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San Diego, Calif.-based Acadia Pharmaceuticals has received a notification of deficiencies from the FDA regarding its supplemental New Drug Application (sNDA) for Nuplazid (pimavanserin), an anti-psychosis drug being reviewed for treating dementia-related hallucinations and delusions. Read More
The European Commission (EC) will kick off a new pilot program later this month to collect information from drug sponsors to better understand why oncology and orphan drug products may be unevenly marketed across the 27-member bloc. Read More
More than two dozen PhRMA members have sent a letter to President Biden, imploring him to oppose India’s and South Africa’s proposal to the World Trade Organization (WTO) to waive intellectual property (IP) rights for COVID-19 innovations during the pandemic. Read More
The Senate passed a $1.9 trillion COVID-19 relief bill on Saturday in a 50-49 vote along party lines, including a $500 million appropriations injection for the FDA — equivalent to a 16 percent increase in the agency’s fiscal year 2021 funding. Read More
A large study has found that the Medicare Part D program could have saved almost $1.7 billion in one year if prescribers and patients had chosen generic drugs over their brand-name equivalents. Read More
The FDA has challenged a lawsuit filed by pharmacies against its compounding drug distribution regulations issued last year, contending it is too early to take the matter to court. Read More
An FDA expert panel on vaccines met on Friday to review strains to include in influenza vaccines for the next flu season and heard that the COVID-19 pandemic has changed the production landscape. Read More
As authorized COVID-19 vaccines are modified to protect against emerging strains of the pandemic disease, the UK will require only short clinical trials enrolling small numbers of volunteers to prove the altered vaccines are safe and effective, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said. Read More
The European Medicines Agency (EMA) has begun a rolling review of the Sputnik V COVID-19 vaccine developed by Russia’s Gamaleya Research Institute, but the European Commission doesn’t appear in a rush to secure doses. Read More
The FDA has released more meeting minutes from its talks with industry on reauthorization of the Prescription Drug User Fee Act (PDUFA), noting that there is interest in seeing the agency commit to expanding its use of real-world data in drug reviews, its capabilities for cell and gene therapy products, and other changes. Read More