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1025
Pliant Therapeutics Announces Stratα&egic Collaboration to Develop Novel Therapies •€∑for NASH and Fibrotic Diseases
Pliant Therapeutics •λAnnounces Strategic Collaboration to Deve→≠✔↕lop Novel Therapies f"'×or NASH and Fibrotic ©₽★¥DiseasesTHURSDAY, OCTOBER 24, 2019Pliant Therap©↓<♣eutics, Inc., a clinical st•≤€age biopharmaceutical company focused on disc↓§πovering and developing nov€'★el therapies for the treatment of fibrosis, tα↓☆σoday announced it has entered into a strategi©☆↔≥c collaboration and li'§cense agreement with Novartis covering t¥φ↕•he development and commercialization of P₩±$ liant's preclinical product candidat©φe, PLN-1474 and up to§♠₹ three additional inπ±₽tegrin targets. PLN-1474 is an i™∞nternally discovered sm'®≥βall molecule selective inhibitor ↔©of integrin αVβ1, cu≈≤rrently being developed for the treatmσσent of liver fibrosis associated with nonalc©★λoholic steatohepatitis (Nδ☆ASH)."Our research coδntinues to generate compelling prec✔ linical evidence that supports the ¶∞®advancement of PLN-1474 as a clinical÷•♠™ candidate and validates our approac ←∏h of evaluating αVβ1 integrin ÷ ♠inhibition to treat advanced liver fibrosis asλλ₽♣sociated with NASH," said Bernard Coulie, M.D.,≈♦→$ Ph.D., president and ↓α★chief executive officer of Pl→¶iant Therapeutics. "Pairinφ<g Pliant's leading integ§↑₽&rin biology and drug discovery capabi¥ε€lities with Novartis, a w∞₹±§orld-leader with one of the broadest pipelines ©≠♣investigating mono and combinβ™δation therapies for liver dis↓∑λeases including NASH, will support ouλ©¥¥r goal of developing novel≤• therapies for fibrotic disea₹γ≤ses and potentially bring meaningful treatmentσ< options to patients."Pliant δ≥•will initially receive $80 mill★ion from Novartis, includinα ≥←g an upfront payment in connection with the co'λ↕llaboration agreement as well$↓σ as equity investment commi→Ω©πtments. The collaboration agreement is£σ for a worldwide exclusive liceαΩ×nse to PLN-1474 and up to three additional produ ct candidates generated under the collΩ§aboration. In addition, Novartis will f♠γund Pliant's research and ®• development activities under the co ★↓llaboration. Pliant will be res™'ponsible for development of PLN-1474 through Phaε≠se 1 after which Novarti ¥δs will assume responsibilit">y for all future development, manufΩ♥γacturing and commerciali₩↑zation. Pliant is eligible ¶'§to earn milestone payments, contingent↑© upon the achievement o₹↕£f specified development,¥≤✘✔ regulatory and commercial milestones. The ag¶≠"πreement also provides↔&>↔ for tiered royalties payabl™$'×e to Pliant ranging from the mid-singl×→ ♠e digits to low double digits on prγ≠oduct sales upon commercialization. The tranπ∑≤εsaction is subject to customary ♦←'πclosing conditions, including clea♥©'rance under the Hart-Scott-Rodino Antitrust Iε mprovements Act.NASH associated cirrhosis is ✘★'₽the fastest growing indica ♣♠tion for liver transplΩ✘ antation in the United States. Man≥≈y patients with NASH develop a≠₹ssociated liver fibrosis, which can lead toφ↑ complications such as ↔>♣ cirrhosis and ultimately liver failure. While sev★↓×¥eral investigational agenε↑ts target mechanisms th★δ'★at impact the earlier stages of the N∞★≥ASH continuum, Pliant is targeti™γ∑ng αvβ1, an integrin that activates T¥★GF-β, a putative master✘< regulator of hepatic fibrosβ•$ is. PLN-1474 has shown significant i"±'nhibition of fibrosis in live human ♥tissue models. Pliant expects to s¥±≠₩ubmit an investigational new drug (Iε∏→±ND) application to the U.S. Fo→∑od and Drug Administration before the end of 2↑δ019.information source:pharma focus AsiaThe ♣α♥original link:https://www.pharmafocu"$sasia.com/news/pliant-therapeutics$>-announces-strategic-collabor±♦×ation-to-develop-novel-therapies-for<₽γ-nash-and-fibrotic-diseases2019 Asia-≈<pacific pharma IP Leader Summit: ≈∏∞http://en.zenseegroup.com/p/510934/ will be γ↑held in Beijing o§÷₹n November 14-15, and will attr₹<act more than 500 industry experts from dome∏₽stic and foreign pharmaceutical com×♣♣ panies, biotechnology c" →÷ompanies, governments, assocγ≈€iations, law firms, intellec£♦→γtual property agents and other companies to ™¶attend.Official registration and consultat ion channels:Contact：AnnPhone: 021-65650305σ®<¶Email：Marketing@zenseegroup.comhttp←Ω★://en.zenseegroup.com/p/510934 -
1024
PDS Biotechnology Co✔↕≥mpletes Manufacturing of Clinical B±★atches of PDS0101
PDS Biotechnology Completes Manufacturφ"ing of Clinical Batches of PDS0101WEDNESDAY, ∏&OCTOBER 23, 2019PDS Biotechnolo≤∑gy Corporation, a clinical-stage immuno-oncolog$™¶y company pioneering development of multi-funδσ♦ctional novel immunotherapies, today anno§αunced that it has completed manufacturing of c↕γ"¥linical batches of PD≈α€÷S0101 with its partner BSP Pharmaceutic✘÷als S.p.A, a leading manufacturer of anti÷↓≠cancer drugs.The clinical batch€£<es of PDS0101 will be us→←ed in the Company’s two upcoming Phase 2§ π€ studies, which are expected to start i¶≈n the first quarter of →πα 2020. The trials include a combination study wi♠≤♦th Merck to evaluate PDS0101 in combinat"₩₽ion with KEYTRUDA® in first-line€☆←✔ treatment of head and ∞≈ neck cancer and a study to evaluatσ←e PDS0101 in combination with two novel clinical∏δ∏-stage immunotherapies in advanced HPV ™↓associated cancers with the←♦ National Cancer InstituteΩ₹.“We are pleased to ±φhave completed the manufacturing of t>≤¶he clinical batches of P↔<£αDS0101 with our partner BSP Pharβ≥πmaceuticals and are honored to be collaε∞ borating with two leaders in t≈↓€₽he field of immuno-oncology,” s≥∏aid Dr. Frank Bedu-Addo,₹&≥ CEO of PDS. “Based on our ≠±×recently announced Phase 1 clinical out₩ ←≈come data which demonstrated PDS0101β$’s unique ability to promote the i↑$¶n-vivo induction of σhigh levels of HPV-specific CD8+ killer T-cells™ ☆¥ as well as the regression of pre-c±ancerous lesions in 60% of pγ↑atients, we believe that PDS0101 >σcould expand the clinical efficacy of checkpo£ ®int inhibitors such as KEYTR"Ω UDA®. We are now working diligently to qualify § αclinical sites for ou♣↕r combination trial withδ KEYTRUDA® in first λ✘line treatment of head and neck cancer a★α÷&nd look forward to initiating bot∑←&♥h our planned combinat↔&ion trials by the first qu↑♥∞arter of 2020.”information source:pharma f©¥¥ocus AsiaThe original link:https://www.p←' ☆harmafocusasia.com/news/pds-biotec₹¶£≤hnology-completes-manufacturing-oα§f-clinical-batches-of-pds01012019♦← Asia-pacific pharma IP Leader Summit: http:/δ'↓/en.zenseegroup.com/p/404716/ w€δπill be held in Beijing&nb¥←sp; on November 14-₽©÷15, and will attract mor≤↓α☆e than 500 industry experts from domestic and forλeign pharmaceutical companies, biotechnology com¥δπ≠panies, governments, associations, law firms,≥₹ intellectual property agents and other ↑Ω∞companies to attend.Offi©♥cial registration and consultation chan¶≤nels:Contact：AnnPhone: 021-656503φ©£γ05Email：Marketing@zenseegroup.comhtt"♣¥p://en.zenseegroup.com/p/510934 -
1023
Moberg Pharma and DongKoo Sign Agree÷≠ment for MOB-015 in the Republic of Korea
Moberg Pharma and DongKoo Sign Agreement ∞↓®for MOB-015 in the Republic of Korea↕•TUESDAY, OCTOBER 22, 201↔φφ9Moberg Pharma AB has signed a distribu↑ππ¶tion agreement with DongKoo Bio &≤∏™♦; Pharma Co., Ltd for MOB-015 in the Republ≤••×ic of Korea. Under the agreement DongKoo iα ♦πs granted exclusive righ¥δσ×ts to market and sell MOB-01"α5 in the Republic of Korea. Mobergφ'★↑ Pharma assumes prod™≥±uction and supply responsibility.Dong λ♥βKoo will conduct registrat₩§ion activities in the Republic ofφ↑☆π Korea, and will be marketing, distributing'♣☆ and selling MOB-015 iπ€®n the Republic of Korea upon complet✘®ion of registration."₹∑♥This is the fourth commeφγ''rcial agreement for MOB-015, this time <♣&with the market leader in dermatφ β"ology in Korea with excelle↓φαnt coverage of the dermatology clinics. We look f←↔♦orward to work with DongKoo and mak₩ing MOB-015 available in Korea, c♣↑ontributing to our vision of making MOB-015 € the leading nail fungus treatment worldwide",≤÷ says Anna Ljung, CEO of Moberg Pharma.Accord↔∑ing to Moberg Pharma's marke₩♦ t intelligence, the Korean market for topical ™×♥ drugs for onychomycosis©™≥ amounts to $40 million (rolling 12m e∞£<nding June 2019).informatαβ>ion source:pharma focus AsiaThe o€ §riginal link:https://www.phar©β✔→mafocusasia.com/news/moberg-phar∞§ma-and-dongkoo-sign-agreement-for-mob-015-inσπ-the-republic-of-korea2019ε§♥Ω Asia-pacific pharma IP Le$∞' ader Summit: http://en.zenseegroup.com/p¶/510934/ will be held in B φ★ eijing on Nov★ ember 14-15, and will attract more t &←han 500 industry experts from domestic and foreφ ign pharmaceutical companies, ♠≤→biotechnology companies, governments↓♠§, associations, law firms, intellectual propert←<y agents and other companies to attend.Official ✘<÷₽registration and consultation channels:Contact↑↑：AnnPhone: 021-65650305Email：Marketing@zens£'eegroup.comhttp://en.zenseegroup.com/pδ★×$/510934 -
1022
Sanofi to conduct precautionaryλβ← voluntary recall of Zantac OTC in U.S. and Canad↑βa
Sanofi to conduct precau←&tionary voluntary recall of Zantac₽¥γ OTC in U.S. and CanadaSATUR∞¶∑>DAY, OCTOBER 19, 2019As &σa precautionary measure, Sanofi will ©≤conduct a voluntary recall of Zanα'∏tac OTC (over-the-co÷ unter) in the U.S. aε nd Canada. This recall ♣¶is being taken due to p↑<→ossible contamination wiσ↓→th a nitrosamine impurity called N-nitrosodimet∑♠hylamine (NDMA). The company is wor>®βking with health autho¶rities to determine the level and extent♣≥ of the recall.On Se§★λptember 13, 2019, the U.S Foo♦≈✔d and Drug Administration and He∞αalth Canada issued public s₹§™↑tatements alerting tha &t some ranitidine medicines, ♠♣♣including Zantac OTC, could contain NDMA at low →∞×≤levels and asked manufacturers to conduct♦§ testing.Evaluations are ongoing on both drug su→↑bstance (active ingre£♣dient) and finished drug p≥♠$×roduct. Due to inconsistencies in p♠✘reliminary test results of the ac≠< tive ingredient used in the U.S. and Canadian p₹♠§roducts, Sanofi has made the decision to con↓<§duct the voluntary recall in the U.≠↓S. and Canada as the investigation co¶≥♦γntinues.Active ingredients used♦£¶ in Sanofi's ranitid∑φ↔ine products outside of the U.S. and♠σα Canada are sourced from § different suppliers. Sanofi is committed to≤π transparency and will continue to communica>±te results with health authorit★≈ies from the ongoing testing, and work with ÷<εthem to make informed dΩσ£ecisions based on available data and ↓♠₩evidence.Sanofi encourages an$φ☆™yone using Zantac OTC to speak with their healt∑Ωh care providers or pharmacists if they have any ★£↓additional questions.inf< ↕ormation source:pharma focus Asia©α♣The original link:https:https:ht ♣tps://www.pharmafocusas≈♥→ia.com/news/sanofi-to-conduct-↔£↔precautionary-voluntary-recall-of-zan÷☆tac-otc-in-us-and-canada↔☆♦2019 Asia-pacific pharma IP Leader Summit: http≥↑βα://en.zenseegroup.com/p/510934/ wil §♣l be held in Beijing on&n♠←β←bsp;November 14-15, and will att&ract more than 500 in¥↑dustry experts from domestic and≤♣ foreign pharmaceutical ≈¶companies, biotechnology comp∏γanies, governments, associations, law firms♠Ω, intellectual property agents ₽♣σand other companies to attend. ≥®×Official registration and consultation Ω channels:Contact：AnnPh≤♦one: 021-65650305Email：Mark↓ ∏→eting@zenseegroup.comhttp://enΩ↓.zenseegroup.com/p/510934 -
1018
HitGen Enters into DNA-Encoded Library ✔₹π'Based Drug Discovery Research±" Collaboration with Galapagos NV
HitGen Enters into DNA-Encoded Library Based D÷<rug Discovery Research Collab↕♣±oration with Galapagos NVTHURSDAY, OCTOBER 17≥δ, 2019HitGen Inc. today announced that it β≈has entered into a dr×≠φug discovery research col₹★laboration with Galapagos NV ↔ to identify potential small molecule leads λ¥₽§against targets of interest t₽♥♦☆o Galapagos NV. In this coll₽®↑aboration, HitGen will apply its techσδnology platform, based on DNA-encoded∏€ library design, synthesis and interrogatio∞₽γ n, to discover novel lead→♣₽s. Under the terms of the agreement, HitGen ¶ will receive an undisclosed upfron£∞↕t payment and will be eligible for milestone αpayments from Galapagos NV.“We are delighted t₩"€o enter this collaboration with 'Ω∞✘Galapagos NV, a leading biotechnology company↕©, specializing in the di§ δεscovery and development of small molecu≠®le medicines with novel modes of action. We beλ←lieve the collaboration reinforces the role of HαΩitGen’s platform in the rapidly developing fi≥↓eld of DNA-encoded chemistry. We will work→€₩☆ closely with Galapagos NV ×≤<™scientists to generat®β£∑e new small-molecule lead ≥compounds for their research programs ∏Ωto help bring transformative me$✔≤←dicines to patients,” said Dr. Jin Li>>, Chairman of the Board and Chief Executi ↑ve Officer of HitGen.“We look forwar'★≤d to working with HitGen an䧱βd tap into their estab®××♦lished DEL technology p'φΩ§latform to complement our internal scre≥÷♠ening and drug discov↔≠<☆ery technologies.” said Romain Gosmini, Director ββ¥Medicinal Chemistry at↔✔¶ Galapagos.information sourc÷∑←e:pharma focus AsiaTh®λe original link:https:https://www.pharma±₩focusasia.com/news/hitgen-enters-into-dna-encodedπ↕÷ε-library-based-drug-discove"®ry-research-collaboration-with-gal₹apagos-nv2019 Asia-pacific pharma •≠IP Leader Summit: htt&₹÷→p://en.zenseegroup.co★§m/p/510934/ will be heldδ$β∏ in Beijing ®★₽on November 14-15, and will attr'€εact more than 500 industry§∏≈☆ experts from domestic and foreign pharmaceutica©ε₽l companies, biotechnologyα>§☆ companies, governments, associations, law ≈♣↔✘firms, intellectual property agents and ♥§other companies to attend.Official re€↔$gistration and consultatΩ₩δ∞ion channels:Contact：AnnPhone: 021-65650305Eπ♣↑σmail：Marketing@zenseegroup.comhttp://en.zensee£₽✔group.com/p/510934
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