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Pharmafile 09/22/2020 07:16
MSD took the opportunity at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 to unveil new Phase 3 efficacy data for its anti-PD-1 therapy Keytruda (pembrolizumab) in the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients with PD-L1-positive tumours with no EGFR or ALK genomic aberrations.
Pharmafile 09/21/2020 08:04
New data from two studies investigating the combination of Eisai’s multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib) and MSD’s blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) were revealed at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. In the first study, the combo was found to generate an objective response rate (ORR) of 21.4% in the treatment of unresectable or advanced melanoma which has progressed following anti-PD-1/PD-L1 therapy, representing 22 out of 109 patients.
Pharmafile 09/21/2020 07:54
AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation across the European Union for the first-line maintenance treatment with bevacizumab for patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer. This came after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave the recommendation based on a positive opinion of the PAOLA-1 Phase 3 trial which was published in The New England Journal of Medicine . Image caption:. Photo by D Wells.
Pharmafile 09/21/2020 07:49
Acella Pharmaceuticals is recalling two types of its thyroid medication as the drugs may be too weak to properly treat those who take them. This follows a similar recall of thyroid medications that was issued by the FDA in recent weeks. Acella’s two drugs are NP Thyroid 15 and NP Thyroid 120, which are sold in 15mg and 120mg strengths, and they contain both the T3 and T4 hormones for those who are able to be treated with synthetic T4 hormone. They have contacted wholesalers by email and phone to discontinue distribution of these two treatments. Image caption:. Photo by Adam from UK.
Pharmafile 09/21/2020 07:44
The Centers for Disease Control and Prevention has identified nearly 11,000 people who were potentially exposed to coronavirus while flying. This comes after the CDC investigated 1,600 people who flew while at risk of spreading COVID-19. The agency says that a significant amount of the people exposed fell ill with the virus, but there could be more cases due to incomplete contact tracing information and the virus incubating over several days. Image caption:. Photo by Solitude
Pharmafile 09/18/2020 07:17
Promising Phase 2 data has been released at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 for Sanofi and Regeneron’s jointly-developed PD-1 inhibitor Libtayo (cemiplimab) in the treatment of locally advanced basal cell carcinoma (BCC) in patients for whom hedgehog inhibitor (HHI) therapy is not applicable. The presented findings revealed that patients receiving the therapy showed an objective response rate of 31% after a median follow-up of 15 months, including a partial response rate of 25% and a complete response rate of 6%, regardless of baseline tumour.
Pharmafile 09/18/2020 07:10
Around one in seven patients who have received Russia’s vaccine against COVID-19 have displayed side-effects in clinical studies, according to the country’s Health Minister. Russian Minister of Health Mikhail Murashko told journalists on 15 September that, so far, more 300 people have been vaccinated with Sputnik V, with 14% displaying undesirable side-effects.
Pharmafile 09/18/2020 04:24
The top ten news stories this week centre around coronavirus vaccines, with Russia signing a deal with an Indian pharma firm to test and deliver 100 million doses of its controversial Sputnik V vaccine while the illness of one of the participants in the Oxford-AstraZeneca vaccine trial may not have been caused by the treatment itself, according to newly revealed information.
Pharmafile 09/17/2020 07:21
Novartis has unveiled promising new Phase 3 data for its combination of Tafinlar (dabrafenib) with Mekinist (trametinib) in the treatment of resected, stage 3 BRAF V600-mutated melanoma. The data was published in The New England Journal of Medicine following their presentation at the 2020 ASCO Virtual Scientific Programme. It was found that 52% of patients receiving the combo therapy survived relapse-free for five years, while only 36% of placebo patients achieved the same.
Pharmafile 09/17/2020 07:14
NICE has announced its recommendation of Bristol-Myers Squibb’s blockbuster immunotherapy drug Opdivo (nivolumab) for the treatment of two non-small cell lung cancer (NSCLC) indications in the second-line, it has emerged. Currently, chemotherapy or a PD-1/PDL-L1 inhibitor is used as standard first-line treatment of locally advanced NSCLC, with Opdivo recommended only as a treatment for patients who have received chemotherapy.
Pharmafile 09/17/2020 07:12
The illness of one of the participants in the Oxford-AstraZeneca COVID-19 vaccine trial may not have been caused by the treatment itself, according to newly revealed information. The University of Oxford sent a document to other participants on the trials which said: "After independent review, these illnesses were either considered unlikely to be associated with the vaccine or there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine.".
Pharmafile 09/17/2020 07:09
The Trump administration has laid out its strategy to distribute COVID-19 vaccines for free across the US. The Department of Health and Human Services (HHS) and the Department of Defense (DoD) coordinated with the Centers for Disease Control and Prevention (CDC) to release documents that outline what steps they will take to ensure all states have access to potential vaccines. They organisations have laid out the four tasks necessary for a successful COVID-19 vaccine programme:. Image caption:. Photo by Gage Skidmore from Peoria, AZ, United States of America.

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