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Headlines > November 2014

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Happy Thanksgiving for GSK with FTC approval of Novartis vaccine biz

27-Nov-2014 - Just in time for the holidays, GSK can ‘give thanks’ to the US Federal Trade Commission (FTC) which has approved the $7bn acquisition of Novartis’ vaccine business.

News in brief

Aurobindo recalls empty epilepsy capsules

27-Nov-2014 - Aurobindo Pharma has recalled one lot of Gabapentin for the treatment of epilepsy and postherpetic neuralgia (pain after shingles), after it was found to contain empty capsules.

Recipharm adds French plant and drug delivery tech in strategic deal with Flamel

27-Nov-2014 - Recipharm will acquire a facility and add technologies including spray granulation and spray coating as part of a “truly strategic” collaboration with France-based Flamel Technologies. 

Dr Reddy's API plant receives USFDA 483 with nine observations

27-Nov-2014 - Dr Reddy’s says an API plant in India is unlikely to be subject to further regulatory enforcement after receiving a US FDA 483 with nine observations.

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.

Why cashews and coconuts are Merck's green energy secret

26-Nov-2014 - Merck KGaA will run its manufacturing plant in Goa on fuel from cashews and coconuts.

Chinese excipient market set to more than double by 2017

26-Nov-2014 - With more than 90 excipient manufacturers in China dedicated to the pharma industry, the country expects its output of excipients to more than double to about $8.9bn (€7.1bn), according to...

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...

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.

AMRI re-opens troubled sterile injectable facility in New Mexico

25-Nov-2014 - AMRI’s Albuquerque, New Mexico sterile injectable facility has resumed full manufacturing operations following an environmental deviation. 

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...

$15k and API info: FDA releases guide to registering drug compounders

24-Nov-2014 - The US Food and Drug Administration (FDA) is encouraging hospitals to purchase their compounded drugs from organisations registered as outsourcing facilities, and has issued guidance on accreditation.

Johnson Matthey: APIs down but Sigma-Aldrich acq could bring opportunities

24-Nov-2014 - The acquisition of Sigma-Aldrich by Merck KGaA could provide some opportunities for Johnson Matthey, the fine chemical company says as it reports a flat first half 2014/15.

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

24-Nov-2014 - BASF says the supply of API to GSK and other pharma customers will not be affected by the divestment of an omega-3 production plant in Norway.

People on the Move

Does Sanofi have a replacement CEO in its sights?

24-Nov-2014 - Plus the latest drug industry hirings, firings and awards in this week's column.

Dispatches from the FT Global Healthcare and Biotech Conference

EMA: New pathways and Ebola vaccines can help expedite approvals

20-Nov-2014 - The EMA is “caught between a rock and a hard place” in expediting drug development, but an agency Executive says change can come through its new adaptive licensing pathway.

UK Hospitals to play part in Gov efforts to speed clinical trial process

20-Nov-2014 - UK life sciences minister George Freeman wants hospitals to play more of a role in clinical trials and says accelerating the drug development process in the post block-buster era is...

MHRA says quality system deficiencies are most common issue from inspections

20-Nov-2014 - Deficiencies related to manufacturers’ quality systems are by far the most prevalent issue cited from inspections by the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency), the agency said in...

US FDA calls out two companies over fake Ebola treatments

20-Nov-2014 - The US FDA and the Federal Trade Commission have sent warning letters to two companies claiming to have drugs that treat Ebola though no such product has been approved by...

Do laws hindering umbrella-wielding assassins also hurt Pharma?

19-Nov-2014 - The US Government has asked drugmakers and fine chemicals firms if laws designed to stop the proliferation of chemical weapons are hurting legitimate business.

Pfizer hails portable manufacturing as latest in lean

19-Nov-2014 - How can a pharma company invest in continuous manufacturing without bleeding money when it retreats from a local market? Pfizer’s answer is production pods it can roll out anywhere in...

Mind the gap: GSK and UK scientists say smaller is better for some biopharmaceuticals

19-Nov-2014 - UK researchers working with GSK say a newly identified immune cell communication mechanism could explain why some drugs don’t work and drive development of smaller, large molecule meds.

People on the Move

Going places: pharma's movers and shakers

19-Nov-2014 - The Association of the British Pharmaceutical and novel drugmakers feature in this week's People on the Move column.

Questions raised over new $2.6bn price tag to bring a new drug to market

19-Nov-2014 - The Tufts Center for the Study of Drug Development is out with a new study claiming that the average cost of bringing a new drug to market is around $2.6bn,...

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