Lori Clapper

A number of U.S. legislators are calling for legislation to make the overdose prevention pill naloxone more readily available in order to save lives.  Continue Reading..

The Argentinian government announced last week it will now allow finished pharmaceutical exports from Indian drug makers. Up until now, Argentina, which currently houses a $6-billion drug market, had only permitted imports of raw materials, not finished pharmaceuticals, from Indian firms due to local regulations.  Continue Reading..

The National Institutes of Health (NIH) is urging the medical, pharmaceutical, and biopharmaceutical industries to focus their studies on a select group of pediatric therapeutic areas and medical products they say are of “elevated need” for kids in 2014.  Continue Reading..

Sterile injectables company, Claris Lifesciences, announced last week that the MHRA approved its second manufacturing plant located in Ahmedabad, India. The company says the addition of a second facility will help improve its capacities and expand its presence in regulated markets, particularly the European Union (EU).  Continue Reading..

Last year, research from the University of Chicago was released that investigated the effect that patents have on pharmaceutical industry innovation, suggesting that patents could be responsible for distortions in research and development. Just this week, Forbes released its own article questioning the role patents play in pharma companies’ drug development decisions.  Continue Reading..

In a news conference last Wednesday, President Obama said Congress needs to help stop U.S. corporations from transferring their headquarters to acquired overseas companies, just to lower their taxes. It’ll be a tough argument, though, since the U.S. tax inversion rate is 35 percent, the highest in the industrialized world, according to a report in the Pittsburgh Post-Gazette — and the pharmaceutical industry in one of the biggest...  Continue Reading..

The Central Drugs Standard Control Organization (CDSC), which oversees drug approvals and clinical trials in India, released a letter last week outlining steps Indian drugmakers need to take to tighten inspection procedures, issue reports, and improve processes for qualifying inspectors. The regulator hopes its effort will increase confidence in the Indian pharmaceutical manufacturing industry globally as well as improve quality domestically,...  Continue Reading..

New data released from the U.S. Food and Drug Administration (FDA) last month showed that 2014 could very well be the biggest year for drug recalls in the past decade.  Continue Reading..

Despite going above and beyond its normal approval processes, UK’s National Institute for Health and Care Excellence (NICE) said “no” to Roche’s breast cancer drug Kadcyla. The organization said it had considered the cost-effectiveness of end-of-life cancer drugs, but concluded in final draft guidance that the price for Roche’s treatment was too high to be available through the NHS.  Continue Reading..

Celltrion filed an application with the U.S. Food and Drug Administration (FDA) last week for the first ever approval of a monoclonal antibody. Remsima, the company’s biosimilar version of Jannsen's Remicade (infliximab), is also the second filing of a biosimilar drug through the FDA’s new 351(k) biosimilar pathway.  Continue Reading..