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FDA proposes cGMP rule for combination products

29-Sep-2009 - The FDA is to establish current good manufacturing practice (cGMP) requirements for combination products to eliminate inconsistencies that could affect product safety and public health.

Controlled-release can deliver for generics firms, says Espicom

03-Sep-2009 - Wyeth’s battles to protect the controlled-release (CR) version of its anti-depressant Effexor are a sign of things to come according to a new Espicom report identifying 30 CR drugs likely...

Biosimilars market to be worth $19.4bn by 2014

03-Sep-2009 - The biosimilars sector is predicted to be worth $19.4bn (€13.6bn) by 2014, by which time the US will have overtaken Asia as the dominant market, according to a report.

Pfizer inaugurates new $214m Swedish biotech plant

26-Aug-2009 - Pfizer’s new $214.8 million (€150m) biotechnology facility in Strangnas, Sweden was inaugurated yesterday, securing the country’s future in the company’s manufacturing network according to global manufacturing president Natale Ricciardi....

Microneedle patch could boost compliance

24-Aug-2009 - Researchers have presented new microneedle drug delivery patches, which, using technology developed in the electronics sector, could improve compliance and treat ocular diseases.

Eastern Europe drug market worth $41bn by 2014; but rules complex

19-Aug-2009 - Eastern Europe’s pharmaceutical market is growing at an impressive rate, but the complex regulatory rules being introduced may make it a less attractive proposition that it first appears, according to...

West’s operating income drops in Q2

05-Aug-2009 - West Pharmaceutical Services’ operating income fell by 33 per cent in Q2 but the company reported that demand for some of its drug delivery technology is strong.

Positive Phase II for intranasal antiemetic

04-Aug-2009 - Shin Nippon Biomedical Laboratories (SNBL) has posted a positive first report on the Phase II trial of its intranasal antiemetic, which it claims is a more convenient treatment for cancer...

BioMarin: good news on Kuvan patents; bad news as costs hit Q2 profits

03-Aug-2009 - New US patents for the PKU drug Kuvan will “significantly strengthen” BioMarin’s position according to CEO Jean-Jacques Bienaime.

Medingo’s insulin patch approved; shares rocket

30-Jul-2009 - Medingo’s insulin dispensing patch has been approved by the US Food and Drug Administration (FDA), sending shares in its parent company soaring to a 12 month high.

News in brief

Wyeth shareholders OK Pfizer takeover

21-Jul-2009 -  Wyeth’s shareholders gave Pfizer’s $68bn (€48bn) takeover a ringing endorsement late yesterday, with 98 per cent voting in favour of the deal.

Pfizer may bid for Turkey’s Abdi Ibrahim

20-Jul-2009 -  Rumours suggest that US drug giant Pfizer is considering a bid for Turkish generics group Abdi Ibrahim as part of its strategy of expanding in emerging markets.

Pfizer plans Irish process lab, shelves SF unit and sells skin drugs to Graceway

07-Jul-2009 -  Pfizer will invest €11m ($15.3m) in a new kilo technology R&D laboratory at its API manufacturing facility in Ringaskiddy, Ireland.

News in brief

GSK buys 13 B-MS generics for North African market

06-Jul-2009 -  UK drug major GSK has paid Bristol-Myers Squibb’s (BSM) $23.2m (€16.6m) for 13 generic products that it sells in North Africa and the Middle East.

Mylan partners to create FOBs

30-Jun-2009 -  Mylan has followed Teva’s lead by partnering to develop follow-on biologics (FOB), with the Indian generic maker regarding Biocon as the “ideal partner” to help it enter the market. ...

Bio drugs to dominate top ten list by 2014

18-Jun-2009 - Seven of the top ten drugs will be biopharmaceuticals by 2014 according to sector analysts Evaluate Pharma.

Mega deals not ‘mega’ for Big Pharma R&D long term, says F&S

17-Jun-2009 - As rumours of a failed Sanofi Aventis’ bid for a US rival circulate, F&S’ analysis of M&As is well timed, even if its conclusions will be difficult reading for a...

FTC calls for biogenerics path and end of “pay for delay” deals

11-Jun-2009 -  The US Federal Trade Commission (FTC) believes that an effective FOB approval pathway and laws preventing “pay-for-delay” deals are the only ways of reducing the cost of biologic drugs.

FDA revises ICH Q8 guidance

10-Jun-2009 - The FDA has revised its guidance on ICH Q8, adding an annex that clarifies the original document and adds the principles of quality by design (QbD).

UK trade office may check GSK and Pfizer HIV joint-venture

28-May-2009 -  GSK and Pfizer’s HIV joint venture (JV) may be subject to an investigation by UK competition watchdog the Office of Fair Trading (OFT), according to various media reports.

BIO 2009: snapshot of an evolving biotech industry

22-May-2009 - in-Pharmatechnologist's Nick Taylor looks back on BIO 2009, an event at which uncertainty about the development of the biotechnology industry’s future shape dominated proceedings.

Healthcare reform could suffocate innovation; BIO 2009

22-May-2009 - Karl Rove and Senator Tom Daschle were among the political figures at BIO 2009 discussing how the US healthcare system should be reformed, which some believe could have grave consequences...

Biosimilar bill could be "stake in the heart"

19-May-2009 - In a session chaired by at BIO 2009 John Lechleiter, CEO at Eli Lilly, speakers discussed patent reform, biosimilar bills and why certain options on the table could be a...

Mutiple parameters are key to powder analysis, says Freeman

18-May-2009 -  Freeman Technologies, which showcased its FT4 Rheometer at Achema in Frankfurt, Germany, last week, says pharmaceutical powders are complex systems that require analysis of multiple parameters. 

Hospira calls time on US biogenerics delays

06-May-2009 -  Drug delivery specialist Hospira has set up a “biologics clock” that counts the amount spent on cell culture-derived medications in the US in a bid to highlight the potential savings...

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