Breaking News on Global Pharmaceutical Technology & Manufacturing

Teva's troubled Godollo plant earns firm US FDA warning letter

20-Oct-2016 - The US FDA has warned Teva Pharmaceutical Industries about its facility in Godollo, Hungary over ongoing concerns about manufacturing operations.

Second Form 483 for Montana Compounding Pharmacy in two years

19-Oct-2016 - US FDA inspectors found vermin in drug production areas at a manufacturing facility operated by Montana Compounding Pharmacy.

US FDA publishes Akorn Pharmaceuticals' Form 483

19-Oct-2016 - The US FDA has identified quality control problems at a sterile drug manufacturing facility operated by Akorn Pharmaceuticals.

Regeneron and Teva to bar OA patients from fasinumab trials after US study halt

18-Oct-2016 - Advanced osteoarthritis patients will be barred from taking part in fasinumab trials after a sufferer enrolled in a Phase IIb study developed joint disease.

Recipharm commits SEK5m to bioanalysis lab citing lack of Nordic capacity

18-Oct-2016 - Recipharm has said it will spend SEK5m ($567,000) on a bioanalysis laboratory in Sweden citing the lack of capacity in the Nordic region as a driver for the investment.

FDA and CDC links B. cepacia outbreak to contamination at PharmaTech

13-Oct-2016 - The US FDA has found a direct link between contaminated water at CMO PharmaTech and a multistate B. cepacia outbreak.

Three European and one Chinese drugmakers slammed by US FDA

12-Oct-2016 - The US FDA has issued fours warnings against foreign drugmakers, citing reasons including problems with QC, a non-registered facility, and finished products that “did not contain any of the labeled active ingredient.”

Biotrial: transparency key as CRO moves forward in US

12-Oct-2016 - Biotrial looks to run 50 clinical trials per year at its new US-based facility as it says group activities are up – with the exception of Ph I activities in France.

US FDA rejects Nicox's topical Zyrtec rival over concerns about API supplier

10-Oct-2016 - The US FDA has rejected an eye drug developed by Nicox SA as a result of manufacturing problems at the firm’s API supplier.

News in brief

Mappel doesn't want to supply US after warning letter

07-Oct-2016 - Mappel Indústria de Embalagens says it did not know the US would regulate the dermacosmetic products made at its Sao Paulo plant as OTC drugs after FDA warning.

Nippon staff formed barrier to block QC lab inspection says US FDA

07-Oct-2016 - Nippon Fine Chemical staff formed a human barricade to prevent a US FDA team inspecting a quality control laboratory at its site in Takasago City, Japan according to a warning letter published this week.

Dispatches from CPhI

APIC concerned about EU API import rules

06-Oct-2016 - European Union API import rules do not ensure ingredients shipped to Europe are of appropriate quality according to APIC board member, Marieke Van Dalen.

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

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.


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?

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.

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