logo

Biotech Daily Dose

Share

New York-based pharmaceutical company Pfizer Inc (PFE) and its German partner BioNTech SE (BNTX) have requested the U.S. Food and Drug Administration to grant expanded Emergency Use Authorization of their COVID-19 vaccine in adolescents aged between 12 and 15. BNT162b2, the covid vaccine produced...

Merck & Co. Inc. (MRK), known as MSD outside the U.S. and Canada, announced Thursday that the pivotal Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, met its primary endpoint of disease-free survival (DFS) for the potential adjuvant treatment of patients with renal cell carcinoma...

astrazeneca covid19 040721 The European Medicines Agency said Wednesday blood clots are a "very rare" side effect of AstraZeneca's COVID vaccine. However, the EU drug regulator emphasized that the vaccine's benefits continue to outweigh its risks.

Pfizer Inc. (PFE) said Wednesday the FDA has extended the review period for the New Drug Application for its atopic dermatitis drug candidate Abrocitinib, with decision date extended by three months to early third quarter. The review period for the Supplemental New Drug Applications for XELJANZ/...

symbiotica april07 The U.S. Food and Drug Administration issued an emergency use authorization or EUA for the COVID-19 Self-Collected Antibody Test System developed by Symbiotica, Inc. It is the first antibody test authorized for use with home collected dried blood spot samples. The collected samples will be sent to a Symbiotica laboratory for analysis.

pfizer israel 040621 US pharma giant Pfizer (PFE) has halted a shipment of 700,000 COVID-19 vaccines to Israel after the country reportedly failed to make payment. According to the Jerusalem Post, a shipment of 700,000 doses of the Pfizer-BioNTech COVID vaccine was due to arrive in Israel last Sunday but was delayed indefinitely,...

The University of Oxford reported on Tuesday that it is halting the trial of the COVID vaccine developed by AstraZeneca PLC (AZN) on children and teenagers. The vaccine, developed in collaboration with AstraZeneca and Oxford, is under scrutiny for resulting in blood clots in the recipients. The...

Biotechnology company Exelixis, Inc. (EXEL) announced Monday that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with advanced solid...

Cidara Therapeutics, Inc. (CDTX) has entered into an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals, Inc. to develop and commercialize Cidara's Cloudbreak antiviral conjugates for the prevention and treatment of seasonal and pandemic influenza. Cidara will be responsible...

clia waived2 033121 The U.S. Food and Drug Administration or FDA has allowed the use of Binx Health IO CT/NG Assay at point-of-care settings for the detection of Chlamydia and gonorrhoea - the two most tested-for sexually transmitted infections. This action is the result of the FDA granting a waiver under the Clinical Laboratory Improvement Amendments of 1988.

illuminagrail march31 The U.S. Federal Trade Commission or FTC has challenged Illumina Inc.'s proposed $7.1 billion acquisition of cancer detection test maker Grail, alleging that a merger would harm competition for life-saving Multi-Cancer Early Detection or MCED tests in the United States. In a statement, the FTC said it has filed an administrative complaint and authorized a federal court lawsuit to block the deal.

Swiss drug major Roche (RHHBY) announced Wednesday the launch of Elecsys EBV panel in countries accepting the CE Mark. The company said it plans to file for approval with the FDA in the future. The Elecsys EBV panel accurately identifies the Epstein-Barr virus or EBV infection stage from a single...

Medical technology company BD (Becton, Dickinson and Company) (BDX) announced that the Food and Drug Administration has granted emergency use authorization (EUA) for the company's combination Covid-19, Flu rapid antigen test. The new antigen test on BD Veritor plus System can detect SARS-CoV-2, influenza...

CytoDyn Inc. (CYDY) announced that its Covid-19 drug candidate leronlimab decreased mortality rate by 82% at 14 days in critically ill Covid-19 patients. Monday the company had reported the publication in the Journal of Translational Autoimmunity "Case study of a critically ill person with COVID-19...

Denmark-based Genmab A/S (GMXAY.PK) announced Tuesday that the European Commission has granted Novartis (NVS) marketing authorization to use Kesimpta (ofatumumab) to treat relapsing forms of multiple sclerosis or RMS in adults with active disease defined by clinical or imaging features. Multiple sclerosis...

Follow RTT