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Moderna Receives FDA Fast Track Des&φ≈ignation for Zika Vaccine mRNA-1893
2019-08-21

Moderna, Inc., a clinical sta≥​β©ge biotechnology company p≠≈ioneering messenger RNA (mRNA) therapeutics∑✔≤ and vaccines to create a new generati"≈on of transformative&< medicines for patients, today announced tha®‌t the U.S. Food and Drug Administration (FDA) ¶≠₩¶has granted Fast Track designation for its inve↕★stigational Zika vaccine (mRNA-1893) c$≈ ≤urrently being evaluated in a Phase 1 stu♥≈↓σdy for the prevention of Zika v±¶ αirus infection in healthy aduβ>→lts.

Fast Track is designed to fac€<ilitate the development and exp↓←φedite the review of therapies and vaccine  ≥s for serious conditio€'​ns and fill an unmet medical need. Pr'≤£ograms with Fast Trac☆ k designation may benefit from early and frequen ∏t communication with the F•☆•DA, in addition to a rolling submission ≤φ>of the marketing application. Moderna previously £ ♣received Fast Track designation for its σ€↑methylmalonic acidemia (MMA) program (mRNA-§ 3704), which is now recruiting patients for ♥™≤×a Phase 1/2 clinical study.

“Protecting against Zika virus transmissionφ<↕, particularly in women during$↑ pregnancy, continues to be an area of hiδ←©Ωgh unmet need. Fast Track designation supports ou‍ ←™r belief in the clinical potential of mRNλ £A-1893 and the importance of developing an effe αctive vaccine that can be ₩₹ ™rapidly developed and deployed,” sa‍¥id Tal Zaks, M.D., Ph.D., chief m↕★"edical officer at Moderna. ¶♠♥“Our Zika program is pa‍Ω≥'rt of Moderna’s broader commitment to improving gσ€lobal public health through deve®♠loping mRNA vaccines to prevent the£ ★γ spread of infectious diseases.”

mRNA-1893 contains an mRNA sequence enco✘§ding for the structural proteins of Zi↓γka virus and is designed to cause cells to secreε¶ ∏te virus-like particles, mimic≥Ω™§king the response of the cell afte♠★₩r natural infection. Preclinica₩$✘€l data published in The Jou≤×rnal of Infectious Diseases have shown that vβ★<accination with mRNA-1893 prot✔≤ected against transmission of Zika viru✘¥§<s during pregnancy in mice.1 mRNA-1893 is cuε←♥rrently in a Phase 1 study ev♦δaluating safety, pharmacok ₽inetics and pharmacod≤♣αynamics in healthy volu€σ♣nteers.

This project has been funded in whole or in ÷±part with Federal funds fro≤₩​m the Department of Health a♣≠nd Human Services (HHS); Office of the™π₩ Assistant Secretary for Preparedness and Responγ©✘σse; Biomedical Advan☆•ced Research and Developmeα&₽nt Authority (BARDA), under Contract No.πΩ→γ HHSO100201600029C.

from--Pharma Focus Asia

In recent years, the size of the global pharmaceu<¥¶tical market has mai☆Ω‍£ntained a steady growth, with China, Sout↑₽h Korea, India and oth€•→er emerging markets presenting a rapi∞λd growth momentum. Due to the different inte‍•↔βllectual property policies of different countrie©δφ≈s, the strategic layout< ☆ of global intellectual property, the diffe™€rences of pharmaceuti  ↑cal intellectual property policies of Asγ£≥ia-pacific countries, the patent review process, ≥₽γ litigation procedures and Generic §¥drug patent strategy have gradually≥π☆ become the hot spots of the pharmaceutical intel$♣ασlectual property industry.

 In this context, the 2019 Asia-paδ "cific Pharmaceutical IP Leader Summit will be hel<∞d in Beijing on Novemb ★≤✘er 14-15, and will at≠₩≤tract more than 500 π±♦₽industry experts from domest↕'ε↔ic and foreign pharmaceutical companies, ≥εbiotechnology companies, governments, assoc↔∞iations, law firms, intellλ±ectual property agents and other companies to a✘₩ttend.


2019 Asia-pacific pharma IP Leader Summit 

Official registration and consultation ch‌‌✔annels:

ContactAnn

Phone: 021-65650305

EmailMarketing@zenseegroup.com

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From :businessinsuranceU.S. ÷♦♥commercial property/casualty rates roseλ∞ 5% on average in the fε←®<ourth quarter of 2019, up from 4% in the↕® third quarter, refl≠λ♣×ecting insurers’ intent  ↕☆≈to continue to increase prices acr©'↑oss most lines, online insurance exchange Marke  πtScout Corp. said Monday.“Auto rate inc☆©'reases have been up all y©¶ear long; however D&O (directors &a$♥σmp; officers) and professional rate increase≈∞φ♣s have spiked signifi↑→cantly in the fourth quarter≤<,” Richard Kerr, CEO of MarketSα≈✔ cout Corp. said in a stat✔Ωement.Insurers are carefully a≠¶≤​nalyzing their property ↑​exposures using catastrophe ₽Ω£​modeling tools, he said. “We expect many oδ‌πf the major property catastrophe insurers to cu•β₩rtail their 2020 writings in California brush an±λ→βd East and Gulf Coas ✔≠t wind areas. Naturally, this will result in hi£÷®gher rates to insureds,” Mr. Kerr saγ→id.D&O liability rates inc™→×↓reased by 8.25%, while commerc>×‌ial auto increased 8% in the ™€$quarter, and professional liability rates ↑∑γδwere up 6%, and umbrella/excess rates weλΩ♣re up 5.5%, according to Market↕₹₽±Scout.Commercial prope©αrty rates increased 5.25% in the quarter, an♥£×d business interruption rates were up∏¶÷÷ 5%, while all other £↕lines showed smaller increases, excep✔←t for workers compensatioφ∏αn, where rates fell 1%, MarketScout said.By indus£'✔✔try class, transportation and  ←habitational saw the highest average rate increa↔ ‌ses at 9% and 8.25% resp★→₹≈ectively, MarketScout said.La€↕σ rge accounts – those with ☆"♥$250,001 to $1 million in premium – saw a ₩αrate hike of 5.5% in the foα‍™urth quarter, as did jumbo acco∞±•☆unts, which have more than $1 million in premium.± δ Small accounts – those wi ↓th up to $25,000 in p₹>remium – were up 5%, while medium acco↓‌unts – those with $25,001 to $250,00ε₩π∏0 in premium – were up 4.5%.The “steady trend”  €of upward rates reflects in≈™surers’ plans to continue increasing prices ac★​↑ross all lines excep$δ≥'t for workers compensation, MarketScout sa ‍↔id.Organizer:China Insurance Digital &aγ≥mp; AI Development 2₽≥•020Web:http://en.zen♥∑✔seegroup.com/p/560573/Contact:Ann 021-65650305

From :insurancejournalIt≠↑→ was a relatively quiet yea $r for the Southeast iβ♦≥↕n terms of major catastrop♥®±hes compared with 2018 ©→≠when Hurricane’s Michael and Florence cau✘∏&←sed major damage in the region. This year₩≤, Hurricane Dorian sides©☆εwiped the Southeast coast&n ®bsp;and made landfall ♥< βon the Outer Banks of North Carolina butσα most of the area was spared. Still, A​Ω§✘on said economic damage in the U.S↓$. and Canada was poised to a↑∏pproach a combined $↕$"1.5 billion.Florida spent the ☆¶year recovering from Hurricane Michael, which&nbs↕γβp;was upgraded to a Category 5 storm by $±★£NOAA in April. Florida officials have r>↕♠<epeatedly called on the≥★↓✔ insurance industry to s<σ>peed up the recovery process, w≠≥ith nearly 12% of claims still open a year af‍$÷ter the storm hit.Organi↑π♦<zer:China Insurance Digital &♠‍amp; AI Development 2020Web:h£>ttp://en.zenseegroup.₹​com/p/560573/Contact:Ann 021-6≥€↕Ω5650305

From:businessinsurancee£÷✔≤insurance renewals at Jan. 1,★→∞✘ 2020, mainly saw single-digit in≈<&'creases, with some exceptions, a÷£ccording to reports by reinsurance brokers relea♠σ'sed Thursday.Willis Re, the reinsurance br>β✘×okerage of Willis Towers∑↑ Watson PLC, and Guy Carpenter & Co. LLC, ∞✘a unit of Marsh & McLennan Cos. Incβ™↑. both reported that year-end reinsurance rene£λ♠ wals varied by accou$γφnt and region, but the retrocessional rein"±∑surance was under pressure.Rates on line f✘↔×‌or property catastrophe reinsurance p₹®★✔rograms remained stable and prope< ≈‌rty per risk pricing was driven by individual p₩•rogram performance, the✘♠Ω Willis report said.Although som★£®™e Lloyd’s of London syndicate≠σוs took firm positions on rate increas×₽σes and the London market auth'≈orized capacity decreased, that capactiy   ™was replaced by new capital ∑γand a strong supply from other m≤×¶ arkets, Willis Re said.U.S. loss-fπδ®☆ree accounts renewed at flat to up "®€10% while those with losses saw increases ε‌¶δof 10% to 50%, the Willis Re report said, whicα®↔h was among the largestφ¶€δ increases. Property catastrophe↔¶  accounts without losses re"≤₹♣newed at flat to up 5%, while loss hi •t accounts were up 10% ≤ π×to 20%, Willis Re said.Acco↑©rding to the Guy Carpenter reportπ↑, the brokerage’s global property catastroph♠←λ♦e rate on line index rose 5% in•∞α 2019.According to the Willis Re report, oth↑£er large increases were seen in Central and Eas≤★≠&tern Europe, where proper♠≤ty programs with losses saw i↑<ncreases of 5% to 20%¶™±↕, and Canada, where such accounts♥₽ renewed up 10% to 40%.Mos↔→♥≤t other regions and countries saw property increa→↔ses in the single or low double digits, th♣•e report said.The Jan. 1 rene↑→♦wals saw some “difficuΩδ₽lt” negotiations, accor∞↕π♣ding to a letter in the report from James Kent,π©↕↕ global CEO, Willis Re.The Guy€±∞ Carpenter report said♣‌δ the reinsurance market was “asymmetrical,” ππ"Ωadding “this is cert♠£>​ainly not a one-size-fits-all marke♣‌t” and while overall capacity reδΩ≈mained adequate, “allocated capacity tightene↓‍"d notably in stressed classe≥₹€s.”Dedicated reinsurance capital rose 2% in¥& 2019 and the year saw approximately &★"Ω$60 billion in global insured catastrophe losse$↑s, according to Guy Ca•≠rpenter, which was significΩ ±​antly lower than 2017 and 2018.Alternative capit¶≤♦al, however, contracted by approximat£∞>ely 7% percent “as investor§¶s were more cautious with new i₩εαnvestments after ass↕ &essing market dynamics and®©‍α pricing adequacy,” Guy Carpenter ↕©>said.The retrocession ≠★÷₩market “was challenged … by trapped ​₩♠capital, a lack of new capital and continued re©Ωdemptions from third-party c≈±apital providers,” a statement issued w‌§ith the Guy Carpenter report ≠£said.However, signific∑↓÷>ant retrocession provid↔☆ers returned to the market in the past two we←"eks, Willis Re said.Or←‍"©ganizer:China Insura₽₹©nce Digital & AI Develoλπ∏pment 2020Web:http://en.z♦<×εenseegroup.com/p/560573/Contact:Ann 021-÷✘✘λ65650305

Major information technol≥>♠ogy companies in India are runn↔± ing the risk of termination of their←€ $1 billion contracts following Boδ♠eing Co.’s decision to halt→‌  the production of its 737 Max jets, MoneyCon•   trol reported citing Ω±the Business Standard. Companies like Tata Co±>§nsultancy Services Ltd., Infosys Ltd., HCL Techn↔ε€ologies Ltd., Cyient Ltd. and L&am​‍p;T Technology Services Ltd. have ou®←tsourcing contracts with Boe ♦ing or its suppliers and Boeing’s jet crisis i↔ s expected to affect these IT companies in §±the short run.From:businessinsuαλranceOrganizer:China Insurance Digital &"<→♦; AI Development 2020Web:http://en.zenφ♥γ↔seegroup.com/p/560573/Contact:Ann 02↔☆§×1-65650305

France-based eyewear maker Essi ÷≤¥lor International S.A. has discovered fraudulent≠≠≤ activities at one of its factories in Thai'♦land that could cause €190 mi€¶☆llion ($213 million) in financiα✔≈ al losses to the company, Th Ω←☆e Irish Times reporte↓αλ¶d citing Reuters. The company ha<$ s filed complaints in✔↕' Thailand and has fired all the i÷Ωαnvolved employees. It hopes to recover the ₹ $♣losses from frozen bank acco< unts, insurance and lawsuits.Organizer∏γ≠₽:China Insurance Digital &am ☆↔p; AI Development 2020Web:http://en.zenseegrouπ↑p.com/p/560573/Contact:Ann 021-656≥ ≠50305

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