Friday, June 26, 2015

This Week in BioPharma: 6/22-6/26

Here is the top news from the biopharmaceutical industry this week:

Organic Industry Wants Biotechnology Regulated By Process, Not Product: About 40 activist organizations that usually can be counted upon to rally with the organic industry against genetically engineered (GE) plants and animals weighed in with a letter to USDA’s Animal and Plant Health Inspection Service (APHIS) for the federal regulation of biotechnology products. Monday’s letter, which included some food company signatures as well as those from organizations, called for APHIS to “regulate biotechnology based process, not product.” The letter also called for adding noxious weeds to biotechnology regulations, which the signers want regulated to the “fullest extent.”

Saudi Engineer Invents Unique Biotechnology: Saudi engineer and inventor Ibrahim Alalim has 
come up with a new biotechnology to break down the composition of any animal fat, crude oil or any petrochemical product. “This biotechnology involves a liquid extract from vegetables that could be instrumental in coming up with products that will be useful in cleaning utensils, floors and marble,” Alalim said.

These are the Fortune 500's Fastest-Growing Pharma Companies: The pharmaceutical industry has been rocked in recent years by a confluence of patent expirations of blockbuster drugs, increasing competition from generics and new governmental and industry efforts to control costs the world over. That’s made growth prospects for many pharma companies a risky and uncertain proposition. 

The Importance of Real-World Data to the Pharma Industry: For years, randomized controlled trials (RCTs) were considered the gold standard for generating clinical data on efficacy and safety to support product registration and subsequent prescribing. Recently, analysts and academics have discussed the promise of real-world data (RWD), signalling its potential to contribute to improved health outcomes. Data's role in normal clinical practices, or in settings that reflect the reality of healthcare delivery, is likely to become increasingly important in ensuring that medicines are accepted by national policymakers and are adopted into practice.

Is the FDA Too Tough on Medical Device Makers?: In a new paper, “Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices,” Wharton health care management professors Matthew Grennan and Robert Town shed light on the question: Are the FDA’s medical device regulations too hard, too soft, or just right? Town recently sat down with Knowledge@Wharton to discuss their findings.

House Ignores Veto Threat and Backs Repeal of Medical Device Tax: The House on Thursday easily backed repeal of a tax on the medical device industry. But President Obama has threatened to veto the bill, which would add more than $24 billion to the deficit over the next 10 years. With not all House members voting Thursday, that chamber's 280-140 vote fell one vote shy of a veto-proof majority to repeal the tax, which helps pay for the expansion of health insurance under the 2010 Affordable Care Act.

Short Sellers Become More Focused on Big Pharma: The short interest data has been released for the June 15 settlement date. Pharmaceutical companies are usually involved in a lengthy process in getting their drug candidates to market through clinical trials. There is a fair amount of risk involved, should a study come back negative or a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be big upside.

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