December 9, 2021

Aspaveli receives positive CHMP opinion for treatment of paroxysmal nocturnal haemoglobinuria – SOBI + Apellis Pharma

Swedish Orphan Biovitrum AB (publ) (Sobi) and Apellis Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorisation of Aspaveli (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least […]

admin Health 0 56 sec read
November 4, 2021

Moderna provides update on timing of U.S. Emergency Use Authorization of its COVID-19 Vaccine for adolescents

Moderna, Inc. provided an update that the FDA has notified the Company that it will require additional time to complete its assessment of Moderna’s Emergency Use Authorization (EUA) request for the use of the Moderna COVID-19 vaccine (mRNA-1273) at the 100 µg dose level in adolescents 12 to 17 years of age. The FDA has informed Moderna that the agency […]

admin Health 0 1 min read
November 2, 2021

FDA approves Vuity for presbyopia – Allergan / AbbVie

Allergan announced the FDA approval of Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. Vuity is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population. The FDA approval of Vuity […]

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November 1, 2021

Phase III MIRROR trial of Krystexxa meets primary endpoint in chronic gout – Horizon Therapeutics

Horizon Therapeutics announced topline results of the phase III MIRROR trial met the primary endpoint, showing a significant increase in efficacy using Krystexxa (pegloticase injection) with the immunomodulator methotrexate as compared to the response rate of Krystexxa with placebo for people with chronic gout refractory to conventional therapies – also known as uncontrolled gout. Results were from the Methotrexate to […]

admin Health 0 51 sec read
October 31, 2021

Moderna announces positive top line data from phase II/III study of COVID-19 vaccine in children 6 to 11

-Moderna Inc. announced positive interim data from the Phase II/III study, called the KidCOVE study, of mRNA-1273 , the Company’s vaccine candidate against COVID-19, in children 6 to under 12 years of age. This interim analysis showed a robust neutralizing antibody response after two doses of mRNA-1273 at the 50 µg dose level with a favorable safety profile. Moderna plans […]

admin Health 0 1 min read
October 30, 2021

Phase III ATOM trial of Tymlos shows positive results in osteoporosis – Radius Health

Radius Health announced positive topline results from the ATOM study evaluating Tymlos (abaloparatide) 80mcg subcutaneous (SC) for use in males with osteoporosis. The ATOM study met its primary endpoint – the percentage change in lumbar spine (LS) bone mineral density (BMD) compared to placebo – demonstrating statistical significance after 12 months (p-value < 0.0001). Study participants receiving abaloparatide-SC experienced an […]

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October 29, 2021

NICE (UK) recommends Adakveo as a treatment for preventing recurrent sickle cell crises – Novartis

Novartis is pleased to announce that eligible patients in England and Wales will soon have routine access to Adakveo (crizanlizumab) under a Managed Access Agreement (MAA). The news comes as the National Institute for Health and Care Excellence (NICE), published the Final Appraisal Determination (FAD) recommending crizanlizumab as an option for preventing recurrent sickle cell crises (two or more vaso-occlusive […]

admin Health 0 32 sec read
October 27, 2021

FDA Advisory Committee unanimously votes in support of emergency use for a booster dose of Moderna’s COVID-19 Vaccine in the U.S

Moderna, Inc. confirmed that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and […]

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October 26, 2021

FDA approves expanded indication of Biktarvy for treatment of HIV-1 in pediatric populations – Gilead Sciences

Gilead Sciences, Inc. announced the FDA approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy. The approval of this supplemental New Drug Application (sNDA) expands the indication for Biktarvy […]

admin Health 0 42 sec read

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