Sat.Oct 09, 2021

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Moderna, Racing for Profits, Keeps Covid Vaccine Out of Reach of Poor

NY Times

Some poorer countries are paying more and waiting longer for the company’s vaccine than the wealthy — if they have access at all.

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FDA Advisory Committee Recommends Use of Investigational Drug Maribavir (TAK-620) to Treat Post-Transplant Recipients with Cytomegalovirus (CMV) Infection and Disease Refractory to Treatment With or Without Resistance

The Pharma Data

If approved by the FDA, maribavir will be the first and only treatment indicated for adults in this patient population CMV is one of the most common infections experienced by transplant recipients, with an estimated incidence rate of around 16–56% in solid organ transplant (SOT) recipients and 30–70% in HSCT recipients 3,7 Regulatory submission is based on the Phase 2 and Phase 3 TAK-620-303 (SOLSTICE) trial of maribavir Maribavir is one of four Wave 1 pipeline new molecular entities that Takeda

Drugs 52
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Adverum Presents Clinical Data on ADVM-022 at the American Society of Retina Specialists 39th Annual Scientific Meeting

BioTech 365

Adverum Presents Clinical Data on ADVM-022 at the American Society of Retina Specialists 39th Annual Scientific Meeting Adverum Presents Clinical Data on ADVM-022 at the American Society of Retina Specialists 39th Annual Scientific Meeting — Company maintains focus on advancing … Continue reading →

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Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

The Pharma Data

Gantenerumab is an investigational antibody in Phase III development for early Alzheimer’s disease (AD) Gantenerumab is the first and only anti-amyloid antibody being investigated for subcutaneous administration in late-stage trials for the treatment of AD Ongoing Phase III GRADUATE programme with gantenerumab is anticipated to deliver a comprehensive data set with expected readout in the second half of 2022.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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#news #biotech Chilean scientist plans to clean up mining with ‘metal eating’ bacteria

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Chilean scientist plans to clean up mining with ‘metal eating’ bacteria.

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Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis

The Pharma Data

Application utilizes extrapolation-based strategy across existing breadth of STELARA data in patients living with this chronic inflammatory disease. The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).

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Amgen and Neumora Therapeutics Announce Strategic R&D Collaboration to Accelerate Novel Precision Therapies for Brain Diseases

The Pharma Data

Collaboration Leveraging Neumora’s Precision Neuroscience Platform with Amgen’s deCODE Human Genetics Capabilities to Advance Innovative Medicines for Brain Disease. Amgen and Neumora Therapeutics, a clinical-stage biopharmaceutical company pioneering precision medicines for brain diseases, announced a strategic collaboration to advance neuroscience discovery, development and commercialization.

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Bristol Myers Squibb Provides Update on Phase 2 Study of Deucravacitinib in Patients With Moderate to Severe Ulcerative Colitis

The Pharma Data

LATTICE-UC proof of concept study did not meet primary nor secondary endpoints. Safety profile of deucravacitinib consistent with other trials and no new safety signals reported. Bristol Myers Squibb. today announced the Phase 2 LATTICE-UC study evaluating deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, compared to placebo in moderate to severe ulcerative colitis (UC) did not meet the primary efficacy endpoint of clinical remission at Week 12, nor secondary

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Tezepelumab granted Orphan Drug Designation in the US for eosinophilic esophagitis

The Pharma Data

Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE). Tezepelumab is being developed by AstraZeneca in collaboration with Amgen and is under Priority Review for patients with asthma in the US. The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

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Novartis to present broad range of portfolio data at ECTRIMS, reinforcing long-standing commitment to people living with multiple sclerosis

The Pharma Data

Novartis will present 41 abstracts from a wide-ranging multiple sclerosis (MS) portfolio, including new data on Kesimpta ® (ofatumumab) and Mayzent ® (siponimod) Novartis will be commencing Phase III pivotal trials investigating remibrutinib in RMS. Remibrutinib is a highly selective, potent oral BTK inhibitor with a potential best-in-class profile 1 Late-breaking safety data will be presented, including outcomes of COVID-19 in relapsing forms of multiple sclerosis (RMS) patients treated with

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations