Committee on Herbal Medicinal Products

European Commission Approves the Commercialisation of RYEQO® for the Symptomatic Treatment of Endometriosis

Retrieved on: 
Thursday, November 2, 2023
Type, Gedeon Richter, Health care, CHMP, Gesellschaft mit beschränkter Haftung, History, Scott Richter, Committee, Committee on Herbal Medicinal Products, European Medicines Agency, Health, Uterine fibroid, Women's Healthcare in the 20th Century United States, SMPS, European, EMA, Committee for Medicinal Products for Human Use, Woman, SMPA, Endometriosis, Dietary supplement, Pharmaceutical industry, EU

('Richter') together with Sumitomo Pharma America, Inc. ('SMPA') and Sumitomo Pharma Switzerland, GmbH ('SMPS') today announce that the European Commission ('EC') has granted approval of a Type II Variation application for RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) for the symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

Key Points: 
  • ('Richter') together with Sumitomo Pharma America, Inc. ('SMPA') and Sumitomo Pharma Switzerland, GmbH ('SMPS') today announce that the European Commission ('EC') has granted approval of a Type II Variation application for RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) for the symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.
  • RYEQO® was initially approved by the EMA in July 2021 for the treatment of moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age.
  • "We are delighted that this approval has opened the way to offer a viable symptomatic treatment option for many women living with endometriosis" - said Dr. Peter Turek, Global Head of Women's Health at Gedeon Richter.
  • "Approximately 14 million women in the European Union are living with endometriosis, a chronic condition whose painful symptoms can impact a woman's ability to engage in certain daily activities.

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for HER2-Negative Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Expressing PD-L1 (CPS ≥1)

Retrieved on: 
Friday, October 13, 2023
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, European, MRK, NYSE, Committee on Herbal Medicinal Products, CHMP, European Medicines Agency, Trastuzumab, GEJ, PD-L1, Gastrointestinal cancer, European Commission, Stomach, Merck & Co., Immunotherapy, Adenocarcinoma, Head, CPS, Neoplasm, Civil service commission, Patient, Pharmaceutical industry, Merck, EU

“This positive CHMP opinion builds on our efforts to treat advanced gastric and gastroesophageal junction cancer in Europe, including in patients with HER2-negative disease, which accounts for the vast majority of gastric cancer cases,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories.

Key Points: 
  • “This positive CHMP opinion builds on our efforts to treat advanced gastric and gastroesophageal junction cancer in Europe, including in patients with HER2-negative disease, which accounts for the vast majority of gastric cancer cases,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories.
  • In the study, approximately 80% of patients had tumors which expressed PD-L1 (CPS ≥1).
  • If approved, this will be the second indication for KEYTRUDA in advanced gastric or GEJ cancer in Europe.
  • Merck has an extensive clinical development program evaluating KEYTRUDA in gastrointestinal cancers and is continuing to study KEYTRUDA for multiple uses in gastric, hepatobiliary, esophageal and colorectal cancers.

Akari Therapeutics Reports First Half 2023 Financial Results and Highlights

Retrieved on: 
Friday, September 29, 2023
Consensus, Manchester University NHS Foundation Trust, EBMT, Male, PRV, Ministry of Health (Poland), Medical device, IMPD, Civil service commission, Leukotriene B4, Blood, Priority review, Marketing, Health care, Clinical trial, Pediatrics, Royal Manchester Children's Hospital, Geographic atrophy, Committee on Herbal Medicinal Products, CTA, Medication, GA, Type, HSCT, Hot game, Hematopoietic stem cell transplantation, European Commission, Patient, NHS foundation trust, Akari, CFO, Diagnosis, Poster, Hospital, Regulatory affairs, European Society for Medical Oncology, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, LTB4, Food, Autoimmunity, Safety, C5, Inflammation, Pharmaceutical industry, Nursing

Adult study design will be an important topic of discussion during a Type C meeting with the U.S. Food and Drug Administration (FDA) scheduled for November 15, 2023.

Key Points: 
  • Adult study design will be an important topic of discussion during a Type C meeting with the U.S. Food and Drug Administration (FDA) scheduled for November 15, 2023.
  • Akari was granted orphan drug designation from the European Commission for treatment in hematopoietic stem cell transplantation.
  • Akari also selected Wacker Biotech GmbH as the manufacturing partner to support production of PAS-nomacopan for use in clinical trials.
  • Akari appointed experienced life sciences executive Wendy DiCicco as interim Chief Financial Officer (CFO).

Geron Announces EMA Validation of Marketing Authorization Application for Imetelstat for the Treatment of Lower Risk MDS

Retrieved on: 
Friday, September 29, 2023
Research, Hospitals, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, European Medicines Agency, Committee on Herbal Medicinal Products, Marketing, EMA, MDS, Imetelstat, Corporation, Geron Corporation, Patient, Risk, Transfusion-dependent anemia, Anemia, MAA, CHMP, Medical device, EU

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for imetelstat, a first-in-class investigational telomerase inhibitor, for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS).

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for imetelstat, a first-in-class investigational telomerase inhibitor, for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS).
  • “The EMA validation of the marketing authorization application for imetelstat brings us one step closer to potentially offering this first-in-class therapeutic to lower risk MDS patients in the EU suffering from anemia,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer.
  • Statistically significant and clinically meaningful efficacy results were achieved across key MDS subgroups irrespective of ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category.
  • Consistent with prior imetelstat clinical experience, the most common serious adverse events were primarily short-lived, manageable cytopenias.

Biophytis releases its half-yearly accounts as of 30 June 2023 and provides an update on its operations

Retrieved on: 
Wednesday, September 27, 2023
US Foods, SARA, Marketing, AMD, COVID-19, Atlas, Committee on Herbal Medicinal Products, European Agency for Special Needs and Inclusive Education, Trial of the century, EMA, HAS, Evaluation, FDA, Vaccine, Pharmaceutical industry

As in the previous year, Biophytis did not record any revenues in the first half of 2023.

Key Points: 
  • As in the previous year, Biophytis did not record any revenues in the first half of 2023.
  • The change in net financial expense is mainly due to the valuation of financial liabilities in accordance with IFRS 9.
  • As a result of the above, the half-year loss has been significantly reduced, from €12.4 million at 30 June 2022 to €7.8 million at 30 June 2023.
  • Continuing pre-clinical development work on Macuneos (BIO201) and its back-up BIO203 and preparing for clinical development in dry AMD.

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adults with Non-Small Cell Lung Cancer at High Risk of Recurrence Following Complete Resection and Platinum-Based Chemotherapy

Retrieved on: 
Friday, September 15, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, T2A, European Organisation for Research and Treatment of Cancer, Civil service commission, Committee on Herbal Medicinal Products, MRK, Lung cancer, NSCLC, Rated R, II, Merck & Co., EORTC, Patient, European, European Medicines Agency, Recurrence, PD-L1, NYSE, Treatment, DFS, Disease, European Commission, CHMP, Pharmaceutical industry, Cancer, Merck

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC), who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC), who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
  • The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the fourth quarter of 2023.
  • “While KEYTRUDA is foundational in the treatment of metastatic non-small cell lung cancer, there continues to be an unmet need to help more patients with lung cancer in earlier stages of disease,” said Dr. Gregory Lubiniecki, vice president, global clinical development, Merck Research Laboratories.
  • In January 2023, KEYTRUDA was approved, as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 centimeters), II, or IIIA NSCLC in the U.S.

ENHERTU® Recommended for Approval in the EU by CHMP for Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer

Retrieved on: 
Friday, September 15, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Neutropenia, Civil service commission, American Journal of Clinical Oncology, HER2, Neoplasm, DCR, European Medicines Agency, Committee on Herbal Medicinal Products, International Association, Lung cancer, Mutation, ILD, Pneumonitis, ERBB2, NSCLC, Immunotherapy, Lung, AstraZeneca, Doctor of Philosophy, Committee, EMA, Journal, Dor, MD, Patient, European, Daiichi Sankyo, Anemia, CR, Committee for Medicinal Products for Human Use, ADC, R, Conference, ORR, European Commission, CHMP, Pharmaceutical industry, Fine chemical, Bachelor of Medicine, Bachelor of Surgery, EU

ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo (TSE:4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).

Key Points: 
  • ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo (TSE:4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).
  • The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.
  • “ENHERTU is the first therapy to demonstrate a strong and durable tumor response in patients with previously treated HER2 mutant advanced non-small cell lung cancer, validating HER2 as an actionable target in lung cancer and supporting the potential to provide a much-needed option for these patients,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo.
  • Grade 3 or higher treatment-related treatment emergent adverse events (TEAEs) occurred in 38.6% of all patients receiving ENHERTU 5.4 mg/kg.

European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol® (ciclosporin ophthalmic solution) 0.1% for the Treatment of Dry Eye Disease

Retrieved on: 
Thursday, August 24, 2023
Pharmaceutical, Health, Optical, DED, Dry eye syndrome, Therapy, European Medicines Agency, Committee on Herbal Medicinal Products, Visual impairment, Hope, Inflammation, Committee, EMA, Pharmacotherapy, Telecanthus, Oil, Patient, Water, European, Ciclosporin, Committee for Medicinal Products for Human Use, MAA, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, CHMP, Pharmaceutical industry, EU

Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review.

Key Points: 
  • Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review.
  • CyclASol is an investigational new drug treatment for dry eye disease in patients not responding to tear substitutes.
  • Dry eye disease (DED) affects millions of people in Europe and is one of the most common ocular surface disorders.
  • “The acceptance of the EU Marketing Authorization Application is a key milestone in our global efforts to address high unmet needs to better serve patients suffering from dry eye disease.

EMA Accepts LEO Pharma’s Marketing Authorization Application (MAA) for Delgocitinib Cream in Chronic Hand Eczema (CHE)

Retrieved on: 
Friday, August 18, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Janus, Leo Pharma, Marketing, DELTA, JAK, European Medicines Agency, Committee on Herbal Medicinal Products, Inflammation, EMA, Pain, Patient, Standard of care, Delgocitinib, LEO, Itch, MAA, Skin, Safety, CHMP, Pharmaceutical industry

LEO Pharma A/S announces today that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for delgocitinib cream, an investigational product and topical pan-Janus kinase (JAK) inhibitor for the treatment of adult patients with moderate to severe chronic hand eczema (CHE).

Key Points: 
  • LEO Pharma A/S announces today that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for delgocitinib cream, an investigational product and topical pan-Janus kinase (JAK) inhibitor for the treatment of adult patients with moderate to severe chronic hand eczema (CHE).
  • “We are delighted that delgocitinib cream has entered this first stage of the European regulatory process.
  • “Chronic hand eczema negatively impacts patients’ quality of life, psychological well-being, physical functioning, and ability to work.
  • LEO Pharma is currently developing delgocitinib in a cream formulation for the treatment of moderate to severe CHE in adults.

Mirati Therapeutics Reports Second Quarter 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Tuesday, August 8, 2023
PDAC, Docetaxel, KRAS, American Journal of Clinical Oncology, Marketing, MTA, Pharming, European Medicines Agency, Cholangiocarcinoma, New Drug Application, American Society of Clinical Oncology, SOS1, Cancer Discovery (journal), SAPPHIRE, Cancer, Clinical trial, Committee on Herbal Medicinal Products, Mirati Therapeutics, NSCLC, Cetuximab, TPS, Trial of the century, Committee, EMA, ASCO, Conditional, Shanda, Journal, Outline, Patient, Investment, Manuscript, Meekness, Colorectal cancer, Committee for Medicinal Products for Human Use, Annual general meeting, MAA, Research, FDA, Pembrolizumab, Therapy, Society, Nivolumab, PRMT5, CHMP, Cryptocurrency, Communications satellite, Pharmaceutical industry, Nursing

SAN DIEGO, Aug. 8, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc.® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the second quarter 2023 along with recent pipeline and corporate updates.

Key Points: 
  • ET / 2:30 p.m. PT
    SAN DIEGO, Aug. 8, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc. ® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the second quarter 2023 along with recent pipeline and corporate updates.
  • Based on these results, the Company plans to discuss a tumor agnostic Accelerated Approval approach with FDA by year-end 2023.
  • Net reduction in cash, cash equivalents and short-term investments for the second quarter of 2023 was $122.9 million.
  • ET / 2:30 p.m. PT during which company executives will review financial information for the second quarter and provide corporate updates.