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ASCO: I-Mab's checkpoint inhibitor drug helper uliledlimab sees early promise in Tecentriq cancer combo test


(Aquila)
In the first data drop for the drug, I-Mab has some early positives from a phase 1 trial of its CD73 antibody uliledlimab when wedded to Roche’s Tecentriq.
China’s I-Mab made headlines over the past year for a huge $418 million raise followed swiftly by a $2 billion biobucks pact with AbbVie for its other pipeline asset lemzoparlimab, the biotech’s anti-CD47 monoclonal antibody, which AbbVie is also eyeing as a potential combination med with the blood cancer drug Venclexta.
The data out at ASCO next month, with a peek today via its abstract, isn’t for that drug but rather for I-Mab s earlier effort, the CD73 antibody uliledlimab, from a small phase 1 trial that combined the drug with Roche’s PD-1 checkpoint inhibitor Tecentriq. ....

Bristol Myers Squibb Opdivo , Roche Tecentriq , Bristol Myers Squibb , Jingwu Zang , Fierce Biotech , பிரிஸ்டல் மைஸ் ஸ்க்விப்ப் , கடுமையான பயோடெக் ,

2nd time lucky for Sanofi-GSK after passing small midstage COVID shot; eye approval by year-end


(Prostock-Studio / GettyImages)
After fumbling their first attempt, once rivals but now partners Sanofi and GlaxoSmithKline have passed a small phase 2 COVID-19 vaccine test, plotting a much larger phase 3 in the coming weeks and a late 2021 approval.
The data are very top-line, with results yet to be published in a journal (though we’ve become used to that over the past year), but the headlines look encouraging for the vax: Its adjuvanted recombinant shot “achieved strong rates of neutralizing antibody responses,” which the pair said was “in line” with those measured in people who have recovered from COVID-19.
The test, in adults 18 to 95 years, was only in 722 volunteers in the U.S. and Honduras, but the inoculation after both shots (and across all doses) showed 95% to 100% seroconversion (when your immune system responds by producing antibodies in response to the virus). ....

United States , Pharmas Astrazeneca , Fierce Biotech , Alaskan Native , African American , Big Pharmas Astrazeneca , Sanofi Pasteur , Covid 19 , ஒன்றுபட்டது மாநிலங்களில் , கடுமையான பயோடெக் , அலாஸ்கன் பூர்வீகம் ,

Daiichi Sankyo, AstraZeneca's $5B Enhertu follow-up shows early signs of success in breast cancer


(Daiichi Sankyo)
Daiichi Sankyo and partner AstraZeneca’s next-gen antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) has show glimmers of efficacy and a reasonable safety profile in its first data release in breast cancer.
Having already seen some positives in its non-small cell lung cancer test, which is further along, Daiichi and AstraZeneca published the first look at Dato-DXd in triple-negative breast cancer (TNBC) at a late-breaking mini oral presentation at the 2021 European Society of Medical Oncology (ESMO) Breast Cancer Virtual Congress conference Saturday.
Nearly one year ago, AZ agreed to pay $1 billion upfront over two years for ex-Japan rights to the drug, which works as an ADC that targets tumor-associated protein TROP2, plus another $5 billion in milestones. ....

Daiichi Sankyo , Immunomedic Trodelvy , European Society Of Medical Oncology , Breast Cancer Virtual Congress , Medical Oncology , Gilles Gallant , Fierce Biotech , தய்ச்சி சாங்கியோ , ஐரோப்பிய சமூகம் ஆஃப் மருத்துவ புற்றுநோயியல் , மருத்துவ புற்றுநோயியல் , கில்லஸ் மகத்தான , கடுமையான பயோடெக் ,

Orphan and Rare Disease Products: Driving Product Success, Patient Access


In Partnership With AmerisourceBergen
|
Apr 26, 2021 10:00am
Rare diseases impact about 25 million people in the United States. The vast majority of rare diseases have no effective treatment, creating an urgent need for more research and development in this space. While there is a growing number of therapies in development for rare and ultra-rare conditions, manufacturers developing these products face unique challenges throughout the patient and product journey.
AmerisourceBergen, a global healthcare company, has provided commercialization services for more than 100 rare disease products.  
Rebecca Willumson, Publisher of Fierce Biotech, spoke with Teri Burnell, SVP of Innovative Field Solutions at Xcenda, and Susan Weidner, SVP of IntrinsiQ Analytics, both a part of AmerisourceBergen, about market access and commercialization strategies manufacturers need to consider in order to drive product success and patient access. ....

United States , Teri Burnell , Rebecca Willumson , Xcenda Formularydecisions , Susan Weidner , Innovative Field Solutions At Xcenda , Innovative Field Solutions As Rebecca , Advanceiq Network , Fierce Biotech , Innovative Field Solutions , Intrinsiq Analytics , Him Rebecca , Senior Vice President , Im Susan Weidner , Orphan Drug Act , ஒன்றுபட்டது மாநிலங்களில் , கடுமையான பயோடெக் , இம் ரிபேக்க , மூத்தவர் துணை ப்ரெஸிடெஂட் , ஆர்ஃபந் மருந்து நாடகம் ,