Bio Pharma Dive

JUNE 1, 2021

A deal with Kyowa Kirin gives Amgen rights to an experimental treatment aimed at an autoimmune target that has drawn interest from multiple drugmakers.

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Drugs 311

World of DTC Marketing

JUNE 1, 2021

SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Kesselheim, a professor of medicine at Harvard Medical School via the Washington Post , says “the worst thing for people with Alzheimer’s would be to put out a product that doesn’t work.” For Biogen, the stakes are high as approval is likely to earn tens of millions, of to billions, in profits but is hope a reason to approve a drug over science?

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Drugs Trials Doctors Doctor 187

Bio Pharma Dive

JUNE 1, 2021

Lybalvi is meant to be as effective as marketed antipsychotics but without the weight gain patients typically experience. Alkermes will introduce the drug into a competitive market, however.

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Drugs Marketing 196

Pharma Mirror

JUNE 1, 2021

SIRIO Group’s global Nutra-Innovation Team is rapidly intensifying efforts to create new formulations in different delivery formats for mood and stress relief. The team’s focus follows a year of global lockdowns in which consumers faced significant challenges. This has led to a rise in demand for products that enhance personal health and wellness – mind and body – with formulations that boost mood and reduce stress in strong demand.

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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

Clinical Research

Bio Pharma Dive

JUNE 1, 2021

The French pharma halted a late-stage trial of venglustat, one of its priority drug candidates, in a type of kidney disease, months after stopping testing in Parkinson's.

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Drugs Trials 171

pharmaphorum

JUNE 1, 2021

Novo Nordisk is paying $55 million upfront to secure rights to a cell therapy for heart failure developed by Japanese startup Heartseed. The Danish drugmaker has acquired exclusive rights outside Japan to Heartseed’s HS-001 therapy based on heart muscle cells (cardiomyocytes) derived from human stem cells, and is due to start the phase 1/2 LAPiS trial in Japan later this year.

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Trials Development Licensing Licensing 138

BioSpace

JUNE 1, 2021

Calliditas is developing Nefecon, a down regulator of IgA1 and proprietary, novel oral formulation of budesonide – a potent and established immunosuppressant – for the treatment of IgAN.

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Regulation Development 107

Bio Pharma Dive

JUNE 1, 2021

Here are four things we have learned about DCTs that biotech companies can consider when designing a decentralized or hybrid trial.

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Trials 130

BioPharma Reporter

JUNE 1, 2021

The EMPHATHY clinical trial will enroll patients with COVID-19 to test the drugâs effectiveness in preventing worsening of symptoms and hospitalization.

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Trials Clinical Trials Clinical Trials 111

BioSpace

JUNE 1, 2021

Here we will see what qualities a great employee should have and answer the questions of “what are the best qualities in a person for a job?” and “what do companies normally look for in a person?

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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

Clinical Trials

Scienmag

JUNE 1, 2021

Credit: 2021 Symposia on VLSI Technology and Circuits Scientists at Tokyo Institute of Technology (Tokyo Tech) have developed a wirelessly powered relay network for 5G systems. The proposed battery-free communication addresses the challenges of flexible deployment of relay networks. This design is both economical and energy-efficient. Such advances in 5G communications will create tremendous opportunities […].

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Scientist Development Engineer 98

BioSpace

JUNE 1, 2021

The new vaccination, dubbed VAXELIS, is indicated for active immunization to help prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b.

Vaccination 101

Vaccination Vaccine 101

Scienmag

JUNE 1, 2021

Expectation for transportation of biological medical products and vibration sensitive products Credit: Tamagawa Seiki Co. Ltd., Tamagawa Seiki Co. Ltd., developed a non-shaking system for transportation sector with support of the Japan Science and Technology Agency (JST) in Adaptable and Seamless Technology transfer Program through target driven R&D (A-STEP)*.

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Development Production Engineer 98

BioSpace

JUNE 1, 2021

When Iveric Bio established its gene therapy advisory committee recently, the move signaled the opening of a second front in its mission to treat retinal diseases for which there are no treatments.

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Gene Therapy Gene 98

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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.

Clinical Supply

Pharma Times

JUNE 1, 2021

KHK4083 is an anti-OX40, fully human monoclonal antibody in development for the treatment of atopic dermatitis

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Development Antibody 119

BioSpace

JUNE 1, 2021

MorphoSys is acquiring Constellation Pharmaceuticals for about $1.7 billion. It is a stock deal at $34 per share in cash. Morphosys also announced a partnership with Royalty Pharma, with Royalty paying MorphoSys $1.425 billion up front.

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Scienmag

JUNE 1, 2021

The Vilcek Foundation and The Arnold P. Gold Foundation have announced Dr. Jirayut ‘New’ Latthivongskorn and Dr. Denisse Rojas Marquez as joint recipients of the 2021 Vilcek-Gold Award for Humanism in Healthcare Credit: The Vilcek Foundation NEW YORK, June 2, 2021–The Vilcek Foundation and The Arnold P. Gold Foundation are pleased to announce that the […].

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BioSpace

JUNE 1, 2021

Repertoire believes the findings, which provide an updated understanding of viral antigen presentation and epitope selection, may assist in vaccine development for COVID-19.

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Vaccination Vaccine Development 98

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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.

Clinical Trials

Scienmag

JUNE 1, 2021

Credit: Maria Fernanda Maioli Popcorn. What would movies and sporting events without this salty, buttery snack? America’s love for this snack goes beyond these events. We consume 15 billion quarts of popped popcorn each year. When it comes to popcorn, consumers want a seed-to-snack treat that leaves more snacks than seeds when popped. This means […].

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Genetics Development Research 92

BioSpace

JUNE 1, 2021

Researchers at multiple companies and institutes are doggedly pursuing clinical programs so the virus can become little more than a hindrance in the future.

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Research 98

Scienmag

JUNE 1, 2021

Credit: Edward Levri, Pennsylvania State University-Altoona Invasive species, beware: Your days of hiding may be ending. Biologists led by the University of Iowa discovered the presence of the invasive New Zealand mud snail by detecting their DNA in waters they were inhabiting incognito. The researchers employed a technique called environmental DNA (eDNA) to reveal the […].

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DNA Research 92

BioPharma Reporter

JUNE 1, 2021

Moderna has initiated the rolling submission process with the US Food and Drug Administration (FDA) for a Biologics License Application (BLA) to distribute and market its mRNA COVID-19 vaccine in the US for use in individuals aged 18 and older.

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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.

Clinical Supply

XTalks

JUNE 1, 2021

Each year on June 1 st , World Milk Day is celebrated worldwide to honor the beverage’s many benefits and contributions to society as well as the people that make milk production possible. . Established by the United Nations’ Food and Agriculture Organization (FAO) in 2001, World Milk Day is celebrated with various programs and events highlighting the importance of milk.

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Drug Patent Watch

JUNE 1, 2021

Annual Drug Patent Expirations for CARAC Carac is a drug marketed by Valeant Pharms North and is included in one NDA. It is available from three suppliers. There is one…. The post New patent expiration for Valeant Pharms drug CARAC appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 88

BioPharma Reporter

JUNE 1, 2021

The World Health Organization (WHO) is assigning âsimple, easy to say and rememberâ labels to key variants of SARS-CoV-2, using letters of the Greek alphabet.

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Regulation Marketing 81

Pharma Times

JUNE 1, 2021

Phase II/III trial of the drug did not meet its futility criteria of the annualised rate change in total kidney volume (TKV)

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Trials Drugs 107

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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.

Clinical Trials

Scienmag

JUNE 1, 2021

Increasing darkness without increasing nutrients will limit plant growth in lakes Credit: Jonathan Stetler TROY, N.Y. — As more dissolved organic matter enters lakes across the northeast United States, darkening the lakes in a phenomena called “browning,” new research shows that these waters may be growing less productive and able to sustain less life.

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Production Research 82

Drug Patent Watch

JUNE 1, 2021

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

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Drugs Marketing 81

Scienmag

JUNE 1, 2021

Animal’s “Swiss Army Knife” could help build better robots Credit: Andrew Schultz, Georgia Tech New research from the Georgia Institute of Technology finds that elephants dilate their nostrils in order to create more space in their trunks, allowing them to store up to nine liters of water. They can also suck up three liters per […].

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BioSpace

JUNE 1, 2021

BioSpace continues to take a look at some of the data that will be shared at the 2021 ASCO meeting. Here are some of them.

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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.

Clinical Trials