Industry news

Look for orphan drugs to keep fueling M&A, Moody's says

Carly Helfand / FiercePharma

Orphan drugs are attractive to make thanks to premium pricing prospects, limited competition and regulatory perks. But those factors also make them attractive to buy, and they'll continue to spur M&A activity in the biopharma field, Moody's predicts.

New Chart Pack: Big Strides in Fight Against Cancer

John Castellani / PhRMA

In December 2009, Matt Ellefson received news from his doctor that no one ever wants to receive: a diagnosis of advanced non-small cell lung cancer. He faced a five-year survival rate of less than five percent. Nearly six years later, Matt is not only surviving, but thriving, thanks in part to innovations in cancer medicines.

High Prices for Drugs Attacked at Meeting

Joseph Walker / The Wall Street Journal

In a sign of growing frustration with rising drug prices, a prominent cancer specialist on Sunday sharply criticized the costs of new cancer treatments in a high-profile speech at one of the largest annual medical meetings in the U.S.

Big Pharma and Insurers Play Nice

Arlene Weintraub / Bloomberg

In the summer of 2014, biotechnology company Amgen seemed to be on the verge of a breakthrough with an injectable anti-cholesterol drug. Just four years into its development, the drug, Repatha, was showing an unprecedented ability to lower LDL, the so-called bad cholesterol.

02 June 2015

Celtaxsys Inc. Receives $5M Research Award to Advance Once Daily, Oral Anti-Inflammatory Medicine into Phase 2 CF Patient Lung Function Preservation Trial

Celtaxsys, a clinical stage drug development company focused on advancing care for patients suffering from inflammatory diseases, including those with rare and orphan inflammatory diseases, announced today that it has received a development award for $5 million from Cystic Fibrosis Foundation Therapeutics, Inc. ("CFFT"), the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation The development award will help support a Phase 2 clinical trial of the Company's lead development candidate, a once daily, oral anti-inflammatory drug CTX-4430 in adults with cystic fibrosis ("CF"). CTX-4430 is a selective inhibitor of Leukotriene A4 Hydrolase that targets re-balancing of a patient's over activated inflammatory response without increasing susceptibility to infection. CTX-4430 has been granted orphan status for CF in both the US and the EU. 

Germany dominates global league table of most influential pharma research institutions

Nick Paul Taylor / Fierce Biotech

German institutions have claimed four of the top 5 spots on Thomson Reuters' list of the most influential pharma research centers. A clean sweep of the top four positions was only prevented by Gilead Sciences ($GILD), which the report ranked second behind Goethe University Frankfurt Hospital.

Untried drug candidates can find a home at Japan's newly minted AMED

EJ Lane / FeircePharmaAsia

Are you a drugmaker with a lot of untried substances hanging around in your closet of drugs? Has Japan's AMED got a deal for you. The Japan Agency for Medical Research and Development, created less than two months ago in the model of the U.S. NIH, is now ready to receive up to 200,000 substance samples from more than 10 drugmakers.

Considerations for Clinical Trial Design in Public Health Emergencies

Jeffry Liu, B.A. / The TRIbune

While the fundamental concerns behind the design of most modern clinical trials are effectively the same, clinical trials that take place during public health emergencies face additional layers of challenges. This article will provide an overview of clinical trial design issues that arise due to the time-sensitive nature of public health emergencies, the ethical considerations of study design during emergency situations, and data validity concerns that must be addressed, all while juggling regulatory and practical considerations.

Redefining The Sciences Of Drug Safety- Innovative Opportunities For Drug Safety & Risk Management

Dr. Magalie Emile-Backer / The TRIbune

The field of Drug Safety has evolved into a dynamic specialty area with growing potential and new outsourcing opportunities for Clinical Research Organizations (CROs).  After decades of public health issues relating to the safety of medicines, the biopharmaceutical industry has undergone volatile changes due to increasing regulatory oversight around product surveillance of marketed products.  

01 June 2015

Epic Sciences Expands Silicon Valley Bank Credit Facility

Epic Sciences, Inc., a private diagnostics company that designs and develops products and offerings to personalize and advance the treatment and management of cancer, announced today that it has expanded the available credit under its existing credit facility with Silicon Valley Bank (SVB).  The amended agreement increases the available capacity of the facility from $5 million to $15 million and has extended the maturity by 27 months to April 1, 2019.