Pfizer on Wednesday said its experimental vaccine targeting the potentially deadly bacterial disease Group B Streptococcus returned strong mid-stage clinical trial results, a promising step as the drug inches toward potential approval. Pfizer is among several drugmakers racing to develop the world’s first shot targeting Group B strep disease, which is linked to nearly 150,000 infant deaths worldwide each year, especially in lower-income countries. The Food and Drug Administration in September granted breakthrough therapy designation to Pfizer’s vaccine, which is intended to expedite the development and review of the shot. Pfizer’s single-dose shot generated antibodies that may provide infants with meaningful protection against the disease, according to the data released Wednesday from a phase two clinical trial. The jab is administered to expectant mothers, who pass vaccine-induced antibodies to their fetuses. One of the company’s vaccines targeting respiratory syncytial virus also uses that maternal vaccination method. ...
Pfizer is looking to enrich its pipeline with up to 10 new innovative medicines by partnering with startup creator Flagship Pioneering, the companies announced Tuesday. Under the terms of the agreement, Pfizer and Flagship will each contribute an upfront investment of $50 million. The collaboration will leverage Flagship’s rich ecosystem of biotechnology platforms and more than 40 human health companies. Pfizer and Flagship will explore up to 10 single-asset programs, which Pfizer will fund and have the option to acquire. Flagship and its companies will be eligible to receive up to $700 million in milestones and royalties for each program that hits the market, giving Tuesday’s deal a maximum potential value of $7 billion. This partnership will bring together expertise from Pfizer and Flagship “to maximize discovery and development potential from inception to impact,” Paul Biondi, executive partner at Flagship and president of Pioneering Medicines, said in a statement. ...
Pfizer and Flagship Pioneering are partnering in a drug research alliance leveraging the capabilities of the more than 40 biotech startups in the venture capital firm’s portfolio. The new partners aim to develop drugs for unmet needs, including those in broad patient populations. Pharmaceutical companies frequently strike deals with smaller biotech companies as a way to build up their drug pipelines, and Pfizer is no exception. But in a twist to this strategy, the pharma giant is now turning to Flagship Pioneering, the venture capital firm whose highest profile creation might be the messenger RNA company Moderna. The alliance announced Tuesday calls for Flagship and Pfizer to each invest $50 million up front. The cash will go toward the R&D of 10 single-asset programs. Flagship does not create single-asset companies. The startups that spring from its labs are all formed around platform technologies, each with the capability of yielding ...
CureVac is adding fuel to its COVID-19 vaccine patent fire by asserting more claims against Pfizer and BioNTech in both its U.S. and German cases. The German mRNA specialist put a tenth patent on the table in its U.S. litigation and three more to its five in Germany, expanding the scope of the disputes. CureVac went after BioNTech in Germany last summer, starting off with four claims and adding a fifth in May. The original patents it claimed its fellow German mRNA maker stepped on related to inventions considered “essential to the design and development” of BioNTech and Pfizer’s Comirnaty, including sequence modifications and mRNA vaccine formulations, the company noted in a statement at the time. Its lawsuit doesn’t aim to stop the production and distribution of the shot but wants recognition and royalties from past and future sales. That likely puts $500 million on the line, Berenberg Capital Markets analyst Zhiqiang ...
Caught in a litigation crossfire, Moderna has reportedly opened two new fronts in its COVID-19 vaccine patent war with Pfizer and BioNTech.Seeking damages from Pfizer and BioNTech for alleged infringement, Moderna has lodged new lawsuits at the High Court in Dublin, Ireland, and the Brussels Commercial Court in Belgium, European intellectual property outlet Juve Patent reported Tuesday. The Irish court, where Moderna is claiming infringement by Pfizer-BioNTech on a pair of Spikevax patents, is set to hear the case in early 2024, according to the publication. Less is known about the status of Moderna’s Belgian lawsuit, Juve points out. A spokesperson for Moderna didn’t immediately respond to a request for comment. The new lawsuits add to a complex web of ongoing mRNA patent litigation. The legal melee began last August when Moderna filed patent infringement lawsuits in the U.S. and Germany. Separately, Moderna has also sued Pfizer and its German partner BioNTech in the Netherlands, plus ...
Just days after sewing up a pair of $897 million deals with Pfizer, Samsung Biologics has added a few hundred million dollars more to its partnership cash pile—this time courtesy of an expanded pact with Novartis. Monday, Samsung Bio said in a regulatory filing that it’s inked a $390.9 million deal to help crank out Novartis drugs. The latest production pact builds on an earlier Samsung-Novartis tie-up worth $81 million in June 2022. Last week, meanwhile, Samsung Bio said Pfizer had added $486 million to two biosimilar production accords the companies made in early 2023. In June, the partners signed a contract for the Korean CDMO to produce biosimilar drugs in the fields of immunology, oncology and inflammation. And in March, the companies linked up on a deal worth $193 million, according to a regulatory filing. Samsung’s Novartis deal comes in below that Pfizer deal from June. Still, the Novartis tie-up now represents ...
Pfizer has invested $25m in the clinical-stage, clustered, regularly interspaced, short palindromic repeats, genome-editing biopharmaceutical firm, Caribou Biosciences. Pfizer purchased 4,690,431 common shares of Caribou at $5.33 per share. Pfizer global product development multiple myeloma vice-president and development head Sriram Krishnaswami will now join the scientific advisory board of Caribou. The investment will be used to progress an immune-cloaked allogeneic CAR-T cell therapy, CB-011. The company is currently evaluating the cell therapy in a Phase I CaMMouflage clinical trial for relapsed or refractory multiple myeloma. The US Food and Drug Administration granted fast track designation for CB-011 in April 2023. The complete ownership and control of the pipeline comprising allogeneic CAR-T and CAR-NK cell therapies will be retained by Caribou. Caribou president and CEO Rachel Haurwitz stated: “We believe Pfizer’s investment in Caribou highlights the potential of our clinical programmes and we are excited to establish this partnership with one ...
The Centers for Disease Control and Prevention on Thursday recommended that adults ages 60 and above receive a single dose of RSV vaccines from Pfizer and GSK after consulting their doctors. Outgoing CDC Director Rochelle Walensky signed off on the recommendation, which an advisory panel of outside experts made last week. That endorsement says seniors should work with their health-care providers to decide if taking a shot is right for them. The CDC said the shots are expected to be available to the public this fall, when respiratory syncytial virus – along with Covid and the flu – typically begins to spread at higher levels. “These vaccines provide an opportunity to help protect older adults against severe RSV illness at a time when multiple respiratory infections are likely to circulate,” the CDC said in a statement. The virus is a common respiratory infection that usually causes mild, cold-like symptoms, but ...
Pfizer’s Litfulo (ritlecitinib) has been approved by the US Food and Drug Administration (FDA) as the first treatment option for patients aged 12 years and older with severe alopecia areata. Affecting almost seven million people in the US and approximately 147 million people globally, alopecia areata is an autoimmune disease characterised by patchy or complete hair loss on the scalp, face, or body. The condition can develop at any age, with nearly 20% of patients diagnosed before the age of 18. Litfulo, which is a one-daily oral kinase inhibitor, is thought to work by blocking the activity of signalling molecules and immune cells believed to contribute to the loss of hair in patients with alopecia areata. Angela Hwang, chief commercial officer, president, Global Biopharmaceuticals Business, Pfizer, said: “Litfulo is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options ...
By Tristan Manalac Pictured: Pfizer sign on building/Tobias Arhelger/Adobe Stock Pfizer is discontinuing the clinical development of its investigational GLP-1 receptor agonist lotiglipron, which was being developed for obesity and Type 2 diabetes mellitus, the company announced Monday. The decision to cut lotiglipron from Pfizer’s pipeline comes after the company detected heightened concentrations of liver transaminases in patients treated with the investigational drug. Lotiglipron was being evaluated in two Phase I drug-drug interaction studies and one Phase II trial. Pharmacokinetic data from the two Phase I studies also contributed to the candidate’s discontinuation. None of the patients developed liver-related symptoms or similar side effects and neither required medical intervention. Pfizer also did not document signs of liver failure among these patients. The company will present lotiglipron data at an upcoming conference or will submit it for publication in peer-reviewed journals. With lotiglipron’s discontinuation, Pfizer will instead focus on the clinical ...
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