Showing 2011-2020 of 5643 results for "".
- Novartis Announces FDA BLA Acceptance of Brolucizumab for Wet AMDhttps://modernod.com/news/novartis-announces-fda-filing-acceptance-and-priority-review-of-brolucizumab-for-wet-amd/2476468/Novartis announced that the FDA has accepted the company’s biologics license application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD). Novartis used a priority review voucher to expedite FDA review and anticipates launching brolucizumab, if
- Alcon Debuts as Independent, Publicly Traded Companyhttps://modernod.com/news/alcon-debuts-as-independent-publicly-traded-company/2476453/After 8 years under Novartis ownership, Alcon is officially an independent, publicly traded company. On Tuesday, Alcon completed its separation from Novartis and its shares begin trading on the SIX Swiss Exchange and New York Stock Exchange under the symbol “ALC.” American depositary recei
- Ocular Therapeutix Announces Supplemental NDA Accepted by FDA for Dextenzahttps://modernod.com/news/ocular-therapeutix-announces-supplemental-nda-accepted-by-fda-for-dextenza/2476429/Ocular Therapeutix announced the FDA has accepted the filing of the supplemental new drug application (sNDA) for Dextenza (dexamethasone ophthalmic insert) to include the treatment of ocular inflammation following ophthalmic surgery in its label. The notice of acceptance confirms the FDA has comp
- Novartis Plans for Alcon Spin-Off on April 9, 2019https://modernod.com/news/novartis-plans-for-alcon-spin-off-on-april-9-2019/2476408/Novartis confirmed that conditions needed for the 100% spin-off of the Alcon eye care business have been met, and the spinoff is expected to be completed on April 9, 2019. Each Novartis shareholder will receive 1 Alcon share for every 5 Novartis shares/American Deposit
- New Study Shows an Eye Scan Can Detect Signs of Alzheimer’s Diseasehttps://modernod.com/news/new-study-shows-an-eye-scan-can-detect-signs-of-alzheimers-disease/2476384/Researchers from the Duke Eye Center have shown that a new, noninvasive imaging device can see signs of Alzheimer’s disease in a matter of seconds. The researchers found that the small blood vessels in the retina at the back of the eye are altered in patients with Alzheimer’s, and showed that the
- Morphic Therapeutic Enters Into Integrin Research and Development Collaboration with J&J’s Janssenhttps://modernod.com/news/morphic-therapeutic-enters-into-integrin-research-and-development-collaboration-with-jjs-janssen/2476272/Morphic Therapeutic announced that it has entered into a research and development collaboration with Johnson & Johnson’s subsidiary Janssen Biotech, to discover and develop novel integrin therapeutics for patients with conditions not adequately addressed by current therapies. Johnson &a
- Melt Pharmaceuticals Improves Patent Estate for Sublingual Non-Opioid Pain and Sedation Formulationshttps://modernod.com/news/melt-pharmaceuticals-improves-patent-estate-for-sublingual-non-opioid-pain-and-sedation-formulations/2476298/Melt Pharmaceuticals, a specialty pharmaceutical company recently deconsolidated from Harrow Health, announced the U.S. Patent and Trademark office has issued two additional patents covering the company’s innovative sublingual, non-opioid pain and sedation formulations. U.S. Patents 10,16
- Tangible Science Introduces Lens Care System for Custom Contact Lenses Coated with Tangible Hydra-PEGhttps://modernod.com/news/tangible-science-introduces-lens-care-system-for-custom-contact-lenses-coated-with-tangible-hydra-peg/2479600/Tangible Science will be unveiling at the Global Specialty Lens Symposium this week its complete system of products designed to ensure that custom contact lenses coated with Tangible Hydra-PEG offer benefit for the prescribed life of the lenses. Tangible Hydra-PEG is a unique polymer coati
- Aerie Pharmaceuticals Announces Acceptance of Its Investigational NDA for AR-1105 (Dexamethasone Intravitreal Implant)https://modernod.com/news/aerie-pharmaceuticals-announces-acceptance-of-its-investigational-nda-for-ar-1105-dexamethasone-intravitreal-implant/2476183/Aerie Pharmaceuticals announced that the FDA has reviewed the investigational new drug application (IND) for AR-1105 (dexamethasone intravitreal implant) and it is now in effect, allowing Aerie to initiate human studies in the treatment of macular edema due to retinal vein occlusion (RVO). The IN
- ProQR Reaches Agreement with the FDA on Design of Phase 2/3 Pivotal Trial for Sepofarsen (QR-110) for Leber’s Congenital Amaurosis 10https://modernod.com/news/proqr-reaches-agreement-with-the-fda-on-design-of-phase-2-3-pivotal-trial-for-sepofarsen-qr-110-for-lebers-congenital-amaurosis-10/2476214/ProQR Therapeutics announced that it has reached agreement with the FDA on the design of a phase 2/3 pivotal trial (ILLUMINATE) for QR-110, now renamed to sepofarsen, in patients with Leber’s congenital amaurosis 10 (LCA10) due to the p.Cys998X mutation in the CEP290gene. LCA is the lead