pharmaphorum
MAY 14, 2021
China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. Kintor is in talks with the Brazilian health regulator Anvisa about a further trials.
Drug Discovery World
NOVEMBER 3, 2023
First spaceflight mission for drug development lab Redwire will launch its in-space pharmaceutical manufacturing platform, PIL-BOX, onboard SpaceX’s 29th cargo resupply services mission (SpaceX-29) for NASA to the International Space Station (ISS).
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pharmaphorum
DECEMBER 1, 2022
Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. About the author.
Advarra
MARCH 21, 2023
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?
XTalks
APRIL 26, 2021
After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. Malaria Vaccine Phase II Trial.
FDA Law Blog
MAY 3, 2021
The “responsible party” is the sponsor or principal investigator of the trial. An “applicable clinical trial” is generally defined to mean any clinical trial (other than a device feasibility trial or a phase I drug trial) to collect data to support an FDA premarket submission, such as a New Drug Application or 510(k) premarket notification.
pharmaphorum
AUGUST 4, 2020
Germany had the highest approval rate of orphan drugs at 98% – however most of these recommendations (73%) were awarded a ‘non-quantifiable benefit’ rating, the automatic rating for an orphan drug, which shows the regulator did not see any benefit compared to comparator products (see graph 1).
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