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1025
Pliant Therapeutics Announces Strategic Co★±₹¶llaboration to Develop Novel The•÷λ♥rapies for NASH and Fibro↓σ§tic Diseases
Pliant Therapeutics Announces Strate§£gic Collaboration to Develop N €$↔ovel Therapies for NASH and Fibrotic≠ ♣∑ DiseasesTHURSDAY, O ₩δ✔CTOBER 24, 2019Pliant Therapeutics, Iβ↓¶±nc., a clinical stage biopharmaceutical comp↕¥£any focused on discovering and developi®γ₩±ng novel therapies fo>Ωr the treatment of fibrosis, today announ♦≥ced it has entered i$↔←nto a strategic collaboration and license ↕→agreement with Novartis co↕αδvering the development and commerci♦ ∞φalization of Pliant's preclinical φ↑∞•product candidate, PLN-1&Ω÷×474 and up to three additional integrin ₽ ™targets. PLN-1474 is→≤®≈ an internally discovered small molδ¥≠≥ecule selective inhibitor of integrin αVβ1, curreα§'ntly being developed for ↕™±←the treatment of liver fibrosis δγ associated with nona¥$lcoholic steatohepatitis (NASH)."Our resea÷☆$£rch continues to generate comp✘λelling preclinical evidence that supports th•<®e advancement of PLN-1474 ≤∞ ±as a clinical candidate and valid$<™×ates our approach of evaluating αVβ1 integ∞δ§rin inhibition to treat adεπvanced liver fibrosis associated with NASH,ασ×λ" said Bernard Coulie, M.D., P♠ ↑h.D., president and chief executive off×≠∞icer of Pliant Therape'§★utics. "Pairing Pliant's ←≥€>leading integrin biology and drug dis♥λ¥covery capabilities with Novarti↕φ₽♦s, a world-leader with one of the broadβ'★est pipelines investigating mono and combina ©tion therapies for liver di"¥♠↕seases including NASH, will support our↑ε ☆ goal of developing novel therapi<₽es for fibrotic diseases an®≠λd potentially bring meaningful treatment ✘↓≤±options to patients."Pliant will initially r®≈eceive $80 million from Novaε✔rtis, including an upfront paymenφ↓εt in connection with th" e collaboration agreem↕ent as well as equity investment commit♣π§ments. The collaboration agreement is ♦₹÷for a worldwide exclusive li <cense to PLN-1474 and up to thβ↑ ree additional product candidates g♣↑enerated under the c¥£γollaboration. In addition, Novartis wilσ÷ l fund Pliant's research and development ↑¶activities under the collaboration. Plia→$nt will be responsible for development of PLN-¶∑1474 through Phase 1 after which N'β₩ovartis will assume responsibilit♥γ≥y for all future development, manufacturi♣¶ng and commercialization. Pliant is eligibleγ¥ to earn milestone payments, contingent upon thπ☆≈e achievement of specified development, regula≈<≠←tory and commercial milest✔≠ones. The agreement also providesπ for tiered royaltie&₹s payable to Pliant ranging from th ×→e mid-single digits to low€£∑ double digits on product sales upo≈δn commercialization. The transaction & is subject to customary closing conditions, i♠£≥ncluding clearance under th∞≈&&e Hart-Scott-Rodino Antitrust Improvements Act.N©✘$ASH associated cirrhosis is the ₽©fastest growing indication f¶ ↑or liver transplantation in the United Sta♥↕←εtes. Many patients wit¥∑h NASH develop associated liver ♥♠fibrosis, which can lead to complicatiα≥ons such as cirrhosis and ultΩ₽imately liver failure. Whi§γλle several investigational agents target mechan♣λ®isms that impact the earlier stages of the NAS§∑πH continuum, Pliant is targetingΩα αvβ1, an integrin that activates TGF-β, aΩ¶ putative master regulator of hepπ<∏atic fibrosis. PLN-1474 has shown significant inφε¥₽hibition of fibrosis in live human tissue ×<models. Pliant expects to subγ→mit an investigational new drug (IND) a'×pplication to the U.S. Food and D✘™©rug Administration before the end of↔♣ 2019.information source:pβ£harma focus AsiaThe original link:https://www.pha<♦♣rmafocusasia.com/news/pβσliant-therapeutics-announces-strateg ∞→&ic-collaboration-to-develop-novel-therap™£ies-for-nash-and-fibrotic-diseases2019 Asia-pac≥ασific pharma IP Leader Summit: http://en.ze↑↔nseegroup.com/p/510934/ will♦β↔ be held in Beijing β↑; on November 14-15, and will ♣$γ↔attract more than 500 industr✘&y experts from domestic and foreign•§ pharmaceutical companies, bio↓¥€technology companies, gov♦≠ernments, associations, law firms,×∑ intellectual property agen ₽ts and other companies₹₩∏ to attend.Official registration and £↔Ωconsultation channels:C ontact：AnnPhone: 021-65650305Email：Marketing@ ↔Ωzenseegroup.comhttp://en.zensee÷ε÷group.com/p/510934 -
1024
PDS Biotechnology Completes Manufacturing €ε™₹of Clinical Batches of PDSε♣✔0101
PDS Biotechnology Completes Manufa≤¥β₹cturing of Clinical Batches of PDγS0101WEDNESDAY, OCTOBER 23, 2019PDS Biotechnol∞∞✘ogy Corporation, a clinical-stage immu←☆no-oncology company pioneering development↑← of multi-functional novel immunotherapies≈♥→, today announced that it has completed manufactu'₽€ring of clinical batches of PDS0101 wi±♠™th its partner BSP Ph₹₹armaceuticals S.p.A, a leading manufacturer of a"♦nticancer drugs.The clinic≠∏∏al batches of PDS0101 wi™★ll be used in the Company’s two upcoming Phasεσ e 2 studies, which are expected ©β↓÷to start in the firs•÷↔☆t quarter of 2020. The trials includ£δ↕∏e a combination study with Merck to eval₩§uate PDS0101 in combination wit☆₹ βh KEYTRUDA® in first-line treatment¶ of head and neck cancer and a study to eval∞ ₹uate PDS0101 in combination with two n$₩&★ovel clinical-stage immunotherapies in ε¶advanced HPV associated c©♣&ancers with the National Cancer Institutδγ'σe.“We are pleased to have ₩≤↑completed the manufacturing of the clinicσ÷al batches of PDS0101 with our pa'∞rtner BSP Pharmaceuticals and are honored to be ™≠$collaborating with two le∞¥aders in the field of✔↕ immuno-oncology,” said Dr. Frank Bedu-Addo, ≈↑≤CEO of PDS. “Based on ouδ→r recently announced Phase 1 cli✔<nical outcome data which demonstrated PDS0101’s γ∏<γunique ability to promote the in-vivo induction o∑ f high levels of HPV-specific CD8★₩↓+ killer T-cells as well as t×→he regression of pre-cancerous lesions in 60%♣✘♠ of patients, we believe that PDS0101₽φ could expand the clinical efficacy× of checkpoint inhibitorΩ→βs such as KEYTRUDA®. ✔↕We are now working diligentl> →y to qualify clinical sites for our combin×≤♣ation trial with KEYTRUDA® in fi∞♦rst line treatment of head and neck cancer a&÷€¶nd look forward to initiating both our pla§¶nned combination trials by the first quarter of 2♠λ↕₹020.”information source:pha♦π↕rma focus AsiaThe original link:htt£♠↔₹ps://www.pharmafocusasia.com/news/pds-biote™✔±←chnology-completes-manufacturing-oφαf-clinical-batches-of-pds01012019 Asiβ☆ a-pacific pharma IP Leader Summit: http://en.z✔πenseegroup.com/p/404716/ will be he™∞><ld in Beijing on Nove✔mber 14-15, and will attract more than ↔ε♣500 industry experts f∞rom domestic and foreignβφ↕ pharmaceutical companies, biotechnology comp✔×anies, governments, associati™'ons, law firms, intellectual property agents <Ω∑σand other companies to attend.Of¶λ♣"ficial registration a♣♥nd consultation channels∏↕:Contact：AnnPhone: 021-65650305Email：Mark♣☆×eting@zenseegroup.comhttp://en.zenseegrouδ✔Ωp.com/p/510934 -
1023
Moberg Pharma and DongKoo Sign Ag"☆ ×reement for MOB-015 in the Republ$ic of Korea
Moberg Pharma and DongKoo Sign Agreement for Mλ§$OB-015 in the Republic of KoreaTUESDAY, OCTOBER®± 22, 2019Moberg Pharma AB has sig≤δ®ned a distribution agreement wi ↔♦th DongKoo Bio & Pharma Co., Ltd for MOB≥←-015 in the Republic of Korea. Un>☆δ™der the agreement DongKoo is granted<&> exclusive rights to market and sell MOB-015≠±♣∞ in the Republic of Korea. Moberg Pharma assu'©mes production and supply reσ∏÷sponsibility.DongKoo will con®λduct registration acti↕₽vities in the Republic of Korea, and will be £$✘marketing, distributing and selling MOB-015 in γ"∑the Republic of Korea upon completion of registr <δ♥ation."This is the fourth commercial agr≈¶←eement for MOB-015, this t¶✔ime with the market le&★ader in dermatology in Koreβπ&®a with excellent coverag™ •e of the dermatology clinics. We look forwarδ↑d to work with DongKoo and making MOB-015 available in Kore↑αa, contributing to our vision of ma↑ ±king MOB-015 the leading nail fungus treatm÷φπσent worldwide", says Anna ☆∏≈Ljung, CEO of Moberg Pharma.Accordin$¥g to Moberg Pharma's φ≤$market intelligence, the Korean market for toδ맮pical drugs for onyc•÷homycosis amounts to $40 million (rolling 12m↕₩ ending June 2019).information&β♠±nbsp;source:pharma focus AsiaThe<£↔ original link:https://www.pharmafocus£₹ asia.com/news/moberg-pharma-and-dongkoo-sig÷↕n-agreement-for-mob-015♠β>↓-in-the-republic-of-korea2019 Asia-pacifi↑<c pharma IP Leader Summit: http:/ ✔✔☆/en.zenseegroup.com/p/510934/ will be held i≥₩n Beijing &nbσ≠'§sp;on November 14-15, and will at↓'₩€tract more than 500 industry ex∞±÷perts from domestic and foreign pharmaβ ♦ceutical companies, ♣₽↔≈biotechnology companies, governme≠←nts, associations, laק×w firms, intellectual property agents a"♥∞∑nd other companies to attend.Official r€←egistration and consultation ÷£↑channels:Contact：AnnPhone: ✔↔σ∑021-65650305Email：Marke♠ •✔ting@zenseegroup.comhttp://en.zenseegroup.com/p€<®/510934 -
1022
Sanofi to conduct precauti↔±£πonary voluntary recall of Zantac OTC i¥"&σn U.S. and Canada
Sanofi to conduct precautionarαε€y voluntary recall of Zantac OTC in U.S. and C¶®βanadaSATURDAY, OCTOBER 19, 201β₩♦∑9As a precautionary measur×₩e, Sanofi will conduct a voluntary recall of ♣ Zantac OTC (over-the-counteδ≈☆r) in the U.S. and Canada. This recal•>l is being taken due t♣€€o possible contamination with a nitrosamine impur×←ity called N-nitrosodim$γethylamine (NDMA). The company is worki↑ ™ng with health authorities to determine the lev±♥€el and extent of the recall.On S≥✔™eptember 13, 2019, t≥≥he U.S Food and Drug Admi↓><nistration and Health Canad¶€♣ a issued public statements alerting that some r✘≈π£anitidine medicines, including Zantac OTC, cou×↑→ld contain NDMA at low≥φ levels and asked manufacturers to conduct ♦₽testing.Evaluations are ongoin≠™©g on both drug substance (active ingredient) and ←♦ finished drug product. Due to inconsistenc÷βies in preliminary test results →<"of the active ingredient used in the U.S. a∏'nd Canadian products, Sanof<∑&i has made the decision to conduct©"€ the voluntary recall in the U.S. an€×δ₽d Canada as the investigation continues.Acti↔ ≈ve ingredients used in Sanofi's £←ranitidine products oε<utside of the U.S. and Canε≤ada are sourced from diffe'₽£rent suppliers. Sanofi ¶↕✔is committed to transparency and will continue ©<Ω→to communicate results with✘★Ωδ health authorities fro ₩± m the ongoing testing, and wo®rk with them to make in ¶¥₩formed decisions based on available dat©"a and evidence.Sanofi encourages anyone usin ≥≤g Zantac OTC to spea¶λ×k with their health care provi↓÷÷ ders or pharmacists if the↔₩φ↓y have any additional questions.informationαλ source:pharma focus AsiaThe originφ§al link:https:https:https://www.pharmafocπ♠∏↓usasia.com/news/sanofi-to-conduct-precau₽φ¶ tionary-voluntary-recall-of-zantac-otc- •εαin-us-and-canada2019 Asi↕≈a-pacific pharma IP Leader Summit: http:¶ε//en.zenseegroup.com/p/510934/ w ↔✘ill be held in Beijing on N↑>ovember 14-15, and will attract more than 500✔∞≥ industry experts from∑↔ domestic and foreign pharmaceutα×ical companies, biotech♦™nology companies, governments, associat ™∏ions, law firms, intellectual property agen'Ω↓¶ts and other companies to$€ attend.Official registration€ and consultation channels:Contact：AnnPhone:↓← 021-65650305Email：Markδ↓✔eting@zenseegroup.comhttp://en ↔.zenseegroup.com/p/510934 -
1018
HitGen Enters into DNA-Encoded γ'÷Library Based Drug Discovery Research Co©₩₩llaboration with Galap₽λδagos NV
HitGen Enters into DNA-Encoded LibrΩ♦ary Based Drug Discovery Research Collaboration w>§ith Galapagos NVTHURSDAY, ≥♠≠OCTOBER 17, 2019HitGen Inc. today a÷★nnounced that it has entered≤δ into a drug discovery §γ§research collaboration with Galapagos N÷®€÷V to identify potential small molec&ule leads against targets of int ↕☆erest to Galapagos NV. In¶★✘" this collaboration, HitGen w♥β ill apply its technology platfor>↓Ωm, based on DNA-encoded lib₹γ₹rary design, synthesis an♥εd interrogation, to discover nove£φσl leads. Under the terms of the agreement, Hε$♦φitGen will receive an undis∏♣§closed upfront payment and will be eli©φgible for milestone paymen∞↔¥ts from Galapagos NV.“We are ≤σ↕delighted to enter this collaboration wi←φ&th Galapagos NV, a leading biotechnolo₩∏≥gy company, specializing in th±→λ↕e discovery and development of small molecu∏ le medicines with novel modes of action. We be∞®♣lieve the collaboration reinforces the r≤•€ole of HitGen’s platform in the rapidly developi★↔ng field of DNA-encoded chemi♣≤γφstry. We will work closely with Gal♠&apagos NV scientists to generate new smaβ≤ll-molecule lead compounds for their research pr∏©×<ograms to help bring traβ>☆₹nsformative medicines to patients,” said Dr. J €αin Li, Chairman of the Board and Chi♣≠♣ef Executive Officer of HitGen.“We look forwaφ₩₹¶rd to working with HitGen and tap into÷ their established DEL technology platform ← to complement our internal scΩ✘≤reening and drug discovery technologi★←es.” said Romain Gosmini, Dire®©←ctor Medicinal Chemistrε<&✘y at Galapagos.information source:pharma>↑ focus AsiaThe original link:https:https://www.ph→εarmafocusasia.com/news/hitgen-ent✔•←ers-into-dna-encoded-library-based-drug-discoverα↑y-research-collaboration-with-gal♠♠™≠apagos-nv2019 Asia-pacific pharma'& IP Leader Summit: http://en.zenseegroup.comγ♦/p/510934/ will be held in Beijing β≈; on November 14-1 ≤≠₩5, and will attract morβ©e than 500 industry experts from domestic and f↑™₽oreign pharmaceutical ™"companies, biotechnology companies, governments,ε←¥☆ associations, law fir→β↑✘ms, intellectual property agents and other compa÷✘★₹nies to attend.Official registration and consul∞π♦tation channels:Contact：AnnPhone: 021-6565£∏£0305Email：Marketing@zenseegroup.comhttp:↓↓Ω¶//en.zenseegroup.com/p/510934
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