Search Results for “ Pfizer” – Page 3 – media

Pfizer Asks FDA to Approve RSV Vaccine for Adults as Young as 18 Years Old

Mike HollanIt could be time for many Americans to add another vaccine to their list. Pfizer recently announced the results of a study for its RSV vaccine. While the vaccine is already approved for older Americans, the results of the study reportedly show that it is also effective for adults as young as 18. As such, Pfizer is asking FDA to approve the vaccine for adults aged 18 to 59. In a press release, Pfizer stated that Abrysvo met all of its primary endpoints for adults in specified age range who had an increased risk of RSV.1 The study was named MONeT, which is short for RSV Immunization Study in Adults at Higher Risk of Severe Illness. It was conducted to see the efficacy of the vaccine in adults who suffer from certain conditions, such as asthma, diabetes, and chronic obstructive pulmonary disease. These conditions put the patients at a ...
- Source: drugdu
- 142
- April 15, 2024
Pfizer meets Phase III primary endpoints for RSV vaccine Abrysvo

Pfizer has reported positive top-line results from its Phase III MONeT study (NCT05842967) evaluating the efficacy of single-dose Abrysvo for adults at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD). As per the 9 April press release, Abrysvo met its co-primary immunogenicity and safety endpoints, with patients demonstrating non-inferior RSV-A and RSV-B neutralising responses compared to the Phase III RENOIR study (NCT05842967) where the vaccine previously showed efficacy. Compared to pre-vaccination, the vaccinated patients also demonstrated a minimum of a four-fold increase in serum-neutralising titers for RSV-A and RSV-B a month after being vaccinated. The MONeT trial did not identify any new safety signals for Abrysvo. The pharma giant plans to publish the findings in a peer-reviewed journal and submit the results to regulatory agencies in a bid to expand the vaccine’s label from its current indication to include adults 18 years and older, the ...
- Source: drugdu
- 104
- April 11, 2024
Pfizer’s Bivalent Respiratory Syncytial Virus Vaccine Shows Promising Efficacy Across Two Seasons

Davy James Abrysvo was found to produce durable efficacy against respiratory syncytial virus across two seasons in adults 60 years of age and older. Top-line data from the ongoing, pivotal Phase III RENOIR clinical trial (NCT05035212) demonstrated that Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine Abrysvo produces durable efficacy against respiratory syncytial virus (RSV) across two seasons in adults 60 years of age and older. Efficacy against RSV-associated lower respiratory tract disease (LRTD), defined as three or more symptoms, was 88.9% after the first season, whereas efficacy was 77.8% after the second season.1 “We are encouraged by the level of protection that we observed after two full RSV seasons for Abrysvo,” Annaliesa Anderson, PhD, Pfizer senior vice president and chief scientific officer, Vaccine Research and Development, said in a press release. “This new data indicate that broad and durable protection against both types of RSV that cause ...
- Source: drugdu
- 154
- March 4, 2024
Pfizer’s Velsipity granted EC approval for ulcerative colitis in patients aged from 16 years

Pfizer’s S1P receptor modulator Velsipity (etrasimod) has been approved by the European Commission (EC) to treat moderately-to-severely active ulcerative colitis (UC) in patients aged 16 years and older. Those eligible for the drug, which is now the first and only oral advanced UC therapy approved in the EU for this patient population, will have had an inadequate response, lost response or been intolerant to conventional therapy or a biological agent. Affecting approximately 2.6 million people in Europe, UC is a chronic, immune-mediated condition where the colon and rectum become inflamed, causing symptoms such as frequent diarrhoea, bowel urgency, rectal bleeding, abdominal pain, fatigue, fever and anaemia. The EC’s decision on Velsipity follows a recommendation from the European Medicines Agency’s human medicines committee in December and was supported by positive results from the late-stage ELEVATE UC registrational programme. The ELEVATE UC 52 and ELEVATE UC 12 studies, which evaluated Velsipity 2mg ...
- Source: drugdu
- 109
- February 23, 2024
MHRA agrees licence change for Pfizer-BioNTech’s Comirnaty vaccine

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for a variation in licence for Pfizer-BioNTech’s 30 micrograms dose of Comirnaty XBB.1.5, a Covid-19 vaccine targeting the Omicron variant. The decision follows the vaccine’s fulfilment of the UK regulator’s safety, quality and effectiveness standards. The latest approval for the single-dose vials allows for the vaccine’s thawing and re-labelling by an authorised manufacturer outside of the UK’s National Health Service (NHS), adhering to good manufacturing practice standards. The NHS previously managed the thawing and distribution of the Comirnaty Omicron XBB.1.5 vaccine centrally. The vaccine requires ultra-low temperature storage at -80°C before it is thawed for usage. MHRA noted that the formulation of the Comirnaty vaccine, approved in September 2023, remains unchanged. The new authorisation by the MHRA is applicable only in Great Britain. The UK regulator also approved Novavax’s Nuvaxovid, an adapted vaccine targeting the Omicron XBB 1.5 ...
- Source: https://www.pharmaceutical-technology.com/news/mhra-licence-pfizer-biontech-vaccine/?cf-view
- 100
- February 13, 2024
Pfizer Teams With American Cancer Society to Reduce Cancer Care Disparities

Pfizer announced a partnership with the American Cancer Society aimed at reducing disparities in cancer treatment. As part of the initiative, Pfizer is providing $15 million in funding. This money will go towards improving the health outcomes of cancer patients from underrepresented communities in the United States. This will include working to improve access to cancer screenings, clinical trial opportunities, and patient care. In a press release, Pfizer’s chief oncology officer and executive vice president Chris Boshoff said, “Cancer doesn’t discriminate–and neither should cancer care. Everyone should have the same opportunity to access the latest advances in care, regardless of their background or where they live. We’re proud to partner with the American Cancer Society on a broad, community-focused initiative to reach people living with cancer where they are, with urgency, and connect them to resources to receive the care they deserve.” The partnership will work under the banner of ...
- Source: drugdu
- 77
- February 8, 2024
Pfizer’s layoff campaign ramps back up with dozens of SF-area cuts expected next month

The start of the new year doesn’t seem to have dulled the zeal of Pfizer’s global cost-cutting campaign, which has already left hundreds of jobs in its wake.Come mid-February, Pfizer will lay off some 52 employees at a facility in South San Francisco, according to a recent Worker Adjustment and Retraining Notification Act (WARN) alert. That address matches the former headquarters of Global Blood Therapeutics, which Pfizer scooped up for $5.4 billion back in 2022. Along with the deal, Pfizer gained GBT’s marketed sickle cell disease drug Oxbryta. “As previously communicated, Pfizer has launched an enterprise-wide cost realignment program,” a Pfizer spokesperson said via email. The program will “result in some job loss across a number of our locations, including South San Francisco,” the spokesperson said.“Pfizer does not take these changes lightly,” she added. GBT’s Oxbryta won FDA approval in sickle cell disease back in 2019. When Pfizer closed its GBT buyout in October 2022, ...
- Source: drugdu
- 159
- January 31, 2024
Pfizer’s Talzenna recommended by NICE for advanced breast cancer

Pfizer’s Talzenna (talazoparib) has become the first targeted treatment to be recommended by the National Institute for Health and Care Excellence (NICE) to treat HER2-negative locally advanced or metastatic breast cancer with BRCA1/2 mutations. Patients eligible for the PARP inhibitor will have previously been treated with anthracycline or taxane chemotherapy, or both, unless these treatments are not suitable. Additionally, those with HR-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for this.NICE’s final draft guidance, which reverses its earlier draft decision not to recommend Talzenna for this patient population, follows Pfizer’s offer of an increased discount of the treatment.The agency estimates that 300 breast cancer patients, who would otherwise be limited to chemotherapy and best supportive care, will benefit from the new recommendation. Stefano Podesta, oncology lead at Pfizer UK, said: “[The] decision is an important milestone for eligible patients with advanced-stage breast ...
- Source: drugdu
- 88
- January 23, 2024
Gearing Up to Challenge Pfizer in a Rare Disease, BridgeBio Secures Up to $1.25B

BridgeBio will receive $500 million in exchange for royalties from sales of acoramidis, a drug currently under FDA review for treating heart complications caused by the rare disease transthyretin amyloidosis. The deal also refinances lending agreements, providing BridgeBio with access to additional capital. By FRANK VINLUAN BridgeBio Pharma is preparing to compete against a blockbuster Pfizer product for a rare disease with few treatment options. A new financing deal provides the company with the capital to support planned commercialization of its drug, which is currently under FDA review. The agreement announced Thursday calls for Blue Owl Capital and Canada Pension Plan Investment Board to pay BridgeBio $500 million cash in exchange for royalties of 5% from sales of the biotech’s drug, acoramidis. The deal provides the Palo Alto, California-based biotech an additional $450 million in committed capital by refinancing its lending agreement with Blue Owl. The company could also receive ...
- Source: drugdu
- 175
- January 20, 2024
Pfizer’s eye for China ADC deals; Astellas’ gastric cancer rejection

Pfizer is still hungry for ADC opportunities, including in the Far East. Astellas’ impressive phase 3 data for its gastric cancer candidate couldn’t garner an approval because of manufacturing issues. Takeda’s 2022 TYK2 buy from Nimbus was highly competitive, an exec said. And more. 1. JPM24: Even after Seagen buyout, Pfizer oncology chief still eyes ADC deals As Pfizer continues its prowl for antibody-drug conjugate (ADCs) deals, the company is keeping an eye on opportunities around the globe. In an interview, Pfizer’s new oncology chief Chris Boshoff, Ph.D., said the company is looking for opportunities in China, which he said “is important in this whole area, especially ADC development.” The company is “not currently looking for big acquisitions,” Boshoff added. 2. Astellas’ gastric cancer candidate rejected by FDA because of manufacturing issues After running two phase 3 trials, Astellas’ near-term approval ambitions for its zolbetuximab have been dashed because of ...
- Source: drugdu
- 141
- January 17, 2024

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