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Biogen Files New Drug Application for Aducanumab in Japan

Biogen and Eisai, Co., Ltd. announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. Aducanumab, an amyloid beta-targeting antibody, has...

U.S. Government Exercises 1st Option for Additional 100 Million Doses of Moderna’s COVID-19 Vaccine Candidate

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that the U.S. government has exercised its option to purchase an additional 100 million doses of...

AstraZeneca reports Trixeo Aerosphere approved in EU for COPD maintenance

AstraZeneca’s Trixeo Aerosphere has been approved in the European Union (EU) for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS)...

SpiceXpress strengthens pharma cold chain capabilities with Om partnership

SpiceXpress, the cargo division of India-based carrier SpiceJet, has partnered with Om Logistics to strengthen its capabilities to transport temperature-sensitive Covid-19 vaccines. The carrier said the partnership aims to provide a “speedy, seamless and reliable solution” for the movement of...

Sanofi, GSK COVID-19 vaccine rollout delayed on low immune response in older adults

Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in older adults. Phase 1/2 study interim results showed an immune response comparable to patients who recovered from COVID-19 in adults...

CHMP recommends approval of Plavix with aspirin in adults for certain types of strokes

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an additional indication for Plavix® (clopidogrel) in adult patients with high-risk transient ischemic attack (TIA) or minor ischemic stroke (IS). This...

Astrazeneca To Test Combining COVID-19 Vaccine With Russian Shot

Britain's AstraZeneca said on Friday it would investigate combining its experimental COVID-19 vaccine with Russia's Sputnik V vaccine candidate, a move Russian scientists have suggested could sharply boost efficacy. The developers of Sputnik V suggested on Twitter last month that...

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