Medications

FDA Approves Gemtesa

FDA Approves Gemtesa (vibegron) Tablets for the Treatment of Patients with Overactive Bladder (OAB) IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Dec. 23, 2020– Urovant Sciences (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg Gemtesa (vibegron), a beta-3 adrenergic receptor (β3) agonist, […]

Medications

FDA Approves Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis

South San Francisco, CA — December 14, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for Ocrevus® (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have […]

Medications

Magenta Therapeutics and bluebird bio Announce a Phase 2 Clinical Trial Collaboration to Evaluate Magenta’s MGTA-145 for Mobilizing and Collecting Stem Cells in Adults and Adolescents with Sickle Cell Disease

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Dec. 4, 2020– Magenta Therapeutics (NASDAQ: MGTA) and bluebird bio, Inc. (NASDAQ: BLUE) today announced an exclusive clinical trial collaboration to evaluate the utility of MGTA-145, in combination with plerixafor, for mobilization and collection of stem cells in adults and adolescents with sickle cell disease (SCD). The data from this clinical trial could provide proof-of-concept for MGTA-145, […]

Medications

Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19

NEW YORK & MAINZ, Germany–(BUSINESS WIRE) December 02, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use […]

Medications

Second Interim Analysis of Clinical Trial Data Showed a 91.4% Efficacy for the Sputnik V Vaccine on Day 28 After the First Dose; Vaccine Efficacy is Over 95% 42 days After the First Dose

The efficacy of the Sputnik V vaccine is 91.4%, based on the second interim analysis of data obtained 28 days after administering the first dose (7 days after the second dose). Calculation was based on the analysis of data on volunteers (n = 18,794) who received both the first and second doses of the Sputnik […]

Medications

Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Evidence of Efficacy in First Interim Analysis from Phase 3 Study

NEW YORK & MAINZ, GERMANY–(BUSINESS WIRE) November 9, 2020 Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis Analysis evaluated 94 confirmed cases of COVID-19 in trial participants Study enrolled 43,538 participants, with 42% having diverse backgrounds, […]

Medications

Update on CALAVI Phase II Trials for Calquence in Patients Hospitalised with Respiratory Symptoms of COVID-19

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. The addition of Calquence to best supportive care (BSC) did not increase the proportion of patients who remained alive and free of respiratory failure. No new safety signal for Calquence was observed in the […]

Medications

Simponi Aria (golimumab) Approved by the FDA for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older

HORSHAM, PA, September 30, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Simponi Aria (golimumab) for patients 2 years of age and older for the treatment of active pJIA and has extended the PsA indication for this same patient population. “This […]