We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The Combination Products Coalition (CPC) intends to submit a draft report to
the FDA with recommendations on how FDA intercenter agreements can be modified
to better define roles and responsibilities for handling approvals, modifications
and preapproval inspections for combination products.
The controversy surrounding Pfizer's Cox-2 inhibitors, Celebrex and Bextra,
took a new turn when the company was cited by the FDA for making false and misleading
statements in advertisements for the painkillers.
To help speed the availability of innovative medical products, HHS should create
a forum that will enable investigators and developers to discuss their products
with key research, regulatory and reimbursement agencies, according to an HHS
task force report.
Solvay Pharmaceuticals has announced the successful
completion of the acquisition of Neopharma AB, a company based in Uppsala, Sweden,
as shareholders representing 100 percent of the company's capital accepted the
friendly takeover bid launched by Solvay last December.
Bolder BioTechnology has been awarded a $100,000 Phase I Small Business Innovation
Research (SBIR) grant from the National Institute of Arthritis and Musculoskeletal
and Skin Diseases (NIAMS) of NIH.
Seeking to improve its drug discovery technology and establish a beachhead in
the fertile Cambridge biotechnology cluster, drug giant Schering-Plough of Kenilworth,
N.J., said it would buy NeoGenesis Pharmaceuticals of Cambridge for an undisclosed
sum.
CollaGenex Pharmaceuticals has said it intends to seek "prompt injunctive
relief" to protect its patent and intellectual property rights following
a decision by the U.S. District Court for the District of Columbia.
Cardinal Health, the leading provider of products and services supporting the
healthcare industry, has reached agreement with Eisai to provide distribution
services for Eisai's life-enhancing therapies.
Cipher Pharmaceuticals will sell its Pharma Medica Research division to the
current management team of Pharma Medica for $19.1 million, the company said.
The Mumbai-based Eisai Pharmaceuticals India has identified Wockhardt as the
company's partner for the manufacture of its Alzheimer's drug Aricept (donepezil
hydrochloride tablets) in India.
Akesis Pharmaceuticals (formerly known as Liberty Mint) has completed the acquisition
of Akesis Pharmaceuticals (Delaware) and named key employees and directors of
the post merger company.
The Serious Fraud Office is investigating a division of Novartis, one of the
world's largest pharmaceutical firms, for alleged criminal marketing practices
as part of its investigation into alleged price-fixing by drugs companies.