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The end for AbbVie’s bestseller? US FDA approves Amgen’s Humira biosimilar

26-Sep-2016 - Amid ongoing patent litigation, the FDA has approved Amgen’s Amjevita: the first US biosimilar version of AbbVie’s top selling rheumatoid arthritis biologic Humira.

DSP: Pharmas must be open about API suppliers to fight antibiotic resistance

26-Sep-2016 - Drug companies need to me more open about their API suppliers to help fight the spread of antimicrobial resistance (AMR) according to DSM Sinochem Pharmaceuticals.

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.

Urine derived clot busters do not pose Zika risk says EMA

22-Sep-2016 - Clot busting drugs derived from human urine are no more likely to be contaminated with Zika virus than other medicines according to research by the EMA.

Johnson Matthey's refurbished Annan API plant passes MHRA GMP inspection

20-Sep-2016 - The UK MHRA has awarded Johnson Matthey’s API facility in Scotland a GMP certificate.

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.

Pii faces EU ban following GMP issues at Maryland facilities

19-Sep-2016 - The EMA has recommended a European ban of all non-critical drugs made by US CMO Pharmaceutics International Inc (Pii).

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).

Bayer committed to pharma R&D and CapEx despite planned Monsanto buy

15-Sep-2016 - Bayer has said it will not cut drug R&D or manufacturing investment as a result of its planned acquisition of Monsanto.

Indoco Remedies stresses that Form 483s are not data integrity related

14-Sep-2016 - Indoco Remedies says problems the US FDA identified at an ophthalmic and injectable drug plant in Goa, India last month are “correctable.”

Takeda hands regulatory affairs work to PRA in new deal

13-Sep-2016 - Takeda will hand regulatory affairs work to PRA Health Sciences under the clinical development services deal announced last night.

More Cambrex capacity expansion: API firm to grow Karlskoga facility

07-Sep-2016 - Cambrex will spend $9m (€8m) to add large-scale manufacturing capability at its API production facility in Karlskoga, Sweden.

Chemical fast-track could speed up nitrile drug synthesis

06-Sep-2016 - A synthetic short cut could make it easier and cheaper to produce nitrile-containing compounds, a group which includes dozens of marketed and pipeline drugs.

US FDA slams Elite Pharma for adverse reaction monitoring failures

05-Sep-2016 - Elite Pharmaceuticals has received a US FDA warning letter for failing to adequately monitor adverse drug experiences (ADEs).

India turns to certification in pharma manufacturing quality drive

01-Sep-2016 - India's government has launched a certification programme aimed at tightening up quality standards in its domestic drug industry.

'Chipped paint' and 'flying insects,' FDA slams two Chinese API plants

01-Sep-2016 - Xinxiang Tuoxin Biochemical has received a US FDA warning letter after manufacturing equipment at two API facilities were found to be in a state of disrepair.

Out-of-spec assay drove Teva to recall antibiotic from Canadian plant

31-Aug-2016 - An out-of-specification assay result resulted in Teva recalling over 50,000 bottles of the antibiotic amoxicillin made at a facility in Canada.

Impax recalls tablets due to incorrect labeling

30-Aug-2016 - Impax Laboratories has issued a voluntary recall for one lot of its Lamotrigine Orally Disintegrating Tablet due to incorrect labeling of its blister packs.

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.

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