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ACRO urges FDA to expedite modernizing clinical trials | Bioeconomy report sets White House agenda | FDA approves Novartis' Afinitor as renal angiomyolipoma treatment
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April 27, 2012
FDLI SmartBrief
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Drugs & Biologics
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Drugs & Biologics
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ACRO urges FDA to expedite modernizing clinical trials
The Association of Clinical Research Organizations asked the FDA to accelerate the modernization of regulations covering U.S. clinical trials. Though there have been some advances in "developing basic building blocks," product development is still expensive, unproductive and slow, ACRO said. The group suggested the FDA hire a chief innovation officer who has the power to authorize new approaches to trials.
PharmaTimes (U.K.) (4/26) 
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Bioeconomy report sets White House agenda
The National Bioeconomy Blueprint released Thursday lays out proposals to encourage growth in bio-based industries. Among the initiatives are a USDA expansion of the federal BioPreferred procurement program, an effort to expand FDA medical device reviewers' knowledge of emerging technologies and a Homeland Security program to use genomics-based microbial analysis.
GenomeWeb Daily News (free registration) (4/26),  Forbes (4/26) 
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FDA approves Novartis' Afinitor as renal angiomyolipoma treatment
The FDA approved Novartis' Afinitor, or everolimus, to treat renal angiomyolipomas in patients with tuberous sclerosis complex. The drug previously was approved for patients with advanced renal cell cancer who failed to respond to treatment with Onyx Pharmaceuticals and Bayer HealthCare Pharmaceuticals' Nexavar or Pfizer's Sutent.
Medscape (free registration) (4/26),  Fox Business/Dow Jones Newswires (4/26) 
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GSK's soft-tissue sarcoma drug Votrient gains FDA approval
GlaxoSmithKline's Votrient obtained FDA approval to treat patients with soft-tissue sarcoma who already received chemotherapy. Votrient has orphan-drug status, giving GSK seven years of market exclusivity.
Reuters (4/26) 
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FDA panel will review Onyx's myeloma drug carfilzomib June 20
Onyx Pharmaceuticals said an FDA advisory panel is set to meet June 20 to review carfilzomib as treatment for relapsed and refractory multiple myeloma. The FDA has until July 27 to decide whether to approve the drug.
MyelomaBeacon.com (4/26) 
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FDA user fee act is an opportunity to maintain innovation
America's medical research system operates like an ecosystem with four vital components: intellectual property protection, open access to markets, free-market pricing and a predictable regulatory system, writes Eli Lilly & Co. CEO John Lechleiter. With reauthorization of the Prescription Drug User Fee Act, Congress has an opportunity to "achieve a higher standard of transparency and accountability at the FDA, and provide the agency with the resources it needs to keep pace with emerging medical discoveries," Lechleiter writes.
Forbes (4/25) 
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Repligen announces setback for pancreatic drug
The FDA called off a May 31 panel meeting regarding Repligen's new-drug application for RG1068, an imaging agent that spots abnormalities in pancreatic ducts. "We intend to continue our dialogue with the FDA to assess a potential path forward for RG1068," CEO Walter Herlihy said.
The Wall Street Journal (tiered subscription model) (4/26) 
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EndoSphere obtains EU approval for anti-obesity device
EndoSphere has earned CE Mark approval to market an incisionless anti-obesity device, called Satisphere, in Europe. The device, which is implanted in the small intestine via an endoscope, is designed to help patients shed excess weight without the need for drugs or surgery.
MedCity News (4/26) 
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Senate committee raises FDA's discretionary fund
The Senate Appropriations Committee has cleared a $22 million increase in the FDA's discretionary budget for fiscal year 2013. The boost in funding approved by the group is allocated specifically for the enforcement of the Food Safety Modernization Act, according to the committee. "This funding level takes into consideration the federal government's responsibilities to protect public health and safety, especially in the areas of food, drugs, medical devices and biologics," the committee said.
Food Safety News (4/27) 
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Medical Devices
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Bill seeking stronger FDA oversight of medical devices advances
A Senate panel on Wednesday cleared a bill that would allow the FDA to evaluate the safety of approved medical devices and give conditional approvals dependent on further studies. The measure also would tighten the agency's 510(k) process that permits firms to prove the similarity of their devices to products already approved without needing extensive trials.
MassDevice (Boston) (4/25) 
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Latest version of GE's cardiovascular ultrasound wins FDA nod
GE Healthcare has received FDA clearance for Vivid E9 Breakthrough 2012, the latest version of its cardiovascular ultrasound device. The newly approved product, which features a 4D transducer, is designed for use in transeophageal echocardiography, mitral valve repair and related procedures.
Health Imaging online (4/30) 
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FDA approves advanced laser sheath from Spectranetics
The FDA has given Spectranetics approval for its next-generation GlideLight Laser Sheath. The device allows more accurate control and less force for safer extraction of cardiac leads.
Reuters (4/25) 
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HeartWare's cardiac pump gains support of FDA panel
A panel of FDA advisers voted in favor of approving the HeartWare ventricular assist device, a blood pump tailored for use in severe heart failure patients awaiting transplants. The panel concluded that the device was helpful in saving lives, but urged HeartWare to run additional safety studies if it obtains FDA approval.
Reuters (4/26) 
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Tobacco
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Major tobacco firms fund fight against Prop 29 in Calif.
R.J. Reynolds and Philip Morris are contributing to a campaign to vote down Proposition 29, which would impose a $1 tax increase to packs of cigarettes sold in California. The measure would enable the state to generate funds for cancer research. The new tax is estimated to translate to a yearly loss of $1 billion in tobacco sales.
San Jose Mercury News (Calif.) (4/27) 
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Food and Drug Law Institute Highlights
Don't miss Introduction to Medical Device Law in Palo Alto, Calif., in June
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theLINK: A Comprehensive FDA Directory -- save $250 on your online subscription
FDLI's FDA directory, theLINK, is a comprehensive directory of FDA employees and select employees of other agencies including USDA, FTC, CMS, CDC and AHRQ. Its unique functionality makes it a must-have, go-to resource for companies, law firms, libraries and every food and drug law professional. theLINK is continuously updated, well organized, accessible in print and online, and has detailed information on the roles and duties of employees and offices. Learn more and save up to $250 on your new subscription.
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