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Showing 15 posts of 1442 posts found.

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FDA expand REMS education program in effort against opioid crisis

September 19, 2018
Research and Development FDA, IR, opioid crisis, opioids, rems

The US Food and Drug Administration is set to introduce a requirement that all healthcare providers be offered educational training …

News
teva_copy

Teva shares soar after migraine treatment Ajovy approval

September 17, 2018
Sales and Marketing FDA, Teva, US, ajovy, approval, israel

Shares in the Israeli pharma firm Teva soared on Sunday after the announcement that the US Food and Drug Administration …

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

September 14, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Bristol-Myers Squibb, FDA, NICE, Novo Nordisk, Spinraza, brexit, bristol myers squibb, top 10

With the Pharmafocus team having avoided hurricane Florence and finally arriving back in the UK just last night, after stopping …

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FDA launch plan to tackle e-cig epidemic

September 14, 2018
Medical Communications FDA, Scott Gottlieb, USA, e-cig, juul

The FDA have announced a plan to crack down on the so-called ‘e-cig epidemic’, following revelations that vaping and use …

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GSK’s Nucala data insufficient for US COPD approval

September 10, 2018
Sales and Marketing COPD, FDA, GSK, Nucala, US, pharma

GlaxoSmithKline has suffered a regulatory blow in the label expansion of its interleukin-5 (IL5) inhibitor Nucala (mepolizumab), with the FDA …

News

Akcea cuts 10% of staff following FDA rejection

September 10, 2018
Manufacturing and Production, Sales and Marketing Akcea, FDA, Waylivra, pharma

Akcea Therapeutics has been hit hard by the FDA’s decision to reject its drug Waylivra (volanesorsen) for the treatment of …

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FDA recruitment official says Trump’s policies are making hiring difficult

September 7, 2018
Medical Communications FDA, Trump, US, hiring, recruitment

Melanie Keller, Acting Associate Commissioner for Scientific and Clinical Recruitment at the US Food and Drug Administration (FDA) has said …

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FDA turns to real-world evidence to improve regulatory process

September 5, 2018
Medical Communications, Research and Development, Sales and Marketing FDA, pharma, real world data, real world evidence, real-world data, real-world evidence

The FDA has announced its intention to incorporate real-world data elements to a greater degree into its regulatory decision-making framework …

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FDA rejects Sunovion’s ADHD drug dasotraline

September 3, 2018
Sales and Marketing ADHD, FDA, dasotraline, drug, sunovion

The US Food and Drug Administration (FDA) have rejected American pharma firm Sunovion’s application to market dasotraline for the treatment …

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Opioid prescriptions hit 15 year low, as FDA’s Gottlieb reaffirms commitment against crisis

August 30, 2018
Medical Communications FDA, opioid crisis, prescriptions, scott gottleib

The amount of opioids prescribed to patients in the United States has fallen to a 15 year low according to …

News
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FDA warns against King Bio products after company expands recall

August 29, 2018
Research and Development Contamination, FDA, homeopathy, king bio, recall

The US Food and Drug Administration is warning consumers and pet owners not to use products that have been manufactured …

News

Ionis/Akcea’s ultra-rare disease drug rejected by FDA

August 28, 2018
Manufacturing and Production, Sales and Marketing Akcea, FDA, Ionis, familial chylomicronemia syndrome, pharma, rare disease

The FDA has opted to refuse approval to Akcea and Ionis’ Waylivra (volanesorsen) for the treatment of the ultra-rare hereditary …

News

Dompé gives the FDA its first approved neurotrophic keratitis treatment

August 24, 2018
Medical Communications, Sales and Marketing Dompe, FDA, Oxervate, eye disease, pharma

Milan-based biotech firm Dompé has revealed that the FDA has awarded approval in the US to its Oxervate (cenegermin-bkbj ophthalmic …

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allergan

FDA refuses Allergan’s uterine bleeding therapy with a request for more data

August 22, 2018
Research and Development, Sales and Marketing Allergan, Esmya, FDA, pharma

Allergan has shared the news that the FDA has refused to award marketing authorisation to its ulipristal acetate product Esmya …

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Image Credit: Bristol-Myers Squibb

FDA approves Bristol Myers Squibb’s Opdivo in small-cell lung cancer

August 20, 2018
Sales and Marketing Bristol-Myers Squibb, FDA, approval, bristol myers squibb, lung cancer, opdivo

The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) for patients with metastatic small-cell lung cancer (SCLC), as the first …

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