With Covid-19 vaccine distribution in poor countries showing no signs of improvement, Anglo-Swedish drugmaker AstraZeneca and the Covax vaccine sharing program have come fire. The relatively short shelf-life of the pharma group’s viral vector-based shot Vaxzevria in particular is complicating the worldwide rollout, Reuters reports, citing World Health Organization (WHO) documents.
AstraZeneca and Ionis Pharmaceuticals have finalized their agreement to develop and commercialize investigational therapy eplontersen, formerly known as Ionis-TTR-L. The companies previously announced their intention to collaborate on Dec. 7, 2021.
The delta variant of the coronavirus is taking its toll on Europe as vaccine skepticism shows no signs of going into remission, and promising oral treatments developed by Pfizer and Merck & Co have not yet been approved. With deaths now feared to top 2 million by March 2022, the World Health Organization (WHO) says the pandemic has become the leading cause of death in the region, whereby it helps to know that the WHO’s definition includes such countries as Russia, Ukraine, Tajikistan and Israel.
AstraZeneca has agreed to transfer its global rights to two drugs for treating patients with chronic obstructive pulmonary disease (COPD) to Switzerland’s Covis Pharma for $270 million. The transaction is expected to close in the fourth quarter of 2021.
AstraZeneca’s rare diseases unit Alexion has taken full control of Caelum Biosciences, gaining access to another rare disease drug, CAEL-101, which is a potential treatment for light chain amyloidosis (AL) that has been granted Fast Track status by the US Food and Drug Administration (FDA).
AstraZeneca has provided the US Food and Drug Administration (FDA) with encouraging study evidence that its antiviral cocktail candidate AZD7442 can prevent Covid-19 infections in vulnerable people, such as those who are unlikely to respond well to vaccines. This followed disappointing results from an earlier study.
AstraZeneca is building what it said is a “next-generation” active pharmaceutical ingredient (API) manufacturing plant for small molecules near Dublin, Ireland. A start-up date was not announced for the new facility that will be the Anglo-Swedish drugmaker’s first investment in the country.
With changes made to the age group of people receiving the AstraZeneca Covid-19 vaccine, the rare but troubling incidence of blood clots seen earlier this year has disappeared, a new study published this week says.
US biotech Regeneron is collaborating with AstraZeneca to research, develop and commercialize small molecule medicines targeting GPR75 for treating obesity.
The bark of the UK’s Competition and Markets Authority (CMA) evidently is worse than its bite – which in the case of AstraZeneca’s $39 billion acquisition of Alexion was none at all. Only a week after European authorities approved the deal, the CMA also gave the green light, without voicing any competition concerns. With this behind it, the two drugmakers are free to merge by Jul. 21.
EU competition authorities have approved AstraZeneca’s $39 billion takeover of US biopharma Alexion. Europe’s green light for the deal sealed in December 2020 follows the approval of the US Federal Trade Commission (FTC) in April 2021.
In the aftermath of a far-reaching mix-up of Astra Zeneca’s Covid vaccine ingredients with those of Johnson & Johnson’s shot, US CDMO Emergent BioSolutions not only has lost half of its stock market value but is also facing shareholder lawsuits related to other offenses, including securities fraud.
The US Food and Drug Administration (FDA) added information about myocarditis and pericarditis to its fact sheets for the mRNA-based Moderna and Pfizer/BioNTech Covid-19 vaccines on Jun. 25.
In a closely watched whistleblower suit, a federal court jury in the US state of Oregon has awarded $2.4 million to a former sales manager for AstraZeneca, who claimed the drugmaker fired her after she raised concerns of off-label marketing.
The European Commission’s attempt to hold AstraZeneca (AZ) responsible for the delayed and truncated supply of its Covid-19 vaccine appears to have not produced the desired result, at least not in the first lawsuit to be heard.
After losing Emergent BioSolutions as a Covid-19 vaccine production partner, AstraZeneca has been looking for a new CDMO to fulfil its $1.2 billion contract with the US Biomedical Advanced Research and Development Authority (BARDA). Citing people familiar with the matter, the newspaper New York Times reports that the Anglo-Swedish drugmaker is now in talks with the US government about transferring dose manufacture to Catalent.
AstraZeneca’s agreement to acquire Alexion Pharma for $39 billion, sealed in December 2020 and approved by the US Federal Trade Commission (FTC) in April 2021, may not be a done deal after all. The UK’s Competition and Markets Authority (CMA) announced on May 25 that it has launched an anti-competition investigation into the transaction.
US president Joe Biden announced this week that his administration will send an additional 20 million Covid-19 vaccine doses abroad by the end of June, this time including some approved for use in the US.
US Covid-19 vaccine manufacturer Moderna said it is planning to make major renovations at its Norwood, Massachusetts, mRNA production site with the aim of more than doubling its size by late 2021 or early 2022. The plans call for transforming the facility from a production and lab space to an industrial technology center by acquiring another building located on the same campus.
The EU has clinched the deal with vaccine team Pfizer/BioNtech hinted at in mid-April. European Commmission president Ursula von der Leyen late last week informed member states about the agreement that foresees delivery of 1.8 billion additional doses of the duo’s mRNA-based Covid-19 vaccine though 2023. This includes an initial 900 million doses with an option for another 900 million.
As India’s Covid-19 infections soar and the death toll nears 200,000, wealthier countries – including the US, UK, Germany, France and Australia – are rushing supplies of oxygen, ventilators and protective gear to the subcontinent.
The European Commission has confirmed rumors that it has initiated legal action against AstraZeneca for failing to meet contractual obligations for deliveries of Its Covid-19 vaccine. Health commissioner Stella Kyriakides said the action is being taken jointly with all 27 member states.
The US Centers for Disease Control and Prevention (CDC) and the Food & Drug Administration (FDA) announced on Apr. 23 that they would lift the two-week pause on administration of the Johnson & Johnson Covid-19 vaccine for all adults and require a warning label about the possibility of a rare but dangerous blood clotting disorder combined with a low level of platelets.
Johnson & Johnson will now resume the rollout of its Covid-19 vaccine in the EU, with the shot carrying a label warning that blood clots are a possible risk. The announcement came after the European Medicines Agency (EMA) said on Apr. 20 that the benefits of the vaccine exceed the risk but mandated the label.
Activist hedge fund Elliott Management, also known as Elliott Associates or Elliott Advisers, has a new target – GlaxoSmithKline (GSK). Over the past decade, the fund has gone after chemical companies DuPont, Bayer and most recently Akzo Nobel, with mixed results.
Denmark has taken what it said was a final decision to discontinue using the AstraZeneca Covid-19 vaccine in its national inoculation campaign after an unusual string of rare blood clots. A discussion has begun over what to do with the remaining supply.
US health authorities paused the rollout of Johnson & Johnson’s Covid-19 vaccine on Apr. 13 after reports of six serious blood clots occurring in nearly 7 million people vaccinated. The Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) said they would release guidance following an emergency meeting on Apr. 14.
Johnson & Johnson has joined AstraZeneca in the negative spotlight, giving the latter some likely welcome relief. After studying a spate of usually rare blood-clotting issues in people receiving the Anglo-British drugmaker’s Covid-19 vaccine, the European Medicines Agency (EMA) is now looking at similar incidents with the US healthcare group’s single-dose shot.
The more things change, the more they stay the same, at least in pandemic times, in Europe. After its second look at an unusual string of rare blood clotting incidents, mostly in younger women receiving AstraZeneca's Covid-19 vaccine, the European Medicines Agency (EMA), the EU’s drugs regulator, said on Apr. 7 it believes there is probably a “strong association” but stressed once again that the benefits of vaccination outweigh any risks.
With the backing of the US government, Johnson & Johnson has taken over “full responsibility" for manufacturing at the Bayview plant operated by its Baltimore, Maryland-based vaccine ingredients supplier, US biotech Emergent BioSolutions.
AstraZeneca has released an updated statement on the efficacy of its Covid-19 vaccine after US health authorities criticized its analysis of US Phase 3 trial results as confusing and suggested that the company might be combining results from different phases.
The AstraZeneca Covid vaccine’s brief respite from global negative headlines achieved after it published positive results from its US clinical trial on Mar. 22 was even briefer than usual. Soon after publication, the figures were criticized by the trial’s independent data safety monitoring board (DSMB), a move experts called unprecedented or at least highly unusual. The drugmaker promised to publish more information within 48 hours.
Preliminary results from AstraZeneca’s recently completed US Phase 3 trial showed its Covid-19 vaccine to be 79% effective against symptomatic forms of the disease, along with offering 100% protection against severe disease, hospitalization and death, the company revealed on Mar. 22. In participants over 65, efficacy was even higher at 80%.
After a day’s deliberation, the European Medicines Agency (EMA) has decided that AstraZeneca’s Covid-19 vaccine is safe and effective and that potential side effects observed across the EU are not too great to run the risk of being infected with the virus.
As the world awaited conclusive words from the European Medicines Agency (EMA) on the safety of the AstraZeneca Covid-19 shot, the vaccine war between the UK and the EU appeared to be intensifying. With manufacturers struggling to meet supply commitments, both sides see their inoculation programs at risk.
