Top Ten most popular articles on Pharmafile.com this week!
pharmafile | August 9, 2019 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | AI, CAR T, CAR-T, Eli Lilly, Lexicon, Medicare, Novartis, Pfizer, Sanofi, pharma
This week’s top story covered the scandal surrounding Novartis over its covering up of faulty data from the FDA. The Swiss firm’s integrity was called into question after it waited until it’s $2.1 million gene therapy had been approved before informing the US regulator of inaccuracies in its data.
In other news, Medicare said it would vocer the costs of CAR-T therapies Kymriah and Yescarta as Roche’s immunotherapy Tecentriq met its primary endpoint in a Phase 3 bladder cancer trial. In another Phase 3 success Eli Lilly’s Emgality showed success in treating migraine. However, Pfizer’s sickle cell drug rivipansel flopped when it came to the late stage trial. For all this and more check out this week’s top 10 on Pharmafile.com
10. Sanofi ends partnership with Lexicon after release of Phase 3 data
French firm Sanofi has said it is ending its partnership with Texas-based firm Lexicon Pharmaceuticals over the development of diabetes drug Zynquista (sotagliflozin).
9. AI accurately detects subtle signs of atrial fibrillation even in normal tests
A new study from the Mayo Clinic shows that artificial intelligence (AI) can detect signs of atrial fibrillation (AF) in an electrocardiogram (EKG), even if the heart is in a normal rhythm at the time of the test.
Top scientists from some of the UK’s foremost nuclear medicine associations have written a letter to recently-anointed Prime Minister Boris Johnson voicing concerns over the nation’s ability to deliver cancer treatments to patients if the UK crashes out of the EU without a deal.
7. Roche’s Tecentriq meets primary endpoint in Phase 3 bladder cancer trial
Roche has said its immunotherapy drug Tecentriq (Atezolizumab), when used in combination with platinum-based chemotherapy, significantly reduced the risk of disease worsening and death in a Phase 3 trial of patients with bladder cancer.
6. Daiichi Sankyo’s Turalio becomes first FDA-approved therapy for rare tumour
Daiichi Sankyo has seen Turalio approved by the FDA in the treatment of symptomatic tenosynovial giant cell tumours (TGCT) in adult patients whose disease is associated with severe morbidity or functional limitations and cannot be improved with surgery, making it the first and only therapy available in the US for this indication.
5. Pfizer’s sickle cell drug flops at Phase 3 trial
Pfizer has said its sickle cell drug rivipansel failed to meet its primary endpoint or key secondary endpoints in a Phase 3 trial.
4. Medicare will cover CAR-T therapies in United States
Medicare will cover the cost of Novartis’ and Gilead’s CAR-T therapies Kymriah and Yescarta, the US Centers for Medicare and Medicaid services (CMS) said.
3. Lilly’s Emgality smashes all Phase 3 endpoints in migraine sub-population
New Phase 3 data have been revealed on Eli Lilly’s Emgality (galcanezumab-gnlm), detailing its success in meeting all of its primary and secondary endpoints as a preventive treatment for chronic and episodic migraine in patients who have previously failed to control their condition with other migraine medications.
2. NICE reject Clovis Oncology’s ovarian cancer drug Rubraca
Britain’s cost-effectiveness body NICE has chosen not to recommend Clovis Oncology’s cancer drug Rubraca (rucaparib).
1. Novartis hid faulty data from FDA over $2.1 million gene therapy Zolgensma
Novartis hid faulty data from the FDA until their drug was approved, according to a statement from Dr Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER).
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