Industry News
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
USP and ChP jointly host two-day meeting to strengthen cooperation.
Manufacturing Issues Crucial to Combating Ebola
The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.
FDA Requests Comments on Generic Drug Submission Criteria
FDA opens public docket on proposed criteria for “first generic” ANDAs.
GPhA Issues Statement on Generic Drug Costs
Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.
FDA Practices Discourage Biologic Market Competition, Says PCMA White Paper
A new report from The Pharmaceutical Care Management Association alleges that FDA hinders competition in the pharmaceutical industry and influences how a drug's price is calculated.
FDA Issues Draft Guidance on Rare Pediatric Diseases
FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.
Roche's Avastin Gains Ovarian Cancer Indication
Avastin plus chemotherapy for the treatment of ovarian cancer increased progression-free survival by 62% compared with chemotherapy alone.
FDA Approves Lemtrada for the Treatment of Multiple Sclerosis
After being plagued by numerous delays, Lemtrada (alemtuzumab) has finally been approved by FDA for the treatment of multiple sclerosis.
FDA Issues Warning Letter to Cadila Pharmaceuticals for CGMP Deviations
The agency cites deviations from CGMPs for the manufacture of APIs at the company's Gujarat, India plant.
USP Releases Compounding Compendium
USP releases compendium of quality standards for compounded medicines.
Amgen's Psoriasis Candidate Bests Stelara in Head-to-Head Comparison
Amgen's Phase III candidate for the treatment of psoriasis was found to clear skin lesions better than Johnson & Johnson's Stelara.
EMA Responds to Questions about Confidential Information
The European Medicines Agency responds to the European Ombudsman's letter regarding redacted documents.
FDA Grants Orphan Drug Designation to Pancreatic Cancer Treatment
FDA gives orphan drug designation to Merrimack Pharmaceuticals' MM-141 for the treatment of pancreatic cancer.
Combination Products Challenge Biopharma Manufacturers
Most new injectable drugs and biologics are being designed as combination therapies, presenting difficult regulatory and production issues for manufacturers. FDA policies are encouraging this trend.
M&A Activity in Pharma Still Strong Despite New Tax Rules
M&A transactions accounted for nearly $15 billion more this year than for the same period a year ago.
EMA: Extrapolation Across Indications for Biosimilars a Possibility
The final guidance explains some principles for developing biosimilars and establishes some rules about extrapolation across indications for various medical conditions.
FDA Approves Pfizer's Trumenba for the Prevention of Meningitis B
Pfizer's Trumenba is the first FDA-approved immunization against meningococcal disease for individuals 10-25 years old.
Contract Research and Manufacturing Organization Paragon Bioservices Raises $13 Million
The company receives backing to continue its work in research services, process development, and cGMP manufacturing activities.
EMA Works to Speed Up Ebola Treatment
The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.
FDA Approves CMO Facilities for Halozyme Product
FDA approved a Cook Pharmica facility and a Patheon facility for manufacturing of Halozyme products.
Industry Stakeholders Tackle the Use of Biological Qualifiers at WHO Naming Session
Many European biosimilar groups argue that biological qualifiers should not be implemented in countries where the brand name or INN of a drug is already well established.
ISPE Releases its Drug Shortages Prevention Plan
The International Society for Pharmaceutical Engineering (ISPE) released its Drug Shortages Prevention Plan as part of an initiative to address drug shortage prevention due to manufacturing and quality issues.
CPhI Releases Part 3 of its Annual Industry Report
CPhI released Part 3 of its annual industry report featuring three experts in the pharmaceutical industry.
NIH Invests in Biomedical Research Data
The National Institutes of Health announces grants for the development of strategies for the utilization of biomedical data sets.
CSL Behring Announces Global Facility Expansions
CSL Behring announced that it plans to invest $450 million to expand its Melbourne, Australia and Kankakee, Illinois facilities, which will increase production of albumin and plasma intermediates.
Change is Afoot at CPhI
New investments, expansions, and company rebranding are discussed at CPhI.
FDA Releases Guidance on Critical Path Innovation Meetings
FDA outlines procedures for having a Critical Path Innovation Meeting with CDER.
FDA Releases Guidance on OTC Pediatric Drug Products
FDA draft guidance outlines ways to minimize risk from acetaminophen-containing over-the-counter pediatric liquid drug products.
Meet This Year's CPhI Pharma Awards Winners
Celebrating the best of pharma and recognizing companies that turn inspiration into innovation.
FDA Releases Q&A on DQSA
FDA releases question and answer draft guidance on drug product tracing and licensing requirements.
