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Pfizer’s RSV vaccine granted EC approval to protect infants and older adults

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 ...
- Source: drugdu
- 125
- August 30, 2023
Pfizer, Moderna Target Emerging Variants with Updated COVID-19 Shots

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 ...
- Source: drugdu
- 191
- August 22, 2023
With trial win, Seagen’s breast cancer drug Tukysa boosts Roche’s Kadcyla—and Pfizer’s $43B buyout

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 ...
- Source: drugdu
- 151
- August 19, 2023
Pfizer Bispecific Drug Wins FDA Accelerated Approval for Multiple Myeloma

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 ...
- Source: drugdu
- 216
- August 17, 2023
Chasing AstraZeneca and Pfizer, Johnson & Johnson snags FDA nod for prostate cancer combo Akeega

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 ...
- Source: drugdu
- 118
- August 16, 2023
Pfizer faces whistleblower lawsuit from former compliance manager who says he flagged possible fraud in China

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 ...
- Source: drugdu
- 460
- August 12, 2023
GSK files lawsuit against Pfizer over RSV vaccine patent infringement

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 ...
- Source: drugdu
- 116
- August 7, 2023
As COVID revenues disappoint, once-high-flying Pfizer looks at possible cost cuts

As COVID-19 revenues ebb and flow—but mostly ebb—Pfizer is eyeing the cost-cutting shears. “Clearly, there is a higher level of uncertainty regarding the demand projections for our COVID-19 products than for the rest of our business,” Pfizer chief Albert Bourla, Ph.D., admitted on a conference call Tuesday. While the shift to a traditional commercial market for Paxlovid and Comirnaty could help, a veil of uncertainty persists. In turn, “we are also preparing to have the ability to adjust our 2024 total cost base” to align with future COVID needs, the CEO added. “In fact, we have already identified specific areas where we can make adjustments primarily within our COVID-19 cost base,” he said. Paxlovid generated just $143 million in worldwide sales for the second quarter, down 98% from the $8.1 billion it pulled down over the same stretch in 2022. MRNA vaccine Comirnaty, for its part, brought home $1.4 billion, ...
- Source: drugdu
- 170
- August 3, 2023
Pfizer and Flagship Pioneering Sign Drug Discovery Partnership Worth up to $7bn

Pfizer has signed a deal with Flagship Pioneering worth up to $7bn to develop new drug candidates using the venture firm’s large portfolio of biopharma companies. Under the terms of the agreement, Pfizer and Flagship will each invest $50m upfront to develop a new pipeline of up to ten programmes for areas including internal medicine, oncology, infectious diseases, and immunology. The new partners outlined in a statement that the collaboration will focus on addressing unmet needs within Pfizer’s core therapeutic areas, including “broad patient populations and diseases with high potential to benefit from a diverse range of technology platforms and modalities”. Flagship’s drug discovery initiative, Pioneering Medicines, working in collaboration with Pfizer’s research and development leadership, will lead the exploration process. Paul Biondi, president, Pioneering Medicines, and executive partner, Flagship Pioneering, said: “This new partnership brings together the best of our organisations to maximise discovery and ...
- Source: drugdu
- 110
- July 24, 2023
US FTC Requests More Information on Pfizer’s Proposed $43bn Seagen Acquisition

The US Federal Trade Commission (FTC) has requested more information and documentary material regarding Pfizer’s proposed $43bn acquisition of Seagen. The second request is a standard review procedure by which the FTC and the Antitrust Division of the US Department of Justice investigate mergers and acquisitions. If a second request is submitted, the law forbids merging companies from completing a transaction until they have substantially complied with the additional investigatory request. The Pfizer/Seagen agreement, which was originally announced in March this year, would mark a significant boost to the US pharma’s oncology pipeline. At the time of the announcement, Pfizer’s oncology portfolio included 24 approved drugs, while Seagen’s included Adcetris for lymphomas, Padcev for bladder cancers, Tivdak for cervical cancer, and Tukysa for breast and colorectal cancers. The deal would also grant Pfizer access to Seagen’s drug development pipeline as well as its proprietary ...
- Source: drugdu
- 220
- July 21, 2023

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