Search Results for “ Pfizer” – Page 5 – media

Pfizer Nixes Twice-Daily Oral GLP-1 Candidate After High Rates of Side Effects

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 ...
- Source: drugdu
- 203
- December 5, 2023
FDA signs off on new uses for Astellas and Pfizer’s Xtandi, Merck’s Keytruda

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 ...
- Source: drugdu
- 115
- November 21, 2023
Pfizer to Cut 500 Jobs at UK Site as Part of $3.5B Cost-Savings Campaign

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 ...
- Source: drugdu
- 125
- November 17, 2023
Pfizer’s cost-cutting campaign hits Sandwich site in UK, where 500 workers will lose jobs

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 ...
- Source: drugdu
- 173
- November 16, 2023
Pfizer’s Litfulo approved by MHRA for adults and adolescents with alopecia areata

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 ...
- Source: drugdu
- 116
- November 5, 2023
Pfizer Continues COVID Cliff in Q3 with First Quarterly Loss Since 2019

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 ...
- Source: drugdu
- 114
- November 2, 2023
Amid COVID slump, Pfizer turns attention to RSV launch and a potential future in obesity

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. ...
- Source: drugdu
- 104
- November 2, 2023
With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts

As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. Pfizer has stepped up to the plate with an update, and its effects are staggering as the company has slashed its 2023 revenue projection by $9 billion. Pfizer now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion. In delivering its update late Friday afternoon, a time often reserved by companies to reveal bad news, Pfizer chalked up most of the decline to a $7 billion decrease in its projection for sales of oral antiviral Paxlovid. The company has also cut its forecast for sales of COVID vaccine Comirnaty by $2 billion. Pfizer also sees earnings per share plummeting to between $1.45 and $1.65, down from ...
- Source: drugdu
- 119
- October 18, 2023
Pfizer announces FDA approval for Braftovi/Mektovi combination in lung cancer

Pfizer has announced that a new personalised treatment option, Braftovi (encorafenib) plus Mektovi (binimetinib), has been approved by the US Food and Drug Administration (FDA) for certain lung cancer patients. The regulator’s decision specifically applies to adults with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. Lung cancer is the second most common type of cancer and NSCLC accounts for up to 85% of all lung cancers cases. Certain lung cancers are linked to acquired genetic abnormalities such as a BRAF V600E mutation, which occurs in approximately 2% of NSCLC cases. “BRAF V600E mutations identify a unique subtype of metastatic NSCLC that presents an actionable biomarker that precision medicines like Braftovi plus Mektovi combination therapy can help address,” explained Gregory Riely, an investigator in the ongoing mid-stage PHAROS trial that supported the FDA’s approval. The study, which is evaluating the combination ...
- Source: drugdu
- 119
- October 17, 2023
FDA Approves Pfizer’s Ulcerative Colitis Drug, $6.7B Arena Buy Pays Off

By Connor Lynch Pictured: Pfizer’s office in Belgium/iStock, Alexandros Michailidis The FDA has greenlit Pfizer’s ulcerative colitis drug etrasimod, marketed as Velsipity, based on Phase III results published in The Lancet, the company announced Friday. Pfizer’s Elevate UC Phase III registrational program, consisting of the Elevate UC 52 and Elevate UC 12 clinical trials, examined the safety and efficacy of a 2-mg daily dose of the oral medication for patients intolerant to or who had failed on trials of a conventional, biological, or Janus kinase inhibitor therapy. Both studies “achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of Velsipity,” Pfizer said in Friday’s announcement. In the Elevate 52 UC trial, 27% of patients achieved clinical remission, compared to 7% of patients receiving a placebo at week 12, and by week 52 it was 32% versus 7%. In the Elevate 12 UC ...
- Source: drugdu
- 106
- October 17, 2023

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