Biotech Strategy Blog

Commentary on Science, Innovation & New Products

Posts from the ‘FDA’ category

ASCO 2013 CLL Runners and Riders in Race to Market #ASCO13

By on May 28, 2013

THE data of the 2013 annual meeting of the American Society of Clinical Oncology (ASCO) that starts later this week in Chicago is expected to be the early clinical trial results for new breakthrough immunotherapies that target PD-1/PD-L1.

However, I’m also excited about the data being presented for the treatment of Chronic Lymphocytic Leukemia (CLL), a disease that kills 75,000 people a year around the world. ASCO typically does not have a strong focus on hematology and blood cancers, so it’s a reflection of the clinical significance of the data that it’s a hot topic at the meeting.

This is a preview of ASCO 2013 CLL Runners and Riders in Race to Market #ASCO13. Read the full post

Leave a comment

Biosimilars could be a casualty of Supreme Court Health Care Decision

By on June 26, 2012

The decision expected this Thursday by the Supreme Court of the United States on the constitutionality of the Patient Protection and Affordable Care Act (PPACA) may impact the development and approval of biosimilars.

United States Capitol Building 300x225 Biosimilars could be a casualty of Supreme Court Health Care DecisionPart of the PPACA signed into law by President Obama on March 23, 2010 was the Biologics Price Competition & Innovation Act (BPCI).

This amended the Public Health Service Act (PHS) to create a pathway under section 351(k) for the licensing of biological products that are “interchangeable” or “biosimilar” to an FDA-licensed product.

This is a preview of Biosimilars could be a casualty of Supreme Court Health Care Decision. Read the full post

1 Comment

AACR 2012: Future is combinations of novel cancer agents

By on April 23, 2012

A standing room only audience at the recent annual meeting of the American Association for Cancer Research (AACR) heard from several distinguished speakers on what the future of cancer drug therapy is likely to look like: combinations of novel cancer agents.

This AACR session was one of the highlights of the meeting and would have merited from being part of the plenary program.

AACR 2012 Engelman Strategies to Overcome Resistance 300x215 AACR 2012: Future is combinations of novel cancer agentsJeffrey Engelman from MGH persuasively presented on why we need combination therapies to overcome resistance. He noted that:

  • Most cancers are not sensitive to currently available single-agent therapies
  • Even when sensitive to single-agent therapies, cancers develop resistance, often necessitating combinations
This is a preview of AACR 2012: Future is combinations of novel cancer agents. Read the full post

4 Comments

MDV3100 shows survival in Advanced Prostate Cancer

By on November 3, 2011

Medivation Logo MDV3100 shows survival in Advanced Prostate Cancer Prostate cancer is the second leading cause of cancer death in men, so it was good news this morning when Medivation & Astellas issued a press release that showed positive data from the phase 3 AFFIRM trial for MDV3100.

MDV3100 produced a 4.8-month advantage in median overall survival compared to placebo.

The estimated median survival for men treated with MDV3100 was 18.4 months compared with 13.6 months for men treated with placebo.

MDV3100 provided a 37 percent reduction in risk of death compared to placebo (Hazard Ratio=0.631).

This is a preview of MDV3100 shows survival in Advanced Prostate Cancer. Read the full post

Leave a comment

ECCO ESMO 2011 radium-223 Alpharadin media briefing video

By on September 29, 2011

The phase 3 ALSYMPCA prostate cancer trial results for radium-223 chloride (Alpharadin) were presented at the recent ECCO ESMO ESTRO 2011 European Multidisciplinary Cancer Congress in Stockholm. This was the highlight of the meeting for me.

There was also exciting data in Breast Cancer (BOLERO-2) that you can read more about on Pharma Strategy Blog.

Alpharadin from Norwegian company, Algeta, is the first new treatment for advanced prostate cancer that not only prolongs overall survival (OS) but delays time to first skeletal related event (SRE) in metastatic castration resistant prostate cancer patients.

This is a preview of ECCO ESMO 2011 radium-223 Alpharadin media briefing video. Read the full post

1 Comment

Alpharadin wlll be new treatment option for Prostate Cancer

By on September 25, 2011

One piece of hot news at the 2011 European Multidisciplinary Cancer Congress (twitter #EMCC2011) taking place in Stockholm this weekend is the data on radium-223 chloride (Alpharadin) in metastatic castration resistant prostate cancer. The phase 3 ALSYMPCA trial results were presented in yesterday’s presidential symposia by Dr Chris Parker, Consultant Clinical Oncologist at The Royal Marsden Hospital.

Dr Chris Parker Alpharadin Presentation Stockholm Cancer Congress 2011 Alpharadin wlll be new treatment option for Prostate Cancer

The Scandinavian location for the presentation could not have been better, given that Alpharadin was developed by the Norwegian company Algeta. Bayer Schering Pharma AG have the worldwide commercial rights, but Algeta maintains a co-promotion option in the United States.

This is a preview of Alpharadin wlll be new treatment option for Prostate Cancer. Read the full post

1 Comment

Serious eye infections reopen Lucentis v Avastin debate

By on September 2, 2011

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. The New York Times today reports that five patients at the Veterans Affairs Medical Center in Los Angeles have gone blind as a result of an eye infection following injection of compounded Avastin.

I have written previously about the Lucentis v Avastin debate and the results in the Comparison of Age-related macular degeneration treatment trial (CATT) published earlier this year in the New England Journal of Medicine.

This is a preview of Serious eye infections reopen Lucentis v Avastin debate. Read the full post

1 Comment

Alpharadin on fast track to FDA prostate cancer approval in 2012

By on August 25, 2011

Algeta Alpharadin 223 147x300 Alpharadin on fast track to FDA prostate cancer approval in 2012

Earlier this week Bayer & Algeta announced that Alpharadin™ (radium-223 chloride) had received Fast Track designation from the FDA for the treatment of castration-resistant prostate cancer (CRPC).

Bayer signed an agreement with Norwegian based Algeta in 2009 for the global commercial rights to Alpharadin™, with Algeta retaining a 50/50 co-promotion and profit-sharing in the United States.

According to the Algeta August 23, 2011 press release, in light of the FDA fast track designation they plan on filing for United States approval in mid-2012, ahead of previous expectations.

This is a preview of Alpharadin on fast track to FDA prostate cancer approval in 2012. Read the full post

Leave a comment

$500M Google Online Pharmacy Settlement does not address why drugs are cheaper in Canada

By on August 25, 2011

Yesterday, it was announced that Google had reached a settlement with the United States Department of Justice and would forfeit $500M in gross revenue received from Canadian online pharmacies advertising to US consumers through the Google AdWords program.

According to the Government, these advertisements then led US consumers to buy and illegally import prescription drugs from Canada.

The settlement with the Department of Justice (DOJ) was in many ways inevitable.  Once the Government decided to go after Google to the extent of submitting fake online ads on behalf of fake online pharmacies, that Google ran and provided customer support to, the question was not if Google would settle, but for how much?

This is a preview of $500M Google Online Pharmacy Settlement does not address why drugs are cheaper in Canada. Read the full post

Leave a comment

Zytiga European Prostate Cancer approval may kill Jevtana sales

By on August 4, 2011

With the collapse of the Dendreon share price today following poor sales data (Adam Feuerstein on The Street has an excellent write up about this), attention has again focused on the prostate cancer market.

Zytiga (abiraterone acetate) was recently approved by the European Medicines Agency (EMA), following FDA approval earlier this year.

The EMA Committee for Medicinal Products for Human Use granted the marketing authorization for Zytiga at it’s July 2011 meeting.  The approval noted,

“The poor prognosis of the target patient population represents a high unmet medical need while the novel mechanism of action of abiraterone has the potential to offer an alternative therapeutic option for these patients.”

This is a preview of Zytiga European Prostate Cancer approval may kill Jevtana sales. Read the full post

Leave a comment