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Delayed Pfizer vaccine dose gives 3.5 times more immunity, study shows

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The Pfizer-BioNTech COVID-19 vaccine is around three and a half times more effective when dosed 12 weeks apart, a Birmingham University study has shown.

AstraZeneca and Amgen asthma drug shows positive results in Phase III trial

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AstraZeneca and Amgen’s new tezepelumab drug for the treatment of severe asthma has shown superiority across all primary and secondary endpoints in a Phase III trial.

India report record number of COVID deaths as bodies drift down Ganges

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Image Credit: Pexels/Still Pixels

India yesterday reported the country’s highest COVID-19 death total for a single day, with 4,205 fatalities officially confirmed.

Astellas prostate cancer drug gets third approval from MHRA

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The MHRA has approved Astellas Pharma’s XTANDI (enzalutamide) drug for the treatment of a third form of prostate cancer, making it the only oral therapy approved by the agency for three different types of the illness.

Bayer’s cardiovascular drug shows impressive Phase III results

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Bayer’s finerenone drug has been shown to significantly reduce cardiovascular death or other cardiovascular events in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), according to results from a Phase III trial.

NICE rejects Merck Serono’s Bavencio for urothelial cancer

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The use of avelumab for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy is not recommended by NICE following an announcement on May 6.

EMA begin review of GSK & Vir COVID-19 treatment

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The EMA has begun a rolling review of GSK and Vir’s sotrovimab treatment for COVID-19, which will continue until there is enough evidence available for a marketing authorisation application for the drug.

Pfizer commences process for full FDA approval of COVID-19 vaccine

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Pfizer and BioNTech have begun a Biologics Licence Application (BLA) with the FDA for full approval of their mRNA COVID-19 vaccine in the US in people aged 16 years or older.

Pharmafile.com's top 10 news stories of the week

Pharmafile's top 10 news roundup

Among our ten most-read stories this week: NICE has announced that more patients are eligible for a £75,000-a-vial SMA drug, while Celltrion’s COVID-19 treatment has shown promise against the South African variant of the virus; elsewhere, GSK’s lupus treatment has been approved by the European Commission.

Merck kidney and uterus cancer treatments granted priority review by FDA

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The FDA has granted priority review for Merck (MSD) and Eisai’s application for two new approvals for the combination of Merck’s KEYTRUDA and Eisai’s LENVIMA for the treatment of certain kidney and uterus cancers. 

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