Industry News
NIH Researchers' HIV Finding May Lead to New Treatments
The National Institutes of Health says researchers have found a way to block a step in the HIV invasion process that may lead to the development of new drugs.
FDA Warns India Facility Over Sterility Failures
The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.
GMP Issues Derail a Drug Approval for the Second Time
One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.
2017 CPhI Pharma Awards Open for Entries
The 2017 CPhI Pharma Awards program features 20 categories covering achievements in the pharma industry.
Woodcock Sees Future for Precision Medicine
In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.
FDA Develops Assay to Assess Ebola Antibody Response
The assay assesses the ability of antibodies to neutralize the Ebola virus.
Malaria Drug Shown to Protect Against Zika, NIH Says
The National Institutes of Health says a new study showed that hydroxychloroquine reduced the transmission of Zika in pregnant mice.
EMA Recommends Restrictions on Multiple Sclerosis Medicine
The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.
Data Integrity and Quality Problems Found at China Facility
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
Biosimilars Overcome Legal and Analytical Hurdles
A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.
Will regulators be able to keep pace with biotechnology developments?
A new study predicts a potential disconnect between regulatory science and biotechnology product development, unless regulators scan the horizon for new developments and consider new potential risk pathways.
FDA to Eliminate Backlog of Orphan Drug Designation Requests
The agency announced a plan to eliminate its existing orphan designation request backlog.
Pharmapack Europe Returns to EU in 2018
The conference will return to the EU and is featuring its Start-Up Hub and Pharmapack Awards.
EDQM Releases Annual Report
The directorate highlights its 2016 achievements.
Dissolving Microneedle Patch May Be Effective Drug Delivery Technology
An NIH study examined a dissolving microneedle technology as a way to deliver the influenza vaccine to patients.
Report: Biopharma Investments Down in 2016
BIO report measures decade-long investment and acquisition trends for emerging biotech companies.
Pricing Pressure Drives Down Drug Sales Forecasts
Drug sales forecasts fall for first time in 10 years, thanks to pressures to reduce drug prices and the advent of biosimilars.
FDA Acts to Improve Market Competition
The agency announced it is taking steps to increase competition within the prescription drug market.
Hospira Sterility Problems Cause Another Recall
Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.
EMA Recommends Approval for Eight New Drugs, One Biosimilar
The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.
Seqirus Produces Cell-Based Influenza Vaccines at Commercial Scale
The company successfully produced cell-based influenza vaccines at a commercial scale in its facility in NC.
FDA Announces Public Meeting on Generic Drugs
FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.
MA Governor Announces $500-Million Investment in Life-Science Industry
Charlie Baker announced a plan to invest up to $500 million in the MA life-science industry.
BIO Releases Workforce Principles for the Biotechnology Industry
The organization released principles related to workforce development, diversity, and inclusion that it believes are key to the biotechnology industry.
Alvogen Recalls Clindamycin Injection Because of Sterility Problems
The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.
Hospira Recalls Sodium Bicarbonate
The company recalled a variety of products due to the potential of microbial contamination.
EMA Progresses on Brexit Plans
The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.
Advanced Pharma Recalls Nitroglycerin Products
The company is voluntarily recalling all unexpired lots of nitroglycerin products produced at its Houston location for potency issues.
Congress Struggles to Address Drug Prices
Congressional measures lack the support to move forward.
FDA Warns Company Over Drug Listing Failures
The agency sent a warning letter to A-S Medication Solutions LLC after it found the company didn’t comply with drug listing file requirements.
