AstraZeneca Archives - Page 4 of 9 - Medical Design Sourcing

Nirsevimab offers significant protection against RSV in infants in Phase 3 trial

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 cause of lower respiratory tract infections in infants.

AstraZeneca has announced that the immunostimulant nirsevimab is the first potential therapy that could offer sustained protection for an entire RSV season with a single dose.

In the placebo-controlled MELODY Phase 3 trial, nirsevimab had 74.5% efficacy against medically-attended lower respiratory tract infections from RSV in healthy infants.

The Phase 3 study was recently featured in NEJM. Another article in the same journal focused on nirsevimab’s safety profile in the MEDLEY Phase 2/3 study, c…

J&J and Roche named to Clarivate’s Top 100 Global Innovators list

Photo by Chokniti Khongchum from Pexels

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 in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last 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 application.

In 2019, Enhertu first won FDA approval for HER2-positive unresectable or metastatic breast cancer after two or more prior anti-HER2-based regimens.

Two years later, the agency extended approval to patients with previously-treated HER2-positive advanced gastric cancer.

The recent application includes data from the DESTINY-Breast03 study,

That study found that Enhertu demonstrated a statistically significant improvement in progression-free survival compared with trastuzumab emtansine (T-DM1) (Kadcyla…

7 potential applications of mRNA-based therapeutics

mRNA image courtesy of Wikimedia Commons.

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 mRNA could find use in the coming years.

1. Cardiovascular applications

Image by Raman Oza from Pixabay

Researchers at the University of Pennsylvania recently shared positive data related to the use of mRNA and CAR-T cell therapy to treat cardiac fibrosis in a mouse model.

Last year, AstraZeneca (LON:AZN) announced positive results from a Phase…

The top 5 drug discovery stories of 2021

Image courtesy of Pixabay

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 drew revenue figures from the prior year. But in 2021, companies like Pfizer and Moderna sold tens of billions of dollars of COVID-19 vaccine alone. As a result of the ongoing pandemic, significant shifts are likely in 2022’s forthcoming ranking of pharma leaders.

Here, we provide an opportunity to review the 2021 pharma landscape, including stories that received the most attention on social media.

1. Pharma 50: The 50 largest pharmaceutical companies in the world

The top 50 largest pharmaceutical companies raked in $851 billion…

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 to individuals who have contracted the respiratory illness.

The EUA requires recipients to be at least moderately immunocompromised or to have had a history of severe adverse reactions to a COVID-19 vaccine.

AstraZeneca announced in October that it had filed for the EUA, including data form the PROVENT and STORM CHASER Phase 3 trials.

“Vaccines have proven to be the best defense available against COVID-19. However, there are certain immune compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and t…

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 gene who have had disease progression after receiving EGFR inhibitor therapy.

In June, Orpathys from AstraZeneca and HutchMed won conditional approval in China for patients with lung cancer with MET exon 14 skipping alterations. The drug is an oral MET tyrosine kinase inhibitor (TKI).

FDA and the E.U. first approved AstraZeneca’s Tagrisso in 2018. The drug is an irreversible epidermal growth factor receptor TKI. Last year, the drug brought in $4.32 billion in international revenue.

AstraZeneca and HutchMed dosed the first patient in the SACHI study

T…

TIME recognizes Abbott among this year’s 100 best inventions

The BinaxNow COVID-19 Ag Card [Image courtesy of Abbott]

Abbott (NYSE:ABT) was among a series of medtech companies to receive recognition from TIME in its list of 2021’s best inventions.

The list of the year’s top inventions included Abbott’s innovations twice, with a nod to its NeuroSphere Virtual Clinic and its at-home COVID-19 testing offerings.

NeuroSphere Virtual Clinic allows physicians to speak to patients over a video app and to remotely adjust Abbott’s implanted neuromodulation devices. The platform won FDA approval in March and Time reported that the company plans to expand availability of NeuroSphere Virtual Clinic soon.

Abbott’s BinaxNOW was one of several at-home, over-the-counter COVID-19 tests to receive a mention from Time as the news organization recognized the tests for aiding in efforts to prevent the spread of the virus.

In a post on LinkedI…

Lancet study could bode well for mix-and-match COVID-19 vaccination

[Image by Sam Moqadam on Unsplash]

The mRNA vaccines from Pfizer-BioNTech and Moderna appear to work well as a second dose in recipients of a single dose of the AstraZeneca 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 a dose of Moderna’s mRNA-1273 vaccine had adjusted vaccine effectiveness of 79%. Those who received an initial dose of AZD1222 followed by the Pfizer-BioNTech BNT162b2 vaccine saw vaccine effectiveness of 67%.

The report authors stopped short of claiming that a heterologous AZD1222 and mRNA prime-boost vaccination strategy is superior, concluding that it “may be an effective alternative to increase population immunity against COVID-19.”

“These results could have important implications for vaccination strategies and consequently in the battle against the…

AWS and pharma heavyweights join forces on AI-based drug discovery lab

The goal of using AI to transform drug discovery and development may not be novel. But a recent 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 Web Services Inc. (NSDQ:AMZN) and the Israel Biotech Fund (IBF) on what they term a “first-of-its-kind innovation lab” known as AION Labs.

“The launch of AION Labs will provide an opportunity for the healthcare and life sciences industry to uncover new ways to reduce the time and cost for discovery, facilitate open collaboration and interoperability, and ultimately improve patients’ health outcomes,” said Dan Sheeran, director of healthcare and life sciences at Amazon Web Services, in a statement.

AION Labs has also formed a strategic partnership with the biomedical research institute BioMed X (Heidelberg, Germany).

The lab…

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 to the placebo, the investigational drug offered 77% protection in the PROVENT trial against symptomatic disease compared to placebo.

The PROVENT study included 5,197 participants, with two-thirds receiving AZD7442 and the remainder getting placebo.

A single injection of AZD7442 could offer up to 12 months of protection from symptomatic SARS-CoV-2 infection.

The study also found that the drug was well-tolerated.

AstraZeneca foresees that the drug would be used alongside vaccines to protect vulnerable populations.

AZD7442 comprises two agents, tix…

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. Ann E. Taylor

Dr. Taylor currently serves on the board of directors of Unlearn.AI, a company focused on accelerating clinical trials with artificial intelligence.

She has authored and co-authored 48 peer-reviewed papers, 27 book chapters and reviews and served on the editorial board of the Journal of Clinical Endocrinology and Metabolism.

Foster City, California–based Terns is focused on developing therapies for nonalcoholic steatohepatitis (NASH), which involves liver inflammation and potentially scarring (cirrhosis…