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Biotech Strategy Blog – the year of the paywall

Thank you to all our subscribers for a great year!

September 17, 2014
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Cellectis CSO CEO

Can Cellectis Revolutionize CAR-T cell immunotherapy?

Cellectis is a Paris based biotechnology company with a “blue ocean” strategy that, if successful, could revolutionize cancer immunotherapy.

July 7, 2014
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Liverpool World Heritage Waterfront

Can Liverpool become a global biomedical hub?

Liverpool like many UK cities with a teaching hospital and local universities is trying to grow and develop companies in the life sciences sector, but can it compete with the "Golden Triangle"?

April 21, 2014
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Foundation Medicine ASH 2013

Insights on Foundation Medicine and how molecular testing will transform cancer research

Increasingly, we are seeing the evolution of diagnostic tests in cancer research. Foundation Medicine are using their gene sequencing platform to identify actionable mutations and assist oncologists make better treatment decisions for their patients.

January 8, 2014
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St Jude Penn Legal Case Citation

Juno Therapeutics takes on Penn in dispute over St Jude Chimeric Antigen Receptor Patent

Start-up Juno Therapeutics is now in control of a legal dispute between St Jude Children’s Hospital and the University of Pennsylvania over chimeric antigen receptor (CAR) T cells intellectual property that contributed to the development of CTL019 licensed by Penn to Novartis. Penn are seeking to invalidate a St Jude patent that if upheld, CTL019 may infringe.

January 6, 2014
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Fall NYC Central Park

FDA Breakthrough Therapy Designation Benefits – part 2 of an interview with John Jenkins

FDA Office of New Drugs Director John Jenkins discusses the benefits of the Breakthrough Therapy designation and some of the challenges the agency faces in administering it.

November 26, 2013
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Washington DC Fall Colors

Understanding the Breakthrough Therapy Designation – Part 1 of an interview with FDA New Drugs Director John Jenkins

John K. Jenkins, MD, Director of the Office of New Drugs, Center for Drug Evaluation and Research at the FDA offers a senior management perspective on what is a breakthrough?

November 15, 2013
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Aragon Pharma Website

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
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Clinicaltrials.gov snapshot Feb 14, 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
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Medivation v University of California IP dispute court docket

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
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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
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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
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US Capitol Photo Credit Pieter Droppert

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
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Follow 2012 BIO CEO Investor Conference news on twitter #BIOCEO2012

Aggregation of tweets from #BIOCEO2012 conference in NYC

February 13, 2012
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BioPharm America 2011 Biotech Partnering Conference #BPA11

Aggregation of tweets from BioPharm America 2011 - 4th International Biotechnology Partnering Conference in Boston.

September 7, 2011
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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
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$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
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Boston Charles River

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
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BIO 2011 Conference Video

BIO 2011 International Convention Video Review #BIO2011

A short video with reflections on BIO 2011.

July 1, 2011
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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
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Bio Maryland

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
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BIO 2011 Washington DC

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
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NEJM CATT trial

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
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Antonin_Scalia_official_SCOTUS_portrait

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
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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
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Storify Lessons from MA Healthcare Reform

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
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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
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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
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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
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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
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Gilead-Sciences-Logo

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
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Downtown Disney Orlando

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
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Austin’s growing and emerging biotechnology cluster

Austin, TX is an emerging and growing biotechnology cluster.

February 7, 2011
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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
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Elena_Kagan_official_SCOTUS_portrait

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
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Avid Radiopharmaceuticals Logo

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
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Forteo Logo

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
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Amphastar Lovenox Enoxaparin

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
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Antares Pharma Logo

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
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FDA Logo

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
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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
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Arc de Triomphe Paris

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