Director of the US FDA’s Office of New Drugs says there will be a greater focus on identifying the optimal dose before a drug candidate advances into Phase III trials, but the problem is not limited to oncology, the target of Project Optimus.

Despite acknowledging that fully in-person meetings overall are better, survey respondents said they still want the flexibility that virtual attendance offers.

Study data met two key endpoints laid out in agency guidance, but Pfizer may not have enough evidence of the booster’s impact on current circulating virus variants, particularly Delta. It is also unclear Pfizer has made the case to FDA that a booster dose is need at this time or that they provided enough safety data.

If regulators agree with Pfizer’s conclusions – and briefing documents suggest that’s a big if – about real-world studies showing Comirnaty’s effectiveness waning over time, thereby justifying the need for a booster dose, it could be part of a historical moment for FDA’s use of RWE.

Sponsors of three drugs have withdrawn their EU marketing authorization applications in the middle of the assessment process, including one for a bladder cancer therapy that was recently turned down in the US.

The EU vaunts its vaccine donations and starts building resilience against future health threats, and the UK MHRA says Moderna can be used as a booster dose. Aviptadil has received scientific advice from the MHRA for its potential use as a treatment for COVID-19 patients.

Two orphan drugs, Chiesi’s Proscybi and Insmed’s Arikayce, were rejected for funding on the Scottish National Health Service.

The International Vaccine Institute’s director general warns about COVID-19 vaccine distribution inequalities and its serious consequences, arguing the case for increased global coordination and responsibility for action to improve the situation.

Peter Stein says FDA will set criteria for holding a virtual meeting and will be seeking stakeholder feedback.

The EU vaunts its vaccine donations and starts building resilience against future health threats, and the UK MHRA says Moderna can be used as a booster dose. Aviptadil has received scientific advice from the MHRA for its potential use as a treatment for COVID-19 patients.

Big pharma leaders warn of steep cuts to R&D and US jobs if US drug pricing reform legislation paves the way for direct government price negotiations.

From a record more than 100 entries, the finalists have been selected for 12 awards, representing the best and brightest of biopharmaceutical research. 

Drug and medical device company payments to doctors and hospitals for non-research related activities dropped for the first time in 2020 since CMS’s Open Payments database began collecting the information. 

Pink Sheet reporters and editors discuss Bluebird Bio’s decision to pull its gene therapy business from Europe, Eli Lilly potentially pushing regulatory boundaries with its Olympic TV spots, and the CMS decision to scrap the Trump aministration’s most favored nation reimbursement rule.

Novartis gets some praise for being willing to embrace cost-effective drug prices, but health policy analysts are skeptical the industry would truly adopt the idea for its best-selling drugs, particularly if the appropriate guardrails were put in place to ensure broader budget impact was controlled.  Holes were also poked in the way Novartis determined the total cost of drug utilization management on the US health system. 

The Cuban government has approved the country’s home grown COVID-19 vaccine for emergency use in children, while Mexico is poised to authorize another Cuban vaccine.

Having decided to suspend 12 million doses of Sinovac’s coronavirus vaccine, Brazil’s regulatory agency says it will need to make its own on-site assessment of conditions at the Chinese facility that makes the product.

World Health Organization director general says poorer countries should not have to be satisfied with richer country “left overs.”