AstraZeneca’s (LON:AZN) and Sanofi‘s (Nasdaq:SNY) nirsevimab had 75% efficacy against lower respiratory tract infections resulting from rr (RSV) in a Phase 3 study. There are currently few treatment options for lower respiratory tract infections stemming from RSV. Two antivirals, palivizumab and ribavirin, are available, while new vaccines are currently authorized. RSV is the most common…
J&J and Roche named to Clarivate’s Top 100 Global Innovators list
Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT). Two companies in pharma and another in medtech, however, made the cut. Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator. Roche was included for the 11th consecutive year…
FDA grants Enhertu priority review for HER2-positive positive metastatic breast cancer
FDA has accepted the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate from AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS:DSNKY). The sBLA pertains to treating adults with unresectable or metastatic HER2-positive breast cancer previously treated with an anti-HER2-based regimen. FDA also granted priority review to the…
7 potential applications of mRNA-based therapies
Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory. Researchers are now exploring dozens of new possibilities for the mRNA platform. Here, we summarize several areas where…
The top 5 drug discovery articles of 2021
The pandemic continued to remake the pharma and biotech industry this past year. A handful of companies fared exceptionally well at commercializing COVID-19 therapies. This fact promises to lead to sizable shifts in the rankings of pharma leaders. These trends were not yet evident in our spring roundup of the 50 largest pharma companies, which…
FDA authorizes AstraZeneca’s Evusheld for the pre-exposure prophylaxis of COVID-19
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…