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Governments Advance Pandemic Agreement for Future Emergency Preparedness

  • The Pharma Data
  • September 23, 2024

Negotiations on the world’s first agreement to safeguard people from future pandemics, led by the World Health Organization (WHO), made significant strides during the latest round of discussions, which concluded…

Read MoreGovernments Advance Pandemic Agreement for Future Emergency Preparedness
  • Regulatory

Elanco Launches FDA-Approved Zenrelia for Canine Dermatology

  • The Pharma Data
  • September 23, 2024

Elanco Animal Health Incorporated (NYSE: ELAN) has announced that the U.S. Food and Drug Administration (FDA) has approved Zenrelia™, a once-daily oral JAK inhibitor for the control of pruritus (itching)…

Read MoreElanco Launches FDA-Approved Zenrelia for Canine Dermatology
  • News

Positive CHMP Opinion Granted to Samsung Bioepis and Biogen for Aflibercept Biosimilar, OPUVIZ

  • The Pharma Data
  • September 21, 2024

Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) have announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion…

Read MorePositive CHMP Opinion Granted to Samsung Bioepis and Biogen for Aflibercept Biosimilar, OPUVIZ
  • Regulatory

US Approves Sarclisa as First Anti-CD38 Therapy for Non-Transplant Multiple Myeloma Patients

  • The Pharma Data
  • September 21, 2024

The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment for adult patients with newly diagnosed multiple…

Read MoreUS Approves Sarclisa as First Anti-CD38 Therapy for Non-Transplant Multiple Myeloma Patients
  • News

Pfizer and BioNTech Get Favorable CHMP Opinion for Omicron KP.2-Adjusted COVID-19 Vaccine in the EU

  • The Pharma Data
  • September 21, 2024

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have received a recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines…

Read MorePfizer and BioNTech Get Favorable CHMP Opinion for Omicron KP.2-Adjusted COVID-19 Vaccine in the EU
  • Regulatory

Fasenra Receives U.S. Approval for Treating Eosinophilic Granulomatosis with Polyangiitis

  • The Pharma Data
  • September 21, 2024

AstraZeneca’s Fasenra (benralizumab) has received U.S. approval for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare and potentially fatal immune-mediated vasculitis that can damage multiple organs. This…

Read MoreFasenra Receives U.S. Approval for Treating Eosinophilic Granulomatosis with Polyangiitis
  • Regulatory

FluMist Receives Approval for Self-Administration in the US

  • The Pharma Data
  • September 21, 2024

FluMist has become the first self-administered influenza vaccine approved in the US. This needle-free nasal spray can now be self-administered by adults up to 49 years old or given by…

Read MoreFluMist Receives Approval for Self-Administration in the US
  • Press Releases

Phase III Study Confirms Xofluza Significantly Reduces Influenza Virus Transmission

  • The Pharma Data
  • September 21, 2024

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from the phase III CENTERSTONE study of Xofluza® (baloxavir marboxil), an antiviral medication, demonstrating a significant reduction in the…

Read MorePhase III Study Confirms Xofluza Significantly Reduces Influenza Virus Transmission
  • News

Merck Gets EU CHMP Nod for KEYTRUDA in Two Gynecologic Cancers

  • The Pharma Data
  • September 21, 2024

Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions recommending…

Read MoreMerck Gets EU CHMP Nod for KEYTRUDA in Two Gynecologic Cancers
  • Research

Positive Phase 1 Results for Personalized Vaccine in Lymphoplasmacytic Lymphoma

  • The Pharma Data
  • September 20, 2024

A team of researchers from City of Hope® and The University of Texas M.D. Anderson Cancer Center has shared promising safety and efficacy results from a Phase 1 trial involving…

Read MorePositive Phase 1 Results for Personalized Vaccine in Lymphoplasmacytic Lymphoma
  • News

Family Heart Foundation Partners with Health Systems to Use AI Model for Detecting Genetic Heart Condition

  • The Pharma Data
  • September 20, 2024

The Family Heart Foundation, a prominent research and advocacy organization, has announced the successful completion of its Flag, Identify, Network, and Deliver™ “FIND Lp(a)” machine learning model. This groundbreaking tool…

Read MoreFamily Heart Foundation Partners with Health Systems to Use AI Model for Detecting Genetic Heart Condition
  • News

Organon Acquires Dermavant, Securing Breakthrough Dermatology Treatment VTAMA (Tapinarof) Cream 1%

  • The Pharma Data
  • September 20, 2024

Organon (NYSE: OGN), a global healthcare company dedicated to improving women’s health, has announced a definitive agreement to acquire Dermavant Sciences, a subsidiary of Roivant (NASDAQ: ROIV). Dermavant specializes in…

Read MoreOrganon Acquires Dermavant, Securing Breakthrough Dermatology Treatment VTAMA (Tapinarof) Cream 1%
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