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Cell Culture Media Polymer Designed for Lot-to-Lot Consistency
MilliporeSigma released a new surface-active nonionic polymer to ensure lot-to-lot consistency.
Pfizer and Sangamo Team Up on Hemophilia A Gene Therapy
The companies entered a license agreement that includes Sangamo’s SB-525, one of the company’s lead product candidates for the treatment of Hemophilia A.
FDA Warns Vikshara Trading & Investments Ltd
FDA sent a warning letter to the company in India for delaying and limiting an FDA inspection in addition to problems related to cGMP.
Modernizing Organic and Elemental Impurities Standards
At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.
Avantor Expands cGMP Product Portfolio
The company will display its expanded supply chain product portfolio at CPhI North America 2017.
CPhI North America Hosts Women’s Leadership Forum
The Women’s Leadership Forum includes a panel of female executives from the pharmaceutical and specialty chemicals market.
PhRMA Increases R&D Criteria for Member Companies
More stringent R&D investment requirements for PhRMA membership reduces the association ranks by 22 associate and member companies.
Aseptic Filling Machine for Vials for Fast Changeover
The Dara SX-310-PP/D aseptic filling, stoppering, and capping machine for vials features full servo-driven automation and a compact footprint.
Syrris Launches Titan System at CPhI North America/InformEx
The company will be releasing its Titan continuous process scale-up system at CPhI North America/InformEx 2017.
Halo Pharma Forms Pediatric Center of Excellence
The company has formed a Pediatric Center of Excellence in support of the development and manufacture of dosage forms for pediatric indications.
FDA Moves Forward on Mutual GMP Inspections with Europe
FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.
Oxford Genetics Licenses CRISPR Gene Editing Technology from ERS Genomics
Licensing agreement will expand Oxford Genetics bio-therapeutic discovery, design, and development service business.
Bosch Introduces Continuous OSD Manufacturing Platform
Bosch’s Xelum platform is designed for continuous production of oral solid-dosage forms.
CPhI Worldwide Experts Make Predictions for 2017
Industry experts forecast the changes to the pharma industry for 2017.
Comar Redesigns DoseGuard Valved Bottle Adapter
The new DoseGuard design is compatible with standard 20-mm containers.
CPhI Worldwide Announces 2017 Advisory Board
CPhI Worldwide announced new additions to its 2017 advisory board.
C.O. Truxton Expands Recall
The company is expanding their April 2017 voluntary recall of phenobarbital tablets.
EMA Finds Patient Involvement Beneficial
The agency released its report on pilot project to involve patients in the assessment of medicines.
Compounding Pharmacy Cited for Unlicensed Biologics
FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
Gottlieb Faces Multiple Challenges at FDA
User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.
The Complexity of IDMP
Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.
Transforming Regulatory Data Management
The Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.
Improving Productivity to Drive Drug Discoveries to Patients
Biomedical researcher shares insights from a career dedicated to advancing therapeutic innovations for unmet medical needs.
Croda Completes Global EXCiPACT Accreditation
The company is the first multi-site excipient supplier to achieve accreditation across production facilities.
Reducing ANDA Approval Timeframes Can Lower Drug Costs, CPhI Expert Says
CPhI expert, Girish Malhotra believes drug costs could be lower if approval timeframes can be cut from 10 to three months.
WHO Launches Biosimilar Pilot Program
The program aims to make biosimilars for the treatment of cancer more widely available in middle- and low-income countries.
Novartis Licenses CAR-T Patents in Separate Deals
Novartis entered separate license agreements with bluebird bio and Celyad for patents related to the manufacture of CAR-T cells.
EMA Promotes Understanding and Use of Biosimilars
EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.
API from Unregistered Companies Entered US, According to FDA
The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.
US Prescription Drug Spending to Hit $610 billion in 2021, according to Quintiles/IMS
Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.
