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...
View ArticleFDA 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...
View ArticlePharma 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...
View ArticlePatent 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...
View ArticlePharma & 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...
View ArticlePharma & 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 ---...
View ArticleProtecting 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,...
View ArticleBiotech 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...
View ArticleSCOTUS: 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...
View ArticleSuccessful 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...
View ArticleIntegrating 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...
View ArticleSupremes 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...
View ArticleGenetic 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...
View Article97 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...
View ArticleBionics 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...
View ArticleBristol-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...
View ArticleHybrigenics 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...
View ArticlePharmaceutical 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...
View ArticleGilead 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...
View ArticleThe 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...
View Article
More Pages to Explore .....