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.
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.
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.
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.
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.
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.
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.
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.
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 .
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.
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.
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.
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.
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.
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.
17-Nov-2014 - [View the story "Live from the FT Pharma Conference in London" on Storify]
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).
12-Nov-2014 - Cadila Pharmaceuticals was cited by the US FDA for failing to respond appropriately and to correct issues related to customer complaints.
06-Nov-2014 - BARDA, the US government’s Biomedical Advanced Research and Development Authority, has revealed it sees Ebola “as a bioterrorism threat.”
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.
Although USP <232> and <233> are still under discussion, a good deal of work is going on ahead of implementation in terms...