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Pharma Law and Business Roundup: June 2013

After years of debate and controversy, the US Supreme Court ruled that drugmakers can face lawsuits over so-called pay-to-delay patent settlements, but that such deals should not necessarily be assumed...

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FDA Approves New Labeling for Merck Blockbuster HIV Drug ISENTRESS

This newly approved, updated prescribing information for ISENTERSS now includes 240-week results from the STARTMRK study, the double-blind Phase III study that evaluated integrase inhibitor in...

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Pharma Update July 2013: FDA, Preemption & SCOTUS

The FDA is following through on plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current regulations that prevent generic...

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Patent News and Notes

1. Reed Tech takes over USPTO Contract from Google. 2. Pharma Patent Settlements Saved $25.5 Billion for US Health System. 3. Coffee Analysis Smart Phone App for that Perfect Brew. 4.FDA Approves Brain...

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Pharma & Biotech News for September 2013

Mark Lemley's Firm Files DJ Against Myriad in Northern California ----- Promise Not to Infringe Insufficient in ANDA Litigation ----- Licensing Deals Stall in Pharmaceutical Sector in First Half of...

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Pharma & Biotech Update: News for October 2013

Mouse Model of Parkinson's Disease Shows Improved Brain Function --- DARPA Awards $25 Million To Develop Messenger RNA Therapeutics™ --- Actavis Files ANDA for Generic Suboxone® Sublingual Film ---...

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Protecting Data Exclusivity, Protecting the Future of Medicine

Traditionally, “small molecule” drugs are patent protected for a twenty-year term. Biologic medicines, however, are more difficult to comprehensively protect with patents due to their size, complexity,...

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Biotech and Pharma Update: January 2014

Kava Plant May Prevent Cigarette Smoke-induced Lung Cancer *** Conditional Approval for Treatment of T-cell Lymphoma in Dogs *** All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C...

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SCOTUS: FDA Regulations No Bar to Lanham Act Claims

The Supreme Court reversed a decision from the Ninth Circuit that held that within the realm of labeling for food and beverages, a Lanham Act claim asserting that the label is deceptive and misleading...

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Successful Phase 1 Trial for Parkinson’s Vaccine

The study looked at groups of patients receiving various levels of the PD01A vaccine and evaluated them over a 12-month period. Patients receiving the vaccine were given PD01A subcutaneously in four...

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Integrating the Federal R&D System into the Economy

We have made significant strides over the past 30 years through laws like the Bayh-Dole Act, the Federal Technology Transfer Act, and supporting Executive Orders leading to the creation of 9,000 new...

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Supremes Say Reverse Payments May Be Antitrust Violation

On Monday, June 17, 2013, the United States Supreme Court issued its much-anticipated decision on so-called “reverse payments.” This decision will impact how brand name drug companies and generics...

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Genetic and Stem Cell Therapies to Treat Cancers

There are certainly some signs for hope. One of them came recently from Princeton University, where graduate students worked on a project which identified a treatment for blocking an enzyme which is...

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97 percent of Internet pharmacies pose a public safety threat

Unfortunately, the high cost of pharmaceutical medications is why about 50 million adults between the ages of 19 and 64 do not fill out a prescription every year. Medications purchased over the...

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Bionics are starting to reverse vision loss and restore sight to the blind

There have been reports of technological advances which could make bionic vision a reality. One company, Occumetrics Technology Corp. of British Columbia, Canada, has been making a stir with claims of...

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Bristol-Myers Squibb, Exelixis drugs to aid in fight against kidney cancer

Bristol-Myers Squibb was able to move on in clinical trials of its cancer drug Opvido more quickly than anticipated after kidney cancer patients who were administered the medication showed superior...

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Hybrigenics gets Orphan Drug designation for the treatment of Acute Myeloid...

Hybrigenics (ALHYG), a French bio-pharmaceutical company with a focus on research and development of new treatments against proliferative diseases, has announced that the Food and Drug Administration...

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Pharmaceutical greed makes Martin Shkreli public enemy #1

On August 10th, the rights to sell Daraprim were bought from Impax Laboratories Inc. (NASDAQ:IPXL) of Hayward, CA, by Turing Pharmaceuticals, a privately held company with headquarters in New York City...

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Gilead Sciences continues to produce new pharmaceuticals to treat hepatitis...

Although not a prolific filer of U.S. patent applications, Gilead does currently holds 2,131 active patent grants according to data collected by Innography... Despite all of the recent focus on...

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The future of agricultural pest control is biopesticides, IoT insect...

The Internet of Things has been lauded as a potential boon for crop production, including pest control. Automated IoT pest control systems have been developed by Spensa of West Lafayette, IN. Its...

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