Center for Drug Evaluation and Research

Zai Lab Obtains Breakthrough Therapy Designation for Efgartigimod Alfa Injection (Subcutaneous Injection) in Patients with Chronic Inflammatory Demyelinating Polyneuropathy in China

Retrieved on: 
Monday, September 18, 2023
SC, Safety, Policy, Breakthrough therapy, Quality of life, Medicine, ECI, Autoimmunity, HKEX, Chronic inflammatory demyelinating polyneuropathy, Patient, Risk, National Medical Products Administration, Breakthrough, Immunoglobulin G, CDE, International development, Biology, Center for Drug Evaluation and Research, NMPA, Infection, Autoantibody, Pharmaceutical industry, Rare-earth element, CIDP, Neuroscience

SHANGHAI, China and CAMBRIDGE, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Key Points: 
  • SHANGHAI, China and CAMBRIDGE, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
  • The Breakthrough Therapy Designation for efgartigimod SC was supported by data from both global and Chinese patients enrolled in the ADHERE study.
  • “We have seen how efgartigimod SC can meaningfully improve and stabilize disease symptoms in these patients.
  • Existing treatment options are quite limited, and problematic given the general reliance on long-term steroid or chronic immunoglobulin therapy.

Connect Biopharma Reports First Half 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, September 12, 2023
Insurance, Maintenance, Asthma, American Academy of Dermatology, Week, Center for Drug Evaluation and Research, New Drug Application, NDA, American Academy, Atopic dermatitis, Research, CNTB, Polyp (medicine), USD, Ulcerative colitis, Accounting, Congress, UC, Patient, AAD, Spirometry, Investment, SAN, CDE, Sinusitis, Entrepreneurship, Cytokine, R, AD, FDA, Type 2 inflammation, FEV1, RMB, Safety, Pharmaceutical industry, Vaccine, Medical imaging, Cryptocurrency, Dermatology

SAN DIEGO and TAICANG, China, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today reported financial results for the six months ended June 30, 2023 and provided a business update.

Key Points: 
  • SAN DIEGO and TAICANG, China, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today reported financial results for the six months ended June 30, 2023 and provided a business update.
  • “We also reported positive long-term data from the Phase 2 maintenance period in ulcerative colitis with our other late-stage asset – icanbelimod.
  • There were no new safety signals and icanbelimod continued to be well-tolerated, consistent with observed induction period safety data.
  • Published in July 2023 the pre-clinical data characterizing rademikibart in Nature’s Scientific Reports.

Global Healthcare Cold Chain Logistics Market Outlook & Forecasts Report 2023-2028: Technology Advancements Driving Competition - Blockchain Integration Elevating Industry Growth - ResearchAndMarkets.com

Retrieved on: 
Monday, September 11, 2023
Health, Other Health, Vaccine, Workforce, Kuehne + Nagel, Deutsche Post DHL Group, FedEx, Center for Drug Evaluation and Research, AmerisourceBergen, Quick (restaurant), Internet of things, Clinical trial, Temperature, Transport, USD, DB Schenker, United Parcel Service, Counterfeit, DB Group, Ageing, Joint Medical Service (Germany), Developed country, Investment, Patient, Growth, API, CEVA Logistics, FDA, Cholinergic crisis, Nippon Express, Safety, Pharmaceutical industry, Warehouse, Research

The "Healthcare Cold Chain Logistics Market - Global Outlook & Forecast 2023-2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Healthcare Cold Chain Logistics Market - Global Outlook & Forecast 2023-2028" report has been added to ResearchAndMarkets.com's offering.
  • North America accounted for the highest revenue share of over 37% of the global healthcare cold chain logistics market in 2022.
  • The global healthcare cold chain logistics market is highly fragmented and concentrated, with many key players in the industry.
  • The pharmaceutical/biotech companies' end-user segment accounted for the highest revenue share of the global healthcare cold chain logistics market in 2022.

FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products

Retrieved on: 
Tuesday, September 12, 2023
Marketing, Glaucoma, Eye, Silver, Skin, Research, FDA, Conjunctivitis, Cataract, Risk, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Center for Drug Evaluation and Research, Dietary supplement

SILVER SPRING, Md., Sept. 12, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law. These warning letters are part of the agency's ongoing effort to protect Americans from potentially harmful ophthalmic products.

Key Points: 
  • SILVER SPRING, Md., Sept. 12, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law.
  • These warning letters are part of the agency's ongoing effort to protect Americans from potentially harmful ophthalmic products.
  • Eye products addressed in the eight warning letters are illegally marketed to treat conditions such as conjunctivitis ("pink eye"), cataracts, glaucoma and others.
  • Some of the FDA warning letters also cite the companies involved for quality issues related to product sterility.

Healthcare Logistics Market to increase by USD 87.9 billion during 2022 to 2027; Growing global pharmaceutical sales to drive the growth- Technavio

Retrieved on: 
Tuesday, September 5, 2023
Vaccine, CDER, Medicine, FDA Center for Devices and Radiological Health, Center for Drug Evaluation and Research, Health care, Medication, AmerisourceBergen, DSV, Transport, YOY, USD, DB Schenker, FedEx, Plasma protein binding, Internet, Incidence, Air Canada, Patient, Nature, United Parcel Service, Agility, United States Secretary of Labor, Conditional sentence, Growth, McKesson Corporation, PDF, CEVA Logistics, SF Express, Deployment, NME, Deutsche Post DHL Group, Pharmaceutical industry, Pet industry, Geography, Research

NEW YORK, Sept. 5, 2023 /PRNewswire/ -- The healthcare logistics market size is expected to grow by USD 87.9 billion between 2022 and 2027.

Key Points: 
  • NEW YORK, Sept. 5, 2023 /PRNewswire/ -- The healthcare logistics market size is expected to grow by USD 87.9 billion between 2022 and 2027.
  • The report analyses the market size and growth and provides accurate predictions on the growth of the market.
  • View a PDF Sample
    Growing global pharmaceutical sales drives the growth of the healthcare logistics market.
  • The growth of the global market can be attributed to factors such as the growing geriatric population and new product launches by pharmaceutical manufacturers.

Zai Lab Announces Breakthrough Therapy Designation Granted for Repotrectinib for Treatment of Patients with NTRK-positive TKI-pretreated advanced solid tumors in China

Retrieved on: 
Wednesday, August 30, 2023
TKI, Policy, New Drug Application, NDA, Quality of life, Medicine, NSCLC, HKEX, Patient, NTRK, National Medical Products Administration, Breakthrough, CDE, Center for Drug Evaluation and Research, NMPA, TRK, Pharmaceutical industry

The Breakthrough Therapy Designation for repotrectinib was supported by data from both global and Chinese NTRK-positive TKI-pretreated patients enrolled in the Phase 1/2 TRIDENT-1 study.

Key Points: 
  • The Breakthrough Therapy Designation for repotrectinib was supported by data from both global and Chinese NTRK-positive TKI-pretreated patients enrolled in the Phase 1/2 TRIDENT-1 study.
  • “We are excited to receive our fourth Breakthrough Therapy Designation for repotrectinib in China.
  • Today’s recognition further supports repotrectinib as a potential first-in-class treatment for patients with NTRK-positive, TKI-pretreated solid tumors in China,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab.
  • Drugs granted Breakthrough Therapy Designations receive priority communications and guidance from the CDE to promote and expedite the drug development process.

Sino Biopharmaceutical (1177.HK) Announces 2023 Interim Results

Retrieved on: 
Friday, August 25, 2023
Neutropenia, Hepatitis, NASH, Marketing, Sino Biopharmaceutical Limited, Liver disease, Clinical trial, Cancer, Breakthrough therapy, Respiratory system, Research, COVID, YOY, Tablet, Patient, ROCK2, CDE, Growth, HK2, Development, Center for Drug Evaluation and Research, NMPA, Idiopathic pulmonary fibrosis, Lumbar spinal stenosis, Safety, Flurbiprofen, Pharmaceutical industry, Generic drug, Fine chemical, Q2, PRC

HONG KONG, Aug 25, 2023 - (ACN Newswire) - Sino Biopharmaceutical Limited ("Sino Biopharmaceutical" or the "Company", together with its subsidiaries, the "Group") (HKEX:1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its unaudited interim results for the six months ended 30 June 2023 (the "Period").

Key Points: 
  • HONG KONG, Aug 25, 2023 - (ACN Newswire) - Sino Biopharmaceutical Limited ("Sino Biopharmaceutical" or the "Company", together with its subsidiaries, the "Group") (HKEX:1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its unaudited interim results for the six months ended 30 June 2023 (the "Period").
  • In the first half of 2023, two innovative products were launched to market and two biosimilar drugs received marketing approval.
  • -- Annike (Penpulimab monoclonal antibody) injection was approved in January 2023 for treating, in combination with chemotherapy, first-line locally advanced or metastatic squamous non-small cell lung cancer.
  • -- Yilishu (Efbemalenograstim alpha) injection was approved in May 2023 for the prevention and treatment of neutropenia in cancer patients taking chemotherapy drugs.

FDA Approves First Biosimilar to Treat Multiple Sclerosis

Retrieved on: 
Thursday, August 24, 2023
China Biologic Products, Sclerosis, Infection, Vagina, REMS, Hepatotoxicity, Communication, Gastroenteritis, Disease, Risk factor, Central nervous system, Human, Depression, Crohn's disease, Diarrhea, PML, Human polyomavirus 2, Center for Drug Evaluation and Research, Pharmacy, Biosimilar, Disability, Urinary tract infection, Woman, Liver injury, Brain, Inflammation, Multiple sclerosis, Arthralgia, Antibody, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Rash, MS, Pain, Patient, Division, Risk, Anaphylaxis, Autoimmune disease, Viral, Research, FDA, Headache, JC, Death, Immunosuppression, Thrombocytopenia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Vaginitis, Safety, Fatigue, Pharmaceutical industry, Generic drug, Nursing, Natalizumab

SILVER SPRING, Md., Aug. 24, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS).

Key Points: 
  • SILVER SPRING, Md., Aug. 24, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS).
  • "Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis," said Paul R. Lee, M.D., Ph.D., director of the Division of Neurology 2 in the FDA's Center for Drug Evaluation and Research.
  • This means patients can expect the same safety and effectiveness from the biosimilar as they would the reference product.
  • The FDA granted approval of Tyruko, the first biosimilar to Tysabri (natalizumab), to Sandoz Inc.

BioCorRx Submits Expanded Access Treatment Protocol to FDA for BICX104, Implantable Biodegradable Naltrexone Pellet for Treatment of Opioid Use Disorder

Retrieved on: 
Tuesday, August 15, 2023
CDER, The Washington Post, US Food Sovereignty Alliance, Center for Drug Evaluation and Research, Opioid use disorder, NDA, OTCQB, OUD, Fast Track, Naltrexone, CDC, Patient, FDA, Death, Fentanyl, Food, Pharmaceutical industry, Research

ANAHEIM, CA, Aug. 15, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – BioCorRx Inc. (OTCQB: BICX) (the “Company”) today announced its submission to the US Food and Drug Administration (FDA) of an expanded access program application for BICX104 (implantable naltrexone pellet) for the treatment of opioid use disorder (OUD) patients that meet program eligibility criteria.

Key Points: 
  • Brady Granier, President of BioCorRx, Inc., and CEO of BioCorRx Pharmaceuticals, Inc., stated, "We chose to submit this expanded access treatment protocol to bring the benefits of our safe, effective, and potentially life-saving naltrexone implant to patients suffering with OUD.
  • Our Phase I clinical trial results encouraged us to apply to the FDA to get our BICX104 treatment to the public as soon as possible.
  • If our expanded access application is approved, we look forward to implementing our program to promote the distribution of BICX104 to OUD patients through qualified health care providers.
  • By providing enhanced relapse protection during the crucial early stages of treatment, BICX104 can make a significant impact on this harrowing crisis."

SinoMab Announces IND Application of SM17 for the Treatment of Asthma was Accepted by NMPA CDE

Retrieved on: 
Monday, May 22, 2023
Drug development, T helper cell, Therapy, Lincoln Hospital (Bronx), Clinical trial, Quality of life, Atopic dermatitis, Research, Innate lymphoid cell, Trial of the century, Frost, Investigational New Drug, Patient, Risk, Health, Allergy, ILC2, National Medical Products Administration, FIH, Center for Drug Evaluation and Research, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Idiopathic pulmonary fibrosis, Food, NMPA, Safety, Pharmaceutical industry, Vaccine, Asthma

The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of asthma.

Key Points: 
  • The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of asthma.
  • Current approved therapies for severe asthma, including biologics, can reduce asthma annual exacerbations to a certain extent.
  • The Company believes SM17 may have great potential to satisfy unmet medical needs in asthma treatment.
  • It is expected that this new treatment option will benefit more Chinese patients in the future and bring a promising treatment for severe asthma patients.