Pfizer and BioNTech submit proposal to US FDA to expand COVID-19 vaccine trial
The companies expect that a conclusive readout on efficacy is likely by the end of October
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Clinical trials of AstraZeneca-Oxford COVID-19 vaccine candidate resumes in UK
This is following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so
PNB Vesper gets DCGI nod to test proprietary drug PNB 001 in COVID-19 patients
A study will be conducted on 40 moderately-ill COVID-19 patients at BMJ Medical College, Pune who are on oxygen support
KSRPO asks government to bring in centralised drug enforcement department
Highlights need for uniformity in designations and functioning mechanisms of all state FDAs
DCGI instructs industry to follow defined pathways for application submission of rational FDCs
It gives six months to the manufacturers to submit the applications
DCGI issues notice to Serum Institute over AstraZeneca-Oxford COVID-19 vaccine trial suspension
If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocol, said SII in response to…
TN’s industrial policy shall offer specific higher incentives for sunrise sectors
Dr Neeraj Mittal, MD & CEO, Guidance, Industries Department, Government of Tamil Nadu showcases how the State is an ideal…
Kerala FDA raids premises of firm making illegal hand sanitisers
Officials seize materials, finished formulations and equipment worth Rs six lakhs
US FDA issues warning to Mylan for Telangana plant
It has also recommended the company to engage a cGMP Consultant
US FDA releases guidance to detect and prevent nitrosamines in drugs
It recommends steps, including a comprehensive risk assessment strategy and other actions
Plans to revamp D&C Act 1940, launch Sugam portal Version II: Dr Eswara Reddy
The CDSCO is also making a list of government facilities for R&D and innovation and will be making it available on their…
Only drug inspectors can probe, file FIRs for certain cognizable offences under D&C Act 1940:…
Industry experts and regulators appreciate judgement but seek clear SOPs for implementation
US FDA broadens EUA for Veklury (remdesivir) to treat all hospitalised COVID-19 patients
The expansion is supported by the FDA’s analysis of additional data from two randomised, controlled clinical trials that included…
Himachal Pradesh raises concerns over bulk drug park evaluation criteria
Reportedly, other hilly, landlocked states share similar concerns
India’s proposed new agile pharma regulations will benefit innovator companies: GlobalData
This could mean accelerated access of multiple novel therapies and vaccines for Indian patients
NPPA to fully automate ecosystem for applications
Also outlines timelines for disposal of received applications
Govt likely to announce short term incentive scheme, excipient makers may get benefit
DoP officials are formulating the guidelines
Intas gets DCGI nod for clinical trials of hyperimmune globulin for COVID-19 treatment
It can be an important therapeutic option that can potentially help combat the disease until a vaccine is available, states the…
US charges Teva in price-fixing investigation of generic drugs
The Justice Department has been investigating allegations the company colluded with other drugmakers to push up the prices of…
Merck files petition in US court against Aurobindo Pharma for Janumet
In June, Merck had filed a petition against Dr Reddy's Laboratories in a US court over similar patent issues on Janumet and…