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QA/QC

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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.

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, though some are saying that number seems inflated.

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.

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.

API shipment delays, New Mexico site issues hamper AMRI Q3 earnings

11-Nov-2014 - Power interruptions and remediation work at AMRI’s Albuquerque, New Mexico facility, as well as unexpected delays to API shipments have driven down the company’s Q3 profits.

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.

Dispatches from AAPS

US FDA offers more perspective on real-time release testing

04-Nov-2014 - As manufacturers begin to implement new RTRT (real-time release testing) models, a US FDA expert on the matter is offering additional help.

AAPS 2014: Avoiding pharmageddon and pharma innovation discussed in San Diego

03-Nov-2014 -   [View the story "Cali-pharm-ia: Live from AAPS 2014" on Storify]

GSK, Sanofi see setbacks in flu vaccine production for US market

03-Nov-2014 - Two major influenza vaccine producers have run into manufacturing issues that have delayed and reduced the number of doses that will be provided for the US.

Novo Nordisk to hire 90 at newly acquired plant in New Hampshire

30-Oct-2014 - Novo Nordisk on Wednesday announced plans to hire up to 90 people at its newly-acquired manufacturing facility in West Lebanon, New Hampshire. 

EDQM sets new policy for testing of bacterial endotoxins

29-Oct-2014 - The European Directorate for the Quality of Medicines & Health Care, under the European Pharmacopeia, has set a new policy for the testing of bacterial endotoxins.

Lawyers question legality of US FDA final guidance on delaying, denying inspections

27-Oct-2014 - What may seem to be relatively minor changes between the FDA’s draft and final guidance on delaying, denying, limiting or refusing a facility inspection could actually be more major as two lawyers called the final guidance , “critically vague and legally questionable in several ways.”

FDA to combine all of its quality ops under a new ‘super’ office

21-Oct-2014 - By early next year the US FDA is set to launch a new “super” office known as OPQ (Office of Pharmaceutical Quality), which will better align the review, inspection, and research of drugs.

Canada issues licenses for critical drugs hit by Apotex/IPCA import alert

20-Oct-2014 - Over forty “necessary products” made at Apotex and IPCA facilities hit with an import alert can be sold in Canada after regulators took steps to prevent shortages.

News from cphi

Big Pharmas and API suppliers eyeing Brazilian Government deals says EMS

16-Oct-2014 - Government contracts guaranteeing market share in Brazil are starting to attract innovators like Roche, Novartis and Sanofi and may see API suppliers get long-term work according to a spokesman for Sao Bernardo do Campo-based drugmaker, EMS.

Exclusive interview

Global regulators demanding needless drug quality levels, says Indian Gov

15-Oct-2014 - Overzealous and unnecessary quality demands by some regulatory agencies are driving up the cost of medicines, according to the Indian Government.

News from edqm 50th anniversary conference

IPEC calls for inclusion of excipient compound monographs in Ph. Eur.

14-Oct-2014 - 'Excipient compound' monographs should be included in the European Pharmacopoeia according to IPEC, which argues they would help manufacturers and promote acceptance of the standards outside Europe.

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