Breaking News on Global Pharmaceutical Technology & Manufacturing

DSP: "quality mark" would engage patient choice in fight against antimicrobial resistance

04-Oct-2016 - A “quality mark” for firms that source from green API suppliers would add patient choice element to fight against antimicrobial resistance according to DSM Sinochem Pharmaceuticals.

GDUFA II negotiations: CMOs to pay one third of facility fees

03-Oct-2016 - The Pharma & Biopharma Outsourcing Association (PBOA) has helped negotiate reduced fees for CMOs in the FDA’s proposed reauthorisation of the Generic Drug User Fee Amendment (GDUFA).

China made APIs shipped to fake Viagra lab via UK say Polish police

28-Sep-2016 - Viagra counterfeiters in Poland imported APIs made in China via the UK, Greece and Romania according to police who shut down a major manufacturing operation last week.

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.

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.

Cell and gene therapy investment to continue to grow post-Brexit, CGT Catapult

21-Sep-2016 - Brexit will not stifle interest in the UK’s cell and gene therapy space, says the CGT Catapult which has reported a tenfold growth in investment since 2012 to £400m ($520m).

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).

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.

Teva months from restarting production at Hungary plant banned by US FDA

15-Sep-2016 - Teva expects to restart drug manufacturing at the Hungarian plant under US import alert in the next few months.

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.

Attention Amgen: Canada OKs Samsung Bioepis and Merck's Enbrel biosimilar

12-Sep-2016 - Canada has approved Brenzys, its first biosimilar version of Amgen’s Enbrel (etanercept) made by Korean drugmaker Samsung Bioepis.

Germany's Merck latest to commit to UK post-Brexit

06-Sep-2016 - Companies are continuing to invest in the United Kingdom as the country grapples with the post-Brexit industry.

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.

Needle-free tech company partners with WHO as part of polio eradication effort

01-Sep-2016 - PharmaJet has inked a multi-year deal with the World Health Organization for its needle-free technology, which uses 80% less vaccine than traditional methods.  

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.

Quality issues at ex-Sun Pharma plant land Frontida with US FDA warning

29-Aug-2016 - The Pennsylvania plant released 27 lots of clonidine HCl tablets containing potentially contaminated active pharmaceutical ingredients (APIs), among several violations of cGMP the Agency said.

CPhI South Korea

Korea positioned to be global biopharma powerhouse, says industry association

25-Aug-2016 - Stem cells and biosimilars are driving the Korean pharma market, according to the country’s Biomedicine Industry Association KoBIA.

update - Hospira regrets non-compliance

Pfizer unit Hospira and Napp broke APBI code during Remsima push

24-Aug-2016 - Pfizer’s Hospira unit and Napp Pharmaceuticals broke ABPI rules covering the promotion of biosimilar medicines according to the UK industry group.

Sagent recalls second lot of antibiotic made by Astral SteriTech after rust found in vial

23-Aug-2016 - Sagent Pharmaceuticals has recalled another lot of its injectable penicillin in the US after a customer found rust in a vial of the drug.

UK MHRA strips Pfizer-owned India antibiotics plant of GMP certificate

22-Aug-2016 - An Indian facility owned by Pfizer’s Hospira unit has been banned from supplying some drugs to the EU after MHRA inspectors found breaches of manufacturing regulations.

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