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• Omnicell to Present at the Piper Sandler 35th Annual Healthcare Conference

  11/27/2023

  Omnicell, Inc. (Nasdaq:OMCL), a leading provider of medication management solutions and adherence tools for healthcare systems and pharmacies, will present at the Piper Sandler 35th Annual Healthcare Conference on Tuesday, November 28, 2023 at 1:00 p.m. ET.

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  Top Life Sciences Startups to Watch in 2022

  1/6/2022

  BioSpace is proud to present its NextGen Bio “Class of 2022,” a list of up-and-coming life sciences companies in North America that recently launched.

• Arcellx Announces Continued Robust Long-Term Responses from Its CART-ddBCMA (anito-cel) Phase 1 Expansion Trial in Patients with Relapsed or Refractory Multiple Myeloma at ASH

  12/8/2023

  Arcellx, Inc. (NASDAQ: ACLX) today announced new clinical data from its Phase 1 expansion study of CART-ddBCMA, now known as anitocabtagene autoleucel (anito-cel). Anito-cel utilizes a novel D-Domain BCMA binder that is compact and stable, which results in a drug product with a high proportion of CAR+ cells and high surface expression, potentially enhancing antigen binding and more efficient Multiple Myeloma cell killing.

• Agrivalle and Ginkgo Bioworks Enter Multiyear Strategic Partnership to Accelerate Next-Gen Ag Biological Products

  12/8/2023

  Agrivalle, a leading Brazilian agricultural biologicals company, today announced a new partnership with Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity.

• Kura Oncology’s Menin Inhibitor Ziftomenib Selected for The Leukemia & Lymphoma Society’s Pediatric Acute Leukemia (PedAL) Master Clinical Trial

  12/8/2023

  Kura Oncology, Inc. (NASDAQ: KURA) and The Leukemia & Lymphoma Society (LLS), the largest private funder of blood cancer research, today announced a clinical collaboration to evaluate Kura’s menin inhibitor, ziftomenib, in combination with chemotherapy in pediatric patients with relapsed/refractory KMT2A-rearranged, NUP98-rearranged or NPM1-mutant acute leukemia.

• European Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma

  12/8/2023

  Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab). ELREFXIO is a targeted immunotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

• AMETEK Completes Acquisition of Paragon Medical

  12/8/2023

  AMETEK, Inc. (NYSE: AME) today announced that it has completed its acquisition of Paragon Medical, a leading provider of highly engineered medical components and instruments, from affiliates of American Securities LLC, in an all-cash transaction valued at approximately $1.9 billion.

• Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions

  12/8/2023

  Novartis today announced results from an updated invasive disease-free survival (iDFS) analysis of the pivotal Phase III NATALEE trial, with a median follow-up of 33.3 months and following Kisqali® (ribociclib) treatment completion by 78.3% of patients.

• FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease

  12/8/2023

  Today, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older.

• Genentech’s Kadcyla Is the First Targeted Therapy to Show Significant Overall Survival Benefit in People With HER2-Positive Early-Stage Breast Cancer With Residual Invasive Disease After Neoadjuvant Treatment

  12/8/2023

  Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive long-term follow-up data from the pivotal, Phase III KATHERINE study in people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant (before surgery) treatment.

• RevBio Receives FDA Approval to Conduct a First-in-Human Clinical Trial for its Regenerative Bone Adhesive for Cranial Flap Fixation

  12/8/2023

  RevBio, Inc., announced that it has received approval from the U.S. Food and Drug Administration to start a 20-patient pilot clinical trial to examine the safety and efficacy of the company’s bone adhesive biomaterial called TETRANITE® to immediately stabilize and fixate cranial flaps following craniotomy procedures associated with brain surgery.

• Genentech’s Inavolisib Combination Reduces the Risk of Disease Progression by 57% in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

  12/8/2023

  Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presented today positive results from the Phase III INAVO120 study evaluating inavolisib in combination with palbociclib (Ibrance®) and fulvestrant as a first-line treatment for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer.

• bluebird bio Announces FDA Approval of LYFGENIA™ (lovotibeglogene autotemcel) for Patients Ages 12 and Older with Sickle Cell Disease and a History of Vaso-Occlusive Events

  12/8/2023

  bluebird bio, Inc. (Nasdaq: BLUE) (“bluebird bio” or “bluebird”) today announced the U.S. Food and Drug Administration (FDA) has approved LYFGENIA™ (pronounced as ‘lif-JEN-ee-uh’) (lovotibeglogene autotemcel), also known as lovo-cel, for the treatment of sickle cell disease in patients ages 12 and older who have a history of vaso-occlusive events (VOEs).

• Vertex and CRISPR Therapeutics Announce US FDA Approval of CASGEVY™ (exagamglogene autotemcel) for the Treatment of Sickle Cell Disease

  12/8/2023

  Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) announced today that the U.S. Food and Drug Administration (FDA) has approved CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 genome-edited cell therapy, for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso-occlusive crises (VOCs).

• bluebird bio Details Plans for the Commercial Launch of LYFGENIA™ Gene Therapy for Patients Ages 12 and Older with Sickle Cell Disease and a History of Vaso-Occlusive Events

  12/8/2023

  bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “bluebird”) today announced the details of its U.S. commercial infrastructure to support timely, equitable access to LYFGENIA™ (lovotibeglogene autotemcel, also known as lovo-cel), an FDA-approved gene therapy for the treatment of patients 12 years of age and older with sickle cell disease and a history of vaso-occlusive events (VOEs).

• FDA Approves Expanded Use of CRESEMBA® (isavuconazonium sulfate) in Children with Invasive Aspergillosis and Invasive Mucormycosis

  12/8/2023

  Astellas Pharma US, Inc. (President: Mark Reisenauer, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved CRESEMBA® (isavuconazonium sulfate), an azole antifungal drug, for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients.

• Jazz Pharmaceuticals Presents Updated Phase 2a Data at SABCS 2023 Showcasing Potential of Zanidatamab in HER2+/HR+ Metastatic Breast Cancer

  12/8/2023

  Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today presented updated data from the Phase 2a trial of investigational zanidatamab, a HER2-targeted bispecific antibody, in combination with palbociclib, a CDK4/6 inhibitor, and fulvestrant, a selective estrogen receptor antagonist, in patients with HER2-positive (HER2+)/HR-positive (HR+) metastatic breast cancer (mBC) as part of a late-breaking oral presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).

• Boston Medical Center to Offer First FDA-Approved Gene Therapy Treatment Program for Sickle Cell Disease

  12/8/2023

  Boston Medical Center (BMC), a national leader in the treatment of sickle cell disease for more than 50 years, announced today that it will offer the first-ever gene therapy treatment program for sickle cell disease that uses a type of novel genome editing technology.

• Full-Life Technologies Breaks Ground for GMP Manufacturing Facility in Belgium to Advance Its End-to-end Solution for Radiopharmaceuticals

  12/8/2023

  Full-Life Technologies, a fully integrated global radiotherapeutics company, announced the construction of its new Good Manufacturing Practices compliant manufacturing facility in Gembloux, Belgium, for radiopharmaceuticals.

• Seres Therapeutics Announces Presentation of Preliminary PK/PD and Safety Data for Investigational Microbiome Therapeutic SER-155 at ASH 2023

  12/8/2023

  Seres Therapeutics, Inc., a leading microbiome therapeutics company, announced that preliminary clinical data from a currently enrolling Phase 1b study of SER-155 study in adult patients undergoing allogeneic hematopoietic cell transplantation will be presented at the 65th American Society of Hematology Annual Meeting held from December 9-12, 2023, in San Diego, California, USA.