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Pfizer and OPKO Health drew a Complete Response Letter (CRL) from the FDA for their Biologics License Application (BLA) for Ngenla (somatrogon), an injectable, long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients. Read More
“Giving foreign drug manufacturers in countries like China a ‘heads up’ before facility inspections … makes about as much sense as relying on the [Chinese Communist Party] to make these critical goods in the first place,” said Sen. Joni Ernst (R-Iowa). Read More
Kura Oncology said Friday that the FDA has lifted a partial clinical hold placed on the company’s early-stage clinical trial of its drug candidate, KO-539, in patients with relapsed or refractory acute myeloid leukemia (AML). Read More
The UK’s National Institute for Health and Care Excellence (NICE), the body that evaluates medicines for use by the National Health Service (NHS), is changing the way it makes judgments on treatments. Read More
Despite the pandemic, the FDA’s product review performance as it related to the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Amendments (BsUFA) remained relatively stable through fiscal year 2020 to fiscal year 2021, according to the latest data posted on the agency’s “dashboard” — which tracks how well the agency is living up to its review commitments under the user fee programs. Read More
The next FDA commissioner — most likely Robert Califf, who is now awaiting a confirmation vote by the Senate — will face a tough 2022 on multiple fronts, beyond just dealing with the ongoing pandemic and drug supply-chain shortages. Read More
The European Parliament has endorsed a plan to strengthen the powers of the European Medicines Agency (EMA) to increase monitoring of the supply chain for drugs and medical devices. Read More
In early January, HHS appealed decisions issued in three federal courts that called into question the agency’s authority to punish drug companies who refuse to participate in the 340B program. Read More