Pelosi plan could lead to 56 fewer new medicines over decade
US Speaker Pelosi’s new drug pricing plan could impact small biotech companies, reducing their innovation by 90 percent, says new research.
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Medical device design – a key consideration when entering biosimilars market
A recent industry report projects a boom in the biosimilars market over the next three years and highlights key considerations for meeting its potential.
Bristol-Myers Squibb completes acquisition of Celgene
After regulatory approval, Bristol-Myers Squibb has announced its successful acquisition of Celgene, completing the merger.
Orally disintegrating tablets market driven by CNS disease treatments
The preference for orally disintegrating tablets (ODT) to treat CNS-related diseases will increase the market from $12bn in 2018, with a solid growth rate.
Medicine regulators should increase collaboration, says new report
The US National Academies of Sciences, Engineering, and Medicine have released a report that suggests regulators need to collaborate more to ensure drug quality.
First treatment for inherited rare disease approved by the FDA
Givlaari (givosiran) has been approved by the FDA for the treatment of adult patients with the rare genetic disorder, acute hepatic porphyria.
EC approves two new regimens of Keytruda for HNSCC
The European Commission has given its approval to Keytruda to treat head and neck squamous cell carcinoma as a monotherapy or in combination with a chemotherapy.
Precision Dose voluntarily recalls ranitidine oral solution
The FDA has announced that Precision Dose Inc is voluntarily recalling five lots of its ranitidine oral solution in the US.
Healthcare sector often fails to implement new digital initiatives, finds report
A new report has found that even though ambitions are high in the healthcare sector to invest in digital initiatives, the rate of implementing these initiatives are low.
UK authorisation granted for first in-human CAR-Treg cell therapy study
Authorisation has been granted in the UK for the STEADFAST clinical study of TX200, which is the first-in-human trial to evaluate a CAR-Treg cell therapy.
White House announces plan to increase US drug price transparency
Donald Trump has issued a statement outlining a plan to make drug costs in the US clearer for patients, which could also help to drive competition.
Enzyme-coated protocells could be used as targeted drug-delivery system
A study has shown that using certain enzymes on liposomes could be an effective form of directed drug delivery.
Ninety-seven percent response rate reported in advanced prostate cancer treatment study
A Phase III study of oral relugolix has met its primary efficacy endpoint in men with advanced prostate cancer, supporting a New Drug Application submission to the FDA.
Purdue to pay states’ legal fees and urged to help opioid victims
Purdue Pharma is to reimburse the legal fees for states that backed its proposed $10 billion settlement of opioid lawsuits, but with a condition meant to help victims of the addiction crisis.
Keytruda overtakes Opdivo in Q3 sales to reach $3.1bn
Sales of Merck’s drug Keytruda have grown beyond those of Bristol-Myers Squibb’s Opdivo, to become the global leading PD-1 inhibitor.
