Like Minded People
2.247
PORTFOLIO ITEMS
158
FEATURED ARTICLES
28.731
DAILY SEARCHES
Like Minded People
2.247
PORTFOLIO ITEMS
158
FEATURED ARTICLES
28.731
DAILY SEARCHES
Recently Posted Blogs
- All
- Analytical Discussion
AstraZeneca today announced a collaboration with the Montreal Heart Institute (MHI) in Quebec, Canada, to search the genomes of up to 80,000 patients for genes associated with cardiovascular diseases and diabetes, their complications and treatment outcomes. This is one of the largest such screens of its type to date and will drive understanding of the biological mechanisms underlying these conditions […]
F2 parameter is widely used parameter in drug dissolution testings where it is often used to predict similarity of two dissolution profiles. F2 factor In short, two profiles are considered identical when f2=100. An average difference of 10% at all measured time points results in a f2 value of 50. A public standard of f2 value between 50-100 to indicate similarity […]
The FDA cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation. This expanded use allows healthcare providers to use one or two negative Xpert MTB/RIF Assay test results to help them determine whether a patient showing signs and symptoms of pulmonary TB should continue to be […]
Pharmaceutical Technology‘s 2015 Solid Dosage and Excipients eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms. Issue topics include: Advances in Tableting Analytical Techniques for Efficient OSD Formulation Improving Pharmaceutical Palatability Improving Efficiency in Hot Melt Extrusion and Spray […]
The new ICH Q3D Guideline for Elemental Impurities has initiated reviews and changes in quality testing programs in bio/pharmaceutical companies around the world. Companies need to assess the risks of potential elemental impurities in their process and materials streams. In this webcast, experts review the requirements of elemental impurities guidelines, practical recommendations to address implementation challenges, and key considerations for […]
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment. Register free: www.pharmtech.com/pt/stabilitySponsored by Patheon
This webcast invites all pharmaceutical scientists and formulators from R&D and analytical departments that have an interest in the solubilization of poorly soluble drugs, and in understanding the importance of choosing a proper dissolution method in the solubilization tests to reveal the full potential of the tested solubilization method. Register free www.pharmtech.com/dissolutionSponsored by BASF
Strategies and case studies on Systematic and Efficient Analytical Method Development for A Speedy Clinical Product Development presented by experts at Patheon. Learn how to accelerate your first-in-man studies with a deliberate approach to analytical method development for early stage drug products. Register free www.pharmtech.com/efficientSponsored by Patheon
Recently Posted Blogs
- All
- Analytical Discussion
AstraZeneca today announced a collaboration with the Montreal Heart Institute (MHI) in Quebec, Canada, to search the genomes of up to 80,000 patients for genes associated with cardiovascular diseases and diabetes, their complications and treatment outcomes. This is one of the largest such screens of its type to date and will drive understanding of the biological mechanisms underlying these conditions […]
F2 parameter is widely used parameter in drug dissolution testings where it is often used to predict similarity of two dissolution profiles. F2 factor In short, two profiles are considered identical when f2=100. An average difference of 10% at all measured time points results in a f2 value of 50. A public standard of f2 value between 50-100 to indicate similarity […]
The FDA cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation. This expanded use allows healthcare providers to use one or two negative Xpert MTB/RIF Assay test results to help them determine whether a patient showing signs and symptoms of pulmonary TB should continue to be […]
Pharmaceutical Technology‘s 2015 Solid Dosage and Excipients eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms. Issue topics include: Advances in Tableting Analytical Techniques for Efficient OSD Formulation Improving Pharmaceutical Palatability Improving Efficiency in Hot Melt Extrusion and Spray […]
Member Activity
-
Pharma Live wrote a new post
The astoundingly wonderful radio program/podcast Radiolab just recently had an episode called“Worth” — which included a few different stories trying to establish how much something is truly “worth.” The first story in the collection talked about how much extra time...
-
Pharma Live wrote a new post
NOVARTIS spent nearly 15 years seeking a patent in India for Glivec, a medicine for chronic myeloid leukemia. That quest reached its dead end, at last, on April 1st. India’s Supreme Court rejected the Swiss drugmaker’s patent application. Glivec...
-
Pharma Live wrote a new post
POSTED BY JACOB D. MOORE AND COURTENAY C. BRINCKERHOFF ON 21 MAY 2015POSTED IN FEDERAL CIRCUIT DECISIONS;INFRINGEMENTOn May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval...
-
Pharma Live wrote a new post
POSTED BY COURTENAY C. BRINCKERHOFF ON 19 MAY 2015POSTED IN FEDERAL CIRCUIT DECISIONS;INFRINGEMENTThe Federal Circuit issued its remand decision in Akamai Technologies, Inc. v. Limelight Networks, Inc., this time affirming the district court decision that Limelight was not liable for infringing Akamai’s patents...
-
Pharma Live wrote a new post
POSTED BY COURTENAY C. BRINCKERHOFF ON 14 MAY 2015POSTED IN FEDERAL CIRCUIT DECISIONSIn Sukumar v. Nautilus, Inc., the Federal Circuit took its first look at the standing requirements to bring a false marking case under the America Invents Act (AIA). The court rejected...
-
Pharma Live wrote a new post
POSTED BY COURTENAY C. BRINCKERHOFF ON 12 MAY 2015POSTED IN ANTITRUSTIn In Re Cipro Cases I & II, the California Supreme Court laid out a four-part rule of reason analysis for evaluating ANDA settlements that involve a reverse payment to the generic challenger...
-
Pharma Live wrote a new post
POSTED BY COURTENAY C. BRINCKERHOFF ON 23 APRIL 2015POSTED IN BIOSIMILARSAmgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. (I wrote about the court’s decision in this article.) The...
-
Pharma Live wrote a new post
POSTED BY COURTENAY C. BRINCKERHOFF ON 23 MARCH 2015POSTED IN BIOSIMILARSJudge Seeborg of the U.S. District Court for the Northern District of California issued an order inAmgen, Inc. v. Sandoz, Inc., ruling that the patent dispute resolution procedures of the Biologics Price Competition and Innovation Act...
-
Pharma Live wrote a new post
POSTED BY COURTENAY C. BRINCKERHOFF ON 10 MARCH 2015POSTED IN BIOSIMILARSWhile Sandoz has grabbed the biosimilar headlines for being the first company to have a product approved under the Biologics Price Competition and Innovation Act (its product Zarxio™ (filgrastim-sndz) is a biosimilar of Amgen’s Neupogen®...
-
Pharma Live wrote a new post
POSTED BY COURTENAY C. BRINCKERHOFF ON 9 FEBRUARY 2012POSTED IN BIOSIMILARSOn February 9, 2012, the FDA issued long-awaited (draft) guidance documents on biosimilars. The three guidance documents address scientific considerations, quality considerations, and implementation of the Biologics Price Competition and Innovation Act...
-
Pharma Live wrote a new post
POSTED BY COURTENAY C. BRINCKERHOFF ON 24 FEBRUARY 2015POSTED IN CLAIM CONSTRUCTION;FEDERAL CIRCUIT DECISIONSPacing Technologies, LLC v. Garmin International, Inc. is one of those Federal Circuit decisions that may send patent practitioners running to their files to double-check the phrasing used in their...
-
Pharma Live wrote a new post
POSTED BY COURTENAY C. BRINCKERHOFF ON 22 JANUARY 2015POSTED IN CLAIM CONSTRUCTION;SUPREME COURT DECISIONSOn January 20, 2015, the Supreme Court issued its decision in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., finding that the Federal Rules of Civil Procedure call for some deference in...
-
Pharma Live wrote a new post
POSTED BY JUSTIN M. SOBAJE ON 19 MAY 2015POSTED IN DIVIDED INFRINGEMENT;DIVIDED INFRINGEMENT;PATENTS;PLEADINGS;SUPREME COURTIt has been about a year since the Supreme Court rendered its decision in Limelight v. Akamai regarding induced infringement for methods performed by two or more actors. At that time, commentators...
-
Pharma Live wrote a new post
POSTED BY COURTENAY C. BRINCKERHOFF ON 26 FEBRUARY 2014POSTED IN FDAIn a Federal Register Notice dated February 24, 2014, the U.S. FDA announced a draft guidance for industry that will provide a 5 year NCE exclusivity period to fixed-combination drug products that include at...
-
Pharma Live wrote a new post
POSTED BY COURTENAY C. BRINCKERHOFF ON 7 AUGUST 2014POSTED IN ANTITRUST;FDA;FEDERAL CIRCUIT DECISIONSIn Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust...
-
Pharma Live wrote a new post
POSTED BY COURTENAY C. BRINCKERHOFF ON 3 NOVEMBER 2011POSTED IN FEDERAL CIRCUIT DECISIONS;PATENT TERM EXTENSIONI wrote previously about the patentability issues raised in Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc., and Novartis’ ability to rely on unexpected results discovered after the filing date...
-
Pharma Live wrote a new post
Regenerative Sciences, a medical company that pioneered a procedure to treat orthopedic injuries using patients’ own stem cells, is fighting the Food and Drug Administration tooth and nail over a claim that human cells should be federally regulated as...
-
Pharma Live wrote a new post
ABOUT AUTHORS:Kamshette Sharada*, Poul Bhagwat, Ghodke AmolDepartment of Quality Assurance,Maharashtra College of Pharmacy,Nilanga, Maharashtra, India.*[email protected] ABSTRACTSimply receiving a diagnosis of a rare disease often becomes a frustrating quest, since many doctors may have never before heard of or seen the...
-
Pharma Live wrote a new post
-
Pharma Live wrote a new post
- Load More Posts