(RTTNews) – Today’s Daily Dose brings you news of the EMA’s research of AstraZeneca AZD1222’s COVID-19 vaccine in blood clot reports, Intec Pharma’s planned announcement dating from Decoy Biosystems, which fosters Solid Biosciences’ knowledge of the DMD trial, Regeneron Pharmaceuticals Inc. (REGN) and Sanofi Phase III trial (SNY) of Libtayo monotherapy in cervical cancer, and encouraging Rubius’ initial knowledge of his ongoing phase I/II clinical trial of RTX-240 in patients with complex forged tumors.
Read. . .
1. The EMA Safety Committee shall read in more detail the thrombotic occasions of the COVID-19 AstraZeneca vaccine.
With several Countries in the European Union temporarily postponing vaccination with the COVID-19 vaccine of AstraZeneca AZD1222 due to reports of blood clots in other people receiving the vaccine, the European Medicines Agency is proceeding with the investigation.
Ann Taylor, medical director of AstraZeneca, said: “Approximately 17 million more people in the EU and the UK have won our vaccine, and the number of cases of blood clots reported in this organisation is lower than expected. the general population. ” To date, in the EU and the UK, 15 times of deep vein thrombosis and 22 times of pulmonary embolism have been reported among those who won the vaccine.
The Pharmacovigilance Risk Assessment Committee, the EMA Protection Committee, is in a position to conduct an additional review of the data on Tuesday and an ordinary assembly should be convened on Thursday to conclude on the accumulated data and additional actions that may be necessary.
AZD1222, now called the COVID-19 AstraZeneca vaccine, approved for emergency use in the UK on 30 December 2020. La vaccine, developed through AstraZeneca and the University of Oxford, is also approved for emergency use in India, Argentina and the Dominican Republic. Republic, El Salvador, Mexico and Morocco.
AstraZeneca has partnered with the Serum Institute of India (SII), the world’s most giant vaccine manufacturer, for the vaccine for the Indian government and also for a giant number of low- and middle-income countries. In India, the COVID-19 AstraZeneca vaccine is known as Covishield.
2. Intec to mix with decoy
Intec Pharma Ltd. (NTEC) has signed a definitive agreement for a commercial mix with Decoy Biosystems Inc. , a prectinical biotechnology company.
Following the merger, Decoy’s former shareholders are expected to own approximately 75% of the merged company and Intec shareholders are expected to own approximately 25% of the merged company. The merger is expected to close in the third quarter of 2021, subject to approval by corporate shareholders.
NTEC closed Monday at $5. 96, an increase of 29. 85%.
Solid Biosciences Inc. (SLDB) on Monday reported knowledge on efficacy and protection of its ongoing IGNITE DMD trial in SGT-001 and the resumption of the patient’s dose in the trial in accordance with its modified clinical protocol and SGT-001 manufactured with a second generation device. . Treat.
IGNITE DMD is a phase I/II examination of the treatment of the SGT-001 microditrophin gene in patients with Duchenne muscular dystrophy. The IGNITE DMD trial suspended through the FDA in November 2019 following a case of a serious adverse occasion considered similar to the drug under FDA suspension was lifted last October.
The provisional knowledge of six IGNITE DMD patients provides evidence of the potential advantages of SGT-001 in service parameters such as North Star outpatient testing (NSAA), 6-minute gait test (6MWT), pulmonary control function (PFT), and clinically validated measurements of final patient-informed results (PROM), according to the company.
With the resumption of the patient’s dose in the IGNITE DMD trial, Patient 7 has become the first patient to obtain a dose of IGNITE DMD under an amendment to the clinical protocol reported in the past and SGT-001 manufactured with a second generation procedure.
SLDB closed Monday trading at $9. 51, a drop of 0. 11%. Outside of business hours, inventory dropped by approximately 16% to $8. 00.
4. The Regeneron/Sanofi cervical cancer trial stopped to take advantage of its advantages
Libtayo’s Phase III trial of Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNY) alone in relation to chemotherapy in complex cervical cancer was discontinued prematurely following a positive result in overall survival.
In the Phase III trial, Libtayo advanced the overall survival of cervical cancer patients, reducing the death threat by 31% to chemotherapy.
Regeneron has net sales of Libtayo products in the United States, while Sanofi has net sales of Libtayo products outside the United States. The drug had total annual sales of $348. 2 million in 2020, up from $193. 8 million in 2019.
REGN closed on Monday at $483. 94, an increase of 2. 65%.
5. Rubius Sparkles on RTX-240 data
Rubius Therapeutics Inc. (RUBY) rose more than 80% on Monday after encouraging initial knowledge about the protection and efficacy of its ongoing Phase I/II clinical trial of RTX-240 in patients with complex forged tumors.
The company plans to launch a Phase 2 expansion cohort in the first quarter of 2022 and a new Phase 1 arm from the ongoing RTX-240 clinical trial to compare RTX-240 in mixture with anti-PD-1 treatment in patients with counterfeit tumors at the time part of 2021.
In addition, Rubius announced that it had introduced a $150 million public offering of shares into its non-unusual shares. The company also intends to give subscribers a 30-day option to acquire up to 15% more of the shares in its non-unusual shares. sold as a component of public provision.
RUBY closed Monday at $30. 29, up 84. 36%.
6. Actions that have reached a new high
Amneal Pharmaceuticals Inc. (AMRX) closed at $6. 98, an increase of 15. 95%.
Soliton Inc. (SOLY) closed at $16. 71, an increase of 13. 44%.
Community Health Systems Inc. (CYH) closed at $12. 7, an increase of 12. 68%.
Gemini Therapeutics Inc. (GMTX) closed at $18. 00, an increase of 5. 88%.