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Ingredion Announces Strategic Investments in India Expanding into High-Value Pharmaceutical Ingredients
Ingredion has completed two strategic investments in India with Amishi Drugs & Chemicals and Mannitab Pharma Specialties.
Moderna and Generation Bio Announce Strategic Collaboration
Moderna and Generation Bio have announced a strategic collaboration to develop non-viral genetic medicines.
Curia and Corning Collaborate to Advance Biopharmaceutical Continuous-Flow Development
Curia is collaborating with Corning to advance biopharmaceutical continuous-flow development and manufacturing programs.
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.
Frontrunners in the Latest Stem Cell Technology
TreeFrog Therapeutics is leaping ahead in cell therapies through resources such as new technologies and investor partnerships.
Invitae and Deerfield Management Team Up on Novel Therapeutics for Rare Diseases
Under a new partnership, Invitae and Deerfield Management will harness genetic and clinical testing data from patients to discover potential novel therapeutics for treating rare diseases.
Scorpius BioManufacturing Announces New Microbial Capacity and New Interim President
In addition to a new interim president, the company is opening new microbial capacity at its San Antonio facility and has plans to construct a commercial-scale facility in Manhattan, Kan.
TrakCel and Lonza Reach Integration Milestone to Combine Cell and Gene Therapy Manufacturing, Orchestration Solutions
The combined solutions are currently available on the market.
PurePep EasyClean Services Set to Accelerate Development and Manufacturing of Peptide-based Drugs
The services are based on the company’s PurePrep EasyClean (PEC) orthogonal peptide purification technology.
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.
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.