Iterum Therapeutics US FDA Approval On October 25, 2024, Iterum Therapeutics (ITRM) announced that the U.S. FDA has approved Iterum’s new drug application for ORLYNVAH™ (sulopenem, etzadroxil, and probenecid) for the treatment of the uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. This is the first approved …

Vera Therapeutics and Viking Therapeutics Today, October 29, the market stocks’ prices moved south, including good companies, which dropped by the stock market investors. These companies are: Vera Therapeutics (VERA) In addition to today's early bad market, VERA price decline is happening because the firm has announced a Proposed Public Offering of Class A Common Stock following the outstanding . . . This content is …

Vera Therapeutics Announcement Two days ago, Vera Therapeutics, Inc. (VERA) announced data from its ORIGIN Phase 2b trial of atacicept in immunoglobulin A nephropathy (IgAN). The trial demonstrated a stabilization of kidney function through 96 weeks of long-term follow-up. These data were presented in a late-breaking oral presentation at the American Society of Nephrology Kidney . . . This content is for paid subscribers. Please …

Intellia Therapeutics Intellia Therapeutics (NTLA) is a clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies. The company’s in vivo programs use CRISPR to enable precise editing of disease-causing genes directly inside the human body. Intellia’s ex vivo programs use CRISPR to engineer human cells outside the body for the treatment of cancer and autoimmune diseases. Intellia’s . . . This content is for paid subscribers. …

Astellas Pharma Inc Announcement Tokyo, Oct. 18, 2024, Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, Astellas) announced that the United States FDA has approved VYLOY (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) …

Vertex Pharmaceuticals Announcement October 18, 2024, Vertex Pharmaceuticals  (VRTX) today announced that the company will present its pivotal Phase 3 data on suzetrigine, an investigational, oral, highly selective NaV1.8 pain signal inhibitor for the treatment of moderate-to-severe acute pain, at the annual meeting of the American Society of Anesthesiologists . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

AbbVie FDA Approval for VYALEV for Parkinson’s Disease AbbVie (ABBV) announced that the U.S. FDA  approved VYALEV™ (foscarbidopa and levodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). From the Experts Robert A. Hauser, M.D., MBA, Professor of Neurology and Director of the Parkinson’s and Movement Disorder Center at …

Aligos Therapeutics On September 20, 2024, we posted a press release stating that Aligos Therapeutics (ALGS) announced successful topline results from a phase 2A HERALD study of ALG-055009, a thyroid hormone receptor . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Novo Nordisk Childhood Obesity Prevention Initiative  From Bagsværd, Denmark, on October 8, 2024, Novo Nordisk (NVO) announced a new global initiative to prevent obesity in children. The Childhood Obesity Prevention Initiative aims to accelerate the prevention of childhood obesity in disadvantaged urban communities globally. Together with partners, which include city governments, academic institutions, and non-profit organizations, the initiative will support six cities in designing, implementing, …

Intellia Therapeutics Announcement Intellia Therapeutics (NTLA) announced the initiation of HAELO, a pivotal Phase 3 study of NTLA-2002 for the treatment of hereditary angioedema (HAE). NTLA-2002 is a wholly owned investigational in vivo CRISPR-based gene editing therapy developed as a single-dose treatment for life-threatening diseases. Patient screening is active following Intellia’s successful end-of . . . This content is for paid subscribers. Please click here to …

AstraZeneca Agreement with CSPC Pharmaceutical Group Yesterday, October 7, 2024, AstraZeneca (AZN) announced it entered into an exclusive license agreement with CSPC Pharmaceutical Group Ltd (CSPC) to advance . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

 Vera Therapeutics in the NEWS Today, October 02, 2024, Vera Therapeutics (VERA) announced the expansion of its development pipeline for its lead asset, atacicept. This program is expected to build on the positive data reported to date from the ongoing ORIGIN Phase 2b and 3 clinical program developing atacicept to treat patients with IgAN, by extending into a broader population of IgAN and . . …

Johnson & Johnson New TECNIS Odyssey On September 30, 2024, Johnson & Johnson (JNJ) announced expanding the roll-out of its latest advancement in presbyopia-correcting intraocular lenses (PC - IOL), TECNIS Odyssey, in the U.S. TECNIS Odyssey IOL is built on the TECNIS platform, providing two . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Bristol-Myers Squibb COBENFY™ Approval Bristol Myers Squibb (BMY) announced that the U.S. FDA has approved COBENFY™ (xanomeline and trospium chloride) for schizophrenia in adults.  Schizophrenia is a persistent disabling mental illness affecting how a person thinks, feels, and behaves. It is estimated to impact approximately 2.8 million people in the US. The initial symptoms appear in early adulthood and . . . This content is for …

Pfizer OXBRYTA® Worldwide Withdrawal Pfizer (PFE) announced today that it is voluntarily withdrawing all lots of OXBRYTA® (voxelotor) for the treatment of sickle cell disease (SCD) in all markets where it is approved. Pfizer is also discontinuing all active voxelotor clinical trials and expanding access programs worldwide. Pfizer's decision is based on the totality of clinical data, which currently indicates . . . This content …

IntraBio Inc in the NEWS  IntraBio Inc. announced that the FDA has approved AQNEURSA (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg.  IntraBio Inc., a US biopharmaceutical company, focused on the development of novel drugs addressing rare and common neurological diseases. IntraBio’s platform technologies result from decades of research and collaboration with …

UCB and Biogen Positive Results UCB (Euronext Brussels: UCB) and Biogen Inc. (BIIB) announced positive . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Sanofi Approval The United States FDA approved Sanofi (SNY) product Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). Sarclisa . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Aligos Therapeutics in the NEWS Yesterday, Sept. 19, 2024, Aligos Therapeutics (ALGS) - a small clinical-stage company, announced positive topline results from the Phase 2a HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in metabolic-dysfunction associated steatohepatitis (MASH) subjects. Aligos Therapeutics is a clinical-stage biopharmaceutical company founded with the mission to improve patient outcomes by . . . This content is for …

AstaZeneca Fasenra Approval AstraZeneca (AZN) product Fasenra (bevacizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) - a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal. The approval in the United States FDA was based on positive results from the MANDARA Phase III trial published in . …