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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.

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 a new report.

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.

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.

$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.

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 key for Big Pharma and patients.

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 a report on 2013 inspections .

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 the agency.

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.

Dispatches from the Financial Times Global Pharmaceutical and Biotechnology Conference

Pipelines not tax cutting should prompt smaller pharma mergers says AstraZeneca exec

18-Nov-2014 - 2014 has seen record pharma M&A activity but top management of some of the key dealmakers – including Novartis, AstraZeneca and Shire – say size doesn’t always matter.

Expert cautions: DSCSA deadlines may cause drug shortages

18-Nov-2014 - Drug shortages could be an issue in the near future as some wholesale distributors and drug suppliers may not be able to meet a key Jan. 1 deadline from the Drug Supply Chain and Security Act (DSCSA), an expert says.

FDA commish in China in search of more facility inspector visas

18-Nov-2014 - US FDA commissioner Margaret Hamburg is traveling to China this week and at least part of her trip will be devoted to securing visas for new drug manufacturing site inspectors.

'Killer experiments' and reimbursement are the keys to VC backing says Index

17-Nov-2014 - Investors only back drug innovators because they have to according to Index Venture Management's Kevin Johnson, who says less risky 'first to be second' firms are much more attractive.

Live from London: FT Global Pharma and Biotechnology Conference

17-Nov-2014 -    [View the story "Live from the FT Pharma Conference in London" on Storify]

EU Ombudsman raises issues with some of EMA’s redactions of AbbVie data

13-Nov-2014 - The EMA said Wednesday it will formally respond to a letter sent by EU ombudsman Emily O'Reilly to the agency in which she took particular issue with some redacted information from AbbVie’s CSRs (clinical study reports).

Indian API manufacturer earns FDA warning letter due to cGMP violations

12-Nov-2014 - Cadila Pharmaceuticals was cited by the US FDA for failing to respond appropriately and to correct issues related to customer complaints.

Dispatches from AAPS 2014

BARDA: Ebola is “a bioterrorism threat”

06-Nov-2014 - BARDA, the US government’s Biomedical Advanced Research and Development Authority, has revealed it sees Ebola “as a bioterrorism threat.”

Dispatches from AAPS

Pfizer Director: Need for regulatory commitments clarity in NDAs, and US FDA concurs

05-Nov-2014 - A Pfizer Director has called for clearer manufacturing commitments in NDA and post-approval applications and the US FDA says, following its restructure, this will come.

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