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- AVROBIO Receives Orphan-Drug Designation ↔☆from the U.S. FDA for A→©↔VR‑RD‑02 for the Treatment of Gaucher Disease
AVROBIO Receives Orphan-Drug Designation fromαε' the U.S. FDA for AVR‑RD‑0λβ₩&2 for the Treatment o→'f Gaucher Disease
FRIDAY, OCTOBER 25, 2019
AVROBIO, Inc., today announced that the β αU.S. Food and Drug Administration (FDA) has✔¥ granted orphan-drug designatio↓✘↔n for the Company’s investigational geφ±₽↔ne therapy, AVR-RD-02, for the treatβ©λ₹ment of Gaucher disease. AVR-RD∑-02 consists of the patient’s own hema©β™£topoietic stem cells, genλ☆↕etically modified to expre∑ '≈ss glucocerebrosidase (GCase), λ↓ the enzyme that is deficient in Gauc™σ♦©her disease. The Company is activ₩'ely recruiting in Canada for ε∞its Phase 1/2 clinical trial of AVR-∞RD-02, which seeks to evaluate the saf↑≠ety and efficacy of the therapy in patients with &¶✔Type 1 Gaucher disease.
“Under the existing standard of care, patients∏¥ with Gaucher disease are bound to₩®∏ a lifelong infusion schedule ™≠of enzyme replacement therapies, an★λλd still experience painful and progressi€λ¶ve symptoms such as debilitating muscu<®♦loskeletal pain and fatigue,” said Birgitteφ δ± Volck, MD, PhD, President of ♣←πResearch and Development∏★ at AVROBIO. “Orphan-drug designati§♣on recognizes the unmet need of £• populations with rare di₽βseases like Gaucher where AVROBIO strives to tra™π÷nsform lives by addressing the unde£>•®rlying cause of the disease with a single dose o♦≥f gene therapy.”
Orphan-drug designation is granted by the ©±FDA to drugs and biologics which are intended ←¥for the safe and effective treatment, >∏✔diagnosis or preventio ↔n of rare diseases or conditions that affect $λπ₹fewer than 200,000 people in the United©λ≈ States. Orphan-drug ↓®πdesignation provides certain incentives, w→≤hich may include tax c≥×redits towards the cost of clinical trials anφλd prescription drug user >αfee waivers.
information source:pharma focus Asia
The original link:https:https://www.pharmaγ✘×↕focusasia.com/news/avrobio-receives-orphan-$Ω∑drug-designation-from-≠"¥the-us-fda-for-avrrd02-for-the-treatment-of-gau¶εβcher-disease
2019 Asia-pacific pharma IP L$π♣☆eader Summit: http://en.zenseegroup.com/p≥ ♥¥/510934/will be held in Beijing on November 14-15, and will attract more than ←♥500 industry experts from domesti™δc and foreign pharmaceu¥£tical companies, biotechnology companies, govern↑λ∏↑ments, associations, law firms, intellect↔'">ual property agents and other companies to at™ €tend.
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From :businessinsuranceU.S. comme≥↑"¶rcial property/casualty rates rose 5% on average ♦$in the fourth quarter o &₽f 2019, up from 4% in the third•£ quarter, reflecting in±★surers’ intent to continue to increλ✔•♠ase prices across most lines, online insu&☆↑rance exchange MarketSco€ut Corp. said Monday.“Auto rate increases£δ have been up all year long; however D&a≈↔ →mp;O (directors & officers) a<©nd professional rate in&♦ ©creases have spiked significa®Ω>ntly in the fourth quarter,” Richard K×€£err, CEO of MarketScout Corσ✘p. said in a statement.Insurers are car↕efully analyzing their pro>"perty exposures using catastrophe modβ↔eling tools, he said. “We expect many of✘ → the major property cata ♥¥★strophe insurers to curtail their 2'≤>€020 writings in California brush and East and×™ Gulf Coast wind areas. Naturally×€, this will result in higher rates to insur"λφeds,” Mr. Kerr said.D&a☆☆∑mp;O liability rates in© ←★creased by 8.25%, while commδ♥ercial auto increased 8%&ββ★ in the quarter, and professional∞® liability rates were up 6%, and umbrella/exc₩>•ess rates were up 5.5%, according to Mark'₹€etScout.Commercial prope÷ ©rty rates increased 5.25% inΩ the quarter, and busine↕£↑™ss interruption rates'♠↔ were up 5%, while all oσα¥ther lines showed smaller increas•₽ γes, except for workers ↑♥ compensation, where rates fell 1%, M→↑₽arketScout said.By industry cla♠<ss, transportation andδ☆®¶ habitational saw the highest averα•age rate increases at 9% and 8.25% respectiδΩ↑∑vely, MarketScout said.Large accounts – those<±β with $250,001 to $1 million i↓☆≤>n premium – saw a rate hike of 5.λ5% in the fourth quar↕≥♣ter, as did jumbo accounts,> which have more than $1 million in premium. Smal× ₽l accounts – those with up to $25,000 in pr♦'∞emium – were up 5%, while medium accounts – thos≈e with $25,001 to $250,000 in premium – we©&re up 4.5%.The “steady trend” of upwa<φrd rates reflects insurers’ plansβ★' to continue increasing prices across→← all lines except for w γ↕orkers compensation, MarketScout δ₩÷said.Organizer：China Insurφδ£₹ance Digital & AI Development 20Ω 20Web:http://en.zenseegroup.com/p/560573/ § "Contact:Ann 021-65650305
From :insurancejournalIt was a∑" relatively quiet year for the Southeast in term≤φβs of major catastrophes compared witγ∞♥h 2018 when Hurricane’s Michael and >λδ£Florence caused major damage in♥∏ the region. This year, Hurri♣♥cane Dorian sideswipe∏εd the Southeast coast and made landfa₽>ll on the Outer Banks of North Carolina but £ βmost of the area was spared. Still, Aon s↓∞aid economic damage in the U.S. a≤♥♥nd Canada was p↕∏oised to approach a combined $1.¥♥5 billion.Florida spent the year rec↕≥ε₩overing from Hurricane Michael, which was up♥≤∞≠graded to a Category 5 storm by NOAA in April.±∞↑ Florida officials have repeatedly&€><↕nbsp;called on the insurance ind©≈'ustry to speed up the rec®αφovery process, with nearly 12% of claims still ≥ ®open a year after the storm hit.Organizer：Chβ≠♦♥ina Insurance Digital & AI Dev≠↔elopment 2020Web:http://★÷&☆en.zenseegroup.com/p/560573/Contact:≥Ann 021-65650305
From:businessinsuranceeinsurance renewals a→σt Jan. 1, 2020, main₩<↑ly saw single-digit increases↕÷≈, with some exceptioσ♠ αns, according to reports by reinsurance★₹≥ brokers released Thursday.Willis Re, tβ ♥he reinsurance brokerage of Willis Tower≤βs Watson PLC, and GuΩ™≈≈y Carpenter & Co. LLC, a uni←&₹t of Marsh & McLennan Cos. Inc. both re↕ported that year-end reinsurance renewa∑ λ'ls varied by account andδ region, but the retrocessional reinsurance $±¥Ωwas under pressure.Rates on line for pλ♥♠♥roperty catastrophe reinsurance programs rem $$ained stable and property per r≠←isk pricing was driven by individual progr∑¶™am performance, the Willis report said.Althou↑✔↓∑gh some Lloyd’s of London syndi≥™♠ cates took firm positionΩ α¥s on rate increases and the London markσ<et authorized capacity decreased, thaφφ™t capactiy was replaced b✔Ωy new capital and a stronδ §©g supply from other markets,±>↔ Willis Re said.U.S. lo" ₩ss-free accounts renewed at flat to up>'★ 10% while those with loφ¶sses saw increases of 10% to 50%, the Willis Rσ×e report said, which wa 's among the largest i&↓®ncreases. Property catastrophe account∑s without losses renewed at flat to up 5%, ÷₹εwhile loss hit accounts were up 10% to↑φ π 20%, Willis Re said.According to the Guy Carpen₽★ter report, the broke"÷rage’s global property catastrophe rate on line ≥£index rose 5% in 2019.According to the Willis♦π Re report, other large increas ±&↓es were seen in Central and Eastern E≠α≠urope, where property progrβ÷ams with losses saw increases of 5% to ×™20%, and Canada, whe©→re such accounts renewed up 10% to 40%.Most ← other regions and countries←©λλ saw property increases in the∏δλ single or low double digits,★±€ the report said.The Jan. 1 renewals saw so Ω✔me “difficult” negotiations•♣π, according to a letter in t±✘₩he report from James Kent, glo≈©bal CEO, Willis Re.The Guy Carpe₽£σnter report said the r↓σ∏einsurance market was >䣓asymmetrical,” addin₹β g “this is certainly not a one-size-fits-all ma♦"¶rket” and while overall capacity remained ade♣©↑quate, “allocated capacity tightened notably in₹$ stressed classes.”Dedicated reinsurance cap>λ★δital rose 2% in 2019 and the yα→©ear saw approximately $60 billi>$on in global insured catastrophe losses, accordiε★≠↓ng to Guy Carpenter, which was s∞★ignificantly lower than 2017 and 2Ω≈018.Alternative capital, however,>↓×≥ contracted by approxima∏σ±tely 7% percent “as investors were mוore cautious with new investments after ass€↑™δessing market dynamics a✘↓₩nd pricing adequacy,” Guy Carpenter ✘₽≠said.The retrocession market “was Ω"γchallenged … by trapped capital, a lack §→of new capital and continued redemptions from th☆ §ird-party capital providers,” a statement issu™ε♠ed with the Guy Carpenter α←αreport said.However, significant retrocess™←Ωαion providers returned to the ma"∑<∏rket in the past two we<σeks, Willis Re said.Organizer：Chin÷ Ωa Insurance Digital & AI Development 2020Web: ↕®http://en.zenseegroup.com/p/560573/Contact∞≈:Ann 021-65650305
Major information technology companies in ∞≥ΩIndia are running the risk of termination of their $1 billion™γΩ contracts following Boeing Co.’λ¥✔★s decision to halt the production of its 7ε₩π"37 Max jets, MoneyControl reportedδ' citing the Business St♠δΩandard. Companies like Tata Consultancy®π Services Ltd., InfosysΩ↔★ Ltd., HCL Technologies Ltd., Cy↑$Ωient Ltd. and L&T Technology Se∞≤rvices Ltd. have outsourcing contracts ↓εwith Boeing or its suppl∑↑iers and Boeing’s jet crisis is expected to affec&←αt these IT companies in the short run.From:₹δbusinessinsuranceOrganizer：China In≥δ≈✘surance Digital & AI Dev♥±¶elopment 2020Web:http://en.zensee✘∏group.com/p/560573/Contact:Ann 021-65650305
France-based eyewear maker Essilor Intern≥♠©♦ational S.A. has discovered fraudulε§ent activities at one o★•πf its factories in Thail≤™and that could cause≈£¶✘ €190 million ($213 million) i'n financial losses to the company, T∑ ≤he Irish Times reported citing Reuters. The co£mpany has filed complaints in T§¶↑hailand and has fired all the involved emplo& ©&yees. It hopes to recover the losses from froze≤n bank accounts, insurance and lawsuits.Organiz•εer：China Insurance DigitalΩα≤ & AI Developmentδ¥♠ 2020Web:http://en.zenseegro§up.com/p/560573/Contact:Ann 021-65650305
