| Date | Title | Description |
| 04.11.2024 | Krystal Biotech Announces Third Quarter 2024 Financial Results and Provides Business Updates | Net product revenue of $83.8 million in 3Q and $250.1 million since launch in August 2023
JNDA for B-VEC filed and on track for commercial launches in Japan and Europe in 2025
French health authority approved pre-marketing early reimbursed ... |
| 01.11.2024 | Revolutionizing Cancer Treatment: The Promise of SUPLEXA | In the battle against cancer, a new weapon has emerged from the laboratories of Australia. SUPLEXA, a groundbreaking treatment, is turning the tide by harnessing the power of the patient’s own immune cells. This innovative approach is not j... |
| 31.10.2024 | Breakthrough Australian Cancer trial: retraining immune cells offers new hope for patients | ADELAIDE, Australia and BOSTON, Oct. 31, 2024 /PRNewswire/ -- In a remarkable development for cancer research, Australian patients with advanced-stage cancer have benefited from SUPLEXA, a personalised treatment that trains the patient's ow... |
| 31.10.2024 | Cancer trial: retraining immune cells offers new hope for patients in personalized medicine breakthrough | BOSTON, Oct. 31, 2024 /PRNewswire/ -- In a remarkable development for cancer research, patients with advanced-stage cancer have benefited from SUPLEXA, a personalized treatment that trains the patient's own immune cells to fight cancer.
&qu... |
| 30.10.2024 | New data for emapalumab in the treatment of macrophage activation syndrome to be presented at the ACR conference | New data for emapalumab in the treatment of macrophage activation syndrome to be presented at the ACR conference
Wed, Oct 30, 2024 08:00 CET Report this content
Sobi® (STO: SOBI) today announced that new research showing the effect of emapa... |
| 29.10.2024 | Novartis Scemblix® FDA approved in newly diagnosed CML, offering superior efficacy, and favorable safety and tolerability profile | Ad hoc announcement pursuant to Art. 53 LR
Scemblix, a new first-line option for adults with CML, is first to show superior efficacy and favorable safety and tolerability profile in a Phase III trial vs. all standard of care (SoC) therapies... |
| 29.10.2024 | KIND Presents Positive Results of AND017 to Treat Anemia Associated with Chronic Kidney Disease in Two Phase II and Two Phase I | Clinical Trials at American Society of Nephrology (ASN) – Kidney Week 2024
SAN FRANCISCO, Oct. 29, 2024 /PRNewswire/ -- Kind Pharmaceutical ("Hangzhou Andao Pharmaceutical Ltd. and Kind Pharmaceuticals LLC"), a clinical-stage biop... |
| 28.10.2024 | SHINKEI Therapeutics Initiates Enrollment in Phase 2 Clinical Trial of MR-301 in Severe Traumatic Brain Injury (TBI) | PRINCETON, NJ, UNITED STATES, October 28, 2024 /EINPresswire.com/ -- SHINKEI Therapeutics, a clinical-stage pharmaceutical company dedicated to developing treatments for central nervous system (CNS) disorders, is pleased to announce that it... |
| 26.10.2024 | Novartis oral Fabhalta® (iptacopan) sustained clinically meaningful results at one year in Phase III C3 glomerulopathy (C3G) trial | New APPEAR-C3G data show Fabhalta sustained proteinuria reduction at 12 months1
Upon Fabhalta initiation, improvement observed in estimated glomerular filtration rate (eGFR) slope – a key measure of kidney function – vs. patients’ historic ... |
| 24.10.2024 | FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent | MELBOURNE, Australia, Oct. 24, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) fo... |
| 24.10.2024 | Medera Announces Completion of Cohort A and Initiation of Dosing in Cohort B of MUSIC-HFpEF, a Phase 1/2a Clinical Trial Evaluating First-In-Human Gene Therapy SRD-002 for Heart Failure with Preserved... | Heart failure is a global pandemic with an estimated 64.3 million cases worldwide, costing over US$100B per year
Heart failure with preserved ejection fraction (HFpEF) accounts for nearly half of all heart failure cases, but has limited dis... |
| 22.10.2024 | Wainzua: A New Hope for Patients with Hereditary Transthyretin-Mediated Amyloidosis | In the world of medicine, every breakthrough is a beacon of hope. Wainzua, also known as eplontersen, shines brightly as it moves closer to approval in the European Union. This innovative treatment targets hereditary transthyretin-mediated ... |
| 22.10.2024 | Akiram Therapeutics' drug candidate AKIR001 cleared to start Phase 1 clinical trial | Akiram Therapeutics' drug candidate AKIR001 cleared to start Phase 1 clinical trial
Tue, Oct 22, 2024 07:15 CET Report this content
Akiram Therapeutics, a Swedish biotech company specializing in molecular radiation therapy, announces that t... |
| 21.10.2024 | Wainzua recommended for approval in the EU | Wainzua recommended for approval in the EU
Mon, Oct 21, 2024 08:00 CET Report this content
21 October 2024
Wainzua (eplontersen) recommended for approval in the EU by CHMP for the treatment of adult patients with polyneuropathy associated w... |
| 18.10.2024 | Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer | If approved, patients in Europe with stage II or III HR+/HER2- early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease, will be eligible for adjuvant treatment with Kisqali® (ribociclib) in combinati... |
| 17.10.2024 | Telix Q3 2024 Business Update - Quarterly Revenue Exceeds AU$200M | MELBOURNE, Australia, Oct. 17, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today provides an update on its revenue and operational performance for the quarter ended 30 September 2024 (Q3 2024).
Revenue ... |
| 16.10.2024 | Copper-67 SAR-bisPSMA updates | SYDNEY, Oct. 16, 2024 /PRNewswire/ --
HIGHLIGHTS
Cohort 4 - SECuRE Trial
The third participant of cohort 4 (multi-dose) of the SECuRE trial1 has now completed the Dose Limiting Toxicity (DLT) period after a second dose of 12GBq of 67Cu-SAR-... |
| 16.10.2024 | Adhera Health Pioneers Family-Focused Digital Health Solutions for Children with Chronic Conditions | Adhera Health Inc. Logo
Reveals Transformative Research Results at ISPAD 2024
These findings validate our mission to adopting a holistic approach that supports the entire family unit.”
— Ricardo C. Berrios, Co-Founder and CEO of Adhera Heal... |
| 15.10.2024 | PharmAbcine Announces Safety Approval for 4mg Single-dose Cohort in Phase 1 Clinical Trial of PMC-403 for Neovascular Age-related Macular Degeneration | Safety Review Committee (SRC) approves single ascending dose 4mg cohort in Phase 1 trial of PMC-403, preparing for multiple ascending dose 4 mg cohort.
PMC-403 is being explored in broader therapeutic areas, including rare vascular disease ... |
| 14.10.2024 | Fastenal and Eli Lilly: Two Titans of Industry on the Rise | In the world of stocks, two companies are making waves: Fastenal and Eli Lilly. Each stands tall in its respective field, showcasing resilience and innovation. Fastenal, a giant in inventory management, is poised to reclaim its all-time hig... |
| 13.10.2024 | Why Eli Lilly Stock Is Soaring—and How It Plans to Stay on Top Eli Lilly is the most valuable pharmaceutical company in the world. I believe the company has what it takes to stay there. |
In a year and a half, Eli Lilly (NYSE: LLY) has roughly doubled in value. It is now the most valuable pharmaceutical company in the world. It took that mantle from the long-held dominance by Johnson and Johnson (NYSE: JNJ) back in May of 2... |
| 08.10.2024 | Australian TGA Approves Additional Indication for Telix's Illuccix® to Include Patient Selection for PSMA-Targeted Therapy | MELBOURNE, Australia, Oct. 8, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Australian Therapeutic Goods Administration (TGA) has approved the use of Illuccix® (kit for the prepar... |
| 04.10.2024 | Nature's Microbes: A New Hope for Atopic Dermatitis | In a world where hygiene reigns supreme, our bodies are paying the price. The rise of immune-mediated diseases, particularly atopic dermatitis, is alarming. But a glimmer of hope shines from the forests of Finland. A recent study by Uute Sc... |
| 04.10.2024 | First Patient Dosed in Phase II 'CA-NINE' Trial of TLX250-CDx for Detection of Recurrent Kidney Cancer After Surgery | MELBOURNE, Australia, Oct. 4, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first patient has been dosed in a Phase II trial exploring the clinical utility of Telix's first-in-cla... |
| 03.10.2024 | New study by Uute Scientific proves that microbial extract from Finnish nature helps patients with atopic dermatitis | New study by Uute Scientific proves that microbial extract from Finnish nature helps patients with atopic dermatitis
Thu, Oct 03, 2024 09:30 CET Report this content
Due to the modern lifestyle of extreme hygiene and lack of exposure to natu... |
| 02.10.2024 | BioStem Technologies Initiates BR-AC-DFU-101 Clinical Trial to Study BioREtain® in Diabetic Foot Ulcers | Strategic head-to-head study of BR-AC vs. standard of care aims to demonstrate healing superiority potential to support increased payor coverage and market growth
The study will be conducted in 60 patients at 10 sites across the U.S. and th... |
| 28.09.2024 | Регенерация синапсов и лекарство от шизофрении | Нейродегенеративные заболевания стали пандемией нашего времени. С одной стороны, мы технически стали «доживать до возраста», когда подобные болезни развертываются в полную силу. С другой стороны, решив проблему с регенерацией синапсов или н... |
| 23.09.2024 | Fasenra recommended for EU approval in EGPA | Fasenra recommended for EU approval in EGPA
Mon, Sep 23, 2024 08:05 CET Report this content
23 September 2024
Fasenrarecommended for approval in the EU by CHMP for the treatment of
eosinophilic granulomatosis with polyangiitis
New indicatio... |
| 23.09.2024 | Stroke devicemaker Route 92 Medical raises $50M to go global | The stroke devicemaker Route 92 Medical has raised $50 million in funds, as it looks to expand the worldwide commercial reach of its clot-busting hardware.
Supplied by Novo Holdings, the financing comes as an extension to its series F round... |
| 23.09.2024 | Final OS results reported for TROPION-Breast01 | Final OS results reported for TROPION-Breast01
Mon, Sep 23, 2024 08:00 CET Report this content
23 September 2024
Datopotamab deruxtecan final overall survival results reported in
patients with metastatic HR-positive, HER2-low or negative br... |
| 21.09.2024 | Camurus Takes a Step Forward in Rare Disease Treatment with Octreotide SC Depot | In the world of pharmaceuticals, breakthroughs often emerge from the shadows of rare diseases. Camurus, a Swedish biopharmaceutical company, is making waves with its recent positive opinion from the European Medicines Agency (EMA) regarding... |
| 20.09.2024 | Press Release: Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for trans... | Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for transplant
Approval based on positive results from the IMROZ... |
| 20.09.2024 | Communiqué de presse : Approbation du Sarclisa aux États-Unis : premier anti-CD38, en association avec un traitement conventionnel, pour les patients atteints d’un myélome multiple nouvellement diagno... | Approbation du Sarclisa aux États-Unis : premier anti-CD38, en association avec un traitement conventionnel, pour les patients atteints d’un myélome multiple nouvellement diagnostiqué, non éligibles à une transplantation
Approbation fondée ... |
| 20.09.2024 | EMA positive opinion for orphan drug designation to Camurus’ octreotide SC depot for the treatment of polycystic liver disease | EMA positive opinion for orphan drug designation to Camurus’ octreotide SC depot for the treatment of polycystic liver disease
Fri, Sep 20, 2024 08:00 CET Report this content
Lund, Sweden — 20 September 2024 — Camurus (NASDAQ STO: CAMX) tod... |
| 20.09.2024 | Press Release: Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for trans... | Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for transplant
Approval based on positive results from the IMROZ... |
| 20.09.2024 | Press Release: Tolebrutinib demonstrated a 31% delay in time to onset of confirmed disability progression in non-relapsing secondary progressive multiple sclerosis phase 3 study | Tolebrutinib demonstrated a 31% delay in time to onset of confirmed disability progression in non-relapsing secondary progressive multiple sclerosis phase 3 study Data presented at ECTRIMS show that tolebrutinib, a brain-penetrant BTK inhib... |
| 19.09.2024 | Telix and Cardinal Health: A New Era in Kidney Cancer Diagnostics | In the ever-evolving landscape of cancer diagnostics, Telix Pharmaceuticals Limited has made a significant move. The Australian biopharmaceutical company has chosen Cardinal Health, Inc. as its U.S. commercial distributor for Zircaix® (TLX2... |
| 19.09.2024 | Promising Advances in Cancer and Heart Failure Treatments: A Look at Harbour BioMed and AnaCardio | In the world of biopharmaceuticals, innovation is the lifeblood. Two companies, Harbour BioMed and AnaCardio, are making waves with their latest clinical trials. Both are pushing the boundaries of treatment for serious health conditions: ad... |
| 18.09.2024 | Telix Announces Cardinal Health as U.S. Commercial Distributor for Zircaix® | MELBOURNE, Australia, Sept. 18, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has selected Cardinal Health, Inc. (NYSE: CAH, Cardinal Health) as a commercial radiopharmaceutical di... |
| 18.09.2024 | FASENRA EGPA US FDA APPROVAL | FASENRA EGPA US FDA APPROVAL
Wed, Sep 18, 2024 08:45 CET Report this content
18 September 2024
Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis
New indication supported by the MANDARA trial which showed nearly 60... |
| 17.09.2024 | DBP International AB: transition of the SI053 clinical trials protocol to a new Clinical Trial Information System has been completed | DBP International AB: transition of the SI053 clinical trials protocol to a new Clinical Trial Information System has been completed
Tue, Sep 17, 2024 07:00 CET Report this content
Double Bond Pharmaceutical International AB (publ) ("D... |
| 17.09.2024 | AnaCardio successfully completes first part of AC01 HFrEF study and provides a clinical update | AnaCardio successfully completes first part of AC01 HFrEF study and provides a clinical update
Tue, Sep 17, 2024 08:30 CET Report this content
PRESS RELEASE
Stockholm, Sweden, September 17, 2024
AnaCardio, a Swedish clinical-stage biopharma... |
| 17.09.2024 | FDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancer | Ad hoc announcement pursuant to Art. 53 LR
Broad indication in HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence approximately doubles population eligible for CDK4/6 inhibitor adjuvant therapy1,2
Kisqali® (ribo... |
| 16.09.2024 | Pioneering New Frontiers in ALS and Cancer Treatment: The Role of QRL-101 and mIDH1 Inhibitors | In the realm of medical science, innovation is the lifeblood that fuels progress. Two recent developments stand out: QurAlis Corporation's QRL-101 for ALS and Vazyme's contributions to mIDH1 cancer treatment. Both represent significant stri... |
| 16.09.2024 | Positive clinical progress in the biotech scene |
With the dosing of its first patient for lead candidate CDR404, CDR-Life has made significant clinical progress in its M-gager® portfolio for solid tumors, marking important milestones in the company’s mission to deliver innovative, antibo... |
| 14.09.2024 | Новый анализ крови может выявить риск сердечно-сосудистых заболеваний за несколько лет до симптомов | Новое исследование показывает, что анализ крови на содержание определенных жиров и маркеров воспаления позволяет предвидеть сердечно-сосудистые заболевания (ССЗ) у женщин за несколько лет до появления симптомов, что является значительным ша... |
| 14.09.2024 | Harbour BioMed Announces the Latest Clinical Data on the First-in-Class Fully Human Anti-B7H7/HHLA2 Monoclonal Antibody HBM1020 at the ESMO Congress 2024 | CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Sept. 14, 2024 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercializat... |
| 13.09.2024 | New Frontiers in Cancer Imaging and Treatment: A Look at SECuRE and ZIRCON Trials | In the ever-evolving landscape of cancer treatment, two recent trials have emerged as beacons of hope. The SECuRE trial and the ZIRCON trial are paving the way for innovative therapies and diagnostic tools that could redefine patient care. ... |
| 12.09.2024 | Communiqué de presse : Accord de licence entre Sanofi, RadioMedix et Orano Med pour le développement d’une nouvelle génération de radiothérapies internes vectorisées contre les cancers rares | Accord de licence entre Sanofi, RadioMedix et Orano Med pour le développement d’une nouvelle génération de radiothérapies internes vectorisées contre les cancers rares
Paris (France) et Houston (Texas), le 12 septembre 2024. Dans le cadre d... |
| 12.09.2024 | Press Release: Sanofi, RadioMedix, and Orano Med announce licensing agreement on next-generation radioligand medicine for rare cancers | Sanofi, RadioMedix, and Orano Med announce licensing agreement on next-generation radioligand medicine for rare cancers
Paris, France, and Houston, Texas, September 12, 2024. As part of its effort to develop innovative treatments for people... |
| 12.09.2024 | F2G raises $100M to fund 2nd attempt to get new antifungal class to market | After F2G’s first attempt to get a brand-new class of antifungal to market was derailed by the FDA, the U.K.-based biotech has secured $100 million in fresh funding to bankroll another push towards commercialization next year.
The asset in ... |
| 12.09.2024 | SECuRE trial advances: No dose limiting toxicities and strong preliminary efficacy data in first multi-dose cohort | Highlights
Cohort 4 of the SECuRE trial is the first to assess multiple cycles of 67Cu-SAR-bisPSMA at the highest dose of 12GBq.
The Safety Review Committee (SRC) assessed early data from the first 3 participants in cohort 4 who received 2 ... |
| 11.09.2024 | Building Bridges in Cancer Care: The Push for Diversity and Inclusion | In the heart of Washington, D.C., a significant conversation unfolded at the National Comprehensive Cancer Network (NCCN) Policy Summit. The focus? Diversity, equity, and inclusion (DEI) in oncology. This summit was not just another meeting... |
| 11.09.2024 | TREMFYA® (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson's leadership in inflammatory bowel disease | The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, TREMFYA® showed highly statistically significant rates of endoscopic remission at one year in the pivotal QUASAR program1,2,3,4,5
TREMFYA® is now... |
| 11.09.2024 | 'Highly Accurate': Telix's Phase III ZIRCON Trial for Kidney Cancer Imaging Published in The Lancet Oncology | MELBOURNE, Australia, Sept. 11, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that primary results from its Phase III ZIRCON[1] trial have been published in The Lancet Oncology, reporting ... |
| 10.09.2024 | QurAlis Doses First Participant Cohort in Phase 1 Multiple-Ascending Dose (MAD) Clinical Trial Evaluating QRL-101, a First-in-Class Kv7 Precision Therapy for ALS | QRL-101 aims to reduce hyperexcitability-induced neurodegeneration, which is present in approximately 50 percent of all ALS patients
Completed Phase 1 single-ascending dose (SAD) clinical trial of QRL-101 enrolled 88 participants; no report... |
| 10.09.2024 | Molecular Profiling May Improve Meningioma Decisionmaking | Investigators have demonstrated how molecular profiling tumors can be used to help predict treatment response and survival in patients with meningiomas, the most common type of primary brain tumor, according to a recent study published in N... |
| 10.09.2024 | Dexamethasone reduces infusion-related reactions in patients with EGFR-mutated non-small cell lung cancer treated with intravenous RYBREVANT® (amivantamab-vmjw) | Pre-medication regimen showed an infusion-related reaction rate of 22.5 percent with intravenous RYBREVANT®, a three-fold reduction from 67.4 percent historically seen with standard IRR management
SAN DIEGO, Sept. 10, 2024 /PRNewswire/ -- J... |
| 07.09.2024 | CatalYm Announces New Financing of $150M to Support Broad Phase 2b Development Program for Visugromab | Munich, Germany, July 16, 2024 – CatalYm today announced the completion of a $150 million Series D financing. The oversubscribed round was led by new investors, Canaan Partners and Bioqube Ventures, and joined by Forbion’s Growth Opportunit... |
| 06.09.2024 | Zevra Therapeutics Presented New Data for Arimoclomol and OLPRUVA® (Sodium Phenylbutyrate) at the Society for the Study of Inborn Errors of Metabolism (SSIEM) 2024 Annual Symposium | New clinical efficacy and safety data for arimoclomol as a possible treatment for Niemann-Pick disease type C, including from long-term and real-world settings, demonstrate clinically meaningful reduction in disease progression
Arimoclomol ... |
| 05.09.2024 | Promising Advances in Cancer Treatment: A Look at TiNivo-2 and TLX101 | In the ever-evolving landscape of cancer treatment, two recent studies stand out like beacons of hope. The TiNivo-2 trial by AVEO Oncology and the IPAX-1 study by Telix Pharmaceuticals both unveil new possibilities for patients battling agg... |
| 05.09.2024 | BioNTech to Present Clinical Data Updates Across mRNA and Immunomodulatory Oncology Portfolio at ESMO Congress 2024 | MAINZ, Germany, September 05, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data for selected assets from its multi-platform oncology pipeline at the European Society for Molecular Oncology (“ESM... |
| 05.09.2024 | BioNTech präsentiert auf dem ESMO-Kongress 2024 klinische Daten-Updates aus dem mRNA und immunmodulatorischen Onkologie-Portfolio | MAINZ, Deutschland, 05. September 2024 – BioNTech SE (Nasdaq: BNTX, „BioNTech“ oder „das Unternehmen“) wird auf dem diesjährigen Kongress der European Society for Molecular Oncology („ESMO“), der vom 13. bis 17. September 2024 in Barcelona,... |
| 04.09.2024 | IPAX-1 Study of TLX101 Investigational Glioblastoma Therapy Published in Neuro-Oncology Advances | MELBOURNE, Australia, Sept. 4, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Company's IPAX-1 Phase I study has been published in Neuro-Oncology Advances, confirming the safety an... |
| 03.09.2024 | IPAX-1 Study of TLX101 Investigational Glioblastoma Therapy Published in Neuro-Oncology Advances | MELBOURNE, Australia, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Company’s IPAX-1 Phase I study has been published in Neuro-Oncology Advances, confirming the safe... |
| 03.09.2024 | AVEO Oncology, an LG Chem company, Announces Acceptance of Late-Breaking Oral Presentation of TiNivo-2 Results at ESMO 2024 | BOSTON, Sept. 3, 2024 /PRNewswire/ -- AVEO Oncology, an LG Chem company ("AVEO"), announced today their late-breaking abstract detailing their Phase 3 TiNivo-2 trial has been selected as a Proffered Paper oral presentation at the ... |
| 02.09.2024 | CP- Tolebrutinib satisfait au critère d’évaluation primaire de l’étude de phase III HERCULES ; premier et seul médicament qui a permis d’observer une réduction de l’accumulation du handicap chez des p... | Le tolebrutinib satisfait au critère d’évaluation primaire de l’étude de phase III HERCULES ; premier et seul médicament ayant permis d’observer une réduction de l’accumulation du handicap chez des personnes présentant une sclérose en plaqu... |
| 02.09.2024 | Press Release: Tolebrutinib meets primary endpoint in HERCULES phase 3 study, the first and only to show reduction in disability accumulation in non-relapsing secondary progressive multiple sclerosis | Tolebrutinib meets primary endpoint in HERCULES phase 3 study, the first and only to show reduction in disability accumulation in non-relapsing secondary progressive multiple sclerosis
In the HERCULES study, tolebrutinib met the primary end... |
| 02.09.2024 | Press Release: Tolebrutinib meets primary endpoint in HERCULES phase 3 study, the first and only to show reduction in disability accumulation in non-relapsing secondary progressive multiple sclerosis | Tolebrutinib meets primary endpoint in HERCULES phase 3 study, the first and only to show reduction in disability accumulation in non-relapsing secondary progressive multiple sclerosis
In the HERCULES study, tolebrutinib met the primary end... |
| 28.08.2024 | Telix Submits NDA for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent | MELBOURNE, Australia, Aug. 28, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) fo... |
| 14.08.2024 | Positive Phase 3 Results in Hidradenitis Suppurativa Further Strengthen Competitive Profile of Izokibep | Positive Phase 3 Results in Hidradenitis Suppurativa Further Strengthen Competitive Profile of Izokibep
Wed, Aug 14, 2024 08:30 CET Report this content
• Phase 3 trial of izokibep in patients with hidradenitis suppurativa met primary endpoi... |
| 14.08.2024 | Alpha Tau Medical Announces Second Quarter 2024 Financial Results and Provides Corporate Update | - First patient treated in May for liver metastases from colorectal cancer -
- Publication in June in Cancers journal of long-term safety and efficacy data in multiple hard-to-treat superficial cancers, with an overall response rate of almo... |
| 12.08.2024 | Aprea Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update | Enrollment commenced in the ACESOT-1051 Phase 1 trial evaluating APR-1051 – no myelosuppression observed in the first of eight planned cohorts at sub-therapeutic dose
$28.7 million in cash and cash equivalents as of June 30, 2024 with cash ... |
| 12.08.2024 | Linshom Medical Completes Clinical Study Enrollment at The Ohio State University Wexner Medical Center | BALTIMORE, MARYLAND, US, August 12, 2024 /EINPresswire.com/ -- The study, “Advanced Prediction of Respiratory Depression Episodes with the Linshom Continuous Predictive Respiratory Sensor”, completed enrollment of 508 patients well ahead of... |
| 08.08.2024 | Press Release: Sarclisa induction treatment demonstrated significantly improved progression-free survival in patients with newly diagnosed multiple myeloma eligible for transplant | Sarclisa induction treatment demonstrated significantly improved progression-free survival in patients with newly diagnosed multiple myeloma eligible for transplant Sarclisa (isatuximab) in combination with standard-of-care lenalidomide, bo... |
| 08.08.2024 | Dianthus Therapeutics Highlights Recent Business Achievements and Reports Q2 Financial Results | Phase 2 MaGic trial in generalized Myasthenia Gravis (gMG) ongoing; top-line results anticipated in 2H’25
IND for Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy (MMN) cleared by FDA in June; top-line results anticipated in 2H’26
Phas... |
| 08.08.2024 | Tenaya Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update | Received Rare Pediatric Disease Designation from U.S. Food and Drug Administration for TN-201 for MYBPC3-associated Hypertrophic Cardiomyopathy
Received UK Clearance to Initiate Clinical Testing of TN-401 for PKP2-Associated Arrhythmogenic ... |
| 08.08.2024 | Vincerx Pharma Reports Second Quarter 2024 Financial Results | Vincerx continues to enroll its Phase 1 studies of antibody-drug conjugate (ADC) VIP943, with data expected by the end of Q4 2024, and small molecule drug-conjugate (SMDC) VIP236, with data expected at the end of Q3 2024
Expected cash runwa... |
| 08.08.2024 | SCYNEXIS Reports Second Quarter 2024 Financial Results and Provides Corporate Update | Clinical study reports for the FURI, CARES and NATURE trials in refractory or resistant invasive fungal infections were delivered to GSK, triggering a $10 million development milestone payment to SCYNEXIS which we expect to receive in Q3 20... |
| 07.08.2024 | Novartis receives FDA accelerated approval for Fabhalta® (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN) | Fabhalta achieved a 44% proteinuria reduction from baseline in Phase III APPLAUSE-IgAN interim analysis, compared with 9% in placebo arm, demonstrating a clinically meaningful reduction of 38% vs. placebo (p |
| 07.08.2024 | Novartis receives FDA accelerated approval for Fabhalta® (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN) | Ad hoc announcement pursuant to Art. 53 LR
Fabhalta achieved a 44% proteinuria reduction from baseline in Phase III APPLAUSE-IgAN interim analysis, compared with 9% in placebo arm, demonstrating a clinically meaningful reduction of 38% vs. ... |
| 07.08.2024 | Pliant Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results | Positive data from a 12-week Phase 2a PET imaging trial demonstrated reduced total lung collagen, improved FVC and reduced cough severity in IPF patients treated with bexotegrast
Positive long-term data from INTEGRIS-PSC 320 mg dose group d... |
| 07.08.2024 | Healionics announces 12-month clinical results for STARgraft | STARgraft vascular graft
SEATTLE, WA, USA, August 7, 2024 /EINPresswire.com/ -- Healionics Corporation, a developer of synthetic biomaterial-based medical devices, today announced 12-month clinical results in the ongoing human trial of its ... |
| 06.08.2024 | Caribou Biosciences Reports Second Quarter 2024 Financial Results and Provides Business Update | -- Advancing four clinical-stage programs for hematologic malignancies and autoimmune diseases; clinical data reports planned for 2024 and H1 2025 --
-- Enrolling 2L LBCL and prior CD19 relapsed LBCL patients based on CB-010 ANTLER Phase 1 ... |
| 05.08.2024 | Spero Therapeutics Announces Second Quarter 2024 Operating Results and Provides a Business Update | Enrollment concluded in the Phase 2a proof-of-concept clinical trial evaluating SPR720 in nontuberculous mycobacterial pulmonary disease (NTM-PD); preliminary data expected in 4Q 2024
New SPR720 in-vitro resistance data to be presented at I... |
| 30.07.2024 | Bridge Biotherapeutics Announces Completion of Enrollment in the Phase 2a Clinical Study of BBT-877 for the Treatment of Idiopathic Pulmonary Fibrosis | SEONGNAM, South Korea, July 30, 2024 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a clinical-stage biotech company based in South Korea developing novel drugs for fibrosis and cancer, today announced that patient participant enrollmen... |
| 30.07.2024 | Drug Application and Approval Process - "Questions and Answers" | How do I report adverse events associated with the use of a drug?
FDA’s MedWatch Web site provides various means for voluntary reporting of serious postmarketing adverse events, product quality problems, product use error, or therapeutic in... |
| 28.07.2024 | New Frontiers in Cancer Treatment: Breakthroughs from Harbour BioMed and Astellas Pharma | In the relentless battle against cancer, innovation is the sword that cuts through despair. Two recent announcements from Harbour BioMed and Astellas Pharma illuminate the path forward, showcasing novel therapies that could reshape treatmen... |
| 26.07.2024 | Astellas Receives Positive CHMP Opinion for Zolbetuximab in Combination with Chemotherapy for Treatment of Advanced Gastric and Gastroesophageal Junction Cancer | - If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2-targeted therapy approved in the European Union
- A decision on the EU marketing authorization is expected by October 2024
TOKYO, July 26, 2024 ... |
| 26.07.2024 | GO2 for Lung Cancer Honors Dr. Pasi A. Jӓnne with 2024 Bonnie J. Addario Lectureship Award | Pasi A. Jӓnne, M.D, Ph.D., recipient of the 2024 Bonnie J. Addario Lectureship Award
Dr. Jӓnne has had a remarkable impact on identifying risks for lung cancer through his groundbreaking research.”
— Bonnie J. Addario, co-founder and board ... |
| 26.07.2024 | Harbour BioMed to Present the Latest Progress of the First-in-Class Fully Human Anti-B7H7/HHLA2 Monoclonal Antibody HBM1020 at the ESMO Congress 2024 | CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China , July 26, 2024 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercializat... |
| 25.07.2024 | Harbour BioMed to Present the Latest Progress of the First-in-Class Fully Human Anti-B7H7/HHLA2 Monoclonal Antibody HBM1020 at the ESMO Congress 2024 | CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China , July 25, 2024 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercializat... |
| 25.07.2024 | Idorsia announces financial results for the first half 2024 | Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland – July 25, 2024
Idorsia Ltd (SIX: IDIA) today announced its financial results for the first half of 2024.
Business highlights
Viatris collaboration: Global research and devel... |
| 19.07.2024 | Knockout of CD5 on CAR T Cells Boosts Anti-Tumor Efficacy | PHILADELPHIA – The effectiveness of CAR T cell therapy against a variety of cancers, including solid tumors, could be boosted greatly by using CRISPR-Cas9 technology to knock out the gene for CD5, a protein found on the surface of T cells, ... |
| 16.07.2024 | CatalYm Announces New Financing of $150M to Support Broad Phase 2b Development Program for Visugromab | Munich, Germany, July 16, 2024 – CatalYm today announced the completion of a $150 million Series D financing. The oversubscribed round was led by new investors, Canaan Partners and Bioqube Ventures, and joined by Forbion Growth Opportunitie... |
| 08.07.2024 | Sirnaomics Announces Interim Results for Successful Completion of the Second Cohort of Phase I Clinical Study of GalNAc-Based RNAi Therapeutic STP122G for Anticoagulant Therapeutics | HONG KONG and GERMANTOWN, Md. and SUZHOU, China, July 8, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", together with its subsidiaries, the "Group" or "Sirnaomics"; stock code: 2257), a leading biopharmac... |
| 08.07.2024 | PharmAbcine Announces Safety Approval for the First Dose Cohort in Phase 1a/b Clinical Trial of PMC-309 in Patients with Advanced or Metastatic Solid Tumors | PMC-309 receives safety approval for first dose cohort (0.2mg/kg), and second dose cohort (0.5mg/kg) is currently underway in Australia.
DAEJEON, South Korea, July 8, 2024 /PRNewswire/ -- PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stag... |
| 02.07.2024 | ASPIRE-FTD Phase 1/2 Clinical Trial Opens in the U.S. at The Ohio State University Wexner Medical Center | LONDON — July 1, 2024 — AviadoBio, a pioneering gene therapy company dedicated to developing and delivering potentially transformative medicines for neurodegenerative disorders, today announced that its Phase 1/2 ASPIRE-FTD clinical trial i... |
| 01.07.2024 | Lynparza & Imfinzi positive CHMP in endometrial | Lynparza & Imfinzi positive CHMP in endometrial
Mon, Jul 01, 2024 08:00 CET Report this content
1 July 2024
Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for patients with mismatch repair proficient advance... |
| 28.06.2024 | Sirnaomics Announces Completion of STP707 Phase I Clinical Study with Strong Safety Profile and Disease Activity for the Treatment of Pancreatic Cancer Patients | HONG KONG, GERMANTOWN, Md. and SUZHOU, China, June 28, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", together with its subsidiaries, the "Group" or "Sirnaomics"; stock code: 2257), a leading biopharmaceu... |
