Breaking News on Global Pharmaceutical Technology & Manufacturing

Japan hits Pfizer with business improvement order after ADR reporting failures

03-Sep-2015 - Pfizer failed to report hundreds of serious adverse drug reactions (ADRs) in the required timeframes according to Japan’s Ministry of Health, Labor and Welfare (MHLW) which has issued the US firm with a business improvement order.

Update - Wholesale cost of Zarxio will be 15% less than Amgen's Neupogen

Biosimilars land in the US as Sandoz launches Zarxio

03-Sep-2015 - Sandoz has launched Zarxio, the first biosimilar in the US, despite a last ditch effort to block the copycat version of Neupogen by Amgen.

Bear-faced lie? Amgen retracts diabetes-obesity paper due to data manipulation

02-Sep-2015 - Amgen has retracted a study showing how grizzly bears could hold the key to understanding diabetes after one of the authors was found to have manipulated data.

Pfizer confirms it is evaluating Korea operations amid job cut rumours

02-Sep-2015 - Pfizer has confirmed it is in discussion with labour unions in Korea as part of an evaluation of its business in the country.

Progress seen In addressing US drug shortages, but challenges remain

31-Aug-2015 - New US drug shortages this year are running roughly at the same levels as the last two years, and far below the record highs seen earlier this decade, the US FDA told in-Pharmatechnologist.

Europe bans drugs tested by GVK; FDA monitors but keeps allowing sales

31-Aug-2015 - The US FDA has found no systemic issues affecting the safety or efficacy of generics clinically tested at GVK BioSciences, but says it supports Europe’s ban of around 700 products.

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.

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.

MHRA launches fees calculator

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

‘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.

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