Thu.Jun 20, 2024

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STAT+: Gilead’s twice-yearly antiviral protected women from HIV infection in large trial

STAT

Gilead said Thursday that twice-a-year injections of a new antiviral drug, called lenacapavir, completely protected cisgender women from contracting HIV in a large Phase 3 trial. In the study, none of the 2,134 women who received lenacapavir contracted HIV. By comparison, 16 of the 1,068 women who received the long-running daily pill Truvada contracted HIV.

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Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention

Fierce Pharma

For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.

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STAT+: Doctors Without Borders is closing its widely regarded access-to-medicines campaign

STAT

In a surprise move, Doctors Without Borders is closing down its access-to-medicines campaign, which has been credited with ensuring needed drugs and vaccines have been made available to countless patients in low-income countries around the world. The organization plans to close its campaign by the end of this year and create a new effort devoted to access to products for health care.

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Study: Ultraviolet-B Radiation Could Improve Widespread Vitamin D Deficiency

Pharmacy Times

Ambient-UVB radiation could improve 25(OH)D prediction in the future, improving widespread vitamin D deficiencies among non-White individuals.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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STAT+: Top FDA official Peter Marks overruled staff, review team to approve Sarepta gene therapy

STAT

For a third time, Sarepta Therapeutics has convinced a top Food and Drug Administration official to overrule the prevailing view of their staff and approve a drug for Duchenne muscular dystrophy. On Thursday evening, the FDA announced it expanded the approval of Elevidys, Sarepta’s Duchenne gene therapy, to cover nearly all patients, regardless of age or wheelchair status, despite the fact that the drug failed a large, Phase 3 trial last year.

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UnitedHealthcare offers a look at results from its Level2 diabetes program

Fierce Healthcare

UnitedHealthcare is offering a look at the impacts its Level2 diabetes program is having on members. | UnitedHealthcare unveiled the program in 2020. Level2 provides members with multiple connected devices they can use to manage Type 2 diabetes, including a continuous glucose monitor and activity tracker.

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Sarepta scores 'transformational' FDA label expansion for Duchenne gene therapy Elevidys

Fierce Pharma

There’s no slowing the momentum of Sarepta’s groundbreaking Duchenne muscular dystrophy (DMD) gene therapy Elevidys—not even the failure of a confirmatory trial. | The FDA has expanded the label for Sarepta's Elevidys to all Duchenne muscular dystrophy patients ages 4 and older. It’s a major boost for the first gene therapy to treat the inherited disorder, which received an accelerated approval a year ago—nearly to the date—but only for ambulatory boys ages 4 to 5.

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Coalition wages campaign for retractions of Richard Lynn’s racist journal articles

STAT

A coalition of researchers, historians, and journalists is urging that major scientific publishers, including Elsevier and Springer, retract the racist articles of an academic known — and sometimes lauded for — a long career espousing ideas of racial superiority and eugenics. The call for retraction, made Thursday in a First Opinion published in STAT, focuses on hundreds of papers published by the late Richard Lynn of the University of Ulster, who has described “the decay of

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In fight against knockoff weight loss meds, Eli Lilly accuses sellers of 'deceptive' advertising

Fierce Pharma

Eli Lilly is stepping up its effort to combat the improper sale of compounded versions of its popular diabetes and weight loss drugs. | Eli Lilly is stepping up its effort to combat the improper sale of compounded versions of its popular diabetes and weight loss drugs. The Indianapolis-based drugmaker is suing six wellness centers, medical spas and others that it claims are using "deceptive" advertising.

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STAT+: FDA approves Sarepta’s Duchenne gene therapy for nearly all patients

STAT

The Food and Drug Administration on Thursday approved Elevidys, Sarepta’s gene therapy for Duchenne muscular dystrophy, for nearly all patients with the fatal muscle-wasting disease, dramatically expanding the initial, narrow authorization handed down last year. The decision will likely be greeted by many families and doctors as a turning point in the fight against the muscle-wasting disease, even if it’s not nearly the seismic shift some had hoped for just a couple of years ago.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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J&J's subcutaneous version of Tremfya excels in Crohn's disease study

Fierce Pharma

In May, Johnson & Johnson touted the success of its intraven | After touting the success of its intravenous (IV) formulation of Tremfya in two head-to-head trials against its own Stelara in Crohn’s disease, Johnson & Johnson has shown the success of a subcutaneous (SC) version of Tremfya in another Crohn's disease study.

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Opinion: Getting ahead of a non-alcoholic beverage boom among youths

STAT

The non-alcoholic beverage market is booming right now : zero-proof bottle shops and bars are popping up across the country ; a non-alcoholic beer brand is even taking over as the top selling beer at Whole Foods. And the Olympic Games have their first beer sponsor , courtesy of alcohol-free Corona Cero. While it’s great that more people are taking to heart public health messages that reducing alcohol consumption can improve well-being and extend life , an important lesson from vaping as a

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The next frontier: How to use AI-powered analytics for life sciences marketing

pharmaphorum

Discover how AI-powered analytics are revolutionising life sciences marketing. Learn how to leverage these cutting-edge technologies to drive insights and success in the industry.

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STAT+: New immunotherapy combination could ‘change the landscape’ of cancer treatment

STAT

When they work, immunotherapy drugs called checkpoint inhibitors can shrink cancers and, in some cases, eradicate tumors altogether. These drugs, which include Keytruda and Opdivo, are prescribed to hundreds of thousands of patients a year for dozens of different kinds of cancer — but they only work for a minority of them. Most patients ultimately end up progressing or relapsing.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Samsung Biologics upgrades another production pact, this time with Baxter for $223M

Fierce Pharma

On a revised dealmaking spree this year, Korea’s Samsung Biologics is re-tooling its long-running drug manufacturing pact with Baxter Healthcare. | The revised deal, first established back in July of 2017, will now see Baxter pay Samsung upwards of $223 million for its manufacturing services through end of 2034. Previously, Baxter was on the hook to pay just $15 million for Samsung’s production assistance.

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Screen early in pregnancy for gestational diabetes, new Lancet series urges

STAT

Gestational diabetes affects one in seven expecting women globally and rates of this troubling condition are rising. Blood glucose levels that become elevated for the first time during pregnancy can lead to severe complications, such as preeclampsia, and increase the risk of stillbirth. And while the condition typically resolves after birth, it is linked to a tenfold increase in the risk of developing type 2 diabetes, along with risks for the child including obesity, cardiovascular disease, and

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Johnson & Johnson blueprints €125M plant upgrade as part of 5-year Italy investment

Fierce Pharma

After plugging nearly 50 million euros into its Italy operations in the first half of the decade, Johnson & Johnson Innovative Medicine is significantly upping its commitment to the country.

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STAT+: Zealand’s amylin-targeting drug shows early potential in obesity

STAT

Zealand Pharma on Thursday reported early positive results of an investigational obesity drug that activates a hormone that’s not targeted by popular treatments Wegovy and Zepbound. In one part of a Phase 1b study, petrelintide, which targets the amylin hormone, led to 8.6% weight loss at 16 weeks, more than the 1.7% weight loss among patients taking placebo, the Danish company said.

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No sweat for dermatology specialist Botanix as hyperhidrosis gel Sofdra gains FDA approval

Fierce Pharma

Everybody sweats, but for the 10 million people in the U.S. living with primary axillary hyperhidrosis, sweating can take on a whole new meaning. | The med is the first new chemical entity to win FDA approval specifically to treat primary axillary hyperhidrosis, or excessive underarm sweating. It's also Botanix's first approved product.

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STAT+: A primer on HELIOS-B, an enormous stock-moving event for Alnylam Pharmaceuticals

STAT

This is the online edition of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered every Thursday to their inbox. The outcome of the HELIOS-B study — expected at the end of June or early July — is an enormous stock-moving event for Alnylam Pharmaceuticals. Billions of dollars in potential revenue — sufficient to power Alnylam into profitability — are on the line.

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AbbVie breaks new ground for IL-23 drug Skyrizi in IBD

pharmaphorum

AbbVie’s Skyrizi is approved by the FDA for ulcerative colitis, making it the first IL-23 inhibitor indicated for both major types of inflammatory bowel disease.

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STAT+: Vertex reaches a new deal with NHS England over its pricey cystic fibrosis treatments

STAT

After months of haggling, Vertex Pharmaceuticals and the National Health Service in England reached agreement over access to several cystic fibrosis treatments, capping an end to a long-running saga that frequently enraged patients and families who sought the treatments. Specific details were not released, but the deal was announced after a U.K. cost-effectiveness watchdog decided to recommend the Vertex medicines for coverage by the NHS.

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FDA approves AbbVie’s Skyrizi for UC treatment

Pharmafile

AbbVie has announced that the US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) and moderate to severe Crohn’s disease. The post FDA approves AbbVie’s Skyrizi for UC treatment appeared first on Pharmafile.

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STAT+: Bold’s CEO on fall prevention, ageism in health care, and ‘movement is medicine’

STAT

BEVERLY HILLS, Calif. – When Amanda Rees was in her twenties she moved in with her grandmother, who was in her 80s, and saw first-hand the issues older adults face with falls and balance. “It really radicalized how I thought about aging,” she said. Serving as her grandmother’s caretaker inspired her to shift into health care and start Bold , a health tech startup that provides at-home digital exercise programs targeted at adults 65 and older.

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Infectious disease group ISID names six global priorities

pharmaphorum

International Society for Infectious Diseases (ISID) publishes six priorities focusing on challenges faced by low- and middle-income countries (LMICs).

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Lilly takes more actions against unapproved versions of Mounjaro

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. Here in Chicago, temperatures are high and tensions are even higher as two major hot dog restaurants are  reportedly beefing. Apparently PETA is involved and taunted one of the restaurants with a “pig mobile” even though that restaurant doesn’t even serve pork.

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Vanda rejects buyout offers, pans 'opportunistic attempts' at securing its shares at a discount

Fierce Pharma

A series of increasing buyout offers has failed to convince Vanda's board of directors that the company should sell itself. | Vanda is turning away buyout offers from Future Pak and Cycle Pharma. In a statement, Vanda said its revenue base, cash position and efficient operations position the company "for significant long-term growth and value creation far in excess of the" other firms' offers.

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STAT+: Ginkgo Bioworks lays off 158 employees, with more to come

STAT

BOSTON — Ginkgo Bioworks, the once-high-flying Boston life sciences firm, on Thursday said it has notified 158 employees that they will be laid off and expects to announce another batch of layoffs next week. On May 9, Ginkgo said it would slash labor costs by at least 25 percent. But the Boston-based cell programming and biosecurity company declined to specify the number of workers who would be let go.

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Sanofi: NICE would reject Sarclisa even if it cost nothing

pharmaphorum

After rejection of its multiple myeloma therapy Sarclisa by NICE, Sanofi claims the drug would not have been deemed cost-effective 'even at zero price'

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STAT+: Pharmalittle: We’re reading about Lilly lawsuits, Novo Nordisk fires and much more

STAT

Rise and shine, everyone, another hot day is on the way. The forecast – at least on this side of the pond – is warning us to find some shade. So to prepare, we are grabbing a parasol and, naturally, brewing a few cups of stimulation to see us through. Our choice today is orange creme. No matter the weather, though, there is work to be done.

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Can you drink while taking quetiapine?

The Checkup by Singlecare

Quetiapine, commonly prescribed under the brand name Seroquel, is an atypical antipsychotic medication used to treat mental health conditions such as schizophrenia and bipolar disorder. This medication affects dopamine and serotonin receptors in the brain, which may help balance mood. Quetiapine is typically taken daily, on a long-term basis, to manage symptoms.

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Listen: Fauci’s memoir, Alnylam’s tenuous trial, and a mid-year review

STAT

Can Alnylam find success with its latest cardiac treatment after tweaking the trial? And did STAT’s editorial team pull off a covert mission to get an advanced copy of a new book? We cover all that and more on this week’s episode of “The Readout LOUD.” STAT reporter Jason Mast joins us to discuss Anthony Fauci’s memoir “On Call,” which was published this week.

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Semi-automation of manual interventions in high-speed filling lines

European Pharmaceutical Review

Researchers have developed a novel, gloveless intervention method with remote robotic interventions for high-speed pharmaceutical isolator filling lines. While these high-speed lines are currently fully automated, Dekker et al. noted that operator interventions are still done manually. For example, a common intervention is the removal of erroneous plungers or stoppers.

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Trust Between Patient, Provider Key to Reducing Vaccine Hesitancy

Drug Topics

Research presented at ASHP 2024 found that concerns around the safety of COVID-19 vaccines and the credibility of information from public health authorities were the biggest drivers of vaccine hesitancy during the COVID-19 pandemic.

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