Breakthrough

EQS-News: Grünenthal reports strong 2023 results with record revenue and continued investments in R&D and acquisitions

Retrieved on: 
Wednesday, April 10, 2024
Trigeminal neuralgia, Knee, Growth, Rheumatoid arthritis, Neuropathic pain, Pain, GRM, DPN, ESG, Patient, Prednisolone, Research, Sustainalytics, Breakthrough, Glucocorticoid, Quality of life, PSNP, Research and development, Investment, Diabetic neuropathy, NOP, Kyowa Kirin, Osteoarthritis, RTX, Food, FDA, Corporation, Pharmaceutical industry

In 2023, Grünenthal generated €1.8 billion in revenues, an increase of 10 percent over the prior year.

Key Points: 
  • In 2023, Grünenthal generated €1.8 billion in revenues, an increase of 10 percent over the prior year.
  • Grünenthal owns 51 percent of the new enterprise Grünenthal Meds and intends to acquire the remaining share in 2026.
  • Aachen, Germany, 25 March 2024 – Grünenthal, the leading pharmaceutical company in pain research and management, released its 2023 full-year results, announcing a double-digit revenue growth.
  • The 2023 results were driven by strong business performance in the United States, Latin America and Europe.

Burning Rock Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
Research, Fulvestrant, NMPA, AstraZeneca, Disease, Progression-free survival, CDX, Boehringer Ingelheim, Patient, Webcast, NGS, Hospital, Breast, Breakthrough, Safety, HR, Depreciation, ID, Precision, Food, Marketing, FDA, Cryptocurrency

Precision oncology diagnostics product supports advancement in late-stage breast cancer treatment, with results published in the New England Journal of Medicine in June 2023.

Key Points: 
  • Precision oncology diagnostics product supports advancement in late-stage breast cancer treatment, with results published in the New England Journal of Medicine in June 2023.
  • Total value of new contracts entered into during 2023 amounted to RMB310 million, representing a 24% increase from 2022.
  • Revenues were RMB121.1 million (US$17.1 million) for the three months ended December 31, 2023, representing a 14.9% decrease from RMB142.2 million for the same period in 2022.
  • Burning Rock will host a conference call to discuss the fourth quarter and full year 2023 financial results at 8:00 a.m. U.S. Eastern Time (8:00 p.m. Hong Kong time) on March 29, 2024.

The Breakthrough Institute Endorses the EMIT LESS Act, A Step Toward Reducing Enteric Methane Emissions

Retrieved on: 
Thursday, March 28, 2024
Health, USDA, Methane, Meat, Congress, Farmer, University, EMIT, Livestock, Research, Milk, Food, Breakthrough, Diet, Drinking, Legislation

Targeting enteric fermentation in livestock production represents an opportunity to curb nearly one-quarter of U.S. methane emissions.

Key Points: 
  • Targeting enteric fermentation in livestock production represents an opportunity to curb nearly one-quarter of U.S. methane emissions.
  • Reducing enteric methane emissions can be both a climate win, and an economic imperative by reducing the cost of cattle feed.
  • The legislation directs the U.S. Department of Agriculture (USDA) to expand domestic capacity to develop and increase the adoption of enteric methane solutions.
  • Furthermore, the bill would make enteric methane reduction products and practices eligible for cost-share under several USDA conservation programs.

Fiverr and Steven Bartlett partner to support UK SMBs to reach their breakthrough moment

Retrieved on: 
Wednesday, March 27, 2024
Partnership, Gallia Celtica, Luigi, Growth, Breakthrough

Through Fiverr’s new ‘Break The Breakthrough’ campaign, Fiverr has launched a competition for UK residents above 18 years old who have an established business to win expert consultation with Bartlett and Fiverr.

Key Points: 
  • Through Fiverr’s new ‘Break The Breakthrough’ campaign, Fiverr has launched a competition for UK residents above 18 years old who have an established business to win expert consultation with Bartlett and Fiverr.
  • Three grantees will be awarded £10,000 in Fiverr Credits, dedicated guidance from a Fiverr Customer Success Manager and a 45-minute mentorship session with one of Britain’s most respected entrepreneurs.
  • Following rough economic headwinds, skills shortages and rising costs, UK businesses continue to face hurdles that impact their growth.
  • We’re excited to see freelancers become indispensable partners for these SMBs, helping them in their breakthrough journey.” comments Bukki Adedapo, UK Country Manager at Fiverr.

Santhera Announces NDA for Vamorolone in Duchenne Muscular Dystrophy Accepted and Granted Priority Review by China’s NMPA

Retrieved on: 
Wednesday, March 27, 2024
Diagnosis, NMPA, Patient, Ageing, NDA, Breakthrough, CDE, Duchenne muscular dystrophy, Therapy, Vamorolone, Safety, File, DMD, Neuromuscular disease, Pharmaceutical industry

Pratteln, Switzerland, March 27, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that the China National Medical Products Administration (NMPA) has accepted for priority review the new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) which was submitted by Sperogenix Therapeutics, Santhera's specialized rare disease partner for China.

Key Points: 
  • Pratteln, Switzerland, March 27, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that the China National Medical Products Administration (NMPA) has accepted for priority review the new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) which was submitted by Sperogenix Therapeutics, Santhera's specialized rare disease partner for China.
  • The Center for Drug Evaluation (CDE) of the Chinese drug authority NMPA accepted the filing and granted priority review for vamorolone in DMD for patients aged 4 years and older which could, subject to a positive outcome, lead to approval by Q1 2025.
  • Duchenne muscular dystrophy is a rare neuromuscular disease affecting about 70,000 patients in China.
  • The submission is further supported by a study which investigated the pharmacokinetic parameters of vamorolone in healthy adult Chinese volunteers.

FDA Grants Breakthrough Therapy Designation to Sunvozertinib for the First-Line Treatment of Patients with advanced Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Retrieved on: 
Sunday, April 7, 2024
PART, EGFR, Mutation, BTD, NSCLC, Disease, Progression-free survival, Patient, Heel, Corr, NDA, Breakthrough, Non-Euclidean geometry, Doctor of Philosophy, CDE, Society, ESMO, Safety, ASCO, FDA, Annual general meeting, Food, Pharmaceutical industry

SHANGHAI, April 7, 2024 /PRNewswire/ -- Dizal (688192.SH) today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.

Key Points: 
  • SHANGHAI, April 7, 2024 /PRNewswire/ -- Dizal (688192.SH) today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.
  • This Breakthrough Therapy Designation (BTD) approval was based on results from the global multi-center phase I/II study (WU-KONG1).
  • This new BTD will enable us work more closely with the FDA and accelerate its clinical development and regulatory submission."
  • Affecting roughly 2%-4% of NSCLC patients, EGFR Exon20ins mutations have been difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity.

TMC Announces Fourth Quarter and Full Year 2023 Results

Retrieved on: 
Monday, March 25, 2024
Letter, The Metals Company, Exercise, UNCLOS, Environmental issues, Domestic, International Seabed Authority, Breakthrough, The Hidden Gem, Council, Memorandum of understanding, Representative, Legislation, ISA, Mining Code, Seabed, Manganese, Hand, Senate, State, CCZ, Hidden, National security, Research, LTIP, House, Louisiana House of Representatives, Pentagon, Engineering, Government, TMC, National Defense Authorization Act, EDT, Nickel, Sea, Bangladesh Technical Education Board, Ecosystem, Data, Collection, Total

NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- TMC the metals company Inc. (Nasdaq: TMC) (“TMC” or “the Company”), an explorer of lower-impact battery metals from seafloor polymetallic nodules, today provided a corporate update and fourth quarter and full year financial results for the period ending December 31, 2023.

Key Points: 
  • NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- TMC the metals company Inc. (Nasdaq: TMC) (“TMC” or “the Company”), an explorer of lower-impact battery metals from seafloor polymetallic nodules, today provided a corporate update and fourth quarter and full year financial results for the period ending December 31, 2023.
  • Meanwhile, two new applications for deep-sea mineral exploration have recently been submitted to the ISA by the government of India.
  • Exploration and evaluation expenses during the quarter ended December 31, 2023 were $26.7 million compared to $81.8 million for the quarter ended December 31, 2022.
  • We will hold a conference call today at 4:30 p.m. EDT to provide an update on recent corporate developments, fourth quarter and full year 2023 financial results and upcoming milestones.

Breakthrough’s Research Reveals Extreme Weather Is the Top Challenge for Transportation Professionals in 2024

Retrieved on: 
Wednesday, April 3, 2024
Other Transport, Green Technology, Trucking, Rail, Maritime, Environment, Retail, Transport, Research, Sustainability, Supply Chain Management, Logistics, Science, Other Energy, Oil, Gas, Alternative Energy, Energy, Climate Change, EVS, Panama Canal, Climate change, Breakthrough, Weather, Cargo

Both shippers and carriers named extreme weather events the top transportation challenge for 2024 amid an ongoing drought in the Panama Canal, intensified winter weather, and a highly active hurricane season.

Key Points: 
  • Both shippers and carriers named extreme weather events the top transportation challenge for 2024 amid an ongoing drought in the Panama Canal, intensified winter weather, and a highly active hurricane season.
  • On top of climate-related disruptions, climate change is pushing sustainability to the top of the agenda for both shippers and carriers.
  • Last year, transportation professionals were focused on reducing costs as a means to overcome volatile diesel prices.
  • Breakthrough surveyed 500 transportation leaders, including carriers and shippers, across the United States about their goals, priorities and predictions for 2024.

Star Refrigeration awarded two major Sustainability Awards at Cold Chain Federation Climate Summit 2024

Retrieved on: 
Friday, March 22, 2024
Frozen food, Temperature, Culture, Climate change, Innovation, Cold, Business development, Heat, Partnership, SDA, Star, Climate, Research, Food court, Breakthrough, AI, Carbon, University of Warwick, CO2, Nomad Foods, Safety, Sustainability, Renewable energy

LONDON, March 22, 2024 /PRNewswire-PRWeb/ -- Star Refrigeration received the Cold Chain Federation's 2024 'Technological Breakthrough - Innovation of the Year' award in partnership with their customer Tesco, while Dr Rob Lamb received the 'Cold Chain Climate Champion' accolade for driving sector-wide energy efficiency. The Cold Chain Sustainability Awards were revealed at a presentation held during the Cold Chain Climate Summit at Warwick University on 13th March.

Key Points: 
  • The Cold Chain Sustainability Awards were revealed at a presentation held during the Cold Chain Climate Summit at Warwick University on 13th March.
  • "I'm sincerely honoured to have been named Cold Chain Climate Champion 2024 at the Cold Chain Federation's Sustainability Awards.
  • "I'm sincerely honoured to have been named Cold Chain Climate Champion 2024 at the Cold Chain Federation's Sustainability Awards.
  • For more information about the Cold Chain Sustainability Summit, visit Cold Chain Climate Summit 2024 - Cold Chain Federation
    For more information about Star Refrigeration, visit https://www.star-ref.co.uk

Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ Spinal Interbody Cage

Retrieved on: 
Thursday, March 14, 2024
CE, Acceleration, Patient, Trauma, Health care, Breakthrough, Quality of life, USD, FDA, Hospital, Pharmaceutical industry

TAMPERE, Finland, March 14, 2024 /PRNewswire/ -- Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has today been granted Breakthrough Device Designation for its RemeOs™ Spinal Interbody Cage implant from the US Food and Drug Administration, confirming that the product represents a breakthrough technology in spinal surgery.

Key Points: 
  • TAMPERE, Finland, March 14, 2024 /PRNewswire/ -- Bioretec Ltd., a pioneer in biodegradable orthopedic implants, has today been granted Breakthrough Device Designation for its RemeOs™ Spinal Interbody Cage implant from the US Food and Drug Administration, confirming that the product represents a breakthrough technology in spinal surgery.
  • RemeOs Spinal Interbody Cages are intended to be used to restore intervertebral height and facilitate intervertebral body fusion in the cervical spine.
  • Bioretec's biodegradable RemeOs™ Spinal Interbody Cage met the strict criteria set for entering the FDA's Breakthrough Device Designation program.
  • Under the Breakthrough Devices Program, the FDA will enable an ongoing and prioritized interactive discussion between Bioretec and the authorities regarding the commercial access of RemeOs™ Spinal Interbody Cage implant in the U.S. market.