Breaking News on Global Pharmaceutical Technology & Manufacturing


News headlines

Biotrial says Le Figaro coverage of BIA 10-2474 trial is "smear campaign"

24-Oct-2016 - Biotrial has accused French newspaper Le Figaro of leading a “smear campaign” through its coverage of the Phase I trial in which one man died and five others were hospitalised in January. 

Lannett compiling evidence to block FDA efforts to pull generic Concerta ANDA

24-Oct-2016 - Lannett is confident it can prove the extended release tech in its Concerta generic is equivalent to the original after the US FDA said it will seek withdrawal of firms ANDA.

Laxachem Organics ban not linked to B. cepacia outbreak says US FDA

24-Oct-2016 - APIs made by Laxachem Organics pvt ltd were not the source of bacteria in Pharmatech laxatives linked to a spate of Burkholderia cepacia infections according to the US Food and Drug Administration (FDA).

Bespak launches autoinjector for high viscosity formulations; signs global pharma deal

20-Oct-2016 - Bespak has launched an auto-injector designed to deliver higher viscosity drug formulations.

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.

WHO adds gatifloxacin to prequalification list to encourage API manufacturers

17-Oct-2016 - The WHO has added side-effect heavy, TB drug ingredient gatifloxacin to its prequalification list to encourage production.

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.

Pfizer on CMOs: $180bn is at stake so being first-to-market is critical

13-Oct-2016 - With the top 500 molecules in development having a commercial potential of $180bn by 2022, being first-to-market is critical says Pfizer.

Online API platform could help secure supply chain, says consultancy firm

12-Oct-2016 - Finding and validating an ingredient supplier can take up to 26 weeks says consultancy firm Rephine, which hopes to address the burden through an online API sourcing platform.

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.

Aralez buys rights to AZ heart drug; encouraged by generic quality issues

10-Oct-2016 - AstraZeneca will supply Toprol-XL to Aralez Pharmaceuticals Trading for at least 10 years after selling the US rights to the off-patent beta blocker for $175m.

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.

Dispatches from CPhI Worldwide

UK-based CMOs benefitting from currency exchange post-Brexit vote

07-Oct-2016 - UK-based contract manufacturers are benefitting from the weak pound following the country’s referendum in June, but the long-term impact of Brexit is still unknown.

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

Continuous manufacturing: pharma adoption challenges remain according to CMAC

06-Oct-2016 - Economics, regulatory inexperience and a lack of technical skills are holding back drug industry adoption of continuous manufacturing says CMAC industrial director, Craig Johnston.

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.

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