PharmExec Blog

Catching Biopharmaceutical Sponsors by Surprise

The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects. During an update on The Future of FDA’s Drug Safety Program, Andrew C. von Eschenbach stated, “The full magnitude of some potential risks does not always emerge during the mandatory clinical trials conducted before approval.”

In this Applied Clinical Trials article, Moe Alsumidaie discusses FDA’s post-marketing surveillance programs, and how biopharmaceutical sponsors can work with the FDA to identify unreported Adverse Events (AEs).

Posted in Biotech, FDA, Regulatory, Safety | Tagged | Leave a comment

Sandoz Wins Biosimilar Filing Race

 After months of speculation about prospects for biosimilar development in the U.S., Novartis announced July 24 that FDA has accepted Sandoz’ biologics license application (BLA) for a similar version of Amgen’s Neupogen (filgrastim). Assuming FDA approval within a year, this action sets the stage for testing whether and how biosimilars will gain acceptance in the U.S. healthcare market, and the impact these products will have on new drug development and product pricing and marketing. Read More »

Posted in FDA, R&D, Safety | Tagged , , , , | Leave a comment

Roche Reports Good Half-Year Performance

Roche reports a rise in sales to 22,974 million Swiss francs (+5%, US$25.5 billion) for the first half of 2014, with strong growth from HER2 breast cancer medicines, Herceptin, Perjeta and Kadcyla, and other oncology medicines, Avastin and MabThera/Rituxan. Sales of Xeloda, a chemotherapy drug which is no longer patent-protected, were lower, as a result of generic competition.

Reported sales in Swiss francs were 1 percent lower than the first half of 2013, as the US dollar, along with a number of Latin American currencies and the Japanese yen, have weakened against the Swiss franc.

Roche’s pipeline currently has 66 new molecular entities in clinical development; 12 are in late-stage development.
Its investigational cancer immunotherapy anti-PDL1 (MPDL3280A) has  been granted Breakthrough Therapy Designation by the FDA.

CEO Severin Schwan is confident that the drug maker will meet its full-year targets. Low- to mid-single digit growth in group sales at constant exchange rates is expected. 


Posted in Europe, Guest Blog | Tagged , | Leave a comment

Pharm Exec's 2014 Dealmakers Outlook

After fading to dreary summer stock for the past few years, dealmaking is today back to center stage, but with the major roles reversed— small biotech, yesterday’s understudy, now gets top billing, while big Pharma has to work harder for its close-up.

Pharm Exec brought partner Campbell Alliance and a select group of West Coast dealmakers to a Sonoma raceway for a test performance on what lies ahead for asset licensing and M&A activity in 2014. Despite all the high-octane rhetoric around deals, the key differentiator of success hasn’t much changed. It’s still that hard—and honestly wrought–evidence of value to payers and patients. Read More »

Posted in Deals, Global, Strategy | Tagged , , , | Leave a comment

Compounding Pharmacy Issues Recall, But Challenges FDA Decision

FDA has posted on a July 19, 2014 press statement from Unique Pharmaceuticals, which reports a voluntary nationwide recall of all sterile drug preparations compounded by the outsourcing facility that have not reached the expiration date listed on the products. Read More »

Posted in FDA, Regulatory, Safety | Tagged , | Leave a comment
  • Categories

  • Meta