regulation

Showing 15 posts of 68 posts found.

Nice backs UCB’s Cimzia as alternate therapy for severe rheumatoid arthritis

July 13, 2016
Research and Development, Sales and Marketing Cimzia, NICE, UCB, regulation, rheumatoid arthritis

The National Institute for Health and Care Excellence (Nice) has recommended UCB Pharma’s Cimzia (certolizumab pegol) on its own or …

astrazeneca_sign_sky

AstraZeneca files suit to block FDA from approving copies of cholesterol drug Crestor

July 11, 2016
Sales and Marketing AstraZeneca, Crestor, US FDA, patent, regulation

Anglo-Swedish drug firm AstraZeneca (LSE: AZN) has filed a temporary restraining order to prevent the US Food and Drug Administration from …

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US FDA approves Roche Cobas HPV Test

July 8, 2016
Medical Communications, Research and Development HPV, Roche, US FDA, regulation

The US Food and Drug Administration (FDA) has approved cancer drugmaker Roche’s (VTX: ROG) cobas HPV Test. The first test …

Nice rejects BMS’ immunotherapy Opdivo for previously treated kidney cancer on pricing

July 5, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Bristol-Myers Squibb, NICE, QALY, immunotherapy, opdivo, regulation

UK regulators have rejected Bristol-Myers Squibb’s (NYSE: BMY) immunotherapy Opdivo for previously treated kidney cancer on pricing and substantial uncertainty …

US doctors received $6.5 billion from drug, device firms in 2015

July 1, 2016
Medical Communications, Research and Development, Sales and Marketing US, affordable care act, pharma, regulation

Doctors and hospitals received nearly $6.5 billion in research and speaking fees as well as other goods or services from …

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UK healthcare professionals received £340.3 million in benefits from pharma industry in 2015 discloses ABPI

July 1, 2016
Business Services, Medical Communications, Sales and Marketing ABPI, Pharmacutical, corruption, disclosure, regulation

“We don’t want our neighbours to know what we earn,” said Mike Thompson, the chief executive of industry body Association …

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Shire says trial drug for ADHD shows positive results

June 30, 2016
Research and Development, Sales and Marketing ADHD, Shire, US FDA, drug trial, regulation

UK drugmaker Shire plc (LSE: SHP) said its trial drug to treat Attention-Deficit/Hyperactivity Disorder (ADHD) showed positive topline results.  Philip …

fda_building

Regulus’ shares drop as FDA puts trials for hepatitis C drug on hold

June 29, 2016
Research and Development, Sales and Marketing Regulus Therapeutics, US FDA, drug trial, hepatitis C virus, regulation

Shares in Regulus Therapeutics (Nasdaq: RGLS) plunged as much as 60% after the company said the US Food and Drug …

gilead-sciences

Gilead says US FDA approves Epclusa to treat hepatitis C

June 29, 2016
Research and Development, Sales and Marketing Epclusa, Gilead, HCV, US FDA, drug approval, regulation

US drug firm Gilead Sciences (Nasdaq: GILD) said the US Food and Drug Administration has approved its Epclusa (sofosbuvir/velpatasvir), in …

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AstraZeneca’s new antibiotic Zavicefta gets European approval for serious bacterial infections

June 29, 2016
Research and Development, Sales and Marketing AstraZeneca, European Commission, Zavicefta, bacterial infections, regulation

UK drug firm AstraZeneca (LSE: AZN) said the European Commission has granted marketing authorisation for its Zavicefta (ceftazidime-avibactam), a new combination …

Roche says EMA accepts its marketing applications for Ocrevus to treat multiple sclerosis

June 28, 2016
Manufacturing and Production, Research and Development, Sales and Marketing EMA, Ocrevus, Roche, US FDA, drug development, drug trial, multiple sclerosis, priority review, regulation

Cancer drugmaker Roche (SIX: ROG) said the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for its …

Bristol-Myers Squibb’s Opdivo gets US FDA breakthrough therapy designation for advanced bladder cancer

June 28, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Breakthrough Therapy Designation, Bristol-Myers Squibb, FDA, bladder cancer, opdivo, regulation

Bristol-Myers Squibb (NYSE:BMY) said the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to its immunotherapy Opdivo for the …

Nice rejects AstraZeneca’s Tagrisso for lung cancer in preliminary recommendation

June 24, 2016
Medical Communications, Research and Development AstraZeneca, CDF, NICE, lung cancer, regulation

UK drugmaker AstraZeneca (LSE: AZN) said the National Institute for Health and Care Excellence (Nice) has rejected Tagrisso (osimertinib) to …

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Doctors prescribe more brand drugs for free meals from pharma industry – Study

June 21, 2016
Manufacturing and Production, Research and Development, Sales and Marketing JAMA, regulation, research

Doctors who received free meals from the pharmaceutical representatives were more likely to prescribe the brand-name medication that was being …

Nice backs BMS’ combination immunotherapy Opdivo, Yervoy to treat skin cancer

June 17, 2016
Medical Communications, Research and Development, Sales and Marketing BMS, NICE, oncology, opdivo, regulation, skin cancer

The National Institute for Health and Care Excellence (Nice) has backed a combination of Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) and …

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