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Congress Probes PBM Link to Higher Drug Prices
Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.
Actylis Opens 30,000-square-foot API Manufacturing Facility
Actylis new 30,000-ft² API manufacturing facility is located in Eugene, Ore.
Merck Releases Data on Rare Blood Vessel Disorder Treatment
Sotatercept, a drug candidate acquired by Merck in an $11.5 billion acquisition, showed statistically significant improvements in various measures.
Janssen Receives Positive Opinion for AKEEGA Plus Prednisone or Prednisolone
Janssen has received a positive opinion from EMA for AKEEGA plus prednisone or prednisolone for the treatment of BRCA1/2 gene-mutated metastatic castration resistant prostate cancer.
Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15%
Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.
Guidance on Q13 Continuous Manufacturing of Drug Substances and Drug Products
The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.
FDA Issues Guidance on Potency for mAbs and Therapeutic Proteins
The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle.
Frontrunner in Microbiome Therapeutics
EnteroBiotix is harnessing the power of the microbiome to target an array of diseases.
Implementing Process Analytical Technology
PAT is crucial to process control and real-time release in continuous manufacturing of solid-dosage drugs.
Keeping Europe’s Medicines Stocked
Technological advances will help ease pressure on pharma supply chains, allowing for greater visibility and less uncertainty.
Eli Lilly to Cap Out-Of-Pocket Insulin Costs at $35
Lilly will cap insulin prices for patients with and without insurance at $35 per month.
Outsourcing Still Vital
The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines.
Feeling the Pinch
Soaring energy costs are compounding the challenges currently being faced by the European bio/pharma industry.
Subsurface Currents
That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.
AstraZeneca Strikes $1.16 Billion Licensing Deal for Gastric Cancer Candidate
AstraZeneca has entered into a global exclusive license agreement with KYM Biosciences for CMG901, which is being investigated as a gastric cancer treatment.
AbbVie Receives Positive CHMP Opinion for Crohn’s Disease Treatment
CHMP recommended the approval of AbbVie’s RINVOQ (upadacitinib) as a treatment for adults with moderate-to-severe Crohn’s disease.
Investigational Personalized mRNA Cancer Vaccine Gains Breakthrough Therapy Designation from FDA
Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.
WHO Calls for Increased Funding to Aid Yemen’s Health Crisis
WHO is appealing for US $392 million to reach 12.9 million people with essential health assistance in 2023.
Orchard Therapeutics to Reimburse Access to Libmeldy for MLD Patients in Sweden
Orchard Therapeutics has announced an agreement which will enable reimbursed access to Libmeldy for all eligible MLD patients in Sweden.
Bio-Rad’s New StarBright Blue and Yellow Dyes Enhance Multiplex Flow Cytometry
Bio-Rad’s newly launched StarBright Blue and StarBright Yellow dyes are intended for use in various flow cytometry applications.
Eurofins Viracor Launches Test for Assessing Expansion and Persistence of CAR-T Therapy in Cancer Patients
Eurofins Viracor ExPeCT CAR-T qPCR assay is a tool designed for monitoring and optimizating CAR-T therapies.
Moderna and Life Edit Therapeutics Enter Gene Editing Collaboration
Moderna will leverage Life Edit’s suite of gene editing technologies to advance development of in vivo gene editing therapies.
FDA Approves Sanofi Hemophilia Treatment
Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.
AbbVie and Capsida Strike $674 Million Gene Therapy Development Deal
AbbVie and Capsida have expanded their existing collaboration to advance three new gene therapy programs.
Predictive Oncology and Cvergenx Enter Genomics-Based Personalized Therapy Collaboration
The goal of this collaboration is to develop an approach to personalized radiotherapy and drug discovery that is based in genomics and artificial intelligence.
IRBs Need More Monitoring
GAO calls for more oversight of institutional review boards in clinical trials.
FDA Recommends Recall of Artificial Eye Ointment for Potential Bacterial Contamination
This warning is the second on top of a previous warning not to purchase or use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.
Agilent Gains Design Support from CRB for Manufacturing Facility Expansion
Agilent’s therapeutic nucleic acids facility gains architectural design support from CRB.
Pfizer Announces Positive Data for Prostate Cancer Combination Treatment
Pfizer reports that the combination of talazoparib and enzalutamide demonstrated statistically significant improvement in patient survival in a Phase III trial.
FDA Approves First Treatment for Geographic Atrophy
Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.
