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Nearly two months into the Biden administration, the president has still not nominated a permanent FDA commissioner or spoken publicly on who he’s considering, and a group of six former agency heads are imploring him to prioritize the task. Read More
Moderna has announced that it has begun dosing trial participants with a modified COVID-19 vaccine meant to target the variant SARS-Cov-2 strain first identified in South Africa. Read More
House Democrats passed the $1.9 trillion COVID-19 relief bill yesterday in an 220-211 vote along party lines, sending the legislation to President Biden’s desk for signing on Thursday. Read More
EU member states increasingly frustrated with the speed of vaccine rollouts are going it alone through separate authorizations and side deals for vaccines from Russia and China. Read More
Novartis subsidiary Sandoz is suing the FDA over the new chemical entity (NCE) exclusivity it granted Sanofi’s multiple sclerosis drug Aubagio (teriflunomide), alleging the five-year protection it gave was unlawful and wrongly kept Sandoz’s generic teriflunomide from being reviewed by the agency. Read More
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