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Home » Newsletters » BioWorld

BioWorld

Oct. 13, 2021

View Archived Issues
Syringe with Johnson and Johnson logo

FDA briefing docs build stronger case for 2nd J&J vaccine dose

Should Johnson & Johnson’s (J&J) COVID-19 vaccine be a two-dose series? While not directly asked, that question almost lurks between the lines of the FDA’s briefing document for the Oct. 15 meeting of its Vaccines and Related Biological Products Advisory Committee. The document referred to J&J’s proposed second dose as a “booster,” but the FDA isn’t asking the committee the questions it posed for the Moderna Inc. and Pfizer Inc.-Biontech SE boosters. Instead, it is inviting VRBPAC to advise on whether the second J&J dose should be administered two months or six months following the first shot. Read More

Immusoft, Takeda in potential $900M+ rare metabolic disease deal

In its first big pharma deal since it was founded around a cell programming technology in 2009, Immusoft Corp. signed Takeda Pharmaceutical Co. Ltd. to a research collaboration and license option targeting rare inherited metabolic disorders. The agreement brings an undisclosed up-front fee and research funding to Immusoft, which is also eligible to earn more than $900 million if all options are exercised and all milestones hit. Read More
Eye illustration

Intellia, Sparingvision see new paths to ophthalmology market in partnership

LONDON – Intellia Therapeutics Inc. is to receive 10% of the equity in Sparingvision SAS as part of a deal giving the French ophthalmology specialist certain exclusive rights to in vivo CRISPR/Cas9 technologies in the treatment of ocular diseases. Read More

ECTRIMS opens: Biogen therapies did not reduce COVID-19 antibody responses in MS patients

Biogen Inc. opened the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting with data showing those treated with its multiple sclerosis (MS) therapies had an effective antibody response to COVID-19 vaccination. Read More
Liver and DNA

Hansoh and Olix ink $450M+ liver-focused siRNA therapeutics deal for greater China

In a deal that could be worth more than $450 million, Olix Pharmaceuticals Inc. and Hansoh Pharmaceutical Group Co. Ltd. have agreed to discover, develop, and commercialize siRNA therapeutics for various liver-based targets implicated in cardiovascular, metabolic, and other indications. Read More

Khondrion heading for pivotal trial as mitochondrial disease competition mounts

Mitochondrial disease, where the tiny energy factories in cells aren’t functioning properly, can have devastating and sometimes fatal consequences. As there are no approved treatments, patients rely on strategies such as strict diets and conserving energy to try and control symptoms that can affect organs including the brain, kidneys, muscles, pancreas and heart. Netherlands-based biotech Khondrion BV is one of a group of companies that is making progress against this group of rare inherited conditions that affects around one in every 4,000 people. Read More
Cancer cells under magnifying glass

Aum Biosciences closes $27M series A financing for targeted cancer drugs

Aum Biosciences Pte. Ltd., a company developing targeted cancer therapies, has closed a $27 million series A funding round. The Singapore-based company plans to use the proceeds to advance clinical development of its portfolio with immediate initiation of two phase II programs for MNK and tropomyosin receptor kinase inhibitors. Read More

ICH guidance encourages use of continuous manufacturing

The U.S. FDA issued a draft guidance Oct. 13 on continuous manufacturing of small-molecule drugs and therapeutic proteins. Read More

Appointments and advancements for Oct. 13, 2021

New hires and promotions in the biopharma industry, including: Adicet, Ampio, Cytovia, I2O, J&J, Lianbio, Pepgen, Poseida, Prime Medicine, Reform, Satsuma, Tracon, Travere, Verismo. Read More

Conference data for Oct. 13, 2021: AACR-NCI-EORTC

New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research virtual International Conference on Molecular Targets and Cancer Therapeutics, including: Basilea, Black Diamond, Catalym, Compass, Immuneering, Repare. Read More

Financings for Oct. 13, 2021

Biopharmas raising money in public or private financings, including: Axial, Bicycle, Relay, Rezolute, Sarepta, Xortx. Read More

In the clinic for Oct. 13, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advaccine, Aerie, Agenus, Apeiron, Arcturus, Ascletis, Astellas, BMS, Inflarx, Inhibrx, Inovio, Istari, Otonomy, Vtv. Read More

Other news to note for Oct. 13, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aavantibio, ABVC, Acceleron, Agenus, Albireo, Betterlife, Bionova, Biolite Japan, Bristol-Myers Squibb, Emmaus, Fosun, Helsinn, Jadeite, Kainos, Merck, Mission, Rxcell, Sapience, Sutro, Titan. Read More

Regulatory actions for Oct. 13, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Corium, Curevac, Deciphera, Gensight, Hoth, Intelgenx, Nrx, Ocular, Protara, Sofie, Viiv. Read More

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