Clinical trial fraud has not been on the radar screen for drug and device makers in recent years, but there have been several episodes in which the operators of clinical trial sites had fabricated data for clinical trials. U.S. deputy assistant attorney general Arun Rao said recently that clinical trial fraud is now front and center for federal attorneys, raising the risk that any documentation errors for clinical trials will create a massive liability for the sponsor.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bloom Diagnostics, Intuitive Surgical, Svelte Medical Systems.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alnylam, Alterity, Beigene, Chinook, Hemogenyx, J&J, Kenox, Merck, Moderna, Pfizer, Rockwell, Sparro, TG, Tonix.
There was no slowing of biopharma innovation in 2021, even as industry directed significant resources to, while feeling the impact of, the ongoing COVID-19 pandemic. The year saw big wins for developers of DNA vaccines and biosimilars, while CAR T expanded its reach and a drug target once considered undruggable was finally conquered. And as 2021 gives way to 2022, other potentially game-changing technologies and therapeutics are waiting in the wings.
A cocktail of monoclonal neutralizing antibodies developed by Brii Biosciences Ltd. has become “the first locally-discovered and approved SARS-CoV-2 target-specific treatment in China, through a randomized, double-blind and placebo-controlled trial,” Rogers Luo, president and general manager of greater China at the company, told BioWorld.
The FDA added its green light to Klox Technologies Inc.’s Lumiheal fluorescent and blue light therapy system with de novo clearance for scar management of post-surgical incisions. The system uses fluorescence biomodulation technology to activate cellular processes and treat skin and soft tissue disorders.
Cardiologist Robert Califf has been nominated a second time to lead the FDA, and drug pricing was again high on the agenda at the Dec. 14 Senate hearing for his nomination.
The FDA has granted approval to Urotronic Inc. for its Optilume urethral drug-coated balloon (DCB) for the treatment of male urethral strictures. The device inhibits new scar tissue growth that may form after endoscopic dilations via the controlled release of paclitaxel, an antiproliferative that inhibits scar tissue formation.
While biopharma companies across the world pulled out all the stops in 2021 to develop and manufacture COVID-19 vaccines and therapies, the pandemic highlighted supply chain weaknesses, spurring demands in many countries for more domestic manufacturing and less reliance on production in other countries.
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