Breaking News on Global Pharmaceutical Technology & Manufacturing

Anti social? Big Pharma balks at US FDA social media guidance

17-Apr-2014 - Comments from Novartis, Eli Lilly and Pfizer revealed that industry is taking serious issue with some aspects of the draft guidance from the US FDA on social media and promotional materials online.

Discovery of tampered vials leads to Roche cancer drug recall

16-Apr-2014 - Roche has recalled nine batches of breast cancer drug Herceptin after tampered vials were discovered in the UK, Finland and Germany.

UPDATE

Sugar in place of APIs discovered in EU's largest fake drug seizure

14-Apr-2014 - Fake aspirin and anti-diarrhoeal medicines were amongst the largest counterfeit drugs haul discovered to be destined for the European Union, a French customs official says.

EMA requests more stability data for some manufacturing changes

14-Apr-2014 - Drugmakers in the EU making changes to their manufacturing processes will have to submit additional stability data, according to a new EMA (European Medicines Agency) guideline.

People on the Move

Pfizer MD heads up ABPI, Kay Holcombe joins BIO, and other jobs news

14-Apr-2014 - New appointments at biopharma and equipment companies also feature in this week's column.

Canton Labs hit with US FDA Import Alert at Indian API plant

11-Apr-2014 - The US FDA has banned imports of drug products made at Canton Laboratories’ Baroda, India plant weeks after the plant was pulled up for data failures.

Tamiflu spat: Roche ‘disingenuous,’ say review authors

10-Apr-2014 - Roche has clashed with the authors of a report slamming the efficacy of Tamiflu, each claiming the other’s analysis of patient data is seriously flawed.

Governments urged to rethink stockpiling after Tamiflu and Relenza reviewed

10-Apr-2014 - Tamiflu shortens the duration of influenza symptoms by only half a day, does not stop person-to-person spread and increases the risk of nausea say the authors of a new review who want Governments to rethink stockpiling neuraminidase inhibitors.

EU and Aus to share resources in 'time-saving' orphan drug approval

08-Apr-2014 - The EMA and TGA have agreed to share full assessment reports related to marketing authorisations of orphan drug in the latest regulatory collaboration intended to save time and resources.  

WHO calls for more industry invesment in tick-borne disease treatments

07-Apr-2014 - Better data on the global burden of tick-borne illnesses may encourage profit driven drugmakers to spend their R&D budgets on much needed treatments says the WHO.

EMA slashes fees for small drug developers

07-Apr-2014 - The EMA (European Medicines Agency) has cut what it charges small and medium-sized enterprises (SMEs) and micro businesses to help them comply with regulations once their drugs are approved.

UPDATE

Sun Pharma's $3.2bn Ranbaxy acq: 'Compliance first, synergies later'

07-Apr-2014 - Regulatory compliance will be the number one focus for Sun Pharma, the company says, following its $3.2bn (€2.3bn) takeover of Indian generics firm Ranbaxy.

People on the Move

‘Unacceptable’: Japanese Novartis execs resign over drug trial claims

07-Apr-2014 - Plus other people on the move in the pharma industry in this week's column.

All clinical trials to be published under European law

03-Apr-2014 - Pharmaceutical companies will be made to publish all European clinical trials in a public database under a draft law passed by the European Parliament yesterday.

Counterfeit crackdown: EDQM launches fake drug database

02-Apr-2014 - Collating drug counterfeiting cases from across Europe into a central database will help law enforcement authorities catch criminals trying to flood the region with fake medicines, according to the EDQM.

News in brief

Hikma's NJ plant given the all clear from the US FDA

02-Apr-2014 - Hikma has received a close-out letter for its oral manufacturing facility in New Jersey, two years after the US FDA issued a warning.

Politicians spar over US FDA proposed rule for generic manufacturers

02-Apr-2014 - With generic drugs covering 80% of all dispensed drugs in the US, Democrats and Republicans seem split over a proposed FDA rule that would allow generic manufacturers to submit labelling changes within 30 days after discovering a new adverse event or safety issue.

Dispatches from DIA Euromeeting

Expert: ‘We lack the regulatory models’ for next generation drugs

01-Apr-2014 - The pharmaceutical industry lacks the regulatory models to govern sweeping changes in the near future surrounding combination products and large molecule drugs, said an expert at DIA Euromeeting in Vienna last week.

Portable tech advancing fight against counterfeits, says MHRA

01-Apr-2014 - Making API detecting technologies more portable has been a major development in the fight against counterfeit drugs, according to the MHRA, though the biggest threat comes from online sellers.

Will US track and trace law be enough to stop counterfeiters?

31-Mar-2014 - In light of the implementation of the Drug Quality and Security Act of 2013 in the US, which calls for the phased implementation of electronic tracking down to the package level, companies are looking at options to catch up and reduce counterfeiting at the same time.

People on the Move

Pharma jobs: who's going places?

31-Mar-2014 - People are on the move at Baxter, Merck & Co., Johnson & Johnson, and elsewhere in this week's column.

UPDATE

GSK recalls weight-loss drug Alli following evidence of tampering

27-Mar-2014 - GlaxoSmithKline has issued an alert and US voluntary recall of its OTC weight-loss drug Alli after discovering some bottles had been tampered with.

EMA to rejig variations procedures and industry contact staff in April

26-Mar-2014 - Pharmaceutical firms working in Europe may need to update their address books next month after more reorganisation at the EMA.

Drug industry job changes: People on the move

24-Mar-2014 - New hires at Merck Serono, Amgen, Takeda and Fate Therapeutics this week. It's in-Pharmatechnologist.com's people column.

UK MHRA scheme will allow compassionate use of unlicensed drugs

20-Mar-2014 - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) will launch a scheme next month to allow doctors to prescribe medicines without a marketing authorisation to patients with life-threatening conditions.

Spotlight

EMA to rejig variations procedures and industry contact staff in April

EMA to rejig variations procedures and industry contact staff in April

Pharmaceutical firms working in Europe may need to update their address books next month after more reorganisation...

Janssen Button? Will GSK's F1 team up prompt other collaborations?

Janssen Button? Will GSK's F1 team up prompt other collaborations?

GSK has ‘smashed’ production targets at a UK inhaler plant by revving up manufacturing operations with knowhow...

Indian API maker slammed with US FDA Warning over data issues

Indian API maker slammed with US FDA Warning over data issues

Failure in maintaining test and production data has landed an Indian API maker with a Warning Letter...

US FDA issues new bioavailability guidelines

US FDA issues new bioavailability guidelines

The US FDA has published guidance of how sponsors should best document the bioavailability of products for...

Bioavailability breakthrough key to new cancer drug OKed in Japan

Bioavailability breakthrough key to new cancer drug OKed in Japan

Japan has become the first country to approve a new cancer pill that treats disease by interfering...

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