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Delivery formulations

News headlines

US FDA warns against $30 DIY alternative to Mylan's EpiPen

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.

Colorcon and Dow extend controlled release alliance

22-Sep-2016 - Colorcon and Dow have expanded a nine year controlled release alliance to include further solubility, coating and ion exchange platforms.

Sarepta looks to scale up production on back of its DMD drug success

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.

Shire ends pacritinib development deal with CTI post Baxalta merger

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.

Court rules in favour of Zydus' copy of Shire's controlled-release UC drug

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).

Catalent to plug bioavailability tech gap with Pharmatek Laboratories buy

13-Sep-2016 - Catalent has announced its intention to buy Pharmatek Laboratories to boost its drug bioavailability offering.

LI-COR expansion offers early-phase cGMP services

12-Sep-2016 - LI-COR Biosciences has expanded its production facility to offer contract manufacturing for early-phase cGMP materials.

Spain's Idifarma bolstered by investment from API maker Suanfarma

12-Sep-2016 - Spanish API maker Suanfarma has acquired a stake in contract manufacturer and spray-drying specialist Idifarma, boosting its international presence.

Bioavailability boost: Capsugel to up micronization offering at US site

07-Sep-2016 - Capsugel plans to up micronisation capacity at Quakertown, Pennsylvania facility to provide API processing services for clinical candidates and commercial drugs.

Flexible molecules could be better drugs - for some targets

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.

Mylan price hikes: Congress calls on FDA for generic EpiPen submission info

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.

News in brief

Agilent helps launch carbohydrate analysis lab

29-Aug-2016 - The University of Adelaide and Agilent Technologies Australia Pty have partnered on the analysis of complex carbohydrates (‘glycans’).

Hikma continues beefing up US and European manufacturing capabilities

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.

Grunenthal says anti-crush tech Endo uses for Opana ER helps prevent abuse

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."

US FDA wants to reclassify co-crystals to ease regulatory burden

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.

Public Patheon's $2bn warchest may bolster biologics offering, analyst

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.

Valeant gives six months timeline for FL plant reinspection after eye drug CRL

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.

Catalent wins early-phase contract for Arch's inhaled orphan drug

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.

Acino agrees to sell drug delivery patch business to Luye Pharma for $274m

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.

West: Amgen mAb approval helps validate drug delivery tech

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.

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