Merck and Kintara in the NEWS Treating cancers that have no treatments should be a priority for researchers to create a treatment for them.  Patients who are afflicted with untreatable deadly diseases might not have a single drop of hope in survival  from these untreatable cancers. In yesterday's news, we fell on a treatment by Merck that demonstrated statistically significant and clinically meaningful improvement in …

BioMarin Pharmaceutical US FDA Approval for ROCTAVIAN On June 30, 2023, BioMarin Pharmaceutical (BMRN) announced that the U.S. FDA has approved ROCTAVIAN™ (valoctocogene roxaparvovec-rvox) gene therapy for adults with severe hemophilia A (congenital factor VIII (FVIII) deficiency with FVIII activity < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by . . . This content is for paid subscribers. Please click here to …

BioMarin Pharmaceutical US FDA Approved ROCTAVIAN BioMarin Pharmaceutical (BMRN) announced that the U.S. FDA approved ROCTAVIAN (valoctocogene roxaparvovec-rvox) gene therapy for adults with severe hemophilia A without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test. The one-time, single-dose infusion is the first approved gene therapy for severe hemophilia . . . This content is for paid subscribers. Please click here to subscribe …

Vera Therapeutics Vera Therapeutics (VERA) announced that Phase 2b ORIGIN clinical trial of atacicept for IgA nephropathy  met its primary and key secondary endpoints, with statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR through week 36. The week 36 results of ORIGIN trial were presented at the 60th European Renal Association (ERA

Today at 2.30... Today at 2.30, the Federal Reserve Chairman Jerome Powell will speak to the United States and the rest of the world about the Fed’s decision with regard to interest rates. Financial analysts in five star financial journals expect Chairman Powell not to hike interest rates again, which will be taken as good news by investors.   It is important to watch and …

Inside the Revolution In the Treatments of Untreatable Diseases We are now living a great revolution in the treatment of diseases. We expect to discover novel treatments capable of defeating cancers’ resistance to therapeutics old and new. We are following on all the firms that are discovering the unknown about life-threatening diseases, including the genetically derived diseases or else. Yesterday, May 25, 2023, we studied …

Atea Pharmaceuticals Receives Fast Track Designation for Bemnifosbuvir Atea Pharmaceuticals (AVIR) announced that the U.S. FDA has granted Fast Track designation to its product bemnifosbuvir for the treatment of resistant COVID-19.   Bemnifosbuvir is an oral, direct acting antiviral drug candidate being evaluated in the global Phase 3 SUNRISE-3 registrational trial for the treatment of COVID . . . This content is for paid subscribers. …

News from Innoviva That We Consider Positively Impacting and Extremely Important Innoviva, Inc. (INVA) (Innoviva), announced that the FDA Antmicrobial Drugs Advisory Committee (AMDAC) has unanimously voted 12-0 in favor of approval of sulbactam-durlobactam based on a favorable benefit-risk assessment for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused . . . This content is for paid subscribers. Please click here …

Sanofi Commercial Control of Beyfortus Against RSV In the morning, we promised to tell our readers how AstraZeneca's (AZN), Sobi, and Sanofi (

TG Therapeutics Positive CHMP of BRIUMVI TG Therapeutics, Inc. (TGTX), informed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of BRIUMVI™ (ublituximab-xiiy) for adults with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. BRIUMVI . . . This content is for paid subscribers. Please click here to …

Vertex Pharmaceuticals and Crispr Therapeutics Agreement Aims at Accelerating Vertex's Hypo immune Cell Therapies for Type 1 Diabetes Vertex Pharmaceuticals (VRTX) and CRISPR Therapeutics (CRSP) announced that they have entered into a new non-exclusive licensing agreement for the use of CRISPR Therapeutics’ gene editing . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Important News from Vertex Vertex Pharmaceuticals (VRTX) is a worldwide biotechnology company that invests in scientific innovation. The firm created transformative medicines for people with serious diseases. Vertex has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease. It has several ongoing clinical and research programs in CF. Beyond CF, Vertex . . . This content is …

CymaBay Therapeutics CymaBay Therapeutics (CBAY) is a clinical-stage biopharmaceutical firm focused on improving the lives of people with liver and other chronic diseases that have a high unmet medical need through a pipeline of innovative therapies.   The firm is proud of its deep understanding of the underlying mechanisms of liver inflammation . . . This content is for paid subscribers. Please click here to subscribe or …

The Stock Market The volatility continues in the Bear market with investors not knowing what to do with such instability. Professional traders and robots are all puzzled. Friday, March 10, 2023 the market started the trading day by dropping 150 points and it continued to drop. Nobody knew what would happen by the end of the day, which, in this case, was the end of …

Apellis Pharmaceuticals Apellis Pharmaceuticals, Inc. (APLS) is a biopharma firm developing novel products for debilitating and life-threatening diseases. Currently, Apellis has two approved medicines targeting C3. These drugs include the first and only approved therapy for geographic atrophy, a leading cause of blindness. The firm’s pipeline has dozen clinical and pre-clinical programs convincing the firm's management . . . This content is for paid subscribers. …

Prohost's Beliefs About the Status of the Market That the market is still volatile and Bear. Investors in the biotech sector who intend to bet on clinical stage firms must restrict their choices to companies that already have proof of concept regarding safety and efficacy in some midterm and pre-term clinical trial results. Caution is still important for clinical-stage firms’ stocks that have encouraging clinical …

CytomX Therapeutics  We posted several articles that brought good news from CytomX Therapeutics (CTMX), yet the stock continues to go down instead of up.  A few days ago, CytomX announced the achievement of a clinical candidate milestone under its agreement with Astellas. The clinical . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

TG Therapeutics  TG Therapeutics (TGTX) is a commercial stage, biopharmaceutical company developing and commercializing novel treatments for B-cell diseases. The firm’s research pipeline has several investigational medicines. TG Therapeutics has been granted U.S. FDA approval of its product BRIUMVI™ (ublituximab-xiiy), for adult patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome . . . This content is for paid subscribers. Please click here to …

Jazz Pharmaceuticals and Zymeworks Inc Announce Results of Zanidatamab Jazz Pharmaceuticals (JAZZ) and Zymeworks Inc. (ZYME)

Ionis Pharmaceuticals and Royalty Pharma Ionis Pharmaceuticals (IONS) and Royalty Pharma plc (RPRX) announced that Royalty Pharma has . . . This content is for paid subscribers. Please click here to subscribe or here to log in.