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News headlines

FDA veteran questions science behind antibiotics fast track

03-Aug-2015 - As the US regulator awards iclaprim expedited QIDP status, a former FDA antibiotics expert says the scheme boosts antibiotics without enough evidence for efficacy.

Drugs stolen while trucker changed his clothes recovered thanks to hidden GPS

30-Jul-2015 - A shipment of drugs stolen while a truck driver went home to change his clothes were recovered in half an hour thanks to a GPS tracking device embedded in the cargo.

'Rough notes' and backdated signatures land Indian API maker US FDA warning

29-Jul-2015 - Issues with batch production records at an Indian facility have landed API maker Mahendra Chemicals with a US FDA warning letter.

FDA offers draft guidance on quality metrics used to assess drug manufacturing

29-Jul-2015 - New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes that they use to make drugs and biologics.

US FDA finalises analytical procedures and methods validation guidance

28-Jul-2015 - Pharma firms may need to carry-out an analytical method comparability study as part of the life cycle management of a drug, according to final US FDA guidelines.

EU and Swiss regulators strengthen ties with confidentiality agreement

27-Jul-2015 - A confidential information exchange agreement will strengthen the relationship between the EMA and Swiss regulators and could save on resources, the agencies say.

Less than a year to risk assess excipients: IPEC Europe develops 'how to' guide

27-Jul-2015 - IPEC Europe has reminded drugmakers they have less than a year to risk assess all excipients used in their products under recently introduced EU rules.

First part of European fake fighting database linked to securPharm

23-Jul-2015 - The first part of a Europe-wide database intended to help identify fake drugs is operational after being linked to Germany’s securPharm system.

Funds worth €3.5tr back Alltrials, but none promise to pull cash from drug firms that don't

23-Jul-2015 - Investor backing puts transparency on the pharma agenda says SenseAboutScience, even though none of the funds pledging support for Alltrials have committed to pull investment from drug firms that disagree.

Compound sentence? Two 'outsourcing facilities' hit with US FDA warning letters

22-Jul-2015 - Inspectors found significant violations of cGMP at sterile drug compounders - both registered as outsourcing facilities - in Florida and Arkansas during visits in March.

IPEC calls on FDA to establish new review process for novel excipients

22-Jul-2015 - As part of a push to bring more novel excipients to market, IPEC-Americas is calling on the FDA to create a new regulatory review process that could relieve some of the uncertainty around the use of new excipients.

J&J plans to reopen site in PA, relaunch OTC portfolio

21-Jul-2015 - J&J says it expects to reopen the Pennsylvania site it was forced to close after a spate of manufacturing problems with its OTC pain drugs.

Another injectables recall for Mylan

21-Jul-2015 - Mylan has recalled 14 lots of calcium chloride intravenous infusion after customers found the prefilled syringes were not compatible with needless adaptors.

Planes, drones but no automobiles: NASA pilots pilotless plane for drug delivery

20-Jul-2015 - NASA has used a remote control plane and a fleet of drones to deliver drugs in an approach that could help pharma firms get medicines to patients in hard to reach locations.

Green GMP criteria would help responsible API firms compete with polluters says DSM Sinochem

20-Jul-2015 - API firms that invest in waste management find it hard to compete with those that pollute according to DSM Sinochem, which wants environmental criteria included in GMP standards for environmental and business reasons.

Nordea mulling holdings in drugmakers that source APIs from water polluters

16-Jul-2015 - Drugmakers risk losing financial backing if they source APIs from Indian suppliers that pollute according to Nordea Asset Management's head of responsible investments, Sasja Beslik.

News in brief

Pfizer to close Mumbai manufacturing facility

16-Jul-2015 - With no active production at the plant since 2013, the company said it would shutter its Mumbai, India-based facility in mid-September, according to a Bombay Stock Exchange filing . 

Life ban for founder of fake US drug company with $12m in sales

15-Jul-2015 - The founder of a phony pharma company which made $12m importing fake chemo drugs to the US has been banned for life by the US FDA from working with any pharma businesses.

Environmental group welcomes DSM-Sinochem and GSK efforts to halt spread of antibiotic resistance

13-Jul-2015 - Antibiotic API makers have an obligation to ensure their activities do not spread resistance says a group that welcomed DSM-Sinochem’s commitment to environmentally-friendly production.

Fresenius Kabi fined £500,000 after patient death

13-Jul-2015 - Fresenius Kabi and a UK drug manufacturer have been sentenced for supplying faulty insulin syringes which contributed to a diabetic man’s death.

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