AstraZeneca s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided authorisation for emergency supply of COVID-19 Vaccine AstraZeneca, formerly AZD1222, for the active immunisation of individuals 18 years or older. The authorisation recommends two doses administered with an interval of between four and 12 weeks. This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.
AstraZeneca and MSD s Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers.
The three approvals authorise Lynparza for: maintenance treatment after 1st-line chemotherapy containing bevacizumab (genetical recombination) for patients with homologous recombination repair deficient (HRD) ovarian cancer; the treatment of patients with BRCA gene-mutated (BRCAm) castrate-resistant prostate cancer with distant metastasis (mCRPC); and as maintenance treatment after platinum-based chemotherapy for patients with BRCAm curatively unresectable pancreas cancer.
The concurrent approvals by the Japanese Ministry of Health, Labour, and Welfare are based on positive results from the PAOLA-1, PROfound and POLO Phase III trials, which each were published in The New England Journal of Medicine.
AstraZeneca’s
Tagrisso (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent.
Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 L858R mutations as detected by an approved test.
The approval was granted under the US Food and Drug Administration’s (FDA) Real-Time Oncology Review (RTOR) pilot program. Five other countries participated in a concurrent submission and review process through FDA’s Project Orbis.
While up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is still common in early-stage disease and nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.
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Search jobs 16-Dec-2020 First patients dosed in Phase III trials evaluating Fasenra in hypereosinophilic syndrome, eosinophilic esophagitis and eosinophilic granulomatosis with polyangiitis
New clinical trial also announced for Fasenra
in eosinophilic gastritis/eosinophilic gastroenteritis
The first patients have been dosed in
Fasenra (benralizumab) Phase III trials in three rare eosinophilic diseases: hypereosinophilic syndrome (HES), eosinophilic esophagitis (EoE) and eosinophilic granulomatosis with polyangiitis (EGPA)
AstraZeneca will also initiate a Phase III trial to investigate the potential of
Fasenra in an additional rare eosinophilic disease: eosinophilic gastritis/eosinophilic gastroenteritis (EG/EGE). This trial extends the
Fasenra clinical programme to nine diseases where eosinophils play an important role, in addition to severe asthma.