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Pfizer’s Paxlovid™ can be used for the treatment of COVID-19, says EMA
New European Medicines Agency advice states Paxlovid™ can be used to treat those at high risk of developing severe COVID-19 symptoms.
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Future proofing risk assessment: preventing the next nitrosamine incident
The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
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Gene therapy sustains bleeding control in haemophilia A trial
Giroctocogene fitelparvovec had a mean annualised bleeding rate (ABR) of just 1.4 percent over two years, with no bleeding events in the first year post infusion.
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Six COVID-19 boosters are safe and effective, shows Phase II study
Study finds six different COVID-19 vaccine boosters increase immunity and pose no safety concerns, although immune responses varied.
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CHMP issue positive opinion on Comirnaty® for five to 11 year olds
The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.
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Pfizer and MPP to expand COVID-19 oral antiviral treatment access
The license agreement between Pfizer and the Medicines Patent Pool (MPP) will enable access to Pfizer's antiviral candidate in 95 countries.
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Oral antiviral candidate Paxlovid™ reduces COVID-19 risks by 89 percent
Paxlovid™, Pfizer's investigational oral antiviral candidate, displayed an 89 percent reduction in COVID-19 risks in Phase II/III study.
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Energize initiative to boost renewable energy access for pharma suppliers
The Energize programme will allow 10 big pharma companies to engage with renewable energy suppliers and address their greenhouse gas emissions.
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FDA joins Bespoke Gene Therapy Consortium (BGTC) for rare diseases
The consortium also consists of 10 pharmaceutical companies and five organisations to accelerate gene therapies to treat rare diseases.
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Comirnaty® booster dose displays high efficacy in Phase III study
The vaccine showed a relative vaccine efficacy of 95.6 percent and is the first efficacy results from a COVID-19 vaccine booster trial.
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Indian active pharmaceutical ingredients market to grow by 12.24 percent
The Indian active pharmaceutical ingredients (APIs) market stood at $11.8 billion in 2021 and continues to grow, says market report.
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Promising Phase II results for Lyme disease vaccine candidate
Valneva and Pfizer’s Lyme disease vaccine VLA15 displayed a seroconversion rate of 100 percent for all OspA serotypes in Phase II study.
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FDA authorises Comirnaty® booster dose for certain populations
The US FDA amended the emergency use authorisation to allow for a Comirnaty booster dose in individuals at high-risk for COVID-19.
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Xtandi® reduces prostate cancer death risk by 34 percent
Xtandi reduced the risk of death by 34 percent in men with metastatic hormone sensitive prostate cancer in a Phase III study.
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Comirnaty® effective in children aged five to 11 years
Positive results from pivotal trial show that the COVID-19 vaccine Comirnaty is safe and effective in children aged five to 11 years old.
