All
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.
Preventing Tablet Tooling Problems
Tooling can be damaged by poor handling or problems in process design or material choice.
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.
PCI Completes Full Biotec Rebranding
Five months after PCI acquired Biotec International Services , PCI has completed a complete rebranding of the UK-based Biotec.
Romaco Group Announces Finalization of Innojet Acquisition
Romaco Group announced that it had finished the acquisition of Innojet Herbert Hüttlin, a German company specializing in coating and granulation.
AmeriSourceBergen Adds New Distribution Center in Australia
The new center represents AmerisourceBergen’s first facility erected specifically for clinical trial and commercial third-party logistics activities.
Genzyme Announces $845-Million Gene Therapy Deal
Genzyme will partner with Voyager Therapeutics for the discovery, development, and commercialization of novel gene therapies for central nervous system disorders.
CDER and Biotech Quality Assessment
The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.
FDA After Hamburg
The industry reacts to the departure of Commissioner Margaret Hamburg.
Pfenex Announces Partnership with Hospira to Develop Lucentis Biosimilar
Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.
FDA Approves Lucentis for Diabetic Retinopathy
FDA has approved Genetech’s Lucentis to treat retinopathy in patients with diabetic macular edema.
Amgen Announces Humira Biosimilar Clinical Studies Success
Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.
AstraZeneca Reaches an Agreement to Acquire Actavis’ Respiratory Portfolio
AstraZeneca announced that it would strengthen its respiratory pipeline with the acquisition of Actavis’ branded respiratory business in the US and Canada.
