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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 ...
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- August 17, 2023
Researchers publish early results with new interleukin-targeting antibody

An academic group has published preclinical results with a new antibody that has greater activity and fewer side effects than existing biological therapies for inflammatory conditions. This could translate into a clinical benefit for patients living with rheumatoid arthritis (RA), psoriasis, or inflammatory bowel disease (IBD). Researchers from the University of Birmingham in the UK and the University of Naples Federico II in Italy revealed promising results after designing an antibody that targets a 20-long amino acid sequence in interleukin-17 (IL-17) – a protein important in inflammatory pathways. According to the team, they demonstrated for the first time that this sequence activates the release of cyto-chemokines. The antibody, which has been called Ab-IPL-IL-17, targets this sequence in both IL-17A and IL-17F. In cell studies, it demonstrated an ability to reduce the production of cyto-chemokines and white blood cell migration to inflammation-primed tissue. When the researchers compared it to existing therapies ...
- Source: drugdu
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- August 17, 2023
UK government allocates £250m for more NHS hospital beds in England

The government has announced a fund of £250m to provide another 5,000 NHS England hospital beds this winter, to relieve pressure on hospitals and reduce waiting times. As part of the NHS Urgent and Emergency Care Recovery Plan, over 30 NHS organisations across England will benefit from the investment in urgent and emergency care services. Over 900 new hospital beds, including 60 intermediate care beds, should be ready by January 2024 to increase capacity on hospital wards and A&E to 100,000. The scheme will also improve assessment spaces and cubicles in A&E. Health and social care secretary, Steve Barclay, said: “Creating additional hospital capacity will support staff to provide the best possible care and treat patients more quickly, helping us to improve waiting times and cut waiting lists – one of the government’s top five priorities.” Trusts including Hull Royal Infirmary, James Cook University Hospital and Worthing Hospital will develop ...
- Source: drugdu
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- August 17, 2023
Sandoz says its biosimilar matches Eylea in another threat to Regeneron’s blockbuster

With its blockbuster eye drug Eylea, Regeneron is already juggling between a recent FDA rejection and new competition. Meanwhile, biosimilar players are also eying a piece of the pie. Tuesday, Novartis’ Sandoz said its biosimilar to Eylea showed no clinically meaningful differences with the originator in a phase 3 trial in patients with wet macular degeneration. The two versions were therapeutically equivalent in improving the best vision that patients can achieve. Sandoz now expects to file the Eylea biosimilar in the U.S. and EU in the coming months. The Sandoz drug is only the latest copycat to be closing in on Eylea. Viatris was the first to file an Eylea biosimilar in the U.S. in 2021. That asset now belongs to Biocon Biologics through a $3 billion transaction. In addition, the partnership between Formycon and Coherus BioSciences filed its biosimilar in June, followed on the heels by a separate filing ...
- Source: drugdu
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- August 17, 2023
Stada in ‘exploratory talks’ about possible sale, CEO says, but nothing is certain

Speculation that Stada Arzneimittel may be looking for a buyout has largely been confirmed after the company’s CEO said as much in a recent German-language news story. Responding to recent acquisition rumors, Stada CEO Peter Goldschmidt told the German Press Agency, “Whether and when STADA might be sold is solely the decision of our owners; Bain Capital and Cinven.” From the company’s view, Goldschmidt said, “our owners are in an orientation phase in which initial exploratory talks are taking place.” A Stada press representative emailed a translated version of the remarks early Tuesday along with the company’s second-quarter results. Goldschmidt added that he doesn’t expect a decision before 2024. Additionally, the company’s investors “have no pressure to sell,” the CEO pointed out. “What speaks in favor of a sale process is that it is common for financial investors to exit after five to six years,” Goldschmidt opined. Early this month, ...
- Source: drugdu
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- August 17, 2023
Peripheral tumor biomarkers to guide treatment for HPV-associated malignancies

A new review paper was published in Oncotarget’s Volume 14 on August 10, 2023, entitled, “Peripheral surrogates of tumor burden to guide chemotherapeutic and immunotherapeutic strategies for HPV-associated malignancies.” With the rapid adoption of immunotherapy into clinical practice for HPV-associated malignancies, assessing tumor burden using “liquid biopsies” would further our understanding of clinical outcomes mediated by immunotherapy and allow for tailoring of treatment based on real-time tumor dynamics. In their new review, researchers Meghali Goswami, Jeffrey Schlom and Renee N. Donahue from the National Cancer Institute examine translational studies on peripheral surrogates of tumor burden derived from peripheral blood in HPV-associated malignancies, including levels and methylation of circulating tumor DNA (ctDNA), miRNA derived from extracellular vesicles, circulating tumor cells (CTCs), and HPV-specific antibodies and T cell responses. “We review their utility as prognostic and predictive biomarkers of response to chemotherapy and radiation, with a focus on how they may inform ...
- Source: drugdu
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- August 16, 2023
Study reveals coping mechanisms used by South African healthcare workers during the pandemic

A new study by UC Berkeley Anthropology Professor Andrew Wooyoung Kim reveals resilient coping mechanisms used by healthcare workers during the COVID-19 pandemic in metro Johannesburg, South Africa. Titled “Coping strategies employed by public psychiatric healthcare workers during the COVID-19 pandemic in southern Gauteng, South Africa,” Kim’s paper was published in PLOS ONE in August. It explores the diverse coping strategies employed by public psychiatric healthcare workers during the pandemic in the metropolitan Johannesburg area. Andrew Wooyoung Kim, Anthropology Professor, UC Berkeley, said, “This research illuminates the adaptability and creativity of individuals facing unprecedented healthcare challenges. The psychiatric healthcare workers’ ability to innovate in the face of extreme adversity is particularly inspiring. Understanding these coping strategies is vital for building short-term support systems for healthcare workers, providing a roadmap for bolstering psychiatric service delivery while also improving patient outcomes in times of healthcare emergencies.” The study identified seven major coping ...
- Source: drugdu
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- August 16, 2023
NHS England to offer millions of children flu vaccines from September

The NHS has announced that millions of children in England will be offered a flu vaccine as of September 2023 as part of its “life-saving” vaccination programme to protect the country against deadly viruses ahead of winter. School-aged children will receive the flu vaccine either at school or at community clinics, and those who are aged two and three years or have long-term health condition will be offered the vaccine at GP surgeries. The rollout follows the NHS’s winter flu and COVID-19 vaccination programme to provide protection to those eligible from developing serious illnesses and minimise hospitalisations during the winter months. Professor Sir Stephen Powis, NHS England medical director, said: “Vaccinations are our best defence against flu and COVID-19 ahead of what could be a very challenging winter.” By prioritising flu vaccinations for children, the NHS aims to “break the chain of transmission” to the wider population. Earlier this month, ...
- Source: drugdu
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- August 16, 2023
Novartis acquires Chinook for $3.2bn to boost kidney disease pipeline

Novartis has acquired Chinook Therapeutics for more than $3.2bn in a move to bolster its portfolio of drugs targeting kidney disease. With reported sales of $13.62bn in Q2 2023, Novartis is looking to expand its drug portfolio. Just last month, the company acquired DTx Pharma for $1bn for its small interfering RNA (siRNA) treatment portfolio for rare diseases. As part of Chinook’s acquisition, its shareholders would receive $40 per share, totalling $3.2bn. The shareholders would also be eligible to receive an additional $4 per share contingent (totalling $300m) on regulatory milestones. The acquisition comes at a significant inflection point with two high-profile drugs, atrasentan and zigakibart, in Phase III development for the treatment of IgA nephropathy (IgAN). A pivotal data readout for the Phase III atrasentan trial is planned for Q4 2023. IgAN is a chronic kidney disease, in which immunoglobulin A (IgA) is trapped in the glomeruli of the ...
- Source: drugdu
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- August 16, 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
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- August 16, 2023

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