regulation
Nice backs UCB’s Cimzia as alternate therapy for severe rheumatoid arthritis
July 13, 2016Research 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 files suit to block FDA from approving copies of cholesterol drug Crestor
July 11, 2016Sales 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 …
US FDA approves Roche Cobas HPV Test
July 8, 2016Medical 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, 2016Manufacturing 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, 2016Medical 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 …
UK healthcare professionals received £340.3 million in benefits from pharma industry in 2015 discloses ABPI
July 1, 2016Business 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 …
Shire says trial drug for ADHD shows positive results
June 30, 2016Research 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 …
Regulus’ shares drop as FDA puts trials for hepatitis C drug on hold
June 29, 2016Research 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 says US FDA approves Epclusa to treat hepatitis C
June 29, 2016Research 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 …
AstraZeneca’s new antibiotic Zavicefta gets European approval for serious bacterial infections
June 29, 2016Research 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, 2016Manufacturing 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, 2016Manufacturing 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, 2016Medical 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 …
Doctors prescribe more brand drugs for free meals from pharma industry – Study
June 21, 2016Manufacturing 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, 2016Medical 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 …
