Teva has received FDA approval for the first US generic naloxone nasal spray after a 30-month stay linked to ongoing patent litigation expired. Launch plans have not yet been revealed. Meanwhile, the Israeli firm has also introduced the first generic version of VESIcare in the US.
Teva’s naloxone hydrochloride nasal spray has become the first generic version of Adapt Pharma’s Narcan to receive final US Food and Drug Administration approval, following the expiry of a 30-month stay linked to ongoing patent litigation over the opioid overdose treatment. A tentative approval had been granted in June 2018.
However, the Israeli firm has not announced details of when and at what price it intends to sell its approved...
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
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Japanese generics giant Sawai appears to be turning a corner, but the impact of National Health Insurance pricing revisions continues to hold the firm – and the rest of the country’s generics industry – back.
Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.
Emerging CRISPR innovations, shifting regulatory landscapes, and rising partnerships are accelerating a paradigm shift in biotech pipelines
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
