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Fuji Health Changes Name to Fuji Chemical Industries USA, Inc.
API and drug product manufacturer changes name to align with parent company.
Industry Groups Applaud GDUFA Agreement
GPhA and PBOA commend agreement to reauthorize Generic Drug User Fee Amendments.
Regis Technologies Reports Successful FDA Inspection
FDA found no observations during recent inspection of Regis Technologies manufacturing site.
Evonik Birmingham Laboratories Receives Renewal of EU GMP Certification
Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.
Chinese Facility Receives Warning Letter
FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.
Recipharm Enters Long-Term Supply Agreement with Tillotts Pharma AG
The agreement comprises technology transfer and commercial manufacturing of Tillotts’ gastroenterology products.
Sandoz Enbrel Biosimilar Gets Okay from FDA
Sandoz won FDA approval for its biosimilar version of Enbrel.
Competition and Drug Pricing
Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard
Dalton Expands Canadian Manufacturing Facility
Dalton Pharma Services completed an expansion in sterile filling and API manufacturing at its cGMP facility in Toronto, Canada.
Contact Lenses as a Potential Drug Delivery Method for Glaucoma
Researchers at the Massachusetts Eye and Ear Infirmary developed a potential drug delivery method using a contact lens to deliver glaucoma medication.
Impax Laboratories Recalls Lamotrigine Orally Disintegrating Tablets
The company is voluntarily recalling one lot of product due to a potential packaging mistake.
FDA Publishes Antibacterial Drug Development Guidance
The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.
Compounding Pharmacy Warned Over a Variety of Violations
FDA issued a warning letter to College Pharmacy for multiple violations.
FDA Publishes ANDA Submission Guidance
The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.
Mylan to Launch Generic Version of EpiPen
The company will launch a generic version of EpiPen at the price of $300 for a two-pack.
Quality Issues Cited at Frontida BioPharm
FDA issued a warning letter to the company for quality control violations.
FDA Finds Microbial Contamination at Drug Compounder
The agency sent a warning letter to Cape Apothecary for adulterated drugs.
Metrics Invests in New Stability Storage Facility
The company will be investing $3.5 million in a 15,00-square-foot facility in Greenville, North Carolina.
CPhI’s Pre-Connect Congress Outlines Pharma Trends
CPhI Worldwide’s Pre-Connect Congress will discuss current trends in the pharmaceutical industry.
Takeda Launches Medicines Access Strategy in Regions with High Unmet Medical Needs
The initiative targets countries with less developed and evolving healthcare systems such as Latin America, South East Asia, and Africa.
Recipharm Expands Lyophilization Capacity in Italy
Recipharm is investing EUR3.7 million (approximately $4.18 million) to increase lyophilization capacity at its Masate facility in Italy.
Judiciary Committee Calls on Mylan to Explain EpiPen Price Increase
Ranking members of the Senate Judiciary Committee called on Mylan to explain its decision to raise the price of EpiPens nearly 400%.
ACG APL Receives EXCiPACT Certification
ACG APL is the first Asian company to receive this certification.
AstraZeneca Sells Antibiotics Business to Pfizer
The portfolio in this agreement include approved antibiotics Merrem, Zinforo, and Zavicefta, as well as candidates in clinical development, ATM-AVI and CXL.
AMRI Licenses CRISPR from the Broad Institute
AMRI entered into a non-exclusive license agreement with the Broad Institute for the use of CRISPR-Cas9 gene-editing technology.
When Marketing and Medicine Collide
Steep price increases for a popular drug have created patient and Congressional backlash.
“Go/No Go” Screening Process Can Help Decide Whether to Switch from Batch to Continuous
A recent paper outlines a methodology to help development teams decide whether switching from batch to continuous mode makes financial and technical sense.
Pfizer to Acquire Medivation
Pfizer will acquire Medivation for approximately $14 billion.
The CRISPR Patent Debate
The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.
Casebia Therapeutics Begins Operations
The joint venture, created through a collaboration with Bayer and CRISPR Therapeutics, will be based in Cambridge, MA.
