Out with the old and in with the new: Monday, the U.S. FDA approved retooled mRNA shots against COVID-19 from Pfizer-BioNTech and Moderna, simultaneously bidding adieu to the companies’ bivalent shots in the U.S.The FDA has approved Pfizer-BioNTech and Moderna’s separate vaccine formulations that are more closely targeted to current variants of the disease, the agency said in a release. Specifically, each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old. The vaccines have been updated to include a monovalent component aimed at omicron variant XBB.1.5, according to the companies and the FDA. Meanwhile, Novavax’s revised shot is still pending regulatory approval. Moderna noted the COVID is “on the rise again” and warned of a “’tripledemic’” of COVID, flu and respiratory syncytial virus this winter and fall. Vaccines should remain “top of mind,” the company said. Following ...
By Tristan Manalac Pictured: Pfizer’s office in Belgium/iStock, Alexandros Michailidis Pfizer and German partner BioNTech on Monday asked the U.S. Patent and Trademark Office to reconsider, and ultimately invalidate, Moderna’s patents over core technologies of the COVID-19 vaccine, Reuters reported. In an 87-page document, the partner companies argued that the Moderna patents are “unimaginably broad” and seek to claim ownership of knowledge that had existed long before its asserted priority date of 2015. Pfizer and BioNTech contend that using injecting mRNA into cells to produce a protein—and in turn leveraging this process to produce vaccines that prime immune protection—had been demonstrated and documented in the scientific literature as early as the 1990s. Moderna’s patent claims over any mRNA sequence encoding any betacoronavirus spike protein or its subunit, as well as a lipid-based formulation for delivery, is an “attempt to coopt and entire field of mRNA technology,” Pfizer and BioNTech argued ...
With many medicines from Pfizer’s Rocky Mount, North Carolina, production plant relegated to an emergency ordering list following a devastating tornado last month, hospitals and government health officials are likely eager for the massive injectables facility to restart production. Now, Pfizer has clarified the timeline by which it expects manufacturing to resume. “There are many sequential steps and variables to restart operations and Pfizer is making significant progress,” the company said Monday. The company signaled (PDF) its intention to restart manufacturing at Rocky Mount by the fourth quarter of 2023. After the tornado struck the plant July 19, Pfizer says it reopened parts of the facility Aug. 7. Current efforts to resume production remain “on track,” the company said, with several functions—such as packaging and quality laboratories—now operational. To help with product storage, Pfizer has also locked down a temporary warehouse location and received a certificate of occupancy. The tornado ...
Pfizer’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) to protect both infants and older adults against RSV-caused lower respiratory tract disease (LRTD). The EC’s decision allows Abrysvo to be given as a single dose to adults aged 60 years and older, and those who are 24 to 36 weeks into their pregnancy to protect their babies from birth until they are six months old. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can cause severe illness in young infants and older adults. In the EU, about 245,000 yearly hospital admissions have been associated with RSV in children aged under five years, while the virus is estimated to cause more than 270,000 hospitalisations in older adults each year. The EC’s decision, which follows a recent recommendation from the European Medicines ...
By Tristan Manalac Pictured: Healthcare worker administering a vaccine into a patient’s arm/iStock, Tirachard Moderna on Thursday announced that its updated COVID-19 vaccines can induce neutralizing antibodies against the emerging EG.5 and FL.1.5.1 variants of the virus, dubbed Eris and Fornax, respectively. Pfizer, along with German partner BioNTech, also said on Thursday that its updated shots elicited strong neutralizing activity against the Eris subvariant in a mouse study, reported Reuters. These updated vaccines come just in time for the fall vaccination season, for which the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) in June unanimously recommended using a monovalent vaccine focusing on the Omicron XBB.1.5 subvariant. According to data from the CDC, XBB.1.5 was the most dominant Omicron subvariant in the U.S. throughout most of 2023, accounting for 73.5% of cases in the latter half of April and 64.5% in the first half of May. In the last ...
Pfizer is shelling out $43 billion to acquire Seagen primarily for the Seattle biotech’s antibody-drug conjugate (ADC) capabilities. But a trial win for a small-molecule cancer drug makes the deal more attractive. Seagen on Wednesday said a phase 3 trial testing a combination of its Tukysa and Roche’s Kadcyla has hit its main goal in patients with previously treated HER2-positive breast cancer. Compared with Kadcyla and placebo, the combo significantly reduced the risk of tumor progression or death, Seagen said. Data on patient survival remain immature. Seagen plans to share the detailed results from the HER2CLIMB-02 trial at a medical meeting and will discuss them with the FDA, the company’s R&D chief, Roger Dansey, said in a statement. The positive results further de-risk the Seagen acquisition by Pfizer, Leerink Partners analysts said in a Wednesday note. Since securing FDA approval in 2020, Tukysa has been used alongside trastuzumab (Herceptin) and ...
By Tristan Manalac Pictured: Pfizer office at its South San Francisco campus/iStock, hapabapa The FDA on Monday granted accelerated approval to Pfizer’s bispecific antibody elranatamab, to be marketed as Elrexfio, for the treatment of relapsed or refractory multiple myeloma. Elrexfio’s label covers patients who had been treated with at least four prior lines of therapy, including an anti-CD38 antibody, an immunodulatory agent and a proteasome inhibitor. According to Pfizer’s announcement, Monday’s approval makes Elrexfio the first off-the-shelf, ready-to-use fixed-dose subcutaneous therapeutic that targets the BCMA protein. “With significant responses in a patient population with highly refractory disease, we believe Elrexfio is poised to potentially become the new standard of care for multiple myeloma,” Pfizer Chief Commercial Officer Angela Hwang said in a statement, adding that the company will continue the treatment’s clinical development through its broad MagnetisMM program. The FDA’s approval was supported by data from the Phase II MagnetisMM-3 ...
Following FDA approvals for fellow PAPR inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer. The tablet treatment, known commercially as Akeega, combines J&J’s androgen-directed Zytiga (abiraterone acetate) and the PARP inhibitor niraparib, which is sold by GSK as Zejula in other indications. The FDA has signed off on its use along with the corticosteroid prednisone, but only in a subset of mCRPC patients—those with BRCA mutations. Akeega will compete with AstraZeneca and Merck’s Lynparza as well as Pfizer’s Talzenna in the indication. Eleven weeks ago, the FDA gave Lynparza the same narrow label for those with the BRCA-positive tumors. Talzenna’s approval covers a broader population, including other mutations in the homologous recombination deficiency family. Under a 2016 deal with Zejula’s developer Tesaro, J&J carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. The ...
After Pfizer allegedly fired a compliance manager for raising the flag on potential fraud activity in China, the former employee is hitting back. Frank Han, the former director of global compliance analytics at Pfizer, has filed a civil complaint against the drugmaker. In the California lawsuit, Han claims he was terminated for identifying potential Foreign Corrupt Practices Act (FCPA) issues within the company. Han worked for Pfizer from May 2017 to November 2022, according to the court documents. Back in 2021, Han says he discovered that Pfizer had spent “over ten times the amount of money” on potentially influential government officials (PIGOs) in China than the company had spent on those officials in other countries, the court documents state. Specifically, Pfizer spent $168 million on PIGOs in China between the second quarter of 2019 and the third quarter of 2021, Han’s work found. That compared to $12 million in the ...
GSK has sued Pfizer in a US court, alleging infringement of the patents it holds on vaccines for respiratory syncytial virus (RSV). The lawsuit claims that Pfizer’s Abrysvo infringes on four of GSK’s patents that cover its rival vaccine, Arexvy. In May, Arexvy became the first RSV vaccine to be approved anywhere in the world after it received approval from the US Food and Drug Administration (FDA). The US approval of Pfizer’s vaccine followed shortly afterwards. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease. Both companies’ vaccines aim to prevent lower respiratory tract disease caused by RSV in individuals aged 60 years or older and are expected to be available in the US before the next RSV season. A GSK spokesperson said that “intellectual property protections ...
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