After showing power in its frequency of dosing and efficacy, Vabysmo (faricimab) has been approved by the FDA for treating wet, or neovascular, age-related macular degeneration and diabetic macular edema. The treatment was developed by Genentech Inc., a unit of Basel, Switzerland-based Roche Holding AG, and Chugai Pharmaceutical Co. Ltd. Vabysmo is one of the potential blockbusters outlined in Clarivate’s recently published Drugs to Watch 2022. The list is composed of drugs that could in the next five years each earn more than $1 billion annually and predicts Vabysmo has the potential to be a blockbuster in both indications, reaching sales of $2.72 billion in 2026. A launch could happen in the coming weeks in the U.S.

EMA’s new clinical trials system comes online

LONDON – After six years in development, EMA’s new clinical trials information system (CTIS) is switched on today, bringing to life a law enacted in 2014 to create a single, harmonized regulatory system across the EU. As the embodiment of the Clinical Trial Regulation, CTIS will underpin a long-awaited simplification of the process for approving trials. Rather than separate applications to different national regulators, a single application delivered via CTIS can lead to simultaneous regulatory and ethics approvals in up to 30 countries.

US lawmakers urge more public control of COVID-19 vaccines

Moderna Inc. reached a milestone of sorts today as the U.S. FDA fully approved its COVID-19 vaccine, Spikevax, for use in adults. But that vaccine, as well as the Pfizer Inc.-Biontech SE vaccine, is in the sights of the U.S. Congressional Progressive Caucus as it pushes the Biden administration to do more to ensure global vaccination. In a letter last week, the caucus, led by Rep. Pramila Jayapal (D-Wash.), called on President Joe Biden to persuade EU leaders to sign on to a proposal before the World Trade Organization that would waive all intellectual property related to COVID-19 vaccines, diagnostics and therapies. The caucus also requested that Biden “compel” technology transfer of the mRNA vaccines and retain public ownership over any new COVID-19 vaccine manufacturing capacity established in the U.S.

Becerra asked to intervene in US agency turf war over Alzheimer’s drugs

While comments continue to stream in, both in opposition and support, on the U.S. Centers for Medicare & Medicaid Services’ (CMS) proposed national coverage decision that would restrict Medicare coverage of monoclonal antibodies intended to treat Alzheimer’s to use in CMS- or certain NIH-approved clinical trials, some groups also are appealing to Health and Human Services (HHS) Secretary Xavier Becerra to step into an HHS agency turf war. “Something is very, very wrong within HHS when two of its agencies are at war,” patient advocacy group Us Against Alzheimer’s said in a letter to Becerra last week. The group called on the secretary to intervene in CMS’ decision-making to ensure patients with Alzheimer’s will have access to new treatments being developed.

FDA combination products guidance offers more flexibility for cross-labeled combos

FDA regulation of combination products has always been complicated, and a new final guidance takes up the long-standing controversy over FDA review of these applications. The final guidance makes explicit the possibility that the individual components of a cross-labeled combination product will be reviewed separately, a concession that industry saw as critical to ensure that these applications can make it through the FDA gauntlet without undue delay.

Australia hammers out new models to improve access to innovative therapies

PERTH, Australia – A new parliamentary report, The New Frontier: Delivering better health for all Australians, is recommending significant reforms to the health care system to ensure Australians have faster access to new drugs and devices. The House of Representatives Standing Committee on Health, Aged Care and Sport examined the range of new drugs and emerging medical technologies that are in development and progressing through the regulatory system in Australia and in other countries. It made 31 recommendations that include streamlining the health technology assessment process, particularly for cell and gene therapies, and establishing a separate center for precision medicine and rare diseases within the Australian Government Department of Health.

Blueprint’s Ayvakyt among drugs heading for label extensions in Europe

Blueprint Medicines Corp.’s cancer drug Ayvakyt (avapritinib) looks set to gain an expanded label in Europe, amid a flurry of decisions from the European Medicines Agency’s CHMP scientific committee. Late last week the CHMP gave a positive opinion for Ayvakyt for treatment of adults with advanced systemic mastocytosis, meaning the drug is likely to gain a further European indication in the coming weeks.

Also in the news

Akeso, Altimmune, Aurealis, Avicanna, Blueprint, Can-Fite, Catalyst, Celltrion, Celsion, Cybin, Eagle, Elusys, Filament, Gandeeva, Genentech, Hanbio, Humacyte, Ideaya, Immunoprecise, Innocoll, Ionis, Janssen, Juvenescence, Kaleido, Kite, Madrigal, Mainz, Nordic, Novelmed, Nrx, Pfizer, Precisionlife, Reata, Regeneron, Sanofi, Scancell, Shionogi, Takeda, Taysha, Tollys, Veru, Viracta, Viridian