The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to score against their opponents via health care issues or accomplishments threatens to undermine confidence in the FDA, the products it approves and even the guidance offered by the Centers for Disease Control and Protection (CDC). In the past, politicians from both parties blamed “greedy” biopharma companies and self-appointed social influencers for patients refusing to fill prescriptions, get tested or be immunized. Now they have themselves to blame.
In releasing its annual report card for drug manufacturing inspections in which the per-country/region grading curve peaked at 77% and bottomed at 68%, the FDA said, “All of these scores indicate an acceptable level of compliance to CGMPs [current good manufacturing practices] on average.”
It should be motoring to profitability, but nine months after the U.S. launch of its new antibiotic, Zemdri (plazomicin), Achaogen Inc. has filed for chapter 11 bankruptcy and is now selling off its assets.
In many ways, 2018 resembled the previous year in fast motion. Political turmoil accelerated on both sides of the Atlantic, with Asia swept into the fold, while the “estrangement" previously seen between President Donald Trump and the scientific community morphed into global revulsion against a rogue research rule-breaker. Not all was well in biopharma-land, either. The groundswell of anger against rising U.S. drug prices looked likely to spill into multiple pieces of legislation in a rebalanced Congress. And the ongoing tragedy of opioid abuse and addiction prompted the FDA to put the brakes on certain drugs while the CDC warned...
The holidays are (already) here again. Much as we try to push back the calendar, those Thanksgiving doorbuster, Black Friday blowout, Small Business Saturday, Cyber Monday and Giving Tuesday pitches keep knock, knock, knocking at our doors. And those salebrations don’t even count the actual seasonal holidays, like Hanukkah, which begins at sundown on Dec. 2 to kick off an early start to this year’s festivities. Before you hit the stores – or, more likely, that “Purchase Now” icon on your phone – take a spin through these suggestions from the BioWorld team and from our fans and followers. For...
Defying the laws of nature, many drug companies seem intent on proving that what goes up doesn’t have to come down. For them, the sky’s the limit when it comes to U.S. drug prices. Despite all the public outrage and all the talk and threats on Capitol Hill, several drug companies ushered in the second half of 2018 with more price increases. Most of them were “modest” in the single-digit range. But when piled on top of previous hikes, those modest increases add up to skyrocketing prices. Take Seattle Genetics Inc.’s cancer drug Adcetris (brentuximab vedotin). Its wholesale acquisition...
On what planet are the PABNAB (Party at BIO not associated with BIO) organizers living to think it was acceptable to spotlight topless dancers with company logos painted on their bodies at an apparent business networking event? It is reasonable to believe the 40-plus sponsors of the event in Boston last week would not want their brands associated with such an archaic objectifying source of “fun,” and the Biotechnology Innovation Organization (BIO) itself, which held its annual international convention at the same time in Boston, has publicly denounced the party, putting at risk the membership of those who support similar...
Summer arrives with a bang for biopharma in the dueling agendas of the American Society of Clinical Oncology (ASCO) annual meeting, the BIO International Convention, Digestive Disease Week (DDW) and ASM Microbe – all packed into a 12-day period – not to mention overlapping health care conferences sponsored by several major investment banks. What’s a harried insider to do? Breathe deeply, then take a gander at BioWorld’s 12th annual Summer Reading List before you head to the airport for 10 days of sleep deprivation and jet lag. As always, our staff and readers from across the industry have you covered....
Robert Califf said it when he was serving as FDA commissioner. Patient advocates have said it when testifying before Congress or commenting at public meetings. And this week, experts on the FDA’s Psychopharmacologic Drug Advisory Committee (PDAC) said it again: Doctors don’t read drug labels. Yet drug companies continue to invest millions of dollars on aspects of clinical trials that are designed to inform labeling, and FDA reviewers spend untold hours scouring the data to ferret out what should be included in the prescriber information as contraindications, warnings and cautions, boxed warnings, the mechanism of action and clinical trial findings....
NEW YORK – While listening to panelists during the BIO CEO & Investor conference discuss the current state of the opioid epidemic, it occurred to me that there was something about this narrative that seems familiar. I feel like I’ve written this story before. And I have. About 10 or 12 years ago. Only then, instead of pain drugs, it was antibiotics. Despite the need for new antimicrobial treatments to combat the growing resistance problem, many companies were shying away from antibiotic drug development. Part of that was due to the shifting regulatory landscape at the FDA regarding noninferiority studies....
RSS
