CDE

Zai Lab Announces NDA Acceptance of Repotrectinib for Patients with ROS1-positive NSCLC by China’s NMPA

Retrieved on: 
Wednesday, June 28, 2023

SHANGHAI, China and CAMBRIDGE, Mass., June 28, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has accepted the New Drug Application (NDA) for repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).

Key Points: 
  • SHANGHAI, China and CAMBRIDGE, Mass., June 28, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has accepted the New Drug Application (NDA) for repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
  • “We are pleased to obtain the NMPA’s acceptance of our NDA for repotrectinib, which further supports repotrectinib as a potential best-in-class treatment for patients with ROS1-positive NSCLC in China.
  • There is a significant unmet need for these patients given the limited durability of benefit, the emergence of resistance to approved therapies and eventual tumor progression,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab.
  • “We look forward to collaborating with the NMPA during the review process in a joint effort to bring this important medicine to patients in need as soon as possible.”
    In May 2023, the Center for Drug Evaluation (CDE) of China’s NMPA granted priority review to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

CANbridge Reports Positive Preliminary Data in the Omoprubart (CAN106) Phase 1b Trial in Paroxysmal Nocturnal Hemoglobinuria (PNH) in China

Retrieved on: 
Monday, June 26, 2023

The goals of the study are to assess safety, pharmacokinetics, pharmacodynamics and efficacy in subjects with PNH.

Key Points: 
  • The goals of the study are to assess safety, pharmacokinetics, pharmacodynamics and efficacy in subjects with PNH.
  • Data from the two lower dose cohorts was reviewed through 26 weeks, while data from the highest dose cohort was reviewed through 13 weeks, the latest timepoint.
  • CANbridge plans to advance Omoprubart to a pivotal trial in PNH in China, where there are no approved long-acting PNH treatments.
  • Based on the strength of these data, we plan to advance omoprubart to a pivotal trial in PNH in China and will meet shortly with the CDE to discuss our next steps.

Coeur Announces C$25 Million Private Placement

Retrieved on: 
Thursday, June 22, 2023

Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today announced that it has arranged a private placement (the “Offering”) of 5,276,154 flow-through common shares of the Company that will qualify as “flow-through shares” within the meaning of subsection 66(15) of the Income Tax Act (Canada) (the “flow-through shares”) for gross proceeds of approximately $19 million (C$25 million) and will be subject to a six-month hold period.

Key Points: 
  • Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today announced that it has arranged a private placement (the “Offering”) of 5,276,154 flow-through common shares of the Company that will qualify as “flow-through shares” within the meaning of subsection 66(15) of the Income Tax Act (Canada) (the “flow-through shares”) for gross proceeds of approximately $19 million (C$25 million) and will be subject to a six-month hold period.
  • The Company has granted an overallotment option of up to 3,000,000 additional flow-through shares.
  • Prior to the Offering, Coeur received an affirmative Advance Income Tax Ruling from the Canada Revenue Agency confirming the tax consequences of certain aspects of the Offering.
  • The flow-through shares will be privately placed with investors in certain provinces in Canada pursuant to applicable exemptions from the prospectus requirements.

Coeur Provides Silvertip Exploration Update

Retrieved on: 
Thursday, June 22, 2023

Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today provided plans for a sustained 24-month exploration program beginning July 1, 2023 at its expanding high-grade Silvertip polymetallic exploration project in northern British Columbia.

Key Points: 
  • Coeur Mining, Inc. (“Coeur” or the “Company”) (NYSE: CDE) today provided plans for a sustained 24-month exploration program beginning July 1, 2023 at its expanding high-grade Silvertip polymetallic exploration project in northern British Columbia.
  • Since late 2017, Coeur has discovered several new, stacked manto horizons hosted at different elevations throughout the McDame Limestone.
  • Alongside the known silver, lead, zinc carbonate replacement style mineralization, the Silvertip District is prospective for porphyry and / or skarn mineralization.
  • “We believe the resource base currently outlined at Silvertip represents a distal portion of a large mineralizing system and the detailed geological analysis and modelling completed during the first half of 2023 supports that thinking,” said Aoife McGrath Senior, Coeur Vice President of Exploration.

XiFin Enlists Former CVS Health Physician Executive in Advocacy Efforts to Advance Healthcare Access and Equity via Expanded Coverage of Pharmacy Clinical Services

Retrieved on: 
Tuesday, June 13, 2023

Dr. Rhee serves as a physician executive across the healthcare industry, and most recently, was Senior Vice President and Aetna Chief Medical Officer at CVS Health.

Key Points: 
  • Dr. Rhee serves as a physician executive across the healthcare industry, and most recently, was Senior Vice President and Aetna Chief Medical Officer at CVS Health.
  • Dr. Rhee’s work will include support for passage of bipartisan legislation in Congress, the Equitable Community Access to Pharmacist Services Act (H.R.
  • While at HRSA and NIH, he led numerous national initiatives related to prevention, health care quality, research, health equity and public health.
  • Joining Dr. Rhee in the discussion are Jane Hermansen, Manager, Outreach and Network Development, Mayo Clinic, and Dean Braun, Senior Vice President, OmniSYS | XiFin Pharmacy Solutions.

CDE Complaint Decision Denies Reading Fluency; Impacts 40,000+ California Students with Dyslexia

Retrieved on: 
Tuesday, June 13, 2023

PLEASANTON, Calif., June 13, 2023 /PRNewswire/ -- Everybody Advocate™, a nonprofit for the support and advancement of special education, today announced they will be offering free second opinions to California families denied reading intervention due to an alleged systemic failure by the California Department of Education (CDE) to find students eligible for specially designed instruction. The decision comes in response to a refusal by the CDE's special education Complaint Resolution Unit (CRU) to correct the absence of a checkbox for reading fluency on a statewide eligibility form for special education.

Key Points: 
  • The decision comes in response to a refusal by the CDE's special education Complaint Resolution Unit (CRU) to correct the absence of a checkbox for reading fluency on a statewide eligibility form for special education.
  • The form is provided through a special education information system (SEIS) used by more than 90% of California districts.
  • "A shocking number of schools insist that they do not consider below-grade-level reading fluency a problem until it also impacts reading comprehension, which has a checkbox on the form.
  • On behalf of three families, Maehr filed a complaint against Pleasanton Unified School District, the Tri-Valley Special Education Local Plan Area, and the CDE.

Innovent Presents Phase 1 Clinical Data of IBI351 (KRASG12C Inhibitor) as Monotherapy for Metastatic Colorectal Cancer at the 2023 ASCO Annual Meeting

Retrieved on: 
Tuesday, June 6, 2023

Data presented in ASCO 2023 was from a pooled analysis of two Phase 1 studies (NCT05005234, NCT05497336).

Key Points: 
  • Data presented in ASCO 2023 was from a pooled analysis of two Phase 1 studies (NCT05005234, NCT05497336).
  • Favorable safety and tolerability and promising antitumor activity of IBI351 monotherapy were observed in advanced colorectal cancer harboring KRASG12C mutation.
  • The preliminary data shows favorable safety and promising activity of IBI351 monotherapy in KRASG12C mutated advanced colorectal cancer.
  • The data reported at ASCO 2023 showed that IBI351 monotherapy has excellent efficacy and safety in previously treated advanced colorectal carcinoma.

VIEW LIST OF FAMILY-FRIENDLY EVENTS HAPPENING ON DAIRY FARMS ACROSS PA THIS SUMMER

Retrieved on: 
Wednesday, May 31, 2023

HARRISBURG, Pa., May 31, 2023 /PRNewswire/ -- With June being National Dairy Month and July being National Ice Cream Month, several Pennsylvania dairy farms and organizations are hosting on-farm events to give families a firsthand look at Pennsylvania agriculture and local dairy products. The "Celebrate Dairy Across PA" initiative features an online listing of 15 dairy-themed events happening across the state in June and July. Many of the events feature outdoor, family-friendly activities at no cost, including farm-fresh ice cream, farm tours, hayrides, calf and cow petting, and more. Visit www.centerfordairyexcellence.org/celebratepadairy to view an interactive map and the 2023 event listing.

Key Points: 
  • The "Celebrate Dairy Across PA" initiative features an online listing of 15 dairy-themed events happening across the state in June and July.
  • "There are 5,000 dairy farms in Pennsylvania, and 99 percent of these farms are family owned," said Emily Barge, communications and marketing manager at the Center for Dairy Excellence.
  • The following events, listed in order of occurrence, are featured on the "Celebrate Dairy Across PA" listing:
    Scooped: PA Ice Cream Trail – State-Wide – Launches June 1.
  • During the giveaway, meet a dairy calf from Destiny Dairy Bar and enjoy their delicious ice cream to celebrate June Dairy Month.

Ascentage Pharma's Novel Drug Olverembatinib Recommended for a Breakthrough Therapy Designation in China for the Treatment of SDH-Deficient GIST, the Second BTD for the Drug

Retrieved on: 
Wednesday, May 31, 2023

To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.

Key Points: 
  • To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.
  • Drugs that have been granted BTDs are prioritized by the CDE in communications and exchange, and in receiving guidance to advance the drug development progress.
  • Furthermore, BTD-designated drugs will be eligible for Priority Review status and conditional approvals upon submission of a New Drug Application (NDA).
  • Antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor (TKI)–resistant succinate dehydrogenase (SDH)–deficient gastrointestinal stromal tumor (GIST).

Zai Lab Announces That Repotrectinib Granted Priority Review by China’s NMPA

Retrieved on: 
Thursday, May 18, 2023

SHANGHAI, China and CAMBRIDGE, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).

Key Points: 
  • SHANGHAI, China and CAMBRIDGE, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
  • “The CDE’s decision to grant priority review to repotrectinib underscores repotrectinib as a potential next-generation best-in-class treatment for ROS1-positive NSCLC in both TKI-naïve and pretreated patients in China,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab.
  • It is implemented under the Drug Registration Regulation (Bureau Order 27) and the Working Procedure for Priority Review and Approval of Drug Marketing Authorization (Interim, NMPA 2020 No.
  • According to the regulation and guidance, the regulatory authority will prioritize the evaluation resources for applications under priority review to expedite the review and approval timelines.