Targeting the toxic alpha-synuclein protein found in the brains of people with Parkinson’s is one of the most promising approaches to treat the disease in the clinic – but getting any drug into the brain is a challenge. Sanofi SA has joined with ABL Bio Inc. to solve this problem, in-licensing ABL-301, a preclinical bispecific antibody that locks on to misfolded alpha-synuclein but also includes a molecular “shuttle” that allows it to penetrate the blood-brain barrier. Read More
In proposing a national coverage determination to limit coverage of a class of Alzheimer’s drugs to those being used in clinical trials approved by the U.S. Center for Medicare & Medicaid Services or the NIH, CMS appears to be treading in FDA territory. “For the first time ever, Medicare is second-guessing FDA – and not only on work that it has already done, but on work FDA will do in the future,” said George Vradenburg, chair and co-founder of Us Against Alzheimer’s, a patient advocacy group. “HHS [the Department of Health and Human Services] is clearly at war with itself, with one agency approving this class of drugs and another slamming the door shut on treatment. . .. Does CMS no longer trust the FDA’s work?” Read More
The value of biopharma deals in 2021 rose above the prior year’s record by about 8%, thanks to an increasing number of high-money transactions. Mergers and acquisitions, however, fell 32% below 2020 as the industry gravitated more toward financings. Read More
LONDON – There was a marked increase in the projected return on investment in pharma R&D in 2021, which rose to 7%, the highest level since 2014. That was up from a lowly 2.7% in 2020 and – even worse – 1.8% in 2019, according to the 12th annual report tracking ROI by the consultants Deloitte. But while 7% is a significant improvement, it is still below the projected ROI when the first edition of ‘Measuring the Return from Pharmaceutical Innovation’ was published in 2010, in response to concerns that pharma was spending more and more on R&D while getting less out. At that point, projected ROI was 10.1%. Read More
Drug sponsors should not focus on influencing legislators about how to price rare-disease and orphan therapies, Ovid Therapeutics Inc. CEO Jeremy Levin said during a panel talk at Biotech Showcase. “The game is not in Washington,” he said. “The game is on the ground in each state, where you need to convince the public, the individuals, the patients that, in fact, you are bringing value.” Read More
Cellusion Inc. recently closed a ¥1.1 billion ($9.5 million) financing, bringing its total 2021 fundraising to ¥1.7 billion. The company is preparing to enter the clinic with CL-S001, its corneal endothelial substitute cell candidate for treating corneal edema due to endothelial dysfunction, or bullous keratopathy. Read More
Cansino Biologics Inc. has received marketing approval from the NMPA for its ACYW-135 meningococcal conjugate vaccine, Menhycia, making it the first of its kind to be authorized in China. The approval marks “an important step in accelerating the development of China’s meningococcal vaccine immunization strategy,” the company said. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advaxis, Aldeyra, Amryt, Ascletis, Awakn, Antares, Applied Genetic Technologies, Basilea, Cansino, Myrtelle, Nascent, Pharmamar, Quantum Leap. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aramis, Artelo, Biomica, Immunome, Phio, Polynoma, Snipr, Vertex, Wesana.
