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This edition of Quick Notes features announcements of Merck’s acquisition of EyeBio, J&J’s agreement with Numab Therapeutics, Becton Dickinson’s acquisition of Edwards Lifesciences Critical Care product group and Boston Scientific’s purchase of Silk Road Medical. Read More
Several Philips BiPAP devices and certain Baxter Life2000 ventilator systems are under FDA Class I recalls, the most serious type of recall, as use of the devices can result in serious injury or death. Read More
Identifying disease biomarkers in rural and medically underserved populations through breath-based diagnostics devices is the goal of the FDA’s partnership with the Bill & Melinda Gates Foundation, CDRH announced Wednesday. Read More
Changes to the Risk Evaluation and Mitigation Strategy (REMS) for all six approved CAR-T cell therapies remove the requirement for providers to engage in specific educational activities and allow them to report adverse events directly to the FDA’s MedWatch reporting system. Read More
This month Takeda struggles to find the bright side of disappointing phase 3 data, Pfizer touts “unprecedented” lung cancer success, NS Pharma’s Duchenne muscular dystrophy drug fails in phase 3, and GLP1-agonists are not only reducing mortality, but getting a subdermal device makeover. Read More
Merck and Daiichi Sankyo’s non-small cell lung cancer drug suffered a setback with the companies’ receipt of an FDA complete response letter (CRL) identifying third party manufacturer inspection issues as the reason for rejecting the drug application. Read More
The ongoing effort by the FTC to remove what it labels improper and inaccurate — or “junk” — listings of drug patents in the FDA’s Orange Book continues, with all cited drugmakers refusing to delist the 300 patents called out by the commission on April 30. Read More
In this edition of Quick Notes EU, we take a peek at new advice regarding phthalates in medical devices, advice for drugmakers facing shortage woes and Finland’s worry over the deadly side effects of a painkiller. Also, when is an orphan device an orphan? Read More
The FDA issued a complete response letter (CRL) for foscarbidopa/foslevodopa (ABBV-951) based on observations from an inspection at one of AbbVie’s third-party manufacturing facilities, the company announced yesterday. Read More
In a reversal of the previous court’s decision, the US Court of Appeals for the Federal Circuit gave Amarin a win in its fight over Hikma’s generic version of Amarin’s cardiovascular drug Vascepa (icosapent ethyl). Read More
The seven-year effort to modernize FDA’s New Drugs Regulatory Program (NDRP) has paid off, with improvements in assessing drug approval applications, monitoring drug safety, operational efficiency and recruiting and retaining staff, according to a new CDER report. Read More
Finding troubling irregularities in their analysis of FDA’s foreign drug manufacturer inspections, House Energy and Commerce Republicans are pressing the agency for answers. Read More