ImmunoGen Reports Recent Progress and First Quarter 2023 Financial Results  On April 28, 2023, ImmunoGen (IMGN) reviewed recent progress in the business and reported financial results for the quarter ended March 31, 2023.  Immunogen's drug ELAHERE® (mirvetuximab soravtansine-gyn) is a first-in-class antibody drug conjugate (ADC) comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid . . . This content is for paid subscribers. Please …

Vertex Pharmaceuticals ORKAMBI Receives Positive CHMP Opinion Today, April 27, Vertex Pharmaceuticals  (VRTX) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) embraced a positive opinion for the label extension of ORKAMBI® (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis (CF) ages 1 . . . This content is for paid subscribers. Please click here to subscribe or here to log …

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. …

Apellis Pharmaceuticals Validation for Pegcetacoplan Apellis Pharmaceuticals (APLS) announced the receival of validation of its marketing applications by regulatory authorities in Canada, Australia, the United Kingdom, and Switzerland for intravitreal pegcetacoplan regarding the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The decisions by the local regulatory authorities in these four countries are . . . This content is for paid subscribers. Please …

Important News from CymaBay Therapeutics Primary Biliary Cholangitis Today, April 21, 2023, CymaBay Therapeutics (CBAY) announced that results from the ENHANCE phase 3 global study evaluating seladelpar for Primary Biliary Cholangitis (PBC) have been published in Hepatology. The authors . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

From Novartis on April 20, 2023 The ALITHIOS open-label extension study demonstrated that continuous treatment with Kesimpta® (ofatumumab) for up to five years in relapsing multiple sclerosis (RMS) was associated with reduced risk of disability progression versus those who switched later from teriflunomide to Kesimpta. Outcomes related to both disability progression and brain volume change up to five years favored earlier initiation of Kesimpta in people …

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 …

Merck in the NEWS Merck (MRK) announced that the U.S. FDA has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of HER2 negative patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The American Agency's acceptance of . . . This content is …

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

Regenxbio in the NEWS Today, the U.S. FDA granted Fast Track designation for Regenxbio (RGNX) Gene therapy RGX-202 a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne). Therapies granted Fast Track designation are given the opportunity for more frequent interactions with the FDA and may qualify for priority review. The FDA has granted RGX-202 . . . This content is for paid …

Vertex Pharmaceuticals and CRISPR Therapeutics Completion of BLAs Vertex Pharmaceuticals (VRTX) and CRISPR Therapeutics (CRSP) announced the completion of the . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

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 …

New Study from Neuvivo On March 30, 2023, Neuvivo – a private Company, announced the publication of a peer-reviewed paper in ‘Cells‘ titled: “Regulation of the Innate Immune System as a Therapeutic Approach to Supporting Respiratory Function in ALS”.   The biomarker study used vital capacity (VC), a quantitative test for respiratory function, to highlight the relationship between a compromised innate immune system and ALS disease activity.  …

TG Therapeutics TG Therapeutics, Inc. (TGTX) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of BRIUMVITM (ublituximab-xiiy) for the treatment of adult patients relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features . . . This content is for paid subscribers. …

Checkpoint Therapeutics Checkpoint Therapeutics (CKPT) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing open-label, multi-regional, multicohort . . . This content is for paid subscribers. Please …

BrainStorm Cell Therapeutics Inc BrainStorm Cell Therapeutics Inc (BCLI) develops innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. FDA . . . This content is …

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 …

23andMe Aims To Raise Awareness of Lipoprotein(a), a Little-Known Genetic Risk Factor for Cardiovascular Disease March 24, 2023 (GLOBE NEWSWIRE) — In support of Lipoprotein(a) Awareness Day, 23andMe Holding Co. (ME) announced a collaboration with Novartis Pharmaceuticals Corporation (NVS) to increase awareness for Lipoprotein(a) (Lp(a)). The Information to Learn High levels of Lp(a) are associated with increased risk of heart attack, stroke and other life …

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 …