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The FDA’s approval of Biogen’s Aduhelm for treatment of Alzheimer’s disease (AD) has taken regulators, payers and patients to an unprecedented intersection of medical need, clinical benefit and cost. Read More
Federal overreach in attempting to curb patent practices that allegedly lead to high drug prices could stifle innovation, an attorney for the Pharmaceutical Research and Manufacturers of America (PhRMA) told a Senate subcommittee yesterday. Read More
The Biden administration has walked back a proposal from the waning days of the Trump administration that would have restricted federal use of march-in rights for drugs. Read More
A federal court judge has dismissed all complaints against generic drug manufacturers and pharmacy chains regarding allegations that they knowingly sold the heartburn drug ranitidine containing a likely carcinogen. Read More
AstraZeneca and Johnson & Johnson are looking at modifying their COVID-19 vaccines to reduce the risk of blood clots, while the European Medicines Agency (EMA), following the lead of the FDA, is analyzing data on rare cases of the nerve disorder Guillain-Barré syndrome (GBS) reported among people who had the J&J vaccine. Read More
The first doses are expected to arrive by the end of September or possibly later, depending on BioNTech’s production schedules and the progress of vaccinations in Taiwan. Read More
The FDA issued an advisory to drugmakers about the risk of bacterial contamination of non-sterile water-based drug products by Burkholderia cepacian (BCC). Read More