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.
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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FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.
Avastin plus chemotherapy for the treatment of ovarian cancer increased progression-free survival by 62% compared with chemotherapy alone.
After being plagued by numerous delays, Lemtrada (alemtuzumab) has finally been approved by FDA for the treatment of multiple sclerosis.
The agency cites deviations from CGMPs for the manufacture of APIs at the company's Gujarat, India plant.
USP releases compendium of quality standards for compounded medicines.
Amgen's Phase III candidate for the treatment of psoriasis was found to clear skin lesions better than Johnson & Johnson's Stelara.
The European Medicines Agency responds to the European Ombudsman's letter regarding redacted documents.
FDA gives orphan drug designation to Merrimack Pharmaceuticals' MM-141 for the treatment of pancreatic cancer.
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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 transactions accounted for nearly $15 billion more this year than for the same period a year ago.
The final guidance explains some principles for developing biosimilars and establishes some rules about extrapolation across indications for various medical conditions.
Pfizer's Trumenba is the first FDA-approved immunization against meningococcal disease for individuals 10-25 years old.
The company receives backing to continue its work in research services, process development, and cGMP manufacturing activities.
The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.
FDA approved a Cook Pharmica facility and a Patheon facility for manufacturing of Halozyme products.
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.
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 released Part 3 of its annual industry report featuring three experts in the pharmaceutical industry.
The National Institutes of Health announces grants for the development of strategies for the utilization of biomedical data sets.
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.
New investments, expansions, and company rebranding are discussed at CPhI.
FDA outlines procedures for having a Critical Path Innovation Meeting with CDER.
FDA draft guidance outlines ways to minimize risk from acetaminophen-containing over-the-counter pediatric liquid drug products.
Celebrating the best of pharma and recognizing companies that turn inspiration into innovation.
FDA releases question and answer draft guidance on drug product tracing and licensing requirements.
Inversions in the pharmaceutical sector could become less lucrative as a result of new tax laws.
NIH seeks new therapeutic products to bolster the protective properties of vaccines.
Partnership is awarded for licensing of low-cost vaccine for the treatment of bacterial meningitis.
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