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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.
BioNTech and OncoC4 to Co-Develop mAb for Solid Tumor Indications
BioNTech will receive an exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 mAb candidate for solid tumor indications.
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.
Sartorius and Teknova Team Up for Gene Therapy Process Development
Sartorius BIA Separations and Teknova will collaborate to combine their technologies in an effort to streamline the downstream purification process.
Samsung Biologics to Build Plant 5 as Part of Capacity Expansion to Bio Campus II
Samsung Biologics plans to invest more than ₩1.9 trillion (US$1.5 billion) in the new Incheon, South Korea, facility, which will hold a manufacturing capacity of 180,000 L.
Polyplus Introduces Novel LNP Formulation for Use in mRNA Therapeutics
Polyplus’ LipidBrick is designed to expand the scope of lipid nanoparticle formulation usage in mRNA therapeutics and vaccine development.
Stevanato Group and Recipharm to Collaborate on Pre-fillable Syringes for Soft Mist Inhaler
Stevanato Group will support development and production of pre-fillable syringes for use in Recipharm’s soft mist inhalers.
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.
Sandoz to Build New Biologics Production Facility in Slovenia
Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.
Catalent Licenses Bhami Research Laboratory Technology for Biologics Formulation Development
Under a technology licensing agreement with Bhami Research Laboratory, Catalent intends to develop formulations that will allow for the delivery of high-concentration biologics subcutaneously.
Genuv and Celltrion Partner on Development of Novel Therapeutic Antibodies
The collaboration between Genuv and Celltrion will utilize Genuv's proprietary mouse platform for antibody discovery.
Pfizer to Acquire Seagen in $43 Billion Blockbuster Deal
Pfizer will acquire all outstanding shares of Seagen for a total of $43 billion.
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.
Pharmacovigilance Automation
Organizations can better understand the maturity of AI-driven automation technology across their organization’s IT landscape through effective pharmacovigilance.
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.
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.
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.
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.
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.
