FEATURE

SCLC Treatment Gets a Boost as PharmaMar’s Lurbinectedin Bags Priority Review Status

By Ruchi Jhonsa, Ph.D. The FDA has accepted PharmaMar and Jazz Pharmaceuticals’ request to process the new drug application (NDA) for Lurbinectedin on priority review. If approved, Lurbinectedin will be used for the second-line treatment of Small Cell Lung Cancer (SCLC). More importantly, it will be the first drug to be approved in 20 years that can treat SCLC in relapsed patients. The agency has set the Prescription Drug User Fee Act (PFUDA) target action date as August 16th of this year. PharmaMar submitted the priority review application to the FDA on the basis of successful Phase II, monotherapy trials. Following the positive results in the trial, late last year, Jazz pharmaceuticals had struck a deal with PharmaMar, according to which the former would become the exclusive license holder of Lurbinectedin with US marketing rights following FDA approval. Small Cell Lung Cancer SCLC is an aggressive cancer of the lungs,...
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SCLC Treatment Gets a Boost as PharmaMar’s Lurbinectedin Bags Priority Review Status
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Weekly Cover:Foundation Medicine and Chugai Partnership with National Cancer Center

By Ching-Hsu Yang, Ph.D. Candidate 0210-0216 Foundation Medicine and Chugai Announce Partnership with National Cancer Center for the Use of FoundationOne®Liquid in the Third Stage of SCRUM-Japan  SCRUM-Japan, the largest nationwide cancer genome screening consortium in Japan, aims to apply genomic insights based on the blood to educate and accelerate the production of precision medicine strategies for advanced cancer patients. Foundation Medicine, Inc. and Chugai Pharmaceutical, Ltd. announced on February 13, 2020 that the two companies have entered into an agreement with the National Cancer Center (NCC) for the use of FoundationOne®Liquid, Foundation Medicine’s proprietary liquid biopsy test, in the third stage of SCRUM-Japan. The international initiative, in cooperation with hospitals on a regional scale in Japan and other countries in Asia, offers genomic screening and aims to accelerate the development of novel biomarker-driven precision cancer therapies. About SCRUM-Japan The third stage of SCRUM-Japan is structured in two programs –...
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Weekly Cover:Foundation Medicine and Chugai Partnership with National Cancer Center
FEATURE

VEGF Inhibitor, Beovu Gets EC Approval for Wet Age-Related Macular Degeneration Treatment

By Ruchi Jhonsa, Ph.D. Developed by Novartis, Beovu becomes the first anti-VEGF treatment of wet age-related macular degeneration to receive approval from the European Commission today. Beovu is the first EC-approved treatment to demonstrate superior resolution of retinal fluid (IRF/SRF), a key marker of disease activity in comparison to Eylea (aflibercept) developed by Regeneron. The EC approval came after the drug met the primary endpoint in Phase III HAWK and HARRIER clinical trials that demonstrated gains in best-corrected visual acuity (BCVA) when compared to aflibercept. The biggest advantage of Beovu in comparison to other drugs like Lucentis and Eylea is reduced need to visit clinics as it offers three-month dosing intervals immediately after the loading phase to eligible individuals. This is a big achievement for wet AMD treatments as more than 20 million people worldwide affected by the disease drop off existing treatments because of the frequent need to get...
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VEGF Inhibitor, Beovu Gets EC Approval for Wet Age-Related Macular Degeneration Treatment
FEATURE

GSK Wins EMA Approval to Market Multiple Myeloma Treatment

By Judy Ya-Hsuan Lin Multiple myeloma is the second most common blood cancer, as more than 48,000 people in the European Union were diagnosed with it in 2018. Multiple myeloma is treatable, but not curable. The high number of diagnoses and the limitations in current treatment options warrant greater R&D and investment opportunities for developing a potential panacea for the illness. Belantamab mafodotin (GSK2857916) is a new multiple myeloma treatment developed by GlaxoSmithKline (GSK), a global healthcare company. It is an investigational, antibody-drug conjugate for which GSK had sought approval from regulatory bodies in the US and Europe. At the start of this month, the drug received marketing authorization and an accelerated assessment by the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP). The drug had earned EMA’s PRIME designation back in 2017. PRIME is a program seeking to expedite the development of investigational medicines that demonstrate clinical...
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GSK Wins EMA Approval to Market Multiple Myeloma Treatment
FEATURE

New ‘Minigene’ Insertion Approach Could Treat Rare Liver Disease in Mice

By Ruchi Jhonsa, Ph.D. Ornithine transcarbamylase (OTC) deficiency is an X linked, rare genetic disorder that is caused by a complete or partial lack of enzyme ornithine transcarbamylase. Resulting in an excessive accumulation of ammonia in the blood, OTC deficiency can lead to neurological abnormalities, reduced muscle tone and enlarged liver, respiratory abnormalities and eventually coma. Although the occurrence of OTC disorder is rare (1 in 40000), it can occur by genetic aberrations at more than 300 different regions on the gene. Current therapeutic methods aim at suppressing the symptoms by reducing protein amount in the food or supplementing citrulline or ornithine or essential amino acids in the diet. However, when ammonia levels shoot up in the blood, a drug intervention is needed to clear it. Buphenyl and Ravicti by Hyperion Therapeutics and Ammonul by Valeant Pharmaceuticals are the only drugs approved by the FDA for the treatment of chronic...
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New ‘Minigene’ Insertion Approach Could Treat Rare Liver Disease in Mice
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INTERVIEW

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FEATURE INTERVIEW

Peeking into the Future of Synthetic Biology and Gene Editing, an Exclusive Interview with Dr. George Church

GeneOnline interviewed the legendary Dr. Church, while he was invited to the National Institute of Genomics and Proteomics of Taiwan University, and had him share some of his opinions on the field of genetic engineering with the audience. The Father of Synthetic Biology If you want to describe Dr. George Church in one sentence, many people will say that he is "the most daring synthetic biologist." You may have heard of genetic engineering, but you probably haven't thought about the crazy things that genetic engineering can do! The fictional genetic engineering ideas that occur only in movies has now been gradually realized. This includes editing DNA to treat hereditary diseases, editing aging genes to reverse aging, replacing USB with DNA...
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Peeking into the Future of Synthetic Biology and Gene Editing, an Exclusive Interview with Dr. George Church
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INDUSTRY

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First AI-Guided Ultrasound ECHO Software Approved for Marketing

Caption Guidance, an echocardiography software, offers real-time guidance for ultrasound image acquisition using artificial intelligence technology.  On February 7th, San Francisco-based startup Caption Health (previously known as Bay Labs), announced …

ASIA INSIGHT

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Weekly Cover:Foundation Medicine and Chugai Partnership with National Cancer Center

By Ching-Hsu Yang, Ph.D. Candidate 0210-0216 Foundation Medicine and Chugai Announce Partnership with National Cancer Center for the Use of FoundationOne®Liquid in the Third Stage of SCRUM-Japan  SCRUM-Japan, the largest …

TECHNOLOGY

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Scientists Use CRISPR To Fight Duchenne Muscular Dystrophy

The Disease  Duchenne Muscular Dystrophy (DMD) is an X-linked recessive disorder predominantly affecting male children. This debilitating, muscle-weakening disease is the most common and severe form of muscular dystrophy. It is caused due to defective frameshift mutations in the …

NORTH AMERICA

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JP Morgan Healthcare Conference 2020 Updates

By Rajaneesh K. Gopinath, Ph.D. Although major merger or acquisition announcements have eluded the 38th Annual JP Morgan Healthcare Conference so far, several companies have shared important updates and collaboration deals. …

TODAY IN HISTORY

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