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FDA grants emergency authorisation to Lilly’s COVID-19 antibody combination

February 11, 2021
COVID-19, Eli Lilly

The FDA has granted emergency use authorisation for Eli Lilly’s antibodies bamlanivimab (LY-CoV555) 700mg and etesevimab (LY-CoV016) 1400mg, to be …

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WHO panel recommends AstraZeneca COVID-19 vaccine for over-65s

February 11, 2021
AstraZeneca, COVID-19, WHO

Scientists advising the WHO have recommended the use of the Oxford-AstraZeneca COVID-19 vaccine in all adults, including those aged over …

Accure Therapeutics’ drug candidate can slow epilepsy progression, study shows

February 10, 2021
Research and Development epilepsy

Accure Therapeutics, an R&D pharmaceutical company in the central nervous system (CNS) field, has announced the publication of a pivotal …

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Pharmafile.com’s weekly COVID-19 news round-up

February 10, 2021
Research and Development COVID-19

The past week has seen lots of positive COVID-19 vaccine news; Oxford University and AstraZeneca have announced development of another …

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South Korea approves AstraZeneca COVID-19 vaccine for use

February 10, 2021
Research and Development AstraZeneca, COVID-19

South Korea is to grant first approval for the Oxford University-AstraZeneca vaccine later today, with the rollout expected to start …

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FDA approves Sanofi’s Libtayo for advanced basal cell carcinoma

February 10, 2021
Research and Development Cancer, FDA, Sanofi

The FDA has approved Sanofi’s PD-1 inhibitor Libtayo (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell …

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Janssen announces positive Phase III results for prostate cancer drug apalutamide

February 10, 2021
Research and Development Cancer, Janssen

Final results from Janssen’s Phase III TITAN study have shown its cancer drug apalutamide improved overall survival (OS) in patients …

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Takeda’s breast cancer treatment approved in Scotland

February 9, 2021
Manufacturing and Production Takeda, breast cancer

The Scottish Medicines Consortium has accepted Takeda’s PROSTAP 3 DCS (leuprorelin acetate) treatment for use in patients with early and …

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WHO backs AstraZeneca vaccine against South African variant

February 9, 2021
Manufacturing and Production COVID-19, WHO, vaccines

World health officials have moved to ease concerns over the efficacy of the Oxford University-AstraZeneca vaccine against new variants of …

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AbbVie’s rheumatoid arthritis drug Rinvoq approved for NHS Scotland

February 9, 2021
Manufacturing and Production AbbVie, rheumatoid arthritis

The Scottish Medicines Consortium (SMC) has recommended AbbVie’s rheumatoid arthritis (RA) drug Rinvoq (upadacitinib) for use on the NHS in …

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ViiV’s HIV drug Rukobia gets EC marketing authorisation

February 9, 2021
Manufacturing and Production HIV, ViiV

The European Commission (EC) has authorised ViiV Healthcare’s Rukobia (fostemsavir) 600mg extended-release tablets for use in combination with other antiretroviral …

spravato

Janssen’s esketamine nasal spray gets Europe approval for new indication

February 9, 2021
Manufacturing and Production Europe, Janssen

The European Commission (EC) has authorised the expanded use of Janssen’s Spravato (esketamine nasal spray), co-administered with oral antidepressant therapy in …

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Merck, Pfizer, and 4D pharma join forces for bladder cancer clinical trial

February 8, 2021
Sales and Marketing Cancer, Merck, Pfizer

A clinical trial collaboration between 4D pharma, Merck, and Pfizer to treat locally advanced or metastatic urothelial carcinoma (UC), also …

Researchers make neuroblastoma drug target discovery

February 8, 2021
Sales and Marketing Cancer, GOSH, neuroblastoma

Scientists conducting the largest single cell study to date of the childhood cancer neuroblastoma have made a breakthrough in identifying …

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CureVac enters collaboration with UK government on coronavirus variant vaccines

February 8, 2021
Sales and Marketing COVID-19, CureVac

CureVac has entered a collaboration with the UK government to develop and manufacture potential vaccine candidates against coronavirus variants, with …

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South Africa halts rollout of AstraZeneca’s COVID-19 vaccine amid efficacy concerns

February 8, 2021
Sales and Marketing AstraZeneca, COVID-19

AstraZeneca is racing to adapt its COVID-19 vaccine as new data suggests it offers little protection against the more dominant …

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South Korea approves Celltrion’s COVID-19 treatment Regdanvimab for emergency use

February 8, 2021
Sales and Marketing COVID-19, celltrion

The South Korean Ministry of Food and Drug Safety (MFDS) has granted a conditional marketing authorisation (CMA) for the emergency …

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

February 5, 2021
Medical Communications COVID-19

In the last week, a number of COVID-19 vaccine developments have been made. Johnson & Johnson’s one-shot jab was found …

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New Oxford University-AstraZeneca vaccine against COVID-19 mutations could be available by October

February 5, 2021
Medical Communications AstraZeneca, COVID-19

Oxford University and AstraZeneca could release a new vaccine by October in order to counter the new mutations of COVID-19 …

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