An international task force launched in March to identify new approaches for analyzing and addressing competitive concerns arising from biopharma M&As is now seeking public comment to inform their review.
While acknowledging the net health benefit over standard of care in heavily pretreated multiple myeloma patients, CAR T-cell therapies Abecma (idecabtagene vicleucel) and ciltacabtagene autoleucel (cilta-cel) represent low long-term value at their current pricing levels, according to the Institute for Clinical and Economic Review (ICER) in a final evidence report released May 11.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alume, Biocryst, Cstone, Endogena, Evofem, Fulcrum, Northwest, Wake Network.
HONG KONG – The Biden administration’s support for a TRIPS waiver of COVID-19 vaccine patents has already met a chorus of resistance from Western companies. In Asia, skepticism about how it would be achieved and what it will cover, is widespread.
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).
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