National Medical Products Administration

Amarin Reports Third Quarter 2023 Financial Results

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水曜日, 11月 1, 2023
Research, SMC, Medicare, Prescription, Risk, Forecasting, CVRR, Telephone, Health technology assessment, GAAP, HTA, Commercial, Marketing, Healthcare Improvement Scotland, Professional corporation, Investment, Patient, Hypertriglyceridemia, National Medical Products Administration, Conference, Organization, IPE, Medicaid, NMPA, File, Socialist Alternative (England, Wales & Scotland), ASEAN, Rare-earth element, Management, Pharmaceutical industry, Health insurance, Video game, Cryptocurrency, Bank, Amarin

-- Company to Host Conference Call Today at 8:00 a.m. ET --

Key Points: 
  • ET --
    DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced financial results for the quarter ended September 30, 2023 and provided an update on company operations.
  • “As we focus on demonstrating results that will drive shareholder value, there are reasons to be optimistic about the future of Amarin,” said Patrick Holt, President & CEO of Amarin.
  • U.S. product net revenue was $62.4 million in the third quarter of 2023, a decline of $2.2 million versus the second quarter of 2023, a decrease of 3% sequentially.
  • The company has provided these non-GAAP financial measures in addition to GAAP financial results because it believes that these non-GAAP adjusted financial measures provide investors with a better understanding of the company’s historical results from its core business operations.

Burning Rock and Boehringer Ingelheim Achieved a Master Service Agreement in Oncology Companion Diagnostics

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月曜日, 10月 30, 2023
MSA, NMPA, TP53, Hope, Boehringer Ingelheim, National Medical Products Administration, Master service agreement, Research, Rock, Partnership, Cancer, LSE, BTC, Safety, Patient, Pharmaceutical industry, Water Drops on Burning Rocks

GUANGZHOU, China, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that the Company and Boehringer Ingelheim officially have signed the Master Service Agreement (MSA) in the field of oncology companion diagnostics.

Key Points: 
  • GUANGZHOU, China, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that the Company and Boehringer Ingelheim officially have signed the Master Service Agreement (MSA) in the field of oncology companion diagnostics.
  • This partnership will primarily focus on advancing the clinical trials related to Boehringer Ingelheim's MDM2-p53 antagonist, brigimadlin (BI 907828), and the development of companion diagnostic products in China.
  • Mr. Yusheng Han, Founder and CEO of Burning Rock, expressed, “We are delighted to establish a deep collaboration in companion diagnostics with Boehringer Ingelheim.
  • Burning Rock has a comprehensive layout and supports companion diagnostics development with a global perspective for pharmaceutical companies.

ImmunoGen Reports Recent Progress and Third Quarter 2023 Financial Results

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木曜日, 11月 2, 2023
Oncology, Health, Other Health, General Health, Pharmaceutical, Biotechnology, Novartis Institute for Tropical Diseases, Research, NSCLC, Acute myeloid leukemia, IMGN, Food, PIN, Biomedical Research, ImmunoGen, European Medicines Agency, Doctor of Philosophy, Medicine, Capital expenditure, New Drug Application, Takeda Pharmaceutical Company, Marketing, BPDCN, ESGO, US Foods, Azacitidine, European Society of Gynaecological Oncology, EMA, ORR, NDA, Safety, Cancer, György Enyedi (geographer), Patient, National Medical Products Administration, Eli Lilly and Company, MAA, Congress, Mirvetuximab soravtansine, Blastic plasmacytoid dendritic cell neoplasm, ASH, Growth, ADC, Spacecraft, FDA, NMPA, PROC, University Clinical Centre in Gdańsk, Society, Senior, Inc., Huadong Medicine, AML, PARP, Vaccine, Pharmaceutical industry, Dietary supplement, Takeda

ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended September 30, 2023.

Key Points: 
  • ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended September 30, 2023.
  • We also continued to monitor the NSCLC cohort with IMGC936 and advanced dose escalation with IMGN151, our second-generation ADC targeting FRα.
  • Selling, general and administrative expenses were $37.7 million for the quarter ended September 30, 2023 compared to $33.6 million for the quarter ended September 30, 2022.
  • Capital expenditures were $1.6 million and $1.1 million for the first nine months of 2023 and 2022, respectively.

The 2nd Boao International Conference on Real World Studies of Medical Products Held in Hainan

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金曜日, 11月 3, 2023
National Medical Products Administration, Real World, RWD, NMPA, Economics, Conference, Merck, Research, Medicine, Pharmaceutical industry, Biostatistics, Epidemiology

HAIKOU, China, Nov. 3, 2023 /PRNewswire/ -- On 31st Oct., the 2nd Boao International Conference on Real World Studies of Medical Products, held in Boao, Hainan, was attended by nearly 1,000 participants from domestic and international pharmaceutical regulatory agencies, academic societies, industrial associations, pharmaceutical enterprises, etc.

Key Points: 
  • HAIKOU, China, Nov. 3, 2023 /PRNewswire/ -- On 31st Oct., the 2nd Boao International Conference on Real World Studies of Medical Products, held in Boao, Hainan, was attended by nearly 1,000 participants from domestic and international pharmaceutical regulatory agencies, academic societies, industrial associations, pharmaceutical enterprises, etc.
  • The conference featured a plenary session and eight sub-forums, and encompassed various fields related to international real-world research, and the scientific development of pharmaceutical product regulation.
  • According to Deputy Director of Biostatistics and Epidemiology, Real World Evidence Department, Merck, Germany, Real world study is a significant institutional innovation in the Hainan Free Trade Port.
  • "We learnt that four drugs and nine medical devices have been approved by National Medical Products Administration (NMPA) using Real World Data(RWD) from Hainan Boao Lecheng.

The 2nd Boao International Conference on Real World Studies of Medical Products Held in Hainan

Retrieved on: 
金曜日, 11月 3, 2023
National Medical Products Administration, Real World, RWD, NMPA, Economics, Conference, Merck, Research, Multimedia, Medicine, Pharmaceutical industry, Biostatistics, Epidemiology

HAIKOU, China, Nov. 3, 2023 /PRNewswire/ -- On 31st Oct., the 2nd Boao International Conference on Real World Studies of Medical Products, held in Boao, Hainan, was attended by nearly 1,000 participants from domestic and international pharmaceutical regulatory agencies, academic societies, industrial associations, pharmaceutical enterprises, etc.

Key Points: 
  • HAIKOU, China, Nov. 3, 2023 /PRNewswire/ -- On 31st Oct., the 2nd Boao International Conference on Real World Studies of Medical Products, held in Boao, Hainan, was attended by nearly 1,000 participants from domestic and international pharmaceutical regulatory agencies, academic societies, industrial associations, pharmaceutical enterprises, etc.
  • The conference featured a plenary session and eight sub-forums, and encompassed various fields related to international real-world research, and the scientific development of pharmaceutical product regulation.
  • According to Deputy Director of Biostatistics and Epidemiology, Real World Evidence Department, Merck, Germany, Real world study is a significant institutional innovation in the Hainan Free Trade Port.
  • "We learnt that four drugs and nine medical devices have been approved by National Medical Products Administration (NMPA) using Real World Data(RWD) from Hainan Boao Lecheng.

Apollomics Announces Report of Activity of Vebreltinib in Glioblastoma Multiforme (GBM) with PTPRZ-MET Fusion

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木曜日, 10月 26, 2023
APLM, National Medical Products Administration, GBM, Temozolomide, NMPA, ESMO, SPARTA, Radiation, Cancer, Partial-response maximum-likelihood, New Drug Application, NDA, European Society for Medical Oncology, Patient, MET, Communication, Aviston, Illinois, Pharmaceutical industry

The patient with GBM with PTPRZ-MET fusion who had previously received radiotherapy and temozolomide, was reported to have an impressive Partial Response (PR) after 8 weeks of treatment with vebreltinib monotherapy during participation in the SPARTA study ( NCT03175224 ) .

Key Points: 
  • The patient with GBM with PTPRZ-MET fusion who had previously received radiotherapy and temozolomide, was reported to have an impressive Partial Response (PR) after 8 weeks of treatment with vebreltinib monotherapy during participation in the SPARTA study ( NCT03175224 ) .
  • “PTPRZ-MET fusions are known to cause aggressive forms of GBM and are associated with poor prognosis.
  • We are pleased to achieve positive clinical results in patients with this deadly disease, further demonstrating the potential of vebreltinib as a new treatment for patients with cancers driven by MET alterations,” said Guo-Liang Yu, Ph.D., co-founder, Chairman and Chief Executive Officer of Apollomics.
  • GBM with MET fusion is an indication pursued by Apollomics and its China partner, Avistone Biotechnology.

LianBio Announces Presentation of Data from Phase 2a Study of Infigratinib in Patients with Gastric Cancer at ESMO Congress 2023

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水曜日, 10月 25, 2023
Gene amplification, Corr, Stomach, NMPA, ESMO, Trae tha Truth, FGFR2, ATP, DOR, DCR, MOS, FGFR, Congress, Safety, National Medical Products Administration, Disease, Oncology, Hepatotoxicity, RECIST, European Society for Medical Oncology, GC, GEJ, Death, Pharmaceutical industry, Patient

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Key Points: 
  • 1527P)
    The study enrolled 21 GC and GEJ patients with FGFR2 gene amplification.
  • Among 20 evaluable patients who had post-baseline assessments, cORR was 25.0% (95% CI: 8.7–49.1) and DCR was 80.0% (95% CI: 56.3–94.3).
  • “China has an acute need for new effective treatment options as there is a disproportionately higher number of patients with gastric cancer in the region.”
    FGFR pathway aberrations are common in multiple cancer types, including gastric cancer.
  • Infigratinib received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) for the treatment of gastric cancer.

LianBio Enters into Agreement with Bristol Myers Squibb for Mavacamten in China and Other Asian Markets

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火曜日, 10月 24, 2023
Bristol Myers Squibb, Oxford Handbook of Clinical Medicine, NMPA, Jefferies Group, Priority, National Medical Products Administration, BMS, Quality of life, Medicine, Employment, NDA, HCM, Patient, Centerview Partners, Pharmaceutical industry

Under the terms of the agreement, LianBio will receive a one-time payment of $350 million.

Key Points: 
  • Under the terms of the agreement, LianBio will receive a one-time payment of $350 million.
  • In addition, LianBio will be released from payment obligations of up to $127.5 million in remaining milestone payments under the MyoKardia license agreement.
  • LianBio received approval in Macau and Singapore for mavacamten for the treatment of adults with symptomatic oHCM in 2023.
  • The LianBio Board of Directors expects to provide an update on its strategic review in the first half of 2024.

Life Molecular Imaging and Sinotau Pharmaceutical Group Announce the Regulatory Approval of their Amyloid PET Imaging Radiopharmaceutical Neuraceq® in China

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火曜日, 10月 24, 2023
Alzheimer's disease, Amyloid, FDA, LMI, United Kingdom, Trial of the century, AD, Radiopharmaceutical, NMPA, Plaque, MCI, Food, Medication, Physician, European Medicines Agency, Dementia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research, PET, Disease, MHRA, National Medical Products Administration, EMA, Brain, Medicines and Healthcare products Regulatory Agency, GMP, Patient, Diagnosis, Medical imaging

BERLIN and BEIJING, Oct. 24, 2023 /PRNewswire/ -- Life Molecular Imaging (LMI) and Sinotau Pharmaceutical Group are pleased to announce Neuraceq® (with Chinese trade name 欧韦宁®, florbetaben F-18 injection) has received regulatory approval from National Medical Products Administration (NMPA) in China. Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer, is the first radiopharmaceutical targeting β-amyloid approved in China to be used to support diagnosis of Alzheimer's disease (AD). It visualizes beta-amyloid plaque accumulation in the brain, an established biomarker for AD. Neuraceq® (欧韦宁®) will be manufactured by Sinotau and made commercially available. With this diagnostic tool, Chinese physicians will have access to state-of-the-art imaging technology to accurately evaluate patients with cognitive decline. The density of amyloid plaques can be assessed to guide early diagnosis and patient management.

Key Points: 
  • BERLIN and BEIJING, Oct. 24, 2023 /PRNewswire/ -- Life Molecular Imaging (LMI) and Sinotau Pharmaceutical Group are pleased to announce Neuraceq® (with Chinese trade name 欧韦宁®, florbetaben F-18 injection) has received regulatory approval from National Medical Products Administration (NMPA) in China.
  • Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer, is the first radiopharmaceutical targeting β-amyloid approved in China to be used to support diagnosis of Alzheimer's disease (AD).
  • With this diagnostic tool, Chinese physicians will have access to state-of-the-art imaging technology to accurately evaluate patients with cognitive decline.
  • "Neuraceq® (欧韦宁®), an amyloid PET imaging radiotracer which can be imaged through PET-CT/MRI is the first approved Aβ-PET tracer in China and the first approved PET tracer in China in recent 20 years.

AnHeart Therapeutics’ Investigational Medicine Taletrectinib Shrank Tumors in More Than 90 Percent of People With ROS1-Positive Non-Small Cell Lung Cancer Who Were ROS1 TKI Naïve in Global Pivotal TRUST-II Trial

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土曜日, 10月 21, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, TKI, ROS1, NSCLC, Corr, Journal of Thoracic Oncology, NMPA, Food, Lung cancer, Dizziness, National Medical Products Administration, Doctor of Philosophy, Incidence, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lung, Disease, Medicine, Interim, Brain, European Society of Gynaecological Oncology, Cancer, Patient, IRC, Pharmaceutical industry

Taletrectinib shrank tumors in 57% of patients who had previously been treated with a ROS1 TKI (TKI pre-treated).

Key Points: 
  • Taletrectinib shrank tumors in 57% of patients who had previously been treated with a ROS1 TKI (TKI pre-treated).
  • Taletrectinib also showed robust intracranial activity in the subgroup of patients with disease that had spread to the brain.
  • Median progression-free survival (IRC-assessed) was not reached for TKI naïve patients and was 11.7 months for TKI pre-treated patients, respectively.
  • In both trials, taletrectinib shrank tumors in almost every ROS1 TKI naïve person and more than half of people previously treated with a ROS1 TKI, and the responses were durable.