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European Commission approves Genmab’s Darzalex combo in newly diagnosed multiple myeloma

November 20, 2019
Research and Development, Sales and Marketing Europe, Genmab, darzalex, pharma

Genmab’s Darzalex (daratumumab) has secured approval from the European Commission and is now authorised in Europe for the treatment of …

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Keytruda overtakes Opdivo to lead sales in global immune checkpoint inhibitor market, report reveals

November 19, 2019
Manufacturing and Production, Sales and Marketing Bristol-Myers Squibb, MSD, keytruda, opdivo, pharma

MSD’s Keytruda (pembrolizumab) overtook Bristol-Myers Squibb’s (BMS) blockbuster drug Opdivo (nivolumab) in total sales in the third quarter of 2019 …

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Amgen poised to cut 172 positions across US, including California HQ

November 19, 2019
Manufacturing and Production Amgen, US, pharma

As revealed in correspondence with the California Employment Development Department, Amgen plans to axe 172 staff positions across the US, …

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Bayer and MSD’s chronic heart failure drug meets main goal at Phase 3

November 19, 2019
Manufacturing and Production, Research and Development Bayer, MSD, pharma, vericiguat

MSD and Bayer have made it known that their jointly-developed soluble guanylate cyclase (sGC) stimulator vericiguat met its primary endpoint …

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Data revealed on novel CRISPR/Cas9 gene-editing therapy for first two severe haemoglobinopathy patients

November 19, 2019
Manufacturing and Production, Research and Development Vertex, crispr, pharma

Vertex and CRISPR Therapeutics have unveiled the first interim Phase 1/2 data demonstrating the safety and efficacy of the investigational …

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Alkermes snaps up Rodin Therapeutics for a potential $950 million

November 19, 2019
Manufacturing and Production, Sales and Marketing Alkermes, Rodin Therapeutics, pharma

Dublin’s Alkermes is set to acquire US firm Rodin Therapeutics in a deal worth a potential $950 million, it has …

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Bringing the clinical trial home

November 18, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing clinical trials, feature, research

Clinical trials are the backbone of healthcare and drug research, but many key patient populations have in the past been …

Feature

Pfizer’s Humira biosimilar secures FDA approval, due to launch in 2023

November 18, 2019
Sales and Marketing Abrilada, FDA, Humira, Pfizer, biosimilar, pharma

Pfizer has confirmed the FDA approval of Abrilada (adalimumab-afzb),  its biosimilar version of AbbVie’s Humira, the world’s best-selling drug,   …

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EMA advisory panel recommends Mayzent for secondary progressive multiple sclerosis

November 18, 2019
Sales and Marketing Europe, Mayzent, Novartis, multiple sclerosis, pharma

Novartis has revealed that Mayzent (siponimod) has been recommended by the European Medicines Agency’s (EMA) Committee for Medicinal Products for …

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resTORbio shuts down Phase 3 trial in clinically symptomatic respiratory illness

November 18, 2019
Research and Development, Sales and Marketing pharma, resTORbio

US firm resTORbio has revealed its intention to terminate a Phase 3 trial of its oral, selective TORC1 inhibitor RTB101 …

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Jazz Pharma sleep disorder drug secures CHMP backing for treatment of excessive daytime sleepiness in Europe

November 18, 2019
Research and Development, Sales and Marketing EMA, jazz pharma, narcolepsy, pharma, solriamfetol

Jazz Pharma’s solriamfetol has secured a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human …

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Novartis’ Adakveo becomes first FDA-approved P-selectin inhibitor for sickle cell disease

November 18, 2019
Sales and Marketing Adakve, Novartis, pharma, sickle cell disease

The FDA has chosen to award Novartis’ Adakveo (crizanlizumab) with marketing authorisation, it has emerged, as a treatment to reduce …

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Over half of all anti-vaccine ads on Facebook stem from just two advertisers

November 15, 2019
Medical Communications, Research and Development Facebook, anti-vaccine, pharma

A new study has revealed that the largest share of anti-vaccine advertisements on Facebook originate from just two organisations, both …

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Shionogi gains US approval in complicated urinary tract infections with Fetroja

November 15, 2019
Medical Communications, Sales and Marketing FDA, Fetroja, Shiogoni

Shionogi’s antibacterial therapy Fetroja (cefiderocol) has secured approval in the US for the treatment of complicated urinary tract infections (cUTI), …

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Label expansion of Amarin’s Vascepa has unanimous backing of FDA advisory panel

November 15, 2019
Medical Communications, Sales and Marketing Amarin, FDA, vascepa

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in favour of expanding the existing approval of Irish …

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Top Ten most popular articles on Pharmafile.com this week

November 15, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

As we close in on the weekend, it’s been a week characterised by data reveals and crucial marketing approvals, including …

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AstraZeneca’s Qtrilment scores European authorisation in type 2 diabetes

November 15, 2019
Medical Communications, Sales and Marketing AstraZeneca, EU, Europe, Qtrilmet, diabetes, pharma, type 2 diabetes

Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) has secured approval in Europe, its manufacturer AstraZeneca has revealed, as a therapy to …

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New report reveals shocking knowledge gaps around type 2 diabetes risk factors

November 14, 2019
Medical Communications, Research and Development Merck KGaA, diabetes, pharma, type 2 diabetes

A new report released on World Diabetes Day has shone a light on a startling lack of knowledge surrounding type …

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FDA advisory committee votes down approval of Boehringer and Lilly’s drug for type 1 diabetes

November 14, 2019
Sales and Marketing Boehringer Ingelheim, Eli Lilly, empagliflozin, jardiance, pharma

Boehringer Ingelheim and Eli Lilly’s have been dealt a blow from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), …

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Myeloma UK reveals new Director of Research appointment

November 14, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Myleoma UK, appointment, multiple myeloma, pharma

UK non-profit organisation Myeloma UK has selected Sarah McDonald as its new Director of Research, who in her new role …

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