We would love to hear your thoughts about our site and services, please take our survey here.
straZeneca (NASDAQ:AZN) said on Feb. 17 that the European Medicines Agency accepted its application for nirsevimab under an accelerated assessment for the prevention of lower respiratory tract infections (LRTI) in all infants through their first respiratory syncytial virus (RSV) season.
The British drugmaker is developing nirsevimab in collaboration with Sanofi (NASDAQ:SNY).
AstraZeneca said nirsevimab is the first investigational long-acting antibody designed to provide RSV protection for all infants.
It is being developed as a single dose for infants experiencing their first RSV season and for children at higher risk in their second RSV season.
The company's Marketing Authorization Application (MAA) is backed by data from the MELODY Phase 3 trial, MEDLEY phase 2/3 study, and phase 2b trial which showed nirsevimab’s safety and efficacy in providing protection against the virus for all infants with a single dose for the RSV season.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted nirsevimab accelerated assessment, which aims to reduce the timeframe for the CHMP to review a MAA compared to the standard procedure and follows the EMA granting access to the PRIority MEdicines (PRIME) scheme in 2019.
The company said additional regulatory submissions are planned to take place in 2022.
"I would strongly advise you shorters to start selling your borrowed shares as soon as you can." So you are encouraging Shorting are you?
For those that don't know The object of borrowing shares is to sell what you don't own in the hope/belief that the share price will fall. Eventually the short has to be covered by buying shares back so that they can be given back to their original owner.
If they buy back at a lower price than they sold at then they are in profit. The danger is that the share price unexpectedly rises and then loses can be immense as come what may they same number of shares has to be bought.
Now there is the argument that vultures perform a valuable service by removing dead carrion from the savannah.
1. Go to https://www.gov.uk/government/organisations/companies-house
2. select Find company information
3. scroll down & click Start Now.
4 Search the register will open. Enter Avacta
5. Click on Avacta Group PLC
6. On the next page select Filing History
7 Lots of choice but I'd selected Companies Account & filed on 07/07/2021
8 Down load pdf -135 pages worth!
8. Lots of other goodies to brows on the site.
AstraZeneca said its Enhurtu breast cancer drug had demonstrated a "statistically significant and clinically meaningful improvement" in survival a phase three trial versus chemotherapy.
AstraZeneca stated DESTINY-Breast04 met its primary endpoint, where Enhertu demonstrated "superior" PFS in previously treated patients with HR-positive HER2-low metastatic breast cancer compared to the standard-of-care chemotherapy.
The company, which is working on the drug with Japan's Daiichi Sankyo, said Enhertu prolonged survival and slowed the progression of metastatic breast cancer in women with low levels of a protein known as HER2.
Enhertu also met its key secondary endpoint of progression-free survival in patients with HER2-low metastatic breast cancer regardless of hormone receptor status and also met its key secondary endpoints of overall survival in patients with HR-positive disease and in patients regardless of hormone receptor status at interim analysis.
Susan Galbraith, AstraZeneca's executive vice-president of oncology R&D said: "Today's historic news from DESTINY-Breast04 could reshape how breast cancer is classified and treated. A HER2-directed therapy has never-before shown a benefit in patients with HER2-low metastatic breast cancer." "These results for Enhertu are a huge step forward and could potentially expand our ability to target the full spectrum of HER2 expression, validating the need to change the way we categorise and treat breast cancer."
Pharmaceutical company AstraZeneca said on Tuesday that results from a recent study revealed that its Lynparza asset reduced the risk of first-line metastatic castration-resistant prostate cancer progression by 34% when used in combination with abiraterone. AstraZeneca stated the combination demonstrated "a statistically significant and clinically meaningful improvement" in radiographic progression-free survival versus current standard-of-care. Susan Galbraith, AZN's executive vice president of Oncology R&D, said: "This Lynparza combination has the potential to afford first-line patients more time without disease progression while also maintaining their quality of life. "The PROpel results are impressive because active comparator trials set a high bar and, in this trial, Lynparza plus abiraterone showed a significant clinical improvement when compared to an active standard of care in patients with metastatic castration-resistant prostate cancer, regardless of whether they have an HRR gene mutation."
AstraZeneca announced the first increase to its dividend for a decade and an upbeat outlook as the drugs company swung to a fourth-quarter loss driven by higher costs. The drugs company posted a $636m pretax loss for the three months to the end of December from a $1.49bn profit a year earlier as revenue rose 62% to $12bn. The cost of sales rose to $4.63bn from $1.53bn. Core earnings rose 56% to $1.67 in the fourth quarter. That figure excludes items related to acquisitions, amortisation of intangibles and restructuring costs. The company declared a second interim dividend of $1.97 a share, taking the annual payout to $2.87. AstraZeneca said it intended to increase the annualised dividend by $0.10 to $2.90, "reflecting increased confidence in future growth and cash generation". The increase is the first for 10 years. Shares of AstraZeneca rose 3.8% to £86.81 at 08:56 GMT and were the biggest gainers in the FTSE 100 index. AstraZeneca's Vaxzevria coronavirus vaccine added $1.76bn to fourth-quarter revenue and $3.98bn to income for the full year. AstraZeneca swung to an annual pretax loss of $265m from a $3.92bn profit a year earlier as costs more than doubled to $12.44bn from $5.3bn. AstraZeneca said it expected revenue to rise by a mid-teens percentage in 2022 and for core earnings per share to increased by a percentage in the mid-to-high 20s. The FTSE 100 group predicted Covid-19 revenue would decline by a percentage in the low-to-mid 20s and that the gross profit margin from Covid-19 sales would be lower than the company average. The company bought Alexion, a US biotech specialising in rare diseases, in July for $39bn to deepen its focus on immunology and strengthen its position in the US. Pascal Soriot, AstraZeneca's chief executive, said: "AstraZeneca continued on its strong growth trajectory in 2021. The positive news from our pipeline, including approvals for Evusheld and Tezspire, supports the outlook for 2022. This, along with the transformative acquisition of Alexion, means that we are confident in our long term growth and profitability. After a landmark year in 2021, we are increasing the dividend for our shareholders." AstraZeneca makes one of the leading Covid-19 vaccines, developed with Oxford University, and has also produced a coronavirus prevention treatment, Evusheld. Tezspire, an asthma treatment, was also approved in 2021. The company has 13 so-called blockbuster medicines. Five of these crossed annual revenue thresholds including Tagrisso, which sold more than $5bn, and Farxiga, which passed the $3bn mark. Keith Bowman, an analyst at Interactive Investor, said: "Core earnings per share of $1.67 [were] at the upper end of forecasts. Some 22 regulatory drug approvals during 2021 continue to underline its innovation, with a marginal increase in the annual dividend also suggesting long term confidence."
https://www.thetimes.co.uk/article/revealed-unilever-bids-50bn-for-gsks-consumer-empire-zwtqjcmtw
AstraZeneca's Alexion rare diseases unit has inked an exclusive collaboration and license agreement with Neurimmune that will see the pair develop and commercialise NI006, an investigational human monoclonal antibody for the treatment of transthyretin amyloid cardiomyopathy. AstraZeneca said on Friday that under the agreement, Alexion will be granted an exclusive worldwide licence to develop, manufacture and commercialise NI006, with Neurimmune receiving an upfront payment of $30.0m and the potential for additional contingent milestone payments of up to $730.0m, as well as low-to-mid teen royalties on net sales of any approved medicine resulting from the collaboration. The FTSE 100-listed group stated there was "a significant unmet medical need" for patients with various types and levels of severity of amyloidosis that may require multiple mechanisms of action to address them and that NI006, an ATTR depleter, added a "novel and complementary approach" to its pipeline of investigational therapies focused on amyloidosis and strengthened its "broader commitment to addressing cardiomyopathies that can lead to heart failure". Alexion chief executive Marc Dunoyer said: "With 30 years of experience in developing medicines for people with rare diseases, Alexion is uniquely positioned to advance innovative science for small patient populations who are frequently underdiagnosed. "We look forward to applying this expertise to the development of NI006, which is designed to clear cardiac amyloid fibril deposits with the potential to improve cardiac function for patients living with advanced ATTR-CM, who are currently underserved by existing treatment options."
A Covid-19 vaccine booster being developed by GlaxoSmithKline and Sanofi has been shown to be effective across all age groups tested, according to data released by the UK drugs firm on Wednesday.
Rather than develop its own vaccine, GSK has instead focused on launching an adjuvant to boost the efficacy of other vaccines, including one developed by French peer Sanofi, and on Wednesday the firm said a single booster dose of the drug candidate delivered "consistently strong immune responses".
It said preliminary results from the VAT0002 clinical trial showed neutralising antibodies increased 9- to 43-fold, regardless of which vaccine participants had received, across all age groups tested.
It was also well tolerated, with a safety profile similar to the current Covid-19 vaccines.
The Phase III trial - VAT0008 - is ongoing, however. GSK said the latest review by the Data Safety Monitoring Board identified no safety concerns but recommended the trial continued to early 2022 to accrue more data. Participants in the trial are required to have never had Covid-19 and most volunteers were recruited in the third quarter, when there was a spike in the number of people being infected with the virus globally.
GSK said: "To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in the first quarter of 2022.
" Thomas Triomphe, executive vice president of Sanofi Pasteur, said: "These preliminary data show we have a strong booster candidate, whatever primary vaccine you received.
"While pursuing a phase III trial is a challenge in a quickly shifting pandemic environment, we look forward to seeing the results to support submissions of our boost vaccine as quickly as possible."
Roger Connor, president of GSK Vaccines, said: "As the pandemic threat continues with the current dominant Delta variant and Omicron rapidly gaining ground, boost vaccines will continue to be needed to help protect people over time. The initial booster data are promising."
Samsung Biologics continues its strategic biopharmaceutical manufacturing collaboration with AstraZeneca (NASDAQ:AZN).
The partnership is based on an expanded deal this year in May 2021 which followed the signing of a long-term strategic agreement made in September 2020.
Under the agreement, valued at ~$380M up from the initial $331M for the production of drug substance and drug product, Samsung Biologics manufactures AstraZeneca's COVID-19 long-acting antibody (LAAB) combination, AZD7442, and will start to manufacture a cancer immunotherapy product from next year.
Worth noting that Mitsubishi Tanabe Pharma Corporation (MTPC) Group, is the majority parent company of Medicago.Mitsubishi Tanabe Pharma Corporation (MTPC) Group, is one of the large Japanese pharmaceutical companies,
Try this recent piece
:https://seekingalpha.com/article/4466591-astrazeneca-azn-lagging-for-a-reason
Oh do stop whining about AZN share price and the London market. It is what it is and if you think it unjust and being manipulated sell out and buy one of the American stocks. FWIW my AZN holding is into six significant figures.
Have you considered that price the movements may be driven by the belief that a higher return may be had in Pfizer or Moderna (short term) as compared with AZ. Fund managers will redistribute their funds selling and buying accordingly.
For us long term investors my advice is to chill out .
I hold AZ and Pfizer. I was seriously considering selling my Pfizer shares last spring. That would have been a mistake. I have just sold Novo Nordisk even though it is a very good company but possibly a little over priced at the moment.
Old news but I’ve not seen it reported before.
https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-request-for-emergency-use-authorization-for-covid-19-prophylaxis-filed-in-us.html
https://www.reuters.com/business/healthcare-pharmaceuticals/astrazeneca-says-seek-commercial-price-preventive-antibody-****tail-2021-11-18/