Pfizer already reported its experimental drug for hemophilia A and B met a pivotal study’s goals of reducing bleeding episodes. During the annual meeting of the American Society of Hematology, the company presented a full look at the results, which are expected to support regulatory submissions soon. By FRANK VINLUAN Patients with hemophilia A or B can manage the inherited bleeding disorders with regular infusions of the clotting proteins they lack. This treatment helps—until it doesn’t. One problem with these infused factor replacement therapies is patients can develop inhibitors, which are antibodies that render the clotting proteins ineffective. Experimental Pfizer drug marstacimab takes a different approach to both forms of hemophilia. Results from a pivotal study show the subcutaneously injected drug met the main goals of reducing bleeding episodes. The company also has some additional long-term data showing continuing improvement beyond the initial clinical trial evaluation period. The full Phase ...
Pfizer and Arvinas are broadening their vepdegestrant programme to include more settings, as positive data is reported from the Phase Ib study of the drug to treat breast cancer. Vepdegestrant is an orally administered protein degrader designed as a proteolysis targeting chimera (PROTAC) that targets both wild-type and mutant oestrogen receptor (ER) found in some breast cancers. The collaboration between the two companies began in July 2021 in a $2.4bn deal to develop the PROTAC drug. Under the terms of the agreement, both firms would co-develop and market vepdegestrant. In the abstract on data from a Phase Ib study (NCT04072952) presented at the ongoing 2023 San Antonio Breast Cancer Symposium (SABCS), the reported clinical benefit rate (CBR) was 37.1% with 200mg and 38.9% with 500mg of the drug amongst 71 patients who received either dose (abstract no. Abstract GS3-03). The treatment was generally well tolerated, with the most common side ...
By Tristan Manalac Pictured: GSK building in Poznan, Poland/iStock, Wirestock GSK CEO Emma Walmsley on Thursday touted the smooth launch of its respiratory syncytial virus vaccine Arexvy and its strong potential for growth in the coming years. In an interview with Reuters, Walmsley said the British biopharma is “delighted” with the progress it has made in the RSV vaccine race with Pfizer. “We are delighted with the start of our RSV vaccine,” Walmsley said, adding that the company expects Arexvy “will be more than £1 billion in its first year, (it) has lots of headroom for growth.” GSK is positioning Arexvy to be its next blockbuster asset. The U.S. launch of the vaccine has so far reached three million of the more than 80 million adults over 60 at risk from RSV, according to Walmsley. Arexvy became the first FDA-approved RSV shot in May 2023 and is authorized for use ...
By Tyler Patchen Pictured: Sign at Pfizer’s headquarters in New York/iStock, JHVEPhoto Pfizer on Friday said it is scrapping an investigational twice-daily oral Glucagon-like peptide-1 receptor agonist candidate after topline data from a Phase IIb trial of obese patients without type 2 diabetes showed high rates of adverse events. While the trial did reach the primary endpoint of a statistically significant change in body weight, there were high rates of adverse events. According to Pfizer, the adverse events in the obesity trial for the twice-daily dosing of GLP-1 danuglipron were mild and included gastrointestinal symptoms that were “consistent with the mechanism” of the candidate. However, the company noted high rates of these side effects. Up to 73% of patients experienced ...
The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. Keytruda’s expansion is in stomach cancer, allowing its use alongside chemotherapy to treat first-line patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Xtandi’s new indication expands its already deep portfolio in the treatment of prostate cancer. It now becomes the only androgen receptor inhibitor approved by the FDA for patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). These patients can be treated with Xtandi with or without GnRH analog therapy. Of men who have had prostate cancer treatment, 20% to 40% will have BCR within 10 years. Of those with high-risk BCR, 90% will develop metastatic disease, with one in three dying. The nod was backed up by the phase 3 EMBARK ...
Pictured: Sign at Pfizer’s headquarters in New York/iStock, JHVEPhoto Pfizer is planning to lay off around 500 of its staffers and terminate its Pharmaceutical Sciences Small Molecule functions at its facility in Sandwich, Kent in the U.K., according to several media reports on Tuesday.The business scale-back comes amid Pfizer’s sweeping cost-reduction plan announced last month, which will see the company generate $3.5 billion in savings through 2024. At the time, the company noted that the “cost realignment” initiative would include layoffs across its global operations, though the exact number of affected employees is still unknown. Local news outlet Kent Online reported that Tuesday’s layoffs were also part of a redundancy consultation program at the Sandwich site.In an emailed statement to Fierce Pharma, a Pfizer spokesperson clarified that the Sandwich facility would remain operational but “with a different size.” There are currently 940 employees at the U.K. site. It is the latest Pfizer location to ...
Earlier this month, Pfizer’s $3.5 billion cost-cutting campaign crossed overseas to Ireland. Now, just a week later, Pfizer is announcing hundreds more job cuts in the U.K. Pfizer plans to cut approximately 500 roles and ax its Pharmaceutical Sciences Small Molecule (PSSM) capabilities at its site in Sandwich in Kent in the U.K., a company spokesperson confirmed over email. The spokesperson described the layoffs as a “one of the consequences” of Pfizer’s enterprisewide cost realignment program, which the drugmaker unveiled in mid-October. Under the current plan, the Sandwich site isn’t closing, and other functions will continue “with a different size,” the spokesperson added. Currently, around 940 people are employed at the facility. Local news outlet Kent Online earlier reported that Pfizer was proposing to discontinue all lab and manufacturing work at the Sandwich site.The site is the location where Pfizer scientists first discovered Viagra. During the pandemic, Pfizer invested 10 ...
Pfizer’s Litfulo (ritlecitinib) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat severe alopecia areata in patients aged 12 years and older. Affecting 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 and nearly 20% of patients are diagnosed before the age of 18. Litfulo, which is a one-daily oral kinase inhibitor, works by blocking the activity of enzymes in the body involved in inflammation at the hair follicle. This reduces the inflammation, leading to hair regrowth in patients with alopecia areata. The MHRA’s decision on the drug was supported by positive results from the phase 2b/3 ALLEGRO trial, which evaluated Litfulo in patients aged 12 years and older with 50% or more scalp hair loss, including those with total scalp and body ...
By Tyler Patchen Pfizer reported third-quarter financial results Tuesday, pulling in $13.2 billion in revenues, a 42% drop compared to the prior-year period and the first quarterly loss since 2019. Third-quarter revenues for antiviral treatment Paxlovid dropped 97% operationally compared with the prior-year period, while COVID-19 vaccine Comirnaty revenues declined 70% in the quarter. However, Pfizer’s non-COVID products grew 10% operationally. Sales of its other vaccines, such as Prevnar 13 and 20 for pneumococcal conjugate vaccination, brought in over $1.8 billion in the third quarter while its RSV vaccine Abrysvo pulled in $375 million. “We are encouraged by the strong performance of Pfizer’s non-COVID products in the third quarter of 2023, including significant contributions from new launches and robust year-over-year growth for several key in-line brands,” CEO Albert Bourla said in a statement. Pfizer CFO David Denton noted in the release that new product launches will meet the company’s non-COVID ...
As COVID revenues dwindle for pandemic stalwart Pfizer, the company is turning attention to its respiratory syncytial virus (RSV) vaccine launch and a potential entry into the hot obesity market. With only five months of sales under its belt, Pfizer’s RSV vaccine Abrysvo is “doing better than we thought,” Chief Commercial Officer Angela Hwang said on the company’s third-quarter earnings call, touting “very fast uptake” for the new shot. After a pair of approvals in late May and August, Abrysvo pulled in revenues of $375 million during the third quarter, Pfizer said Tuesday. Earlier this year, the shot won FDA nods to immunize older adults and then as a maternal vaccination to protect infants. In both settings, the Pfizer offering is facing off against Big Pharma competition. In the adult RSV vaccine marketplace, Pfizer is challenging GSK and its immunization Arexvy. GSK is set to report its third-quarter results Wednesday. ...
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