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NSF International Publishes National Standard for Excipient Good Manufacturing Practices
NSF's consensus-based standard incorporates multiple regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients.
Penn Pharma Adds Contained Roller Compaction Equipment in South Wales
Penn Pharma's equipment addition meets growing need for continuous dry granulation and for handling of highly potent drugs.
Valeant Adds $1 Billion to Salix Offer, Amid Bid Battle
Valeant announced that it would increase its original acquisition agreement with Salix to approximately $15.8 billion.
Mundipharma Launches Infliximab Biosimilar (Remsima) in Six European Markets
Remsima has demonstrated comparability to the reference product, Remicade, in terms of safety, efficacy, and quality.
McNeil Hit with $25 million Fine for Adulterated Medications
McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.
BIO Encourages Transparency with Support of Biologic Interchangeability Bill
BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.
23andMe Adds Therapeutics Unit
The company will build an R&D team to find promising drug targets with genetic information submitted by customers in its database.
Drug Spending Highest Since 2003, Says Report
Drug spending rose last year at the highest rate since 2003, driven by specialty medicines, according to a report from pharmacy benefit manager Express Scripts.
Zogenix Ditches Its Controversial Drug Zohydro
Zogenix agreed to sell Zohydro, its controversial pain medication, to Pernix for $100 million.
Dr. Reddy’s Expands Formulation Development Capabilities
Dr. Reddy’s announced that it expanded its facilities to include a formulation development laboratory at its Miyapur, Hyperabad, India plant.
FDA Approves Astellas’ Anti-Fungal Drug
Astellas Pharma announced that it received FDA approval for its treatment of fatal invasive fungal infections in patients with blood cancers.
Mallinckrodt Accents Critical Care With Ikaria Acquisition
Mallinckrodt Pharmaceuticals has bought Ikaria, a privately-held critical care company, for $2.3 billion.
WHO to Launch Ebola Vaccine Efficacy Trial March 7
The agency will employ a ring vaccination method similar to the one used to eradicate smallpox.
FDA Approves First Biosimilar
In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.
Baxter Builds Immunology Portfolio by Acquiring Autoimmune Specialist
Baxter has bought SuppreMol, a German biopharmaceutical company that focuses on autoimmune treatments, for €200 million ($225 million USD).
BASF Shores Up Specialty Amines Supply
BASF is expanding its Verbund site in Ludwigshafen to include production capacity for about 20 specialty amines.
AbbVie to Acquire Pharmacyclics for $21 billion
AbbVie’s acquisition of Pharmacyclics establishes the combined company as an emerging leader in hematological oncology.
Should the Term "Key Opinion Leaders" be Replaced?
Survey reveals pharmaceutical and medical attitudes towards “KOL” terminology.
Patheon Acquires IRIX Pharmaceuticals
Patheon cites expanded API services with acquisition of IRIX Pharmaceuticals.
Teva Announces Sale of Facility
Teva announced that it would sell its Sellersville, Pennsylvania facility to G&W Laboratories.
Canon Announces New Biomedical Company
Canon announced that it established Canon BioMedical, a wholly owned biomedical business to develop, manufacture, and market operations related to Canon’s life-science and molecular diagnostics platform.
Grand River Names Director of Manufacturing
Steve Nole joins Grand River Aseptic Manufacturing as director of manufacturing.
WellSpring Pharma Services Names New President
WellSpring Pharma Services has announced the appointment of David Mayers as president.
Repligen Expands US Manufacturing Facility
A facility expansion adds space for production of Repligen’s tangential flow system.
PBOA Supports Legislation to Protect FDA User Fees
The Pharma & Biopharma Outsourcing Association announced its support of legislation that would preserve FDA user fees from sequestration.
SGS Adds Amino Acid Analysis at German Facility
SGS Life Science Services adds analytical methods to identify amino acid impurities in bio/pharmaceutical manufacturing at facility in Germany.
Novasep to Manufacture Celladon's Mydicar API
Novasep has entered into an agreement with Celladon to provide scale-up and pre-validation studies for the drug substance for MYDICAR.
Hemispherx Biopharma Incorporates Continuous Manufacturing at its NJ Facility
The upgrades will offer the opportunity for higher product yields and higher purity levels.
Europe Strives for a More Efficient Generic-Drug Approval Framework
Proposals to make the decentralized procedure more efficient were discussed at the January 2015 EGA conference.
Kason Offers Screen Replacement
Kason’s K-Series screen replacement program for round vibratory screeners decreases downtime and cost and offers screens designed for any make or model of screener.