In an open letter to Pfizer Inc. employees, the company’s CEO, Albert Bourla, provided some insight about why some countries don’t have COVID-19 vaccines and others have a surplus. It has nothing to do with intellectual property (IP), or even price, Bourla said.
A cautious optimism pervaded the March 11 Senate Health, Education, Labor and Pensions (HELP) Committee update on COVID-19, with witnesses and lawmakers alike welcoming the continuing decline of infections, hospitalizations and deaths in the U.S.
Building on existing guidance and nearly eight years’ experience with biosimilar monoclonal antibodies and fusion proteins, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a final guidance detailing a streamlined approach to licensing biosimilars.
As expected, the FDA has expanded emergency use authorization (EUA) for Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), to include adolescents 12 through 15 years of age, marking what Acting FDA Commissioner Janet Woodcock called "a significant step in the fight against the COVID-19 pandemic."
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Bold, Cerecor, Foghorn, Organicell Regenerative Medicine, Pfizer, Rocket, Samus.
Biopharma companies need to provide unredacted access to both positive and negative clinical data for all new drugs and vaccines, whether the drugs have been rejected, authorized for emergency use, or granted full or conditional approval, according to the World Health Organization (WHO) and international regulators. “The COVID-19 pandemic has brought into sharp focus the need for improved transparency of medical research,” said EMA Executive Director Emer Cooke, who also chairs the International Coalition of Medicines Regulatory Authorities (ICMRA).
Despite the demonstrated benefits of using patient-reported outcomes (PROs) in clinical trials assessing new cancer drugs in adults, PROs are rarely used in pediatric cancer trials. Hoping to change that, the FDA is convening the pediatric subcommittee of its Oncologic Drugs Advisory Committee (ODAC) May 11 to discuss how to effectively use a pediatric form of the PRO version of the common terminology criteria for adverse events.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Ampio, Astrazeneca, Biocorrx, Eagle, Kyowa Kirin, Liquidia, Merck, Mustang, Pfizer, Smart.
The COVID-19 pandemic’s impact on inspections of drug and device manufacturing sites is a matter of record, but the agency says it is on track to resume inspections for high-risk considerations. However, the FDA also said it will likely make more extensive use of virtual inspection tools going forward, a development that may ease some of the operational interruptions engendered by conventional on-site inspections.
While it remains to be seen whether the FDA will break with its advisory panel and approve Biogen Inc.’s high-profile Alzheimer’s candidate by the June 7 PDUFA date, the clinical data for beta-amyloid-targeting aducanumab didn’t exactly impress experts at the Institute for Clinical and Economic Review, who suggested an annual price tag of $2,560 to $8,290.
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