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FDA Issues Guidance on Environmental Assessments
The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.
Novartis' Cosentyx Shows Promise in the Treatment of Psoriasis
Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.
FDA Issues Guidance on Lot Distribution Reports for Biologics
Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.
Biogen Idec Drops the Idec
The company’s new corporate name will be simply Biogen.
Recipharm Delivers Serialization Solutions for Abbott in Korea
Recipharm expects to be rolling out further serialization projects during 2015.
Laurus Synthesis Launches New Facility in Woburn, MA
The investments made in analytical and process development equipment will enable Laurus Synthesis to offer chemistry services to its clients.
WHO Joins Forces with ESCMID in the Battle against Global Infections
International day for fighting infection sees European infection specialists advocating vaccines as a viable solution to tackle antimicrobial resistance.
International Transport for Biologic Substances Expands
UPS expands its special commodities program to more countries.
Removing Aggregates from Monoclonal Antibodies
Several chromatographic resins are available for downstream purification.
Porvair Opens New Facility in Hampshire, UK
Member of parliament, Desmond Swayne, will officially open the 42,000-square-foot facility on March 20, 2015.
Catalent Unveils New Organization to Speed Up Drug Development
Sharon Johnson, senior vice president, Global Quality & Regulatory Affairs, will head the organization.
Sartorius Stedim Biotech Forms Pact with em-tec to Develop PAT Solutions for Flow Rate Measurements
The new flow sensors, BioPAT Flow, enable precise, reproducible data to be collected on flow rates and mass balances without coming in contact with the medium during measurement.
Nanobiotix Appoints CordenPharma as Manufacturing Partner
The manufacture and scale up production mark a significant milestone in the commercialization route of Nanobiotix lead product, NBTXR3.
WuXi PharmaTech To Build New Cell Therapy Manufacturing Facility
WuXi's new facility in Philadelphia will manufacture CAR T-cell therapies and other cancer immunotherapies.
Kite Pharma Inks Deal to Spur Move into European T-Cell Market
Kite Pharma announced that it acquired T-Cell Factory B.V. in an effort to strengthen its T-cell portfolio.
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).
