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Headlines > September 2016

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

29-Sep-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).

Cel-Sci's Multikine Phase III trial placed on hold by US FDA

29-Sep-2016 - The US FDA has placed a Phase III trial for Cel-Sci’s head and neck cancer candidate on clinical hold.

AbbVie API plant opens in Singapore as first part of larger $320m site

29-Sep-2016 - AbbVie has opened an oncology and women’s health API plant, part of its planned 120,000m2 small and large molecule manufacturing site in Singapore.

Opinion

Brand biosimilar: does Amjevita give away Amgen's biologics strategy?

28-Sep-2016 - Biosimilar makers have been vocal about product names not differentiating from their reference biologics, so why does the newly-approved Humira copy appear to reference its sponsor, Amgen?

US FDA: Cheng Fong Chemical must do more to investigate complaints

28-Sep-2016 - Cheng Fong Chemical has addressed problems at its Taoyuan City plant but still needs to identify the source of foreign matter found in its APIs according to the US FDA.

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.

UPDATE

Regeneron thanks Abec for helping it avoid "gremlins" during bio plant set-up

27-Sep-2016 - Abec has completed work on Regeneron’s biologics facility in Ireland just 28 months after it was hired to kit out the repurposed computer plant.

Moody's maintains B1 rating of merger-bound Avantor

27-Sep-2016 - Avantor Performance Materials has had its positive rating reiterated by Moody’s just days before its merger with Nusil Technology is expected to complete.

BASF set to start making PVP in China

27-Sep-2016 - BASF is poised to start making polyvinylpyrrolidone (PVP) at its facility in Shanghai, China after completing work on a $70m (€62m) manufacturing expansion.

BD injects $100m into Nebraska insulin syringe plant

27-Sep-2016 - Becton Dickinson says it is upgrading equipment and technology at its Holdrege manufacturing facility to better serve the global diabetes market.

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.

Cambrex bolstering API services through $25m PharmaCore acquisition

26-Sep-2016 - Cambrex will acquire clinical-scale API maker PharmaCore for $25m adding a standalone GMP facility in North Carolina approved to make Schedule II to V products.

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.

News in brief

Analytik Jena sets up joint application center

26-Sep-2016 - Analytik Jena and the Fresenius University of Applied Sciences are to create a joint application center for customers for teaching and research.

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.

Sartorius pledges to cut development times with upstream suite

22-Sep-2016 - Sartorius Stedim Biotech claims it has a platform that can help biopharma companies carve months off the development time for new products.

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.

Moderna to spend $110m on mRNA therapeutics manufacturing plant

21-Sep-2016 - Moderna Therapeutics has announced plans for a $110m (€98m) API manufacturing facility for its pipeline of mRNA therapeutics.

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).

US FDA warns API firm Hebei Yuxing Bio-Engineering

21-Sep-2016 - Banned API firm Hebei Yuxing Bio-Engineering has had a microbial contamination problem at its plant since 2013 according to the US FDA.

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).

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