The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
AstraZeneca PLC on Wednesday announced its drug Farxiga has been granted priority review in the US for the treatment of adult patients with chronic kidney disease.
The British-Swedish pharmaceutical company said the US Food & Drug Administration granted priority based on clinical evidence from its DAPA-CKD phase 3 trial, which showed that Farxiga "reduced the risk of the composite of worsening of renal function or risk of cardiovascular or renal death by 39%", in patients with stages two to four of chronic kidney disease.
"This decision brings us a step closer to delivering this new treatment option for the millions of patients living with chronic kidney disease in the US. Farxiga has the potential to be a truly transformational medicine across a breadth of diseases, including type-2 diabetes, heart failure with reduced ejection fraction and, if approved, chronic kidney disease," said Mene Pangalos, Executive Vice President at BioPharmaceuticals Research & Development.
Back in March, AstraZeneca said an independent data monitoring committee recommended the trial be stopped early, based on its overwhelming efficacy and in October, Farxiga received breakthrough therapy designation in the US for patients with chronic kidney disease with and without type-2 diabetes.
AstraZeneca PLC on Monday said it has completed the divestment of commercial rights to Atacand and Atacand Plus in over 70 countries to Cheplapharm Arzneimittel GmbH.
The British-Swedish pharmaceutical company said it has received a payment of USD250 million from Cheplapharm. Under the terms of the agreement, Astra will also receive further non-contingent payments equal to USD150 million during the first half of 2021, it said.
The consideration was and will be paid in cash, and the proceeds used for general corporate purposes, the Cambridge, England-headquartered company noted.
In 2019 Atacand and Atacand Plus generated product sales of USD148 million, the company said, and pretax profit of UDS89 million in the countries covered by the agreement.
Mexico has approved the Oxford University and AstraZeneca PLC coronavirus vaccine for emergency use, hoping to spur a halting vaccination effort that has only given about 44,000 jabs since the third week of December, about 82% of the doses the country has received.
The Pfizer Inc vaccine had been the only one approved for use in Mexico, until Mexican regulators approved the AstraZeneca vaccine on Monday.
Foreign relations secretary Marcelo Ebrard wrote on Twitter that "the emergency approval for the AstraZeneca vaccine is very good news…with this, production will begin very soon in Mexico!"
A Mexican firm has arranged to do part of the finishing and packaging of the vaccine.
Assistant health secretariat Hugo Lopez-Gatell said he erroneously reported approval for Chinese vaccine maker CanSino, noting it had not yet submitted full study results for safety and efficacy.
Mexico has pinned much of its hopes on the inexpensive, one-shot CanSino vaccine. "It will makes things a lot easier for us," Lopez-Gatell said.
The Mexican Social Security Institute also released more information about a doctor in northern Mexico who had such a severe allergic reaction to the Pfizer vaccine last week that she was hospitalised in intensive care.
The doctor suffered difficulty breathing, brain inflammation and convulsions a half-hour after getting the shot.
Experts are running tests to determine whether she suffered a rare inflammation of the spinal cord called transverse myelitis. She is reportedly recovering.
Mexico has nearly 1.5 million coronavirus cases and 127,757 deaths.
Jan. 02, 2021 7:41 AM ETAstraZeneca PLC (AZN)By: Dulan Lokuwithana, SA News Editor2
India has granted the emergency use approval for the COVID-19 vaccine developed by AstraZeneca (NASDAQ:AZN) and the Oxford University, a day after an advisory panel in the country issued its recommendation.
Announcing the decision, Information and Broadcasting Minister Prakash Javadekar told reporters on Saturday at least three more vaccines were on track to receive the approval: local company Bharat Biotch’s COVAXIN, Zydus Cadila’s ZyCoV-D, and Russia’s Sputnik-V.
According to reports, the Indian regulator has also received an emergency-use application for the COVID-19 vaccine made by Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX).
The announcement of the approval comes on the day of a nationwide drill in India testing the vaccine delivery system as the country with the second-largest population and second-highest number of COVID-19 cases prepares to kick start the inoculation of 300M people under the first phase of the vaccination campaign.
UP Date
India drug regulator approves AstraZeneca COVID vaccine, country's first - sources
https://uk.reuters.com/article/uk-health-coronavirus-india-vaccine/india-drug-regulator-approves-astrazeneca-covid-vaccine-countrys-first-sources-idUKKBN29628Y
The AZN vaccine is supplied ready to use.
This is the procedure that must be followed to make up the Pfizer vaccine immediately prior to use:
Method of administration
Administer the COVID-19 mRNA Vaccine BNT162b2 vaccine intramuscularly in the deltoid muscle after dilution.
Do not inject the vaccine intravascularly, subcutaneously or intradermally.
Preparation: The multidose vial is stored frozen and must be thawed prior to dilution
Frozen vials should be transferred to 2 °C to 8 °C to thaw. Alternatively, frozen vials may also be thawed and kept at temperatures up to 25 °C for a maximum of two hours in preparation for dilution for use.
When removed from the freezer, the undiluted vaccine has a maximum shelf life of up to 5 days (120 hours) at 2 °C to 8 °C, and and additional 2 hours at temperatures up to 25 °C in preparation for dilution.
When the thawed vial is at room temperature gently invert 10 times prior to dilution. Do not shake. Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.
The thawed vaccine must be diluted in its original vial with 1.8 mL sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.
Warning: Unpreserved sodium chloride 9 mg/mL (0.9%) solution for injection is the only diluent that should be used. This diluent is not provided in the vaccine carton.
Equalise vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe.
Gently invert the diluted solution 10 times. Do not shake.
The diluted vaccine should present as an offwhite solution with no particulates visible. Discard the diluted vaccine if particulates or discolouration are present.
The diluted vials should be marked with the dilution date and time and stored between 2 °C to 25 °C.
Use as soon as practically possible, and within 6 hours after dilution.
After dilution, the vial contains 5 doses of 0.3 mL. Withdraw the required 0.3 mL dose of diluted vaccine using a sterile needle and syringe and administer. Vial volume was optimised to reliably obtain 5 doses regardless of syringe type used as most syringe and needle combinations require withdrawal of excess volume in order to ensure the full 0.3 mL dose of vaccine can be administered. When low dead-volume syringes and/or needles are used, the amount remaining in the vial after 5 doses have been extracted may be sufficient for an additional (sixth) dose. Care should be taken to ensure a full 0.3 mL will be administered to the subject and that all doses from a single prepared vial are administered within 6 hours of the time of dilution. Where a full 0.3 mL dose cannot be extracted the contents should be discarded.Any unused vaccine should be discarded 6 hours after dilution.
After dilution, the vaccine should not be shipped (transported) by motor vehicle away from the site of dilution. Any shipping (transportation) by mo
For background about Ocugen/Bhaart Biotech see:
https://seekingalpha.com/news/3647906-ocugen-shares-get-hit-experts-slam-covidminus-19-vaccine-partner?mail_subject=azn-ocugen-shares-get-hit-as-experts-slam-its-covid-19-vaccine-partner&utm_campaign=rta-stock-news&utm_content=link-1&utm_medium=email&utm_source=seeking_alpha
Just to be clear The Serum Institute is NOT connected with the AZN/Oxford vaccine.
Bharat Biotech is in partnership with Ocugen.
Bharat were heavily criticised for unethical conduct of recruiting vaccine trial volunteers.
Press release here:
https://seekingalpha.com/pr/18120337-astrazeneca-to-acquire-alexion-accelerating-companys-strategic-and-financial-development
Slides Presentation here:
https://www.astrazeneca.com/content/dam/az/PDF/2020/20201212_Call_Alxn_Cmb_prsn.pdf?source=content_type%3Areact%7Cfirst_level_url%3Anews%7Csection%3Amain_content%7Cbutton%3Abody_link
Alexion Pharmaceuticals, Inc. (ALXN)By: Stephen Alpher, SA News Editor
Alexion (NASDAQ:ALXN) owners will receive $60 per share in cash and 2.1243 ADS of AstraZeneca (NASDAQ:AZN) for each share of Alexion they own. Based on AZN's recent closing price, that implies a deal value of $39B, or $175 per share. That's about a 45% premium to Alexion's close on Friday.
Alexion's leading expertise in complement biology will accelerate AstraZeneca's growing presence in immunology, say the companies. The deal is expected to be immediately accretive to core earnings.
A conference call is set to begin shortly.
AstraZeneca PLC is to use one of the two components of Russia's Sputnik V vaccine in clinical trials, it was announced on Friday.
Sputnik V is being developed by the Russian Gamaleya Research institute and financed by the Russian Direct Investment Fund. The pair "offered AstraZeneca to use one of the two components (human adenoviral vectors) of the Sputnik V vaccine in AstraZeneca's clinical trials."
Cambridge, England-based Astra has accepted the proposal and will start clinical trials of its vaccine plus Sputnik's type Ad26 human adenoviral vector by 2020 end, investigating the possibility of boosting its own vaccine's efficacy using the combined approach.
A unique feature of the Russian vaccine is that is uses two different components based on human adenovirus in two separate inoculations with the aims of delivering generic material from the spike of the coronavirus into the human body.
Sputnik V's developers said: "This approach provides for a stronger and longer-term immune response compared with vaccines using the same component for both inoculations."
Russian Direct Investment Fund Chief Exec said: "The decision by AstraZeneca to carry out clinical trials using one of two vectors of Sputnik V in order to increase its own vaccine's efficacy is an important step towards uniting efforts in the fight against the pandemic. We welcome the beginning of this new stage of cooperation between vaccine producers. We are determined to develop this partnership in the future and to start joint production after the new vaccine demonstrates its efficacy in the course of clinical trials. We hope that other vaccine producers will follow our example."
Shares in Astra were down 0.2% at 8,085.00 pence in London on Friday morning.
Paper is here.
https://www.thelancet.com/lancet/article/S0140-6736(20)32661-1
https://news.yahoo.com/testing-times-more-needed-astra-161045620.html
At this stage I can't find the original paper on line.
TOP NEWS: AstraZeneca Publishes Final-Stage Vaccine Trial Results
(Alliance News) - Oxford University and AstraZeneca PLC became the first Covid-19 vaccine makers to publish final-stage clinical trial results in a scientific journal Tuesday, clearing a key hurdle in the global race to develop safe and effective drugs for the new coronavirus.
The study published in the respected Lancet medical journal confirmed that the vaccine works in an average 70% of cases, with efficacy of 62% for those given two full doses, and of 90% in those given a half then a full dose.
The results are the "first full peer-reviewed efficacy results" published for a Covid-19 vaccine, the Lancet said.
Why Oxford's Covid-19 vaccine could do more for the world than other shots
https://edition.cnn.com/2020/11/28/health/oxford-astrazeneca-vaccines-developing-countries-intl/index.html