XTalks

FEBRUARY 21, 2022

The BioNTainer is housed in shipping containers equipped with state-of-the-art technology for producing the mRNA vaccines from start to finish, except for the final fill-and-finish step that will be performed by local manufacturing partners. Each module contains six standard sized containers, which measure 2.6

Vaccination 105

Vaccination Vaccine Production Manufacturing 105

pharmaphorum

MAY 24, 2021

Savana’s Dr Ignacio Medrano explains how machine learning and natural language processing technology is opening up huge amounts of previously-inaccessible real-world evidence (RWE) for pharma and regulators. One problem is that most RWE is contained in inflexible, siloed databases. It’s just not in that particular database.”.

Drugs 83

Drugs Clinical Trials Clinical Trials Doctors 83

pharmaphorum

AUGUST 31, 2021

For the innovators and early adopters of the life sciences industry, engineering a regulatory-grade ECA can be daunting. The industry has looked to regulators for guidance, and the Food and Drug Administration (FDA) has been quick to respond. It is true that RWD contains more potential bias as a result.

Clinical Trials 88

Clinical Trials Clinical Trials Life Science Trials 88

XTalks

MAY 4, 2021

These modifications regulate gene expression without changing the sequence or structure of DNA. Related: 2020 Year in Review: COVID-19, CRISPR and Immunotherapies Define the Year for the Life Sciences. It’s a great tool for controlling gene expression.”. pyogenes dCas9.

DNA 98

DNA Gene Gene Silencing Genome 98

Pharma in Brief

MAY 29, 2023

The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices. Certificate of Supplementary Protection Regulations , SOR/2017-165

Regulation 59

Regulation Sales Drugs Clinical Trials 59

XTalks

NOVEMBER 9, 2022

GLP-1 receptor agonists, or incretin (metabolic hormones) mimetics, are analogs of the GLP-1 peptide hormone that binds to the GLP-1 receptor to regulate blood sugar levels by boosting insulin secretion. Accordingly, the diabetes drug market is expected to balloon from $29.81 billion in 2021 to $61.6 billion by 2030. What Are GLP-1 Agonists?

Insulin 98

Insulin Hormones FDA Approval Sales 98

XTalks

AUGUST 28, 2020

And to ensure that the user is breathing clean, filtered air, the mask contains FDA-approved HEPA filters that provide up to 99 percent protection against particles including dust, aerosols and droplets. The parts contain magnets that allow for optimal adjustment of the mask to the user’s face.

Containment 111

Containment Bacteria Marketing Production 111

XTalks

JANUARY 28, 2022

Immunocore received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators. Kimmtrak is a bispecific protein that contains a soluble T cell receptor fused to an anti-CD3 immune-effector function.

FDA Approval 98

FDA Approval Development Containment Licensing 98

The Pharma Data

OCTOBER 26, 2020

Novasep provides cost-effective and sustainable manufacturing solutions for the life sciences industries. This press release contains certain forward-looking statements concerning Sensorion and its business. The communication of this press release in certain countries may constitute a violation of local laws and regulations.

Gene Therapy 52

Gene Therapy Gene Manufacturing Production 52

The Pharma Data

AUGUST 18, 2020

The drug repositioning pillar builds on Johnson & Johnson’s ongoing partnership with the prestigious Rega Institute at KU Leuven in Belgium, where a team of scientists are screening molecule libraries containing thousands of existing compounds to determine if they have potential as COVID-19 treatments.

Development 52

Development Research Containment Production 52

XTalks

APRIL 29, 2022

Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. percent and 22.5

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

The Pharma Data

FEBRUARY 22, 2021

It will be applied broadly, fairly and in compliance with all applicable employment laws and regulations worldwide and across all management teams in Bayer.”. Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. About Bayer. Capital expenditures amounted to 2.9

Life Science 52

Life Science Compliance Development Containment 52

XTalks

AUGUST 6, 2020

Epidiolex is the only FDA-approved formulation that contains CBD derived from the cannabis plant. CBD is the most abundant non-psychoactive cannabinoid compound found in the cannabis plant, making up about 40 percent of the plant’s extract, which contains over 100 different cannabinoid compounds.

FDA Approval 64

FDA Approval Protein Containment Genetic Disease 64

XTalks

APRIL 26, 2021

The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. Once the malaria vaccine is approved by regulators, The Serum Institute of India says it will be ready to deliver more than 200 million doses of the vaccine.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

pharmaphorum

MAY 25, 2021

One of the main reasons to use RWE is to counter a common criticism of the large phase 3 trials that for so long have been the ‘gold standard’ when developing drugs and gaining authorisations from regulators. Data can be difficult to find and difficult to access and equally very difficult to use,” she told the webinar.

Big Data 104

Big Data Clinical Research Research Trials 104

XTalks

MAY 4, 2021

These modifications regulate gene expression without altering the sequence or structure of DNA. Related: 2020 Year in Review: COVID-19, CRISPR and Immunotherapies Define the Year for the Life Sciences. It’s a great tool for controlling gene expression.”. pyogenes dCas9.

DNA 52

DNA Gene Gene Silencing Genome 52

XTalks

SEPTEMBER 5, 2024

” Opzelura (ruxolitinib), which contains 1.5 Opzelura works by inhibiting the JAK-STAT pathway, a critical regulator of inflammation in the immune system. As eczema can vary in severity, not all patients respond to the same treatment regimen.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Containment 52

XTalks

DECEMBER 2, 2022

Additionally, Rebyota could contain food allergens, which poses an unknown risk for food allergen-related adverse reactions. Despite being classified as investigational by the FDA and hence loosely regulated, fecal microbiota transplants (FMT) performed through a colonoscopy or upper endoscopy are often used to treat CDI.

FDA Approval 59

FDA Approval Bacteria Clinical Trials Clinical Trials 59

XTalks

APRIL 25, 2024

Recent advancements in autonomic regulation therapy have introduced electrical devices designed to restore the autonomic nervous system’s balance. These receptors play a crucial role in regulating blood pressure by balancing sympathetic and parasympathetic activity.

Development 111

Development Trials Clinical Trials Clinical Trials 111

XTalks

DECEMBER 7, 2020

Many times, these commonly overlooked or uninspired spots contain the potential to foster conversations and collaboration that are the spark of innovation. The humble coffee station is a great example of this. As detailed in a case study cited in the Harvard Business Review, a pharmaceutical company wanted to increase sales.

Sales 98

Sales Scientist Production Containment 98

XTalks

JANUARY 9, 2024

The thyroid plays a critical role in the body by producing hormones that regulate metabolism, heart rate and body temperature among others. These include: Desiccated thyroid extract (DTE) : DTE is a natural form of thyroid hormone that contains both T4 and T3 (triiodothyronine).

Hormones 105

Hormones Antibody Trials Production 105

The Pharma Data

DECEMBER 23, 2020

24, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Tauriga Sciences Inc. ABOUT TAURIGA SCIENCES INC. Tauriga Sciences, Inc. TAUG) is a revenue generating, diversified life sciences company, engaged in several major business activities and initiatives. NEW YORK, NY, Dec. Provisional Patent Application No.

Life Science 52

Life Science Manufacturing Development Production 52

The Pharma Data

NOVEMBER 26, 2020

27, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Tauriga Sciences Inc. ABOUT TAURIGA SCIENCES INC. . Tauriga Sciences, Inc. TAUG) is a revenue generating, diversified life sciences company, engaged in several major business activities and initiatives. NEW YORK, NY, Nov.

Life Science 52

Life Science Production Cosmetics Manufacturing 52

pharmaphorum

JANUARY 27, 2021

Corners have been cut,” “The vaccine contains fetuses,” “It’s Thalidomide all over again”, all demonstrate a lack of public knowledge and awareness about how trials are conducted in the present day. “I’m not an anti-vaxxer, but….” Suddenly people were comparing the length of approval processes in the UK, Europe, and the US.

Research 52

Research Clinical Trials Clinical Trials Vaccine 52

Pharma in Brief

SEPTEMBER 5, 2023

If classified instead as edible cannabis, Jolts would exceed the THC content per immediate container permitted by the Cannabis Regulations. Organigram classified Jolts as cannabis extract in notices of new cannabis product to Health Canada.

Production 52

Production Compliance Containment Regulation 52

The Pharma Data

NOVEMBER 23, 2020

Although PP2A is a key tumour suppressor and has a critical function regulating protein de-phosphorylation and tumour growth, it has to-date been very difficult to target pharmaceutically. Rappta Therapeutics is backed by blue-chip investors Advent Life Sciences, Novartis Venture Fund, Novo Holdings and a family office.

Development 40

Development Protein Regulation Drugs 40

The Pharma Data

JANUARY 19, 2021

Ipsen’s R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). With total sales over €2.5 The Group has about 5,700 employees worldwide.

Production 52

Production Clinical Trials Clinical Trials Containment 52

XTalks

OCTOBER 29, 2024

The Role of AI in Enhancing Digitized Protocols Clinical protocols are often lengthy, complex documents—traditionally delivered as PDFs—that contain detailed information. “It does make the humans doing the work much more efficient, and that’s where you start seeing these time savings start to add up,” Matthew explained.

Clinical Research 59

Clinical Research Research Clinical Trials Clinical Trials 59

XTalks

MAY 17, 2024

Lilly said it discovered some products claiming to be compounded tirzepatide medicines that contained bacteria, high impurity levels, different chemical structures and different colors than Mounjaro or Zepbound. “In In at least one instance, the product was nothing more than sugar alcohol,” said Lilly.

Sales 52

Sales FDA Approval Pharmacy Production 52

XTalks

MAY 12, 2022

Lactate is a biomarker related to physical activity, which also influences glucose sensitivity and regulation. The microneedle tips contain enzymes that react with the molecules of interest in the interstitial fluid.

Engineer 59

Engineer Development Containment Regulation 59

XTalks

JUNE 3, 2021

As well as being high in vitamins and minerals, fruits are a great source of phytochemicals which may increase insulin sensitivity, and fibre which helps regulate the release of sugar into the blood and also helps people feel fuller for longer,” she said.

Insulin 59

Insulin Development Research Doctors 59

XTalks

NOVEMBER 10, 2023

cTTP is a very rare, inherited and life-threatening blood clotting disorder caused by a disease-causing mutation in the ADAMTS13 (A disintegrin and metalloproteinase with thrombospondin motifs 13) gene, which encodes the ADAMTS13 enzyme that regulates blood clotting by cleaving the von Willebrand factor (VWF) protease.

FDA Approval 59

FDA Approval Gene Therapy Gene Clinical Trials 59

XTalks

NOVEMBER 9, 2023

Zepbound contains mimetics of the GLP-1 and GIP hormones that regulate appetite and blood sugar. In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”

FDA Approval 59

FDA Approval Manufacturing Drugs Pharmacy 59

The Pharma Data

MAY 15, 2023

Feinglass, MD, MPH was most recently Chief Medical Officer for Life Sciences and Diagnostics and Vice President Global Medical Affairs and Policy, Life Sciences and Diagnostics, at Danaher, a global science and technology company. Urs will be Chair of the Human Capital & ESG Committee of Sandoz. Dr. Shamiram R.

Sales 40

Sales Production Doctors Doctor 40

The Pharma Data

JANUARY 26, 2021

The company assumes no obligation to update any information contained herein.”. It works closely with governments, regulatory authorities, hospitals, clinics, healthcare providers, life sciences companies, NGOs and public institutions to develop strategies that allow them to tackle public health challenges.

Life Science 40

Life Science Production Marketing Dermatology 40

The Pharma Data

NOVEMBER 4, 2020

CorpCann is a Norwegian-based international investment and consulting firm focused on European and North American opportunities in the life science, nutraceutical, aquaculture and energy industries. XPhyto is also pleased to announce a strategic European advisor engagement with CorpCann AS (“CorpCann”).

Drug Delivery 40

Drug Delivery Production Manufacturing Development 40

XTalks

DECEMBER 7, 2020

Many times, these commonly overlooked or uninspired spots contain the potential to foster conversations and collaboration that are the spark of innovation. The humble coffee station is a great example of this. As detailed in a case study cited in the Harvard Business Review, a pharmaceutical company wanted to increase sales.

Sales 52

Sales Scientist Production Containment 52