[Updated May 21, 2024.] 2023 may not go down as the brightest year for the pharma sector, but the entry of Novo Nordisk’s Ozempic (semaglutide) into the ranks of top-selling drugs like Keytruda, Dupixent, and Eliquis signals a new era in the treatment of metabolic disease. Novo Nordisk’s sales jumped by more than one-third in…
AstraZeneca launches pilot program for Cordio Medical’s AI heart failure app
AstraZeneca and the Bellvitge University Hospital plan to launch the first pilot program for the Cordio Medical HearO app. The HearO smartphone app provides widespread access to medical-grade technology for patients with congestive heart failure (CHF). It enables the patient to monitor symptoms, manage treatment and improve quality of life. Astrazeneca said the pilot program aims to…
FDA approves expanded use of Farxiga (dapagliflozin) for heart failure patients regardless of ejection fraction status
FDA has approved an expanded indication for AstraZeneca’s Farxiga (dapagliflozin). This decision, marking a significant milestone in Farxiga’s development, opens up its use in patients with heart failure, regardless of their ejection fraction status. This brings the total number of Farxiga’s approved indications to five. Ejection fraction in heart failure Ejection fraction is a key measure…
10 pioneering companies implementing AI in drug discovery, development and beyond
The pharma industry is embracing artificial intelligence (AI) to streamline drug discovery and development, although adoption remains early. The field, however, is rapidly expanding. The global AI in drug discovery market was worth about $1.1 billion last year but could grow at a 30% clip from 2023 to 2030, according to Grand View Research. In…
An overview of the RSV vaccine candidate landscape in early 2023
Respiratory syncytial virus (RSV) remains a prominent global health concern. Each year, the virus is to blame for 2.1 million outpatient visits for children under 5 years old, according to CDC. Other vulnerable populations, including older adults and immunocompromised individuals, are also at risk. Nevertheless, RSV has long been a research focus. Scientists first identified RSV in 1956.…
The next wave: 10 promising investigational antihypertensive drugs to watch
Cardiovascular diseases remain a leading cause of morbidity and mortality worldwide. This review highlights ten promising antihypertensive drug candidates with the potential to address pulmonary arterial hypertension (PAH), resistant hypertension and uncontrolled hypertension. Aprocitentan, developed by Janssen NYSE:JNJ) and Idorsia (SIX:IDIA), is an experimental oral drug designed to treat resistant hypertension. As a dual endothelin…
Prominent pharma M&A deals to watch in Q1 2023: Pfizer, Sanofi and others on the hunt
After a relatively quiet 2022, 2023 is anticipated to be a more robust year for pharma M&A activity. In recent months, players such as Pfizer (NYSE:PFE), Sanofi (NYSE:SNY), Chiesi, AstraZeneca (LON:AZN) and Amgen (Nasdaq:AMGN) have unveiled acquisition plans that could reshape the landscape of the sector. This article delves into the details of prominent recent…
CinCor stock surges after AstraZeneca announces plan to buy company for up to $1.8B
AstraZeneca (LON:AZN) announced it had reached an agreement to acquire CinCor Pharma (Nasdaq:CINC). After announcing the proposed deal, CinCor’s share price jumped 144% to $28.74. AstraZeneca has agreed to a tender offer to acquire outstanding shares of CinCor for $26 per share, or $1.3 billion. CinCor specializes in developing therapies for hypertension and chronic kidney…
AstraZeneca wins positive CHMP opinion for Imfinzi for unresectable or metastatic biliary tract cancer
Cambridge, UK–based AstraZeneca (Nasdaq:AZN) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended a new marketing authorization of Imfinzi (durvalumab). The recommendation specifically refers to the first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine with cisplatin).…
AstraZeneca’s Vaxzevria COVID-19 vaccine wins full authorization in Europe
Although not available in the U.S., AstraZeneca’s (LON:AZN) Vaxzevria COVID-19 vaccine has won full marketing authorization in the European Union. European authorities initially granted conditional marketing authorization to the vaccine for individuals at least 18 years old in early 2021. However, in April, the European Medicines Agency (EMA) noted that the vaccine had a possible link to…
Ultomiris wins approval in Europe for generalized myasthenia gravis
The complement C5 inhibitor Ultomiris (ravulizumab) from AstraZeneca (LON:AZN) has won approval in Europe as adjunctive therapy for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. The regulatory nod represents the first approval for a long-acting C5 complement inhibitor for treating gMG in Europe. While myasthenia gravis is a chronic…
AstraZeneca executive vice president Susan Galbraith has helped develop seven blockbuster drugs
Dr. Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, says her entry into the pharmaceutical industry was serendipitous. “I always wanted to be a doctor, and during medical school, I was fascinated by the science behind how cancer happens and what we can do to better treat it,” she said. After following this…
FDA approves Enhertu for HER2-low breast cancer
The HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has won FDA approval for patients with unresectable or metastatic HER2-low breast cancer. Enhertu, a HER2-directed antibody drug conjugate, is now the first approved therapy for patients with the HER2-low breast cancer subtype. The recent approval covers patients with HER2-low breast cancer if they have had chemotherapy for…
Merck halts Phase 3 Lynparza for futility
Merck (NYSE:MRK) has announced that it will stop the Phase 3 LYNK-003 trial focused on Lynparza (olaparib) with or without bevacizumab for patients with unresectable or metastatic colorectal cancer. Two experimental arms in the trial, one focused on Lynparza as monotherapy or in combination with the immunotherapy drug bevacizumab, will be suspended. The primary endpoint…
AstraZeneca to scoop up biotech TeneoTwo for up to $1.27 billion
AstraZeneca (LON:AZN) has announced it has entered an agreement to acquire TeneoTwo and its Phase 1 clinical-stage CD19/CD3 T-cell engager TNB-486. The company will pay $100 million on deal closing to acquire all outstanding equity of TeneoTwo. In addition, AstraZeneca will pay an additional $805 million in milestone payments and another $360 million in potential…
Enhertu slashed risk of disease progression or death by half compared to chemotherapy HER2-low breast cancer
AstraZeneca (LON:AZN) and Daiichi Sankyo’s (OTCMKTS:DSNKY) Enhertu (fam-trastuzumab deruxtecan-nxki) showed a dramatic survival benefit in the pivotal DESTINY-Breast04 Phase 3 study focused on a subset of breast cancer patients. The DNA topoisomerase I inhibitor improved median overall survival by more than six months compared to chemotherapy in the study. In addition, the drug met the…
AstraZeneca paying up to $157M for broad-spectrum monoclonal antibodies against COVID
RQ Biotechnology (London) emerged from stealth mode today, saying that AstraZeneca will pay it up to $157 million plus royalties for its existing mAbs against SARS-CoV-2. “Our vision is to build on our successful debut with neutralizing antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral…
AstraZeneca’s Farxiga met primary endpoint in Phase 3 heart failure trial
AstraZeneca’s (LON:AZN) SGLT2 inhibitor Farxiga (dapagliflozin) led to a statistically significant and clinically meaningful reduction in the primary composite endpoint of cardiovascular death or worsening heart failure in the DELIVER Phase 3 study. First FDA approved in 2014 as a type 2 diabetes treatment, Farxiga has scored approvals related to heart failure and chronic kidney…
Imfinzi with chemotherapy gets FDA priority review for locally advanced or metastatic biliary tract cancer
AstraZeneca (LON:AZN) has announced that its supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has received Priority Review from FDA when used with chemotherapy in patients with locally advanced or metastatic biliary tract cancer (BTC). The company had submitted data from the TOPAZ-1 Phase 3 study indicating an improvement in overall survival compared to standard-of-care chemotherapy.…
AstraZeneca and Daiichi Sankyo win new breakthrough therapy designation for Enhertu
The HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has won its fifth breakthrough therapy designation from the FDA. Enhertu was developed jointly by AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS: DSNKY). The latest designation relates to treating adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer. Of the five breakthrough therapy designations for the drug,…
AstraZeneca’s Evusheld offered strong protection against COVID-19 in Phase 3 study
In the Phase 3 Provent trial, Evusheld (AZD442) cut the risk of developing symptomatic COVID-19 by 77% in the primary analysis focused on patients at high risk for severe COVID-19. The monoclonal antibody cocktail, including tixagevimab and cilgavimab cut the risk by 83% in the six-month follow-up analysis compared to placebo. The drug is currently authorized…
15 of the best pharma companies to work for
The pharmaceutical industry continues to see strong growth 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 best pharma companies to work for continue to offer a number of advantages to skilled workers. Pharma positions remain in high demand, and…
Pharma’s top 20 R&D spenders in 2021
If 2020 underscored the importance of the pharma industry’s social importance, 2021 demonstrated the ability of R&D spenders to yield profitable commercialized products. But while strong demand for COVID-19 therapies in 2021 provided unprecedented revenue levels for a handful of Big Pharma companies, it didn’t result in substantial changes in R&D spending. (Look out for more insights…
AstraZeneca announces global R&D postdoctoral program for complex disease research
AstraZeneca (LON:AZN) is looking for final year MD or PhD students and postdoctoral researchers to reach out with ideas to speed drug discovery and development in the company’s core disease areas. The company’s central focus areas include oncology; cardiovascular, renal and metabolism; and respiratory and immunology. Candidates accepted into the program have a fully funded…
Lynparza cut death risk by one-third in adjuvant treatment of germline BRCA-mutated high-risk early breast cancer
Lynparza (olaparib) significantly reduced death risk when treating germline BRCA-mutated high-risk early breast cancer in the Phase 3 OlympiA study, according to AstraZeneca (LON: AZN). Lynparza recently became the first FDA-approved medicine targeting BRCA mutations in the same type of cancer. The drug is the first poly(ADP-ribose) polymerase (PARP) inhibitor to show an overall survival…