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Research & Development

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Amgen, Adaptive Partner In COVID-19 Neutralizing Antibody R&D Effort

The companies are combining their technologies to seek neutralizing antibody therapeutics that could prevent or treat COVID-19, building on their previous partnership in monitoring minimal residual disease in blood cancers.

Coronavirus COVID-19 Deals Research and Development Strategies

Clinical Trials

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Latest From Clinical Trials

Dynacure’s Antisense Approach To Rare Myopathies Gets Funding Boost

France’s fledgling biotech Dynacure has pulled together a series C funding round to support its ongoing Phase I/II study of an antisense molecule for an ultrarare myopathy.

Rare Diseases Financing

Interview: iTeos Attracts Investors By Targeting TIGIT

The Belgian biotech has managed to attract considerable sums from venture capitalists over the past couple of years amid hopes that its two next-generation immunotherapies will be best-in-class agents.

Financing ImmunoOncology

Austria’s Apeiron To Attack COVID-19 At Its Entry Point

Apeiron Biologics has fashioned a recombinant version of the enzyme to which SARS-CoV-2 is thought to bind, and with governmental help has started a Phase II study in Austria, Germany and Denmark. 
 
 
 

 

Coronavirus COVID-19 Clinical Trials

Coronavirus Update: Neurimmune, Ethris, Fujifilm, Brii In New Bids Against COVID-19, Reata, Ionis Delay Studies

Neurimmune and Ethris partner on inhaled therapy. Reata, Ionis and others delay trials, Brii announces China antibody alliance, Fujifilm starts favipiravir trials. World's largest trial for health workers starts. 

Coronavirus COVID-19 Clinical Trials

Otsuka Dermatitis Candidate Looks Good At Phase III

New potential topical therapy in dermatitis space set to move towards Japan approval submission based on positive new results.

Japan Clinical Trials

COVID-19, Lockdown Affect Trials in India But Coping Efforts In Hand

The coronavirus pandemic has thrown up unprecedented challenges for the Indian clinical trials segment, as in other parts of the world. Experts tell Scrip how things are poised in the country including potential impact on some critical milestones, but efforts are underway to tackle the crisis.

Research & Development Coronavirus COVID-19
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Approvals

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Latest From Approvals

Pipeline Watch: Enhertu, Velexbru, Viltepso Approvals

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Sanofi’s Sarclisa Gets EMA Backing In Myeloma, Mirroring FDA OK

The EMA has recommended Sanofi’s anti-CD38 antibody Sarclisa as a combination-based third-line treatment for multiple myeloma, after US approval earlier in March.

Companies Cancer

Japan Tirabrutinib Approval Breaks New BTK Ground In Lymphoma

Japan approval for BTK inhibitor marks new indication but in a small niche market, while another clearance may help extend Latuda's commercial life.

Japan Approvals

Novartis Close To EU Approval For Zolgensma At Last

Novartis’s AveXis unit has received a CHMP nod for the spinal muscular atrophy gene therapy at its latest meeting, sending it on the final steps to market in the EU.

Approvals Companies

BMS Gets US Approval Of Ozanimod For Relapsing MS, But Launch Delayed

Zeposia, one of three Celgene candidates central to last year’s merger with BMS, obtains US FDA approval in relapsing MS. BMS, however, will delay the launch due to the COVID-19 pandemic.

Approvals Business Strategies

Japan Enhertu Nod Another Boost For Daiichi's Oncology Hopes

Novel antibody-drug conjugate receives approval in Japan for second-line breast cancer, providing another push to Japanese firm’s strategic plan to build up its oncology operations.

Japan Approvals
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