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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 inhibitors.

“The POSEIDON data offer patients further benefit from Imfinzi and are an important validation of our development strategy to explore novel combinations,” said Susan Galbraith, AstraZeneca’s executive vice president, oncology R&D.

Imfinzi is a human monoclonal antibody that targets programmed death-ligand 1 (PD-L1).

While many Big Pharma firms have developed PD-L1 drugs, few have become blockbusters — Bristol Myers Squibb’s Yervoy (ipilimumab) is one exception.

The POSEIDON trial had 338 recipients who received Imfinzi, tremelimuma…

AstraZeneca and European Commission settle COVID-19 vaccine supply lawsuit

The Vaxzevria vaccine uses an adenovirus vector. Image courtesy of AstraZeneca.

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, however, ultimately trailed initial expectations, leading to tensions between AstraZeneca and the E.U. AstraZeneca vowed to provide an additional 9 million doses in February to diffuse the tensions.

The E.U., however, pursued legal action in April. In the recent settlement, AstraZeneca agreed to provide the E.U. with 300 million doses by the end of March 2022. That sum includes 75 million doses by the end of the fourth quarter of 2021. In addition, the company will p…

AstraZeneca mandates COVID-19 vaccination for U.S. employees

AstraZeneca (LON:AZN) will require that its American employees be fully vaccinated if they plan to work in its facilities or visit customers.

Cambridge, U.K.–based AstraZeneca said the plan would also apply to workers at Alexion Pharmaceuticals (Boston, Mass.). AstraZeneca completed its acquisition of Alexion in July.

AstraZeneca employees can seek vaccine exemptions but must obtain a weekly COVID-19 test.

Pfizer (NYSE:PFE), Moderna (NSDQ:MRNA) and Lilly (NYSE:LLY) have announced similar initiatives for U.S. employees.

Outside of the pharmaceutical industry, many notable employees also require vaccine mandates. For example, in finance, Goldman Sachs, Bank of America and JP Morgan Chase have announced such policies.

The federal government has embraced vaccine mandates for its employees.

Tech companies such as Google, Uber and Microsoft are also requiring vaccination of office-based workers.

AstraZeneca plans on shipping up to t…

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 vaccines,” said Mene Pangalos, AstraZeneca’s executive vice president, biopharmaceuticals R&D. “We are very encouraged by these efficacy and safety data in high-risk people, showing our long-acting antibody combination has the potential to protect from symptomatic and severe disease, alongside vaccines.”

The company plans to share more data from the PROVENT clinical trial later this year.

The trial includes more than 5,000 participants recruited from the U.S., U.K., Spain, France and Belgium.

AZD7442 consists of two long-acting anti…

FDA OKs AstraZeneca’s Emergent-produced vaccine for export

After facing months of setbacks concerning its contract production of COVID-19 vaccine, Emergent BioSolutions (NYSE:EBS) is making progress.

Most recently, the FDA announced that “certain lots” of AstraZeneca (LON:AZN) COVID-19 vaccine drug substance produced in a facility in Baltimore are acceptable for export.

Last week, the FDA gave the company permission to restart Johnson & Johnson’s (J&J) COVID-19 vaccine production.

While Emergent BioSolutions signed an agreement with AstraZeneca to produce that company’s vaccine in July 2020, the Biden administration required Johnson & Johnson to manage the plant after identifying potential contamination. As a result, FDA ultimately required Johnson & Johnson to discard 60 million doses produced at the Emergent plant.

While the Johnson & Johnson vaccine has won emergency use authorization in the U.S., the AstraZeneca vaccine hasn’t.

The AstraZeneca vaccine, however, has found bro…

COVID-19 vaccination rates ticking up as Delta fuels infections

Image courtesy of Pexels

The rate of vaccination in the U.S. continues to tick upward. On Aug. 1, healthcare workers administered 816,203 doses, marking one of the highest totals in recent weeks.

Vaccination rates have increased about 24% in the past week, according to an estimate from UBS.

If the trend holds, the daily vaccination rate could surpass one million — roughly in line with the pace in late June.

At present, almost 58% of all Americans have received at least one COVID-19 vaccine dose.

In early July, the daily rate of U.S. vaccinations hit its lowest point since the beginning of the year. At that time, health officials administered about 500,000 doses daily.

As a result of the lagging vaccination rate, the U.S. was about a month late in meeting President Biden’s goal to provide at least one vaccine dose to 70% of adults by July 4. Some 60.6% of U.S. adults are fully vacc…

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 linked elevated levels of type I IFN signaling with increased disease activity and severity.

“We have known since the 1970s that interferons were involved with lupus,” said Dr. George Tsokos, a member of the Lupus Foundation of America Medical-Scientific Advisory Council, in a statement. “With the approval of Saphnelo, we now have one more drug that allows us to translate valuable research knowledge into clinical practice with multiple benefits for our patients with lupus.”

In approving the drug, FDA considered data from two TULIP Phase 3 trials and the MUSE Phase 2 trial.

Across those stud…

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 had a similar efficacy after 21 days. In terms of protecting against the Beta and Gamma variants, a single dose of the BNT162b2 vaccine was 83% effective at protecting against hospitalization and death after 21 days. One dose of Moderna’s mRNA-1273 vaccine was 94% effective at the same interval.

A second dose of the Pfizer-BioNTech vaccine boosted its efficacy considerably. It was 98% effective at preventing hospitalization or death from the Beta and Gamma variants 14 days after the second dose. Its protection against other variants was similar following the second dose.

There wa…

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.

Early users of the Cambridge-1 include AstraZeneca (LON:AZN), GSK (NYSE:GSK), Oxford Nanopore, King’s College London, St. Thomas’ NHS Foundation Trust and Oxford Nanopore Technologies.

AstraZeneca’s focus of the computer will be on creating an open-source transformer-based generative AI model for chemical structures. The model can be used to predict chemical reactions, optimize molecules and generate de novo molecules.

AstraZeneca and NVIDIA are also teaming up to use Cambridge-1 to facilitate digital pathology to accelerate the process of annot…

Emergent BioSolutions facing a shareholder lawsuits

The Baltimore-based company Emergent BioSolutions (NYSE:EBS) is the subject of at least four lawsuits asking for refunds and pushing for change in the company’s executive ranks. Some of the lawsuits targeting Emergent accuse the company of securities fraud and insider trading.

Emergent has denied the allegations. “Our executives strictly follow the law and our own internal policies to prevent any improper securities trading,” Emergent spokesperson Matt Hartwig told The New York Times.

In any event, the past year has not been kind to Emergent BioSolutions, the multinational biopharma company focused on vaccines and antibody therapeutics.

After initially scoring the support of Johnson & Johnson (NYSE:JNJ) and AstraZeneca (LON:AZN) to manufacture their respective COVID-19 vaccines, the company saw its stock leap to a peak value of $133.42 on Aug. 14, 2020.

In afternoon trading today, its stock’s value was $61.87.

The drop in valuation resu…

Pfizer-AstraZeneca COVID-19 vaccine combinations are effective, study suggests

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

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 a so-called heterologous prime-boost vaccination would enable more rapid vaccination, but data about the efficacy of such a strategy have been scarce.

In the recent study, researchers randomized 830 adults 50 and older into eight groups to receive the varying combinations of the AstraZeneca and BioNTech-Pfizer vaccines.

To get a sense of the efficacy of the various combinations, the researchers used a geometric mean ratio (GMR) and geometr…

Assessing pharma headwinds and tailwinds in mid-2021

Pfizer-BioNTech COVID-19 vaccine. Image courtesy of Wikimedia Commons.

Now that we have passed the year’s midway mark, pharma continues to be in a unique position.

While COVID-19 gave the industry an opportunity for a reputational reset in 2020, the pandemic is now a net positive for the industry, according to the recent Moody’s report, “Solid demand, lift from COVID-19 products continue to drive positive outlook.”

While demand for COVID-19 vaccines has ebbed recently in the U.S., Moody’s projects strong vaccine sales overall for the remainder of 2021. Pfizer (NYSE:PFE) upped their guidance for vaccine sales to $26 billion in their first-quarter earnings report. “Their approach to guidance for revenue is based on contracts that have been signed,” said Michael Levesque, lead author of the report. Thus, any future contracts that Pfizer signs after that guidance update will further expand their guidance …