Search Results for “FDA” – Page 157 – media

The New CRISPR-Based Covid-19 Test Could Be a Game-Changer

A new test based on gene targeting technology CRISPR could diagnose Covid-19 infections in 45 minutes. It was recently outlined in a paper in the journal Nature Biotechnology.
- Source: drugdu
- 1,536
- August 26, 2021
Covid-19 Covid-19 Test gene targeting technology
China’s Import and Export Market Report of Rheumatoid Arthritis Drugs

Rheumatoid arthritis (RA) is an autoimmune disease with complex pathogenesis and an extremely high morbidity rate, which seriously affects the quality of the life of patients and brings economic burden to society. Thus, effective treatments of RA has become a global concern of the pharmaceutical industry.
- Source: Ddu
- 3,909
- August 26, 2021
Ddu College Market Reports RA
Ddu College——WHO vaccine pre-certification How to conduct effective consultation?

From November 1st to 2nd, 2018, the annual World Health Organization (WHO) Prequalification (PQ) consultation will be held in Kunming, China. Unlike previous years, this year’s consultation will only take the one-on-one format, namely the World Health Organization Vaccine Pre-Certification Review Team and small meetings of various domestic vaccine manufacturers. Although the part of the centralized consultation meeting will be cancelled, which means companies and international organizations are unable to discuss and share the importance of pre-certification, but it’s believed that after several years of consultations, everyone has already cooked up the importance and significance of pre-certification. Evidence? This year’s 14 vaccine manufacturers actively participate in the one-on-one consultation is the best proof. As of November 2018, there were 4 manufacturers and vaccines that successfully passed the pre-certification of vaccines in China, namely, Chengdu institution’s Yinao, Hualan’s Liugan, Kexing’s Miejia and Beishengyan’s bOPV. At the PQ consultation meeting in Beijing ...
- Source: drugdu
- 1,492
- August 25, 2021
Ddu College：Pharmacovigilance

Pharmacovigilance,A discipline that collects, monitors, researches, and evaluates information about health care providers and patients regarding to the adverse drug reactions , biological products, herbs, and traditional medicine.
- Source: Ddu
- 2,072
- August 24, 2021
US approves Pradaxa as oral blood thinning med for children

The Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Pradaxa as the first oral blood thinning medication to treat children aged three months to less than 12 years old in the US. The FDA has cleared Pradaxa (dabigatran etexilate) for use in children with venous thromboembolism, immediately after treatment with a blood thinner given by injection for at least five days. Pradaxa oral pellets have also been approved to prevent recurrent clots among children aged three months to less than 12 years old, who have complete treatment for their first venous thromboembolism. Lastly, the drug has been approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism, directly after they have been treated with a blood thinner given for at least five days, and to prevent clots in patients aged eight years and older who have completed treatment for their first venous ...
- Source: drugdu
- 165
- June 23, 2021
Pradaxa
Gilead’s Trodelvy scores accelerated approval in advanced bladder cancer

Gilead’s antibody drug conjugate (ADC) Trodelvy has received an accelerated approval from the US Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic urothelial cancer (UC), the most common form of bladder cancer. The approval covers the use of Trodelvy (sacituzumab govitecan-hziy) in patients with advanced UC who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. Trodelvy was approved on the basis of results from Gilead’s Phase II TROPHY study, which evaluated the drug as monotherapy or as a combination therapy in patients with metastatic UC after progression on a platinum-based chemotherapy and PD-1/L1 inhibitor. In 112 patients who were evaluable for efficacy, 27.7% of those who were treated with Trodelvy responded to treatment, with 5.4% experiencing a complete response and 22.3% experiencing a partial response. The study also found a median duration of response of 7.2 months for those treated ...
- Source: drugdu
- 174
- April 15, 2021
bladder cancer
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
- 350
- 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
- 352
- 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
- 216
- 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
- 254
- December 8, 2020
RET thyroid cancer

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