Industry News
Feds to Review March-In Authority on Drug Patents
A new Interagency Working Group for Bayh-Dole will review the government’s authority to revoke licenses for medical products.
Digital Health Technologies Document Outlines Framework for FDA
The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.
Lynparza Approved in UK as Combination Therapy for Treatment of Metastatic Castration-Resistant Prostate Cancer
The decision was based on results from the PROpel Phase III trial.
European Commission Approves Dupixent as First, Only Targeted Medicine for Children with Severe Atopic Dermatitis
This approval makes the drug the first and only targeted medicine indicated to treat this population of children in Europe and the United States.
Sanofi Drops Lantus US List Price by 78%, Capping Out-of-Pocket Costs at $35
Sanofi intends to cut its US list price for Lantus (insulin glargine injection) by 78% and cap out-of-pocket costs at $35 for all patients with commercial insurance.
EMA Management Board Continues to Monitor Critical Shortages of Medicines
Additionally, the MSG discussed plans to mitigate shortages of antibiotics for the next autumn and winter season.
Evotec and Bristol Myers Squibb Progress Strategic Partnership
Evotec and Bristol Myers Squibb have announced progress in their strategic protein degradation partnership.
Predictive Oncology and Cancer Research Horizons Partner for Cancer Drug Development
Predictive Oncology and Cancer Research Horizons have partnered to pursue development of cancer drugs utilizing the PEDAL platform.
First Drugs Hit by Inflation Reduction Act Price Controls
27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation.
FDA Seeks $7.2 Billion to Protect and Advance Public Health
FDA is seeking $7.2 billion to enhance food safety and advance medical product availability.
Sumitovant Acquires Myovant for $1.7 Billion
Sumitovant Bipharma has completed its acquisition of Myovant Sciences for approximately $1.7 billion.
Biotech Companies Deal with Silicon Valley Bank Collapse
Silicon Valley Bank has collapsed, leaving many biotechnology companies unsure of the future.
Makena Saga Shows How Hard It Is to Remove Unproven Drug from Market
Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.
Catalent Expands UpTempo AAV Platform
Catalent is expanding its UpTempo AAV platform to accelerate the development of gene therapies.
Vetter Joins United Nations Global Compact
Vetter has become a participant of the UN Global Compact Network.
Congress Probes PBM Link to Higher Drug Prices
Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.
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.
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.
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.
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.
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.
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.
FDA Publishes New Product-Specific Guidelines for Generic Drug Development
Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.
FDA Announces BsUFA III Regulatory Science Program to Support Future Research
The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.
