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Headlines > October 2012

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Non-EU regulators can use EMA/FDA data for API export letters

31-Oct-2012 - Regulators in Non-EU countries can use results of previous inspections of API plants by EU or equivalent authorities in written confirmations, according to the European Commission.

Lonza cuts jobs at Visp API and biomanufacturing plant

31-Oct-2012 - Lonza will cut jobs at its facility in Visp, Switzerland and may enact similar 'productivity improvement programmes’ at other sites. 

Boehringer Ingelheim invests in inhaler tech plant

31-Oct-2012 - German drugmaker Boehringer Ingelheim (BI) plans to double production capacity at its inhaler plant in citing demand. 

News from CPhI

Optimism is returning to the pharma fine chemicals sector, says analyst

31-Oct-2012 - The positive impact drug industry demand for quality is having on the fine chemicals sector was evident at industry trade show CPhI last month according to expert Jan Ramakers. 

News in brief

NZ and Taiwan join PIC/S; API inspection scheme makes progress

31-Oct-2012 - New Zealand regulator Medsafe and the Taiwan FDA will join the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) next year.

News in brief

EMA calls for submission of Type-1 MA variations before end of November

30-Oct-2012 - Pharmaceutical firms should let the EMA know about minor variations to marketing authorisation (MA) by the end of next month if they want to avoid delays over the festive period.

Collective responsibility at heart of India biologics GDP guide

30-Oct-2012 - All parties involved in the distribution of biologics in India must take responsibility for quality and keep seasonal temperature variations in mind says the CDSCO.

Menarini forms ADC manufacturing deal with OBT

30-Oct-2012 - Menarini has committed millions of euros to an antibody drug conjugate (ADC) clinical development and manufacturing pact with Oxford BioTerapeutics (OBT). 

Novartis says banned flu jabs safe and that 'particles' common in vaccines

29-Oct-2012 - Novartis says two seasonal influenza vaccines temporarily banned by several European countries on quality concerns are safe.

News in brief

C4C sets up cell therapy factory in France

29-Oct-2012 - A group combining government agencies and biotechnology firms have established what it claims is the first cell therapy development facility in France.

New device should reduce risk posed by high-dose insulin

29-Oct-2012 - A new delivery device should reduce the risk posed by the availability of high-dose insulin in Europe say regulators, but vigilance is still needed.

Big Pharma contributions favour Romney

25-Oct-2012 - Big Pharma firms want a Republican in the White House judging by contributions received by the two US parties during the current campaign.

Rx360 wants feedback on new EU API import rules

25-Oct-2012 - Rx360 wants industry feedback on import requirements for active pharmaceutical ingredients (API) due to be introduced next year.


UK patent laws hamper drug development in according to IPO

24-Oct-2012 - The UK Intellectual Property Office (IPO) wants to make it easier to develop drugs in the country by changing the rules relating to patent infringement in clinical trials.

Evonik hikes amino acid prices in face of rising maize and sugar costs

24-Oct-2012 - Evonik has raised the price of its pharmaceutical amino acids as a result of rising maize and sugar costs.

Canada wants industry feedback on plans to extend GMP to APIs

24-Oct-2012 - Regulator Health Canada has started a consultation on plans to extend GMP requirements to active pharmaceutical ingredients (API).

EMA wants to revise BVDV testing requirements for bovine serum

23-Oct-2012 - The EMA wants feedback on its plans to revise testing requirements for bovine serum used to manufacture biologics.

News from AAPS

Low API and excipient volumes vital to win authorisation under EU PIP says EMA

23-Oct-2012 - Pharmas should use lower API and excipient volumes if seeking authorisation under the EU Paediatric Investigation Plan  (PIP) says the EMA.

News in brief

Rubicon and Avantor team on excipient development

23-Oct-2012 - Rubicon Research and Avantor have teamed up to develop a gastro-retentive excipient for pharmaceutical applications.

News from Heptares, Cerecor and Dyax Corp – People on the move

23-Oct-2012 - presents its weekly round-up of career changes in the pharmaceutical industry, including news from Heptares, Cerecor and Dyax Corp.

Motion sickness chewing gum gives platform for active ingredient formulation – researchers

23-Oct-2012 - A medicated chewing gum prototype that combats motion sickness could give a platform to incorporate other active ingredients with objectionable tastes into gum.

US FTC forces Watson and Actavis to sell to rivals Sandoz and Par

22-Oct-2012 - Watson and acquisition target Actavis must sell 18 drugs to rivals Sandoz and Par Pharma under conditions imposed by the US Federal Trade Commission (FTC).

Octoplus to be stand alone R&D unit says Dr Reddy's; no job cuts planned

22-Oct-2012 - Indian drugmaker Dr Reddy’s wants to buy Netherland’s-based formulation services firm Octoplus to expand its drug delivery technology portfolio.

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