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GEA Homogenizer Offers Scalability
GEA Niro Soavi’s PandaPLUS 2000 is a tabletop laboratory homogenizer that is designed for the treatment of nanoparticles, nanodispersions, nanoemulsions, and cell disruption.
PolyScience Chiller and Circulator Enhances Temperature Control
PolyScience’s recirculating chillers and refrigerated circulators control temperature with stabilities as precise as ±0.005 °C for analytical instrumentation.
Ross Control System Increases Consistency
Ross’ SysCon PLC-based Control Systems are designed for sequential control of automated processes including mixing, pumping, chemical dosing, water treatment, fractionation, and heat exchange.
Lifting the Veil on Drug Pricing
Every now and then, you will hear about the rising costs of R&D, which in turn, translate into high prices for new drugs entering the market.
FDA Postpones Hearing for Remicade Biosimilar
FDA announced that it would postpone a meeting that would be critical for the advancement of Celltrion’s Remicade biosimilar in the US.
Superbug Antibiotic Lands FDA Approval
FDA approved Actavis’ antibiotic Avycaz designed to combat drug-resistant bacteria.
Catalent Expands Clinical Packaging Capabilities in Europe
The company has increased capacity for cold storage and controlled drug substances handling at its European facilities.
Novel Pharmaceutical Company, Turing, Announces Launch
Turing Pharmaceuticals announced the launch of its company, the acquisition of three assets from Retrophin, and a new senior management team.
Celltrion Launches Remicade Biosimilar in European Markets
Remsima will now be available for patients in 12 additional countries in the European Union.
J&J Loses First Jury Trial for Risperdal
Johnson & Johnson will pay $2.5 million to a plaintiff who developed gynecomastia after using Risperdal.
Sagent Pharmaceuticals Recalls Atracurium Besylate Injection
The company voluntarily recalls product due to FDA observations of potential sterility problems.
Aprecia Expands Capacity for 3D-Printed Dosage Manufacturing
Aprecia Pharmaceuticals' new facility in Ohio will create 150 jobs.
SGS Expands Biomarker Testing Capabilities at Poitiers Facility
SGS has invested in additional modules for its COBAS 6000 analysis system in a move to expand its biomarker analytical capabilities at its Poitiers facility in France.
BMS Furthers its Immuno-Oncology Pipeline with Nearly $1.6 Billion in Investments
Bristol-Myers Squibb announced that it reached an agreement to acquire Flexus Biosciences and has entered into a $309-million partnership with Rigel Pharmaceuticals.
Celltrion Announces that Remicade Biosimilar Could Save Up to $380 Million USD
Celltrion announced that its Remicade biosimilar, Rensima, could save France, Italy, and the UK up to €336 million in costs to treat Crohn’s disease.
Kite Pharma Expands Manufacturing for T-Cell Therapies
Leased facilities in California will expand Kite Pharma's capacity for clinical T-cell therapies.
FDA Issues Warning Letter to India Facility
The agency cites Apotex’s Bangalore facility with quality system failures.
Valeant Acquires Salix for $14.5 Billion
Valeant announced that it acquired Salix Pharmaceuticals for approximately $14.5 billion, which could result in annual cost savings of $500 million.
EMA Establishes Drug Identification Task Force
The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.
Johnson & Johnson’s Remicade Patent Invalidated
The Patent and Trademark Office sends notice rejection of the company’s Remicade patent.
NIST Partners with MedImmune on Protein Characterization Venture
MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.
Sanofi Appoints Bayer's Brandicourt as New CEO
Brandicourt will leave Bayer HealthCare AG to begin his new role as CEO of Sanofi in April 2015.
Revlimid Gains FDA Approval for NDMM Patients
Celgene announced that its drug, Revlimid, gained FDA approval for the treatment of newly diagnosed multiple myeloma.
Cell Medica Begins Commercial Manufacturing of Cell Therapies
The Berlin-Buch facility will begin manufacture of the company’s immune cell therapy.
Siegfried Announces Resolution of Hameln Pharma Regulatory Issues
The company announces that FDA has closed out a 2012 warning letter.
First Hospira Biosimilar mAb Approved in West Europe
Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.
FDA Issues Guidance on Drug Compounding
The agency releases five draft guidance documents related to drug compounding and repackaging.
FDA Announces Approval of Lenvima for Differentiated Thyroid Cancers
FDA announced that it approved Lenvima to treat patients with differentiated thyroid cancer after it was submitted under a priority review and orphan drug programs.
FDA Updates Approved REMS
FDA gives an update on currently approved Risk Evaluation and Mitigation Strategies.
New Financial Strategies Needed to Support Biomedical Innovation
The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.