Amylyx's ALS drug gets approved in Canada
Bio Pharma Dive
JUNE 13, 2022
The Massachusetts-based biotech is awaiting a decision in the U.S., where the FDA recently extended its review after agency advisers narrowly voted against the treatment.
Mon.Jun 13, 2022
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Genomics England will move HQ to Canary Wharf’s new biocluster
pharmaphorum
JUNE 13, 2022
Canary Wharf’s bid to become a new hub for the life sciences sector in the UK has been given a boost following the decision by Genomics England to relocate to the development. The organisation – which analyses sequenced genomes for the NHS and helps researchers access and use data to help identify the causes of disease – will “anchor” the new cluster, according to Canary Wharf Group (CWG), which is behind the initiative.
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What Biotech and Pharma need to consider about decentralized trials
Bio Pharma Dive
JUNE 13, 2022
The pandemic motivated sponsors to reimagine decentralized trials and realize the benefits these models deliver.
F.D.A. Approves Alopecia Drug That Restores Hair Growth in Many Patients
NY Times
JUNE 13, 2022
The drug, made by Eli Lilly, is already used for rheumatoid arthritis, and could be followed by two more drugs from other companies.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Real-world data: A health equity lens for research
Bio Pharma Dive
JUNE 13, 2022
Arising from the circumstances in which people grow, live, work and age, and the systems put in place to deal with illness, these health inequities are avoidable.
Pfizer Vaccine Effective in Children Under 5, the F.D.A. Says
NY Times
JUNE 13, 2022
Outside experts will make their recommendations this week on how the agency should rule on applications from Pfizer and Moderna to vaccinate the nation’s youngest children.
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Appreciating pharmacists’ role in healthcare
pharmaphorum
JUNE 13, 2022
Parisa “Risa” Vatanka, PharmD, CTTS, senior director of corporate alliances at the American Pharmacists Association (APhA), tells us about the ideal role of pharmacists in patient care and their effort to gain provider status. . Pharmacists are the most accessible, most frequently visited healthcare providers, but despite their contribution to supporting communities’ health, pharmacists lack provider status recognition to be appropriately compensated for their services. “
Eli Lilly’s Olumiant Becomes First Systemic Treatment for Alopecia Areata
BioSpace
JUNE 13, 2022
Eli Lilly's Olumiant (baricitinib) received approval from the FDA for the treatment of severe alopecia areata, making it the first systemic treatment for adults living with the disease.
EHA: ADC preps filings for Hodgkin lymphoma drug after ph2 readout
pharmaphorum
JUNE 13, 2022
ADC Therapeutics is looking to add a second approved antibody-drug conjugate to its portfolio after reporting strong phase 2 results with camidanlumab tesirine (cami) in relapsed/refractory Hodgkin lymphoma at the EHA annual meeting. In the study, 70% of patients treated with the CD25-targeting ADC had a response to therapy, with 33% of them having a complete response – in other words their cancer went into remission – with a median response time of 13.7 months.
Alnylam Scores Another FDA Nod in hATTR
BioSpace
JUNE 13, 2022
The FDA has approved Alnylam Pharmaceuticals’ Amvuttra (vutrisiran) for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy in adults.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
EHA: Survival data sets Daiichi Sankyo’s quizartinib back on track
pharmaphorum
JUNE 13, 2022
Three years after Daiichi Sankyo’s FLR3 inhibitor quizartinib was rejected by the FDA, the drugmaker has reported the results of a new phase 3 trial that is key to getting the drug to the US market and chasing down rival drugs from Astellas and Novartis. Data from the QuANTUM-First trial presented at the EHA congress showed that quizartinib more than doubled the median overall survival when added to first-line chemotherapy in patients with newly-diagnosed, FLT3-ITD-positive acute myeloid l
Day One Bio Reports Mid-Stage Success in Childhood Brain Cancer
BioSpace
JUNE 13, 2022
Day One Biopharmaceuticals announced positive early data assessing tovorafenib as a once-a-week treatment in people aged six months to 25 years with relapsed or progressive pediatric low-grade glioma.
Pre-school play with friends lowers risk of mental health problems later
Scienmag
JUNE 13, 2022
Children who learn to play well with others at pre-school age tend to enjoy better mental health as they get older, new research shows. The findings provide the first clear evidence that ‘peer play ability’, the capacity to play successfully with other children, has a protective effect on mental health. Credit: Please credit PEDAL Research […].
Researchers Link Mutations in Long Neglected Non-Coding Genome to Cancer
BioSpace
JUNE 13, 2022
Researchers from the Dana-Farber Cancer Institute looked deeper into a non-coding portion of the human genome, uncovering mechanisms that might drive or suppress cancer development.
Roles and Responsibilities of Specialized Clinical Supply Experts
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
First patient dosed in Scancell’s clinical trial for multiple cancers
Pharma Times
JUNE 13, 2022
First-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer and renal cancer
Charles River and ASC Therapeutics expand gene therapy manufacturing agreement
BioPharma Reporter
JUNE 13, 2022
Charles River Laboratories International and ASC Therapeutics have announced plans to manufacture ASC618, a second-generation gene therapy for hemophilia A.
Insight into the mystery of magnetism
Scienmag
JUNE 13, 2022
Credit: Lancaster University Journal Nature Communications DOI 10.1038/s41467-022-30591-2 Method of Research Experimental study Subject of Research Not applicable Article Title Ultrafast kinetics of the antiferromagnetic-ferromagnetic phase transition in FeRh Article Publication Date 30-May-2022.
FDA Agrees to Meet with Stealth on Barth Syndrome Drug
BioSpace
JUNE 13, 2022
On Tuesday, Stealth Biotherapeutics announced that it plans to meet with the FDA to discuss a potential NDA for its therapeutic, elamipretide, which is intended to treat Barth syndrome.
The New Age of Decentralized Clinical Trials
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Fluorescence microscopy shows how living cells form vesicles to transport cargo like growth factors
Scienmag
JUNE 13, 2022
BIRMINGHAM, Ala. – Cells have a clever way to transport cargos like growth factors across the cell membrane and into the cell. It is called clathrin-mediated endocytosis. Molecules of the protein clathrin gather on the inside of the cell membrane, and they deform the membrane to make what looks like a pit as seen from […].
Pfizer, MorphoSys and Incyte Take Aim at DLBCL in New Collab
BioSpace
JUNE 13, 2022
MorphoSys U.S. Inc., Pfizer and Incyte are teaming up to test Pfizer’s TTI-622 in conjunction with Monjuvi plus lenalidomide in patients with lymphoma.
SNMMI names Helen Nadel, MD, FRCPC, as President-Elect at 2022 Annual Meeting
Scienmag
JUNE 13, 2022
Reston, VA — Helen Nadel, MD, FRCPC, director of pediatric nuclear medicine at Lucile Packard Children’s Hospital at Stanford and clinical professor of radiology at the Stanford School of Medicine, in Stanford, California, has been named president-elect for the Society of Nuclear Medicine and Molecular Imaging (SNMMI). SNMMI introduced a new slate of officers during its 2022 Annual Meeting, held […].
Urovant is Fighting the Urge with a Novel Gene Therapy
BioSpace
JUNE 13, 2022
Treatments for overactive bladder are not one size fits all, which is why Urovant is advancing URO-902, an injectable gene therapy that is currently being investigated in Phase IIa clinical trials.
Accelerating Clinical Supply Through Integrated Drug Development
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
Age 40 is when busy Americans get the least sleep
Scienmag
JUNE 13, 2022
AUGUSTA, Ga. (June 14, 2022) – A graph of how long Americans sleep forms a U-shaped pattern across our lives, with age 40 being the low point and hours of sleep starting to creep back up about age 50, Medical College of Georgia investigators report. Credit: Michael Holahan, Augusta University AUGUSTA, Ga. (June 14, 2022) – A […].
Horizon Therapeutics Quadruples Space in Maryland to Foster Scientific Innovation
BioSpace
JUNE 13, 2022
Horizon Therapeutics’ Bill Rees spoke to BioSpace about the scientific discovery and collaboration potential of its new Rockville, Maryland site, which is expected to open in 2024.
Immunity boosting treatment enhances CAR-T cell therapy for blood cancers
Scienmag
JUNE 13, 2022
Advances in cellular immunotherapy that spur genetically modified T cells to attack cancer cells have revolutionized the treatment of certain blood cancers. Six such CAR-T cell therapies are approved by the Food and Drug Administration to treat certain types of leukemia, lymphoma and multiple myeloma. Still, some patients’ tumors don’t respond well to these therapies, […].
Amarin’s Vazkepa secures NICE recommendation
Pharma Times
JUNE 13, 2022
It is the first treatment in its class to receive NICE approval for cardiovascular risk reduction
How Machine Learning Drives Clinical Trial Efficiency
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Tracing the remnants of Andromeda’s violent history
Scienmag
JUNE 13, 2022
Pasadena, CA— A detailed analysis of the composition and motion of more than 500 stars revealed conclusive evidence of ancient a collision between Andromeda and a neighboring galaxy. The findings, which improve our understanding of the events that shape galaxy evolution, were presented by Carnegie’s Ivanna Escala Monday at the meeting of the American Astronomical […].
Informa Connect’s IDN & Bio/Pharma Partnering Summit
Drug Channels
JUNE 13, 2022
Informa Connect’s IDN & Bio/Pharma Partnering Summit Hybrid Event August 16-17, 2022 | Philadelphia, PA www.informaconnect.com/IDN. Don’t miss the IDN & Bio/Pharma Partnering Summit coming up this summer in Philadelphia, where you'll be part of the important discussions on how to best optimize strategic partnerships to improve patient access and outcomes.
Cellular cleanup
Scienmag
JUNE 13, 2022
Researchers in UC Santa Barbara neuroscientist Kenneth S. Kosik’s lab have discovered a novel organelle — a previously unknown cell structure whose function it is to help clean up faulty proteins in times of stress and keep cells functioning in top condition. Optimizing this membraneless organelle, which they call a BAG2 condensate, could lead to treatments for […].
CDC Says Moderna's COVID-19 Vaccine Poses Higher Risk for Heart Inflammation
BioSpace
JUNE 13, 2022
An FDA advisory committee is set to discuss efficacy and safety data for Moderna's COVID-19 vaccine, which includes concerns related to heart inflammation in some patients.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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