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Biogen and Eisai’s Alzheimer’s drug receives FDA accelerated approval

An application has also been submitted for US approval under the traditional pathway

- PMLiVE

bluebird bio sells second FDA priority review voucher for $95m

The company sold its first voucher to Dutch biotech Argenx for $102m

- PMLiVE

Merck’s Keytruda meets primary endpoint in phase 3 gastric cancer trial

Gastric cancer is the fourth leading cause of cancer death worldwide

- PMLiVE

Merck to acquire Imago BioSciences in deal worth $1.35bn

The agreement includes lead candidate, bomedemstat, for myeloproliferative neoplasms

- PMLiVE

FDA approves first drug to delay onset of type 1 diabetes

Provention Bio’s Tzield delayed the average onset of type 1 diabetes by over four years

- PMLiVE

FDA approves Seagen’s Adcetris combination for paediatric patients with Hodgkin lymphoma

Patients had a 59% reduction in the risk of disease progression or relapse, second cancer or death

- PMLiVE

Sobi’s Kineret granted FDA Emergency Use Authorisation for COVID-19 related pneumonia

The IL-Ra1 inhibitor was found to reduce the risk of disease progression by 64%

- PMLiVE

Merck’s Keytruda receives NICE recommendation as breast cancer treatment option

Patients will now be able to access immunotherapy at an earlier stage in their treatment journey

- PMLiVE

GSK to submit drug application for new antibiotic to US FDA

Gepotidacin could be the first new novel oral antibiotic treatment for uncomplicated urinary tract infections in over 20 years

- PMLiVE

Merck to donate Sudan Ebola virus vaccine to International AIDS Vaccine Initiative

Around 50,000 doses are expected to be provided for further clinical research use

- PMLiVE

Merck’s Prevymis shows promise in phase 3 cytomegalovirus disease prevention trial

The drug demonstrated non-inferior efficacy compared to standard of care valganciclovir

- PMLiVE

Merck and Bill & Melinda Gates Institute sign licensing agreement for tuberculosis candidates

The non-profit will determine their potential for inclusion in new affordable treatment regimens

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