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As the saga of Martin Shkreli continues to unfold in all its obnoxious glory, with every tweet and smirk signifying the former biopharma CEO’s apparent aspirations to a level of sheer jerkiness heretofore unseen on planet Earth, there’s one question that I – and probably a lot of other folks – can’t help but ask: Is this guy for real? I mean, seriously? From his gleefully unapologetic, 5,500-percent price hike for an in-licensed, generic drug, to his now-infamous gray-hoodied perp walk following his arrest on charges of securities fraud, to his juvenile Twitter taunts – not to mention his outlandish...
Whether naughty or nice in 2015, Drugmakers received not what they wanted And not what they needed, For the biggest “must-haves” on their wish list Went mostly unheeded. At the top of that list, and repeated quite often, Was a gift to undo the threat to their patents From that monster of monsters, the IPR Grinch. But 2015 came and is going, with no help in sight, no relief from a mensch. Second in line, but no less desired, Was prayer for relief From a CMS mire. Part B biosimilars must not – no, they must NOT –...
Let’s face it, Star Wars references are unavoidable in this year’s holiday gift guide. Not convinced? I find your lack of faith disturbing. Several members of our intrepid staff and respondents to our annual poll gave a nod to the awakening force. Jennifer Boggs, BioWorld’s managing editor, was lamenting about holiday gifts like toasters that are practical but, let’s just say, not very exciting when she discovered “there are some cool toasters after all. I stand corrected.” Her find was the Star Wars Darth Vader toaster, a true likeness of the famously redeemed villain, although you’ll have to look for...
Too often, drugmakers confuse convenience with quality of life, investing untold R&D resources in devising longer-acting formulations and then calling it “innovation.” The only innovation is in how it fends off competition by extending their patent protection. Such “advances” ignore what truly matters to patients. For cancer patients who are so weakened by drugs that they don’t have the strength to roll over in bed or get out of a chair, taking a medicine once a day or twice a day makes no difference. All they want is their life back. They want to have the strength to hug their...
In a perfect world, doctors would have the diagnostics to determine the right treatment for each patient at the right dose and the right time. It would be called precision medicine. In our world, researchers, doctors and patients are teased by the hope of precision medicine, as investment dwindles for the development of the diagnostics necessary to turn hope into reality. No incentives encourage that investment. Court rulings have rendered most diagnostics unpatentable. The FDA offers no exclusivity. And now Medicare is proposing drastic reimbursement cuts for diagnostic tests. In a perfect world, life-saving drugs would be affordable. Congress and...
Biopharma has a bad PR disease. The diagnosis is pretium offensus, otherwise known as “sticker shock.” The infectious condition has two causes: enormous, inexplicable, overnight price hikes and six-figure drug prices that spread from headlines to become a viral meme in congressional hearings and social media. The symptoms are a growing distrust of drugmakers, demands for comparative effectiveness-based pricing, calls for government price controls and, in an election year, much-hyped presidential campaign promises to curb the “skyrocketing costs of prescription drugs.” The prognosis is disastrous for everyone affected. Industry is responding, but its Rx isn’t working. Historic trending charts, comparisons...
Duchesnay Inc.’s 15-minutes of fame for its morning sickness drug arguably turned into a few hours’ worth by time the drugmaker complied with an FDA warning letter demanding a corrective ad to offset the omission of risk information in paid social media endorsements by She-Who-Must-Not-Be-Named in the serious biopharma world. The first 15 minutes for Diclegis (doxylamine succinate and pyridoxine hydrochloride)came with You-Know-Who’s tweets and posts to her millions of followers on Facebook and Instagram. That fame increased exponentially when the FDA handed down the warning letter last month, daring to name the infamous reality TV maven and setting mainstream...
You’ve likely heard the terrified screams induced by the cost of pricey cancer drugs, Gilead Sciences Inc.’s twin hepatitis C therapies and Vertex’s cystic fibrosis breakthroughs. And you may have been rattled by the nightmarish predictions about how a new class of cholesterol-lowering drugs – PCSK9 inhibitors – is going to break the U.S. health care bank. But those tales from the script are nowhere near as frightening as the potential price for the first effective new Alzheimer’s drug to hit the market. Given the 99 percent fail rate of wannabe Alzheimer’s treatments and the dark shadow the disease casts...
Let’s face it: Imagining the means of humanity’s ultimate destruction makes for great entertainment. There are no shortages of novels, movies and television shows featuring threats of global annihilation – zombie viruses, meteors hurtling through space, nuclear warfare – or opening up post-apocalyptic landscapes laid waste following a collision of unchecked scientific and technologic advances with the those worst of human traits – greed, irresponsibility, megalomania. And as an unabashedly enthusiastic science fiction fan, I love that stuff. So, naturally, when anyone starts talking game-changing technologies such as DNA cloning or CRISPR, my brain almost immediately goes rifling through its...
Summer is not officially here, according to the calendar, but the first long weekend of the season brings thoughts of beaches, mountains, travel, relaxation, lazy days and active ones. No matter what floats your boat over summer vacation, a good book should never be far away. With that in mind, assembled once again for your reading pleasure is BioWorld’s Summer Reading List – our 9th annual edition. Be forewarned: Our respondents dug deep this year, tackling a variety of thoughtful and complex issues. You won’t find any fluff on these pages, but you’ll certainly find opportunities to be dazzled and...
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic...
As the COVID-19 outbreak continues to dominate the news, an increasing number of companies have come forward to help. For its part, CHF Solutions Inc., of Eden...
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention....
BEIJING – Beijing-based Sihuan Pharmaceutical Holdings Group Ltd. said it has initiated clinical trials of broad-spectrum antiviral favipiravir to treat COVID-19....
Mallinckrodt plc is engaging with the U.S. FDA, NIH and the Biomedical Advanced Research and Development Authority to address the potential use of its INOmax...
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