Tag Archives: AstraZeneca

Datopotamab deruxtecan demonstrated statistically significant and clinically meaningful progression-free survival benefit in patients with HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial – AstraZeneca

  1. Datopotamab deruxtecan demonstrated statistically significant and clinically meaningful progression-free survival benefit in patients with HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial AstraZeneca
  2. AstraZeneca, Daiichi hit first goal in breast cancer ADC trial FierceBiotech
  3. AstraZeneca, Daiichi breast cancer treatment succeeds in trial STAT
  4. Dr Liu on the 5-Year OS Data With Atezolizumab and Chemotherapy in ES-SCLC OncLive
  5. AstraZeneca and Daiichi’s breast cancer drug meets goal in study Reuters
  6. View Full Coverage on Google News

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Pfizer’s Talzenna snags broader prostate cancer nod than AstraZeneca and Merck’s rival PARP med – FiercePharma

  1. Pfizer’s Talzenna snags broader prostate cancer nod than AstraZeneca and Merck’s rival PARP med FiercePharma
  2. FDA Approves Talazoparib Plus Enzalutamide for HRR Gene–Altered mCRPC OncLive
  3. Pfizer’s TALZENNA® in Combination with XTANDI® Receives U.S. FDA Approval Yahoo Finance
  4. FDA Approves Talazoparib, Enzalutamide Combination for Metastatic Castration-Resistant Prostate Cancer Pharmacy Times
  5. FDA Approves Talzenna-Xtandi Combo for Subset of Patients With Prostate Cancer Curetoday.com
  6. View Full Coverage on Google News

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AstraZeneca dives into regulatory T cell therapies in deal with Quell Therapeutics – Endpoints News

  1. AstraZeneca dives into regulatory T cell therapies in deal with Quell Therapeutics Endpoints News
  2. AstraZeneca pays $85M to Quell Type 1 diabetes with ‘one and done’ cell therapy FierceBiotech
  3. AstraZeneca signs $2 billion agreement with Quell to develop cell therapies Reuters
  4. Quell Therapeutics Signs a Collaboration, Exclusive Option and License Agreement with AstraZeneca to Develop, Manufacture and Commercialize Engineered Treg Cell Therapies for Autoimmune Diseases GlobeNewswire
  5. Astra Enters Into $2 Billion-Plus Pact With UK Biotech Quell Bloomberg
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AstraZeneca pays $85M to Quell Type 1 diabetes with ‘one and done’ cell therapy – FierceBiotech

  1. AstraZeneca pays $85M to Quell Type 1 diabetes with ‘one and done’ cell therapy FierceBiotech
  2. AstraZeneca signs $2 billion agreement with Quell to develop cell therapies Reuters
  3. AstraZeneca announces agreement with Quell Therapeutics to develop, manufacture and commercialise engineered T-regulatory cell therapies for autoimmune diseases AstraZeneca
  4. Quell Therapeutics Signs a Collaboration, Exclusive Option and License Agreement with AstraZeneca to Develop, Manufacture and Commercialize Engineered Treg Cell Therapies for Autoimmune Diseases GlobeNewswire
  5. Astra Enters Into $2 Billion-Plus Pact With UK Biotech Quell Bloomberg

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AstraZeneca: Tagrisso-chemo combo improved progression-free survival in late-stage lung cancer trial – Endpoints News – Endpoints News

  1. AstraZeneca: Tagrisso-chemo combo improved progression-free survival in late-stage lung cancer trial – Endpoints News Endpoints News
  2. AZ’s Tagrisso plus chemo triumphs in EGFR-mutated lung cancer FiercePharma
  3. Osimertinib and Chemotherapy Improves PFS in Advanced EGFRm NSCLC Targeted Oncology
  4. TAGRISSO® (osimertinib) plus chemotherapy demonstrated strong improvement in progression-free survival for patients with EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial Business Wire
  5. Immunotherapy Plus Chemo Improves Quality of Life in NSCLC Medscape
  6. View Full Coverage on Google News

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Tagrisso plus chemotherapy demonstrated strong improvement in progression-free survival for patients with EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial – AstraZeneca

  1. Tagrisso plus chemotherapy demonstrated strong improvement in progression-free survival for patients with EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial AstraZeneca
  2. AstraZeneca Tagrisso chemo combo cuts risk of lung cancer progression Seeking Alpha
  3. Immunotherapy Plus Chemo Improves Quality of Life in NSCLC Medscape
  4. AstraZeneca’s Tagrisso, chemo combination shows promise in lung cancer trial Reuters
  5. Docetaxel Plus Ramucirumab After Standard Frontline Treatment Elicits Responses in NSCLC OncLive
  6. View Full Coverage on Google News

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Live updates: AstraZeneca buys US biotech CinCor in $1.8 deal

Amid the economic gloom and ongoing conflict in Ukraine, there are signs of a return to normality.

The Golden Globes awards ceremony is back this week in its Los Angeles home, after boycotts over a lack of diversity led to the cancellation of the event last year. Looking further ahead, world leaders, business leaders and economic thinkers will begin arriving in the Swiss resort of Davos this Sunday for the World Economic Forum the following week.

The next seven days also sees the starting gun shot for the official start of the fourth-quarter earnings season, beginning with Wall Street banks and British retailers. This will of course remind us that we are far from back to normal for the global economy — more details below.

For the UK, normality at the moment means widespread industrial action. Ambulance workers and driving instructors stage further walk outs this week, while strike ballots close for teaching unions in England and Wales.

Normality has been restored at least in the US Congress with the vote to install Kevin McCarthy as Speaker of the House of Representatives. Attention can now focus on the economic challenges this year will bring — more about the data announcements coming this week below.

A rocket containing a payload of small satellites sits under the wing of ‘Cosmic Girl’, a converted Boeing 747, at Cornwall Spaceport in Newquay © Tim Hepher/Reuters

Could things be looking up? Yes, if you’re in Cornwall. Monday promises to be a historic day for the UK county — at least according to Virgin Orbit — with the first space satellite launch from mainland Britain.

It could perhaps better be described as a bit of classic British eccentricity since the nine satellites will be shot into orbit using a rocket launched from a repurposed Boeing 747, due to take off from Newquay airport on Monday night. It certainly shows a degree of creativity and should at least lift some British spirits.

Companies

Who likes interest rate rises? Banks, that’s who. This will be made clear this week when several of Wall Street’s biggest lenders report fourth quarter numbers on Friday.

These companies have made money on Fed tightening by raising rates for loans more than deposits. Analysts estimate JPMorgan Chase, Bank of America, Citigroup and Wells Fargo to report collective net interest income for the final three months of 2022 of almost $60bn, up 30 per cent year on year, according to consensus data compiled by Bloomberg. The concern is that this revenue raising party cannot last and that net interest margins have reached a peak.

The flip side of rate rises is the problem of high inflation, which brings me to the other theme of the corporate calendar this week, retailers. Increased check out prices might seem like a good thing for retailers. Not when inflation hits double digits, it isn’t.

We will find out exactly how bad it has been over the Christmas period — or indeed whether stocking up for World Cup viewing provided any sort of fillip — through a slew of trading updates from British high street and online brands this week.

Consumer spending could of course be better than expected, as Next showed last week. Games Workshop, which reports first half numbers on Tuesday, is creating a lot of excitement (and not just among Dungeons and Dragons obsessed teenagers) about growth opportunities due to a spike in role play gaming during the pandemic. Investor (as well as teenager) expectations have been raised further at the fantasy games producer’s recent Amazon TV and film deal.

Economic data

A shopper carries a Zara bag in London’s Regent Street. The British Retail Consortium updates its monthly high street sales survey on Tuesday © Hollie Adams/Bloomberg

Expect a raft of consumer price index and other inflation data over the coming days from the US, China, Japan, Australia, Brazil and Mexico.

The British Retail Consortium updates its monthly UK high street sales survey on Tuesday, while on Friday the Office for National Statistics publishes the latest monthly gross domestic product estimate giving a sense of where the country stands in terms of recession.

Monetary policy comes this week from the Bank of Korea, which is expected to raise the base rate a further 25 basis points to 3.50 per cent on Friday.

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What does the new cancer vaccine trial mean for a cure to the illness?

A cancer jab custom-made from patients’ own tumours has produced ‘really hopeful’ results in a trial.

None of the eight head and neck cancer sufferers, who had a high chance of relapse, saw their tumours return four months after getting the vaccine.

For comparison, two patients in the control group who weren’t given the jab saw their cancers come back.

The vaccine, which uses similar technology to AstraZeneca’s Covid jab – uses DNA taken from each patient’s tumour.

The genetic snippet is then inserted into a weakened virus used to deliver the jab inside the body, training the immune system to recognise and fight the cancer if it returns.

It is given as a weekly jab for six weeks, after which patients are given a booster dose every three weeks for a year.

The new figures are too small to draw any definite conclusions, but researchers say ‘all the data are pointing in the right direction’.

Technology used to make the Pfizer and Moderna Covid vaccines is also being trialled on cancer patients in the US and Europe.

A cancer jab custom-made from patients’ own tumours has produced ‘really hopeful’ results in a trial on NHS patients. It is currently codenamed TG4050 (pictured)

Head and neck cancers are newly diagnosed in more than 12,000 people in the UK each year, and 65,000 in the US. They kill just over 4,000 Britons a year and 14,000 Americans.

There are more than 30 areas within the head and neck where cancer can develop, including the mouth and throat.

The new vaccine — codenamed TG4050 — has been developed by the French company Transgene.

It is known as a ‘viral vector vaccine’, using a genetically modified vaccinia virus, the same family that causes smallpox.

The pathogen has been weakened to the point it cannot cause illness and has been used in vaccination programmes for decades.

A piece of tumour DNA is inserted into the virus so that when it is injected into the body, it can train the immune system to be on watch for these cancer cells.

The hope is that the body will be able to recognise and destroy them before they can start to multiply and form tumours.

Doctors are optimistic about the jab because it is so specific to each individual person’s cancer – even though that will make it more expensive in future.

Transgene’s chief medical officer Dr Maud Brandely said it provided patients with ‘new hope’ in the race to cure cancer.

Cancer mutations can vary between patients, but by making a custom vaccine for every patient, it should be better at targeting these mutant cells.

The vaccine is given to patients after they have had surgery to remove tumours. It is hoped the jab will catch cancer cells before they can even be found on a scan.

Brian Wright was given his 10th vaccine dose at Clatterbridge recently and has 10 more doses to go until January.

A year ago, Mr Wright had a 16-hour operation to get rid of a tumour in his mouth and swap his lower jaw with bone from his leg, followed by weeks of demanding radiotherapy.

He told Sky News: ‘If you have had cancer in your throat, and they say they’re going to inject you with that cancer, it just sounds…’oh no you’re not’.

‘But then they explained it won’t give you cancer back, it will make your body immune to that cancer.’

Transgene plans to treat a total of 30 patients in the trial for head and neck cancer.

Half will be given the jab once their normal treatment ends, and the other half will get it when their cancer returns.

Consultant oncologist and director of clinical research at the Clatterbridge centre, Professor Christian Ottensmeier, told Sky News he was ‘cautiously optimistic’.

‘I am really hopeful, yes,’ he said. ‘I am quite excited about it. All the data are pointing in the right direction.’

‘The immune system can see things we can’t see on scans,’ said Professor Ottensmeier, ‘it’s much smarter than human beings.’

‘If we can train the immune system to pick those cells that would otherwise lead to a relapse at a time when we can’t even see them, then the long-term survival chances for our patients are much higher.’

Another clinical trial of the jab on ovarian cancer patients in France and the US is also showing promising results.

NEW JAB USES A GENETICALLY WEAKENED VIRUS TO TEACH YOUR CELLS HOW TO RECOGNISE YOUR OLD CANCER

How does it work?

Codenamed TG4050, the vaccine is made by a French biotech company Transgene. 

DNA collected from patients’ tumours is inserted into a harmless virus and injected into the patient. 

The genetically modified virus teaches the patient’s immune system to look out for cancer cells, ideally wiping them out before there is even a lump.

Doctors are feeling confident about the jab because it is uniquely made to treat the patient’s individual cancer, and the DNA of tumour cells differs between patients. 

What did the trial find?

None of the eight patients who received the jab had cancer relapses four months later.

And two of the eight patients who didn’t get a jab relapsed, suggesting the vaccine is having a protective effect.

The findings are still too small to draw definitive conclusions, however, and more data is needed. 

 Is it linked to the Covid vaccines?

The Covid pandemic has fast-tracked vaccine development, with the Oxford team of scientists that made the AstraZeneca jab now using the same ‘viral vector’ method to tackle prostate cancer.

Viral vector vaccines use a genetically modified vaccinia virus, from the same family that causes smallpox.

The pathogen has been weakened to the point is cannot cause illness and has been used in vaccination programmes for decades.

A piece of tumour DNA is inserted into the virus so that when it is injected into the body, it can train the immune system to be on watch for these cancer cells.

The hope is that the body will be able to recognise and destroy them before they can start to multiply and form tumours.

The mRNA technology from the Pfizer and Moderna Covid jabs has also been trialled for other cancers in the US and Europe.

Can it work for other cancers?

The jab is already being trialled for ovarian cancer patients in France, with five given the vaccine so far.

It is hoped that it will be used for more cancers in the future, if these trials prove successful.  

What does it mean for cancer care in the future?

Transgene’s chief medical officer Dr Maud Brandely said the results show the jab could give patients more time in remission, providing cancer patients with ‘new hope’.

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AstraZeneca vaccine may increase risk of serious neurological condition

The AstraZeneca vaccine may increase the risk of the serious neurological condition Guillain-Barré syndrome (GBS) with the jab’s Trojan horse delivery system possibly to blame, scientists believe, in a discovery which may apply to similar vaccines.

GBS is a rare condition which causes muscle numbness and pain, and can hinder movement, walking, swallowing and, sometimes, even breathing.

It is commonly caused by the gastroenteritis bug Campylobacter, which has a surface coating which looks slightly human, and so can sometimes trigger the body to attack its own nerves instead of invading germs, leading to GBS.

Now, scientists at University College London (UCL) have found a rise in cases of GBS in the first two to four weeks after the AstraZeneca vaccine, but not in other vaccines, such as Pfizer or Moderna.

Like many vaccines, the Oxford jab uses a weakened chimp adenovirus to deliver the coronavirus spike protein into the body, and scientists have speculated that a reaction to adenovirus may be responsible for the rise in cases.

Adenovirus usually causes the common cold, but scientists are starting to think it may also mimic human cells in a similar way to Campylobacter, confusing the immune system into attacking the body.

Lead author Prof Michael Lunn (UCL Queen Square Institute of Neurology) said: “At the moment we don’t know why a vaccine may cause these very small rises in GBS.

“It may be that a non-specific immune activation in susceptible individuals occurs, but if that were the case similar risks might apply to all vaccine types.

“It is therefore logical to suggest that the simian adenovirus vector, often used to develop vaccines, including AstraZeneca’s, may account for the increased risk.”

Unusual spike in GBS reports

Adenovirus-based vaccines are used against a wide variety of pathogens, tuberculosis, HIV and malaria.

GBS affects about 1,500 people in the UK each year and 30 to 40 per cent of cases have no known causes, leading researchers to suspect that adenovirus could be a factor.

During the 1976 swine flu vaccination campaign in the USA, there was a small increase in GBS associated with the flu jab at that time, leading scientists to question whether the Covid jabs could have a similar effect.

To find out, UCL researchers carried out a population-based study of NHS data in England to track GBS case rates against vaccination rollout.

Between January to October 2021, 996 GBS cases were recorded in the UK National Immunoglobulin Database, but there was an unusual spike in GBS reports occurring between March and April 2021.

For these two months there were about 140 cases per month compared to historical rates of about 100 per month – a 40 per cent increase.

Analysis showed 198 GBS cases (20 per cent) occurred within six weeks of the first-dose Covid-19 vaccination in England.

Overall, following a first dose of the AstraZeneca vaccine there were 5.8 excess GBS cases per million doses of vaccine, equating to an absolute total excess between January-July 2021 of between 98-140 cases.

The rate is still significantly lower than the one in 1,000 rate of GBS associated with Campylobacter.

Data suggest Johnson & Johnson vaccine raises GBS risk

Recent data from the US also suggests that the Johnson & Johnson Janssen vaccine – which also uses an adenovirus entry system – raises the risk of GBS to similar levels as the AstraZeneca jab.

“We know that Pfizer and Moderna don’t cause BDS but Johnson & Johnson and AstraZeneca do and the only commonality link is an adenovirus vector,” added Prof Lund.

“Johnson & Johnson is not the same one because they use a human adenovirus but it’s similar and the implications are broad because adenoviruses are used in quite a lot of vaccines and genetic therapies.

“The benefits from these vaccines and drugs are huge and the risk is tiny and there aren’t that many viral vectors you can use, but it’s good that the public are aware of the risks.

“And theoretically, if we know what virus is causing GBS, we can turn it off and we might be able to prevent disease progression.”

The new research was published in the journal Brain.

Vaccine benefits ‘continue to outweigh potential risks’

An AstraZeneca spokesman said: “Guillain-Barre Syndrome (GBS) has been reported very rarely following vaccination with Vaxzevria. Vaccination of any kind is a known risk factor for GBS and it is noted in the manuscript that the small number of GBS cases appears similar to increases previously seen in other mass vaccination campaigns. 

“It should also be noted that in the UK, Vaxzevria had been administered to more people than any other vaccine during the time frame studied in the manuscript.

“The study observes that the small numbers of cases should be compared to how many infections, hospitalisations and deaths our vaccine has prevented due to Covid-19. Current estimates show that globally the vaccine has helped prevent 50 million Covid-19 cases, five million hospitalisations, and to have saved more than one million lives.

“The EMA and other international bodies including the WHO, have all stated that the benefits of vaccination continue to outweigh any potential risks.”

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Nearly 600,000 course of Pfizer’s Paxlovid are sitting UNUSED in America

Nearly 600,000 courses of Pfizer’s Covid antivral pill Paxlovid are currently sitting on pharmacy shelves unused, official statistics show. 

Data from the U.S. Department of Health revealed the piling up stocks of the drug, which slashes the risk of hospitalization for vulnerable people who catch Covid. 

There are also 200,000 courses of AstraZeneca’s Covid antibody drug Evusheld now waiting to be distributed, while more than a million doses of Merck’s antiviral pill Lagevrio are now available. 

The White House’s chief medical adviser, Dr Anthony Fauci has already admitted that supplies of the drugs are being ‘underutilized’ across the country.

Experts suggest too few doctors are aware that the treatments — which are only available on prescription — are in stock.

They say a lack of Covid testing — leaving many infections unconfirmed — and the pills being available to too few people are also behind the low usage rates. 

It comes amid a rise in cases in the US, which were are up 38 percent over the past week. But hospitalization and death figures remain low. 

Stocks of Covid treatments for immunocompromised people are currently sitting on shelves in pharmacies across the US. The above map shows the location of these treatments, and the numbers that remain available

The federal Government has purchased millions of doses of the Covid-fighting treatments. 

Only last month President Joe Biden pledged to get the drugs to everyone that needed them free of charge.

But statistics suggest that despite the treatments becoming available nationwide, they are failing to reach many Americans. 

What is Pfizer’s ‘gold standard’ Covid drug Paxlovid?

Paxlovid is an antiviral drug designed to halt a Covid infection in its tracks.

The pill works by interfering with the viral replication process, stopping Covid from making copies of itself.

This buys valuable time for the immune system to fight off the virus.

It is available on prescription in the U.S. to any immunocompromised Americans within five days of them developing Covid symptoms.

It is also free, with the Federal Government footing the $530 bill for each course.

Patients who receive the treatment must take three tablets twice a day for five days. 

Clinical trials showed it slashed hospitalisation rates by 89 per cent among at-risk people who took it within three days of developing Covid symptoms. Some of these were vaccinated.

Supplies were scarce when the pill was first approved in December, but there is now an abundance in the U.S. across many states. 

One of the pills available is Paxlovid — an antiviral pill that works by stopping the virus replicating, giving the body time to fight off an infection.

It is available on prescription across the U.S., and involves taking three tablets twice a day for five days.

It is also free to Americans, with the Federal Government footing the bill of $530 for each course.

Clinical trials showed it slashed hospitalization rates by 89 percent among at-risk people who took it within three days of developing Covid symptoms. Some of these patients were vaccinated.

The drug was approved for over-12s with mild or moderate Covid who were at risk from the virus in December. 

But supplies were initially hard to come by, until in recent weeks packets began stacking up on shelves.

Dr Ryan Maves, an infectious diseases expert at Wake Forest School of Medicine in North Carolina, warned few doses were being prescribed because doctors were unaware that the pill is available.

He told NBC News: ‘I think part of the challenge is so early on there was such little supply, and getting ahold of it was a real challenge.

‘But the folks caring for patients who are at high risk may not know it is so much easier to get now.’

Dr Paul Sax, an infectious diseases expert at Harvard Medical School, warned too few pills were being used because of a lack of Covid testing leading to many infections going undiagnosed.

He added that the categories for people to be treated were also too narrow, leading to many not receiving the drugs who could benefit from them.

There have also been problems rolling out Evusheld which, unlike Paxlovid, is meant for immunocompromised patients who have been exposed to Covid but not yet developed symptoms of the virus.

The treatment is available on prescription, and should be given as two injections commonly in each buttocks. 

Scientists say it can spark up to six months of protection from catching the virus.

It was approved by the FDA for immunocompromised over-12s in December, but again, many doses are remaining on shelves.

Janet Handal, who runs an advocacy group for the immunocompromised, told CNN that like with Paxlovid, many doctors were also unaware of this treatment. 

‘We’ve had people in our group call their doctor and ask about Evusheld and been told, “what’s that?”,’ she said.

Dr William Schaffner, a liaison representative for the National Foundation for Infectious Diseases, warned many doctors were unaware of the treatments because they were approved at a time when there was an ‘avalanche’ of Covid news.

‘No one knows about Evusheld,’ he said. ‘I think it’s very sad.

‘There’s never been a mechanism that says “hear ye, hear ye, we have a new way to protect your immune-compromised patients against Covid, and here’s how you get it for your patients”.’

There have also been problems distributing Merck’s Lagevrio — the brand name for molnupiravir — which, like Paxlovid, is available for immunocompromised people within five days of them developing Covid symptoms.

It is taken as four capsules every 12 hours for five days, and is also free to Americans.

Clinical studies show Lagevrio reduces the risk of hospitalization and death by 30 percent among patients with at least one factor putting them at greater risk from Covid — such as being overweight or having an underlying condition.

The U.S. is currently averaging about 39,400 Covid cases a day, up slightly from the 33,000 recorded a week ago.

But there are growing outbreaks in several states — such as New York — which may be being fueled by a new strain of Omicron.

It is thought U.S. case totals are also a serious undercounting of the current situation on the ground, as many people with Covid symptoms do not get tested.

Hospitalizations in the country are currently averaging about 1,400 a day which was barely a change from a week ago.

But some regions — including the city of Philadelphia and several universities — are already bringing back mask mandates fearing another surge in cases.

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