Research and Development

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FDA approved over 1,000 generic drugs in 2019

February 20, 2020 Research and Development, Sales and Marketing FDA, generic drugs, pharma

The FDA covered a lot of ground in 2019 when it came to generic drugs, awarding at least tentative approval …
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Europe approves first treatment for transthyretin amyloidosis in cardiomyopathy patients: Pfizer’s Vyndaqel

February 19, 2020 Research and Development, Sales and Marketing Europe, Pfizer, Vyndaqel, pharma, transthyretin amyloidosis

The European Commission (EC) has awarded marketing approval to Pfizer’s Vyndaqel (tafamidis), it has emerged, for the treatment of wild-type …
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CEO of PixarBio Corporation sentenced to prison for defrauding investors

February 19, 2020 Research and Development Biopharmaceuticals, CEO, FDA, corruption, fraud, investors

Frank Reynolds, the CEO of Boston based PixarBio Corporation, was sentenced to seven years in prison for defrauding investors and …
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FDA teams up with Indian government to crack down on illicit drugs shipments

February 19, 2020 Research and Development FDA, FDA India, FDA trade, Indian Pharma

The FDA announced yesterday its first successful bilateral enforcement operation with the Government of India, where they stopped 500 shipments …
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Opdivo + cabiralizumab combo falls flat in advanced pancreatic cancer

February 19, 2020 Research and Development Bristol-Myers Squibb, Five Prime Therapeutics, Pancreatic cancer, cabiralizumab, opdivo, pharma

Five Prime Therapeutics and Bristol-Myers Squibb have confirmed that their randomised Phase 2 trial investigating the efficacy of the former’s …
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Women who take statins could be less likely to develop ovarian cancer, study finds

February 19, 2020 Research and Development, Sales and Marketing Cancer, Cancer Research UK, cholesterol, ovarian cancer, statins

A study by Cancer Research UK has found that women who take statins, drugs that lower cholesterol, are less likely …
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Janssen shows off Phase 3b interim data for Stelara in Crohn’s disease

February 18, 2020 Manufacturing and Production, Research and Development Crohn’s disease, Janssen, Stelara, crohn's disease, pharma

Janssen has revealed new interim Phase 3b data from a study investigating the efficacy of Stelara (ustekinumab) in the treatment …

Patient Experience: Living with multiple rare diseases

February 17, 2020 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing feature, patient experience, pharma, rare disease

Carole Scrafton discusses her experience living with Ehlers-Danlos syndrome alongside other rare conditions that have manifested throughout her life, and …
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Lawsuit against FDA claims Bernie Sanders played role in approval of rival drug

February 17, 2020 Research and Development, Sales and Marketing Bernie, Bernie Sanders, Catalyst Pharmaceuticals, FDA, TRUMP FDA, US FDA

Catalyst Pharmaceutical is attempting to show in court that pressure from US Senator Bernie Sanders led to the approval of …
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Eisai releases new Phase 2 data for levatinib+everolimus combo in advanced kidney cancer

February 17, 2020 Research and Development, Sales and Marketing Cancer, Eisai, Kidney cancer, Lenvima, pharma, renal cell carcinoma

New Phase 2 data has been revealed for Eisai’s Lenvima (levatinib), delivered alongside Novartis’ everolimus, for the treatment of unresectable …
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Strong Phase 3 data for Takeda’s subcutaneous Entyvio in moderate to severe Crohn’s disease

February 17, 2020 Research and Development, Sales and Marketing Crohn’s disease, Entyvio, Takeda, crohn's disease, pharma

Takeda has shared positive new Phase 3 data on a subcutaneous formulation of its gut-selective biologic Entyvio (vedolizumab) as a …
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Experts call on NICE to recommended a ban on OTC codeine sales

February 17, 2020 Research and Development, Sales and Marketing Codein, NICE, opioid crisis, opioids, prescription drugs

Experts have called for a ban on the sale of over the counter codeine as NICE is set to publish …
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Top Ten most popular articles on Pharmafile.com this week

February 14, 2020 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing China, Chinese Coronavirus, Wuhan, Wuhan Coronavirus, china coronavirus, coronavirus

The coronavirus continues to dominate the news, with the disease finally getting treated. In America, a patient has been successfully …
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Mumps cases in England rocket four-fold to highest point in a decade

February 14, 2020 Medical Communications, Research and Development MMR vaccine, Vaccine, anti-vaccine, pharma

The incidence of mumps in the England has reached its highest level in 10 years, prompting warnings from health officials …
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Eisai withdraws weight loss drug Belviq after FDA highlights cancer risk

February 14, 2020 Medical Communications, Research and Development, Sales and Marketing Belviq, Eisai, FDA, pharma

The FDA has requested that Eisai withdraw its weight loss drug Belviq (lorcaserin) and Belviq XR from the US market …
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