Thu.Mar 28, 2024

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BD to Increase Plastic Syringe Production After FDA Warns on Imports From China

Drug Topics

Following quality concerns voiced by the FDA regarding plastic syringes made in China, medical technology company BD has announced it will increase its production of plastic syringes in the US.

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Covid’s scientific silver lining: A chance to watch the human immune system respond in real time

STAT

While an increasingly anxious world watched a new coronavirus spread across the globe in early 2020, veteran immunologist Rafi Ahmed quickly grasped that his field was about to experience something truly extraordinary. His former student Ali Ellebedy was gnawed by frustration as Covid shutdowns stalled his influenza research; it took until the summer, when mass vaccination planning hit his radar, before the same realization kicked in.

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Supreme Court Considers Mifepristone Limits in First Case Since Dobbs

Drug Topics

This week, a divided America watched as the Supreme Court heard oral arguments regarding whether to reinstate restrictions on accessing mifepristone, an essential drug used in medication abortion.

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STAT+: Why the world’s most expensive drug might not be all that overpriced

STAT

The staff of the Institute for Clinical and Economic Review, or ICER, are known as the nerds of the drug industry: bespectacled killjoys who emerge a few times a year to scold drugmakers for pricing their latest cancer or MS advance far beyond reason. But last year, its staff sat down and concluded a forthcoming treatment was worth up to $3.9 million — more than any medicine in history, more than a 45-year supply of Humira, the autoimmune drug often held up as an emblem of America’

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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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FDA Expands Tenofovir Alafenamide Indication to Treat HBV in Patients as Young as 6

Drug Topics

Tenofovir alafenamide was originally approved by the FDA in 2016 to treat adults with chronic HBV infection with compensated liver disease and in 2022 to treat pediatric patients aged 12 years and older.

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STAT+: Payments by drug and device makers to doctors remain widespread, but also vary considerably

STAT

The financial ties between drug and device makers and some physicians remains pervasive, despite concerns such relationships may influence medical practice, according to a new analysis of payments made over a recent 10-year span. From 2013 to 2022, pharmaceutical and device companies made more than 85 million payments totaling $12.1 billion to approximately 826,300 physicians.

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Does decaf coffee contain a harmful additive? Advocates want to ban a certain chemical in the brew

STAT

WASHINGTON — There’s a fight brewing over the future of decaf coffee. Consumer health advocates are petitioning the Food and Drug Administration to ban a key chemical, methylene chloride, used to decaffeinate coffee beans. While the chemical is almost entirely removed during the decaffeination process, advocates say that a little-known nearly 66-year-old federal law mandates the agency ban the additive because it has been proven to cause cancer in rodents.

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Walgreens takes $6B hit in Q2 from VillageMD investment

Fierce Healthcare

This is a developing story and will be updated following Walgreens' Q2 earnings call this morning. | Walgreens lost nearly $6 billion in its fiscal 2024 second quarter to write down the value of its investment in primary care clinic chain VillageMD.

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Ozempic-like drugs linked to low, but increased risk of post-endoscopy pneumonia, study finds

STAT

Diabetes and obesity GLP-1 drugs like Ozempic, which can delay stomach emptying, have introduced a predicament for patients undergoing surgeries and endoscopies — the patients in some cases may still have food in their stomach even if they’ve fasted, raising concerns that they could accidentally breathe food into their lungs during the procedures.

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US lags other nations in access to primary care, coordination with specialists: Commonwealth Fund

Fierce Healthcare

The U.S. | While there are common struggles for the primary care model in many wealthy countries, the U.S. is a particularly poor performer with overburdened physicians and unsatisfactory patient care in general.

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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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Opinion: Oprah kicked off a national conversation on obesity and GLP-1 drugs. Let’s have it

STAT

Oprah Winfrey, true to form, is forcing America to yet again grapple with a complex topic: weight loss. Her full-throated endorsement on national television last week for using GLP-1 drugs like Ozempic and Wegovy to treat obesity has opened the door for an important conversation about the use of these drugs for people struggling with their weight. As a physician focused on obesity and metabolic disorders, I was troubled by Oprah’s support for these drugs.

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Understanding DSCSA: Insights for All Dispensers

Pharmacy Times

As the full act will be enforced in November 2024, all medication dispensers must ensure they’re fully prepared.

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Who can sue the FDA? Answering Justice Alito’s question from the mifepristone arguments

STAT

WASHINGTON — Supreme Court Justice Samuel Alito had a clear question at Tuesday’s arguments over the abortion pill mifepristone: If the doctors who brought that case can’t sue the FDA over a drug’s label, who can? And when? “Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful? And maybe what they did was perfectly lawful, but shouldn’t somebody be able to challenge that in court?

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NBA champion Robert Horry draws on daughter's health struggles and joins ICHRA movement

Fierce Healthcare

Robert Horry's daughter, Ashlyn, spent the first six months of her life at Texas Children's Hospital in Houston hooked up to oxygen. | Better known for his clutch shots in the NBA finals or his commentary on Lakers games today, Robert Horry is joining SureCo, a company helping employers administer ICHRA plans, as a chief impact officer.

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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+: U.K. becomes the first country to release detailed data on sponsors that fail to register clinical trials

STAT

The United Kingdom has released comprehensive data showing which institutions have failed to register their clinical trials, a move that was hailed by transparency advocates who say this marks the first time that a country has taken such a step. Last week, the Health Research Authority posted complete registration information for 1,545 trials, including the name of the study, the sponsor, and registration number for the trial.

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Kaiser Permanente-backed Habitat Health to offer PACE services in 2025

Fierce Healthcare

Kaiser Permanente and a pair of investment firms have unveiled a joint venture to help older, low-income adults receive care support without needing to be moved from their homes. | The joint venture operates under a capitated payment model and aims to keep low-income seniors in their homes with a combination of medical and social services. It's initially targeting those living in Sacramento and Los Angeles.

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Johnson & Johnson gets a new opportunity to contest science in talc litigation

Fierce Pharma

Johnson & Johnson will get a do-over in its defense against more than 50,000 lawsuits that claim the company’s iconic baby powder can cause ovarian cancer. | Johnson & Johnson will get a do-over in its defense against more than 50,000 lawsuits claiming that the company’s iconic baby powder can cause ovarian cancer. A New Jersey court ruled on Wednesday that J&J can contest the scientific findings that back those cases.

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Highlighting the disruptors: Innovation for now and tomorrow at WIRED Health 2024, Part One

pharmaphorum

Explore the cutting-edge innovations featured at WIRED Health 2024, including insights on Alphafold, clean air technology, and Lingo. Stay informed about the latest disruptors shaping the future.

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Listen: What the mifepristone case means, GLP-1 skepticism, & Chinese biotech

STAT

Who gets to sue the FDA? Is pharma caught in a trade war? And what does “AF” stand for? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Sarah Owermohle joins us to explain the Supreme Court case that could have dramatic effects on access to medication abortion — and the development of new medicines.

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Health equity has become an organizational priority as data capabilities slowly mature, EY finds

Fierce Healthcare

Three-quarters of polled health equity executives expect their area of expertise to become a greater priority over the coming year, a new EY report has found. | Though organizations are increasingly shifting from collecting data to using it to inform efforts, bigger entities with more resources tend to be more mature in these capabilities.

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STAT+: Pharmalittle: We’re reading about a GLP-1 side effect, U.K. clinical trial transparency, and more

STAT

Top of the morning to you and a fine one it is. Despite cloudy skies hovering over the Pharmalot campus, our spirits remain sunny. How so? We will trot out a bit of wisdom from the Morning Mayor, who taught us that “every new day should be unwrapped like a precious gift.” So while you tug on the ribbon, we will proceed by brewing another cup of stimulation.

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Test could give early warning of motor neuron disease

pharmaphorum

Scientists say a test for motor neuron disease, based on an aptamer for biomarker TDP-43 in brain tissue, could detect at-risk people before symptoms develop.

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STAT+: A contrarian view on Viking Therapeutics, biotech’s hottest obesity stock

STAT

This is the inaugural edition of Adam’s Biotech Scorecard, a new subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered every Thursday to their inbox. Hello! Welcome to the premiere issue of Adam’s Biotech Scorecard. I’m excited to get started. Let’s do this! (By the way, the AF in the logo are my initials, not the “other” AF.

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Akebia joins GSK in US market for oral CKD anaemia drugs

pharmaphorum

Akebia’s Vafseo has been approved in the US as a treatment for anaemia caused by chronic kidney disease in dialysis patients, the first direct rival to GSK’s Jesduvroq.

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How GLP-1’s moved from research labs to national TV

STAT

Today is the inaugural publishing day for Adam’s Biotech Scorecard — a subscriber-only newsletter offering senior reporter Adam Feuerstein’s no-holds-barred perspective on the rapidly shifting world of biotech. Sign up to get it in your inbox here. Hello! It’s Meghana. Today, we’re reading about the world’s costliest drug, plus we learn about immune senescence and a potential cause for a kidney autoimmune disease.

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Flip The Pharmacy April Schedule & Sign-Up

Drug Topics

Check out these can't-miss Workflow Wednesdays sessions in April.

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Social Media Users Turn to Twitter for Birth Control Guidance, Education

Pharmacy Times

The authors note that these findings provide opportunities for health care professionals to utilize social media to reach patients and share accurate information.

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Can you take ibuprofen with amoxicillin?

The Checkup by Singlecare

Ibuprofen can be taken along with amoxicillin, but you should recognize the benefits and risks of doing so. The most popular nonsteroidal anti-inflammatory drug ( NSAID ), ibuprofen , is a fever-reducer and pain-reliever. Meanwhile, amoxicillin is a classic member of the penicillin antibiotic class , used in treating ear and sinus infections , pneumonia , strep throat, urinary tract infections , and skin infections.

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Study: ‘gamechanger’ diabetes drugs cost up to 400 times more than needed

The Guardian - Pharmaceutical Industry

Drug companies urged to ‘release stranglehold’ on medicines such as Ozempic and Trulicity, as millions are priced out of treatment Drug companies are pricing diabetes medicines at almost 400 times the level necessary to make a profit, according to a new study. Researchers said it would also be possible for modern insulin pens, which are safer and offer more accurate doses than vials and syringes, to be used even in low-income countries if pharmaceutical firms “put people before their astronomica

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Can amoxicillin treat STDs?

The Checkup by Singlecare

Amoxicillin is an antibiotic approved by the U.S. Food and Drug Administration (FDA) to treat many bacterial infections. These include ear infections, sinus infections, lower respiratory tract infections, and urinary tract infections (UTIs). It can also be combined with other medications to treat Helicobacter pylori infections and duodenal ulcer disease.

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Nanoscope Therapeutics exhibits positive top-line Phase IIb results for MCO-010

Pharmaceutical Technology

Nanoscope Therapeutics released promising top-line results for its RESTORE trial, which is studying the gene therapy MCO-010 in patients with retinitis pigmentosa (RP).

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Beckley builds case for its psychedelic depression therapy

pharmaphorum

New data for Beckley Psytech's psychedelic therapy for treatment-resistant depression builds anticipation for a phase 2b readout later this year

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Patented AI Platform Identifies Promising Early-Stage BioPharma Assets and Companies

Fierce Pharma

Authors: | Gain the competitive edge with accurate probability of success assessments to uncover undervalued companies and early-stage assets for acquisitions.

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Measles cases continue to rise in US amid lagging vaccination rates

Pharmaceutical Technology

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.