In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|June 8, 2022
Pfizer to Invest $120 Million in COVID-19 Oral Treatment Production
Author(s)BioPharm International Editors
Pfizer will invest $120 million to produce COVID-19 oral treatment in the US.
Advertisement
Pfizer announced on June 6, 2022 that it will invest $120 million in its Kalamazoo, MI facility to support the production of its COVID-19 oral treatment, PAXLOVID. The investment is predicted to create more than 250 additional high-skilled jobs at the company’s Kalamazoo site.
The investment is a step towards the company’s goal to further strengthen its commitment to US manufacturing, increasing its capability to produce and supply treatments and medicines for patients in the United States and around the world. Pfizer has shipped 12 million courses of PAXLOVID across 37 countries, including 5 million courses shipped to the US, and has manufactured almost 17 million treatment courses total, to date.
“Pfizer Global Supply has made the impossible possible, making billions of vaccine doses and now millions of treatment courses to help battle the deadly COVID-19 pandemic,” said Albert Bourla, chairman and CEO of Pfizer, in a press release. “By increasing production at our Michigan facility, we are both helping patients around the world and expanding important manufacturing innovation to the US. This investment builds upon our $5 billion of investments across our manufacturing and distribution portfolio since 2017 to support the ongoing growth of US manufacturing leadership.”
“Pfizer’s Kalamazoo facility has been at the forefront of pharmaceutical manufacturing for more than 135 years through the legacy company Upjohn,” added Mike McDermott, chief global supply officer of Pfizer, in the release. “The Kalamazoo facility uses some of our most innovative manufacturing technology and has been essential in Pfizer’s fight against COVID-19, producing nearly one billion doses of COVID-19 vaccine at the site to date. Through this expansion, we will continue to invest in the next generation of manufacturing and supply chain resilience.”
Source:
Advertisement
Related to this article
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
Blackstone Life Sciences will fund up to $1.5 billion of development costs through 2028 for Pfizer’s monthly GLP-1 receptor agonist berobenatide, in exchange for milestone payments tied to approval and sales. Pfizer keeps full control of the program.
Beam Therapeutics’ base-edited cell therapy risto-cel meets its primary endpoint in the BEACON sickle cell disease trial, Amgen’s CD40L antagonist dazodalibep reduces systemic disease activity in the phase 3 OASIZ-301 Sjögren’s disease trial, and ImvivaBio’s allogeneic CD19/BCMA CAR-T CTA313 sustains lupus remission through 12 months.
ImvivaBio’s off-the-shelf CD19/BCMA CAR-T cell therapy CTA313 kept 88% of evaluable patients with refractory lupus in DORIS remission at Month 12, according to longer-term phase 1 data presented at ACR Convergence 2026.
Full phase 3 OASIZ-301 results show both dosing regimens of Amgen’s CD40L antagonist fusion protein dazodalibep reduced systemic disease activity in Sjögren’s disease at Week 48. The every-four-weeks dose also improved patient-reported dryness.
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.
Advertisement
Advertisement
Trending on BioPharm International
1
ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months
2
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
3
Amgen’s Dazodalibep Reduces Systemic Disease Activity in Phase 3 Sjögren’s Trial
4
Beam's Risto-cel Meets Primary Endpoint in Sickle Cell Trial
5