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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.

‘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).

News in brief

Merck recalls 276,000 pill bottles

20-Aug-2015 - Merck & Co. has recalled two chemotherapy products because of cracked caps, including one it manufactures for Novartis’ Sandoz.

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.

Pharma plants strike in Pakistan to protest QC rule changes

19-Aug-2015 - Pakistani pharmaceutical manufacturers are today halting production in protest at changes to manufacturing regulations.

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).

Excipient manufacturers raise concerns over stability testing

13-Aug-2015 - Manufacturers of excipients are being sent inappropriate requests for stability data by some regulators and pharma companies, threatening to disrupt the supply chain, IPEC claims.

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.

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.

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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