Shionogi

Covid-19 development round-up: March 18, 2022

The state of the fight: 

Medicines Patent Pool sublicensed Pfizer’s Paxlovid to 35 generics manufacturers.
  Key WTO members reached a tentative agreement to waive some IP rights on Covid-19 vaccines.
  Moderna and Pfizer asked the U.S. FDA to authorize fourth doses of their respective jabs.   AUTHORIZED VACCINES

 
Medigen’s protein subunit vaccine (MVC-COV1901) offered similar safety and immunogenicity for adolescents as it did for adults, the Taipei-based…

Mentions:
Covid-19, vaccines, drugs, Medigen, WHO, Moderna, Sinovac, AstraZeneca, FDA, Pfizer, BioNTech, CanSino, Anhui Longcom, Clover, SII, CureVac, GSK, WTO, COVAX, Gamaleya Institute, Gavi, Bio E, J&J, MPP, DNDi, Vir, Merck, Shionogi
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Covid-19 development round-up: March 4, 2022

The state of the fight: 

Pfizer/BioNTech’s Comirnaty appeared to offer only 12% effectiveness against Omicron in children ages 5-11.
  South Africa’s Biovac partnered with nine development institutions to boost local vaccine manufacturing capacity.
  Eli Lilly’s arthritis drug Olumiant reduced the risk of death by 13% in hospitalized Covid-19 patients.   AUTHORIZED VACCINES

 
Pfizer/BioNTech’s Comirnaty is far less protective against infection in children ages…

Mentions:
Covid-19, vaccines, drugs, Pfizer, BioNTech, Novavax, Sinovac, Valneva, FDA, Bharat Biotech, Inovio, Shionogi, CureVac, GSK, Biovac, Gamaleya Institute, WHO, MPP, Moderna, Bio Farma, ACT-A, EMA, J&J, AstraZeneca, Merck, Regeneron, Roche, Lilly, Gilead, DNDi
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Covid-19 development round-up: February 25, 2022

The state of the fight: 

Sanofi and GSK’s vaccine candidate demonstrated 58% efficacy against symptomatic Covid-19 in Phase 3.
  Hetero Pharma’s generic version of Merck’s molnupiravir reduced the risk of hospitalization by over 65%.
  Britain and Japan pledged a combined $514 million to CEPI’s pandemic preparedness plan.   AUTHORIZED VACCINES

 
The U.S. FDA lifted its clinical hold on Bharat Biotech’s Covaxin, clearing the way for the inactivated vaccine to…

Mentions:
Covid-19, vaccines, drugs, Bharat Biotech, FDA, Ocugen, Pfizer, BioNTech, CDC, Medicago, GSK, Moderna, Gamaleya Institute, CNBG, Sinopharm, EMA, CanSino, Anhui Zhifei Longcom, Sanofi, Thermo Fisher, Valneva, CEPI, AstraZeneca, Sinovac, Africa CDC, COVAX, WHO, J&J, Vir, Merck, Gilead, Shionogi, Suzhou Abogen, Walvax
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Covid-19 development round-up: February 18, 2022

The state of the fight: 

Moderna applied for South African patents on its vaccine, potentially jeopardizing the work of the WHO-led mRNA vaccine “hub” operating in the country.
  WHO named five additional African countries that will receive vaccine technology from the hub.
  Laboratorios Farmacéuticos Rovi inked a 10-year mRNA vaccine manufacturing extension with Moderna.   AUTHORIZED VACCINES

                                       
Medigen’s protein subunit…

Mentions:
Covid-19, vaccines, drugs, Medigen, AstraZeneca, Biological E, Moderna, Novavax, Abogen, Walvax, Gamaleya Institute, WHO, Afrigen, Pfizer, BioNTech, COVAX, Gavi, Merck, Gilead, Roche, Shionogi
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Covid-19 development round-up: February 4, 2022

The state of the fight: 

South Africa’s Afrigen has produced the first batch of its version of Moderna’s mRNA-based vaccine.
  Afrigen also secured a $45 million grant from the U.N.-backed Medicines Patent Pool.
  Moderna’s Spikevax notched full approval in the U.S.

REGULATORY UPDATES

 
Pfizer and BioNTech have begun rolling data submission for authorization of their Comirnaty shot in children between ages 6 months and 5 years “at the request” of the U.S…

Mentions:
Covid-19, vaccines, drugs, NIH, Moderna, FDA, CDC, Pfizer, BioNTech, Gamaleya Institute, Novavax, J&J, Sinovac, CNBG, Sinopharm, EuBiologics, WHO, Afrigen, Biovac, BioManguinhos, MPP, Zydus Cadila, Merck, Shionogi
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Covid-19 development round-up: January 7, 2022

The state of the fight: 

India granted Biological E’s Corbevax—a low-cost, patent-free vaccine—its first regulatory authorization.
  A J&J booster was 85% effective against hospitalization in South Africa during the Omicron wave.
  India authorized molnupiravir but omitted the antiviral from its recommended clinical protocol on safety concerns.

 

AUTHORIZED VACCINES

 
Bharat Biotech’s Covaxin generated “superior antibody responses” in children…

Mentions:
Covid-19, vaccines, drugs, BBIL, Pfizer, BioNTech, AstraZeneca, J&J, Janssen, CanSino, CDC, Bio E, Novavax, FDA, SII, CNBG, Sinopharm, Moderna, Gamaleya Institute, Sinovac, SK Bioscience, CEPI, GSK, Vir, Merck, Regeneron, Roche, Gilead, Shionogi
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ViiV makes new HIV bet, touts PrEP

GSK subsidiary ViiV announced Tuesday that it will pay Shionogi nearly $27 million upfront (plus royalties and $20 million in milestones) for rights to the Osaka-based drugmaker’s S-365598 third-generation investigational integrase strand transfer inhibitor (INSTI) for potential use in ultra-long-acting HIV regimens (dosing intervals of three months or longer).

Preliminary data has shown that S-365598 “has a high genetic barrier and a resistance profile that is distinct from that of…

Mentions:
GSK, ViiV, Shionogi, HIV, drugs, FDA, PrEP
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European AMR incubator launches

A new nonprofit—dubbed the Incubator for Antibacterial Therapies in Europe (INCATE)—will support the European-based development of novel therapies, diagnostics and interventions to combat antimicrobial resistance. A Novo Holdings REPAIR Impact Fund director announced the incubator’s launch Sunday in a LinkedIn post.

INCATE’s support—a mix of consulting, business networking, and up to approximately $290,000 in non-dilutive funding (for selected projects)—aims to bring companies to “an…

Mentions:
AMR, INCATE, Novo Holdings, CARB-X, Boehringer Ingelheim, Roche, Shionogi
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CHAI, GARDP and Shionogi partner for antibiotic access

The Geneva-based Global Antibiotic Research and Development Partnership (GARDP) announced Tuesday that it has signed a memorandum of understanding (MOU) with the Clinton Health Access Initiative (CHAI) and Shionogi to accelerate LMIC access to the Osaka-based drugmaker’s antibiotic cefiderocol (Fetroja).

The collaboration will help introduce the drug—indicated for bacterial infections in patients with limited treatment options—into health systems and provide clinical guidance to…

Mentions:
GARDP, CHAI, Shionogi, LMICs, drugs, antibiotics, AMR, access to medicines
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Covid-19 development round-up: January 29, 2021

The state of the hunt:

Novavax’s protein-based vaccine candidate demonstrated 89.3% efficacy in a UK Phase 3 trial.
  J&J/Janssen’s single-dose vaccine was 66% effective against moderate to severe disease in Phase 3.
  Vaccines from J&J, Moderna, Novavax and Pfizer/BioNTech appear less effective against the SARS-CoV-2 variant first identified in South Africa.

 

Vaccines


Approved or authorized vaccines

AstraZeneca/Oxford’s…

Mentions:
Novavax, J&J, Janssen, Moderna, Pfizer, BioNTech, EMA, AstraZeneca, Oxford, SII, WHO, SAGE, Fosun, EU, Gamaleya Institute, CNBG, Sinopharm, Sinovac, BBIL, FDA, Imperial College London, Medigen, Dynavax, Providence Therapeutics, Merck, IAVI, Mass General Brigham, Penn Medicine, BMGF, GI-Cell, IVI, EC, Daiichi Sankyo, JCR Pharmaceuticals, CSL, Sanofi, Novartis, Africa CDC, Lonza, COVAX Facility, Pharmaniaga, Duopharma, AVATT, Valneva, COVAX, UNICEF, CEPI, DP World, FEMA, DoD, CDC, BIBP, Regeneron, Lilly, Vir, GSK, NIH, Zydus Cadila, Rigel Pharmaceuticals, Dr. Reddy’s, Fujifilm, Just-Evotec, Humanigen, BARDA, Emergent, Ajinomoto, Shionogi, Bioage Labs, Pulmotect, Civica Rx
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