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.
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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.
FDA issues warning letter for misrepresentation of drug in advertisement
Alkermes, Inc. have received the warning letter after a promotional material review found it failed to adequately represent the risks of using the drug Vivitrol for patients with opioid use disorder.
USMCA to stabilise biologic drug prices in North America
The newly signed deal between the US, Mexico and Canada will hold down the price of biologic drugs in the continent, according to a report.
EC approves expanded indication for cystic fibrosis treatment
The European Commission has approved the label extension for KALYDECO® (ivacaftor) to include the treatment of infants with cystic fibrosis between six and 12 months old.
Consumers told not to use drugs recalled from Basic Reset and Biogenyx
The FDA has informed consumers not to use drugs recalled from Basic Reset and Biogenyx following consent decree for federal violations.
Multiple sclerosis drug market predicted to reach $32.9bn by 2028
Driven by the launch of various pipeline agents, a new report has projected that the multiple sclerosis therapeutics market will reach $32.9 billion in 2028.
Microcapsules provide targeted chemotherapy drug delivery to cancer cells
Development of infrared light-sensitive microcapsules could be the future in targeted drug delivery for cancer treatment, says new research.
Research shows the pharma industry believes AI will likely optimise R&D
A survey has shown that the pharmaceutical industry believes R&D will see a lot of benefit from digital transformation and that AI will be at the forefront of this.
