Moderna Receives FDA Fast Track €✔₹Designation for Zika™λ Vaccine mRNA-1893
Moderna, Inc., a clinical stage biotechnolσ≈βγogy company pioneering messenger RNA (mRNA) th≥αerapeutics and vaccines to create a new genera♠δ≈tion of transformative medicines f✘♥→ or patients, today announced that the U.S. Food ™δ≈₩and Drug Administration (FDA)€±≈ has granted Fast Track designation for i←βεts investigational Zika vaccin≥✘≤e (mRNA-1893) currently being★↔∑ evaluated in a Phase 1 study f§§•or the prevention of Zika virus infection αδ in healthy adults.Fast Track π is designed to facilitate the d∏¶λαevelopment and expedite the review ×βof therapies and vaccines for serious con₩→Ωditions and fill an unmet medical need. Prog♠≤ ¶rams with Fast Track designati↓ε≤on may benefit from ea∏•€rly and frequent communication with the <™FDA, in addition to a ₽←rolling submission of the •α×marketing application. Moderna previously receiveπ'd Fast Track designation for its methylmalonic≥← acidemia (MMA) prog<ram (mRNA-3704), which is now recruiting patient→♠s for a Phase 1/2 clinical study.“P₩&rotecting against Zika virus transmis≈δδsion, particularly in women duri$∏♥ng pregnancy, continues to be an area o↓←f high unmet need. Fast Track designationα supports our belief in the clinical po₩'★©tential of mRNA-1893 and the importance of d<€eveloping an effective vaccine that c↔±"♦an be rapidly developed and deployed,∑§↑” said Tal Zaks, M.D., ♥₽Ph.D., chief medical off εicer at Moderna. “Our Zika program i $→s part of Moderna’s broader commitment t≠÷₩o improving global public health through develop₹&γing mRNA vaccines to prevent the spread of infe <ctious diseases.”mRNA-1893 contains an ±mRNA sequence encoding for the struc≤÷±tural proteins of Zika virus and is desγ←φigned to cause cells to secrete virus-like ×¥π₹particles, mimicking the respon♠¶se of the cell after natuδ ral infection. Preclinicalσ™• data published in The Journal of Infec ↕δtious Diseases have sh•σown that vaccination with mRNA-1893 prote¥λ™ cted against transmission of Zika virus dur♥±↑ing pregnancy in mice.1 mRNA¥¥∞-1893 is currently in a Phase 1 study evalu §ating safety, pharmacokinetics and pharmacodyna₽ ≠mics in healthy volunteers.This proδ∏α•ject has been funded in wh ≈ole or in part with Federal funds from the De→<partment of Health and Human ServΩαices (HHS); Office of the Assistant Ω★☆Secretary for Preparedness an€♦d Response; Biomedical Advanced Research and Deveλ"☆∏lopment Authority (BARDA), under Contr<↕₹βact No. HHSO100201600029C.from--P→®harma Focus AsiaIn recent years, €§ the size of the global pharmaceutical mark'★et has maintained a steady growth, with China,↑←φ± South Korea, India and other e ∏merging markets presenting a rapi♠↑♦d growth momentum. Due t₹÷♥o the different intell πectual property policies✔•λ of different countries, the strategic¶>γ& layout of global intel&lectual property, the differenΩ<ces of pharmaceutical intellectual prope∑α¶rty policies of Asia-pacific countries, the paα←☆tent review process, litigation procedures ₹παand Generic drug patent strategy have ₩♦gradually become the hot spots of the pharmaceuti✘★♦cal intellectual property ®÷industry. In this context, the 201₽ ™λ9 Asia-pacific Pharmaceutic&★al IP Leader Summit will be held in Beijing on© ¶ November 14-15, and will attract more≈↓ than 500 industry experts from do✔✔mestic and foreign ph'↕π¶armaceutical companies, biotechnology co∏§mpanies, governments, associ§¶↔★ations, law firms, intellectua ≠®l property agents and>↑γ other companies to attend.2019β÷♥≈ Asia-pacific pharma IP Leader Summit Offic¶ αial registration and consultation chaΩ δnnels:Contact:AnnPhone: 021-65♠&×650305Email:Marketing@zenseegroup.com