Celltrion received two complete response letters from the FDA regarding biologics license applications for Truxima (rituximab) and Herzuma (trastuzumab) — biosimilars of Roche`s blockbuster cancer drugs Rituxan and Herceptin. Source:…
The FDA published a new draft guidance on the scientific and ethical considerations for including pregnant women in clinical trials, telling sponsors that data are needed to inform safe and…
The Chinese government unveiled a new policy whereby some generics manufacturers could qualify for a “high-tech enterprise” designation, making them subject to a 15 percent corporate tax rate compared to…
The FDA requested stakeholder feedback on its 2003 guidance on exposure-response analyses — prompted by PDUFA VI provisions on advancing model-informed drug development. Source: Drug Industry Daily
India’s Central Drugs Standard Control Organization is creating a national database of pharmaceutical manufacturers, and will require reporting of facility and product details for inclusion in the database. Source: Drug…
A lawsuit from the federal government and 31 states accuses McKesson Corp. of repackaging “overfill” cancer drugs and fraudulently billing federal and state governments. Source: Drug Industry Daily
Internet service providers, social media companies, and other prominent members of the Internet economy need to help identify and remove illegal offers to distribute opioids, FDA Commissioner Scott Gottlieb said…
Osiris Therapeutics filed a lawsuit against MiMedx Group for alleged theft of its clients and pre-paid commissions to Osiris’ longtime distributor Stability Biologics. Source: Drug Industry Daily
The National Institutes of Health launched a new initiative to address the opioid crisis, increasing funding for research on opioid misuse, addiction and pain from approximately $600 million in fiscal…
The FDA published a final guidance for industry on what applicants should submit for NDAs and ANDAs for liposome products. Source: Drug Industry Daily