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- FDA approves first treatment₹♦ for patients with rare type of lung disease
The U.S. Food and Drug Administration today app&α ↓roved Ofev (nintedanib) capsules to slow the rate≈α of decline in pulmon≈αary function in adults with♣¥ ÷ interstitial lung disease♦¥φ↑ associated with systemic sclerosis φor scleroderma, called SSc-ILD. It is the <≤first FDA-approved tε€ reatment for this rare lung condition.
"Patients suffering from scleroderma need eff≥€ective therapies, and the FDA s&™upports the efforts of ♥¥€×drug companies that are designing aβ✔nd conducting the clinical trials necessary ÷$×to bring treatment options↔ to scleroderma patients," said Nikolay Ni∏♠kolov, M.D., associate director for Rh÷←eumatology of the Division of Pulmonary, Allergy↓♥ε, and Rheumatology Products in the FDA©✔'s Center for Drug Evaluation a∏♦♣♠nd Research. "Nintedanib is now a treatment optΩ∞ion to slow the rate of decline in pulmonary®© function in patients who have ✘≤interstitial lung di Ωφsease from scleroderma."
Scleroderma is a rare disease that caus★>es tissue throughout the body, including ¶the lungs and other organs, to±©δ thicken and scar. Interstitial lung di™sease or ILD is a conditio™®n affecting the interstitium, which ££≥∏is part of the lung's struc•&γture, and is one of the most com✔♦mon disease manifestations of scl €erderma. SSc-ILD is a progressive lung d ↔≈isease in which lung function decline♦ ★↓s over time, and it can be debilitating and≥≤< life-threatening. ILD is the leading ca≥→✘use of death among people with scleroderma, t₽£€♥ypically resulting from a loss of pulmonary↓¶ function that occur÷• s when the lungs canno♠β$t supply enough oxygen to th♣♥εe heart. Approximately 100,000λλ↔β individuals in the United States have scle∏ roderma, and approximately half of scleroderma p→©atients have SSc-ILD.
The effectiveness of Ofev to treat S↑"♦¥Sc-ILD was studied in a ra←≠←✘ndomized, double-blind, placebo-contro₩>₽lled trial of 576 patients age₽'s 20-79 with the disease. Patients received t€&↕reatment for 52 weeks,♣™↕$ with some patients treated up to 100 δ≤weeks. The primary test for efficacy meas♥₽™¶ured the forced vital cap'σacity, or FVC, which is ≥a measure of lung function, defined as the a↕✘αmount of air that can be forcib"ly exhaled from the lungs afΩ≠πter taking the deepest breat$εh possible. Those who took Ofev had less lung ≤₹function decline compared to those on place★↕bo.
The overall safety profile ≥≤observed in the Ofev treatment grou∏✔★♠p was consistent with the known ™₽safety profile of the therapy. The most freq§→$αuent serious adverse event reported∞σπ$ in patients treated with Ofev was pneumonia (±←2.8% Ofev vs. 0.3% placebo). Adv&¥>✘erse reactions leading to permanent dose re♦©✘☆ductions were reported in 34% ★αof Ofev-treated patients compared to 4% ofαα↓↓ placebo-treated patients. Diarrhea wa≥×→αs the most frequent adverse reaction that✔∏ led to permanent dose reduction ≥±in patients treated w£♠★₩ith Ofev.
The prescribing informatio∏± ☆n for Ofev includes wa♥$γrnings for patients with moderate or severe hepa₹<π∏tic (liver) impairment, tho"λse with elevated liver enz≠"ymes and drug-induced liver injury and pati↓♥≥ents with gastrointestinal disorders. Ofev <₩ may also cause embryo-fetal toxicity that can re₩εsult in fetal harm, arterial thromboem★αbolic events (blood clots), bl"<♥λeeding and gastrointestinal perforation.¥φ♦≠ P-gp and CYP3A4 inhib±÷±itors may increase nintedanib exposur≥♠βe, and patients taking these inhibitors sφΩ∑Ωhould be closely monitored f¶$>or tolerability of Ofev. Common side effect<₩↑&s noted with Ofev include diarrhea, nausea♠★, abdominal pain, vomitinα✔↑g, liver enzyme elevation, decreased appetite, h¶>eadache, weight loss and hypertenε↑>'sion (high blood pressure σ).
Ofev was originally approved in 2014 for adult↕×$↔ patients with idiopathic pulmonπ∏ary fibrosis (IPF), which is another int♦π≥erstitial lung condition.
Ofev received Priority R♠★♥eview designation, unde&©♥r which the FDA's goal is to ✘∞take action on an application w≤αithin six months where the ♥∞agency determines that the druδεg, if approved, would significantly improve ≈"™the safety or effectiveness∏→∑σ of treating, diagnosing∏± or preventing a serious condition. Ofev a᧶lso received Orphan Drug designation, <✔✘±which provides incentives to assist and encourageα☆↓ the development of dr ugs for rare diseases.
The FDA granted the approval of Ofev to treaδ£t SSc-ILD to Boehringer Ingelheim Pharmaceut♠✘©icals Inc.
The FDA, an agency within the U≤♥.S. Department of Health and Human Service™•>s, protects the public health by a•αssuring the safety, effectiveness, aα☆γ¶nd security of human a♥☆nd veterinary drugs,✔ππ₩ vaccines and other biπ ∑ ological products for hum✘≠✔"an use, and medical device "♦s. The agency also is responsible for the saα&§☆fety and security of our ™←nation's food supply, cosmetics, dietary supplemγ€₹↑ents, products that give off ele₹≈βctronic radiation, and for rδ> egulating tobacco pr♦γoducts.
Media Inquiries: Nathan Arnold, 301-796-6248, nathan.arnold@fd✔↕"φa.hhs.gov
Consumer Inquiries: ™←♥888-INFO-FDA
2019 Asia-pacific pharma IP Leader Summit:↕∏∑ http://en.zenseegroup.com/p/510934/ will be held in Beijing on November 14-15, and will attract more tha♥★↓¶n 500 industry experts from domestic and foreign ✔§pharmaceutical companies, biotechnology companie€≈♣¥s, governments, associations, law firms, in≠ •tellectual property ag♥≈γ€ents and other companies to attend.•&€
Official registration and consultation↑δ' channels:
Contact：Ann
Phone: 021-65650305
From :businessinsuran≥↓£€ceU.S. commercial property/casua★<±lty rates rose 5% on ave ¶ε₩rage in the fourth quarter of 2019, up f≠±rom 4% in the third quarter, β£→reflecting insurers’ inte♥→nt to continue to increase prices across $ $♥most lines, online insur×≈↔ance exchange MarketScout Corp. said Monday.“♦↕Auto rate increases have been ε✘€₩up all year long; however D&O (directors <↑ & officers) and professional rate increasesδ∏>σ have spiked significantly in the fou≠♥rth quarter,” Richard Kerr, CEO of MarketScou ✔¶ t Corp. said in a statement.Insurers are ca≈¥β↔refully analyzing their pro∞©perty exposures using catast®∑rophe modeling tools, he said. “We expect many o♠≤f the major property catastrophe insurers to ≤☆→curtail their 2020 wε ₹"ritings in California brush and East and Gulf Co× ←ast wind areas. Naturally, this will result in hiα↔☆gher rates to insureds,” Mr.≠>♣ Kerr said.D&O liability rates i™★ncreased by 8.25%, wΩγ&∞hile commercial auto increased 8% in the§≠↑♣ quarter, and professional liabil ∏±φity rates were up 6%, ∏×₽and umbrella/excess rates we∏">re up 5.5%, according to MarketScout.Commercia≠₽↓l property rates increased 5.$©☆25% in the quarter, and business ★®£ interruption rates weσα×re up 5%, while all other lines sho ←€∑wed smaller increases, except™₽≈ for workers compensation, where rates ≠♦ $fell 1%, MarketScout sai★≠≤d.By industry class, transporta←÷©tion and habitational saw↑ε the highest average rate incr₽§λ eases at 9% and 8.25%π♦≤λ respectively, Marke™tScout said.Large accounts – those with $250,0σ↓01 to $1 million in premium – saw a rat¥♥e hike of 5.5% in thσ&e fourth quarter, as did jumbo accounts, whic™¥≈h have more than $1 million in premium.✔∑ Small accounts – those with u&p to $25,000 in premium –★♥γ£ were up 5%, while medium¥ ♣ accounts – those with $25,001 t®§±×o $250,000 in premium –₩>™ were up 4.5%.The “steady tre•£"nd” of upward rates reflects in∞<σsurers’ plans to continue incre≈×&asing prices across all line↑↓≈s except for workers comp≤∞♦±ensation, MarketScout sγ←aid.Organizer：China Insuran£>ce Digital & AI Development 2020Web:htt&§♣p://en.zenseegroup.com/p/560573/Contact:Ann♠←← 021-65650305
From :insurancejournalIt was a relativ↕ ely quiet year for the Southeast in terms "♠±¥of major catastrophes compar§×ed with 2018 when Hurric φ♠ane’s Michael and Florence caused β↓ $major damage in the region. This year, Hur¥×↕£ricane Dorian sideswiped tΩ±€¥he Southeast coast and made lan•'<£dfall on the Outer Banks of ₩÷•North Carolina but most of the area &← was spared. Still, Aon★₩×☆ said economic damage in the U.S. and Canada&α≈δ♥nbsp;was poised to app&σroach a combined $1.5§δ₽ billion.Florida spent the year recover£∏☆ing from Hurricane Michael, whichΩΩ±¥ was upgraded to a Category 5 sto¶≥☆rm by NOAA in April. Florida officials have reφ₹peatedly called on the insuran$∏<ce industry to speed up t↕≥he recovery process, with nearly 12% φΩ<≥of claims still open &₹§Ωa year after the storm hit.Organizer：C→×hina Insurance Digital & AI Development ≠✘2020Web:http://en.zensee$÷group.com/p/560573/Coδ>ntact:Ann 021-65650305
From:businessinsuranceeinsurance renewals at εβ™Jan. 1, 2020, mainly saw single-digit increases, &→קwith some exceptions, according to ↕™ reports by reinsurancπ£∑∞e brokers released Thursday.Wil✘λ♦✘lis Re, the reinsurance∞α brokerage of Willis Towers W™↕©atson PLC, and Guy Carpenter & Co. LLC, a uni&§₽t of Marsh & McLennan Cos. Inc. both repo≤ rted that year-end reinsurance reΩ↕ newals varied by account and region, but the re♣♠trocessional reinsurance was un ✘™der pressure.Rates on line for prop←σ∏erty catastrophe reinsurance programs remain×™"ed stable and property per §↕' risk pricing was driven by $↑<individual program performance, ↓¥¥ the Willis report said.Al δthough some Lloyd’s of Lond<★on syndicates took firm positions o↕↓↑πn rate increases and the London •↕∞market authorized capacity decreased, that $ capactiy was replaced by new capital ★©and a strong supply fr♣≠ om other markets, Willis Re said.U.S. ¶♠$loss-free accounts renewed at flat to up 10% whi •£le those with losses saw increases of ↔σ↑Ω10% to 50%, the Willis Re report said, whλ←"♣ich was among the largest increases. Property cat§£φastrophe accounts without losses renewed at fla>δ ₩t to up 5%, while lo ↑Ωss hit accounts were up 10% to 20%, Willis≥✘'♣ Re said.According t ±÷o the Guy Carpenter report,&↕↑∏ the brokerage’s global property¥¶ catastrophe rate on line index rose ₽™→5% in 2019.According to the Wil↔₹₹lis Re report, other large ☆'¶ increases were seen in Central and Eastern Eu∏≥rope, where property pro÷∑grams with losses saw increases of 5% to 2ε±>0%, and Canada, whereα¶ such accounts renew≠♠ed up 10% to 40%.Most other re<∑"gions and countries sa☆λw property increases in the single or low ₽≥•double digits, the report said.The Jan. 1 r×±πenewals saw some “difficult” negotiations, acΩ✔σ cording to a letter in the rep♠§ort from James Kent, π↕♠↔global CEO, Willis Re.The Guy Carpenter report sa∑£₹id the reinsurance market was “asymm♣δ etrical,” adding “th✘≤'is is certainly not a one-size-fits-all m×↑®arket” and while overall capacity €αδremained adequate, “alδφδγlocated capacity tightened notably inλ®✔ stressed classes.”Ded÷★icated reinsurance capi φ×tal rose 2% in 2019 and the year$¥ saw approximately $60 billionφ in global insured catastro ↓phe losses, according to Guy Carpenter,← ☆ which was significantly lower th★₩an 2017 and 2018.Alternative capital, howφ≈<€ever, contracted by approximately 7% p←∏™ercent “as investors were more cautious with n↔αew investments after assessing ma₩↔δrket dynamics and pricing adeπ↓±quacy,” Guy Carpenter said.The retrocession✔α • market “was challenged … by trapped capital, a "α©≠lack of new capital and continued redemptionsγ → from third-party capital providers,” a®λ€ε statement issued with the Guy Carpenter repor±>←§t said.However, signif• icant retrocession pro÷δviders returned to the market in the past two ₽ ♠weeks, Willis Re said.Organ→♣↑"izer：China Insurance Digital & AI Developmen↔★©t 2020Web:http://en.zenseegroup.com/ש♦p/560573/Contact:Ann 021-65650305
Major information technology companε®ies in India are running the risk ★φ of termination of theπλ♦ir $1 billion contracts following Boein₽©g Co.’s decision to halt the productionε₹δ of its 737 Max jets, MoneyControl reported citΩ¶ing the Business Standard. C↕↔Ωompanies like Tata Consultancy Services Ltd., In©☆↓λfosys Ltd., HCL Technologies Ltd., Cyie₹β™nt Ltd. and L&T ↓•Technology Services Ltd. have outsouφ↑rcing contracts with Boeing or✘ασ its suppliers and Boeing’s jet crisis >↕is expected to affect these IT companies in∏™☆ the short run.From:b≈≈→usinessinsuranceOrga₩©>nizer：China Insurance Digital & AI Deve¶ ♥lopment 2020Web:http://en.zenseegroup.com/Ω<p/560573/Contact:Ann 021-65650305
France-based eyewear ma♠™&ker Essilor Internatio↔↕nal S.A. has discover∞↑βed fraudulent activities at one of its factories↓<<φ in Thailand that could cause €190 million ($>•γ©213 million) in financial losses ®₩ to the company, The Irish Times repo₽≤σrted citing Reuters. Theλ≥©≥ company has filed complaint≥$₩πs in Thailand and has fired all the invγ"♦♣olved employees. It hopes to recover the l≥ε₹osses from frozen bank accounts, insurance and ←×∏↓lawsuits.Organizer：Ch ina Insurance Digital &γ ≈amp; AI Development 2020Web:http://en.zens₩£eegroup.com/p/560573/Contact:Ann 021-65α←σ650305
