Feds rebuff Pfizer's pleas to speed up supplies of COVID-19 vaccine raw materials

Pfizer | December 21, 2020

Since the time Pfizer was fixed to partake in the U.S. government's Warp Speed exertion to get COVID-19 antibodies to showcase, the organization has made it very clear it didn't have to take any bureaucratic cash to build up the immunization.

In any case, did that refusal of R&D subsidizing add to Pfizer's failure to produce more dosages of its mRNA antibody for the U.S. market?

Pfizer could give more than the 100 million portions it guaranteed in its unique agreement with the U.S. government in the main portion of one year from now—however just if Trump organization authorities request that providers of crude materials rapidly satisfy the organization's requests. Furthermore, CEO Albert Bourla, Ph.D., is approaching the public authority to utilize the Defense Production Act to do precisely that.

The Trump organization hasn't done as such yet on the grounds that they've zeroed in on giving those materials to antibody producers that took government R&D subsidizing, as Moderna, as indicated by anonymous sources who addressed The New York Times.

A representative for Pfizer declined to remark, refering to the privacy of conversations with the U.S. government. Yet, Bourla said during a CNBC meet that the organization is in exchanges to sell an extra 100 million dosages of Pfizer's COVID-19 immunization to the U.S. government.

"We can give a ton of that in the second from last quarter. The U.S. government needs it in the subsequent quarter," Bourla said in the Monday meet. "We are working cooperatively to attempt to discover an answer and have the option to apportion those 100 million [doses] in the subsequent quarter if conceivable, or a ton of them."

Pfizer mentioned almost immediately that the public authority grant it "supported status" with providers of crude materials, however authorities were anxious about the possibility that that would harm contending immunization programs that took government R&D cash, as per the Times report. Among those organizations is Moderna, which is required to win crisis use approval from the FDA for its mRNA immunization this week—and last Friday, inked an arrangement to add 100 million additional portions to its underlying U.S. request.


Can the therapeutic development timeline be improved and accelerated by addressing challenges and developing opportunities? This infographic from the Institute of Medicine examines those challenges and opportunities. Read more in two workshop summaries: Improving the Utility and Translation of Animal Models for Nervous System Disorders and Improving and Accelerating Therapeutic Development for Nervous System Disorders.


Can the therapeutic development timeline be improved and accelerated by addressing challenges and developing opportunities? This infographic from the Institute of Medicine examines those challenges and opportunities. Read more in two workshop summaries: Improving the Utility and Translation of Animal Models for Nervous System Disorders and Improving and Accelerating Therapeutic Development for Nervous System Disorders.

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Kedalion Therapeutics Secures Series B Funding and Announces Signing of Option to Acquire Agreement

Kedalion Therapeutics, | November 16, 2021

Kedalion Therapeutics is pleased to announce the completion of its Series B financing led by Novartis and involving a combination of new and existing investors. The Novartis investment includes an Exclusive Option to Acquire the company and its AcuStream™ technology. This agreement follows a Feasibility Study agreement with the AcuStream™ technology signed earlier this year. The subsequent feasibility study has been completed with successful results. Collaboration between the two parties is ongoing. The financial and other terms of this transaction are not disclosed. Kedalion’s AcuStream™ platform is a highly innovative, digitally connected, electromechanical topical ocular delivery device that aims to address a potential unmet need for a convenient, user-friendly device that reliably, accurately, and comfortably delivers topical ocular therapy with improved efficiency and patient comfort, and reduced reliance on patient skill and instillation technique when administered by a physician.1 The multi-dose, preservative-free platform strives to enable intended aim, potential for a comfortable patient experience, micro-dosing capability, and in phase 1 proof of concept studies, has shown a potential for a reduction in delivery dose of an intended therapy.1-4 Kedalion will continue to move forward with the development of the AcuStream™ platform across multiple disease categories, drug classes and compositions, including the treatment of presbyopia. The AcuStream™ technology has a potential to enhance the patient experience and optimize treatment outcomes of the company’s highly advanced portfolio of topical ocular drug products in development. The company looks forward to the opportunity to collaborate with Novartis Innovative Medicines as a valued investor and partner in developing our technology platform and therapeutic targets. “At Novartis, we are committed to reimagining medicine and investigating innovative approaches that have the potential to address unmet patient needs. The AcuStream™ technology is a novel platform with broad applicability in ophthalmics and we envisio that it could help us deliver transformative solutions to the patients who rely on our therapeutics to treat a range of eye conditions.” Jill Hopkins, Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals Dr. Mark Blumenkranz, the Chairman and Chief Executive of Kedalion Therapeutics, commented that “this transaction and associated further studies will help us accomplish our goal of revolutionizing the way drugs are delivered to the eye. The AcuStream™ technology, which strives to enable easier aiming, micro-dosing capability, and a potential for a reduction in delivery dose of an intended therapy, has the potential for a comfortable patient experience for patients worldwide.1 The platform could potentially provide convenience and enable micro-dosing capability for various ocular diseases.1 We see our capabilities coupled with the scientific and market leadership of Novartis in ophthalmics to be a winning formula for both organizations.” About Kedalion Therapeutics Kedalion Therapeutics is a venture-backed, clinical-stage biotechnology company whose mission is to bring to market transformative topical ophthalmic therapies for new and existing indications. Kedalion’s proprietary AcuStream™ platform technology delivers topical drugs to the eye in a precise and accurate manner that enables comparable effect with up to an 80% reduction in dose compared to standard eye drops. Kedalion is based in Menlo Park, CA.

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Pluristem Enters Collaboration With Pharmaceutical Company Innovare R&D to Expand Pluristem’s ARDS Associated With COVID-19 Program to Mexico

Pluristem | December 30, 2020

Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a main regenerative medication organization building up a foundation of novel natural helpful items, reported today it has gone into a coordinated effort concurrence with Mexican drug organization Innovare R&D to extend its continuous clinical program of PLX cells in the treatment of Acute Respiratory Distress Syndrome (ARDS) related with COVID-19 in Mexico. The Phase II investigation in Mexico is dependent upon the endorsement of neighborhood specialists, with the objective of being led under the U.S. Food and Drug Administration (FDA) cleared convention. As per the arrangement, Innovare will open clinical destinations and enlist patients for the proposed clinical investigation in Mexico. Innovare will subsidize the examination in Mexico and will buy PLX cells for the investigation from Pluristem. Subject to potential positive clinical investigation results and Mexican administrative endorsement for commercialization, the arrangement awards Innovare restrictive conveyance rights in Mexico to supply PLX cells for treating serious COVID-19 cases confounded by ARDS. All protected innovation and assembling rights stay with Pluristem. With 1,389,430 cases and 122,855 passings as of December 29, 2020, Mexico's COVID-19 disease and death rates have been expanding. Mexico has the most elevated passings relatively to COVID-19 cases or populace on the planet as of December 28, 2020, as announced by Johns Hopkins University of Medicine. "We are satisfied to unite with Innovare, a main imaginative organization intending to be important for the answer for battling the COVID-19 pandemic in Mexico," expressed Pluristem CEO and President, Yaky Yanay. "On account of our key upper hand of having in-house producing office, progressed strategic capacities, and a worldwide reach, we can supply PLX cells to clinical bases on the world while broadening our worldwide help for COVID-19 into Latin America. By directing the examination in both the U.S. furthermore, Mexico, in corresponding to the E.U. furthermore, Israel, we are proceeding with our attention on accomplishing clinical achievements and targets, while bringing the expected treatment of PLX cells to those out of luck." Gerardo Cárdenas Vogel, CEO of Innovare R&D remarked, "As an organization that is looking for overall accomplices indicating clinical guarantee for neglected clinical necessities, we are eager to team up with Pluristem. We anticipate utilizing our clinical and business capacities with Pluristem's high level cell treatment answer for help create and possibly bring a genuinely necessary treatment for ARDS patients related with COVID-19 to Mexico."

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Hovione and Zerion Pharma announce a strategic partnership to market the Dispersome® technology platform

Hovione | February 23, 2022

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