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Lonza and Singzyme Enter Bioconjugates Partnership
Lonza and Singzyme will use Singzyme’s enzymatic conjugation platform to develop novel bioconjugates.
Terumo Pharmaceutical Solutions Expands CDMO Services
The company is expanding its contract development and manufacturing services for parenteral drugs to global customers.
CPHI Pharma Index Indicates Record High for Global Pharma Confidence
Metrics from the CPHI Annual Survey suggest that confidence in the global pharma market has risen significantly in the past year.
Purolite and Repligen Announce Ligand Partnership
Purolite and Repligen have extended their existing ligand partnership through 2032.
Lonza Launches New Capsule Solution for Intestinal Drug Delivery
Lonza has launched a new capsule to deliver acid-sensitive APIs to the intestine.
USP Revises Drug Compounding Chapters
Updates to general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, include requirements for equipment, cleaning, personnel garb, labeling, and surface contamination testing.
Ashland Injectable Pharmaceutical Excipient Accepted into FDA Novel Excipient Review Pilot Program
FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.
FDA Embroiled in Reproductive Rights Debate
A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.
Gerresheimer Showcases DropControl, a New Dropper Solution for Ophthalmic Formulations, at CPHI 2022
Gerresheimer has developed a new dropper insert for ophthalmic formulations that it is showcasing at CPHI 2022 in Frankfurt, Germany.
Thermo Fisher Scientific Showcases at CPHI Frankfurt 2022
Thermo Fisher Experts will demonstrate its various capabilities at CPHI Frankfurt 2022.
Roquette Launches Next-Generation Direct Compression Solutions
Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.
Venture Capital Funding to Fuel Pharma Outsourcing
The CPHI Annual Report 2022 predicts cash reserves from venture capitalists and private equities will drive expansion in the demand for contract research organizations and contract development and research organizations.
CSafe and BioLife Solutions Partnership Will Expand Supply Chain for Cell and Gene Therapies
The newly formed partnership between CSafe and BioLife will expand cold chain supply chain solutions for the cell and gene therapy market.
FDA Approves AstraZeneca’s Imjudo for Combination Liver Cancer Treatment
AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.
Pressure Mounts for FDA to Reform Accelerated Approval Program
An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.
Cambrex Announces Stability Storage Expansions in Ireland and Belgium
Cambrex has expanded its stability storage business, Q1 Scientific, in Ireland and Belgium.
WHO Ranks South Africa’s Vaccine Regulatory System at a Functional Level of Maturity
South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.
Societal CDMO Signs Multiple CDMO Service Agreements
Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.
GSK Expands Precision Medicine Collaboration with Tempus to Accelerate R&D
Under the new collaboration with Tempus, GSK will have access to de-identified patient data to accelerate drug discovery, improve clinical trial design, and speed up enrollment.
At the Heart of Pharma: ESG has Arrived as a Central Strategy
Pharma supply chains are no longer hidden beyond the reach of ESG agendas, making it important for companies to accelerate adoption of new manufacturing processes and environmental technology
Aragen to Invest in New Formulation Manufacturing Facility in Hyderabad, India
Aragen’s new 12,000 ft² facility will include various dosage form capabilities, including oral solids, liquids, topicals, and films.
Recipharm to Add High-Speed Filling Line to Wasserburg Facility
Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.
AAPS to Provide Scientific Programming Oversight for Interphex
AAPS will exclusively advise RX Global on scientific focus areas for Interphex 2023, which is set to take place at the Javits Center in New York City next spring.
Aenova and Microcaps Enter Strategic Collaboration
Aenova Group and Microcaps are partnering to enable new customized formulations for product development and life cycle management solutions.
EMA Extends Use of COVID-19 Vaccines to Children
The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.
EMA Recommends Adapted Spikevax Vaccine
The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.
Gilead and MacroGenics Enter $1.7 Billion Oncology Collaboration
Gilead and MacroGenics will work together on bispecific antibodies for the treatment of blood cancers.
Post-Transplant Lymphoproliferative Disease Treatment Receives Marketing Authorization Recommendation from EMA
Ebvallo (tabelecleucel) would be the first EMA-approved therapy for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.
EMA Announces Positive Indication for Takeda’s Dengue Vaccine
Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.
Merck and Moderna Enter $250 Million Cancer Vaccine Partnership
Merck has exercised a $250 million option with Moderna to jointly develop and commercialize cancer vaccine mRNA-4157/V940.
