The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
AstraZeneca PLC on Wednesday said a US court decided in its favour in litigation over patents for its Symbicort asthma and obstructive pulmonary disease treatment.
The US District Court for the Northern District of West Virginia found in FTSE 100 drug maker Astra's favour in litigation against Mylan Pharmaceuticals Inc and Kindeva Drug Delivery LP. The court determined that asserted claims in three US Symbicort patents were not invalid.
Astra initiated its litigation against Mylan and then 3M Co in October 2018, claiming infringement of various US patents for Symbicort.
Kindeva was added as a defendant in July 2020, while 3M was voluntarily dismissed from the case.
Ruud Dobber, executive vice president of Astra's BioPharmaceuticals Business Unit, said: "AstraZeneca is pleased with the court's decision, and we maintain full confidence in the strength of our intellectual property rights protecting Symbicort."
I was assuming that investors in AZN would be aware of the involvement of AZN in SCLC chemothereapy .
For reference:
12 July 2019 07:00 BST
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Imfinzi (durvalumab) for the treatment of small cell lung cancer (SCLC).
On March 1, Merck announced it had voluntarily withdrawn the U.S. indication for Keytruda for metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other previous line of therapy.
This was done in consultation with the U.S. Food and Drug Administration (FDA). The complete process will take a few weeks. The company notes that this decision has no effect on other indications for Keytruda.
https://www.cbsnews.com/news/coronavirus-variants-oxford-astrazeneca-vaccine-not-yet-approved-fda/
(Alliance News) - The World Health Organization gave emergency use approval to AstraZeneca PLC's Covid-19 vaccines on Monday, allowing distribution to some of the world's poorest countries to begin.
"The WHO today listed two versions of the AstraZeneca-Oxford Covid-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through Covax," a WHO statement said, referring to the programme aimed at equitable distribution of doses.
The two versions given the seal of approval are being produced by the Serum Institute of India, and in South Korea.
"Countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk, contributing to the Covax facility's goal of equitable vaccine distribution," said Dr Mariangela Simao, the WHO assistant-director general for access to medicines.
"But we must keep up the pressure to meet the needs of priority populations everywhere and facilitate global access. To do that, we need two things – a scale-up of manufacturing capacity, and developers' early submission of their vaccines for WHO review."
The UN health agency's emergency use listing procedure assesses the quality, safety and efficacy of Covid-19 vaccines and is a prerequisite for vaccines in the Covax facility.
WHO approval also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines.
The Pfizer Inc-BioNTech SE Covid-19 vaccine is the only other one to have been given the WHO green light so far.
AstraZeneca vaccines from India and South Korea made up almost all of the doses in the Covax facility's first wave of distribution.
The distribution list issued on February 3 broke down the programme's initial 337.2 million doses. First deliveries are expected in late February.
Some 145 participating economies are set to receive enough doses to immunise 3.3% of their collective population by mid-2021.
The distribution list includes 240 million AstraZeneca doses from the SII; 96 million AZ doses being produced in South Korea; and 1.2 million Pfizer doses.
Both vaccines require two injected doses.
I do wish that all concerned would refer back to the original paper published in the Lncet with regards to vaccine efficacy.
In the trial . In the UK trial only 213 active and 213 control vaccines were administered. Of this group there were 5 positive infections in the control group and and 2 in the active group (reminder this means those that actually had the vaccine).
It is reported that one of those infected was HOSPITALISED on the day of the vaccination! Thhe other was hospitalised 10 DAYS after vaccination.
There is a considerable time lag from infection to hospitalisation. This means that both of the vaccine positive cases were already infected when they were vaccinated.
This means that they should he excluded from efficacy calculations.
The Lancet pape.r specifically says that because of the small data set calculation efficacy impossible. They do however present data that shows that this group demonstrated a good immune response.
From Wikipedia on Henry VIII's equivalence to printing money:
The Great Debasement (1544–1551) was a currency debasement policy introduced in 1544 England under the order of Henry VIII which saw the amount of precious metal in gold and silver coins reduced and in some cases replaced entirely with cheaper base metals such as copper. Overspending by Henry VIII to pay for his lavish lifestyle and to fund foreign wars with France and Scotland are cited as reasons for the policy's introduction. The main aim of the policy was to increase revenue for the Crown at the cost of taxpayers through savings in currency production with less bullion being required to mint new coins. During debasement gold standards dropped from the previous standard of 23 carat to as low as 20 carat while silver was reduced from 92.5% sterling silver to just 25%. Revoked in 1551 by Edward VI, the policy's economic effects continued for many years until 1560 when all debased currency was removed from circulation
Yesterdays "news". Today the claim is being rubbished:
https://www.thetimes.co.uk/article/german-media-rebuked-for-casting-doubt-on-oxford-vaccine-6z9w5q69n
From US news site ABC.COM
California's top epidemiologist has recommended pausing the administration of COVID-19 vaccines from Moderna's lot 041L20A due to "possible allergic reactions" that are under investigation.
"A higher-than-usual number of possible allergic reactions were reported with a specific lot of Moderna vaccine administered at one community vaccination clinic," Dr. Erica Pan, state epidemiologist for the California Department of Public Health, said in a statement late Sunday night. "Fewer than 10 individuals required medical attention over the span of 24 hours. Out of an extreme abundance of caution and also recognizing the extremely limited supply of vaccine, we are recommending that providers use other available vaccine inventory and pause the administration of vaccines from Moderna Lot 041L20A until the investigation by the CDC, FDA, Moderna and the state is complete."
The California Department of Health said all of the affected individuals appeared to be experiencing "a possible severe allergic reaction during the standard observation period," which the U.S. Centers for Disease Control and Prevention says some people have experienced when receiving a COVID-19 vaccine.
PHOTO: A health care worker receives a dose of the Moderna COVID-19 vaccine at Rady Children's Hospital in San Diego, California, on Dec. 22, 2020.
Bing Guan/Reuters
Bing Guan/Reuters
A health care worker receives a dose of the Moderna COVID-19 vaccine at Rady Childre...Read More
More than 330,000 doses from that specific lot have been distributed to 287 providers across the state, with the shipments arriving between Jan. 5 and 12, according to the California Department of Public Health, which said it has not been notified of any other cluster or individual events related to this lot.
When asked for comment, a spokesperson for Moderna told ABC News: "Moderna acknowledges receiving a report from the California Department of Public Health (CDPH) that a number of individuals at one vaccination center in San Diego were treated for possible allergic reactions after vaccination from one lot of Moderna’s COVID-19 Vaccine. The company is fully cooperating with CDPH in investigating these reported adverse events. Consistent with the statement from CDPH, at this point Moderna is unaware of comparable adverse events from other vaccination centers which may have administered vaccines from the same lot."
The EU's medicines regulator said Friday that a decision to authorise the use of the AstraZeneca PLC-Oxford coronavirus vaccine could be made by the end of the month.
The announcement came with the bloc under pressure to speed up the rollout of vaccines against the virus, which has claimed the lives of more than 600,000 people across the continent.
The Amsterdam-based European Medicines Agency said it was expecting AstraZeneca to submit a conditional marketing application for the vaccine next week.
"Possible conclusion - end of Jan, depending on data and evaluation progress," it said in a tweet.
The agency approved the use of the Pfizer Inc-BioNTech SE vaccine in December and the Moderna Inc jab on Monday.
Approval of the shot developed by AstraZeneca and Oxford University "will of course depend on the data we receive and the evaluation progress", EMA chief Emer Cooke told a videoconference.
"Once we actually receive the application, we will make a public announcement on this," Cooke added.
Eat at Milliways - the restaurant at the end of the universe
Splash out the billion take care of itself.
All you have to do is deposit one penny in a savings account in your own era, and when you arrive at the End of Time the operation of compound interest means that the fabulous cost of your meal has been paid for.