Sound Pharmaceuticals is all set to launch two Phase II clinical trials of an oral capsule, SPI-1005, for treating patients with moderate or severe Covid-19. Developed for various neurotologic, neuropsychiatric, and respiratory indications, SPI-1005 is a capsule with a small…
UNION therapeutics’ Covid-19 candidates meet endpoints in trial
UNION therapeutics has reported that its Covid-19 candidates, inhaled and intranasal niclosamide (UNI91103 and UNI91104), showed a strong safety profile in a Phase I study, meeting the primary endpoints. UNI91103 and UNI91104 are based on a proprietary salt form and…
Syneos Health and Science 37 partner for decentralised trial delivery
Syneos Health has reached a strategic collaboration with Science 37 to enable the delivery of decentralised clinical trials. The integration of Science 37’s technology-first decentralised clinical trial operating system into Syneos Health’s decentralised solutions helps to deliver such clinical trials.…
Pharmaxis to start world-first trial of scar-reducing wound treatment
Australian pharmaceutical research company Pharmaxis has teamed up with the University of Western Australia (UWA) to start a world-first clinical trial to investigate a cream to stop scars forming after trauma, particularly following burn injuries. Australian pharmaceutical research company Pharmaxis…
Launching of Online National Drug Licensing System
In pursuance to implementation of the e-governance, CDSCO has launched various online services. Launching of Online National Drug licensing System (NDLS) portal for issuance of licenses and certificates for Drugs and Cosmetics across country. The system will be shifted from…
CDSCO has not recommended for grant of Permission for Emergency use to Pfizer COVID-19 Vaccine
The SEC committee noted that incidents of Palsy, anaphylaxis and other SAEs have been reported during the post marketing and the causality of the events with the vaccines is being investigated. Further Pfizer has not proposed any plan to generate…
US Pharma giant to set up global R&D headquarters in Ahmedabad
Baxter, a United States-headquartered pharmaceutical giant, will invest around Rs 100 crore to set up its global research and development (R&D) headquarters in Ahmedabad, a senior state government official said. “Baxter, one of the largest pharmaceutical companies with a turnover…
CureVac begins Phase III trial of Covid-19 vaccine candidate
Clinical-stage biopharma company CureVac has announced the initiation of Phase III clinical study of its Covid-19 vaccine, CVnCoV, in healthcare workers at the University Medical Center Mainz, Germany. Clinical-stage biopharma company CureVac has announced the initiation of Phase III clinical…
Boehringer initiates trial of novel SARS-CoV-2 neutralising antibody
Boehringer Ingelheim, Cologne University Hospital (UKK), University of Marburg (UMR) and the German Center for Infection Research (DZIF) have initiated Phase I/IIa clinical investigation of novel SARS-CoV-2 neutralising antibody, BI 767551. Boehringer Ingelheim, Cologne University Hospital (UKK), University of Marburg…
EMA Server Breached, Hackers Steal Pfizer/BioNTech Vaccine Data
LONDON (Reuters) – U.S. drugmaker Pfizer and its German partner BioNTech said on Wednesday that documents related to development of their COVID-19 vaccine had been “unlawfully accessed” in a cyberattack on Europe’s medicines regulator. The European Medicines Agency (EMA), which…
