Ori Biotech | October 15, 2020
Ori Biotech Ltd (Ori), a leading innovator in cell and gene therapy (CGT) manufacturing, today announced the successful close of a $30 million Series A financing round, bringing the company's total funding to date to $41 million. The new funding will be used to help bring Ori's innovative manufacturing platform to the market. The Ori platform delivers scalable solutions to flexibly address the critical clinical and commercial manufacturing needs of CGT developers. The Series A investor syndicate was led by the experienced life sciences investment team at Northpond Ventures, a leading global science, medical, and technology-driven venture fund, alongside Octopus Ventures, a leading European venture fund. Northpond and Octopus invested alongside significant support from Ori's existing institutional investors, Amadeus Capital Partners, Delin Ventures, and Kindred Capital. "Closing a significant Series A round, during these uncertain times, further validates Ori's disruptive approach to fully automating cell and gene therapy manufacturing to increase throughput, improve quality, and decrease costs," said Jason C. Foster, CEO of Ori Biotech. "We are excited to work with our top tier investors and development partners to bring our platform to market as fast as possible to achieve our mission of enabling patient access to life-saving cell and gene therapies." "As early investors in disruptive life sciences platform technology companies, we have seen how cutting-edge technologies like Ori's can bring significant value to the industry and lead to breakthroughs for patients," said Michael Rubin, M.D., Ph.D., Founder and CEO of Northpond Ventures. "We believe that the Ori team has developed a truly innovative technology that can enable millions of patients to gain access to these important treatments." Ori's bespoke platform was designed specifically to address the unique requirements of a new generation of personalized cell and gene therapies. By fully automating and standardizing CGT manufacturing in a closed platform, Ori offers therapeutics developers the opportunity to seamlessly scale from pre-clinical process development to commercial-scale manufacturing. Its flexible platform enables increased throughput, improved quality, and decreased costs.
Zoetis | June 27, 2022
Zoetis Inc. is the world's largest animal health company committed to providing medicine and vaccinations for pets and livestock. The company announced completing the acquisition of a privately held petcare genetics company, Basepaws, which offers early health risk assessments, genetic tests, and analytics to pet owners. The acquisition was first announced on June 7th. However, the financial terms of the purchase were not disclosed.
Basepaws, founded by CEO Anna Skaya in 2017, provides genetic screening tools for the diagnosis of several pet diseases, health reports, and individualized breeds by identifying traits, potential hereditary conditions, and biomarkers.
With the help of genetic insights from Basepaws, pet owners and doctors can better understand a pet's risk for the disease. This can result in more meaningful interactions and improve the chances of early identification and treatment of the disease.
When we first met Basepaws CEO Anna Skaya and the team, we were immediately drawn to their passion for pets and the role that genetic testing and data analytics can have in advancing animal care – a purpose that drives us every day,The addition of Basepaws will enhance our portfolio in the precision animal health space and inform our future pipeline of petcare innovations. Working together, we can continue to provide veterinarians and pet owners with more comprehensive ways to proactively manage the health, wellness, and quality of care for their animals."
Zoetis, CEO Kristin Peck.
Pfizer, BioNTech | May 10, 2021
Pfizer Inc. and BioNTech SE confirmed today the filing of a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in people aged 16 and above. Companies will send data to help the BLA to the FDA on a rolling basis in the coming weeks, along with a proposal for Priority Review. If the BLA has been completed and duly approved for review by the FDA, the FDA will set a target date for a determination under the Prescription Drug User Fee Act (PDUFA).
The Pfizer-BioNTech COVID-19 Vaccine is now available in the United States under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) on December 11, 2020. Since then, the firms have distributed more than 170 million doses of the vaccine in the United States. The next step in the comprehensive FDA evaluation process is the submission of a BLA, which includes longer-term follow-up data for acceptance and approval.
Pfizer and BioNTech started the BLA process by providing the nonclinical and clinical data needed to justify the licensure of the COVID-19 vaccine for use in people aged 16 and up. This covers the most recent analyses from the pivotal Phase 3 clinical trial, in which the vaccine's effectiveness and safety profile were detected up to six months after the second dose. In the coming weeks, the companies will submit the required manufacturing and facility details for licensure, completing the BLA.
Pfizer and BioNTech have since submitted to expand the new EUA for their COVID-19 vaccine to cover individuals aged 12 to 15. The firms plan to send a supplemental BLA to facilitate vaccine licensure in this age group until the requisite data is available six months after the second vaccine dose.
BioNTech and Pfizer collaborated to create the Pfizer-BioNTech COVID-19 Vaccine, which is built on BioNTech's patented mRNA technology. BioNTech is the European Union's Marketing License Holder, as well as the holder of emergency use authorizations or similar in the United States (along with Pfizer), the United Kingdom, 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 authorized or licensed by the United States Food and Drug Administration (FDA), but it has been authorized for emergency use by the FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in people aged 16 and up. The emergency use of this product is only permitted for the duration of the declaration the circumstances justify the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act until the declaration is terminated or the authorization is revoked sooner.
At Pfizer, they utilize science and its global resources to deliver treatments to patients that significantly extend and change their lives. In the discovery, development, and manufacture of health care products, including innovative medicines and vaccines, they aim to set the benchmark for consistency, safety, and value. Every day, Pfizer colleagues collaborate in developing and emerging markets to advance wellness, prevention, treatments, and remedies for today's most feared diseases. As one of the world's leading innovative biopharmaceutical firms, they partner with health care providers, governments, and local communities to promote and improve access to reliable and affordable health care around the world.
Biopharmaceutical New Technologies is a next-generation immunotherapy firm that is developing novel cancer and other severe disease therapies. For the accelerated production of new biopharmaceuticals, the company makes use of a diverse set of computational discovery and therapeutic drug platforms. Its oncology product candidates include individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies, and small molecules from Fosun Pharma and Pfizer.