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New treatment could extend survival in amyotrophic lateral sclerosis patients

October 20, 2020
Manufacturing and Production, Research and Development als, pharma

Research into an experimental drug combination shows that it could potentially extend the lives for sufferers of amyotrophic lateral sclerosis …

News
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FDA grants priority review to AstraZeneca’s Tagrisso as an adjuvant for early-stage EGFR-mutated non-small cell lung cancer

October 20, 2020
Manufacturing and Production, Sales and Marketing AstraZeneca, FDA, Tagrisso

The FDA has revealed its decision to grant Priority Review to AstraZeneca’s Tagrisso (osimertinib) as an adjuvant treatment of patients …

News
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EMA’s CHMP recommends conditional approval for Kite Pharma’s CAR T therapy for mantle cell lymphoma

October 20, 2020
Manufacturing and Production, Sales and Marketing CAR T, CAR-T, CHMP, EMA, kite pharma, lymphoma

Kite Pharma’s anti-CD19 chimeric antigen receptor (CAR) T cell therapy known as KTE-X19 has received positive recommendation from the EMA’s …

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European Commission stands by €1bn remdesivir supply deal despite disappointing COVID-19 benefit

October 19, 2020
Manufacturing and Production, Sales and Marketing COVID-19, Europe, Gilead, remdesivir

As Europe continues to face down a rising second wave of COVID-19, the European Commission quickly moved to secure a …

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Pfizer won’t apply for COVID-19 vaccine emergency authorisation until after US election, CEO says

October 19, 2020
Sales and Marketing COVID-19, Pfizer, US, Vaccine

The Chief Executive Officer of Pfizer has said that the company will now submit their vaccine for FDA Emergency Use …

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UK life sciences industry does not want no-deal Brexit, says ABPI Chief

October 19, 2020
Sales and Marketing ABPI, EU, UK, brexit, pharma

Prime Minister Boris Johnson’s sudden change of position that the UK is now expecting a no-deal scenario with the European …

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Sanofi’s Dupixent chalks up CHMP recommendation for paediatric severe atopic dermatitis

October 19, 2020
Sales and Marketing Dupixent, EMA, Sanofi, atopic dermatitis

Sanofi’s interleukin-4 and -13 inhibitor Dupixent (dupilumab) has been given the recommendation of the European Medicines Agency’s Committee for Medicinal …

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CHMP recommendation for Janssen’s Tremfya in active psoriatic arthritis

October 19, 2020
Sales and Marketing CHMP, EMA, Janssen, Tremfya

Janssen’s interleukin (IL)-23 inhibitor Tremfya (guselkumab) has scored a recommendation from the EMA’s Committee for Medicinal Products for Human Use …

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FDA approves Venclexta combo in acute myeloid leukaemia, despite it missing main study goal

October 19, 2020
Sales and Marketing AbbVie, FDA, Roche, Venclexta, pharma

The FDA has given approval to AbbVie and Roche’s jointly-developed BCL-2 inhibitor Venclexta (venetoclax) in combination with azacitidine, decitabine, or low-dose …

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NICE approves Sanofi’s Sarclisa combo for relapsed/refractory multiple myeloma

October 16, 2020
Medical Communications, Sales and Marketing NICE, Sanofi, Sarclisa, multiple myeloma

Sanofi’s Sarclisa (isatuximab) has secured a recommendation from NICE for routine use on the NHS in England and Wales as …

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Gilead’s remdesivir and three other repurposed drugs have no impact on COVID-19 mortality, WHO study finds

October 16, 2020
Medical Communications, Research and Development COVID-19, pharma, remdesivir

Gilead’s antiviral therapy remdesivir has emerged as one of the most promising drugs to treat COVID-19 infections, but recent studies …

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Five-year-old girl that was part of Lysogene’s gene therapy clinical trial dies

October 16, 2020
Medical Communications

A five-year-old girl had died while taking part in Lysogene’s clinical trial investigating its gene therapy. The child was suffering …

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‘Long COVID’ could be taking four different forms

October 16, 2020
Medical Communications coronavirus, covid symptoms, long covid, symptoms

People experiencing chronic illnesses after COVID-19 infections could be suffering from one of four separate conditions, according to new research. …

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Top Ten most popular articles on Pharmafile.com this week

October 16, 2020
Medical Communications COVID, herd immunity, top ten, top ten articles

The top ten news stories this week focus on herd immunity, as the Director of the World Health Organization has …

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80 researchers argue COVID-19 herd immunity strategy is a “dangerous fallacy” in open letter

October 15, 2020
Medical Communications, Research and Development, Sales and Marketing COVID-19

A group of 80 researchers have lent their signatures to an open letter published in the The Lancet under the …

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Scottish Medicines Consortium gives go-ahead for Novartis’ Mayzent in secondary progressive multiple sclerosis

October 15, 2020
Sales and Marketing Mayzent, Novartis, Scotland

Novartis’ Mayzent (siponimod) has been approved by the Scottish Medicines Consortium in the treatment of secondary progressive multiple sclerosis (SPMS) …

News

NICE recommends siponimod for treating secondary progressive MS

October 15, 2020
Medical Communications

The National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending siponimod for treating secondary progressive multiple …

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FDA approves Regeneron’s antibody Ebola treatment

October 15, 2020
Research and Development Ebola, ebola antibody., ebola treatment

The FDA has approved Regeneron’s antibody drug inmazeb for treating Ebola. The treatment works through targeting the glycoprotein on the …

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Russia gives regulatory approval to second COVID-19 vaccine after early clinical trials

October 15, 2020
Research and Development COVID Vaccine, Vaccine, coronavirus vaccine

Russian President Vladimir Putin announced on Wednesday that regulators had given approval to a second coronavirus vaccine. This new vaccine …

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Scottish Medicines Consortium approves Revlimid for two groups of blood cancer patients

October 14, 2020
Research and Development Revlimid, SMC

The Scottish Medicines Consortium (SMC) has accepted Revlimid (lenalidomide) for routine use on NHS Scotland for patients with multiple myeloma …

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