Pharma Mirror

JANUARY 10, 2021

By Boris Goldstein, Co-Founder & Executive Chairman at Brain Scientific COVID-19 is known for its impacts on a patient’s respiratory system, but it has also been found to affect individuals in unique ways and with varying severity levels depending on their age, risk factors, and comorbidities. Several studies have recently shown that the development of neurological conditions and symptoms are prevalent in COVID patients.

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Scienmag

JANUARY 10, 2021

Credit: DePaul University/Kenshu Shimada A new study shows that the gigantic Megalodon or megatooth shark, which lived nearly worldwide roughly 15-3.6 million years ago and reached at least 50 feet (15 meters) in length, gave birth to babies larger than most adult humans. This latest research shedding light on the reproductive biology, growth and life […].

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BioSpace

JANUARY 10, 2021

RNAi-focused Atalanta Therapeutics launched with $110 million in combined Series A funding and collaboration deals with Genentech and Biogen to address diseases related to the central nervous system, including Huntington’s, Alzheimer’s and Parkinson’s diseases.

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Scienmag

JANUARY 10, 2021

Credit: Kim Ratliff, Augusta University AUGUSTA, Ga. (January 11, 2021) – To build better vaccines, scientists want to know more about how our bodies make adequate numbers of effective, durable antibodies against the influenza virus. They are looking at a key pathway in how immune cells, called B cells, see the virus, then become the […].

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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

BioSpace

JANUARY 10, 2021

Regulating the activity of the protein called NF-kappa B-inducing kinase (NIK) is emerging as a new and potentially important way to enhance certain immuno-oncology therapies.

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Scienmag

JANUARY 10, 2021

Promises new approaches to treat diseases Credit: Helmholtz Zentrum München The gut plays a central role in the regulation of the body’s metabolism and its dysfunction is associated with a variety of diseases, such as obesity, diabetes, colitis and colorectal cancer that affect millions of people worldwide. Targeting endocrine dysfunction at an early stage by […].

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Regulation Medicine 57

Scienmag

JANUARY 10, 2021

Seasonal variation may be explained by new year’s resolutions Credit: Image by Louliana Voelker for NYU; icons by Guilherme Furtado and Made (Noun Project) licensed as Creative Commons CCBY. Marijuana use increases throughout the calendar year, with use up 13 percent on average at the end of each year (2015-2019) compared to the beginning, according to […].

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The Pharma Data

JANUARY 10, 2021

ASLAN has completed recruitment of patients into the third, highest dose cohort of ASLAN004 in AD patients. ASLAN004 was found to be well tolerated at all dose levels. Data Monitoring Committee approved proposal to open the expansion cohort based on blinded safety data, accelerating study completion timelines. SINGAPORE, Jan. 11, 2021 (GLOBE NEWSWIRE) — ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative

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Scienmag

JANUARY 10, 2021

Rutgers-led research could help scientists improve conservation of species Credit: Katrina A. Catalano How the larvae of colorful clownfish that live among coral reefs in the Philippines are dispersed varies widely, depending on the year and seasons – a Rutgers-led finding that could help scientists improve conservation of species. Right after most coral reef fish […].

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The Pharma Data

JANUARY 10, 2021

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / January 11, 2021 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys, will present at the 39 th Annual J.P.

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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

Pharma in Brief

JANUARY 10, 2021

The Federal Court has found that prosecution history evidence is inadmissible to rebut representations made by a patent licensee (as opposed to the patentee) on claims construction. The Court also considered the issues of “essential elements”, infringement, and obviousness in the context of a formulation patent. Background. The Court’s decision concerns Canadian Patent No. 2,507,002 ( 002 Patent ), which is listed on the patent register against Allergan Inc.’s ( Allergan ) silodosin capsules (ma

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The Pharma Data

JANUARY 10, 2021

The new year began with a fairly low level of clinical trial news. Here’s a look. COVID-19-Related. Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. The trial will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Cerecor announced results from its exploratory Phase II U.S.

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Scienmag

JANUARY 10, 2021

Study of 1,733 patients first diagnosed in Wuhan (China) between January and May followed to June and September Study of 1,733 patients first diagnosed in Wuhan (China) between January and May followed to June and September. 76% of COVID-19 patients have at least one symptom six months after symptom onset. Fatigue or muscle weakness is […].

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Medicine 50

The Pharma Data

JANUARY 10, 2021

Jan. 11, 2021 07:11 UTC. LUXEMBOURG–( BUSINESS WIRE )– Eurofins GeneScan Technologies (Paris:ERF) announces that the VIR Seek SARS-CoV-2 Solution has been evaluated and approved by the AOAC Performance Tested Methods SM (PTM) Program on December 29, 2020 and awarded Emergency Response Validation PTM certification number 122006. The VIR Seek SARS-CoV-2 Solution is a comprehensive workflow for the detection of SARS-CoV-2 on environmental surfaces that includes swabbing of environmental

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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

BioSpace

JANUARY 10, 2021

Bluebird bio announced plans to split its genetic disease and oncology businesses. Bluebird bio will stay focused on severe genetic disease and spin out its oncology business into a new company.

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The Pharma Data

JANUARY 10, 2021

IDE397 is being developed as a potential best-in-class MAT2A inhibitor for MTAP-deletion, which is prevalent in approximately 15% of all solid tumors. IDE397 program update to be presented at the 39th Annual J.P. Morgan Healthcare Conference, including preclinical data showing tumor regressions in MTAP-deleted PDX models and proposed Phase 1 clinical plan. SOUTH SAN FRANCISCO, Calif. , Jan. 11, 2021 /PRNewswire/ — IDEAYA Biosciences, Inc.

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Scienmag

JANUARY 10, 2021

Positive “tipping points” could spark cascading changes that accelerate action on climate change, experts say. A tipping point is a moment when a small change triggers a large, often irreversible, response. Professor Tim Lenton, Director of the Global Systems Institute (GSI) at the University of Exeter, has previously warned the world is “dangerously close” to […].

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Engineer 44

The Pharma Data

JANUARY 10, 2021

A study carried out by the University of Texas Medical Branch and Pfizer has found that the drugmaker’s COVID-19 vaccine still protects against a viral mutation that’s raised concerns around the world, though more research is needed. Source link.

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Vaccination Vaccine Research 52

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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

BioSpace

JANUARY 10, 2021

The new year began with a fairly low level of clinical trial news. Here’s a look.

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Clinical Trials Clinical Trials Trials 66

The Pharma Data

JANUARY 10, 2021

The UK’s National Health Service (NHS) will begin treating adult COVID-19 patients in intensive care with Roche’s and Sanofi’s arthritis medications following positive trial results that showed the drugs were highly effective when given early enough. The UK government is now encouraging the use of Roche’s Actemra (tocilizumab) and Sanofi’s Kevzara (sarilumab) for adults with COVID-19 who have been placed in intensive care units (ICUs), the Department of Health and Social Care said.

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Drugs Trials Antibody Research 52

Scienmag

JANUARY 10, 2021

Comprehensive analysis finds transforming mental health system is possible Conditions are ripe for transforming the U.S. mental health care system, with scientific advances, the growth of Medicaid and political consensus on the importance of improving mental health creating the possibility that goals once thought out of reach may be possible, according to a new RAND […].

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The Pharma Data

JANUARY 10, 2021

SUNDAY, Jan. 10, 2021 – A new year can be a fresh start for you and your kids — and perhaps no year has needed a fresh start more than this one. So, a leading doctors’ group is offering parents tips for a healthy “reset” in 2021. Get immunized. First of all, the American Academy of Pediatrics (AAP) is recommending you make sure your family is up to date on vaccines.

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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

Scienmag

JANUARY 10, 2021

Canada must dismantle anti-Black racism in health care to address its harmful effects on people’s health, argue authors of a commentary in CMAJ (Canadian Medical Association Journal) [link] Racism has significant negative effects on the physical and mental health of Black people and people of nondominant racial groups. For example, there have been significantly higher […].

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The Pharma Data

JANUARY 10, 2021

Jan. 11, 2021 09:00 UTC. INGELHEIM, Germany & MOUNTAIN VIEW, Calif.–( BUSINESS WIRE )– Boehringer Ingelheim announced today a collaborative agreement with Google Quantum AI (Google), focusing on researching and implementing cutting-edge use cases for quantum computing in pharmaceutical research and development (R&D), specifically including molecular dynamics simulations.

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Scienmag

JANUARY 10, 2021

Age at first use and number of tobacco products consumed also increases addiction risk An analysis of a large nationally representative longitudinal study by University of California San Diego Herbert Wertheim School of Public Health and Human Longevity Science report that starting tobacco products, including e-cigarettes, before the age of 18 is a major risk […].

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The Pharma Data

JANUARY 10, 2021

Jan. 11, 2021 06:35 UTC. LA ROCHELLE, France–( BUSINESS WIRE )– Regulatory News: VALBIOTIS (FR0013254851 – ALVAL / eligible for the PEA/SME) (Paris:ALVAL), a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces its participation in the prestigious ‘J.P.

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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

BioTech 365

JANUARY 10, 2021

EOS Imaging Reports Full-Year 2020 Revenue up +19% Year-on-year EOS Imaging Reports Full-Year 2020 Revenue up +19% Year-on-year 400th EOS imaging system installed in December Significant increase in equipment orders in Q4 2020 Continued strong cash position at €9.

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The Pharma Data

JANUARY 10, 2021

Jan. 11, 2021 11:00 UTC. ACTON, Mass.–( BUSINESS WIRE )– Insulet Corporation (NASDAQ: PODD) (Insulet), the global leader in tubeless insulin pump technology with its Omnipod ® Insulin Management System, today announced plans to release its financial results for the fourth quarter and full year of 2020 on February 23, 2021 after the close of the financial markets.

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BioTech 365

JANUARY 10, 2021

VALBIOTIS Announces Its Participation in the 39th J.P. Morgan Healthcare Annual Conference as well as in H.C. Wainwright BioConnect from January 11-14, 2021, in Virtual Format VALBIOTIS Announces Its Participation in the 39th J.P.

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The Pharma Data

JANUARY 10, 2021

Commercial launch activities for Idefirix ® progressing as planned. Patient recruitment in the two phase 2 studies in AMR and GBS was reinitiated in December 2020. Year-end cash position of SEK 1.4 billion. LUND, Sweden , Jan. 11, 2021 /PRNewswire/ — Hansa Biopharma , the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced a business update for the fourth quarter 2020 and certain preliminary, unaudited key financials for its

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Gene Therapy Gene Antibody Trials 52

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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