DIA Global SmartBrief

Reading this on a mobile device? Try our optimized mobile version here: http://r.smartbrief.com/resp/ekwGCfbwocfCdasVdDTk

February 19, 2013

Forward

Archive

Advertise

News on diagnostic and therapeutic innovations and regulatory science

Top Story

Bureaucracy in India sends drugmakers elsewhere for clinical trials
Drugmakers and industry experts say a slowdown in approvals and an unstable regulatory environment have made India less attractive for clinical trials. Piramal and other India-based drugmakers are looking abroad for clinical trial sites. Reuters (2/12)

Europe

Europe anticipates spike in applications for advanced therapies
Despite past concern over whether new regulations were slowing the growth of advanced therapy medical products, the European Medicines Agency foresees a substantial increase in applications for such advanced treatments in the next five to 10 years, based on the robust R&D pipeline, the agency reports. The agency also said it would focus this year on increasing awareness of the certification procedure for advanced medical therapy products. Clinica (2/15)

Asia Pacific

Researchers report progress with experimental dengue vaccine
Researchers at the International Centre for Genetic Engineering and Biotechnology in New Delhi said they are making strides with a vaccine for the dengue virus, which is being developed with technology used to make hepatitis B vaccine. Preclinical tests showed the vaccine addressed all four dengue virus strains, researchers said. Human trials are estimated to be at least five years away. Deutsche Welle (Germany) (2/14)

Japanese drugmakers eye collaboration with Indian drug companies
Representatives of Japanese drug companies attending a trade meeting in New Delhi expressed their willingness to collaborate with Indian pharma companies in such areas as marketing, research and product development. "We are looking for long-term partnerships with Indian companies," said Hamano International President Shoichiro Hamano. The Economic Times (India) (2/13)

North America

Prescription drug costs rise 3.6%
Figures from the Bureau of Economic Analysis show that prescription drug costs increased 3.6% last year, rising faster than inflation and other health care costs. Prices of branded treatments are driving the increase and offsetting rising use of generic drugs. USA Today (2/13)

Increase limits on pain drugs, lawmakers say to FDA
The FDA should increase restrictions on painkillers, a bipartisan group of senators and representatives says in a letter to the agency. The lawmakers want to see a time frame for the reclassification of hydrocodone drugs from Schedule III to Schedule II. "The American people have waited too long for action from this agency," the lawmakers wrote. The Hill/RegWatch blog (2/15) , Pharmalot.com/Pharma Blog (2/15)

Anti-biosimilars bill advances in Colo.
A Colorado House committee passed a bill that would restrict pharmacists' ability to substitute less-expensive biologic drugs for those sold under brand names. Substitution would be allowed only if the FDA has deemed the biosimilar interchangeable with the brand-name drug for the specific indication and if the prescribing doctor allows the substitution. American City Business Journals/Denver (2/13) , Pharmalot.com/Pharma Blog (2/13)

Global

Jordan's pharmaceutical exports post substantial 2012 gains
Despite challenges with accessibility, security, shipping and logistics brought on by the Arab Spring, the pharmaceutical industry in Jordan registered a 20% increase in exports in 2012. If the sector continues to grow, it could reach total sales of $1 billion by 2015, according to Mohammad Ali Shahin of the Jordan Chamber of Industry. Arabian Gazette (United Arab Emirates) (2/17)

FDA accelerates review of ViiV's HIV/AIDS drug dolutegravir
ViiV Healthcare, a joint venture of GlaxoSmithKline, Pfizer and Shionogi, obtained priority-review status from the FDA for its investigational daily HIV/AIDS treatment dolutegravir. The drug is an integrase inhibitor that keeps HIV out of cells. The FDA is set to decide on the drug's approval by Aug. 17. Yahoo/Reuters (2/16)

Australia reviews patent lengths in face of "patent cliff"
The expiration of a large number of drug patents in the next five years -- the so-called "patent cliff" -- could strip an estimated $148 billion in revenue from the world's top drug companies. Australia, which lets drug patents expire after 20 years, is reviewing its laws to see if the time frame provides a reasonable balance between innovation and competition. In its comments to the Australian government, GlaxoSmithKline advocated enhanced patent protection, as well as manufacturing and clinical research incentives, to "encourage future investment in Australia and improve Australian patients' access to new health technologies." WA Today (Australia) (2/16)

DIA News

United in diversity

Europe is a diverse region with a variety of challenges to face in health care. The EMA Roundtable at the EuroMeeting 2013, titled, “Scientific Committees United in Diversity,” will highlight how the EU Scientific Committees come together and interact at the European Medicines Agency to foster scientific excellence in the evaluation and supervision of medicines for the benefit of public health, while being enriched by the EU’s many different cultures and traditions. The session, chaired by Hans-Georg Eichler, senior medical officer at the EMA, will be held on March 6 during the three-day conference in Amsterdam. Download the conference program.

An opportunity to share research

Regulators have thrown the spotlight on drug classes and therapeutic areas associated with cardiovascular toxicity. New regulations have been introduced in some major regulatory jurisdictions to assess and mitigate such adverse cardiac drug effects. This and other key topics in cardiac safety will be discussed at the 4th Cardiac Safety Workshop in Tokyo from July 11 to 12. Submit your abstract before Feb. 28.

Learn more about DIA ->

About DIA | Meetings & Trainings | News & Publications | Membership

SmartQuote

You will become as small as your controlling desire; as great as your dominant aspiration."

--James Allen,
British author

Subscriber Tools

Print friendly format | Web version | Search past news | Archive | Privacy policy

Advertise

Account Director, Life Sciences: Meryl Harold (202) 407-7828