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Swedish manufacturing: special report

‘Embarrassment’ holding back green manufacturing, says Sweden

22-Dec-2014 - Sweden’s pharmaceutical regulator is pushing hard to make water pollution regulations a binding part of GMP, and says “embarrassed” European agencies are dragging their feet more than big pharma.

API supplier issues again cause FDA to reject Pozen drug candidates

18-Dec-2014 - For the second time the US FDA has rejected two versions of Pozen’s investigational drug candidate because of issues with a supplier’s foreign manufacturing facility.

Rouble trouble: Big Pharma exposure to Russian currency volatility limited

17-Dec-2014 - Big Pharma firms’ exposure to Russia’s volatile rouble is limited and planned manufacturing investments will go ahead according to observers.

US FDA calls for prescribing info to be distributed electronically

17-Dec-2014 - The US FDA is now calling for prescribing information intended for health care professionals to be distributed electronically, with few exceptions.

Anti-counterfeiting: EMD Serono lets patients scan meds on iPhone

16-Dec-2014 - Patients and pharmacists can now use smartphones to check biologics are genuine with a new Merck Serono tech launched to combat counterfeiters' growing interest in high-value biopharma drugs.

US FDA warns Pfizer antipsychotic linked to serious allergic reaction

16-Dec-2014 - The US FDA is requiring Pfizer to slap yet another warning label on its antipsychotic Geodon (ziprasidone).

IPEC-Americas aims to make drug excipient users TUPP aware

15-Dec-2014 - Manufacturers should profile the "black specks" created during excipient production and share details with customers according to guidance finalised by IPEC-Americas, which says the unavoidable particles are starting to earn drugmakers 483s.

From CPHI India

IPA says bad inspectors making Indian manufacturers fear visits

11-Dec-2014 - The Indian Pharmaceutical Alliance says the quality of US FDA inspections has “significantly deteriorated” this year, and their approach is creating a climate of fear among Indian manufacturers.

Sun closes in on Ranbaxy deal with CCI approval

10-Dec-2014 - The Competition Commission of India (CCI) has approved Sun Pharma’s $3.2bn acquisition of Ranbaxy.

Foreign investment in UK drugmaking down; ABPI tasks ex-GSK exec with reversing trend

10-Dec-2014 - An ex-GSK staffer charged with winning manufacturing investments for the UK says fostering innovation and “fiscal attractiveness” are vital.

From CPHI India

CPHI India: experts say ‘data fraud’ dragging down Indian manufacturing

09-Dec-2014 - Experts at CPHI India say companies failing manufacturing inspections need to be more honest with their data.

From CPHI India

Eager-to-please Indian manufacturers creating GMP chaos says expert

08-Dec-2014 - Cultural differences and broken promises are behind Indian GMP failures and acute generics shortages in the UK, according to one pharmaceutical distributor.

FDA to allow paper or electronic transaction info transfers under DSCSA

08-Dec-2014 - New draft guidance from the US FDA related to track-and-trace legislation facilitates the transfer of both paper and electronic accounts of transaction info, history and statements for manufacturers, repackagers and wholesale distributors.

From CPHI India 2014

Do you manufacture these APIs? ‘We’re interested in you,’ says WHO

04-Dec-2014 - The World Health Organisation says its prequalification scheme gives free help to makers of selected APIs, drugs and vaccines who want to boost their standards and access international markets.

Spoil sport: Pfizer teams up with WADA to combat drug cheats

04-Dec-2014 - Pfizer scientists wont have to run track, just share data to help catch sports cheats who use candidate drugs to enhance performance according to the World Anti-Doping Authority (WADA).

German regulators hit Ranbaxy with another warning letter

03-Dec-2014 - Another warning letter has landed in the hands of Ranbaxy execs, this time from German regulators charging the company with failing to comply with GMP standards.

EMA seeking drugmaker feedback on cyclodextrin and propylene glycol labelling plan

03-Dec-2014 - The EMA has called for feedback on plans to require drugmakers to state whether their drugs contain solubility-enhancing cyclodextrin excipients.

Two INDs or not two INDs? Unanswered questions in China draft MRCT guide

03-Dec-2014 - Drugmakers that include China in multi-regional trials will need to submit dossiers filed elsewhere for review, open up non-Chinese sites to CFDA inspection and consider additional local studies under draft guidelines issued by Beijing regulators.

Novartis' flu vaccine in the clear over 19 deaths, says Italian regulators

02-Dec-2014 - Novartis’ seasonal flu vaccine Fluad has been deemed safe by the Italian Medicines Agency (AIFA) after testing the two batches connected to over a dozen deaths.

Advanced aspirin aspirations ailing? Sanofi and Pozen terminate deal

02-Dec-2014 - Sanofi and Pozen have dissolved a $35m (Eur28m) ‘advanced aspirin’ partnership less than a month before the US Food and Drug Administration (FDA) decides whether to approve the new drug.

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