Articles by Suzanne Hodsden
-
Europe Commits $254M To Ebola Treatments
10/28/2014
The EU has committed $250 million dollars as part of its Innovative Medicines Initiative (IMI) to the ongoing development of Ebola vaccines, diagnostic tests, and other products with hopes of speeding the start of clinical trials, Reuters reports.
-
FDA Set To Launch Office Of Pharmaceutical Quality
10/21/2014
The Regulatory Affairs Professional Society (RAPS) reports that the FDA is finally ready to launch the Office of Pharmaceutical Quality (OPQ), a new branch of the FDA that will focus exclusively on drug quality both before and after the drug has been released onto the U.S. market.
-
FDA Studies Role Of Shape, Color, And Size In Drug Regimen Adherence
10/21/2014
In an ongoing study of generic drug adherence, the FDA will be studying the role of color, along with a pill’s other physical attributes, to ascertain if changes in a drug’s appearance affects patient’s confidence in continuing treatment, according to Regulatory Affairs Professionals Society (RAPS).
-
CSL Behring Invests $450M In Manufacturing Facility Expansion
10/15/2014
CSL Behring (CSL), a biopharmaceutical company which manufactures plasma protein therapeutics, has launched a multi-year expansion to its manufacturing facilities in Melbourne, Australia and Illinois.
-
Sun Pharma Invests $280M For In-Licensed Psoriasis Drug Deal
10/8/2014
The Economic Times (ET) in India reports that Sun Pharma plans to invest $280 million in an experimental psoriasis drug in-licensed from Merck, Sharp, & Dohme (MSD) and hopes to market the drug globally by 2018.
-
FDA: Drug Companies Must Pay $2.5M To Use Pediatric Disease Priority Review Voucher
10/8/2014
The Regulatory Affairs Professionals Society (RAPS) reports that the FDA has set the fee drug companies must pay to use a priority review voucher at $2.5 million. This fee will be charged over and above the usual new drug application fee of $2.3 million and will reduce the turn-around time for an FDA decision from 10 months to 6 months.
-
Cipla To Open $37M Manufacturing Facility in Iran
10/8/2014
Indian generic drugmaker Cipla announced plans to open a drug manufacturing facility in Iran, despite current trade sanctions issued by the U.S. and E.U, Livemint reports.
-
Oxford BioTherapeutics, Menarini Announce Second ADC Candidate
10/7/2014
Oxford BioTherapeutics (OBT) and Berlin Chemie/Menarini, two companies that partnered in 2012, announced their second of five projected anti-body drug conjugate (ADC) candidates. This newest addition — currently preparing to advance into clinical trials — targets Non-Hodgkin’s B-Cell Lymphoma, solid tumors, and some subsets of breast cancer.
-
Intrexon and Amneal Form Second Exclusive Channel Collaboration For APIs
10/6/2014
Intrexon, a company specializing in synthetic biology, announced a second exclusive channel collaboration (ECC) with Amneal, a generic development and manufacturing company, to streamline and regulate a scalable production process for a target complex API.
-
WuXi PharmaTech Acquires XenoBiotic, Expands Operations In The U.S.
10/3/2014
Shanghai-based WuXi Pharma Tech announced its U.S. expansion with the acquisition of XenoBiotic, a contract research organization (CRO) with operations in both China and New Jersey. WuXi hopes that the deal will augment its existing bio-analytical and drug metabolism and pharmacokinetics (DMPK) services, expand business in North America, and provide options for further expansion.