22-Sep-2016 - The US FDA has warned people not to use a $30 DIY epinephrine delivery device developed after Mylan increased the price of the Epipen.
22-Sep-2016 - Colorcon and Dow have expanded a nine year controlled release alliance to include further solubility, coating and ion exchange platforms.
20-Sep-2016 - Sarepta Therapeutics says it is considering selling its FDA priority review voucher to support manufacturing scale-up for Exondys 51, its approved Duchenne Muscular Dystrophy drug.
20-Sep-2016 - Shire has abandoned its partnership on CTI BioPharma’s oral kinase inhibitor pacritinib seven months after deaths in a Phase III trial halted its clinical development.
19-Sep-2016 - Shire says it will appeal a decision invalidating a patent surrounding the controlled-release composition of its ulcerative colitis drug Lialda (mesalazine).
13-Sep-2016 - Catalent has announced its intention to buy Pharmatek Laboratories to boost its drug bioavailability offering.
12-Sep-2016 - LI-COR Biosciences has expanded its production facility to offer contract manufacturing for early-phase cGMP materials.
12-Sep-2016 - Spanish API maker Suanfarma has acquired a stake in contract manufacturer and spray-drying specialist Idifarma, boosting its international presence.
07-Sep-2016 - Capsugel plans to up micronisation capacity at Quakertown, Pennsylvania facility to provide API processing services for clinical candidates and commercial drugs.
31-Aug-2016 - For drug molecules, having a flexible rather than a rigid structure can sometimes make you a better medicine, say scientists in California.
30-Aug-2016 - Congress has asked the US FDA for information on EpiPen generic submissions and processes in light of a series of price hikes by drugmaker Mylan.
29-Aug-2016 - The University of Adelaide and Agilent Technologies Australia Pty have partnered on the analysis of complex carbohydrates (‘glycans’).
29-Aug-2016 - Hikma invested over $25m in its US facilities in the first half 2016, and plans to use excess capacity at a former Boehringer Ingelheim plant for contract manufacturing.
25-Aug-2016 - Grunenthal has reiterated the benefits of its anti-crush intac tech after licensee Endo withdrew its request to have Opana ER labelled as “abuse deterrent."
18-Aug-2016 - The US FDA wants to reclassify pharmaceutical co-crystals as solvates rather than intermediates to reduce the regulatory burden on manufacturers that work with them.
17-Aug-2016 - Biomanufacturing demand will drive revenues for Patheon according to an Evercore ISI analyst, who has predicted the newly-listed CDMO will strengthen its capabilities through M&A.
11-Aug-2016 - Concerns raised by the US FDA pertaining to cGMP at a Florida facility are expected to be resolved within six months, according to Valeant.
11-Aug-2016 - Arch Biopartners has selected Catalent to carry out studies and make batches of its orphan drug candidate AB569 for upcoming clinical trials.
02-Aug-2016 - Acino has agreed to sell its transdermal delivery patch business Luye Pharma Group in a deal that will include its manufacturing site in Miesbach, Germany.
01-Aug-2016 - Regulatory approvals are driving interest in West's Smartdose and Crystal Zenith delivery technologies, the firm says ahead of the launch of a monthly-dose version of Amgen's Repatha.
Review a new Colorcon Technical Paper offering a concise summary of key points covered in the recent US Center for Drug Evaluation and...