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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