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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.
How Banning Titanium Dioxide Might Impact Pharma
The impact of the potential ban would have serious consequences for the availability of many drugs for European patients.
Pharmacovigilance Automation
Organizations can better understand the maturity of AI-driven automation technology across their organization’s IT landscape through effective pharmacovigilance.
Acadia Pharmaceuticals Receives FDA Approval for First Treatment for Rare Genetic Disorder
FDA has approved Acadia Pharmaceuticlas’ Daybue (trofinetide), the first treatment for Rett syndrome, a rare genetic disorder.
FDA Approves Pfizer’s New Migraine Nasal Spray
FDA has approved Pfizer’s ZAVZPRET (zavegepant), a new nasal spray treatment for migraine.
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.
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.
Feeling the Pinch
Soaring energy costs are compounding the challenges currently being faced by the European bio/pharma industry.
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.
