Takeda Pharmaceutical Company Limited (NYSE: TAK), a Japanese partner of Moderna, Inc. (NASDAQ: MRNA), has submitted a new drug application to Japan’s Ministry of Health, Labour, and Welfare to import and distribute Moderna’s vaccine candidate against COVID-19.
Takeda is leading a placebo meticulous Phase 1/2 study in Japan with 200 participants aged 20 and up to assesses the safety and immunogenicity of two mRNA-1273 vaccinations at the 100 g dose level given 28 days apart.
NASDAQ QLGN at https://www.webull.com/newslist/nasdaq-qlgn two companies signed an agreement in October under which Moderna will supply Takeda with 50 million doses of its vaccine for distribution in Japan. In premarket trading on Friday, Moderna shares were down 1.81 percent to $130.49.
FDA Approves Roche Biologics Products For Lung Disease
The FDA accepted Actemra subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease, a debilitating condition with few treatment options, according to Roche Holding AG (OTC: RHHBY). The FDA has approved Actemra/RoActemra is the first biologic therapy for the treatment of the disease.
SIG-007, a drug developed by Sigilon, has been designated as an orphan drug to treat Fabry disease.
SIG-007 has been given orphan drug designation by the FDA to treat Fabry disease, a progressive, life-threatening lysosomal disease, according to Sigilon.
ALX Oncology and Tallac will work together to progress cancer’s immunotherapies. ALX Oncology Holdings Inc.and Tallac Therapeutics, a confidentially held corporation, have announced a partnership to progress, assemble, and market a new course of cancer immunotherapeutic. They will split the cost of R&D and any profits or losses equally under the terms of the agreement.
The companies said they’ll combine their scientific and technical expertise to develop an anti-SIRP antibody conjugated to a Toll-like receptor nine agonists for targeted innate and adaptive immune system activation.
Apellis Stops Research On APL-9 In COVID-19 Patients With Severe COVID-19
Apellis Pharmaceuticals, Inc. (NASDAQ: APLS) has announced that it will not continue to develop APL-9, an investigational targeted C3 therapy for acute interventions, for the treatment of severe COVID-19. An interim review of mortality data from the Phase 1/2 study by an independent data monitoring committee found no significant reduction in overall mortality in patients treated with APL-9 combined with standard of care therapy compared to standard of care alone, prompting the decision. The DMC did not notice any safety signals.
In after-hours trading, the stock dropped 1.42 percent to $45 per share. Ocular Therapeutix’sDextenza Label Expansion Application Has Been Accepted For Review
The FDA has accepted Ocular Therapeutix, Inc.’s (NASDAQ: OCUL) supplemental new drug application for Dextenza 0.4 mg for intracanalicular use for review. The FDA has set a deadline of Oct. 18 for taking action under the Prescription Drug User Fee Act. The treatment of ocular itching associated with allergic conjunctivitis will be added to Dextenza’s approved indications if this sNDA is approved. Before investing in this stock, you can check more stocks like nyse ba at https://www.webull.com/quote/nyse-ba.