Thu.Jan 04, 2024

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Paxlovid Found Not to Reduce Long COVID Risk

Drug Topics

A new study found that 16.1% of patients treated with nirmatrelvir-ritonavir (Paxlovid) reported long COVID symptoms, compared to 14% of untreated patients.

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Statins Could Potentially Slow Deterioration of Cognitive Function for Those With Alzheimer Disease

Pharmacy Times

Due to the observational nature of the study, the study authors said they cannot determine causal relationships between statins and cognitive decline for patients with Alzheimer disease.

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Hospitals Reinstate Mask Guidelines Against Triple Threat of Respiratory Illnesses

Drug Topics

In response to a surge in cases of COVID-19, flu, and RSV, hospitals are reinstating mask guidelines to avoid adverse capacity outcomes and staffing shortages seen in prior years.

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Poor Sleep Quality in Early Adulthood Linked With Worse Cognitive Performance in Middle Age

Pharmacy Times

The risk of poor cognitive performance was nearly double in participants who had the greatest number of sleep disturbances compared to the least.

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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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Moderate Carbohydrate Diet May Improve Glucose Control in Patients With T1D

Drug Topics

Patients on a moderate carbohydrate diet increased their time in range by 4.7% and decreased their time above range by 5.9%.

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Opinion: Insurance companies are forcing psychiatrists like me to stop accepting their coverage

STAT

“I’m sorry, but I’m unable to take on new patients at this time.” I’ve said that line hundreds of times in the 15 years since I started my solo private practice in psychiatry. I feel terrible each time I say it. Someone on the other end of the phone is suffering and has taken the difficult step to call for help — probably multiple calls, given the longstanding shortage of psychiatrists — and yet I added to their hopelessness.

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STAT+: Feng Zhang, Grail founder join forces on new gene editing startup, Moonwalk

STAT

A new startup co-founded by CRISPR innovator Feng Zhang, a former executive at Grail and Illumina, and others has raised $57 million to develop a defanged form of gene editing that doesn’t cut the DNA strand. Moonwalk Therapeutics launched Thursday with funding from Alpha Wave Ventures, ARCH Venture Partners, Future Ventures, Khosla Ventures, GV, and YK Bioventures.

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COVID-19 May Be Linked to a Long-Term Decrease in Cognitive Abilities in Hospitalized Patients

Pharmacy Times

However, cognitive performance was not significantly worse than patients hospitalized for other conditions of a similar severity.

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Baby monitor videos yield evidence for long-suspected link between seizures and unexplained toddler deaths

STAT

The baby monitor didn’t go off. Any sound or motion in the twins’ room was supposed to set off an alarm — but in the wee hours of Nov. 27, 2022, Katie Czajkowski-Fell and Justin Fell weren’t woken up. They’d gotten it because of Hayden’s febrile seizures. These are common, generally nothing to worry about, the doctors said.

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Why amplifying the patient voice is crucial to clinical trial success

pharmaphorum

Amplifying the patient voice is essential for the success of clinical trials. Learn why it is crucial for patient engagement, recruitment, and overall trial success, and how it can address challenges such as transportation and financial barriers.

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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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STAT+: Allogene to pursue new strategy for development of off-the-shelf cell therapy in blood cancer

STAT

Allogene Therapeutics is making unexpected changes to development plans for its off-the-shelf cell therapy for a type of blood cancer — a concession that competition from personalized CAR-T treatments, already entrenched in the market, has become more challenging. In a strategic pivot, two clinical trials involving patients with later-stage lymphoma are being shut down.

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Ashwagandha: A Case Example of the Supplement Industry

Pharmacy Times

Perhaps ashwagandha may aid in stress management, athletic performance, and sleep, but this effect is far from definitive.

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STAT+: Burning questions for the 2024 JPM Healthcare Conference

STAT

The J.P. Morgan Healthcare Conference is upon us, bringing its frenetic meetings, crowded hallways, and hotel rooms so expensive that even the pharmaceutical industry complains about what a free market does to the prices of scarce goods. This year’s iteration, starting Monday in San Francisco, finds the biotech industry, in particular, in a curious spot.

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Bluebird bio's Lyfgenia launch progresses with 2nd major outcomes-based coverage deal

Fierce Pharma

Despite competitive pressure from a buzzy CRISPR therapy, bluebird bio keeps striding forward with its sickle cell disease gene therapy Lyfgenia. | Despite competitive pressure from a buzzy CRISPR therapy, bluebird bio has signed a second outcomes-based reimbursement agreement for its sickle cell gene therapy Lyfgenia.

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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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STAT+: Illumina chief commercial officer leaves to lead liquid biopsy startup Delfi

STAT

Delfi Diagnostics, a startup devising new ways to use routine blood draws to detect early signs of cancer, told STAT Thursday that it has appointed Susan Tousi, chief commercial officer for genomics giant Illumina, as its new CEO. She is the fourth senior executive to leave Illumina since June. Tousi will start next week, just in time for the J.P. Morgan Healthcare Conference , while founding CEO Victor Velculescu will remain on the company’s board to help guide its research programs.

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2024 forecast: As CDMOs come off pandemic's highs and lows, employment and funding hitches persist

Fierce Pharma

Even after the heady highs of the COVID-19 era, the contract development and manufacturing organization (CDMO) realm remains one of biopharma's buzziest fields. | Even after the heady highs of the COVID era, the CDMO realm remains one of biopharma's buzziest fields. In 2024, CDMOs can advance their priorities on three fronts, a group of experts said during a recent Evaluate webinar on the state of the industry.

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After loved ones’ long-awaited organ transplants, caregivers often find challenges are just beginning

STAT

By the time his wife Glenda Daggert received a double organ transplant in 1999, Ira Copperman already had a lot of experience as a caregiver. The couple had been together for over two decades, married for one, and Copperman had become accustomed to helping Daggert manage her diabetes and its complications. Mixing insulin, going along for doctor’s visits, administering injections: it was all routine.

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Costs of treating COVID-19 hospitalizations quintupled medical inflation across the pandemic

Fierce Healthcare

The cost of treating a COVID-19 hospital patient in the hospital rose by 26% over the first two years of the pandemic, more than five times the rate of medical inflation during that time, according | On average and after adjustments, direct treatment costs for a COVID-19 hospital admission rose 26%, from $10,394 in March 2020 to $13,072 in March 2022, researchers found in a new analysis of 1.3 million inpatient stays.

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STAT+: An injectable gel enters the male birth control fray with early positive clinical data

STAT

Between condoms and vasectomies lies a vast, undeveloped chasm of male birth control. Contraline, a device startup that released early, positive clinical data in a press release on Thursday, hopes to fill it. The company has built an injectable gel that’s inserted into the sperm duct, physically blocking the sperm from coming out. Investigators tested the device on 23 participants in Australia last year and recorded no serious adverse events.

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AGC extends CDMO expansion spree, plans second manufacturing facility in Japan

Fierce Pharma

Already with a manufacturing site in Chiba, Japan, AGC Biologics is doubling down on its presence in the country with a new facility in Yokohama. | Already with a manufacturing site in Chiba, Japan, AGC Biologics is doubling down on its presence in the country with a new facility in Yokohama. The Seattle-based CDMO has unveiled its plan to construct a four-story complex, which will cover 20,000 square meters (215,000 square feet) and is expected to become operational in 2026.

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STAT+: Feng Zhang’s year-old CRISPR delivery startup Aera lays off quarter of staff

STAT

Aera Therapeutics, a startup launched by the CRISPR pioneer Feng Zhang last year to solve one of the biggest bottlenecks in genetic medicine, has laid off a quarter of its staff, the company confirmed to STAT.  The layoffs come as the biotech market remains mired in a now nearly three-year-long downturn that has left startups struggling to attract both private and public funds.

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CVS Caremark to kick AbbVie's Humira off some formularies in favor of cheaper biosimilars

Fierce Pharma

This year, CVS Health plans to employ the classic "out with the old, in with the new" mantra when it comes to AbbVie’s Humira. | The changes to major commercial formularies will take effect April 1 and favor Humira biosimilar options over the branded drug as part of CVS' efforts to ramp up U.S. biosimilar adoption.

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STAT+: Novo Nordisk enlists two Flagship biotechs to develop obesity, MASH drugs

STAT

Novo Nordisk may already have one blockbuster obesity drug in its portfolio, but the Danish drugmaker has actively begun searching out others, including through a new partnership announced Thursday. Novo Nordisk will work with Omega Therapeutics, a startup founded by venture creation firm Flagship Pioneering, to develop a genetic editing treatment for obesity.

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Biologics Treatment Response Patterns Comparable in Patients With ACO, Asthma

Pharmacy Times

The efficacy of biologics suggests a potential for biologic-based treatment for patients with asthma-chronic obstructive pulmonary disease overlap.

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STAT+: FDA is blasted by advocates for pursuing a deal with data provider that has ties to opioid makers

STAT

Several advocacy groups are blasting a Food and Drug Administration proposal to work with a Denver Health surveillance system for monitoring misuse of prescription opioids over long-standing ties the operation has to the pharmaceutical industry. At issue is the Research, Abuse, Diversion, and Addiction-Related Surveillance system, or RADARS, which was originally created as in-house monitoring program by Purdue Pharma and later sold to the Denver Health and Hospital Authority.

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New Maine law prevents insurers from requiring patients meet deductibles for abortion care

Fierce Healthcare

Insurers in Maine will no longer be permitted to require patients meet a deductible or pay other cost-sharing measures before receiving access to an abortion, according to a new law that took effec | Legislators in Maine are removing financial barriers for patients to obtain access to an abortion. Insurers will be prohibited from requiring patients to meet a deductible or other cost-sharing measures.

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STAT+: Health tech’s 2024 hiring outlook: Balance tips toward employers

STAT

Health tech hopefuls might once have been used to a wealth of job options, especially in the pandemic’s early stages when investors pumped record-breaking dollar amounts into an unprecedented number of ventures. That glut of opportunities meant workers could bargain harder for better job offers, demanding perks and flexibilities like permanent remote work or expensive fertility benefits.

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Roche antibiotic tackles serious drug-resistant pathogen

pharmaphorum

Scientists at Roche and Harvard University have discovered a new class of antibiotic that can kill carbapenem-resistant Acinetobacter baumannii (CRAB), a major public health threat

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STAT+: Pharmalittle: We’re reading about CVS dropping Humira coverage, pharma layoffs, and more

STAT

Rise and shine, everyone, another busy day is on the way. Sadly, gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will draw on a bit of insight from the Morning Mayor, who taught us that “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us.

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Click bags FDA breakthrough tag for schizophrenia DTx

pharmaphorum

Digital health company Click Therapeutics has won an FDA breakthrough device designation for CT-155, a digital therapeutic (DTx) for the negative symptoms of schizophrenia, like social withdrawal and apathy, that tend not to respond well to antipsychotic drugs.

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STAT+: Another major pharma company departs BIO

STAT

WASHINGTON — UCB left BIO at the end of 2023, the second major member company to exit after Pfizer pulled out as well. UCB, headquartered in Belgium, decided not to renew its BIO membership after a routine evaluation of its engagement in trade associations, said company spokesperson Erica Puntel. Pfizer, whose departure STAT reported first , was listed on BIO’s website as a sponsor at one of the group’s highest levels.

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Bain Capital eyes potential €1B sale of Dutch antibiotics manufacturer Centrient: report

Fierce Pharma

As bankers predict a rise in private equity exits this year, one of 2024’s M&A moves could come from the drug manufacturing realm. | Investment giant Bain Capital is weighing a potential sale of its Dutch antibiotics and active pharmaceutical ingredients (API) specialist Centrient Pharmaceuticals, which could be valued as high as €1 billion ($1.09 billion), Bloomberg reported Wednesday, citing people close to the talks.

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The popular inhaler Flovent has been discontinued

The Checkup by Singlecare

In 2023, Flovent manufacturer GlaxoSmithKline (GSK) announced their decision to discontinue Flovent-branded products starting January 1, 2024. The popular brand-name inhalers have been a go-to asthma treatment for many patients since the 1990s. Although the manufacturer says a generic is on the way, healthcare professionals have their own concerns. What is Flovent?

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Merck settles with insurance companies over $1.4B claim tied to 2017 cyberattack: report

Fierce Pharma

Merck has reportedly settled with insurance companies that contested the pharma giant’s $1.4 billion claim after it was victimized by a crippling cyberattack in 2017. | Merck has settled with insurance companies that contested the pharma giant’s $1.4 billion claim after it was victimized by a crippling cyberattack in 2017, Bloomberg Law reports. With the settlement—terms of which were not disclosed—the insurance companies avoided a ruling that would have provided precedent for other cases involv

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