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

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星期三, 三月 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.

Coeur Announces First Quarter 2024 Earnings Call

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星期二, 四月 9, 2024

Natural Resources, Other Natural Resources, Mining, Minerals, CDE, Senior, Central Time

Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today announced that it will report its first quarter 2024 operational and financial results after the New York Stock Exchange closes for trading on Wednesday, May 1, 2024.

Key Points:

Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today announced that it will report its first quarter 2024 operational and financial results after the New York Stock Exchange closes for trading on Wednesday, May 1, 2024.
The Company will be hosting a conference call at 11:00 a.m. Eastern Time (10:00 a.m. Central Time) on Thursday, May 2, 2024.
Hosting the call will be Mitchell J. Krebs, President and Chief Executive Officer of Coeur, who will be joined by Thomas S. Whelan, Senior Vice President and Chief Financial Officer, Michael “Mick” Routledge, Senior Vice President and Chief Operating Officer, Aoife McGrath, Senior Vice President of Exploration, and other members of management.
A replay of the call will be available through May 9, 2024.

Expanded Rochester Mine Achieves Commercial Production; Ramp-Up on Schedule

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星期一, 四月 8, 2024

Natural Resources, Other Natural Resources, Mining, Minerals, CDE, Merrill–Crowe process, Gold, Silver, Coeur, Uranium mining

Commissioning of the new three-stage crushing circuit and truck load-out facility was completed on March 7.

Key Points:

Commissioning of the new three-stage crushing circuit and truck load-out facility was completed on March 7.
Since then, the crushing circuit has operated at an average throughput of nearly 70,000 tons per day1 and has exceeded 88,000 tons per day, leading to the declaration of commercial production as of the end of the first quarter.
Ramp-up to full design capacity of 88,000 tons per day—or approximately 32 million tons per year—remains on schedule for completion during the first half of 2024.
Materially higher production levels are anticipated to build throughout the second half of 2024 consistent with completion of Rochester’s ramp-up.

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

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星期日, 四月 7, 2024

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.

Coeur to Present at Gold Forum Europe

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星期四, 四月 4, 2024

Natural Resources, Other Natural Resources, Mining, Minerals, CDE, Senior, Central European Time

Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) announced today that Senior Vice President and Chief Financial Officer Thomas S. Whelan will present at Gold Forum Europe in Zurich, Switzerland on Wednesday, April 10, 2024 at 1:10 p.m. Central European Time.

Key Points:

Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) announced today that Senior Vice President and Chief Financial Officer Thomas S. Whelan will present at Gold Forum Europe in Zurich, Switzerland on Wednesday, April 10, 2024 at 1:10 p.m. Central European Time.
Gold Forum Europe is an invitation-only investment conference.
Presentation materials will be made available on the Company’s website at www.coeur.com .

LIB Therapeutics and Partner Hasten Biopharmaceuticals Announce Lerodalcibep Clinical Trial Application Acceptance by the Center for Drug Evaluation at the National Medical Products Administration in China

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星期二, 三月 19, 2024

LIB Therapeutics, Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a potential best in class PCSK9 inhibitor for the treatment and prevention of cardiovascular disease (CVD), today announced that its regional partner in China, Hasten Biopharmaceuticals Co, Ltd. (Hasten), has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.

Key Points:

LIB Therapeutics, Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a potential best in class PCSK9 inhibitor for the treatment and prevention of cardiovascular disease (CVD), today announced that its regional partner in China, Hasten Biopharmaceuticals Co, Ltd. (Hasten), has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.
In September 2023, LIB announced that it had entered into an agreement granting Hasten the rights to develop and commercialize Lerodalcibep in Greater China (Chinese Mainland, Hong Kong, Macau and Taiwan) and will be responsible for clinical development and regulatory approval in these territories.
The acceptance of the Lerodalcibep clinical trial application by the NMPA was based on the integrated data dossier provided by LIB, including CMC, non-clinical and clinical studies completed in the U.S., Europe, and rest of world as well as the clinical development plan in China proposed by Hasten.
“We are preparing our own Lerodalcibep BLA submission to the FDA, to be followed by MAA submission to EMA.

Spring Capital Successfully Exits Investment in Catenda, a Leader in Construction Project Software

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星期五, 三月 15, 2024

As the lead investor, Spring Capital has sold all its shares in the transaction on a high IRR for itself and co-investors.

Key Points:

As the lead investor, Spring Capital has sold all its shares in the transaction on a high IRR for itself and co-investors.
Founded in 2009 as a spin-off from SINTEF, Catenda is a leader in Building Information Management (BIM) & Common Data Environment (CDE) software.
Since Spring Capital’s investment through its Scandinavian investment entity Polaris, Catenda has grown significantly, becoming a trusted partner for construction companies and municipalities seeking innovative solutions for large-scale projects.
Construction companies across Europe and Japan have widely adopted the company's software, seeking to streamline operations and improve project outcomes.

Kezar Life Sciences Reports Fourth Quarter and Year End 2023 Financial Results and Provides Business Update

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星期四, 三月 14, 2024

(Nasdaq: KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a business update.

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(Nasdaq: KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a business update.
Research and development (R&D) expenses for the fourth quarter of 2023 increased by $7.7 million to $22.6 million, compared to $14.9 million in the fourth quarter of 2022.
General and administrative (G&A) expenses for the fourth quarter of 2023 increased by $0.6 million to $5.8 million compared to $5.2 million in the fourth quarter of 2022.
Restructuring and impairment charges for the fourth quarter of 2023 were $6.2 million.

Sanyou Bio: Sanyou's Intelligence-Enabled Innovative Biologics R&D Platform Leads in the New Era of Biological Drug Development

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星期三, 三月 27, 2024

This is the driving force behind Sanyou's development of an intelligence-enabled innovative biologics R&D platform.

Key Points:

This is the driving force behind Sanyou's development of an intelligence-enabled innovative biologics R&D platform.
This system finds extensive applications across various domains, including research and development, data management, project management, quality control, and marketing.
By optimizing drug development processes and supporting intelligence-enabled decision-making, it comprehensively enhances R&D efficiency and accuracy, potentially playing a critical role in drug development.
In drug development, the modeling and prediction of drug developability analysis aims to comprehensively enhance the efficiency of the drug development process.

ALCANTARA CONTINUES ITS PARTNERSHIP WITH GERMAN CAR OF THE YEAR PROGRAM

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星期二, 三月 26, 2024

DETROIT, March 26, 2024 /PRNewswire/ -- Alcantara, a leading "Made in Italy" luxury brand and the first Italian industrial company certified as Carbon Neutral, will continue its partnership with the annual German Car of the Year (GCOTY) program in 2024.

Key Points:

DETROIT, March 26, 2024 /PRNewswire/ -- Alcantara, a leading "Made in Italy" luxury brand and the first Italian industrial company certified as Carbon Neutral, will continue its partnership with the annual German Car of the Year (GCOTY) program in 2024.
The GCOTY program opens with a Car Design Event (CDE) attended by more than 100 automotive designers and journalists April -10 at the Drivers & Business Club at Motorworld in Munich.
GCOTY's Summer Testing Event takes place June 24-27 in Alsfeld, Germany and features new-model test drives, concept-car displays, technical presentations and product exhibits.
Prior to announcing the 2025 German Car of the Year in November, GCOTY also will host a classic-car event Sept. 16-17 at the Nationales Automuseum in Dietzhoelztal, Germany.