AstraZeneca Archives - Page 2 of 9 - Medical Design Sourcing

AstraZeneca sells Ohio manufacturing site to National Resilience

AstraZeneca (LON:AZN) has sold its site in West Chester, Ohio, to National Resilience, a San Diego–headquartered biomanufacturing company.

Resilience has agreed to maintain the site’s operations and assets while retaining its employees, including executives. The company will also continue investing in the site’s workforce and facility.

Privately-held National Resilience also has separately announced that it had reached a long-term biomanufacturing partnership supporting AstraZeneca’s portfolio.

That deal will give AstraZeneca access to Resilience’s end-to-end manufacturing services. In addition, Resilience agreed to purchase the West Chester facility and to manufacture several AstraZeneca drugs at the site as part of a multi-year supply agreement.

Resilience believes the West Cheser site will become its “global center of excellence for commercial drug product manufacturing,” noted Rahul Singhvi, Resilience CEO, …

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).

In an interim analysis, durvalumab with chemotherapy was associated with a 20% reduction in the risk of death compared to chemotherapy as a monotherapy.

The TOPAZ-1 study found a 24% reduction in the risk of death compared to chemotherapy alone after an additional 6.5 months. In addition, the company estimates that twice as many patients of durvalumab and chemotherapy were alive at two years compared to those on chemotherapy alone.

AstraZeneca notes that durvalumab was generally well tolerated in the TOPAZ-1 study. A total of 60.9…

AstraZeneca abandons plans to launch Vaxzevria COVID-19 vaccine in U.S.

AstraZeneca (LON:AZN) was among the first companies to develop a COVID-19 vaccine, but the firm has given up on marketing its Vaxzevria vaccine in the U.S. The company’s CEO, Pascal Soriot, announced that it had asked the FDA to withdraw its regulatory paperwork for Vaxzevria.

The vaccine developed jointly with Oxford University saw considerable success in Europe and elsewhere. But the replication-deficient chimpanzee adenovirus ChAdOx1/AZD1222 has seen waning use as mRNA-based vaccines have come to dominate the market.

In the third quarter of 2022, sales of the vaccine dropped 83% to $173 million. Earlier this year, developing countries refused tens of millions of vaccine doses.

After giving up on plans to market its COVID-19 vaccine in the U.S., AstraZeneca will focus on the monoclonal antibody cocktail Evusheld (tixagevimab/cilgavimab).

AstraZeneca developed Evusheld in collaboration with researchers at Vanderbilt University. Dr. James E. Crowe…

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 rare cases of blood clots with low platelet levels. Johnson & Johnson’s COVID-19 vaccine was linked to similar reports.

European regulators’ decision to grant full authorization to the AstraZeneca vaccine follows a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

The marketing authorization covers the use of the vaccine for primary vaccination and as a heterologous or homologous booster.

European regulatory authorities decided to provide full authorization for the vaccine after reviewing data…

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 autoimmune, neuromuscular disease associated with weakness of skeletal muscles, in gMG, the weakness extends to ocular muscles along with limb and respiratory muscles.

The onset of gMG is often age-related, frequently beginning in women before 40 and for men after 60.

There are approximately 89,000 patients in Europe with gMG.

AZN shares ticked up 0.55% to £9,989.00.

In July, the Committee for Medicinal Products for Human Use (CHMP) recommended approval of the drug for gMG. CHMP based its decision on data from the Phase 3 CHAMPI…

Women in Pharma: 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 passion and becoming a clinical oncologist, Galbraith had the opportunity to undertake a Ph.D. at the University of London, where she researched a vascular-targeting molecule. “Near the end of my Ph.D., the molecule I was working on was licensed to Bristol Myers Squibb, and I was approached with an opportunity to join the company,” she said. “ So, in 2001, I moved across the Atlantic with my family and entered the pharmaceutical industry.”

Shortly after Galbraith joined the industry, work on the molecule was halted due to a safety signal. “At this point, I could have headed back to clinical research, which at the time was the les…

EU approves AstraZeneca’s Evusheld COVID-19 antibody cocktail

AstraZeneca (LON:AZN) has announced that its long-acting antibody combination Evusheld (tixagevimab and cilgavimab) has received marketing authorization in the European Union.

Formerly known as AZD7442, Evusheld is indicated for treating individuals 12 and older infected with SARS-CoV-2 who are at risk for severe COVID-19. The indication is limited to those weighing at least 40 kg who do not need supplemental oxygen.

European regulators based their recommendations on data from the placebo-controlled Phase 3 TACKLE COVID-19 study that demonstrated a single intramuscular (IM) dose of Evusheld.

Evusheld thus differs from other COVID-19 antibodies that require an infusion.

The placebo-controlled TACKLE study found that Evusheld provided clinically and statistically significant protection against severe COVID-19 or death from any cause compared.

Outcomes were best for individuals who received Evusheld therapy at an early stage of disease pr…

FDA approves Enhertu for HER2-low breast cancer

AstraZeneca/Daiichi-Sankyo

The HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has won FDA approval for patients with unresectable or metastatic HER2-low breast cancer.

Enhertu is now the first approved therapy for patients with HER2-low breast cancer subtype.

The recent approval covers patients with HER2-low breast cancer if they have had chemotherapy for metastatic cancer or if their cancer returned within 6 months of completing an adjuvant chemotherapy regimen.

Patients with low levels of the HER2 protein have traditionally had fewer treatment options than patients with HER2-positive breast cancer, according to the National Cancer Institute. Treatment options for such patients typically included endocrine therapy or chemotherapy.

Overall, about 2 million women per year are diagnosed with breast cancer.

FDA estimated that approximately 60% of patients with…

AstraZeneca installs Michel Demaré as non-executive board chair

AstraZeneca (LON:AZN) has appointed Michel Demaré as the chair-designate of its board.

Demaré will replace Leif Johansson, the current chair of the board of AstraZeneca, who plans to retire in April 2023.

There will be a managed handover period in the coming months.

Demaré joined AstraZeneca’s board of directors in September 2019 as an independent non-executive director.

He now is the chair of AstraZeneca’s remuneration committee and a member of the audit committee and the nomination and governance committee.

“I could not be prouder to be named chair-designate of the board of AstraZeneca and am excited to have the opportunity to build on Leif’s success as chair and work with Pascal and members of the board and senior executive team when I take on my new role in 2023,” said Demaré in a statement.

Pascal Soriot is the CEO of AstraZeneca.

After beginning to serve as chair of the board, Demaré will receive an annual fee of £800,00…

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 of the trial was progression-free survival.

The study focused on patients without progression after first-line therapy.

Merck made the decision after receiving feedback from an independent Data Monitoring Committee (DMC) following review from an interim analysis.

The PARP inhibitor Lynparza was first developed by KuDOS Pharmaceuticals and the University of Pennsylvania.

AstraZeneca acquired KuDOS Pharmaceuticals in 2005.

In 2021, the drug jointly earned AstraZeneca and Merck $3.7 billion.

The two companies continue to develop Lynparza for a variety of on…

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 milestone payments to TeneoTwo’s equity holders.

TeneoTwo is investigating TNB-486 as a potential therapy for relapsed and refractory B-cell non-Hodgkin lymphoma.

AstraZeneca believes TNB-486 can potentially treat B-cell hematologic malignancies such as diffuse large B-cell lymphoma and follicular lymphoma.

In 2017, AstraZeneca won FDA approval for Calquence (acalabrutinib) for mantle cell lymphoma. In 2019, acalabrutinib won an indication for chronic lymphocytic leukemia.

Acalabrutinib is an agammaglobulinemia tyrosine kinase inhibitor.

Conversely, TNB is a T-cell engager, …

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 primary endpoint of progression-free survival in the study, cutting the risk of disease progression or death by 49% compared to chemotherapy.

AstraZeneca reports that the therapy could potentially redefine treatment for roughly half of breast cancer patients.

The DESTINY-Breast04 study focused on previously-treated patients with HER2-low unresectable or metastatic breast cancer.

AstraZeneca notes that Enhertu is the first HER2-focused therapy to show a survival benefit in the patient demographic.

Enhertu met the primary endpoint of progression-free survival in patie…