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Strong Phase 3 showing for Takeda’s dengue vaccine, but concerns remain over consistent coverage

November 7, 2019
Research and Development Takeda, dengue, pharma

Takeda has unveiled new data from its ongoing Phase 3 trial investigating the efficacy of its vaccine candidate TAK-003 in …

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fdaoutsideweb

Aveo backs off on tivozanib approval after FDA calls for more conclusive data

November 6, 2019
Research and Development, Sales and Marketing Aveo Oncology, FDA, pharma

Aveo Oncology has hit another hurdle in its quest for approval of its vascular endothelial growth factor receptor tyrosine kinase …

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Halozyme culls staff by 55% following Phase 3 metastatic pancreas cancer failure

November 6, 2019
Manufacturing and Production, Research and Development Halozyme, pharma, trial failure

Halozyme Therapeutics has announced it is to cull its workforce by more than half in the wake of the news …

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Takeda to jettison non-core asset portfolio to Stada for $660 million

November 6, 2019
Research and Development, Sales and Marketing Stada, Takeda, pharma

Takeda has announced it is divesting a portfolio of its over-the-counter (OTC) and prescription drug products to Stada for a …

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sandoz

Sandoz scores FDA approval for Neulasta biosimilar Ziextenzo to treat febrile neutropenia infection

November 6, 2019
Research and Development, Sales and Marketing Amgen, FDA, Neulasta, Sandoz, Ziextenzo, pharma

The FDA has authorised the availability of Sandoz’s Ziextenzo (pegfilgrastim-bmez), a biosimilar version of Amgen’s Neulasta, it has emerged. The …

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flu_virus

FDA approves Sanofi’s quadrivalent flu vaccine for over-65s

November 6, 2019
Research and Development, Sales and Marketing FDA, Fluzone, Sanofi, flu, influenza, pharma

Sanofi’s quadrivalent influenza vaccine Fluzone High Dose has secured FDA approval in adult patients over the age of 65 for …

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Redefining the value of medicines with patients at the centre

November 4, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Takeda, health economics and outcomes research, market access, pharma

Liz Lewis, Head of Global Oncology Patient Value, Policy and Access at Takeda Oncology, discusses the importance and challenges of …

Feature
fda2outsideweb

FDA approves RedHill Biopharma’s Talicia to combat Helicobacter pylori infection

November 4, 2019
Sales and Marketing FDA, RedHill Biopharma, pharma

RedHill Biopharma is celebrating after the FDA chose to award marketing authorisation to Talicia (omeprazole magnesium, amoxicillin and rifabutin) for …

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International revenue for world’s best-selling drug Humira falls 33.5% in the face of biosimilar competition

November 4, 2019
Sales and Marketing AbbVie, Humira, pharma

With the release of its Q3 financial results, AbbVie confirmed that international revenues for its blockbuster therapy Humira (adalimumab) – …

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Donald Trump nominates Dr Stephen Hahn as next FDA Commissioner

November 4, 2019
Medical Communications, Sales and Marketing Donald Trump, FDA, Ned Sharpless, President trump, Scott Gottlieb, Trump, US

The US FDA could be set to receive its next long-term Commissioner after the White House revealed President Donald Trump’s …

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China green lights first novel Alzheimer’s therapy since 2003

November 4, 2019
Sales and Marketing Alzheimer's, China, Green Valley, Oligomannate, pharma

Shanghai Green Valley Pharmaceuticals has announced that its therapy Oligomannate (GV-971) has secured marketing approval from China’s National Medical Products Administration (NMPA) …

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Promising Phase 3 data for Sanofi’s Toujeo secures CHMP recommendation of label expansion in type 1 diabetes

November 4, 2019
Research and Development, Sales and Marketing EU, Sanofi, Type 1 diabetes, diabetes, pharma, toujeo

Sanofi took the opportunity at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston, Massachusetts to …

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Top Ten most popular articles on Pharmafile.com this week

November 1, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing pharma, top ten

Happy Friday!

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Current drugs are “poisoning” elderly patients due to insufficient trial data, House of Lords committee hears

November 1, 2019
Medical Communications, Research and Development elderly patients, pharma, trial diversity

Elderly patients are being put at risk by prescriptions for drugs which have not been properly tested in their age …

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England’s antibiotic use is down, but antibiotic-resistant infections still spreading, report warns

November 1, 2019
Medical Communications, Research and Development Antibiotics, England, Review on antimicrobial resistance

A new report has revealed that GPs in England are writing fewer prescriptions for antibiotics, but this has done little …

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Amgen drops $2.7bn to acquire stake in Chinese biotech in bid to expand in the region

November 1, 2019
Medical Communications, Research and Development, Sales and Marketing Amgen, BeiGene, Cancer, China, deal, oncology, pharma

Amgen has signed an agreement with Chinese biotech BeiGene to acquire a 20.5% stake in the latter, in a bid …

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Despite some advantages, Novartis’ Cosentyx fails to outclass Humira in active psoriatic arthritis

November 1, 2019
Medical Communications, Research and Development Cosentyx, Humira, Novartis, active psoriatic arthritis, pharma

Novartis has announced new data drawn from a trial pitting Cosentyx (secukinumab) in head-to-head competition with AbbVie’s Humira (adalimumab) – …

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Transactions in the pharma sector: Through the EU merger review looking-glass

October 31, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing mergers, mergers and acquisitions, pharma

With mergers and acquisitions back in full swing after a period of drought, Alec Burnside (Partner) and Delphine Strohl (Associate) …

Feature
abbvie_0

AbbVie’s Rinvoq impresses at Phase 3 in active psoriatic arthritis sub-population

October 31, 2019
Research and Development AbbVie, Rinvoq, pharma

AbbVie has unveiled new Phase 3 data on two doses of its JAK inhibitor Rinvoq (upadacitinib), showing that the therapy …

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Catalyst’s lead candidate Firdapse falls short in Congenital Myasthenic Syndromes

October 31, 2019
Research and Development Catalyst Pharmaceuticals, FDA, firdapse, pharma, trial failure

Catalyst Pharmaceuticals has made it known that its lead product Firdapse (Amifampridine Phosphate) fell short of its primary endpoint in …

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