JNJ acquisition of Aragon ARN-509 deals a blow to Medivation
Johnson & Johnson (JNJ) just announced the acquisition of privately-held Aragon Pharmaceuticals and the rights to ARN-509 a second-generation androgen receptor antagonist that will be a future competitor to Medivation’s Xtandi.
June 17, 2013
ABT-199 clinical trials suspended after patient death $ABBV
Following a death due to tumor lysis syndrome, AbbVie ($ABBV) have suspended the ABT-199 clinical trial program. ABT-199 is a promising new drug in development for chronic lymphocytic leukemia (CLL) that was about to enter phase 3 drug development by the company.
February 15, 2013
Court rules Medivation has no IP rights to Aragon Pharmaceuticals ARN-509 $MDVN
Medivation investors hoping for a windfall will be disappointed to hear that on December 20, 2012 a California judge ruled the company had no rights to what is now known as Aragon Pharmaceuticals ARN-509, a next-generation androgen receptor (AR) antagonist for advanced prostate cancer, similar in chemical structure to enzalutamide (Xtandi)
January 3, 2013
Using CSF Biomarkers for Differential Diagnosis of Neurological Diseases
Swedish researchers describe how a panel of five cerebrospinal fluid (CSF) biomarkers allowed the differential diagnosis of common dementia from Parkinsonian disorders.
August 30, 2012
Improving Clinical Trials through the use of Biomarkers
Biomarkers can be used for diagnosis and for monitoring the safety and effectiveness of treatments. They are increasingly becoming important in the selection of patients for clinical trials, and as potential surrogates for clinical endpoints that may take a long time to occur e.g. measuring how long someone will live in a cancer trial (overall survival).
August 29, 2012
Biosimilars could be a casualty of Supreme Court Health Care Decision
Biosimilar regulations could have been a casualty of Supreme Court ACA decision - fortunately this did not happen
June 26, 2012
Follow 2012 BIO CEO Investor Conference news on twitter #BIOCEO2012
Aggregation of tweets from #BIOCEO2012 conference in NYC
February 13, 2012
BioPharm America 2011 Biotech Partnering Conference #BPA11
Aggregation of tweets from BioPharm America 2011 - 4th International Biotechnology Partnering Conference in Boston.
September 7, 2011
Serious eye infections reopen Lucentis v Avastin debate
The FDA earlier this week issued a safety alert to doctors that repackaged bevacizumab (Avastin®) had caused serious eye infections in 12 patients in Florida.
September 2, 2011
$500M Google Online Pharmacy Settlement does not address why drugs are cheaper in Canada
Google have reached a settlement with the United States Department of Justice and will forfeit $500M in gross revenue received from Canadian online pharmacies advertising to US consumers through the Google AdWords program.
August 25, 2011
Letter from Boston
New England is the No 1 biotechnology region on the East Coast of the United States and the Boston/Cambridge area of Massachusetts is the hub.
August 1, 2011
BIO 2011 International Convention Video Review #BIO2011
A short video with reflections on BIO 2011.
July 1, 2011
BIO 2011 What is the future for innovative medicines in our industry’s pipeline?
What is innovation? Like "strategy" and "leadership" it’s a term we frequently use, something we all seek in the biotech/pharma industry, yet it’s hard to define, even harder to develop or predict.
June 28, 2011
BIO 2011: Ernst & Young Global Biotechnology Report 2011
One of the key issues that biotech companies continue to face is access to funding in order to sustain innovation.
June 20, 2011
BIO 2011: my top 10 sessions at the BIO International convention in Washington DC
My top 10 sessions at BIO reflect my personal interests in innovation, science and new product development
June 18, 2011
Results from NEJM Lucentis v Avastin AMD CATT clinical trial
The New England Journal of Medicine have published online the results of the Comparison of Age-related macular degeneration treatment trial (CATT) comparing the efficacy of FDA approved ranibizumab (Lucentis) to off-label bevacizumab (Avastin).
April 28, 2011
Justice Scalia had the bull by the horns in Sorrell v IMS Health oral argument – Vermont’s chance of winning appears low
The Supreme Court of the United States (SCOTUS) heard oral argument today in William Sorrell, Attorney General of Vermont versus IMS Health Inc., a case involving the right of Vermont to regulate the use of prescription drug data for marketing and sales purposes by pharmaceutical companies.
April 26, 2011
Can States regulate the use of pharmacy prescribing data? A preview of U.S. Supreme Court oral argument in Sorrell v. IMS
In 2007, Vermont passed a law that restricted the use of prescriber-identifiable (PI) data for marketing or promoting a prescription drug.
April 25, 2011
Lessons from Massachusetts Healthcare Reform
My summary of the key points from the MA healthcare reform panel at AHCJ 2011 in Philadelphia
April 25, 2011
Using Social Media to recruit for Cancer Clinical Trials
Richard Schilsky in Science Translational Medicine describes the challenges of enrolling patients into ever more complex cancer clinical trials. It is estimated that only 3-5% of cancer patients participate in clinical trials. Can social media be used to overcome barriers to enrollment?
April 21, 2011
BayBio 2011 Annual Conference on Powering Global Innovation
Twitter aggregation from Northern California's Life Science organization BayBio's annual meeting: 'Powering Global Innovation"
April 20, 2011
Letter from San Francisco
I was recently in San Francisco so thought I would continue my theme of writing about biotechnology regions that I visit around the United States.
March 5, 2011
AB Science – realizing the potential of masitinib in cancer and inflammation
Masitinib is a multi-kinase inhibitor that inhibits wild type and mutant forms of stem cell factor receptor (c-KIT, SCFR), platelet-derived growth factor (PDGFR), fibroblast growth factor 3 (FGFR3) and to a lesser degree, focal adhesion kinase (FAK)
February 23, 2011
Gilead acquires Calistoga and CAL-101 for $375M
In an acquisition that highlights the importance of cancer and inflammation, Gilead Sciences today announced the acquisition of Seattle based Calistoga Pharmaceuticals for $375M.
February 22, 2011
Is Orlando a future biotechnology region?
The opening of a new medical school, children’s hospital and medical research institute in Orlando will undoubtedly lead to biotechnology and biomedical companies considering start-ups in the surrounding area.
February 16, 2011
Austin’s growing and emerging biotechnology cluster
Austin, TX is an emerging and growing biotechnology cluster.
February 7, 2011
US Supreme Court to decide whether Vermont can control the use of prescribing data by IMS health and Pharma companies
The Supreme Court of the United States on January 7 decided to hear the case of Sorrell (Attorney General of Vermont) v. IMS Health Inc & Pharmaceutical Research and Manufacturers of America (PhRMA). This case is about whether States have the right to regulate how physician prescriber data is sold and used.
January 17, 2011
U.S. Supreme Court to decide if only statistically significant adverse events need to be disclosed to investors
At issue is whether knowledge of possible adverse events is material information that must be disclosed to investors, even if not statistically significant. The biotechnology industry argue that such a requirement would impose an unreasonable burden upon them and could lead to drugs not being developed.
January 11, 2011
Lilly completes acquisition of Avid Radiopharmaceuticals
Avid Radiopharmaceuticals is now a wholly owned subsidiary of Lilly. They have a novel imaging biomarker, florebetapir (18F-AV-45) in development for the detection of Alzheimer’s disease.
December 27, 2010
Can teriparatide be used to treat Osteonecrosis of the Jaw?
Because teriparatide activates bone remodelling it may have a role to play in the management of osteonecrosis of the jaw (ONJ).
December 20, 2010
Amphastar sues FDA
The race to bring a biosimilar version of Sanofi-Aventis' low molecular weight heparin, Lovenox® (enoxaparin sodium), to market had three players, Momenta Pharmaceuticals in partnership with Sandoz, Amphastar Pharmaceuticals and Teva.
October 27, 2010
Antares Pharma has promising gel based contraceptive
Antares Pharma has developed a gel based contraceptive that is as effective as taking a pill, acccording to data presented at the annual meeting of the American Society of Reproductive Medicine (ASRM) in Denver.
October 26, 2010
FDA may seek tighter standards for approval of generics
The news that generic companies may be subject to stricter FDA standards in order to show therapeutic equivalence is good news for the biotech industry and consumers.
October 25, 2010
Regeneron announces positive trial results for VEGF Trap-Eye in Diabetic Macular Edema (DME)
VEGF Trap-Eye is a formulation of VEGF Trap (aflibercept) and is an anti-angiogenic agent that can be injected into the eye to stop the proliferation of blood vessels.
February 23, 2010
AB Science plans Euronext IPO based on promise of masitinib
AB Science has grand designs to follow the growth strategy of biotech companies such as Genentech, Celgene and Biogen Idec.
February 22, 2010