Treatment for Prevention of COVID-19 Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of Comirnaty in Individuals 16 and Older New Phase 3 data show booster (third) dose of Comirnaty induces significant SARS-CoV-2 neutralizing antibody titers and demonstrated a favorable safety and tolerability profile SARS-CoV-2 neutralizing
Drugs
VLA2001 is currently being studied in the UK in a pivotal Phase 3 trial, Cov-Compare (VLA2001-301), for which topline results are currently expected early in the fourth quarter of 2021. Subject to positive Cov-Compare data and the review by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Valneva said it believes that initial approval
elamipretide Treatment for Barth Syndrome Stealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth Syndrome BOSTON, Aug. 24, 2021 /PRNewswire/ — Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced the submission of a New Drug Application (NDA)
First ready-to-use liquid glucagon available in a single-dose vial and syringe kit for rescue Gvoke HypoPen®, Gvoke® PFS, and Gvoke® Kit – three different administration options to accommodate patients’ preferences Gvoke Kit eliminates the need for reconstitution Gvoke Kit availability anticipated in early Q1 2022 CHICAGO–(BUSINESS WIRE) August 23, 2021 –Xeris Pharmaceuticals, Inc. (Nasdaq: XERS),
FDA Approves Korsuva (difelikefalin) Injection for the Treatment of Moderate-to-Severe Pruritus in Hemodialysis Patients STAMFORD, Conn. and ST. GALLEN, Switzerland, Aug. 23, 2021 (GLOBE NEWSWIRE) — Cara Therapeutics (Nasdaq: CARA) and Vifor Pharma today announced that the U.S. Food and Drug Administration (FDA) has approved Korsuva (difelikefalin) for injection for the treatment of moderate-to-severe pruritus
Treatment for Major Depressive Disorder Axsome Therapeutics Provides Update on the New Drug Application for AXS-05 for the Treatment of Major Depressive Disorder NEW YORK, Aug. 23, 2021 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA)
FDA Approves Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) to Prevent COVID-19 Individuals 16 Years and Older Comirnaty is the first COVID-19 vaccine to be granted FDA approval Approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose More than 1.2 billion Pfizer-BioNTech doses have been delivered to more than 120
Pfizer invested $25m in Trillium in September as part of the Pfizer Breakthrough Growth Initiative. Pfizer will now acquire all outstanding shares it does not already own, valuing Trillium at $2.26bn. The company was formed in Ontario, Canada; and now has offices in both Ontario and Cambridge, Massachusetts. Trillium’s portfolio includes biologics that are designed to enhance
The Spanish company says it teams are dedicated to making the manufacturing process more cost-effective, scalable and regulatory compliant. In June this year, the CDMO opened a new manufacturing plant, with the objective of significantly increasing its production capacities by 400% and delivering its lentiviral vectors (LVVs) on a commercial scale to meet the growing
The expansion will allow AGC Biologics to generate around 250-300 new workplaces in Denmark. The production will be based on genetically modified organisms, biosafety level 1, manufactured with single-use technology in clean rooms. The new facility will include a manufacturing building, an office building and a visitors center. The manufacturing building will consist of four
But with the rapid growth of the cell and gene therapy sector the demand for innovative technologies to improve process development and facilitate manufacturing scale-up, currently outstrips supply and could delay the commercialization of rAAV products, says Polyplus-transfection. Based in a science park near Strasbourg, the producer maintains that it is one of the few
AZD7442 is the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial. It is a combination of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061) – derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. The antibody combination could help provide extra protection
The Medicines and Healthcare products Regulatory Agency (MHRA) said, following on from its thorough review of the evidence and the recommendation by the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body, it has approved Ronapreve for use in the prevention and treatment of acute COVID-19 infection. Co-developed by Regeneron and Roche,
PRINCETON, N.J.–(BUSINESS WIRE) August 20, 2021 — Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 240 mg every two weeks or 480 mg every four weeks (injection for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at
On Monday, August 16, the US biotech reported it had secured a revised supply agreement with the Canadian government for up to 105 million doses of its COVID-19 vaccine and its booster vaccine candidate, if authorized, for delivery through 2024. The agreement provides for 20 million doses each year in 2022 and 2023, with an
The new Rentschler Biopharma Manufacturing Center US (RBMC US) will add 22,000 square feet of manufacturing cleanroom space. The site is expected to become operational in late 2023, with the building design aimed at accommodating future adaptations for scale and capacity, said the CDMO. Commenting, Dr Frank Mathias, CEO of Rentschler Biopharma SE, said: “With
Moderna is anchor client in new Azzur on-demand cleanroom facility Moderna and Azzur Group have worked together for more than six years in the Boston area, and the mRNA COVID-19 vaccine producer will now become the anchor client in Azzur’s newest COD facility in Burlington, Massachusetts. That site will open in October and is already
Ridgefield, Conn. and Indianapolis, August 18, 2021 – Jardiance (empagliflozin) 10 mg has been approved by the U.S. Food and Drug Administration to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today.
Demand for viral vectors was already high pre-pandemic, with an increasing number of gene and cell therapies. Now recombinant vector COVID-19 vaccines – such as AstraZeneca and Johnson & Johnson’s vaccines – have put a second and more immediate stress on the viral vector supply chain. If it is to meet the near-future need for
August 16, 2021 Audience: Consumer August 16, 2021 — Pfizer is voluntarily recalling an additional four lots of Chantix 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level. Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential
Evotec completed the Washington, US, facility, which is named J.POD 1 US, to provide late-stage clinical and commercial-scale biologics. The facility is another stage in a global build-out of the company’s manufacturing network, after it announced a few months ago that it would build a commercial-scale European facility, based in France. Alongside manufacturing spaces, the
News FDA Alerts Jongu 4308 Issues Voluntary Nationwide Recall of Hydro Pineapple Burn Due to the Presence of Undeclared Sibutramine August 11, 2021 Audience: Consumer August 11, 2021 — Houston, Texas, eBay Seller ID: jongu 4308 is voluntarily recalling all lots of Hydro Pineapple Burn to consumer level. FDA analysis has found the product to
- « Previous Page
- 1
- …
- 28
- 29
- 30
- 31
- 32
- …
- 69
- Next Page »