Wed.Apr 13, 2022

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GSK acquires Sierra Oncology, betting $2B on a bone cancer drug with a long history

Bio Pharma Dive

The British pharma is buying into the potential of a medicine meant to treat the anemia often associated with myelofibrosis, a complication that isn't adequately addressed by current therapies.

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Why the drug pricing debate is focused on insulin

pharmaphorum

The treatment has been around for over a century but insulin has still become the centre of the ongoing discussion over pricing of pharmaceutical products. Ben Hargreaves looks at why insulin’s price is so controversial and whether this could be set to change. It has now been 100 years since the first patient with diabetes received an injection of insulin, when Leonard Thomas, a 14-year-old boy, was treated with the hormone.

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Versant-backed startup launches with plans to broaden cell therapy's reach

Bio Pharma Dive

Cimeio Therapeutics, which emerged Wednesday with $50 million in funding, will use "shielding" technology to try to bring stem cell transplants and adoptive cell therapy to more patients.

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GSK bolsters cancer pipeline with $1.9bn Sierra Oncology buy

pharmaphorum

GlaxoSmithKline has agreed a deal to buy Sierra Oncology and its lead drug momelotinib for anaemia associated with the blood cancer myelofibrosis, sending the US biotech’s shares skywards. GSK is paying $55 per share in cash for Sierra – a 39% premium to its closing share price yesterday – which values the company at around $1.9 billion. Shares in Sierra were up 38% in pre-market trading this morning.

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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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ProQR to lay off 30% of staff following eye drug setback

Bio Pharma Dive

In the near term at least, the biotech company is pinning hopes for its lead eye disease treatment on a new analysis of a recently failed study.

Drugs 264
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The value of coaching as part of an organisation’s DNA

pharmaphorum

Training can be a bore; dull, predictable sessions shoe-horned into the diary when a meeting room is available or via a virtual session full of muted moments and cross-talk confusion. The pharma industry has turned the microscope of every aspect of its delivery in the face of era-defining shifts caused by the pandemic, and now it is time focus on coaching staff to perform across a new sales and information-sharing landscape.

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More Trending

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Unlocking the molecular mechanism of PTSD treatment

Scienmag

Post-traumatic stress disorder (PTSD) is a difficult-to-cure mental health condition that is caused by experiencing a traumatizing event, such as interpersonal violence or disaster. While sufferers of PTSD have existed across all of human history and the condition is even observed in animals, the diagnosis of this condition only appeared in the 1970s after the […].

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McKinsey Opened a Door in Its Firewall Between Pharma Clients and Regulators

NY Times

The firm let consultants advise both drugmakers and their government overseers, internal records show. “Who we know and what we know” was part of their pitch.

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Climate change affects landscape freeze-thaw but not in the same way everywhere, a new Concordia study shows

Scienmag

As any resident of northern climates knows, a seasonal thaw is never straightforward. The freeze-thaw process can last over a period of months and historically was mitigated by predictable air temperature and snow cover depth. Credit: Concordia University As any resident of northern climates knows, a seasonal thaw is never straightforward. The freeze-thaw process can […].

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Cannabis firm launches UK clinic following prescription license allocation

Pharma Times

Cantourage has appointed cannabis prescribers and is now officially operational via a new centre

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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

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UNH research finds a genomic time machine in sea sponges

Scienmag

DURHAM, N.H.—Sponges in coral reefs, less flashy than their coral neighbors but important to the overall health of reefs, are among the earliest animals on the planet. New research from the University of New Hampshire examines coral reef ecosystems with a novel approach to understanding the complex evolution of sponges and the microbes that live […].

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Ampersand Health and UCB partner in new arthritis initiative

Pharma Times

Companies will support a study which provides vital information on arthritis for patient-supporting HCPs

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New COVID-19 nasal spray outperforms current antibody treatments in mice

Scienmag

A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and Washington University at St. Louis is being advanced toward Phase I human clinical trials to treat COVID-19. Credit: Northwestern University/Washington University/University of Washington A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and […].

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NICE backs Biogen’s Vumerity for multiple sclerosis

pharmaphorum

Patients with relapsing-remitting multiple sclerosis (RRMS) in England, Wales and Northern Ireland can now access treatment with Biogen’s oral therapy Vumerity, after NICE recommended the drug for routine NHS use. The decision means that Vumerity (diroximel fumarate) – a follow-up to Biogen’s older oral therapy Tecfidera (dimethyl fumarate) – is now available to eligible patients across the UK, as the Scottish Medicines Consortium approved the drug in February.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Tumors change their metabolism to spread more effectively

Scienmag

Cancer cells can disrupt a metabolic pathway that breaks down fats and proteins to boost the levels of a byproduct called methylmalonic acid, thereby driving metastasis, according to research led by scientists at Weill Cornell Medicine. The findings open a new lead for understanding how tumors metastasize, or spread to other tissues, and hints at […].

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A conversation with BrightFocus Foundation about their new live-streaming talk show

Antidote

We’re excited to share new ways that partners in our network are moving the research and advocacy fronts forward. BrightFocus Foundation funds exceptional scientific research worldwide to defeat Alzheimer’s disease, macular degeneration, and glaucoma. They recently started a live-streaming talk show, Brain Info Live , as part of their mission to provide expert information on Alzheimer’s disease and related dementias and overall brain health.

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Team discovers novel root cause of tau-induced neurodegeneration

Scienmag

SAN ANTONIO (April 13, 2022) — Researchers from The University of Texas Health Science Center at San Antonio (UT Health San Antonio) today reported the discovery of a novel mechanism by which pathological forms of tau protein cause neurons to die. Alzheimer’s disease and chronic traumatic encephalopathy (CTE) are among more than 20 disorders that […].

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New patent for Array Biopharma drug MEKTOVI

Drug Patent Watch

Annual Drug Patent Expirations for MEKTOVI Mektovi is a drug marketed by Array Biopharma Inc and is included in one NDA. It is available from one supplier. There are eleven…. The post New patent for Array Biopharma drug MEKTOVI appeared first on DrugPatentWatch - Make Better Decisions.

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The New Age of Decentralized Clinical Trials

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.

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Research brief: Immune response to parasitic worms

Scienmag

According to the World Health Organization, more than 1 billion people are infected with parasitic helminths worldwide, but the prevention and treatment of helminth infection remain challenging. Research led by the University of Minnesota Medical School looked at if exposure to pathogens, in particular helminths, can stimulate the immune system and reduce predisposition for inflammatory […].

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New patent for Exelixis Inc drug CABOMETYX

Drug Patent Watch

Annual Drug Patent Expirations for CABOMETYX Cabometyx is a drug marketed by Exelixis Inc and is included in one NDA. It is available from one supplier. There are ten patents…. The post New patent for Exelixis Inc drug CABOMETYX appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Small ‘good cholesterol’ particles may have a role in Alzheimer’s prevention

Scienmag

Medical guidelines meant to reduce risk for heart disease focus on levels of cholesterol in the blood, including low-density lipoproteins (LDL), labeled “bad cholesterol,” and high-density lipoproteins (HDL), labeled as “good.” Now, a new study suggests an important connection between good cholesterol particles in cerebrospinal fluid and brain health as well.

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New patent for Exelixis drug COMETRIQ

Drug Patent Watch

Annual Drug Patent Expirations for COMETRIQ Cometriq is a drug marketed by Exelixis and is included in one NDA. It is available from one supplier. There are six patents protecting…. The post New patent for Exelixis drug COMETRIQ appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Tear-free brushing? All you need is math

Scienmag

As anyone who has ever had to brush long hair knows, knots are a nightmare. But with enough experience, most learn the tricks of detangling with the least amount of pain — start at the bottom, work your way up to the scalp with short, gentle brushes, and apply detangler when necessary. Credit: Harvard SEAS […].

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Statins May Lower Parkinsonism Risk + New Genetic Test to Prevent Deafness in Babies – Xtalks Life Science Podcast Ep. 56

XTalks

In this episode, Xtalks marked World Parkinson’s Day (April 11) and Parkinson’s Awareness Month, which are observed every year to help raise awareness about the disease and the individuals living with it. To learn more about new Parkinson’s disease research, Ayesha discussed a new study by researchers at Rush University Medical Center that shows statins may help decrease the risk of parkinsonism in older adults.

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Penn Medicine appoints Robert Vonderheide to second five-year term as director of the Abramson Cancer Center

Scienmag

PHILADELPHIA — Robert H. Vonderheide, MD, DPhil, has been appointed to a second five-year term as director of the Abramson Cancer Center (ACC) at the University of Pennsylvania, following a highly successful tenure that saw 17 FDA approvals in oncology for therapies based on studies led or co-led by ACC investigators, high-impact basic and translational research […].

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AACR: AbbVie says mid-stage trial backs navitoclax in myelofibrosis

pharmaphorum

AbbVie’s BCL-2 inhibitor navitoclax has reported phase 2 results in a trial involving rare and hard-to-treat blood cancer myelofibrosis, eyeing an indication not addressed with Venclexta, its other drug in the class. The results reported at the American Association of Cancer Research (AACR) meeting are from the REFINE trial of navitoclax alongside Novartis and Incyte’s JAK inhibitor Jakafi (ruxolitinib) in 34 patients with myelofibrosis who had not responded well to Jakafi on its own

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Structure of the active ingredient bismuth in Pepto-Bismol revealed

Scienmag

Researchers at Stockholm University have applied advanced electron microscopy techniques to finally unveil the structure of the widely used and century-old active pharmaceutical ingredient bismuth subsalicylate. The discovery provides a major step towards understanding the properties of one of the most commercially significant bismuth compounds, and highlights modern methods of gaining insight into long-used pharmaceutical […].

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TAKHZYRO® (lanadelumab) Open Label Phase 3 Study Met its Objectives in Children Ages 2 to

The Pharma Data

SHP643-301 is A Multicenter, Open-Label Phase 3 Study to Evaluate Safety, PK, Pharmacodynamics, And Clinical Activity/Outcomes of TAKHZYRO for Prevention Against Acute Attacks of HAE in Pediatric Patients 2 To <12 Years of Age Safety Profile Was Consistent With That Seen in the Clinical Program for Patients 12 Years and Older; There Were No Serious Adverse Events Global Regulatory Filing for Children Ages 2 to <12 Years of Age Planned to Begin this Fiscal Year.

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Ice shards in Antarctic clouds let more solar energy reach Earth’s surface

Scienmag

Clouds come in myriad shapes, sizes and types, which control their effects on climate. New research led by the University of Washington shows that splintering of frozen liquid droplets to form ice shards inside Southern Ocean clouds dramatically affects the clouds’ ability to reflect sunlight back to space. Credit: National Center for Atmospheric Research Clouds […].

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Myovant Sciences and Pfizer Provide Update on Supplemental New Drug Application for MYFEMBREE® for the Management of Moderate to Severe Pain Associated with Endometriosis

The Pharma Data

Myovant Sciences (NYSE: MYOV) and Pfizer (NYSE: PFE) announced today an update on the Supplemental New Drug Application (sNDA) for MYFEMBREE® (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis. In accordance with the ongoing review of the application, on April 6, 2022, the U.S.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.