FDA

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Committee advises against FDA approval of Alkermes’ novel depression drug

November 2, 2018
Medical Communications, Sales and Marketing Alkermes, FDA, depression, pharma

Alkermes has been knocked back with the disappointing, though not entirely unexpected, news that the FDA-appointed Psychopharmacologic Drugs Advisory Committee …

J&J’s Invokana becomes first FDA-approved oral diabetes drug to reduce cardiovascular event risk

October 31, 2018
Research and Development, Sales and Marketing FDA, J&J, JJ, invokana, pharma

The FDA has given the go-ahead for Johnson & Johnson’s drug Invokana (canagliflozin) for use in the risk reduction of …

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Top Ten most popular articles on Pharmafile.com this week!

October 26, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, GSK, HDA, J&J, JJ, brexit, clinical trials, pharmafile, resutls, stockpiling, top 10

Winter is coming! And with it an assortment of promising and not so promising results from big pharma. While J&J …

Magic mushroom ingredient psilocybin gains breakthrough therapy designation

October 26, 2018
Medical Communications Breakthrough Therapy Designation, Compass, FDA, Magic mushrooms, psylicobin

The US Food and Drug Administration (FDA) has given psilocybin – the psychoactive ingredient in ‘magic mushrooms’ – breakthrough therapy …

FDA generics approvals up 90% compared to 2014

October 25, 2018
Sales and Marketing FDA, Trump, generics, pharma

Continuing to build on its successes in toppling previous benchmarks, it has emerged that the FDA’s total number of generic …

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First novel, single-dose flu drug approved in US in almost 20 years

October 25, 2018
Sales and Marketing FDA, Shionogi, Xofluza, flu, influenza, pharma

The FDA has announced that it has approved the first single-dose flu drug with a novel mechanism of action in …

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US FDA offers plan for global regulatory harmonisation for generic drugs

October 19, 2018
Medical Communications FDA, ICH, generic drugs, harmonisation, regulatory bodies

The US Food and Drug Administration (FDA) is offering a proposal to the International Council on Harmonisation (ICH) aimed at …

FDA approves Pfizer’s Talzenna for breast cancer alongside tool to identify eligible patients

October 17, 2018
Research and Development, Sales and Marketing Cancer, FDA, Pfizer, Talzenna, breast cancer, pharma

Pfizer’s Talzenna (talazoparib) has secured FDA approval, it has emerged. The poly (ADP-ribose) polymerase (PARP) inhibitor is now set to …

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FDA advisory panel approves AcelRx’s opioid pain drug Dsuvia

October 15, 2018
Sales and Marketing FDA, approval, comittee, opioids

An FDA advisory panel voted 10 to 3 to recommend the approval of AcelRx Pharmaceuticals’ opioid pain drug Dsuvia (sufentanil) …

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Trevena’s opioid injection fails to win over FDA committee

October 12, 2018
Medical Communications, Sales and Marketing FDA, Trevena, US, oliceridine, opioid, opioid crisis, pharma

Trevena has seen its opioid injection oliceridine fail to win over an FDA advisory panel in the management of acute …

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Celltrion’s Rituxan biosimilar gets unanimous backing from FDA committee

October 11, 2018
Sales and Marketing FDA, Oncologic Drugs Advisory Committee, Rituxan, Roche, Truxima

FDA approval looks to be in reach for Celltrion, as an advisory committee for the US regulator voted unanimously to …

US FDA approves HPV vaccine for men and women aged 27-45

October 8, 2018
Sales and Marketing CDC, Cancer, FDA, HPV, approval, infectious diseases, vaccines

The US Food and Drug Administration have approved the use of HPV vaccine Gardasil 9 for both men and woman …

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FDA cracks down on e-cig maker Juul in surprise inspection

October 3, 2018
Research and Development FDA, e-cig, juul, surprise inspection, us San Francisco

The US FDA have launched a surprise inspection of e-cigarette maker Juul’s corporate headquarters in San Francisco, having seized thousands …

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African-American enrollment disproportionately high in no-consent trials

October 2, 2018
Manufacturing and Production, Research and Development FDA, clinical trials, pharma, transparency

A new study has revealed that African-American citizens make up a disproportionately high share of participants in US clinical trials …

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FDA greenlights Teva’s migraine drug Ajovy in two dosage options

September 20, 2018
Sales and Marketing FDA, Teva, US, ajovy, migraine, pharma

Israeli drugmaker Teva has announced that its calcitonin gene-related peptide (CGRP) inhibitor Ajovy (remanezumab-vfrm) has received FDA approval as a …

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