Onesmo Mpanju is the Principal Consultant for Linq Pharma with extensive experience in the development and marketing approval of new pharmaceutical products.
Here's hoping @vandapharma long fired the genius who recommended a court challenge to FDA's imposition of a clinical hold over a friggin' toxicity study. Talk about penny wise and pound foolish.
Today we approved a first-in-class targeted therapy for metastatic pancreatic cancer – one of the hardest cancers to treat. Today’s approval provides a critical new treatment for patients who’ve had very few options. https://t.co/6f9WWJUdQ3
🇺🇬 A moment of hope for Uganda and the continent!
Uganda has officially discharged its last Ebola patient, a Congolese national who has made a full recovery and is now reunited with his family. This marks a powerful milestone as Uganda begins the crucial 42-day countdown to declare the outbreak over, in line with international health protocols.
Today’s discharge ceremony at Mulago National Isolation Unit brought together the Minister for Health, Hon. Dr Chris Baryomunsi (@CHRISBARYOMUNS1), Prof. Olaro Charles (@olaro_charles), Mr Kenneth Akiiri, and senior leaders from Africa CDC, @WHOUganda, @UNICEFUganda, and @MinofHealthUG.
Africa CDC celebrates the resilience, dedication, and teamwork of the Government of Uganda, health workers, and all partners. No new confirmed cases since 21 June: a testament to the unwavering commitment of national authorities and the Continental Incident Management Support Team (IMST).
#AfricaReady #AfricaResponds #EbolaResponse
Today, the FDA announced it has placed Sarepta Therapeutics investigational gene therapy clinical trials for limb girdle muscular dystrophy on clinical hold following three deaths potentially related to these products and new safety concerns that the study participants are or would be exposed to an unreasonable and significant risk of illness or injury. https://t.co/YgyESPmwkV
@dougkalmanphdrd One of the requirements is to "...[convey] all of the product’s most important risk information." For example, the Eli Lilly & Novo Nordisk executives should've provided a toll-free number during their segment for consumers to call for the approved labeling information.
@dougkalmanphdrd A more obvious regulatory jeopardy re: Eli Lilly's & Novo Nordisk's active participation in the Special: FDA Prescription Drug Advertising Regs per 21 CFR 202.1 require companies to comply with the 'Adequate Provision' requirement when engaging in consumer-directed broadcast ads.
Tanzania's health minister @ummymwalimu announces (in Kiswahili) first outbreak of #MarburgVirus in northwest Tanzania, #Bukoba Rural District. So far, 8 confirmed cases and five deaths reported, incl 4 members of one family. Contact tracing ongoing.
This is a proof-of-concept animal study of a novel recombinant chimeric horsepox virus (rcHPXV) based investigational vaccine (#TNX801) being developed by Tonix Pharmaceuticals for protection vs. monkeypox (MPXV). TNX-801 protected…https://t.co/kVckDW4SjD https://t.co/xUpW5Q52La
1/n I’ve been thinking about where we stand in the US currently with respect to COVID19 and how things might proceed until the end of the year and into Q1 2023
Thrilled to partner with Tonix Pharmaceuticals and Kenya Medical Research Institute (KEMRI) to progress this important clinical development project. https://t.co/KO05uqdZ11