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The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended eight drugs for approval, including Vertex Pharmaceuticals’ triple combination therapy for treatment of cystic fibrosis. Read More
The FDA hit AbbVie with a complete response letter (CRL) for abicipar pegol, its investigational drug for treatment of wet age-related macular degeneration. Read More
The Coalition for Epidemic Preparedness Innovations (CEPI) has partnered with the Stevanato Group to help solve a serious problem facing vaccine manufacturers as they scale up production — a global shortage of glass vials. Read More
China has approved phase 1 trials of a COVID-19 vaccine candidate being developed by the country’s military in collaboration with two Chinese companies. Read More
The World Health Organization (WHO) has unveiled a plan to deliver 2 billion doses of COVID-19 vaccines to low- and middle-income countries by the end of 2021, but says it needs almost $28 billion to help fund the initiative, which also includes therapeutics and diagnostics. Read More
The FDA has approved Merck’s Keytruda (pembrolizumab) for patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation. Read More
AstraZeneca released full results from a phase 3 trial of its triple combination inhaled therapy Breztri Aerosphere in moderate to severe chronic obstructive pulmonary disease (COPD) patients, finding that it significantly reduced the rate of flare ups compared to two other combination treatments. Read More
As the race to develop an effective COVID-19 vaccine by year’s end gains momentum, the FDA said it plans to issue a guidance on developing and licensing them. Read More