Industry News
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.
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.
