Romania investigates suspected drug company bribes
04 August 2015
Romanian anti-corruption prosecutors have conducted a series of searches at drug companies, hospitals and clinics this week to investigate suspected bribes paid to doctors for prescribing cancer drugs.
Scientists create noninvasive spinal stimulation tech to help paralyzed move
04 August 2015
Spinal cord stimulation is the med tech trend du jour, and researchers are harnessing the technology to create a noninvasive method that helps restore movement in paralyzed individuals.
Europe's public biotechs blast past 2014 fundraising total in just 6 months
03 August 2015
Biotechs listed on European stock exchanges have raised more money in the first half of 2015 than in all of last year, according to a report by Biocom. Over the first 6 months of 2015, €3 billion ($3.3 billion) flowed into Europe's 161 listed biotechs, one-quarter more than they added to their coffers in all of 2014.
Regulators in Europe propose bans on plants in China and India
03 August 2015
FDA actions taken against Indian drugmakers have grabbed a lot of attention in recent years, but Europe has also been pushing foreign suppliers to hit higher standards. Each country does its own inspections but then shares any issues it finds through a common website. Most recently, Italy flagged problems with three plants, two in China and one in India.
Report Calls for Measures to Preserve India’s Brand in Global Pharma Market
03 August 2015
A new report to the government of India suggests the adoption of a slew of measures to help domestic pharma firms, especially small firms that form the bulk of the industry, better understand the global regulatory landscape and meet compliance standards in advanced countries.
FDA issues draft guidance on quality manufacturing metrics
03 August 2015
After years of dealing with avoidable manufacturing issues that led to questionable meds and drug shortages, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), initiated the Office of Pharmaceutical Quality last January. The idea is for it to work up guidelines that will push even reluctant drugmakers toward quality manufacturing and establish a risk-based method for setting inspections. The office is now providing an idea of how that will work.
Trans-Pacific Partnership impasse on data exclusivity for biologics softens
31 July 2015
Negotiations in Hawaii to reach an agreement on the Trans-Pacific Partnershiptrade pact appear to have made some headway on the thorny issue of data exclusivity for biologics with Australia and other countries opposed to the United States' 12-year standard now willing to consider 8 years, Nikkei Asian Reviewreports.
No 'duh': Obvious answer to drug R&D is not so easy to implement
31 July 2015
The answer to reducing the cost and time of developing drugs for unmet needs seems pretty obvious – a better understanding of the disease, the patient and the molecule being developed.
Innovative drugmakers take note, China plans national serious illness insurance rollout this year
30 July 2015
Last week, China approved the rollout of medical insurance on serious illness nationwide, said Liang Wannian, vice-director of the medical reform office under the State Council and a senior official with China's National Health and Family Planning Commission, at a July 24 policy briefing.
Foresite Capital reloads with a $450M biotech venture fund
30 July 2015
Venture investor Foresite Capital closed a $450 million new fund, its largest ever, and is setting out to find the next generation of promising drug developers. Foresite's latest raise follows a $300 million fund put together last year and a $100 million close in 2013. Since its foundation in 2011, Foresite has made bets on public and private companies alike, searching for "transformative products" in biotech and med tech, CEO Jim Tananbaum said.
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