Industry News
Obama Sends Mixed Message on Support for Biopharmaceutical R&D
President Obama unveils his “Precision Medicine Initiative”.
FDA Names New Deputy Commissioner for Medical Products and Tobacco
Dr. Robert Califf is appointed FDA Deputy Commissioner for Medical Products and Tobacco.
EMA Launches Drug Safety Assessment Platform
The agency creates an electronic central repository to facilitate drug safety assessment reports.
FDA Releases Photosafety Evaluation Guidance
FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.
Ebola Treatments Ramp Up for Clinical Trials
Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials.
EMA Sets Elemental Impurities Implementation Dates
New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.
Compounding Committee Meets to Discuss Drugs Approved for Compounding
FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.
EMA Publishes Safety Monitoring Guide
The European Medicines Agency has published a guide to help industry and regulatory authorities implement safety-monitoring standards.
The Quest Continues for Quality Metrics
FDA aims is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.
Europe Collaborates on Generic Drugs
The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.
USP Elemental Impurities Implementation Set for January 2018
USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.
Catalent and Sanofi to Collaborate on ADC Development
Catalent Pharma Solutions and Sanofi-Aventis R&D have entered into a collaboration to develop Sanofi’s proprietary antibodies using Catalent’s SMARTag antibody drug conjugate (ADC) platform.
FDA Extends Track and Trace Enforcement Deadline
A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.
CDER Announces 2015 Guidance Plan
The FDA center released a list of the guidance documents it plans to publish in 2015.
Drug Approvals Highest Since 1996
In 2014, FDA approved 41 new molecular entities, which is the highest number since 1996.
PDA Publishes Drug Shortage Technical Report
The Parenteral Drug Association report addresses prevention and communication of drug shortages caused by manufacturing and quality related disruptions.
Roivant Neurosciences Acquires GSK’s Novel Neurological Disorder Treatment
Roivant Neurosciences acquired GlaxoSmithKline’s selective 5-HTC receptor antagonist for the treatment of various neurological disorders, specifically Alzheimer’s disease.
More New Drugs and Faster Approvals
FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.
Biosimilar Development Moves Forward at FDA
FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.
Merck Acquires Biotechnology Company, OncoEthix
Merck announced that it acquired OncoEthix, a biotechnology company specializing in oncology drug development, for up to $375 million.
FDA Releases Guidance on Electronic Regulatory Submissions
The agency publishes two guidance documents on providing regulatory submissions in electronic format.
GPhA Supports FDA Proposed Rule on E-labeling
A statement from GPhA’s president expresses the organization’s support of FDA’s proposed rule to amend labeling regulations.
New England CRO/CMO Council Debuts
New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.
Compassionate Use Debate Heats Up
Patient access to critical experimental medicines continues to grab public attention as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients.
CPhI Releases India Market Report
Enhanced R&D efforts and the growing manufacture of finished-dosage drugs in India will shape the country's future success, according to a new report from CPhI.
Lung Therapeutics Receives Orphan Drug Designation for Empyema Treatment
Lung Therapeutics announced that it received Orphan Drug Designation for LTI-01, an injectable designed for the treatment of loculated pleural effusion.
FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma
FDA will delay its decision regarding the new drug application for panobinostat.
Tufts’ New Figures on Drug-Development Costs Spark Debate
Tufts research suggests costs to launch a new drug have doubled since 2003, but some question conclusions.
FDA to Increase its Ties to China
Margaret Hamburg, FDA Commissioner, visited China recently to oversee efforts to strengthen inspection and regulatory reviews and to attend the Ninth International Summit of Heads of Medicines Regulatory Agencies Meeting
IMS: Global Spending on Medicines to Rise 30% by 2018
Approximately 40% of total global growth will come from specialty medications, according to a new report from the IMS Institute for Healthcare Informatics.
