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0902
DarwinHealth announces a scienti↓¶fic collaboration with Celgene on a discovery plaφ≈tform in systems biology
DarwinHealth today announced a multi-yea≤♥r scientific collaboration with Celgene Corpor≤₽≠ation ("Celgene") to use a$≥lgorithms based on quantitative systeλ±∑"ms biology, technoloδ✘×εgies that also underpin th♠≈e evidence of diagnosis approved by © the Reforms on the Improvement of Clinical LεΩ♠aboratories (CLIA) of the S® ↔÷tate of New York in oncology, and novel validated✘≠♣£ approaches focused on therapies aimε≈∑☆ed at control points, in orde ↓r to support clinical developme☆♣♠nt initiatives of Celgene with respect to certa↕ in specified compounds.The research collaborati≈€ ★on, known as C2C (Compound-2-Clinic), wi±÷ll implement the propδ♥™rietary composite / tumor control point matching ≠←platform for the DarwinHealth tuλβ∏mor subtype, based on the VIPER, Oα≥ncoMatch and OncoTreat < algorithms, and its high perfor₩∑mance drug alteration discovery platfφ✘∏¶orm and Plate-Seq to analyze ←π♥the effects of certain specifi→₩σed compounds."The goal of this excεγiting collaboration," said Andrea Califano₩₹★ , a professor at the Clyde and™≈♠ Helen Wu center and a professor in the S•☆&₹ystems Biology department at Columbia ∑ University , and co-founder of DarwinHealth.≠γ¶↓ "It is about evaluating, characterizing and p±∞rioritizing the bioactivity, relevant f ≈÷♥or oncology, of certain co•™↓mpounds, using our alg ≤orithmic framework in order to identif ★y their mechanism of action (MdA) against master×★ regulator (RM) proteins, which ma↑γβ↓ke up the tumor control point₩±s of the selected tumor subtypes contemp©π✘lated in the collabora♦♠®tion. "As part of the C2C initiative, Dar₩αwinHealth will provide a comprehensive reading ofλ the potential clinical v€" alue of certain compounds in a specific context∏σ ≈ of the cancerous tissue, including its mechanism"↓£ of action throughout the genome and the𙶠biomarkers of tumor-specific€• sensitivity and resistance. Througδ∑£≥h quantitative modeling it is possible to pred®→$•ict the development t¥rajectory of possible treatments in↔♦δ order to allow a more effectiγ≠ve design of clinical trials of Celgene.¥₹"C2C promises to be one of the most fruitfuγ≤'✘l and fundamental scientific colla←$¶≥borations," said Dr. Gideon Bosker, £ δσCEO and co-founder of DarwinHealth. "Working h×"≤and in hand with Celgene s←÷φ✔cientists, our goal is to delineate the full ₩βφ±range of tumor subtypes (many of ₹Ωwhich are totally unforeseen), in whi♣≤×ch Celgene-specific compou☆≈γnds show antitumor activity that can be clini£♠cally validated. Identification of €the biomarker alignmγ×ents compound / tumor is theφ★ cornerstone of our technology, so this collabo ←≈™ration is exceptionally suitable to exploit o®♦ε∞ur capabilities in the space of cancer drug disco€§&very. " This collaboration can allow Celgε€ene to quickly mature the compounds for ✘ clinical trials in hu≤↑≤ mans and commercial developmeα♦γnt."We look forward to collaboratin↑ g with the DarwinHealt↕ ≥h team, using quantitative methodologies th≠γat focus on mechanisms that begin to ∑®"revolutionize the approach to cancer ∞♥drug discovery," said Rupert Vessey , pr¥esident of Research and Initial Devel׶∞opment at Celgene Corporation. "Using δ'λsystems biology platforms focused on pre♠&α®cision oncology, we believe that this mechaε>©nism-centric data can facilitate greate$™r speed and likelihood of success in the∞∞ successful application of γ®×treatment options to c&☆™ancer patients."the 2019 Asia-pacific pharma≠€₹σ IP Leader Summit: http://en.z∏→enseegroup.com/p/404716/ will be held in&n ≈®bsp;Beijing on&n•Ω₽'bsp;November 14-15, and wiσ♣×φll attract more than 500 industry ex≈λ±perts from domestic and foreign pharmac₽•eutical companies, biotechnology companies, g¥↓overnments, associations, law firms, intellectual>§" property agents and other companies tσεo attend.Official registration and consultatiβ★on channels:Contact：AnnPhone: 021-≤₽₹65650305Email：Marketing@zenseegroup↑©φ≈.comhttp://en.zenseegroup.com/p/510934/ -
0107
US property/casualty rates climb 5% in Q4: Mark★✔≈etScout
From :businessinsuranceU.S. commercial prop εerty/casualty rates rose 5% on average in th σe fourth quarter of 2019, up from 4% in t¥☆•♠he third quarter, reflecting insurer≤★σs’ intent to continue to increase prices✘λ≥ across most lines, online≤₩₽Ω insurance exchange MarketScout Corp. said Monda♠© y.“Auto rate increases have been→&δ up all year long; however D&O (director✘§<s & officers) and professional rate increases£" have spiked significantly in t↔©¶€he fourth quarter,” Richard Kerr,←≠ CEO of MarketScout Corp. said in a state₩✔♥εment.Insurers are carefully analyzing their propeα¶rty exposures using catastrophe modeli★∞☆φng tools, he said. “We expect many o₩•★£f the major property÷&★ catastrophe insurers to curtail their 2020 w★♣≈&ritings in California brush and Eas☆₩≠t and Gulf Coast wind areas. Naturally, this wi>☆×ll result in higher rates ≠>™to insureds,” Mr. Kerr saπ≥id.D&O liability rates increased by 8.25%∑£λ, while commercial au♥✔™to increased 8% in the ©✘₹quarter, and profess±"ional liability rates were up 6%, and umbrella/ex™♦cess rates were up 5.5%, according to MarketSco★♥♣εut.Commercial property rates increased 5©±↓.25% in the quarter, and business int ™£"erruption rates were up 5%, while all other lin☆π↓es showed smaller in←↓™creases, except for workeδ∞φrs compensation, where rates fell 1%,♥™± MarketScout said.By×≈ industry class, transportation and habi±$±πtational saw the highest average rate increase♦"s at 9% and 8.25% respectively, Ma rketScout said.Large accounts – those with $₹↓250,001 to $1 million in premium – ¥✔σsaw a rate hike of 5.5% in the § ↑★fourth quarter, as did jumbo acc♣ ounts, which have more than $1 million in premi $um. Small accounts – those wδ≠¥©ith up to $25,000 in premium – •∑were up 5%, while med±♠ε¥ium accounts – those with $25,001 to $250,000 &">in premium – were up 4.5%.The “steady tre£¶'βnd” of upward rates reflects insurers’ plans t∞↑o continue increasing € prices across all lines except for workers com₩≠ pensation, MarketScout said.Organizer：China Insur♥↔∏ance Digital & AI Dev≥≤←¥elopment 2020Web:http://en.ze¶nseegroup.com/p/560573/Contact:Ann 02₩$1-65650305 -
0831
Akari Therapeutics’ Nomacopan Granted U.S. O♠♣↓rphan Drug Designation ✘δ≠§for Hematopoietic Stem Cell Transplantation-±γAssociated Thrombotic Mi♦' ₹croangiopathy (HSCT-TMA)
Akari Therapeutics, Plc , σ★a biopharmaceutical co✘ ©mpany focused on innovati≠π£βve therapeutics to treat orphan autoim✘λ↑mune and inflammatory diseases where the comp¶÷©φlement (C5) and/or leukotriene (LTB4) system→€ ¶s are implicated, today₽← announced that the U.S.>®♦∞ Food and Drug Administration (♣∏↑₹FDA) has granted orphan drug desi÷ gnation for nomacopan for the tr✔¥¶¥eatment of hematopoietic stem cell transplanπ>tation-associated thrombotic microang&↔₹αiopathy (HSCT-TMA).Orphan drug designation for n≠εomacopan follows Fast Track designation that ↑÷ the Company received from the FDA e ×₩arlier in August 2019 for the sam♦ε£ e indication in pediatλ☆πric patients. The Company con♥↑♠tinues to progress towards±€↕α a pivotal trial for HSCT-TMA ®∏✔♠with nomacopan, which is expected to start in<¥ the fourth quarter of 2019.“We are ple★&ased to obtain orphan drug designation for noma≈✘copan in HSCT-TMA, a devastating rare dφ>£↕isease for which there are cu rrently no approved ε§treatments,” said Clive Richardson, Chi↑ef Executive Officer of A♣←λkari Therapeutics. “The granting of orphan drug φβdesignation and Fast Track designation by the F ₽∞DA for nomacopan underscores the signif✔$¥±icant unmet medical need in↓← this disease. We loo€∑£δk forward to taking advantage oδ✔↕¶f the opportunities that FDA orphan drug d ₩esignation and Fast Track desig®¥Ωnation provide across ≠₽λall stages of drug developmenσ£§Ωt in order to bring this poten"↑γtial new treatment option to patie∞≈÷∞nts as rapidly as possible.”Orphan drug desig ↑"nation by the FDA is granted to promote the deveλ♠lopment of drugs that target ♥✔Ω¶conditions affecting 200,000 or fewer" ☆ U.S. patients annually and that a$₩↔re expected to provide sig↑♦§λnificant therapeutic advantage $→★over existing treatments. Orphan desγεignation qualifies Akari for various ≥←benefits, including seven years of maλ∑rket exclusivity following marketing approval, ≈$≥tax credits on U.S. c φlinical trials, eligibility for orphan drug gran•₽ππts, and a waiver of certain adminis£∑ trative fees.About Akari ThφπerapeuticsAkari is a biopharmaceu☆€tical company focused on developing inhibit'<♦"ors of acute and chron"'ic inflammation, specificalβαly for the treatment of rare and orphan ∞¥εdiseases, in particular those w here the complement (C5) or leukotrien$★↑e (LTB4) systems, or both complement and £™♥₽leukotrienes togetherφ ¥γ, play a primary role in$ disease progression. Akari's≥$¶₩ lead drug candidate, nomacopan (formerly know§♠ε∑n as Coversin), is a C5 complement inhibitor ±δ¶that also independen α®tly and specifically inhibits↓π leukotriene B4 (LTB4) activity. Nom♦> acopan is currently being clinically evalua♣↑εted in four indications: bullous pemp♣∞higoid (BP), atopic keratoconjunctivitis (AKC), t↓≈hrombotic microangioδ←∑pathy (TMA), and paroxys®∑ mal nocturnal hemoglobinuria (PNH). A↓£kari believes that the dual action of nomacopσ®αan on both C5 and LTB4 may be beneficial in both ✘©λAKC and BP.Cautionary Note Regarding Forward-Look≥ ing StatementsCertain st↑atements in this press r™←₹÷elease constitute “forwσ₹ard-looking statements”≥♠ within the meaning of ×γ✔the Private Securities LitigatΩ§€♥ion Reform Act of 1995 regarding, amon→£Ω₽g other things, statem←≈ents related to the offering, the exp☆±↑←ected gross proceeds and the expected closing≈♦γ± of the offering. These forward-lookingσπ± statements reflect our cur♥$→λrent views about our plans, intentions,÷≠ε♣ expectations, strategies and prospects, which arε☆e based on the information currenγ≤tly available to us and on σ<↑¥assumptions we have made. A£ lthough we believe that our plans, i♦σntentions, expectations, strat•♣♠egies and prospects as refle•®'✔cted in or suggested by those forwa♣≤ Ωrd-looking statements ™&are reasonable, we can giv♦e no assurance that the plans, in∑®tentions, expectations or ♥ ±strategies will be attainedπ ← or achieved. Further㶮more, actual results may differ↕• materially from those describεΩπed in the forward-looki★♥≠ng statements and will be affected by a variet"φy of risks and factors that are beyond our co∞δ≥ ntrol. Such risks and uncertainties for our com>pany include, but are not limited t∑₽™✔o: needs for additiona✔♠l capital to fund our operations, our ability t®™₩o continue as a going concern; uncertainties←$¥ of cash flows and inability to meπ✔•∞et working capital needs; an inability÷ '• or delay in obtaining required regulatoryΩ∑" approvals for nomacopan and any other prod₽εuct candidates, which may r♠'esult in unexpected cost expenditures; our ab¥ ₩ility to obtain orphan drug designati♣↕>♣on in additional indications; risks inhere♠€×nt in drug development in gener↕σ←al; uncertainties in obtaining ∞βδ∑successful clinical results for nom∏ ΩΩacopan and any other product candidates and™ unexpected costs that may result t↓₩herefrom; difficulties enr✘olling patients in our clinical trials; failφε♥ure to realize any value of nom±™≠≠acopan and any other product candidates≤↑&• developed and being λ©developed in light of inherent risks and diffic→ •✔ulties involved in successful₽₹ly bringing product candidate↓☆ s to market; inability to develop new pro☆ ₩₽duct candidates and support existing produΩ≠ct candidates; the approval by the±↓ § FDA and EMA and any other similar foreign regulλ✘λatory authorities of otherλ≤≤ competing or superior products ©¶¶§brought to market; risks resulting fr×™om unforeseen side effects; risk that the marke↔¶±t for nomacopan may not be as large as expα✘✘₹ected; risks associated w₹♥ith the departure of our former Chief Executi×≈ve Officers and other ex↕✔ecutive officers; ri ↕sks associated with the SEC i₽<nvestigation; inability to obt<<®™ain, maintain and enforce patents and oth÷Ω©er intellectual property rights or the&≤Ω unexpected costs associated with such enfo∞rcement or litigation; inability to obtain and m♦ ≥aintain commercial manufacturing arrang 'ements with third party manufact≠Ω<urers or establish commercial s¥✔cale manufacturing capabilities; the inabi©<lity to timely source adequat" e supply of our acti¥★™ve pharmaceutical ing"∑≈<redients from third party manufacturers on ÷∏§whom the company depends; unexpα§λected cost increases and pricing pressures and ri↓×sks and other risk factors de✔εtailed in our public filings with the U.S. Securi•↓→ties and Exchange Commission, including our m€ost recently filed Annual Report on Fo÷✘•∞rm 20-F filed with the SEC. α♣Except as otherwise noted, these forwa¥★×<rd-looking statements speak onl÷π≈←y as of the date of this ≤©→press release and we undertake no obligation ¶£ to update or revise any of these s≤ ÷✘tatements to reflect∞★ events or circumstances∏ occurring after this press release. We cauti §αon investors not to place consider<∏↔₹able reliance on the f&≠γ↕orward-looking statements conta♥₩×≈ined in this press relea∑εse.the 2019 Asia-pacif↓ic pharma IP Leader Summit £±¶;will be held in Beijing on&nbs≥↔p;November 14-15, and will attract m₽Ω✔ore than 500 industry experts f<λπ rom domestic and foreign pharmaceutical co←✔₩mpanies, biotechnology c★™ompanies, governments, associations, law ♥<firms, intellectual property agents and other com∑∑$panies to attend.Off✔>±icial registration and consultation channels:Co↓ntact：AnnPhone: 021-65650305Email：Marketing@zγ× enseegroup.comhttp://♦★≠<en.zenseegroup.com/p ₩♣/510934/ -
0106
Insurance Journal’s Top 10 Southeast Region σ₽÷÷Stories of 2019
From :insurancejournalIt was a relativel£¶♥£y quiet year for the Southeast in "∞♣§terms of major catastrophes compared with®♦ 2018 when Hurricane’s Michael and Flor≥ence caused major damage in the ≠'≈region. This year, Hurricaπ₹<¶ne Dorian sideswiped the Sou≠₹<→theast coast and made landfall on the↔≤ε Outer Banks of North Ca♦πεΩrolina but most of the area was spared. S¶¥☆¶till, Aon said economic d₩↔amage in the U.S. and Canada was↕×< poised to approach a combined § Ω©$1.5 billion.Florida spent the ∞✔ε↑year recovering from Hurr'α→icane Michael, which&n≠✔bsp;was upgraded to a Category 5 storm by NOσ™>AA in April. Florida officials have re'♠peatedly called on th€™÷$e insurance industry to speed up the re&→≥covery process, with nearly>₹β¶ 12% of claims still open a year after the♥♣ storm hit.Organizer：China Ins♣¶∞urance Digital & AI Devel™σopment 2020Web:http://en.zenseegrφ→oup.com/p/560573/Contact:Ann 021-656503$"•ε05 -
0830
European Commission approves Roche↑>×’s Tecentriq in combination with✔®®♥ Abraxane for people with PD-L1-positive, met£♥astatic triple-negative breast cancer
Roche today announced that the European Commissio₩•¶n has approved Tecentriq® (atezoli¶₩×zumab) plus chemotherapy (Abraxa∏×ne® [paclitaxel protein-bound particles for inj®&≤ectable suspension (albumin-bound);✔β nab-paclitaxel]) for the treatment of adult pa♠γ↑tients with unresectable locally advanced o♠'λr metastatic triple-negative breast cance✔$≠ r (TNBC) whose tumours have PD-L1 expression (♦♦λ≥1%) and who have not received prior ch®∑emotherapy for metastati×₹♣c disease. Roche’s VENTANA PD-L1 ∏≥↓(SP142) Assay is now CE marked and δ÷<commercially available in the ₽ European Union as an aid for identifying pa↓™tients with TNBC eligible for treatment with t§∞he Tecentriq combination.“For the pa∞∏st 30 years, we have been dedicated to φ ♦→transforming the lives of people with bre∏¥ ast cancer. Now, we are pleased to ♥♦♣★build on this foundationσ¶γ with the news that the first immunotherapy ♣®treatment for triple-negati♦₹ve breast cancer is availa₹±σ♥ble to people in Europe w'∏β$ith PD-L1-positive, metastatic triple-negativ ₹$e breast cancer,” said Sandr→© a Horning, MD, Roche’s Chief Medical Offic§&↓er and Head of Global×↕≠ Product Development. “The Eur<→₹∞opean approval of this Teα¥ centriq combination represents a ♦♠γsignificant step forward in the treatment♣≈£ of this aggressive breast cancer, where the unme★t medical need is great.”This approval is ba§sed on the results from the Phase III ♣♠↑IMpassion130 study. Progression-free ε™survival (PFS) results demonstrated a γ♠≥>statistically significant benefit for Tecβ$entriq in combination with nab-paclitaxel aγ♥♥nd showed that Tecentriq plus nab-pacl≠÷itaxel significantly reduce↔∞"d the risk of disease worsening or deat ÷"h (PFS) by 38% compared with β nab-paclitaxel alone (median PFS=7.5 vs 5 mon×∞>←ths; hazard ratio [HR]=0.62, 95% CI: 0.49-0.78π←φ, p<0.0001) in people who were ¶ tested positive for PD-L1 expression on tumour-in←®filtrating immune cells. At the secε♠£ond interim analysis, Tecentriq and nab- σpaclitaxel showed a clinica₽•"lly meaningful overall survival (OS) improvemen≤>t of seven months vs placebo and nab-paclitaxel i←α∞"n the PD-L1-positive population (median O≈•♣S=25.0 vs 18.0 months; HR=0.71, 95α< ↕% CI: 0.54 –0.93). OS ©✔γ₽results in the PD-L1-φ positive population were not formally tΩ ¶ested due to the hierarchical des→ ign of the study as statistical significance wa ✘↑®s not met for OS in the intention-to-treat (✔λITT) population (median OS=¶Ω←φ21.0 vs 18.7 months; HR=¶ ÷0.86, 95% CI: 0.72–1.02, p=0.078).Thβ✔'e assessment of PD-L1 on☆λ< tumour-infiltrating immune cellsπ is essential for identifying the patients wit"÷ε♠h TNBC benefiting from this Tec≈←entriq combination. PD-L1 expressi∑₽on status in the IMp®₹assion130 study was assessed by the VENTAN₩≠<A PD-L1 (SP142) assay.Safety in the ¶©'εTecentriq plus nab-paclitaxel arm appeared c¥∏γonsistent with the known safety profiles of the i♣₩ndividual medicines, and no ₹★new safety signals were∑∑₹ identified with the combination. T♦$↕>he nature and incidence of severe adverse event₹<✘s (SAEs) and Grade 3–4 adverse events (AEs) ©γλwere consistent with the known safety profile♦≥s of the individual study drugs o"β©↕r the underlying disease. SAEs were reported in 2£↓♦3% of people receiving Tecentri∏€ε≠q plus nab-paclitaxel compared to 18% of people↕ receiving chemotherapy alone. Grade "←3–4 AEs were reported in 49% of peo¶¥≤ple receiving Tecentriq plus nabΩ"σ-paclitaxel compared to 42% of people receiving←¥★ chemotherapy alone.Currently, there are seven on₹★going Phase III studies investigβε♥ating Tecentriq in TNBC, including early and adΩ✘vanced stages of the disease.the 2019 Asia-p∞☆acific pharma IP Leader Summit will<™∑ be held in Beijing on Novemb≥≤φ✘er 14-15, and will attract moε∏↔re than 500 industry exp∞>erts from domestic and foreign phar>←maceutical companies, biotechnology c∏ ompanies, governments, associations, law firms,÷>₽ intellectual property agents and other€ companies to attend.Official registr•ation and consultation ←✔≤channels:Contact：AnnPhone: 021-65650305Email：Mark φeting@zenseegroup.comhttp://en.zenseegroup.com/p✔¶/510934/
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