July 2, 2020 - BioPharma Dive
cientists, drugmakers and governments are moving with unprecedented speed to deliver a vaccine to protect against the new coronavirus.
The fastest of them have already delivered preliminary data from human studies, and further results from others should come quickly as the year progresses.
The goal, at least in the U.S., is to have a vaccine ready for use in some fashion by the end of the year, or early next. Doing so would be a scientific feat with few parallels. No vaccine has ever been developed so quickly, never mind manufactured for the world.
July 2, 2020 - Fierce Biotech
Sarepta Therapeutics has
a license to a drug that could enable more patients to receive its gene therapies. The deal grants Sarepta the exclusive right to use Hansa Biopharma’s imlifidase to eliminate neutralizing antibodies in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophy (LGMD) patients.
Many gene therapies, including those in development in DMD and LGMD at Sarepta, use a type of adeno-associated virus (AAV) to get the genetic material into cells. Some patients have preexisting antibodies against AAV, rendering them ineligible for treatment with gene therapies that rely on the vector. One
found 17% of patients have antibodies against Sarepta’s AAVrh74 vector.
The Hansa deal gives Sarepta a shot at making the significant minority of patients with anti-AAVrh74 antibodies eligible for treatment with its DMD and LGMD gene therapies. The agreement centers on the antibody-cleaving enzyme imlifidase.
July 1, 2020 - Fierce Pharma
When Novartis shelled out $3.9 billion for France-based Advanced Accelerator Applications in 2017, it had blockbuster hopes for AAA’s Lutathera, a radiotherapy to treat neuroendocrine tumors (NETs).
Those expectations were not misplaced. In fact, demand for Lutathera is so high that AAA is planning to build a new 50,000-square-foot manufacturing plant in Indianapolis’ Purdue Research Park to make the drug and other radiotherapies, the Novartis unit said Tuesday.
The Indianapolis factory will open in 2023, said AAA, which did not release financial terms or hiring plans. It’s the subsidiary’s second U.S. manufacturing plant.
June 30, 2020 - BioPharma Dive
For the third time this month, researchers running a large clinical trial in the U.K. have released results likely to shape how physicians the world over treat COVID-19.
On Tuesday, investigators for the RECOVERY study announced that treatment with Kaletra, an antiviral therapy for HIV, was no better than usual care alone in preventing death among patients hospitalized with coronavirus disease. As a result, the trial committee decided to stop giving the drug in the study.
Only summary results are currently available, and the data has not yet been peer reviewed or published. But the findings from RECOVERY carry weight, as the trial involves thousands of patients randomized to receive either experimental treatments or standard supportive therapy.