive $80 million f∑α♦♠rom Novartis, including an upfr"≠$™ont payment in connectio★"≠n with the collaboration agreement♦★∑' as well as equity investment commitment₽≤s. The collaboration agreem↓←∑☆ent is for a worldwide exclu₽sive license to PLN-14₽λ74 and up to three additional product♥σ candidates generated under the co₩σ∏llaboration. In addition, Novartis will fund₽• ≈ Pliant's research an≤Ω→ d development activities under the collabora∞ ↔πtion. Pliant will be responsible for developme₩•× nt of PLN-1474 through Phase ©Ω≤1 after which Novartis will assume respon±≤sibility for all futurφ≤®φe development, manufacturing and commercializat™λion. Pliant is eligible to earn mile¥ stone payments, contingent >upon the achievement of specified dev≤•→elopment, regulatory and cα₩•±ommercial milestones. The agreement also pro•γδ♠vides for tiered royalties payable to Pli∞♥♥∞ant ranging from the mid-sin✘&♣gle digits to low double digit∏ ↓≥s on product sales upon commercial✘¶≥ization. The transaction is≈> subject to customary closing conditionsσ♦→×, including clearance under t→≈→he Hart-Scott-Rodino Antitrust Improvements Act.N★ ₩ ASH associated cirrhosis is the fastest growing∑← indication for liver trαγansplantation in the United States. Many pati•₩$φents with NASH develop associated∏±' liver fibrosis, whi✘≤"ch can lead to complications such as c★≈irrhosis and ultimate♠§'$ly liver failure. While several investigati×≠π→onal agents target mechanism∏∞¥ s that impact the earlier≤÷$λ stages of the NASH continuum∏÷, Pliant is targeting←& αvβ1, an integrin that ac✔φ>$tivates TGF-β, a putative master regulator of hep≤>atic fibrosis. PLN-1474÷β× has shown significant inhibiα₩♥™tion of fibrosis in live human tissue models. Pli↔§σant expects to submit an investigational new d✘★✔rug (IND) application to the U.S. Food and D©•rug Administration before the end of 2019$★•β.information so •Ωurce:pharma focus AsiaThe original¶' link:https://www.pharmafocusasia.com/news/pl<¶iant-therapeutics-announce αs-strategic-collaboration-δ↑to-develop-novel-therapiσ§es-for-nash-and-fibrotic-diseases2019 ∏Asia-pacific pharma IP Leader Sλ₩♥ummit: http://en.zenseeg♥♥₩roup.com/p/510934/ will be held iπ"n Beijing on Novemb¶✔>≤er 14-15, and will a≠☆ttract more than 500 industry experts from domes♥¥tic and foreign pharmaceutical companies,Ω∑σ× biotechnology companies, governments, asδ sociations, law firms, intellectual property agenγ >↓ts and other companies to attend.Offic'∞>♦ial registration and consultation channels':Contact：AnnPhone: 021-65650✔±305Email：Marketing@zenseegroup.comhttp≠→≥://en.zenseegroup.com/p/510934 -
1024
PDS Biotechnology Completes Manufactur∞₩→'ing of Clinical Batches of PDS0101
PDS Biotechnology Completes ±¥∞Manufacturing of Clinical$β© Batches of PDS0101WEDNESDAY, OCTOBER ∞¶α23, 2019PDS Biotechnology Corp↓®oration, a clinical-stage i♦≤mmuno-oncology company pioneering development σ≠of multi-functional novel immunothera∏§¶pies, today announced that it×∏←© has completed manufa"≥±cturing of clinical bat±×ches of PDS0101 with its par"♥tner BSP Pharmaceuticals S.p.A, a leading manufa¶✔☆cturer of anticancer drugs.The γβclinical batches of PDS0101 will be used in t§♣≠•he Company’s two upcoming Phase 2 stu®δ ←dies, which are expected to starσ×t in the first quarter♦₹< of 2020. The trials include• λ a combination study with Merck to evaluate ↓ σPDS0101 in combination with K ÷₩≠EYTRUDA® in first-line treatment of heaΩβ¶×d and neck cancer and a study to evaluate PDS≥€€0101 in combination with two nov←¥↕el clinical-stage immunotherapies in→λ advanced HPV associated cancer§×≥₽s with the National Cancer I♥£"nstitute.“We are pleased to have comp®≤leted the manufacturing of thφ↕e clinical batches of PDS0101 with our part×≈¶ner BSP Pharmaceuticals and are honored to b≥♣e collaborating with two leaders in theλ↕¥≠ field of immuno-oncoloα★₽gy,” said Dr. Frank Be£♣du-Addo, CEO of PDS. “Based on÷¶ our recently announced Phase 1 clinical out₽α☆come data which demonstrated PDS0101’s unique abi♠ ♦lity to promote the in-vivo induction o✘¥•€f high levels of HPV-specific CD8★ε+ killer T-cells as well as the regresγ±♠sion of pre-cancerous lesion∑©≥πs in 60% of patients, we believe tha£™t PDS0101 could expand the clinical efficacy o Ωf checkpoint inhibitors such as KEYTRUDA®∞✘∏". We are now working diligently to qualify clinicγ✘<al sites for our combination trial ¥↕with KEYTRUDA® in first line treatme↓♦εnt of head and neck cancer and look for'φward to initiating both our planned comb'εination trials by the first quarter© of 2020.”information '"source:pharma focus AsiaThe origina£♠l link:https://www.pharmafocusasia.com/new↔"<γs/pds-biotechnology-compleσ↕ tes-manufacturing-of-clinic ×→al-batches-of-pds01012019 Asia-pacific ph₩♦arma IP Leader Summit: htt≤→p://en.zenseegroup.com/p/404716/ will be he↓§ld in Beijing on ☆≈↑November 14-15, and will attract more than 5₽ε↔00 industry experts from domestic$↕≥< and foreign pharmaceutical companies, biotec δ×¥hnology companies, government₹βγ≠s, associations, law δ'firms, intellectual pr¥δγ→operty agents and other companies to a• ttend.Official registration and consultation cha♣™★nnels:Contact：AnnPhone: 021-6∏©≠÷5650305Email：Marketing@zenseegr™→oup.comhttp://en.zenseegroup.com/p/510934 -
1023
Moberg Pharma and DongKoo¥↓☆£ Sign Agreement for MOB-015 in the Republic¥λ of Korea
Moberg Pharma and DongKoo∏ ₩λ Sign Agreement for MOB-015 in the Republicπ₽ of KoreaTUESDAY, OCTOBER 22, 2019M<→oberg Pharma AB has signed a distribution §♥ agreement with DongKoo Bio &a¶₩Ωmp; Pharma Co., Ltd for MOB-0∏£±15 in the Republic of Korea. Under the agreement ΩDongKoo is granted exclusiveπ♠γ rights to market and sell MOB-015 in the Re♦δpublic of Korea. Moberg Pharma assumes product↓δ"ion and supply responsibility.DongKoo will c↑$onduct registration activities in the Republicβ £© of Korea, and will be ma✘₹rketing, distributing and sellin ¶♥g MOB-015 in the Repβ≠€♥ublic of Korea upon completion ₩™of registration."This is the fourth commercial ag♣φ←reement for MOB-015, this time with the marke♥♦→t leader in dermatology in Korea with excellen∏↓↑t coverage of the dermatology clinics. We lo☆€ok forward to work with DongKoo and making MOB-0÷↔β¶15 available in Korea, $€≈contributing to our vision of maki"₹ng MOB-015 the leading nail fung¥∏us treatment worldwide", says Anna Ljung, Cλ ¶EO of Moberg Pharma.According ™to Moberg Pharma's market intelligence, the K•"orean market for topical drugs for onychomycosis≠ amounts to $40 million (r≈§∑olling 12m ending June 2019).informa ₩tion source:pharma focus Asi§δ§aThe original link:https://www.pha$∑rmafocusasia.com/news/moberg-pharma-and-dongkoπ→¶ o-sign-agreement-for-mob-✔'015-in-the-republic-of-ko ×₹rea2019 Asia-pacific pharma IP Leader↔ ∏ Summit: http://en.zenseegroup.com/p/5109←βγ34/ will be held in>σ Beijing on November 14-15∞ ≈₩, and will attract more than 500 indus♣$try experts from domestic and foreign ph>×armaceutical companies, bioφ£technology companies, governments, a↑®♦§ssociations, law firm$±s, intellectual property agents an♠σd other companies to attend♥↔.Official registration and♦♥'₽ consultation channels:Cont"πact：AnnPhone: 021-65650305Email：Mark≠↔♠eting@zenseegroup.comhttp://en.zenΩ∑®seegroup.com/p/510934 -
1022
Sanofi to conduct pre✘£Ω✔cautionary voluntary recall of Zantac OTC i∑Ω"n U.S. and Canada
Sanofi to conduct precautionary volun ✔β©tary recall of Zantac OTC i÷♣σn U.S. and CanadaSATURDAY, OCTOBER 19, 201¥€♥™9As a precautionary mea€πsure, Sanofi will conduct a voluntary re↓¥call of Zantac OTC (over-the-counter) in the U.☆εS. and Canada. This recall is π ∑✘being taken due to pos♦Ωsible contamination ≥πwith a nitrosamine imp™₹≤∞urity called N-nitrosodimethylamine (NDMA). ÷δβThe company is working with health auλ∞≤πthorities to determine the level and extent of✔® the recall.On Septem≤±ber 13, 2019, the U.S Food and Dr✘§ug Administration and Healt™h Canada issued public statements alerting thaγ ≤αt some ranitidine medicines, in&×"≥cluding Zantac OTC, could contain NDMA at low lev$≥÷>els and asked manufactu↓α>☆rers to conduct testing.Evaluations ar"$★ e ongoing on both drug su←$>φbstance (active ingredient) and finished dru•g product. Due to inconsistencies in preliminary®←♣♦ test results of the active ingre☆£↔dient used in the U.S. and →¶★ Canadian products, Sanofi has made the deci∑↑"sion to conduct the v ₹☆↔oluntary recall in the U.S. and Canada as the inα•δvestigation continues.Active ingredients used inγ←±♣ Sanofi's ranitidine products outside ∏₹∞of the U.S. and Canada are sourced fα₹↕✔rom different suppliers. Sanofi is committed to ↔βtransparency and will continue to coΩ€£∑mmunicate results wit≤÷↔≠h health authorities from the ongo✔ing testing, and work with them to mΩ&>ake informed decision≤ ↕s based on available data and eviden'≤↕≤ce.Sanofi encourages©✘ anyone using Zantac ∞δ"OTC to speak with their health care providers o'≈↕®r pharmacists if they have any additional qu÷¶estions.information source:pharma ≈ ¥©focus AsiaThe original≈λ×♠ link:https:https:https://www.pharmafocusasia.com±→¶♦/news/sanofi-to-conduct-prec÷÷autionary-voluntary-recall-of-zantac-otc-in-us-an↑§ε♦d-canada2019 Asia-pacific pharma ε"IP Leader Summit: http://en.zenseeg£★✘∞roup.com/p/510934/ w≈>♣→ill be held in Beijing on No©"'♠vember 14-15, and will attract more than 500>α industry experts from dom≤×αestic and foreign pharmaceutical companies, biot★"echnology companies, governments, asso✔±™'ciations, law firms, intellectual propert×®y agents and other companies to a₽€£εttend.Official registration and consultatα★ion channels:Contact：AnnPhone: 021-δ&φ65650305Email：Marketing@zenseegroup.com₹×φ http://en.zenseegroup.com/p/510934 -
1018
HitGen Enters into DNA-Encoded®≠♥♦ Library Based Drug Discovery R£★→γesearch Collaboration with Galapagos NV
HitGen Enters into DN↕♦A-Encoded Library Based Drug Discovery Researc♦∑h Collaboration with Galapagos NVTHURSDAY, OCTOB←≠©$ER 17, 2019HitGen Inc. today announced that ✔λ£it has entered into a drug discov±↓ 'ery research collaboration with Galapagosσ♥φ NV to identify potential smallΩ♠ molecule leads against tarφ€<←gets of interest to Galapagos NV♦ . In this collaboration, HitGen will apply its✘"Ω technology platform, based on DNA-encodedσ£ library design, synthesis andβ< interrogation, to discover novel leads. U☆×γnder the terms of the ≈↑§agreement, HitGen willε∞ receive an undisclosed upfront payment and<☆×₽ will be eligible for milestonσ≠♥e payments from Galapagos ∑γ≈★NV.“We are delighted to enter this ©≤®¶collaboration with Galapagos NV, a leadi✘ε₹Ωng biotechnology company, specializing in π♦≠"the discovery and development of small® molecule medicines with novel modes o ©♥f action. We believe the collaboration rei✘nforces the role of HitGen’s platform in t ∑he rapidly developing field <↔←¥of DNA-encoded chemistry↓♥β. We will work closely¶ € with Galapagos NV scientists to ge•λnerate new small-molecule l↕ead compounds for th☆βeir research programs to help bring tr↑γ≈₩ansformative medicines to patients,×₩” said Dr. Jin Li, C♥β♣₽hairman of the Board and Chief Exec×∏utive Officer of HitGen.“We look forward to ₹↑♠×working with HitGen and tap i♦δnto their established DEL technology pl₽±♠atform to complement our internal screening♦∑™ and drug discovery technologies.” said✔™® Romain Gosmini, Director Medicinal Chemistr εy at Galapagos.information source:pharma foc€✘↑≠us AsiaThe original "'¥$link:https:https://www.pharmafocusasia.c←∑≥εom/news/hitgen-enters-in≥÷to-dna-encoded-library-based-✔© ≤drug-discovery-research-collaboration-withπ♣β-galapagos-nv2019 Asia-pacific pharma IP Leader S↔'≥ummit: http://en.zenseegroup ≤".com/p/510934/ will be h•₩≤eld in Beijing on δ<;November 14-15, and will ≤₽attract more than 500 industry e∞ xperts from domestic and foreign p₽harmaceutical companies, biotecβ>☆hnology companies, governments, as≠✔β€sociations, law firms, intellectual property age↑ nts and other companies to attend.Official regi&™¥"stration and consultation channels:Contact：AnnPhγ¶one: 021-65650305Email：Marketing@zenseegγ"Ωroup.comhttp://en.zenseeε★group.com/p/510934
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