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Featured Stories


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

Commercial Companies FDA

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.

Gene Therapy Launches Sales & Earnings

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.

Life Cycle Management Business Strategies Clinical Trials

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.

Commercial Vaccines

Rolling Coverage Of The Coronavirus Outbreak And The Biopharma Industry's Response Is Here.


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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.

Commercial Vaccines

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.

South Korea United States

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.

Commercial India

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.

StartUps and SMEs Business Strategies

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.

Commercial Sales & Earnings

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.

Ophthalmic Approvals

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. 
Metabolic Disorders Drug Safety

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.

 

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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.

 

ImmunoOncology Clinical Trials

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.

International Companies

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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