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Headlines > October 2016

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BASF upping cost of ethanolamines by €100 per tonne in Europe

31-Oct-2016 - BASF will increase the European sales prices for its ethanolamines by €100 ($110) per metric ton due to the rising costs of the raw material.

Sanofi and Regeneron mull FDA CRL after fill/finish plant hit with 483

31-Oct-2016 - The US FDA has issued a complete response letter for Sanofi and Regeneron’s rheumatoid arthritis candidate sarilumab due to manufacturing deficiencies at a fill/finish plant in France.

Bespak welcomes availability of Cimzia autoinjector on the UK NHS

28-Oct-2016 - Bespak says the availability of the autoinjector version of UCB’s Cimzia on the UK National Health Service (NHS) is a validation of its delivery technology.

Lonza ups 2016 forecast citing Q3 biopharma gains; says capex will be higher

28-Oct-2016 - Lonza has raised its 2016 guidance and predicted higher spending on manufacturing equipment after growth of its biopharma businesses in the third quarter.

Envigo testing single wall carbon nanotubes

27-Oct-2016 - Envigo has collaborated with InterTek and OCSiAl to develop TUBALL™ single wall carbon nanotubes, which is the first of its kind to complete REACH registration.

Unilife in talks with customers about planned wind-down of syringe business

27-Oct-2016 - Unilfe has started discussing the wind-down of its prefilled syringe business with customers after deciding to focus on wearable drug delivery technologies.

PepsiCo & TB Alliance partner to improve tuberculosis drug taste

27-Oct-2016 - PepsiCo and TB Alliance are partnering to improve the bitter and unpleasant taste of today’s tuberculosis (TB) treatments - important in the treatment of children.

Daiichi Sankyo to commercialize Inspirion's anti-abuse opioid in the US

27-Oct-2016 - Daiichi Sankyo will commercialize an abuse-deterrent formulation of the opioid painkiller morphine sulphate in the US in an agreement with developer Inspirion Delivery Sciences.

EC: EMA and US FDA GMP inspection deal could be agreed by January

27-Oct-2016 - Development of an EMA and US FDA mutual recognition agreement on drug facility inspections has progressed according to European Commission negotiators who say a deal could be signed by January.

Pfizer fined for hazardous chemical violations at Puerto Rico plant

26-Oct-2016 - The US Environmental Protection Agency (EPA) has fined Pfizer $190,000 for failing to disclose that it had ammonia and methylamine at its facility in Barceloneta, Puerto Rico.

update - Kaleo wants all patients to have access to Auvi-Q, regardless of insurance coverage

Kaleo set to relaunch withdrawn Epipen rival Auvi-Q next year

26-Oct-2016 - Kaleo has said it will relaunch Auvi-Q (epinephrine injection) a year after a recall by licensee Sanofi removed the Epipen rival from the market.

Cel-Sci working to have Multikine trial partial hold lifted after receiving formal US FDA letter

26-Oct-2016 - Cel-Sci has received written confirmation the US FDA has placed a late stage trial of its cancer cell therapy Multikine on partial clinical hold a month after agency first raised...

Fake drug sales mean fewer people are employed by EU drug firms says EUIPO

26-Oct-2016 - Drug counterfeiting means the EU pharmaceutical industry employs 37,700 fewer people than it otherwise would, according to the European Union Intellectual Property Office (EUIPO). 

US FDA still worried about Interpharm's efforts to stop API data manipulation

26-Oct-2016 - The US FDA wants more information on Czech API firm Interpharm Praha AS’s efforts to prevent repetition of data manipulation uncovered during 2015 inspection.

Aduro told to halt cancer vaccine trial enrollment after listeria found in patient sample

25-Oct-2016 - The US FDA has told Aduro Biotech not to enrol subjects in trials of its listeria-based immunotherapies after one study subject tested positive for the bacteria.

CFDA: reports of clinical trial data fraud 'not fact based'

25-Oct-2016 - The Chinese Food and Drug Administration (CDFA) has fired back on lack of context in media reporting “80% of China’s clinical trial data are fraudulent.”

Ashland opens Nanjing excipient plant citing growing local demand in light of new quality regulations

25-Oct-2016 - Ashland has opened a pharmaceutical excipients plant in Nanjing, China in a bid to capture growing local demand for modern formulation technologies.

EAG Laboratories adds to environmental testing capabilities

25-Oct-2016 - EAG Laboratories has added 33,000-square-feet to its Easton, Maryland facility, with space for dedicated laboratories and equipment to support GLP-compliant ecotoxicology, environmental fate, metabolism, and other testing services.

Patheon contracted to make second drug by age-related diseases firm Biophytis

25-Oct-2016 - Patheon will make a candidate AMD treatment under a contract with French biotech Biophytis.

Inovio's DNA vaccine trial on hold over delivery device shelf life concerns

25-Oct-2016 - The US FDA has placed a Phase III trial of Inovio’s candidate DNA cancer vaccine VGX-3100 on clinical hold over concerns about its delivery device.

Everstone Capital buys stake in Rubicon Research citing delivery techs and ANDAs

25-Oct-2016 - Everstone Capital has acquired a 70% stake in drug delivery tech firm Rubicon Research Pvt for $33m (€30m).

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...

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...

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...

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.

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