Drugs

The collaboration covers R&D of ‘off-the-shelf’ cell therapies for up to five shared cancer targets along with the development of a novel allogeneic personalized cell therapy platform. The partners have not disclosed any details on indications or likely targets. The UK biotech will receive US$150m upfront, as well as US$150m over the next five years in

September 7, 2021 Audience: Health Professional, Pharmacy September 07, 2021 — ICU Medical, Inc. is voluntarily recalling one lot (2,112 units) of Aminosyn II, 15%, An Amino Acid Injection, Sulfite Free intravenous (IV) solution to the hospital/user level due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material along with

The site is part of Thermo Fisher Scientific’s strategy to ensure a reliable supply of critical materials for new biologics and vaccines, and is further to a $600m investment in bioprocessing production capabilities announced in March this year. The Nashville facility will be one of the world’s largest SUT manufacturing sites and will more than

September 8, 2021 Audience: Health Professional, Pharmacy  September 08, 2021 — Wilmington, MA, Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (“Firvanq®”) to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI)

The multi-year agreement will see the Californian-headquartered company, founded in 2020 and described as a company seeking to build the ‘world’s most advanced biopharmaceutical manufacturing ecosystem’, produce mRNA in Canada for distribution worldwide. “Moderna’s COVID-19 vaccine has saved countless lives, and we’re excited to manufacture mRNA for this important vaccine,” ​said Rahul Singhvi, Sc.D, Chief

The biosimilar is a recombinant humanized monoclonal IgG1 antibody that targets vascular endothelial growth factor (VEGF), a key mediator of angiogenesis in cancer, and is used in combination with other treatments, said the partners. Guangzhou, China based Bio-Thera will maintain responsibility for development and manufacturing, Sandoz will have the right to commercialize the medicine upon

It is estimated that there are only approximately 70-100 known cases of CN-1 in the world. The goal of the collaboration is to make an mRNA therapy for the treatment of CN-1 available at no cost to patients, said the US biotech. Under the terms of the agreement, Moderna will license mRNA-3351 to ILCM with

That report from the World Health Organization (WHO): Global status report on the public health response to dementia,​​ was released last week, and it suggests there has been a growth of investment in research linked to dementia in markets such as Canada, the UK and the US. Indeed, the US saw an increase in annual investment

There is no vaccine currently available for RSV: a common and pervasive cause of severe acute respiratory illness in older adults (infections can occur in all ages by can be potentially life-threatening in infants, the immunocompromised and older adults). In the US, it is estimated that more than 177,000 adults aged 65 and above are

The vaccine received CMA from the agency in January 2021 as two 100 µg doses given 28 days apart: with the company now seeking to gain the green light for a 50 μg booster dose. In the US, Moderna already has FDA authorization for a third dose for immunocompromised individuals, announced last month. On Wednesday

San Francisco headquartered Atara Biotherapeutics is a pioneer in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBT) T cell platform to develop personalized, off-the-shelf therapies for patients with cancer and autoimmune disease. Multiple sclerosis could be one of the diseases the new therapies could treat. Atara is currently enrolling for a Phase 2 trial

Israel-based Savicell will use its immunometabolism platform, ImmunoBiopsy, to develop assays that will enhance the potency of cell and gene therapies for use within Orgenesis’ point-of-care (POCare) cell therapy platform. Additionally, Germantown, Maryland-based Orgenesis will use the platform to develop and validate diagnostic kits for enhanced quality control (QC) and monitoring purposes when it comes

In April 2020, Santen entered the cell therapy field, having negotiated a $252m ex-US licensing deal for jCyte Inc’s human retinal progenitor cell (hRPC) injectable therapy.  The treatment is initially aimed at treating retinitis pigmentosa, a rare vision-limiting disorder endured by nearly 1.9m people globally. We spoke to the Japanese firm to get a sense

The settlement ends the EU’s legal action with the company and means both parties can forego the hearing in Belgian courts scheduled at the end of this month. According to the settlement agreement, AstraZeneca will deliver the remainder of the doses scheduled under the original contract within a newly negotiated timeframe. It has agreed to

The company has signed a worldwide exclusive licensing agreement for the development and commercialization of RubrYc’s targeting monoclonal antibody, RTX-003, an immunotherapy candidate targeting regulatory T cells (Tregs). This monoclonal antibody [mAb] was initially developed on a traditional mammalian cell manufacturing platform but iBio plans to optimize and manufacture RTX-003 and future antibody candidates using its

FDA Approves Trudhesa (dihydroergotamine mesylate) Nasal Spray for the Acute Treatment of Migraine SEATTLE, Sept. 03, 2021 (GLOBE NEWSWIRE) — Impel NeuroPharma, Inc. (NASDAQ: IMPL), a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on the central nervous system, today announced that the

The original Moderna vaccine contains 100 mcg of mRNA in each shot. The FDA submission is supported by data that shows robust antibody responses for the booster vaccine against the Delta variant, said Stéphane Bancel, CEO, Moderna. “We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2. We will

September 1, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy This information is an update to the FDA Drug Safety Communication issued on February 4, 2021. FDA also previously communicated about the safety clinical trial with Xeljanz, Xeljanz XR (tofacitinib) in February 2019 and July 2019 What safety concern is FDA announcing? Based on a completed

The trial also will investigate whether pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine in this population. The Phase 2 trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, and is being conducted by the NIAID-funded

FDA Approves Invega Hafyera (paliperidone palmitate) for Twice-Yearly Treatment for Adults with Schizophrenia TITUSVILLE, N.J., Sept. 1, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic Invega Hafyera (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia