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FDA approves first oral therapy for rare Fabry disease

August 13, 2018
Sales and Marketing FDA, Fabry disease, US, pharma

Amicus has revealed that its therapy Galafold (migalastat) has been awarded approval by the FDA in the treatment of adult …

News
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NHS scraps restriction on availability of J&J’s Imbruvica in leukaemia patients

August 10, 2018
Medical Communications, Sales and Marketing Cancer, J&J, JJ, Johnson & Johnson, NHS, NICE, UK, imbruvica, leukaemia, pharma

The NHS has dropped a controversial restriction preventing leukaemia patients from accessing Johnson & Johnson’s tyrosine kinase inhibitor Imbruvica (ibrutinib), …

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Top Ten most popular articles on Pharmafile.com this week

August 10, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing ADHD, Allergan, MHRA, UK, brexit, iraq, pharma, top 10

There was some clarity on Brexit this week as the MHRA set out a plan for the implantation period set …

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Letters to doctors reduce opioid prescriptions, study shows

August 10, 2018
Medical Communications OxyContin, USA, fentanyl, opioid, opioid crisis, research, study

A study has shown that Doctors who received a letter from the medical examiner’s office informing them of their patient’s …

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fda2outsideweb

FDA approved more generics in July than any previous month

August 10, 2018
Medical Communications FDA, generics, pharma

FDA Commissioner Scott Gottlieb took to Twitter to announce the news that the FDA smashed its previous record for number …

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ABPI Chief warns of Brexit impact on EU

August 10, 2018
Medical Communications ABPI, EU, UK, brexit, trade lobby

The head of the Association of the British Pharmaceutical Industry (ABPI) has warned that European governments have failed to recognise …

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US Congressman arrested over insider trading in biopharma firm

August 9, 2018
Research and Development, Sales and Marketing Chris Collins, Innate, Innate Immunotherapeutics, US, congress, multiple sclerosis, pharma

A Republican Congressman has been arrested by the FBI over on charges of insider trading with shares in Australian biopharmaceutical …

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FDA expands list of valsartan recalls

August 9, 2018
Medical Communications China, FDA, US, heart medication, recall, valsartan

The US Food and Drug Administration (FDA) has expanded a list of products containing valsartan that are to be recalled. …

News

NICE recommends Eli Lilly’s psoriatic arthritis drug

August 9, 2018
Research and Development, Sales and Marketing Eli Lilly, England, NICE, Wales, psoriatic arthritis

Eli Lilly have announced that the monoclonal antibody ixekizumab, has been recommended by NICE for use as a treatment option …

News

NICE recommends Pfizer’s Besponsa in rare leukaemia following review

August 9, 2018
Sales and Marketing NICE, Pfizer, leukaemia, pharma

Pfizer has revealed that NICE has finally decided to recommend its CD22-targeting monoclonal antibody Besponsa (inotuzumab ozogamicin) in the treatment …

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Insys Therapeutics reaches $150m agreement to settle opioid marketing case

August 9, 2018
Medical Communications, Sales and Marketing Litigation, Subsys, US Department of Justice, fentanyl, insys, opioid, pharma

The Arizona-based pharma company Insys Therapeutics has reached an agreement to pay $150 million to the US Department of Justice …

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AstraZeneca to pay $110m to settle allegations of fraudulent marketing in Texas

August 8, 2018
Medical Communications, Research and Development, Sales and Marketing AstraZeneca, Texaas, US, pharma

AstraZeneca has backed down in a dispute with the State of Texas over allegations it had defrauded the state’s Medicaid …

News

Stem cells could ‘reset’ immune system in Crohn’s disease patients

August 8, 2018
Research and Development Crohn’s disease, Stem cells, crohn's disease, trials

A clinical trial led by researchers at Queen Mary University, London is looking into ways in which patients with Crohn’s …

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MSD’s experimental vaccine to be used in fight against Congo Ebola outbreak

August 8, 2018
Research and Development Congo, Ebola, MSD, Merck, Vaccine, pharma

MSD’s experimental drug rVSV-ZEBOV will be used in tackling the latest Ebola outbreak in the Democratic Republic of Congo, after …

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Strong efficacy but serious side-effects with Spark’s haemophilia drug drop shares by 30%

August 8, 2018
Research and Development Spark Therapeutics, haemophilia, pharma

Spark Therapeutics has been left reeling after it revealed new data on its haemophilia A treatment, which, while promising in …

News

Drugs should be preferred first-choice treatment for ADHD

August 8, 2018
Research and Development ADHD, adults, amphetmines, children, prescription, ritalin

Ritalin and other amphetamines should be the preferred first-choice medications for the short-term treatment of ADHD, according to a study …

News

GSK appoint HSBC director Iain Mackay as new CFO

August 7, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing GSK, GlaxoSmithKline, Iain Mckay, cfo, hsbc

British pharma giant GlaxoSmithKline have appointed HSBC Group Finance Director, Iain Mackay, as its new Chief Financial Officer. The move …

Appointment
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Ironwood returns US Zurampic rights to AstraZeneca, announces operational cuts

August 7, 2018
Manufacturing and Production, Sales and Marketing AstraZeneca, Ironwood, Zurampic, gout, pharma

Ironwood Pharmaceuticals has revealed that it has taken the decision to hand the rights for gout therapy Zurampic (lesinurad) back …

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FDA announces policy shift to encourage new opioid addiction treatments

August 7, 2018
Manufacturing and Production FDA, deaths, opioid crisis, overdose, policy

The US Food and Drug Administration (FDA) have announced that it is altering the way it evaluates a drug’s ability …

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Pain Therapeutics refocuses on Alzheimer’s after FDA turns down abuse-deterrent opioid painkiller

August 7, 2018
Manufacturing and Production, Research and Development, Sales and Marketing FDA, Remoxy, opioid crisis, opioids, pain therapeutics, pharma

The FDA has voted to reject Texas-based Pain Therapeutics’ abuse deterrent opioid painkiller Remoxy (oxycodone), leading the company to consider …

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