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FDA Rejects Keytruda Dosing, Fast Tracks Tecentriq Lung Cancer Review
Keytruda is set to remain dominant despite knockback, though Tecentriq could claim prized NSCLC adjuvant approval first
Bluebird Expects Three Filings In 2020, But US Zynteglo Submission Pushed Back
A BLA filing for Zynteglo in beta-thalassemia is expected in the second half of 2020 instead of the first half, but the first commercial patient in the EU will be treated in the first half of this year.
Incyte Ready To Go For Approval Of Topical Ruxolitinib In Atopic Dermatitis
With positive data from two Phase III trials, Incyte hopes to file an NDA this year for topical Jakafi in mild-to-moderate AD.
Asia Spotlight
Bharat Biotech Plans Coronavirus Vaccine
After two Indian vaccine makers, Serum Institute of India and Cadila Healthcare joined the fight against COVID-19, Bharat Biotech may follow suit. Others like Hilleman have decided against it for the moment while Panacea Biotech is weighing the pros and cons of developing a SARS-CoV-2 vaccine after a sour experience with H1N1.
Rolling Coverage Of The Coronavirus Outbreak And The Biopharma Industry's Response Is Here.
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Outlook 2020
2020 Vision For Biopharma
Crystal ball gazing is a tricky, sometimes futile, endeavor. No one knows what the future holds, but there are consistent scenarios emerging that are being debated by industry leaders as they try to foretell and outsmart key market catalysts expected to ripple across the biopharma sector in 2020. With insights from executives, investors and consultancies, as well as our own experts, In Vivo can paint a picture of biopharma wins and woes expected in the new year and new decade.
Gene Therapy Manufacturers Are Highly Sought Acquisition Targets
Given the transformative nature of regenerative medicines, treatments yielding greatly improved patient responses that now exist as viable products on the market, cell and gene drug developers over the past several years have been drawing deal attention. Not only through collaborative partnerships, but also as acquisition targets.
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Bharat Biotech Plans Coronavirus Vaccine
After two Indian vaccine makers, Serum Institute of India and Cadila Healthcare joined the fight against COVID-19, Bharat Biotech may follow suit. Others like Hilleman have decided against it for the moment while Panacea Biotech is weighing the pros and cons of developing a SARS-CoV-2 vaccine after a sour experience with H1N1.
HLB Takes First Expansion Step Via Immunomic Acquisition
South Korea’s HLB has begun a new growth phase by taking over US-based clinical stage biotech firm Immunomic Therapeutics. Through the acquisition, it is poised to add new pipeline assets including a Phase II vaccine therapy for glioblastoma and proprietary lysosomal targeting technology.
Novartis Logs Into India With Digital Innovation Hub
Novartis’s first digital innovation hub in Asia is launched in India, where the Swiss company hopes to ally with partners to deliver digital solutions for patients at scale.
Axcella Addresses Metabolic Disease Quickly With GRAS Candidates
Emerging Company Profile: Axcella uses Generally Recognized As Safe (GRAS) amino acids to create drug candidates for hepatic encephalopathy, NASH and other diseases.
Seretide Settlement To Lift Glenmark’s Europe Business
Glenmark can sell its partnered generic rival to GSK’s Seretide Accuhaler dry powder inhaler in certain European markets following a settlement with the UK company. The Indian firm has also shelved divestment plans for its API business, at least for now.
Tech Transfer Roundup: Be Cool Therapeutics Sees Potential In Mimicking Hibernation
Biotech licenses drug composition patents from University of Alaska Fairbanks for study in several disease states. Gilead seeks long-acting HIV therapy or prevention with broadly neutralizing antibodies discovered by Rockefeller U.
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Interview: Novartis's Big Hopes For Beovu
After a strong start in the US, Novartis is now ready to take on Bayer's wet age-related macular degeneration blockbuster Eylea in Europe.
FDA Requests Belviq Be Pulled From The US Market Due To Cancer Risk
The agency requested the weight loss pill be voluntarily recalled by Eisai, the death knell for a trio of obesity drugs that launched early in the last decade.
NICE Rejects Keytruda/Inlyta Combo First-Line In RCC
The cost-effectiveness of combination therapies for untreated advanced renal cell carcinoma therapies comes under the spotlight as England's HTA body rejects an immunotherapy/kinase inhibitor combination in draft guidance.
Research & Development Explore this Topic
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Basilea Stresses Derazantinib's FGFR Kinase Differentiation
Switzerland’s SIX exchange-listed drug development company, Basilea, is moving two new oncology candidates along its R&D pipeline, supported by strong revenues from two partnered anti-infective products.
Flu Vaccine Leader Sanofi Joins Fight Against COVID-19
As the coronavirus continues to spread, one of the big four global vaccines companies has committed itself to the fight.
Helixmith Mods Engensis Trial Plans As Probe Unravels PK Anomalies
After probing pharmacokinetic data flaws in the first US Phase III study for its gene therapy Engensis, Korea's Helixmith concludes that these stemmed from clinical operation issues. As a result, it admits a failure to meet the primary endpoint but is still moving forward with new trials given signals of efficacy and safety in an extended study.
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