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WHO warns regulators to consider all available evidence before approving remdesivir for COVID-19

October 26, 2020 Sales and Marketing COVID, COVID-19, Gilead, coronavirus

The World Health Organization’s Chief Scientist Soumya Swaminathan has warned that experts and regulators assessing the use of Gilead’s remdesivir …
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Patient Experience: Living with Timothy syndrome

October 26, 2020 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Timoty syndrome, feature, patient experience, rare disease

Thirteen-year-old Calvin Muir lives with the ultra-rare genetic condition Timothy syndrome. Like many parents of rare disease patients, his mother …
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FDA approves Gilead’s remdesivir for hospitalised COVID-19 patients

October 23, 2020 Medical Communications, Sales and Marketing COVID-19, FDA, Gilead, remdesivir

The FDA has approved Gilead’s antiviral therapy Veklury (remdesivir) for the treatment of hospitalised COVID-19 patients, making it the first …
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Bayer’s Nubeqa secures NICE recommendation for hormone-relapsed prostate cancer at risk of metastasis

October 23, 2020 Medical Communications, Sales and Marketing Bayer, NCIE, Nubeqa, pharma

NICE has given its recommendation to Bayer’s androgen receptor inhibitor Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) for …
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NICE recommends MSD’s Keytruda for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma

October 22, 2020 Sales and Marketing MSD, NCIE, NHS, keytruda

NICE has moved to recommend the use of MSD’s blockbuster immunotherapy drug Keytruda (pembrolizumab) as a monotherapy in the treatment …
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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 …
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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 …

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 …

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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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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