Search Results for “FDA” – Page 161 – media

Positive results for Pfizer/BioNTech’s COVID-19 vaccine in 12-15 year olds

Pfizer and BioNTech have revealed positive top-line data for their COVID-19 vaccine – BNT162b2 – in adolescents aged 12 to 15 years old. The vaccine demonstrated 100% efficacy in a Phase III trial in adolescents aged 12 to 15 years old, with or without prior evidence of SARS-CoV-2 infection. BNT162b2 also produced ‘robust’ antibody responses in the younger population, exceeding those reported in an earlier trial in participants aged 15 to 25 years old. The jab was also found to be well tolerated in the 12 to 15 age group. The companies are now planning to submit the data to the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA) to extend the use of the vaccine for this age group ‘as quickly as possible’. Pfizer and BioNTech will also continue to monitor the participants for long-term protection and safety for an additional two years after their ...
- Source: drugdu
- 359
- April 2, 2021
Covid-19 vaccine
Aimmune’s peanut allergy med Palforzia wins EU approval

The European Commission (EC) has approved Aimmune Therapeutics’ Palforzia, making it the first treatment for peanut allergy in the EU, according to the firm. Following the EC approval, Palforzia will be available to patients aged four to 17 years with a confirmed diagnosis of peanut allergy. It is not, however, indicated for the treatment of allergic reactions – including anaphylaxis – and must be used in conjunction with a peanut-avoidant diet. The drug can also be continued in patients aged 18 years or older, Aimmune added in a statement. The EC approval was based on a data package including two phase III clinical trials – PALISADE and ARTEMIS. Across both studies, Palforzia treatment led to a significant increase in the amount of peanut protein tolerated in participants with peanut allergy, compared to placebo. “Today’s approval is a historic moment for the millions of people living with potentially life-threatening peanut allergy, ...
- Source: drugdu
- 357
- December 22, 2020
Peanut allergy
Janssen eyes US approval for EGFR-targeting NSCLC therapy

4th December 2020 Janssen has submitted an application the US Food and Drug Administration (FDA) seeking approval for its non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 mutations therapy amivantamab. Amivantamab is a bispecific antibody designed to target EGFR and mesenchymal epithelial transition factor (MET) mutated tumours. The FDA submission is based on results from the monotherapy arm of Janssen’s phase I CHRYSALIS study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib, a third generation EGFR tyrosine kinase inhibitor (TKI). An overall response rate (ORR) of 36% was observed in all NSCLC patients and 41% in patients with previously treated with platinum-based chemotherapy. In addition, the median duration of response for all evaluable patients was ten months and seven months for patients previously treated with platinum-based chemoterhapy. The median progression-free survival was 8.3 months for all patients and ...
- Source: drugdu
- 221
- December 11, 2020
NSCLC therapy
Genentech’s Gavreto scores US approval for RET thyroid cancer

4th December 2020 Roche’s Genentech division and its partner Blueprint Medicines have scored a new approval for Gavreto in the US for the treatment of RET-altered thyroid cancer. The US Food and Drug Administration (FDA) has cleared Gavreto (pralsetinib) for the treatment of adult and paediatric patients with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancer. Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations. This newest approval is based on results from the phase I/II ARROW study, in which treatment with Gavreto led to an overall response rate (ORR) of 60% in 55 people with previously-treated RET-mutant metastatic medullary thyroid cancer (MTC). In addition, Gavreto treatment led to an ORR of 66% in 29 people with RET-mutant advanced MTC who had not been previously treated with cabozantinib and vandetanib. Around 10-20% of people with papillary thyroid cancer have RET-fusion positive ...
- Source: drugdu
- 266
- December 8, 2020
RET thyroid cancer
Moderna’s Phase 3 COVE study for its COVID-19 vaccine

30 November 2020 The Phase 3 COVE trial is a randomized, 1:1 placebo-controlled study testing mRNA-1273 at the 100 µg dose level in 30,000 participants in the U.S., ages 18 and older. The primary endpoint is the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2. The trial will continue to accrue additional data relevant to safety and efficacy even after an EUA is submitted. The final estimates of vaccine efficacy for both primary and secondary endpoints will depend on the totality of data that will accumulate to inform the final analysis. Moderna worked closely with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under Operation Warp Speed. Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has ...
- Source: drugdu
- 160
- December 1, 2020
Covid-19 vaccine
How do Coronavirus Antibody Tests Work?

The coronavirus antibody test is performed to determine the blood level of antibodies that are developed against the virus. This test determines if a person was infected by a coronavirus in the past. Image Credit: joel bubble ben/Shutterstock.com What is coronavirus? Coronaviruses are a group of viruses that cause respiratory infections in humans. The infections can range from mild (common cold) to severe (Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS)). Importantly, coronavirus disease 2019 (COVID-19) is a severe, highly infectious disease caused by very recently identified coronavirus namely severe acute respiratory syndrome coronavirus 2 (SARS-CoV 2). How coronavirus is detected in COVID-19 patients? Presently, two types of viral tests are approved by the U.S Food and Drug Administration (FDA): molecular test and antigen test. In molecular tests, the viral genetic material is detected using polymerase chain reaction (PCR). The test is done using biological fluid collected from ...
- Source: drugdu
- 175
- November 25, 2020
Covid-19
‘We will be ready to distribute within hours of authorization’

The companies announced the conclusion of the vaccine’s Phase 3 trial earlier this week: reporting 95% efficacy. They also announced that they had gathered the two months of safety data required by the US’ Food and Drug Administration (FDA) for a Emergency Use Authorization (EUA) submission. Dr. Albert Bourla, Pfizer Chairman and CEO, said: “Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.” Other regulatory submissions will follow ‘immediately’ Pfizer and BioNTech have already started rolling reviews of the ...
- Source: drugdu
- 401
- November 23, 2020
Covid-19 vaccine
PFIZER AND BIONTECH ANNOUNCE VACCINE CANDIDATE AGAINST COVID-19 ACHIEVED SUCCESS IN FIRST INTERIM ANALYSIS FROM PHASE 3 STUDY

Monday, November 09, 2020 – 06:45am Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis Analysis evaluated 94 confirmed cases of COVID-19 in trial participants Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201109005539/en/ NEW YORK & MAINZ, GERMANY–(BUSINESS WIRE)– Pfizer Inc. (NYSE: ...
- Source: drugdu
- 1,240
- November 10, 2020
Covid-19 Pfizer
Enhertu granted Priority Review in the US for the treatment of HER2-positive metastatic gastric cancer

Only HER2-directed medicine to demonstrate significant improvement in overall survival compared to chemotherapy for previously treated patients in this setting AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that offer significant advances over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, will be during the first quarter of 2021. There are more than 27,000 new cases of gastric cancer in the US each year, of which approximately one in five are HER2 positive.1,2 For patients with metastatic gastric cancer who progress ...
- Source: drugdu
- 319
- November 4, 2020
gastric cancer
Bayer to acquire Asklepios Bio in foray into gene therapy worth up to $4 billion

By Ludwig Burger FRANKFURT (Reuters) – Bayer <BAYGn.DE> agreed to acquire unlisted U.S. biotech firm Asklepios BioPharmaceutical Inc for as much as $4 billion in a bet on gene therapy with the help of modified viruses. Germany’s Bayer will pay $2 billion upfront and up to an additional $2 billion in milestone payments contingent on development achievements, it said on Monday. The North Carolina-based takeover target, also known as AskBio, is trying to use the harmless adeno-associated virus as a delivery device to bring genetic repair kits against a range of diseases into the body.Drugs and farming pesticides maker Bayer needs to upgrade its drug development pipeline amid a weaker outlook for agricultural sales and as it seeks to finalise an $11 billion settlement over claims its Roundup weedkiller causes cancer. Among AskBio’s most advanced projects are early tests on volunteers of prospective treatments against Pompe disease – a ...
- Source: drugdu
- 283
- November 2, 2020
Gene therapy

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