Category: Impacting News

Mirum Pharmaceuticals Provides Enrollment Update for AZURE Clinical Program of Brelovitug in Chronic Hepatitis Delta Virus

Mirum Pharmaceuticals Provides Enrollment Update for AZURE Clinical Program of Brelovitug in Chronic Hepatitis Delta Virus

Mirum Pharmaceuticals Mirum Pharmaceuticals (MIRM) is a leading rare disease company with a global footprint of approved products and a broad pipeline of investigational medicines. Purpose-built to bring forward breakthrough medicines for people with overlooked conditions, Mirum combines deep rare disease expertise with strong connections to patient communities. From the Experts Tatyana Kushner, M.D., MSCE, Associate Professor of . . . This content is for …

FDA on Compounded Semaglutide and Teva Pharmacetuical and Blackstone Life Sciences Announce $400 Million Strategic Growth Capital Agreement to Advance Duvakitug

FDA on the Compounded Semaglutide  The FDA warns that compounded semaglutide is not FDA-approved, meaning it has not been reviewed for safety, effectiveness, or quality. Following the resolution of drug shortages for Ozempic/Wegovy, the FDA has limited the legal sale of compounded versions. Risks include overdoses from dosing errors (5-20 times the intended dose), mislabeled products, and unknown ingredients.  The U.S. Food and Drug Administration (.gov)+5 …

Johnson & Johnson Expands U.S. Footprint With More Than $1 Billion Investment In Next Generation Cell Therapy Manufacturing Facility in Pennsylvania

Johnson & Johnson in the NEWS Yesterday, February 18, 2026, Johnson & Johnson (JNJ) announced a more than $1 billion investment in a next generation cell therapy manufacturing facility in Montgomery County, Pennsylvania. This new facility will further expand the Company’s U.S. manufacturing capacity as it advances its industry leading portfolio and pipeline of transformational medicines for cancer, immune-mediated and . . . This content …

Bio-Techne Corp Releases Second Quarter Fiscal 2026 Results

Bio-Techne Corp Q2 Financial Results Yesterday, February 4, 2026 /PRNewswire/ -- Bio-Techne Corporation (TECH) reported its financial results for the second quarter ending December 31, 2025. Second Quarter FY2026 Highlights Second quarter revenue . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Corcept Therapeutics: Overall Survival Primary Endpoint Met In Pivotal Phase 3 Rosella Trial OF Relacorilant in Patients With Platinum-Resistant Ovarian Cancer

Corcept Therapeutics Yesterday, January 22, 2026, Corcept Therapeutics (CORT) - a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that ROSELLA, the company’s pivotal Phase 3 trial of relacorilant plus nab-paclitaxel to treat patients with platinum-resistant . . . This content is for paid subscribers. Please …

Bristol-Myers Squibb Announces Collaboration with Microsoft to Advance AI-Driven Early Detection of Lung Cancer

Bristol-Myers Squibb and Microsoft Collaboration Bristol-Myers Squibb (BMY) - a global leader in oncology, announced an agreement with Microsoft, a market leader in AI-powered radiology and clinical workflow technologies, aiming to accelerate early detection of lung cancer. Through this digital health collaboration, U.S. FDA-cleared radiology AI algorithms will be deployed via Microsoft’s Precision Imaging Network . . . This content is for paid subscribers. Please click here …

GSK Enters Agreement to Acquire RAPT Therapeutics

GSK Agreement to Acquire RAPT Therapeutics Yesterday,  January 20, GSK (GSK) announced that it has entered a definitive agreement to acquire RAPT Therapeutics (RAPT) a California-based, clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

China Approved Myqorzo and Redemplo, Two Sanofi-Licensed Innovative Medicines

Sanofi's Myqorzo & Redemplo Paris, January 15, 2026, the National Medical Products Administration in China has approved two Sanofi-licensed innovative medicines, Myqorzo (aficamten) for the treatment of obstructive hypertrophic cardiomyopathy (oHCM), and Redemplo (plozasiran) for the reduction of triglyceride levels in adult patients with familial chylomicronaemia syndrome (FCS) on the basis of dietary control. From Sanofi Olivier Charmeil, Executive Vice President, General Medicines, Sanofi, Said, “We …

Incyte Announces Positive Topline Results from the Pivotal Study Of the Tafasitamab as First-Line Treatment For Diffuse Large B-Cell Lymphoma

Incyte in the NEWS January 5, 2026 - Incyte (INCY) announced positive topline results from the pivotal Phase 3 frontMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®/Minjuvi®), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, and lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) compared to R-CHOP alone as a first-line treatment for . . . This content is for paid …

The U.S. FDA Approved Vanda Pharmaceuticals Product NEREUS™ for Prevention of Vomiting Induced by Motion

Vanda Pharmaceuticals During December 2025, Vanda Pharmaceuticals Inc. (VNDA) announced that the U.S. Food and Drug Administration (FDA) has approved NEREUS™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion. This approval marks the first new pharmacologic treatment in motion sickness in over four decades, representing a significant advancement . . . This content is for paid subscribers. Please …
Happy New Year 2026

Happy New Year 2026

Happy New Year 2026  Following the celebrations of Faiths, we wish you all that you believe is best for you, your family and friends. May God bless you and protect you, your children and parents. We are optimistic for 2026 and for U.S. citizens. Our optimism is based on great news about the United States' economy, which is ending 2025 strongly with a growing GDP, …

Alnylam Pharmaceuticals Announces Partial Repurchase of 1% Convertible Senior Notes Due 2027

Alnylam Pharmaceuticals Yesterday, December 11, 2025, Alnylam Pharmaceuticals, Inc. (ALNY) announced that it has entered into separate, privately negotiated repurchase agreements with certain holders of its 1.00% Convertible Senior Notes due 2027 (the “Notes”) to repurchase for cash (the “Repurchases”) approximately $34.4 million aggregate principal amount of the Notes for a total repurchase cost (including accrued and unpaid interest) of approximately $51.9 million . . …
Praxis Precision Medicines Alignment with FDA on Simplified and Accelerated Registrational Pathway for Elsunersen In Early Onset SCN2A Developmental and Epileptic Encephalopathy

Praxis Precision Medicines Alignment with FDA on Simplified and Accelerated Registrational Pathway for Elsunersen In Early Onset SCN2A Developmental and Epileptic Encephalopathy

Praxis Precision Medicines Praxis Precision Medicines (PRAX) - a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, announced the completion of a Type C meeting with the U.S. Food and Drug Administration (FDA) and agreement to immediately convert the EMBRAVE3 . . . This content is for paid subscribers. Please click here to …

Ionis receives U.S. FDA Breakthrough Therapy Designation for Zilganersen for Alexander Disease

Ionis Pharmaceuticals On December 2, 2025 - Ionis Pharmaceuticals (IONS) announced that the FDA has granted Breakthrough Therapy designation to zilganersen for the treatment of Alexander disease (AxD), a rare, progressive and often fatal neurological condition. Over time, it can lead to loss of mobility and independence, along with difficulties walking, speaking, swallowing and breathing. There are currently no . . . This content is …

Roche: FDA Clearance with CLIA Waiver and CE Mark for its First Point-of-Care Test for Diagnosing Bordetella Infections, Including Whooping Cough

Roche in the NEWS Basel, December 2, 2025 - Roche (RHHBY) announced that its first point-of-care test for the diagnosis of whooping cough (pertussis) and other Bordetella infections, has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver, in addition to CE IVDR certification. The . . . This content is for paid subscribers. Please …

Novo Nordisk Launches Introductory Self-Pay Offer for Wegovy® and Ozempic® for $199 Per Month

Novo Nordisk in the NEWS  On Monday, November 17, 2025, Novo Nordisk (NVO) announced that Wegovy® (semaglutide) injection 0.25 mg and 0.5 mg and Ozempic® are now available at a limited time price of $199 per month to new self-pay patients between now and March 31, 2026. This introductory offer is good for the first two months of therapy and . . . This content is for paid subscribers. Please click here …

Vertex Pharmaceuticals Never Stops Bringing New Data To Heal Untreated Severe Diseases

Vertex Pharmaceuticals in the NEWS On November 8, 2025, Vertex Pharmaceuticals Incorporated (VRTX) announced updated data for povetacicept (pove) in IgA nephropathy (IgAN) and primary membranous nephropathy (pMN) from the ongoing RUBY-3 trial at the American Society of Nephrology Kidney Week 2025 in Houston, Texas. Pove is an investigational recombinant fusion protein therapeutic and dual inhibitor of the . . . This content is for paid …
Cogent Biosciences Reports Positive Results from Bezuclastinib Peak Phase 3 Trial in Gastrointestinal Stromal Tumors

Cogent Biosciences Reports Positive Results from Bezuclastinib Peak Phase 3 Trial in Gastrointestinal Stromal Tumors

Cogent Biosciences On November 10, 2025, Cogent Biosciences (COGT) reported positive data from its Phase 3 PEAK trial of bezuclastinib plus sunitinib in patients with imatinib-resistant or intolerant Gastrointestinal Stromal Tumors (GIST). The combination reached a median progression free survival (mPFS) of 16.5 months compared to sunitinib monotherapy, which reached a mPFS of 9.2 months. The . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Ionis Pharmaceuticals Groundbreaking Pivotal Study Results of Olezarsen for Severe Hypertriglyceridemia Presented as Late Breaker at AHA Scientific Sessions

Ionis Pharmaceuticals On November 8, 2025, Ionis Pharmaceuticals (IONS) announced positive results from the pivotal Phase 3 CORE and CORE2 studies of olezarsen in people with severe hypertriglyceridemia (sHTG). The studies met the primary endpoint, with olezarsen achieving a highly statistically significant placebo-adjusted mean reduction in fasting triglyceride (TG) levels of up to 72% at six months. The . . . This content is for …

The U.S. FDA Approved GSK Product Blenrepis for Treatment of Relapsed/Refractory Multiple Myeloma

GSK US FDA Approval Yesterday, October 23, 2025, GSK plc (GSK) announced the United States Food and Drug Administration (FDA) has approved Blenrep in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI