Pfizer | July 22, 2021
Pfizer Inc. and BioNTech SE today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, also known as "Biovac," a South African biopharmaceutical business headquartered in Cape Town, to produce the Pfizer-BioNTech COVID-19 Vaccine for sale inside the African Union.
Biovac will manufacture and distribute COVID-19 vaccines as part of Pfizer and BioNTech's worldwide COVID-19 vaccine supply chain and production network, which currently spans three continents and includes more than 20 facilities. Technical transfer, on-site development, and equipment installation operations will begin immediately to enable Biovac's participation in the process.
Biovac's Cape Town plant is expected to be integrated into the vaccine supply chain by the end of 2021, according to Pfizer and BioNTech. Biovac will acquire drug substances from European facilities, and final dosage manufacturing will begin in 2022. Annual production will reach 100 million finished dosages at full operating capacity. All dosages will be delivered solely inside the African Union's 55 member states.
Quality, compliance, safety track record, technical capability, capacity availability, highly trained workforce, project management abilities, prior working relationship, and commitment to working with flexibility through a fast-paced program are all factors that Pfizer and BioNTech consider when selecting contract manufacturers. Since 2015, Pfizer and Biovac have collaborated on the Prevenar 13 vaccine's sterile formulation, fill, finish, and distribution.
Pfizer and BioNTech have delivered more than 1 billion doses of COVID-19 vaccine to more than 100 nations and territories across the globe. The companies are firmly committed to ensuring that all people around the world have equitable and affordable access to COVID-19 vaccines, actively working with global governments and global health partners to provide 2 billion doses to low and middle-income countries in 2021 and 2022 – 1 billion each year. This comprises a non-profit arrangement to provide 500 million doses to the US government, which the government will then give to the African Union and the COVAX 92 Advanced Market Commitment (AMC) nations, as well as a 40 million dose direct supply deal with the COVAX facility.
Both BioNTech and Pfizer worked together to create the Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's unique mRNA technology. In addition to the European Union, BioNTech has emergency use authorizations or equivalent in the United States (jointly with Pfizer), Canada, and other countries in advance of a planned application for full marketing authorizations in these countries.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but it has been approved for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19), which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people aged 12 and up. Unless the declaration is ended or the permission withdrawn sooner, the emergency use of this product is only allowed for the duration of the declaration that conditions exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act.
AstraZeneca | November 13, 2020
Months after drugmakers launched an unprecedented COVID-19 research effort, some existing medicines have turned in promising results—but more of them have failed against the virus. And AstraZeneca’s blood cancer med Calquence just became one of them, falling short in two tests in hospitalized patients. AstraZeneca said Thursday that the medicine—already approved in mantle cell lymphoma—didn't help patients survive the virus and reduce respiratory failure any better than supportive care did, citing data from two phase 2 trials. The company set out to test the medicine back in April after researchers at the NIH’s National Cancer Institute observed “some clinical benefit” when the drug was used in a small number of hospitalized COVID-19 patients with advanced lung disease at the Walter Reed Army Medical Center, Forbes reported at the time.
Nanoform | March 23, 2021
Nanoform innovative nanoparticle medicine enabling company next generation of its STARMAP® AI artificial intelligence platform nanoparticle bioavailability excipient microns nm CESS technology silico pharma drugs lifecycle managementNanoform, an innovative nanoparticle medicine enabling company, has today dispatched the next generation of its STARMAP® AI (artificial intelligence) platform, v2.0. The technology uses scanty information AI to expand trial results from its CESS® nanoparticle designing process with detailed master information, permitting dependable expectations to be made in regards to accomplices' likely success of nanoforming their medication atoms.
CESS® is a nanoparticle platform technology which produces unadulterated homogeneous medication particles from arrangement in a without excipient process. By diminishing the molecule size e.g., from 10 microns to 50 nm, the particular surface territory can be expanded by as much as 1000-crease, subsequently improving disintegration rate, solvency, and bioavailability. Subsequently, Nanoform can help pharma accomplices progress atoms into advancement that in any case might not have been conceivable. It additionally opens up energizing opportunities for a wide scope of novel medication conveyance applications.
STARMAP® is a computerized form of the CESS® technology that empowers in silico tries in enormous amounts, making quick forecasts of which atoms ought to be nanoformed. This is significant since there are more potential medication atoms than particles in the known universe. STARMAP® can be a useful asset for pharma accomplices to pick appropriate medication contender for additional improvement from their huge libraries. The benefits may incorporate quicker way to advertise and additional opportunities for widening and extending drug pipelines while at the same time expanding the likelihood of medication improvement success.
The STARMAP® platform can have wide materialness in drug disclosure and advancement just as in lifecycle management for existing promoted drugs and 505b2-like item improvement methodologies.
"AI algorithms developed for big data have so far struggled to live up to expectations in pharma because the data, especially for early assets (drug discovery, drug screening), that is available to pharma is typically insufficient for generating reliable predictions. We believe sparse-data AI will work much better - in practice, this means augmenting experimental results with detailed expert knowledge, which can be used to prevent the AI from predicting outcomes that are nonsensical based on prior understanding. There is a lot of untapped potential in sparse-data AI for the pharma industry and the field continues to undergo rapid development in both academia and the industry in general," said Prof. Jukka Corander, Head of AI at Nanoform.
"By determining which drug candidates are ideal for our CESS® process, the next-gen STARMAP® platform can potentially create new opportunities for our pharma partners. These can include both revisiting drug candidates unnecessarily discarded by AIs trained on old particle engineering techniques, and rapidly picking winners among new drug candidates. Ultimately, the benefit of more advanced AI will be felt by patients as new therapies are accelerated to market," commented Christian Jones, Chief Commercial Officer at Nanoform