Dr Stephen Hahn appointed as new FDA commissioner
Dr Stephen Hahn has been voted into the role of FDA commissioner by the US Senate, taking over the role from Ned Sharpless.
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Roche purchase of Spark Therapeutics is given the go ahead in UK
The CMA has cleared the anticipated purchase of gene therapy company Spark Therapeutics by pharmaceutical company Roche Holdings.
Drug approved which reduces risk of cardiovascular events
The FDA has approved Vascepa (icosapent ethyl) as a secondary therapy to reduce cardiovascular events in adults.
Survey finds smaller enterprises will drive life sciences in Scotland
Researchers have revealed that small- and medium-sized companies will by key in the growth of the life sciences sector in Scotland.
Timetable reportedly set for national vaccine tracking system in China
A national vaccine tracking system in China will aim to be completed before 31 March 2020, a report has said.
Regulatory submissions made for dispersible formulation of dolutegravir
ViiV Healthcare has filed submissions to the FDA and EMA for the first dispersible formulation of dolutegravir (DTG) for children living with HIV.
Report links greater generic competition and lower generic drug prices
A new report from the FDA has shown that greater competition among generic drug makers is associated with lower generic drug prices.
EMA recommends five drugs for approval after December meeting
The EMA’s CHMP has adopted a positive opinion for five medicines and recommended extending the indications for eight more.
FDA grants accelerated approval for treatment of rare DMD mutation
The FDA has granted accelerated approval to Vyondys 53 for the treatment of patients with Duchenne muscular dystrophy containing a mutation of the dystrophin gene that is amenable to exon 53 skipping.
EC approves treatment for severe osteoporosis postmenopausal women
Marketing authorisation has been granted by the EC for Evenity® (romosozumab) to treat osteoporosis in postmenopausal women.
New drugs more likely to be approved if backed up by genetics, says study
A new study could aid pharmaceutical companies in their drug development efforts after if found that a drug candidate is more likely to be approved for use if it targets a gene known to be linked to the disease.
Sanofi announces it will acquire Synthorx for $2.5 billion
Sanofi has announced it is to acquire Synthorx to bolster its immuno-oncology pipeline for $2.5 billion.
Pelosi’s drug pricing bill passes House of Representatives
The House of Representatives has voted to approve Speaker Pelosi’s drug pricing bill in a Democrat-led chamber, say reports.
Psilocybin study shows positive results in healthy volunteers
In a new study, COMP360 (psilocybin) was well tolerated in healthy volunteers which support further investigation of a simultaneous 1:1 therapeutic administration design.
Pharma industry should stimulate bolder communications, says report
A new report has been published which draws on expertise from within and beyond the pharmaceutical industry to make recommendations for pharma communicators.
