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Breaking News on Global Pharmaceutical Technology & Manufacturing

FDA opts for four-letter suffix to distinguish biologics and biosimilars

28-Aug-2015 - The US FDA has published long-awaited guidelines on the non-proprietary naming of biological products, but biosimilar makers say adding a random four-letter suffix could needlessly complicate the prescribing system.

MHRA uncovers $1m illegal ED drug haul

27-Aug-2015 - A UK man has been sentenced to 16 months in prison for smuggling illegal erectile dysfunction drugs following an MHRA investigation.

Europe, US, Japan: The recall round-up

27-Aug-2015 - Product problems for Allergan and Danish Leo Pharma, plus the Japanese regulator reviews a Bristol-Myers Squibb mAb.

MHRA launches fees calculator

26-Aug-2015 - The UK regulator is launching a calculator to help pharma companies calculate the fees for drug applications.

MHLW urges Japan's generics sector to consolidate

26-Aug-2015 - The Japanese Government says consolidation of the country’s generics sector is needed to secure supplies.

‘Sheer ridiculousness’ or fair play? USPTO turns down patent challenge

25-Aug-2015 - The US Patent and Trademark Office (USPTO) has refused to review a challenge to Acorda Therapeutics’ patents from a group trying to block “abusive” IP claims.

Pfizer’s $17bn Hospira deal set to close in September after US FTC clearance

24-Aug-2015 - Pfizer has received the final regulatory clearances to acquire Hospira but the US FTC says it must divests four sterile injectable products.

US FDA OK with a bit of blue: Colorcon's Spirulina approved for pharma pills

24-Aug-2015 - Drugmakers trying to make blue or green pills for the US market have a new option after the FDA approved a bacteria-derived extract developed by Colorcon for pharma applications. 

UK bioindustry group calls for Government biomedical catalyst scheme to continue

21-Aug-2015 - The UK’s Biomedical Catalyst funding scheme encourages investors to back innovative biopharma research and should be continued according to the BioIndustry Association (BIA).

Valeant to buy "female viagra" maker Sprout for $1bn

20-Aug-2015 - Valeant Pharmaceuticals is set to buy Addyi maker Sprout Pharmaceuticals under a $1bn (€895m) deal agreed today.

Three Mylan plants in India hit with FDA warning letter

19-Aug-2015 - As it tries to close its biggest deal ever -- a $33bn acquisition of Perrigo -- Mylan is now also dealing with an FDA warning letter citing cGMP violations tied to three of its manufacturing facilities in India.

Manufacturing alerts and issues at Teva, Pfizer, and more

18-Aug-2015 - Teva’s UK business has alerted the regulator that packets of the painkiller and anti-seizure medicine Pregabalin are printed with the wrong dosage.

EU lays out draft on new obligatory safety features for medicines

18-Aug-2015 - As part of European efforts to help stem the spread of counterfeit medicines, the European Commission has laid out the details of a key part of its Falsified Medicines Directive (FMD).

News in brief

GSK plans to reopen contaminated NC site this weekend

13-Aug-2015 - The GSK site tainted with Legionella bacteria will likely reopen in a few days, the company says.

Taiwan pharma market to hit $8bn but regs may limit homegrown R&D

13-Aug-2015 - Taiwan’s pharmaceutical market is expected to grow to over $8bn by 2020, driven by chronic and non-infectious therapies, but uncertain relations with China, TPP entry, and price cuts will also influence the region.

Legionella bacteria force GSK to temporarily close North Carolina plant

12-Aug-2015 - GlaxoSmithKline was forced to briefly shutter its Zebulon, NC, manufacturing facility after the company discovered legionella bacteria in one of its cooling towers.

US generic industry preps for GDUFA reauthorisation marathon

11-Aug-2015 - The annual announcement of FDA user fees has brought scrutiny on the price tag for generic drug applications, as the approval backlog is almost a year longer than in 2012.

House to FDA: who’s in charge of clinical trial manufacturing?

10-Aug-2015 - US politicians have given the NIH and FDA until Friday to answer questions about oversight at a contaminated National Institutes of Health clinical trial manufacturing site.

PEOPLE ON THE MOVE

What Hamburg did next...

10-Aug-2015 - Plus more jobs news from the pharmaceutical world, including senior changes at PhRMA.

Concerns about FDA IT security persist, House committee report says

10-Aug-2015 - The US House Energy and Commerce Committee is taking issue once again with the way the FDA manages its IT systems, according to a report released late last week.

Trial Transparency

Positive RCTs drop to 8% under transparency regulations

06-Aug-2015 - Only eight percent of published clinical trials show positive drug results following new transparency standards, a sample study shows.

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.

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