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Home » Newsletters » BioWorld

BioWorld

Sep. 16, 2020

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European Commision headquarters

European Commission president announces plan for EU version of BARDA

LONDON – The EU is to set up an equivalent to the U.S. Biomedical Advanced Research and Development Authority (BARDA), after coming under criticism from pharma companies about Europe’s inability to swiftly seal advance purchase agreements for COVID-19 vaccines. The plan was announced on Sept. 16 by European Commission President Ursula von der Leyen, in her first state of the union address since coming into office at the start of 2020. The new agency will support capacity and readiness to respond to cross-border health threats and emergencies, “whether of natural or deliberate origin,” she said. Read More

Indian study adds to uncertainty about the value of COVID-19 convalescent plasma

A new randomized controlled trial (RCT) of COVID-19 convalescent plasma (CCP) treatment for moderately ill COVID-19 patients run at 39 Indian hospitals found no association between CCP therapy and reduced mortality or progression to severe disease. Read More
Mask with Brazilian flag

Brazil: A battlefield for a vaccine cold war

CAJICA, Colombia – Latin American countries are rushing to sign deals to gain access to SARS-CoV-2 vaccines, with Brazil, the largest in the region, right in the race. Already, the country has the third most COVID-19 cases globally, behind only India and the U.S. Read More

Arrowhead hits the mark with interim phase II data in rare liver disease

The positive interim 24-week liver biopsy results from Arrowhead Pharmaceuticals Inc.’s open-label phase II of its RNAi-based liver-targeted therapeutic, ARO-AAT, came as a surprise to the developers. Read More
Rainbow-DNA.png

Graphite Bio raises $45M series A for targeted DNA integration

DUBLIN – Versant Ventures, the founding investor of Crispr Therapeutics AG, is teaming up with one of the academic founders of that company, Stanford University’s Matt Porteus, to start a new gene editing firm, Graphite Bio Inc., which is focused on targeted integration of DNA to achieve a therapeutic benefit. Read More

Adrecizumab shows apparent mortality benefit in septic shock trial

DUBLIN – Adrenomed AG reported its anti-adrenomedullin antibody, adrecizumab, attained an absolute reduction of 9% in mortality as compared with placebo at both 14 and 28 days (D28) after treatment in a phase II trial in a large subgroup of patients with septic shock. Read More
COVID-19 vaccine vials behind U.S. capitol building

CDC releases vaccination plan, but vaccine for all unlikely before mid-2021

A Sept. 16 Senate hearing revisited the Trump administration’s response to the COVID-19 pandemic, and the CDC took the opportunity to post a vaccine distribution plan. CDC director Robert Redfield advised the committee, however, that sufficient quantities of vaccine to cover everyone in the U.S. might not be available until the third quarter of 2021, adding that now is the time to stand up a distribution network for a vaccine that will require cold-chain storage. Read More

Biopharma companies draw ire for stepping into 340B oversight void

Given the minimal accountability written into the 340B prescription drug discount program, a few biopharma companies recently began taking oversight into their own hands by demanding data claims or refusing to extend the mandated discounts to contract pharmacies. Read More
Gympie Gympie stinging tree

If a tree stings in the wood, it’s with a peptide

BioWorld looks at translational medicine, including: Glial metabolism affects neural recovery; A tense defense. Read More

More than a pledge is needed, CEOs told

The latest global regulatory news, changes and updates affecting biopharma, including: DMF a pathway for cannabis drugs. Read More

Appointments and advancements for Sept. 16, 2020

New hires and promotions in the biopharma industry, including: Acasti, Acceleron, Adicet, Asklepios, Century, Compass, Dicerna, Forendo, Forma, Immunome, Moderna, Pneumagen, Rain, Revitope, Vedanta, Volastra, Voyager. Read More

Financings for Sept. 16, 2020

Biopharmas raising money in public or private financings, including: Inhibikase, Metacrine, Polyneuron, Stemson, Zai. Read More

In the clinic for Sept. 16, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adrenomed, Aim Immunotech, Algernon, Arcutis, Arena, Arrowhead, Aveo, Eli Lilly, Exicure, Galera, Genelux, Heron, Horizon, Immune-Onc, Knopp, Menarini, Ryvu, Springworks, Verastem, Verona. Read More

Other news to note for Sept. 16, 2020

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 4TEEN4, 7 Hills, About, Accustem, Allist, Bioclonetics, Cantabio, Dr. Reddy’s, Enzolytics, Greenlight, Havn, Histogen, Hookipa, Inflammasome, Inmune, Janone, Nanoviricides, Octimet, Oncbiomune, Pfizer, Poseida, Revive, Revolution, Seqirus, Springworks, Synaffix, Tiziana, Transcenta, Yufan. Read More

Regulatory actions for Sept. 16, 2020

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AVM, Cura, Mateon, Mediwound, Orphazyme. Read More

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