BioWorld

U.S. politicking threatens public trust in the FDA and CDC

Wed, 26 Aug 2020 12:00:00 -0400

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.

When it comes to drug quality, is a ‘C’ acceptable?

Mon, 15 Jun 2020 12:00:00 -0400

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.”

A decade of incentives to promote antibiotic development and still no viable route to commercial success

Fri, 01 Nov 2019 03:00:00 -0400

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.

BioWorld's Top 10: Biggest newsmakers and trending stories of 2018

Fri, 28 Dec 2018 14:57:06 -0500

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...

Deck the halls, or get decked out: BioWorld’s 12th annual Holiday Gift Guide

Tue, 20 Nov 2018 15:35:21 -0500

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...

Price increases - tone deaf or defiant?

Tue, 10 Jul 2018 17:34:00 -0400

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...

PABNAB – A disappointing distraction at BIO, not associated with BIO

Thu, 14 Jun 2018 09:11:00 -0400

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...

Shoes, ‘Stones’ and surfing: BioWorld’s 12th annual Summer Reading List

Thu, 31 May 2018 11:54:52 -0400

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....

If no one reads it, what’s the purpose of a drug label?

Thu, 29 Mar 2018 18:29:43 -0400

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....

The opioid crisis: A venture in need of a GAIN?

Fri, 16 Feb 2018 12:01:46 -0500

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....

Real-world optics of biopharma price hikes

Fri, 02 Feb 2018 18:11:30 -0500

While reducing prescription drug prices won’t fix the overall growth in health care spending in the U.S., bringing those prices down is a top priority for most Americans heading into this year’s midterm elections. There’s a reason for that. Because of copays and coinsurance, those prices cut directly into the pockets of more Americans than any other health expense. And unlike health care costs that are hard to segregate in hospital and doctor bills, drug prices – at least the list prices – are front and center these days in headlines, congressional rants and presidential scoldings. Many biopharma companies didn’t...

Science for the season: BioWorld’s 11th annual Holiday Gift Guide

Thu, 30 Nov 2017 18:54:28 -0500

Thanksgiving doorbusters. Check. Black Friday blowouts. Check. Small business Saturday, Cyber Monday, Giving Tuesday. Check, check, check. It's only Dec. 1, with the major holidays some two weeks or more ahead, and major advertisers would have us believe we’re already shopped out. But the intrepid elves at BioWorld, along with some loyal readers and followers, have lined up fun selections for everyone on your list with our 11th annual Holiday Gift Guide. Heidi Chokeir, managing director at Canale Communications Inc., called the Foldscope kit “an AMAZING gift for the budding scientist in people’s lives.” Larger kits are already sold out...

Drug quality from a patient’s perspective

Sun, 10 Sep 2017 09:06:56 -0400

Dirt. Excrement. Glass. Hair. Insects. Mold. Rodent infestation. Scouring pad fibers. Unknown particulates. They’re words too often mentioned in FDA warning letters that describe manufacturing conditions for supposedly sterile drugs. A few years ago when I was a cancer patient hooked up to an I.V. drip for three to four hours every two weeks, I found reading those warning letters a horrifying experience. With a cocktail of generic and brand drugs coming from who knows where being pumped into the port resting a few inches from my heart, I cringed at the thought of what might be entering my vein....

Importation a cliché, not a CAPA

Fri, 04 Aug 2017 18:08:02 -0400

The right hand not knowing what the left hand’s doing. Robbing Peter to pay Paul. Talking out of both sides of the mouth. . . . They’re all clichés that aptly describe how the U.S. Congress too often works. Especially when Congress insists on knee-jerk reactions to plaster complex problems with superficial solutions instead of conducting thorough investigations into the root of a problem, followed by a well-reasoned corrective and preventive action plan (CAPA). If Congress were a biopharma company, the FDA would have hit it repeatedly with warning letters for its inadequate responses, lack of CAPAs, failure to build...

Life and death and #BIO2017

Mon, 26 Jun 2017 17:18:53 -0400

I missed BIO this year – the first time in 40 years as a journalist that I canceled attendance at a major conference due to a death in the family. About 12 hours before I was due to board a plane to San Diego, my brother in-law, Kevin, had a massive heart attack and died at the age of 64. In life, Kevin was what health care professionals likely would describe as a “challenging” patient. Like his father, he was subject to familial hypercholesterolemia. Unlike his dad, who had a proverbial “warning shot” in his 40s and then embraced a...

No choice, no free market

Tue, 20 Jun 2017 13:35:25 -0400

Inundated with heart-wrenching stories about constituents who can’t afford the prescription drugs they need to live, U.S. lawmakers spend a lot of time lamenting a free market that isn’t working and then debating ways to “fix” it. Reality check: A free market thrives on choice. Lots of it. Thus, a free market never has and never will work for prescription drugs. Even when a few drugs compete in the same space, patients have little to no choice in which one they use. As Paul Howard, senior fellow and director of health policy at the Manhattan Institute, politely reminded Sen. Al...

Poverty, politics and preventable disease: Blurring the lines between truth and fiction in BioWorld’s 11th annual Summer Reading List

Thu, 01 Jun 2017 11:13:59 -0400

BioWorld’s inaugural Summer Reading List in 2007 appeared as a simple list of 15 books – including Harry Potter and the Deathly Hallows, harkening to the tone of the times – designed as something a breather from post-ASCO, pre-BIO mania. Ten years later, our Summer Reading List is one of the most widely read pieces of the year, providing heartening evidence that no matter what divides biopharma, individuals across the industry – executives, scientists, investors, analysts – and the folks who report on their business successes and failures are united by enjoyment of a good read. Here are this year’s...

Scientists don’t do politics … until now

Sun, 23 Apr 2017 18:05:40 -0400

LONDON – It was great to be one of the thousands around the world who took to the streets on Saturday to March for Science. In London, people of all ages gathered outside the Science Museum, in high spirits, but serious of purpose, with placards ranging from thought-provoking to profound and onto outright comic. A demure woman belied the eye ‑ and the popular image ‑ with a placard declaring herself to be a “Mad Scientist;” there were several riffs on the infamous “alternative facts;” and quotes from past science greats, such as the words of the father of microbiology...

Myth busters take on drug prices, or do they?

Mon, 27 Mar 2017 17:43:59 -0400

Hoping to debunk biopharma’s biggest justification for high drug prices, Public Citizen released a report Monday showing that the 20 biggest drug companies collectively generated more than $100 billion in annual profits from 2013 through 2015, nearly double what a sizable chunk of the industry spent on R&D for innovative drugs. Biopharma’s “messaging that emphasizes how much the industry spends to develop new drugs has for decades been drug corporations’ central trope” in justifying higher and higher drug prices, the watchdog group said. The cumulative profits Public Citizen reported sound breathtaking, especially when paired with the R&D spending of a...

Is ‘what the patient pays’ the right barometer for pricing drugs?

Thu, 26 Jan 2017 11:08:32 -0500

Just a few months ago, Mylan NV got caught in a net of its own making when it raised the U.S. list price for a two-pack of its Epipen to $608, a 550 percent increase over several years. The hue and cry on Capitol Hill and from angry patients with serious allergies was that Mylan was taking advantage of its near monopoly on the epinephrine auto-injector market. Now that price is looking like a steal. Kaleo Inc. plans to relaunch its Epipen competitor, the Auvi-q auto-injector, Feb. 14 at a list price of $4,500. That’s not a typo. Defending the...

Yes, there’s a doctor in the House (and Senate)

Tue, 03 Jan 2017 18:21:07 -0500

It was out with the old and in with the new Tuesday as the 114th U.S. Congress gave way to the 115th. Among the new delegates taking their seats in the House were a few more doctors, a dentist and the head of a Texas company that commercializes medical-related technologies. And the Senate welcomed a member who has done a stint as an attorney for a major hospital. The new members won’t be a novelty in a Congress that’s already home to more than a dozen doctors, nurses, a pharmacist and other health care providers. That’s a far cry from...

Time for fa-la-la with BioWorld’s 10th annual Holiday Gift Guide

Fri, 02 Dec 2016 14:40:00 -0500

After a bruising U.S. presidential campaign and, let’s just say, less than conventional preparation for the nation’s 45th president, we could all use a bit of holiday cheer. In a neighborly gesture, Peter Winter, Ottawa-based editor of BioWorld Insight, suggested U.S. citizens might treat themselves to a gift of Canadian real estate. “The timing couldn’t be better,” Winter quipped. “Low interest rates and a favorable exchange rate between the U.S. dollar and the Canadian dollar make buying a home in Canada very affordable. What better way to give yourself peace of mind for the next four years?” If that idea...

Biotech’s biggest protesters are turning into its supporters

Wed, 30 Nov 2016 16:50:43 -0500

For decades the biotech industry has been hounded by activists over animal testing. Most notably, a campaign against Huntington Life Sciences in the late 1990s through 2000s included arson, harassment, threats and alleged fire bombings. Less severe, but still troubling for biotech, animal rights activists join with anti-GMOers most years to protest at the Biotechnology Innovation Organization (BIO) convention. But as biotech has branched into cultured meat and alternatives to animal testing, the companies and scientists involved have been praised by animal rights groups. Chip technologies unite animal activists and biotechs Biotechs developing chip technologies are at the forefront...

Sex and drugs: Something doesn’t ‘Addyi’ up

Fri, 04 Nov 2016 17:35:10 -0400

The day before news broke of the lawsuit against Valeant Pharmaceuticals International Inc. – lodged by former shareholders of Sprout Pharmaceuticals Inc. over Valeant’s non-promotion of Addyi (flibanserin) for female sexual dysfunction – officials of Palatin Technologies Inc. groused to me about that very topic. “It’s just there, doing nothing,” he said of Addyi, a non-hormone agonist at the 5-HT1A receptor and an antagonist at the 5-HT2A receptor. Palatin hoped that Valeant’s $1 billion buyout last year of Sprout in order to get its hands on then just-approved Addyi would mean a big push for greater awareness of the drug...

Rules of the PAP road not always clear, even to seasoned travelers

Tue, 25 Oct 2016 18:37:24 -0400

As a veteran health care journalist, I appreciate the need for biopharmas to recoup R&D costs and to operate profitably, so it’s hardly surprising to me when newly approved drugs are priced at a premium. But I’m also a consumer and a caregiver. In the context of those roles, the convoluted prescription drug supply chain with its multitude of handoffs seems purposely designed to obscure the true cost of branded drugs and, in turn, the true value of patient assistance programs (PAPs). The mysteries of drug pricing and efforts to mitigate patient out-of-pocket costs through PAPs hit home at the...

Left on the garbage heap of the 114th Congress?

Fri, 02 Sep 2016 11:19:07 -0400

Add this to the list of things the 114th U.S. Congress likely won’t get done before it fades into history on Jan. 3: Providing relief from the inter partes review (IPR) intimidation racket. It’s not for want of trying. But the only attempts were specifically aimed at keeping drug companies from being pushed around by the government-sanctioned playground bullies who use the threat and filing of IPR patent challenges to demand a lot more than lunch money. The trouble is a lot of lawmakers didn’t want to stand up for drug companies, who aren’t the most popular kids on the...

Will biosimilar carve-outs put R&D for older MAbs on ice?

Thu, 11 Aug 2016 17:47:32 -0400

Unintended consequences. It’s a term that’s bandied about all too often in Washington these days, as it’s become the PC way for lawmakers and agencies like the FDA to save face when they have to admit, “Oops, we didn’t think that one through very well” when confronted with the negative impacts of the laws and regulations they’ve created. A new unintended consequence could be in the offing as the FDA extends its practice of label carve-outs to biosimilars. A familiar feature of the generics scene, carve-outs have allowed the agency to approve a knock-off even though the reference drug may...

Ethically speaking: What’s the right thing to do?

Fri, 29 Jul 2016 14:41:47 -0400

The challenges of drug development are vast and demanding. Keeping up with scientific advances, the competition, clinical trial roller coasters, global regulatory hurdles, financing innovation, pricing … the list is endless. But have the myriad responsibilities distracted us from the assumed main reason for developing new medicines? Is improving the human condition in a way that prioritizes the largest problems first too lofty a goal? What risks should sick patients take in the name of science and who is protecting the vulnerable? Who decides what’s right and safe in tinkering with our genetic makeup? Though watchdogs aplenty monitor various parts...

For the birds, or the BlackBerries: Titles to intrigue and entertain in BioWorld’s 10th Annual Summer Reading List

Wed, 01 Jun 2016 14:52:03 -0400

We’re still a few weeks away from the summer solstice, at least in the Northern Hemisphere, but with BIO around the corner that trip to San Francisco justifies a good read. Whether you’re in the mood for the story of a scientist coming of age or of a world leader seeking to thwart the Axis powers, a street child’s search for his father or a neurologist’s look at psychosomatic illness, BioWorld’s Summer Reading List – our 10th annual – is certain to have something to pique your interest. We culled the top suggestions from our writers and readers, in some...

An end to Charlotte’s web?

Tue, 10 May 2016 16:09:22 -0400

In the annals of popular literature, TV shows and movie scripts, only a handful of pigs have achieved mega stardom: Napoleon, who took over a farm and assassinated his political rivals; Arnold, who epitomized the couch potato at Green Acres; Miss Piggy, who used her feminine wiles and street smarts to become the piglet diva of the Muppets; Babe, who used his sheep-herding skills to survive and land a starring role in a movie; and Wilbur, who had the best ad agent of them all. While other famous pigs were almost human in their aspirations and lifestyle, Wilbur was, well,...