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Breaking News on Global Pharmaceutical Technology & Manufacturing

Festive Flick

Happy Holidays 2014 from William Reed Business Media!

18-Dec-2014 - The holidays are fast upon us, so let’s put ‘business’ to one side and get into the festive mood. To keep in the spirit of things, we’ve got a ‘gift’ for you – enjoy. Happy Holidays!

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.

Compound interest? US FDA sets up compounding pharmacy advisory committee

17-Dec-2014 - The US FDA has set up a committee to provide advice on scientific, technical and medical issues concerning drug compounding.

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).

People on the Move

On the move: changes at EFPIA, Roche, Merck & Co.

15-Dec-2014 - Novartis's CEO becomes President of EFPIA, a new head of R&D for Genentech, and more People on the Move.

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.

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.

People on the Move

Fraud charge dropped against Lilly scientists, Sanofi still leaderless

09-Dec-2014 - The US Government has dropped charges against senior Lilly scientists accused of sharing company secrets.

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.

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.

MHRA says it will review plans for new UK pharma plants free of charge

01-Dec-2014 - Expert advice was key to persuading AstraZeneca to build a £120m ($188m) manufacturing plant in the UK according to the MHRA, which says the same help is available to all drugmakers free of charge.

Death toll rises to 13 as EMA investigates Novartis' flu vaccine

01-Dec-2014 - The EMA is investigating over a dozen deaths in connection with Novartis’ flu vaccine Fluad, following the suspension of two batches in Italy.

Want to relocate to Asia? What pharma recruiters really look for

01-Dec-2014 - Singaporean companies are looking for scientists, while China and India need execs – but don’t count on moving to Japan, says jobs expert Doris Chin.

US politicians plan fast-track vouchers to reward Ebola R&D

26-Nov-2014 - Bipartisan bills introduced in the US House of Representatives and the Senate would give manufacturers of Ebola therapies vouchers to speed up review of a drug of their choice.

EMA adopts guidelines on phthalate excipients, cross-contamination in manufacturing

25-Nov-2014 - The two guidelines offer help to manufacturers looking to use potentially hazardous phthalates as excipients in drugs, as well as those that have shared facilities where multiple drugs are produced.

Diversity in pharma: why ‘risk minimisation’ has it all wrong

25-Nov-2014 - The lack of women on pharma boards is well-known, so why are companies still slow to balance the genders? A recruiter tells us the problem is “demand, not supply” and why quotas aren't a simple fix.

Ousted: rule-breaking Lundbeck CEO and Novartis scientist get the boot

25-Nov-2014 - Two pharma giants are today looking for new employees after pushing out the CEO of Lundbeck and a Novartis researcher for rule-breaking.

US, Chinese regulators forge closer ties as FDA looks to triple staff

24-Nov-2014 - As FDA commissioner Margaret Hamburg wraps up her trip in China it looks like the FDA is creating a stronger bond with its Chinese counterparts as the FDA looks to triple its staff there.

Spotlight

Axim to build Dutch facility for cannabinoid-based chewing gum drug

Axim to build Dutch facility for cannabinoid-based chewing gum drug

A company developing a pharmaceutical chewing gum containing cannabinoids extracted from marijuana has announced plans to build...

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

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

Drugmakers that include China in multi-regional trials will need to submit dossiers filed elsewhere for review, open...

Advanced aspirin aspirations ailing? Sanofi and Pozen terminate deal

Advanced aspirin aspirations ailing? Sanofi and Pozen terminate deal

Sanofi and Pozen have dissolved a $35m (Eur28m) ‘advanced aspirin’ partnership less than a month before the...

Want to relocate to Asia? What pharma recruiters really look for

Want to relocate to Asia? What pharma recruiters really look for

Singaporean companies are looking for scientists, while China and India need execs – but don’t count on...

Chinese excipient market set to more than double by 2017

Chinese excipient market set to more than double by 2017

With more than 90 excipient manufacturers in China dedicated to the pharma industry, the country expects its...

BASF sells Norway plant, focuses on pharma grade omega-3 products

BASF sells Norway plant, focuses on pharma grade omega-3 products

BASF says the supply of API to GSK and other pharma customers will not be affected by...

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