Drugs

In the study that evaluated safety in 43,783 participants (21,895 of whom received the vaccine and 21,888 of whom received saline placebo), hives was reported in five vaccine recipients and 1 placebo recipient in the 7 days following vaccination. In this study, there has been one report of severe hypersensitivity reaction, not classified as anaphylaxis,

Challenge studies in immunized non-human primates has shown the vaccine offers ‘robust protection’ against the virus. The candidate is dubbed a ‘second-generation’ vaccine thanks to its simple storage and transportation requirements: retaining its potency at 37˚ C / 95˚ F for a week, and being shelf-stable for four months at 25 ˚C / 77 ˚F

The field offers great promise. Additional research in this space is critically needed, however. “There is an element of hype, which needs to be tempered, and there is also tremendous hope and opportunity in modulating the microbiome,”​ said Dr Jennifer A Wargo, the University of Texas MD Anderson Cancer Center. Dr Wargo moderated the symposium,

PARP, a protein, helps repair DNA when it becomes damaged. PARP inhibitors are a type of targeted therapy; in cancer treatment, blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are approved as therapeutic and maintenance therapy across a small selection of cancer types, often for

The trial, which was jointly run with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), met its primary and key secondary endpoints, showing that REGEN-COV (1,200mg) administered subcutaneously reduced the risk of symptomatic infections by 81% in contacts of COVID-19 patients. Those individuals who did experience a symptomatic infection also

Roots Analysis has released its latest overview on the Cell and Gene Therapy CROs Market (2nd Edition), 2021-2030,​ covering key aspects of the industry and identifying areas for potential future growth. “The opportunity is likely to be well distributed across therapeutic areas, scales of operation, types of therapies and key geographical regions,”​ said the analysts. The

FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 13, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1

Liquid biopsy company, ANGLE, is presenting the results of two studies evaluating the effectiveness of two assays at the virtual American Association for Cancer Research Conference (AACR) 2021, being held virtually from April 10-15. One poster, Mesenchymal markers: the new avenue for circulating tumor cells detection​, reports on the performance of its new epithelial-to-mesenchymal transition

South San Francisco, CA — April 12, 2021 — 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 the company’s supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications. Xolair is the only

The data, presented at the virtual 47th European Society for Blood and Marrow Transplantation (EBMT) meeting in March 2021, provides the first real-world insights into axicabtagene ciloleucel (Axi-cel) manufacturing for European, Swiss, and Israeli adult patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL) and primary mediastinal large B cell lymphoma (PMBCL), said the biopharma

University of Sheffield to home new gene therapy innovation and manufacturing hub The investment in the three ‘cutting-edge hubs’ totals £18m ($24.9m), with the sites dedicated to advancing the clinical development of new genetic treatments. The Sheffield hub will also include a GMP (good manufacturing practice) facility that will support gene therapy projects emerging from

Stéphane Bancel, Moderna CEO, commented on the data: “This gives us further confidence in the protection afforded by our COVID-19 vaccine.”​ Primary results from Phase 3 trial of the Moderna COVID-19 vaccine (mRNA1273) indicated 94% efficacy in preventing coronavirus disease. But, to date, the durability of protection was not known. Now, new data shows durability

Production will start immediately at the site, which covers more than one million square feet (100,000 square meters) and boasts 8,000 liters of biologics capacity. An additional phase of construction is set to bring total capacity up to 64,000 liters by the end of 2022. BeiGene says the site represents the first paperless biological manufacturing

It announced today that its safety committee, PRAC, is investigating thromboembolic events after vaccination with COVID-19 Vaccine Janssen. PRAC has started a review of a safety signal to assess reports of thromboembolic events (formation of blood clots, resulting in the obstruction of a vessel) in people who received COVID-19 Vaccine Janssen. “Four serious cases of

The trial showed VLA2001 was ‘well tolerated with no safety concerns identified’, with neutralizing antibody titres at or above levels generally seen in convalescent sera. In the study of 153 adults aged 18-55, three doses (low, medium and high) were tested with two doses administered three weeks apart. The French vaccine company will now take

The study is looking at systemic allergic reactions – which occur in one or more parts of the body beyond the injection site – and whether these are more frequent in the above groups than the general population. It will also seek to understand the biological mechanism behind the reactions, and whether other factors (such

The company has pledged to accelerate development of its lead program, gavo-cell, in 2021. The product candidate is currently in a Phase 1/2 clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma.  Preliminary safety, efficacy and translational data from gavo-cel Phase 1 trial is due

After an in-depth analysis, the committee confirmed today that the reported cases of unusual blood clots following vaccination with AstraZeneca COVID-19 vaccine should be listed as possible side effects of the jab. Sabine Straus, PRAC chair, in a press briefing, said: “No specific risk factors could be identified, based on the current data. The PRAC

April 2, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy April 02, 2021 — Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members. See the photo below. This recall is

Yesterday [April 5], two senior sources from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) told Channel 4 that, while the data is still unclear, there are growing arguments to not administer COVID-19 Vaccine AstraZeneca, now called Vaxzevria, to those younger than 30. In an emailed statement to BioPharma-Reporter today, the UK watchdog said

FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 7, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The