Despite the regulatory approval of new antiepileptic drugs (AED) over the past decade and the expansion of indications deemed suitable for epilepsy surgery, individuals with intractable seizures – roughly one in three epilepsy patients – still face a dearth of treatment options. That void is all the more frustrating because epilepsy remains a debilitating condition for reasons beyond the clinical manifestations, often resulting in chronic unemployment or underemployment, social isolation and poor socioeconomic status. It's no surprise, then, that the prospect of a new treatment for people with medically refractory epilepsy would be greeted with great enthusiasm. As an adjunct...

Despite what the New York Times and its echoers have said, makers of innovative biologics have legitimate reason to sound alarms about automatic substitution of biosimilars that have not proven their interchangeability – and it’s not just because of the potential impact to their bottom line. That point was driven home by the recent recall of Affymax Inc. and Takeda Pharmaceutical Co. Ltd.’s Omontys (peginesatide). Although Omontys is not a biosimilar, the unexpected postmarketing reports of serious hypersensitivity reactions linked to the erythropoiesis-stimulating agent (ESA) served as a reminder of the variability of biologics, their sensitivity to minute manufacturing changes...

Robert Miller, the patient advocating for Hemispherx Biopharma Inc.'s Ampligen (rintatolimod) for chronic fatigue syndrome by going on a hunger strike in protest of the FDA's complete response letter, ended the hunger strike over the weekend. Progress was made, he said, as follows from a Facebook post. "1. Dr. Wanda Jones, who I trust and respect, in the Assistant Secretary of Health’s office has engaged with the Secretary of Health over the past days on the need for a serious commitment to address our unmet needs. 2. Dr. Jones committed to me that the Secretary’s office will be engaged in the...

About a week ago, my obituary arrived by email. But something related, which you might think is weirder, happened Tuesday afternoon, and all of it involves chronic fatigue syndrome (CFS), and Hemispherx Biopharma Inc.’s drug candidate for it, Ampligen. More specifically, it involves Bob Miller, 54, who is on a hunger strike. Miller stopped eating about the same time my obituary showed up, in protest of the FDA’s refusal to approve Ampligen (rintatolimod), the Toll like receptor 3 modulator for CFS that was given an unfavorable review by the FDA’s advisory panel in December, which I covered. I talked with...

When the FDA’s Rachel Sherman said the biggest challenge the agency faces with biosimilars is educating the public, she wasn’t exaggerating. An article in the New York Times shows just how big of a challenge it’s going to be. The article “Biotech Firms, Billions at Risk, Lobby States to Limit Generics” slams biotechs for encouraging states to adopt legislation limiting the automatic substitution of biosimilars, which the Times repeatedly called “generics.” As BioWorld Today reported, most of the bills being considered by states would require physician notification of what was substituted, enhanced recordkeeping and an opportunity for doctors (and, in...

I recently took a few months off from daily deadlines to explore the evolving world of biosimilars for the newest BioWorld Data report, The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies. It was quite an eye-opening adventure. Even though I’ve been covering biosimilars for BioWorld for a few years now, I was surprised at the impact these follow-on biologics (FOBs) are having throughout the world, given that the European Union (EU) is continuing its two-year approval slump and no biosimilar candidates have stepped up to bat yet in Canada or the U.S. Some of my surprise undoubtedly...

A lot of ink has flowed describing the tough times that big pharma companies are experiencing as each, lemming-like, tumbles off the patent cliff. Certainly, the pain of shrinking revenues is clear for all to see. AstraZeneca plc, for example, recorded a 15 percent decline in third-quarter revenues, to $6.68 billion, as loss of exclusivity on four products – Seroquel IR, Atacand, Nexium and Merrem – played havoc with its bottom line. Revenues from schizophrenia drug Seroquel IR (quetiapine), alone, dropped by more than $850 million, or 82 percent, in the quarter. Merck & Co. Inc. also lost market exclusivity...

Privacy concerns related to DNA sequencing got yet another airing today when a team from the Whitehead Institute reported in Science that using only publicly available information, they have been able to identify about 50 men who had anonymously donated DNA to projects such as the Thousand Genomes Project. While research subjects and sperm donors by and large want anonymity, others use DNA to find their relatives on the Internet, on sites like Y Search and the Sorenson Molecular Genealogy Foundation. In other words, there is plenty of DNA out there that has an identity attached to it. And if...

Now that 2012 is drawing to a close, it’s once again time to take a look back at a year that saw some big hits and misses for the biotech industry – and there were plenty of both. The hits saw some big drug approvals – some of those well in advance of PDUFA dates, which, hopefully, is a good sign that the FDA is willing to accelerate approvals in areas of high unmet need – and major clinical advances in areas such as hepatitis C, while the misses included disappointing data and some stark realities facing big pharma firms....

It’s that time of year, when some thoughts turn to sugar plum fairies and others to the J.P. Morgan Healthcare Conference – or JPM#13 as it’s now widely known. Before you pop the cork on another New Year, however, it’s time to pick a present for everyone on your holiday list. For your shopping pleasure, BioWorld’s annual gift guide, now in its sixth year, has just the items you’ve been seeking – even for the most finicky friends. The Biotech Exec The first gift suggestions are likely the most popular and practical for your favorite biotech exec. The iPad Mini...