This week’s headlines include, advanced melanoma treatments, new bill with incentives for new indications for old biologics, BrainStorm gets U.S. Patent, 2013 record breaking for orphan drugs, Novartis’ psoriasis drug, Baxter’s 2015 business plans, and report says U.S. can do more to support global health R&D.

Cell Culture Events

Bioprocess International European Summit

April 2-3, 2014 – Clarion Congress Hotel, Prague, Czech Republic

The countdown to BioProcess International Europe SUMMIT 2014 begins!

Join us to reflect on the critical challenges facing the production, analysis and formulation of biologics.

This meeting congregates top industry speakers in 5 conference streams, in 1 unique venue. Don’t miss this opportunity to challenge conventional thinking and prepare for the next wave of products, processes and technologies shaping the future of your industry, your company and ultimately, your career.

Mark your diary to join us in April 2014 in Prague !

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Headlines:

“Drug Firms Focus on Advanced Melanoma,” The Wall Street Journal

“Major pharmaceutical companies are racing to launch breakthrough drugs in the next 18 months to treat advanced melanoma, the deadliest form of skin cancer. Bristol-Myers Squibb Co. BMY -0.63%, Roche Holding AG ROG.VX -0.30% and Merck MRK -0.52% & Co. each are working on a potential blockbuster “immunotherapy” drug that would use the body’s immune system to fight the cancer. If approved, the three drugs could be launched between late 2014 and late 2015. AstraZeneca AZN.LN 0.00% PLC has an earlier-stage candidate in development.”

If you like this story, please see our blog titled “Troubleshooting Media Development for Bioprocessing”

“Baxter Plans to Spin off Biotech Business in 2015,” Reuters

“Baxter International Inc said on Thursday it would spin off its biotechnology operations into a publicly traded company by the middle of next year and focus on its core medical technology business, sending its shares up more than 4 percent. The move, which is similar to Abbott Laboratories’ spinoff of AbbVie Inc at the beginning of 2013, is part of a trend among healthcare companies to divest businesses that are not part of their primary operations.”

If you like this story, please see our blog titled “Biologics Still on Top in Best Selling Drugs of 2013”

“Report: U.S. Can do More to Support Global Health R&D,” Fierce Biotech Research

“In the midst of flat funding for many federal programs as well as last year’s across-the-board spending cuts known as sequestration, global health advocacy groups say Congress needs to adopt a long-term budget solution to sustain R&D activities for new drugs, vaccines and other health technologies to combat global health threats. Though the U.S. is the largest single investor in global health R&D, its investment has declined since 2009, according to a report delivered to Congress March 27 by a group of more than 30 nonprofit organizations known as the Global Health Technologies Coalition. The report seeks a stronger role for the FDA in delivering new products for neglected diseases and calls on Congress to approve the 21st Century Global Health Technology Act introduced in April 2013, which is aimed at bolstering the U.S. Agency for International Development’s product development.”

If you like this story, please see our blog titled “Paper or Plastic: A Study on Single-Use and Sustainability”

“Novartis Psoriasis Drug Effective When Self-Administered – Studies,” Reuters

“Results of two late-stage clinical trials showed high efficacy for Novartis’ drug secukinumab when used by patients suffering from moderate-to-severe plaque psoriasis, the Swiss drugmaker said on Saturday. The results of the Phase III studies presented at the American Academy of Dermatology in Denver showed how effective secukinumab was in clearing patients’ skin when administered with a pre-filled syringe or autoinjector pen. Both methods of delivery allow patients to self-administer the drug at home or in the workplace rather than having to visit a healthcare practice.”

If you like this story, please see our blog titled “Flexible Facilities for Biopharmaceutical Manufacturing”

“Bill Would Create Incentives to Seek New Approvals for Old Biologics,” Regulatory Focus

“A new bill introduced in the US House of Representatives on 24 March 2014 would grant companies additional patent protections for repurposed biological products.

Bill Basics

The bill, the Independent Innovator and Repurposing Act (IIRA), is cosponsored by Reps. Joaquin Castro (D-TX) and Randy Forbes (R-VA) and is intended to provide “appropriate intellectual property protections” for some products.

Those products, the bill explains, are any biologicals regulated under Section 351(i)(1) of the Public Health Service Act:

a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.”

If you like this story, please see our blog titled “Choosing a Cell Culture Media Development Strategy for Biopharmaceutical Production”

“2013 Was a Record Breaking Year for Orphan Drugs,” Med City News

“Over the years we’ve kept track of the success of the Orphan Drug Act (“ODA”), which President Ronald Reagan signed into law on January 4, 1983. We have measured that success by the number of orphan drug designations submitted to and granted by FDA, and the number of orphan drug approvals resulting from those designations. The ODA turned 30 last year, and we celebrated that anniversary – as did FDA (see here) – with a February post titled “The Orphan Drug Act: 30 Years and Still Going Strong!” Although we looked at some new orphan drug metrics in that previous post, we didn’t have any records to report; just some near-records showing that interest in orphan drugs remains quite high. Well, our 2013 numbers are in . . . . and it was an across-the-board record breaking year for orphan drugs. That’s quite appropriate for the 30th anniversary year of the ODA.”

If you like this story, please see our blog titled “2013 FDA New Drug Approvals”

“Israel’s BrainStorm gets U.S. Patent for Stem Cell Technology,” Reuters

“Israel-based BrainStorm Cell Therapeutics said on Monday the U.S. Patent and Trademark Office has granted the company a key patent for its autologous stem cell technology. The patent covers BrainStorm’s stem cells induced to secrete elevated levels of neurotrophic factors for the treatment of neurodegenerative diseases. Pending approval from the U.S. Food & Drug Administration, the company is preparing for its upcoming mid-stage Phase II trial in the United States with its NurOwn adult stem Cell Therapy.

If you like this story, please see our blog titled “Learning More About Your Cells by Employing Flow Cytometry and Cell Imaging Platforms – Troubleshooting Challenges