EC

Context Therapeutics Highlights Clinical Responses from the Phase 2 OATH Clinical Trial Evaluating ONA-XR for the Treatment of Endometrial Cancer

Retrieved on: 
Monday, February 6, 2023
Vomiting, Female, Anastrozole, Diarrhea, Context, Cancer, Nausea, EC, HR, Uterus, Patient, Pembrolizumab, Metastasis, ANA, Woman, Hypertension, AE, Death, Therapy, Platinum, Pharmaceutical industry

PHILADELPHIA, Feb. 06, 2023 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a company developing novel treatments for solid tumors, with a primary focus on female cancers, today announced that two patients have achieved a confirmed partial response (PR) among the first 12 patients (9 evaluable) enrolled in the Phase 2 OATH clinical trial evaluating the potential of Context’s oral progesterone receptor antagonist onapristone extended release (ONA-XR) in combination with anastrozole (ANA) to treat hormone receptor positive (HR+) metastatic endometrial cancer (EC).

Key Points: 
  • “Data from the ongoing Phase 2 OATH clinical trial supports the potential for ONA-XR plus ANA combination therapy to serve as an effective therapeutic option in metastatic EC.
  • We are encouraged by these findings and look forward to continued enrollment in the trial,” said Martin Lehr, CEO of Context Therapeutics.
  • Current treatments are limited, with platinum plus taxane combination chemotherapy being the standard of care for first line metastatic disease.
  • After first-line therapy, patients are typically treated with additional toxic infusion therapies, including chemotherapy or Lenvima® (lenvatinib) plus Keytruda® (pembrolizumab) combination therapy.

Eyenuk Secures the First European Union MDR Certification for Autonomous AI Detection of Diabetic Retinopathy, Age-Related Macular Degeneration, and Glaucoma

Retrieved on: 
Tuesday, January 31, 2023
Regulation, Diabetes, AI, Diagnosis, Medical device, Certification, Severe cognitive impairment, European Commission, Ophthalmology, Diabetic retinopathy, EC, Risk, Glaucoma, CE, Retina, Solanki, MDR, AMD, Patient, Union, FDA, DR, Eye, IIB, EU

The EyeArt AI system was previously approved in the EU for the detection of DR including diabetic macular edema.

Key Points: 
  • The EyeArt AI system was previously approved in the EU for the detection of DR including diabetic macular edema.
  • This EC Certification makes the EyeArt AI system the first and only autonomous AI solution with Class IIb MDR CE marking for the automated detection of all three eye diseases and will allow Eyenuk customers in the EU to detect the diseases in a single exam using the same set of retinal images.
  • It reaffirms the strong results from rigorous clinical validation of the EyeArt AI system.”
    Kaushal Solanki, Chief Executive Officer and Founder of Eyenuk, commented, “This EC certification multiplies our impact in two ways.
  • First, our autonomous AI can now help many more patients at risk of vision loss – the population at risk of AMD and glaucoma, particularly seniors, in addition to people with diabetes.

Dupixent® (dupilumab) Approved by European Commission as the First and Only Targeted Medicine Indicated for Eosinophilic Esophagitis

Retrieved on: 
Monday, January 30, 2023
Royal commission, Inflammation, Immunology, Bruise, Eosinophilic esophagitis, Safety, Conjunctivitis, European Commission, Eosinophilia, Ageing, EC, Esophagus, Medicare Part D, Patient, Union, Arthralgia, Regeneron Pharmaceuticals, DSQ, Choking, Infection, Pain, International development, Pharmaceutical industry, Medical imaging, EU, Sanofi, EOE, Dupilumab, Part

TARRYTOWN, N.Y. and PARIS, Jan. 30, 2023 (GLOBE NEWSWIRE) --  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) expanded the marketing authorization for Dupixent® (dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the U.S.

Key Points: 
  • EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.
  • With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the U.S.
    “This latest approval establishes Dupixent as the only targeted medicine specifically indicated for eosinophilic esophagitis in the European Union.
  • “Since its first approval, Dupixent has redefined the treatment of certain chronic diseases with underlying type 2 inflammation and is now indicated for five conditions in the European Union.
  • The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications.

Shell plc announces Executive Committee and Directorate changes

Retrieved on: 
Monday, January 30, 2023
Executive Committee, Progress, Corporation, Shell, EC, Directorate, EnergySolutions, Sustainability, Downstream, New business development, Marketing, Management, Upstream

The companies in which Shell plc directly and indirectly owns investments are separate legal entities.

Key Points: 
  • The companies in which Shell plc directly and indirectly owns investments are separate legal entities.
  • In this announcement “Shell”, “Shell Group” and “Group” are sometimes used for convenience where references are made to Shell plc and its subsidiaries in general.
  • ‘‘Subsidiaries’’, “Shell subsidiaries” and “Shell companies” as used in this announcement refer to entities over which Shell plc either directly or indirectly has control.
  • Entities over which Shell has significant influence but neither control nor joint control are referred to as “associates”.

Press Release:  Dupixent® (dupilumab) approved by European Commission as the first and only targeted medicine indicated for eosinophilic esophagitis

Retrieved on: 
Monday, January 30, 2023
Inflammation, Bruise, Eosinophilic esophagitis, Safety, Conjunctivitis, European Commission, Eosinophilia, Ageing, EC, Esophagus, Alveolar soft part sarcoma, Patient, Union, Arthralgia, DSQ, Choking, Infection, Pain, Pharmaceutical industry, Medical imaging, EU, EOE, Dupilumab, Part

EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.

Key Points: 
  • EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.
  • Since its first approval, Dupixent has redefined the treatment of certain chronic diseases with underlying type 2 inflammation and is now indicated for five conditions in the European Union.
  • The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications.
  • The safety profile through 52 weeks was generally consistent with the safety profile observed at 24 weeks.

Viracta Therapeutics Announces Orphan Drug Designation Granted by the European Commission to Nana-val for the Treatment of Diffuse Large B-cell Lymphoma

Retrieved on: 
Thursday, January 19, 2023
Disease, Union, European Medicines Agency, Royal commission, Therapy, ODD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Committee, Marketing, Valganciclovir, Food, Survival, Patient, Plasmablastic lymphoma, European Commission, SAN, Post-transplant lymphoproliferative disorder, Peripheral T-cell lymphoma, T-cell lymphoma, DLBCL, EMA, EC, Pharmaceutical industry, Medical device, EU

The EC previously granted ODD to Nana-val for the treatment of peripheral T-cell lymphoma.

Key Points: 
  • The EC previously granted ODD to Nana-val for the treatment of peripheral T-cell lymphoma.
  • In addition, Nana-val was previously granted ODD by the U.S. Food and Drug Administration for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and Epstein-Barr virus-positive (EBV+) DLBCL, not otherwise specified.
  • “This strategy is embodied by our pivotal trial, NAVAL-1, which has more than 60 sites open globally, and cohorts dedicated to multiple subtypes of EBV-positive lymphoma, including DLBCL.
  • Emerging data have shown that EBV-positive DLBCL is a differentiated disease with a significantly lower survival outcome compared to EBV-negative disease.

European Commission Grants Orphan Drug Designation for aTyr Pharma’s Efzofitimod for Treatment of Sarcoidosis

Retrieved on: 
Wednesday, January 18, 2023
Disease, ATyr Pharma, RNA transfection, NRP2, Inflammation, Prognosis, Union, European Medicines Agency, Royal commission, Death, Quality of life, Committee, Safety, Sarcoidosis, Biomarker, FDA, Scar, Granuloma, Biology, Marketing, COMP, Diagnosis, Patient, Prevalence, Degenerative disease, Research, Neuropilin, Fibrosis, SAN, Medicine, FC, EMA, European Commission, EC, Pharmaceutical industry, EU

“The EC’s decision to grant orphan drug designation to efzofitimod acknowledges the unmet medical need in sarcoidosis for the approximately 150,000 people in the European Union (EU) living with this chronic, debilitating disease,” said Sanjay S. Shukla, M.D., M.S., President and CEO of aTyr.

Key Points: 
  • “The EC’s decision to grant orphan drug designation to efzofitimod acknowledges the unmet medical need in sarcoidosis for the approximately 150,000 people in the European Union (EU) living with this chronic, debilitating disease,” said Sanjay S. Shukla, M.D., M.S., President and CEO of aTyr.
  • “The criteria for orphan status in the EU go beyond the rarity of the disease.
  • Efzofitimod received orphan drug and Fast Track designations for sarcoidosis from the United States Food and Drug Administration (FDA) in 2022.
  • aTyr is currently conducting EFZO-FIT™, a Phase 3 study of efzofitimod in pulmonary sarcoidosis patients.

EarthCruiser Announces Expansion Into Overlanding EV Market; Official Launch of a Pre-Order Deposit Program for a slide-in camper designed for EV trucks

Retrieved on: 
Wednesday, January 18, 2023
Travel, EV, EVS, EC, ECI, Propane

BEND, Ore., Jan. 18, 2023 /PRNewswire-PRWeb/ -- EarthCruiser, a globally recognized brand behind the most accomplished 4x4 expedition vehicles available in the world, announces the expansion into overlanding products specifically for electric vehicles. This includes the official launch of a pre-order deposit program for slide-in campers engineered for the next generation of EV trucks.

Key Points: 
  • EarthCruiser expands into overlanding products specifically for electric vehicles and launches pre-order deposit program for slide-in campers engineered for the next generation of EV trucks.
  • This includes the official launch of a pre-order deposit program for slide-in campers engineered for the next generation of EV trucks.
  • EarthCruiser is taking this unparalleled expertise and applying it to develop new approaches and designs to pave the way for electric vehicles in the overlanding sphere.
  • EarthCruiser's innovation division, ECI (EarthCruiser Innovations), is currently developing products for the electrification of overlanding, including the slide-in truck camper for domestic EV trucks.

Global Baby Feeding Bottles Market Report 2022-2027 - Many Manufacturers have Opened their Own Online Selling Platforms to Expand their Customer Base

Retrieved on: 
Friday, January 13, 2023
Online, Drink, BPA, Royal commission, Child, National Health Policy, Internet, FDA, Knowledge, Food and Drug Administration, Nestlé, Health, Columbidae, Supermarket, Policy, Growth, Food, European Commission, Urbanization, Workforce, Sale, Parent, Stainless steel, Hygiene, Investment, Infant, EC, Milk, Online shopping, Bottled water, Retail, Agriculture, Toy

This increase in the sale of infant formula is also driving the growth of the baby feeding bottle market.

Key Points: 
  • This increase in the sale of infant formula is also driving the growth of the baby feeding bottle market.
  • The booming global e-commerce industry is also a major factor that is driving the market growth of baby feeding bottles globally.
  • Moreover, many baby feeding bottle manufacturers have opened their own online selling platforms in order to expand their customer base, thereby bolstering the overall market growth of baby feeding bottles.
  • The market for baby feeding bottles made from new materials such as silicone and stainless steel is also gaining momentum, thus positively impacting the global baby feeding bottle market.

Global IoT WAN Markets Report 2022-2027: Adoption of IoT Connectivity Creates Substantial Opportunities for LPWAN Network, Hardware, and Software Services

Retrieved on: 
Friday, January 13, 2023
Ecosystem, News, Temperature, Wide area network, Pressure, IOT, Internet of things, Environment, Sound, Motion, WAN, LPWAN, Light, EC, M2M, Mobile phone, Video game console

The report assesses developments in the IoT WAN ecosystem, analyzes use cases, and provides a view into the future of IoT WAN communications.

Key Points: 
  • The report assesses developments in the IoT WAN ecosystem, analyzes use cases, and provides a view into the future of IoT WAN communications.
  • The report includes detailed forecasts for cellular and non-cellular IoT WANs 2022 to 2027.
    Who are the cellular and non-cellular solution providers for IoT WAN?
  • How does the IoT WAN ecosystem accelerate IoT adoption of certain applications?
  • Adoption of IoT connectivity creates substantial opportunities for LPWAN network, hardware, and software services.