FDA issued an emergency use authorization (EUA) for AstraZeneca’s (NSDQ:AZN) Evusheld antibody cocktail as pre-exposure prophylaxis for COVID-19. The indications for use limit its use to adults and children at least 12 years old who weigh at least 40 kg. The EUA covers individuals who are not sick with COVID-19 who have not been exposed…
Hutchmed and AstraZeneca launch Phase 3 to test Orpathys and Tagrisso in lung cancer
Hutchmed (HKG:0013) and AstraZeneca (LON:AZN) have announced the launch of the SACHI Phase 3 study to test the combination of Orpathys (savolitinib) and Tagrissso (osimertinib) as a treatment for locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). Specifically, the study will focus on patients with amplification of the MET…
Lancet study could bode well for mix-and-match COVID-19 vaccination
The mRNA vaccines from Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) appear to work well as a second dose in recipients of a single dose of the AstraZeneca (LON:AZN) AZD1222 vaccine. A report in Lancet found that two doses of AstraZeneca’s AZD1222 vaccine were 50% effective. Recipients who received a dose of the AZD1222 vaccine followed by…
AWS and pharma heavyweights join forces on AI-based drug discovery lab
The goal of using artificial intelligence to transform drug discovery and development may not be novel. But a new alliance is unique in both the stature of companies belonging to it and its choice of an innovation model. Big Pharma firms AstraZeneca (LON:AZN), Merck KGaA (ETR: MRK), Pfizer (NYSE:PFE) and Teva (NYSE:TEVA) will partner with Amazon…
AstraZeneca seeks EUA for COVID-19 prophylaxis
AstraZeneca (LON:AZN) has filed paperwork with the FDA for an emergency use authorization (EUA) for AZD7442, a long-acting antibody (LAAB) cocktail, as a COVID-19 prophylaxis. The paperwork filed for the EUA request includes data from the PROVENT and STORM CHASER Phase 3 trials. A Phase 3 trial of AZD7442 showed statistically significant protection against COVID-19 infection. Compared…
Terns Pharmaceuticals adds former AstraZeneca CMO to board
The biopharma Terns Pharmaceuticals (NSDQ:TERN) has appointed Dr. Ann E. Taylor to its board of directors. Taylor, who served as AstraZeneca‘s chief medical officer from April 2019 to August 2021, has more than 35 years of experience in drug development. Other notable companies she has worked for include Pfizer, Novartis and AstraZeneca subsidiary MedImmune. Dr.…
AstraZeneca’s Imfinzi and tremelimumab show promise in non-small cell lung cancer study
AstraZeneca (LON: AZN) announced that Imfinzi (durvalumab) together with tremelimumab and platinum-based chemotherapy improved overall survival by 23% and progression-free survival by 28% compared to chemotherapy alone in patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). The data came from a Phase 3 trial known as POSEIDON. Imfinzi and tremelimumab are immune checkpoint…
AstraZeneca and European Commission settle COVID-19 vaccine supply lawsuit
AstraZeneca (LON:AZN) and the European Union have agreed to end litigation related to the supply of its COVID-19 vaccine Vaxzevria (ChAdOx1-S). AstraZeneca had initially contracted with the European Commission to provide 300 million doses of its vaccine with an option for another 100 million, but fell short of its commitment. The level of vaccine doses,…
AstraZeneca’s AZD7442 reduced risk of symptomatic COVID-19 in trial
The investigational antibody AZD7442 from AstraZeneca (LON:AZN) fared well in the PROVENT study, reading the risk of developing symptomatic COVID-19 by 77% compared to placebo. More than three-quarters of participants in the trial had comorbidities that could potentially reduce their immune response to vaccination. “We need additional approaches for individuals who are not adequately protected by COVID-19…
FDA approves AstraZeneca’s Saphnelo as a new lupus treatment
AstraZeneca (LON:AZN) has won FDA approval for Saphnelo (anifrolumab-fnia) to treat moderate to severe systemic lupus erythematosus (SLE) in adults. The drug is the first treatment for SLE to win FDA approval in more than one decade. Saphnelo targets the type I interferon (IFN) pathway, which plays a role in the pathophysiology of lupus. Researchers have…
AstraZeneca, Pfizer Moderna vaccines fare well against Beta, Gamma and Delta variants in study
A recent Canadian pre-print study found that AstraZeneca’s Vaxzevria vaccine was 82% effective in preventing hospitalization or death from the Beta and Gamma SARS-CoV-2 virus variants. Using the same benchmark, its efficacy against the Alpha and Delta variants was 87% and 90%, respectively, 21 days after administering the first dose. The BNT162b2 vaccine from Pfizer and BioNTech…
NVIDIA debuts supercomputer for healthcare and AI research
Santa Clara, Calif.–based NVIDIA has launched the Cambridge-1, which it hails as “the United Kingdom’s most powerful supercomputer.” Developed with healthcare applications in mind, NVIDIA invested some $100 million in the supercomputer. Initial applications of the Cambridge-1 include using AI to improve drug development, explore the causes of dementia and identify genomic-based disease risk factors.…
Pfizer-AstraZeneca COVID-19 vaccine combinations are effective, study suggests
British researchers report that using distinct COVID-19 vaccine types for the first and second doses appears to be effective, according to a preprint study in The Lancet. As global health authorities seek to vaccinate as many people as possible, a potential hurdle is the need to use identical vaccines for the prime and boost stages. Using…
How lupus clinical trials are evolving
In the past half-century, scores of investigational drugs for lupus have seemingly failed in clinical trials. GSK’s Benlysta (belimumab) is unique in winning approval from the FDA and European regulatory authorities. Anifrolumab from AstraZeneca, which would be a first-in-class type I interferon inhibitor, is one of the most promising investigational drugs for treating systemic lupus…
AstraZeneca’s TULIP trials highlight role of interferon in lupus
A recent post hoc analysis from AstraZeneca (LON:AZN) found that the monoclonal antibody anifrolumab (Saphnelo) led to consistent improvements in skin rash and arthritis in patients with systemic lupus erythematosus (SLE), which is the most common lupus type. A pooled analysis of the Phase 3 TULIP-1 and TULIP-2 clinical trials investigating anifrolumab showed the drug led…
Olaparib improved survival rates in patients with breast cancer subtype
AstraZeneca (LON: AZN) announced that its oncology drug olaparib (Lynparza) led to clinically meaningful improvements in a Phase 3 study. The study focused on patients with germline BRCA-mutated high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. Some 5% of breast cancer patients have BRCA1 and BRCA2 mutations. Clinical trial investigators have repeatedly…
Anifrolumab data promising for systemic lupus erythematosus
AstraZeneca (LON:AZN) has announced that a new posthoc analysis of data from the TULIP Phase 3 clinical trials of anifrolumab showed promise in patients with systemic lupus erythematosus (SLE), the most common type of lupus. Anifrolumab is a monoclonal antibody that blocks the activity of interferons such as interferon-α and interferon-β. If approved, anifrolumab would be…
10 of the best pharma companies to work for
The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research. The industry’s resurgence is a good opportunity for employees in the sector, who frequently enjoy comfortable salaries. To get a sense of which pharmaceutical companies…
Pharma’s top 20 R&D spenders in 2020
The past year has been an unprecedented time for the pharmaceutical industry. On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society. While the…
Pharma 50: Here’s how the world’s largest pharma companies are doing
The global pharmaceutical industry held up well during the pandemic, with 10 of the largest businesses only seeing a roughly –3% drop in revenue in 2020. Eight of the 10 even came out ahead. That’s one of the big takeaways from Drug Discovery & Development’s inaugural Pharma 50, a compilation of data on the largest…
EU won’t renew J&J, AstraZeneca vaccine contracts, report says
Reports from Italy claim that the European Union Commission won’t renew COVID-19 vaccine contracts next year with AstraZeneca and Johnson & Johnson. According to Reuters, Italian outlet La Stampa reported that sources from the Italian health ministry have said the commission does not want to pursue contract renewals with those two companies once those encompassing the…
NIAID expresses concern over AstraZeneca’s COVID-19 vaccine data
The National Institute of Allergy and Infectious Diseases (NIAID) has announced concerns with data from AstraZeneca’s COVID-19 vaccine trial. NIAID, a wing of the National Institutes of Health (NIH), said in a statement today that it was concerned that information the company released from its AZD1222 vaccine clinical trial may be outdated.In turn, that may…
AstraZeneca touts COVID-19 vaccine study results, will seek FDA nod
AstraZeneca announced today that its COVID-19 vaccine demonstrated statistically significant efficacy in preventing COVID-19 in a U.S. trial. AZD1222, developed in a collaboration between London-based AstraZeneca and Oxford University, was 79% effective in preventing symptomatic COVID-19 and 100% effective in preventing severe disease and hospitalization, according to a news release. Efficacy was consistent across ethnicity…
HRS Heat Exchangers is helping to support COVID-19 vaccine production: Here’s how
HRS Heat Exchangers announced that it received orders for pharmaceutical heat exchangers for use with the manufacturing of COVID-19 vaccines. Orders were placed by subcontractors working with Pfizer and Moderna, which both have vaccines authorized in the U.S., and Oxford/AstraZeneca, which has been approved across Europe but not yet in the U.S. The orders are…
AstraZeneca vaccine offers little protection against South Africa SARS-CoV-2 variant
The ChAdOx1 COVID-19 vaccine jointly developed by AstraZeneca and the University of Oxford is not effective against the B.1.351 variant first identified in South Africa, according to a recent study published in NEJM. In a five-month study involving HIV-negative adults, 23 of 717 placebo recipients developed mild-to-moderate COVID-19 while 19 of 750 vaccine recipients did. Based…