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EVENTS
22 March 2010
London, UK
12 April 2010
Orlando, Florida
13 April 2010
London, UK
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DIRECTORY Scrip Directory 2009
Health Canada finalises guidance on biosimilars
Today
Health Canada has issued its much-awaited final guidance on the authorisation of subsequent entry biologics (SEBs), also referred to as biosimilars or follow-on biologics in some jurisdictions. The final document builds on two draft versions of the ...
MannKind's inhaled insulin Afrezza hit with US FDA complete response letter
Today
Shares in the US company MannKind dropped by 25% earlier this week as investors reacted to a US FDA complete response letter for its inhaled rapid-acting insulin product Afrezza (formerly Afresa). The product is awaiting a decision for the ...
The US FDA reorganises its review functions
16 March 2010
The US FDA has realigned various review functions of its six Offices of Drug Evaluation (ODE) within the Center for Drug Evaluation and Research's Office of New Drugs in order to enhance the logical groupings of applications. The realignment, which ...
FDA panel backs InterMune's pulmonary fibrosis drug Esbriet despite reservations
10 March 2010
By a decisive 9-3 vote, the US FDA 's advisory committee on pulmonary drugs on March 9th recommended that the agency approve the new drug application (NDA) from InterMune to market as a treatment its drug Esbriet (pirfenidone) to reduce the decline ...
FDA criminal division may increase misdemeanour prosecutions against execs
10 March 2010
The US FDA may in the future look to increase prosecution of "responsible corporate officials" in both the pharmaceutical and food industry, Commissioner Margaret Hamburg has stated in a letter, which followed a scathing new government report ...
 
Market Insight - Pharma sector in Turkey to shrink 25% under tough conditions
02 March 2010
The pharmaceutical industry has long eyed Turkey as one of its key emerging markets, but recent government action, which could see medicine access delayed by years, is giving it a wake-up call, ...
Market Insight - Fear gives way to prudence as VCs eye return of bull biotech market
19 February 2010
2009 was a bad year for investment in the biotech sector, with venture capital funds fleeing to safer havens and many small firms struggling to get enough financing to keep their R&D projects afloat. ...
Market Insight - Microdosing reaching a tipping point?
05 February 2010
Advocates of microdosing, a technique that involves testing very small doses of products in humans, think it will improve the efficiency of drug development by flagging at an early stage those ...
 
Light Sciences Oncology - making light-activated drug therapy a commercial reality
12 March 2009
As Dr Keltner pulled out what looked like a computer mouse from his briefcase, I was surprised to hear him say it was in fact Litx, the company's innovative light-activated drug technology. It didn't ...
Japan's biosimilar guidelines edge forward
18 February 2009
Japan's regulator, the PMDA , expects to finalise a new guideline for the regulation of follow-on biologics this year, following the first draft put out for public comment last September. This ...
New BTG propels itself for growth
20 January 2009
BTG , the UK's largest speciality pharmaceutical company, has bounced back from a recent dip in its share price, and has set its sights on becoming the next Shire . Earlier this month, BTG's stock ...
 
GSK's malaria vaccine sails towards uncharted territory
05 November 2009
GlaxoSmithKline will enter unknown regulatory waters when it eventually comes to seek approval of its paediatric malaria vaccine, RTS,S, the most advanced in development for this disease. The ...
Commentary - EC final report: bark worse than bite?
23 July 2009
On July 8th, 2009, the European Commission reported on its 18-month inquiry into competition in the pharmaceuticals sector. Bill Batchelor of Baker & McKenzie 's Brussels antitrust practice ...
Commentary: Japan's regulator has a plan, but needs to live up to it
04 June 2009
Scrip's Asia editor Ian Haydock casts a critical eye over a new international plan from Japan's regulator, the PMDA. Scrip's Tokyo-based Asia editor Ian Haydock Last month, Japan's drugs and ...
 
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