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Gates Foundation Forms an Alliance with Global Pharma Companies to

Tuba Khan February 28, 2020

Shots: GSK, Evotec, J&J, Otsuka, the Bill & Melinda Gates Medical Research Institute and its foundation have launched the ‘PAN-TB collaboration’ project to collaboratively accelerate the development of novel TB treatment regimens The global collaboration will focus on developing a new regimen with the drug candidates that demonstrated efficacy in its P-II studies with limited […]Read More

Novartis Reports Acceptance of Ofatumumab’s (OMB157) sBLA from the US

Vartika Singh February 24, 2020

Shots: The approval is based on P-III ASCLEPIOS I and II studies involves assessing of ofatumumab (20mg, SC) vs Aubagio (14mg oral tablets) in 1882 adults with MS between the ages of 18 and 55 years The study resulted in reduction in ARR by 50.5% (0.11 vs. 0.22) and 58.5% (0.10 vs. 0.25), Risk reduction […]Read More

Fresenius Kabi Forms a Joint Venture in Collaboration with Bio-Techne

Tuba Khan January 22, 2020

Shots: The JV leverages the expertise of three companies that includes Wilson Wolf’s G-Rex technology, BioTechne’s proteins, reagents, media, and gene-editing technologies and Fresenius Kabi’s Lovo cell processing system washes, concentrates and harvests cells The JV focus on providing scalable manufacturing technologies and processes required to develop and commercialize new cell and gene therapies. All […]Read More

TB Alliance’s Pretomanid Combination Therapy Receives the US FDA’s Approval

Vartika Singh August 15, 2019

Shots: The approval is based on the Nix-TB trial assessing bedaquiline, pretomanid and linezolid collectively called BPaL regimen in 109 patients with XDR-TB treatment-intolerant or non-responsive MDR-TB across three sites in South Africa The study demonstrated successful outcomes in @6mos. 95/107 patients and for two of the patients the study was extended to nine months. […]Read More

Celgene Reports FDA and EMA’s Acceptance of NDA for Ozanimod

Vartika Singh June 6, 2019

Shots: The acceptance of NDA is based on P-III SUNBEAM and RADIANCE Part B study results assessing oral ozanimod (0.92/0.46 mg) in 1,346 & 1,320 patients with RMS across 152 & 150 sites in 20 & 21 countries respectively The US FDA and EMA accepted the NDA for ozanimod to treat relapsing forms of multiple […]Read More

Novartis’ Gilenya (fingolimod) Receives EU’s Approval for Relapsing-Remitting Forms of

Vartika Singh November 30, 2018

Shots: The approval is based on the results of P-III PARADIGMS study assessing Gilenya (0.5mg/ 0.25mg, qd) vs Extavia (interferon beta-1a, qw) in 215 patients with MS aged 10 to <18 yrs, across 80 centers and 25 countries P-III PARADIGMS study Results: annualized relapse rates by 82%; relapse-free @ 24 months (85.7% vs 38.8%); reduction […]Read More

AstraZeneca to Unveil its Robust Pipeline of Breast Cancer at SABCS

AbbVie Collaborates with Frontier Medicines to Develop Novel Therapies and E3 Degraders Against Difficult-to-Drug Targets

Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

Bio-Thera Reports MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

Alvotech and Alvotech & CCHT Sign an Exclusive Commercialization Agreement with Yangtze River for Eight Biosimilars in China

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Roche’s Gavreto (pralsetinib) Receives the US FDA’s Approval for Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers

AstraZeneca to Unveil its Robust Pipeline of Breast Cancer at SABCS

AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol

Tags : Forms

Gates Foundation Forms an Alliance with Global Pharma Companies to

Novartis Reports Acceptance of Ofatumumab’s (OMB157) sBLA from the US

Fresenius Kabi Forms a Joint Venture in Collaboration with Bio-Techne

TB Alliance’s Pretomanid Combination Therapy Receives the US FDA’s Approval

Celgene Reports FDA and EMA’s Acceptance of NDA for Ozanimod

Novartis’ Gilenya (fingolimod) Receives EU’s Approval for Relapsing-Remitting Forms of

Latest Posts

AstraZeneca to Unveil its Robust Pipeline of Breast Cancer at SABCS

AbbVie Collaborates with Frontier Medicines to Develop Novel Therapies and E3 Degraders Against Difficult-to-Drug Targets

Roche’s Elecsys Anti-SARS-CoV-2 S Receives the US FDA’s EUA to Detect Ab Against SARS-CoV-2 Spike Protein

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

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