Wed.Nov 16, 2022

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New data show how insurers and middlemen shift Rx costs onto patients

PhRMA

There is only one place in the health care system where middlemen refuse to share negotiated prices with patients, and that’s at the pharmacy counter. A new report reveals how this harmful tactic leads to higher costs for patients.

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Rinvoq’s Effectiveness in Treating Crohn’s, Ulcerative Colitis Shown in Studies

Drug Topics

New research illustrates the efficacy of upadacitinib for treating Crohn's and ulcerative colitis.

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Six ways I-MAK is lying about biopharma patents

PhRMA

The Arnold-Venture funded advocacy group Initiative for Medicines, Access & Knowledge, Inc. (or I-MAK) is on a global media tour, espousing their point of view on the patent system. Some experts and congressional leaders don’t buy the rhetoric, and neither should you.

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Working With Discount Cards and Manufacturer Coupons

Drug Topics

Discount cards and manufacturer coupons can cost pharmacies in the long run.

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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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Top U.S. addiction researcher calls for broad deregulation of methadone

STAT

BOSTON — The U.S. government’s top addiction researcher is calling for broad deregulation of methadone , a key drug used to treat opioid use disorder. American doctors should “absolutely” be allowed to prescribe methadone directly to patients, Nora Volkow, the director of the National Institute on Drug Abuse, said Wednesday.

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Almost 1 in 3 Americans Feel Unprepared for 2023 Health Care Costs

Drug Topics

Inflation is the top reason that nearly one-third of Americans are concerned about covering unexpected health care needs.

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More Trending

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FDA Releases Notice on Safety and Effectiveness of Certain Nonprescription Naloxone Products

Drug Topics

We may be one step closer to nonprescription naloxone.

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Novel Migraine Treatment Shows Mixed Results in Phase 3 Efficacy Trial

Pharmacy Times

Investigational migraine drug produces significant effects on both freedom-from-pain and MBS-free endpoints at 3 hours post administration and at additional efficacy measurement timepoints of 4, 6, 12, 24 and 48 hours.

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Novartis said to be eyeing sale of ophthalmology, respiratory units

pharmaphorum

Novartis has already spun out its eyecare business Alcon, and is now considering the sale of its ophthalmology and respiratory medicines businesses as it continues a narrowing of its focus, according to media reports. A Bloomberg article citing people close to the matter claims that Novartis is engaged in early discussions about the sale of the two units, which could raise billions of dollars in capital that could be reinvested into the pharma group’s pipeline.

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Defining SARS-CoV-2 Bivalent Vaccines and Optimizing Protection Through Vaccination

Pharmacy Times

Wendy Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP; Jacinda Abdul-Mutakabbir, PharmD; and Rodney E. Rohde, PhD, MS, SM(ASCP)CM, SVCM, MBCM, FACSc; review what encompasses a bivalent vaccine and give their perspective on how to communicate the role of the vaccine in optimizing protection for patients.

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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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Innovation in pharma manufacturing quality systems

European Pharmaceutical Review

As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment. For young biotechs, scaling up production brings green-field challenges, while for more established pharma a shift may be required to ensure that facilities are optimised for new ways of working.

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Study Finds Significant Drop in Vaccine Confidence During COVID-19 Pandemic

Pharmacy Times

In a 2019 survey, middle-aged participants were considerably more apprehensive about getting vaccinated than younger groups, which was not the case in the 2022 survey.

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WHO, Uganda plan to test three candidate Ebola vaccines in outbreak

STAT

The World Health Organization and the government of Uganda plan to test three candidate Ebola vaccines in a clinical trial during the ongoing outbreak in the East African nation, Director-General Tedros Adhanom Ghebreyesus announced Wednesday, acting on the advice of experts convened by the global health agency. The first doses of vaccine should arrive in Uganda next week, Tedros said, though the WHO has not yet indicated a start date for the trial.

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CDC and FDA Recommendations for SARS-CoV-2 Booster Shots

Pharmacy Times

Experts in the management of SARS-CoV-2 educate on CDC and FDA recommendations for approaching administration of booster vaccines, including those for special patient populations.

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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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Opinion: Unseen mental health experts: people with mental illness

STAT

When I was seven years old, I watched as police carted my father out of the house and took him away. He had severe bipolar disorder and was experiencing what I know now to be an “episode”  of this mental illness. What I learned over the 40 years that my dad was alive is that he could foster a loving relationship despite not ever mastering his recurrent episodes.

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The Promise & Pressures of Biologics R&D

Pharmacy Times

Generic small molecule drugs take advantage of abbreviated approval pathways and have markedly lower development costs compared to their reference products.

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Fentanyl isn’t just causing overdoses. It’s making it harder to start addiction treatment

STAT

Doctors are reporting a troubling trend when it comes to fentanyl. The powerful drug, they say, isn’t just causing overdoses — it’s also making it more difficult to begin addiction treatment. In particular, fentanyl appears more likely to cause severe withdrawal symptoms for patients put on buprenorphine, a key medication used to treat opioid use disorder.

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Study: FGFR mRNA Overexpression Occurs Frequently for Those With Cholangiocarcinoma

Pharmacy Times

Investigators also confirmed that FGFR2 fusion–positive tumors have a higher expression of FGFR2 but were not associated with higher expression of FGFR1, FGFR3, or FGFR4.

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GSK, J&J, and AZ head this year’s access to medicines ranking

pharmaphorum

The 2022 edition of the Access to Medicine Index (ATMI) – which places the top 20 pharma companies for their efforts to improve delivery of medicines to lower income countries – sees GSK retain the number one position, newly joined by Johnson & Johnson in second and AstraZeneca in third. GSK scored highly as its R&D programmes encompass a sizeable chunk of the 83 high burden priority diseases covered in the assessment, an integrated access to medicine strategy in its governance, and robu

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Guselkumab Shows Long-Term Improvement in Quality of Life for Patients With Active Psoriatic Arthritis

Pharmacy Times

Guselkumab (Tremfya) is a fully human selective IL-23 inhibitor therapy FDA-approved for the treatment of adults with active psoriatic arthritis and with moderate to severe plaque psoriasis.

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Hope in sight with Apellis’ pegcetacoplan OAKS/DERBY results for GA

pharmaphorum

Last month, pharmaphorum spoke with Dr Charles C. Wykoff about the results from Apellis Pharmaceuticals’ OAKS study on intravitreal pegcetacoplan for geographic atrophy (GA), otherwise known as atrophic or dry age-related macular degeneration (AMD), a leading cause of blindness worldwide. Having presented the data from the 24-month phase 3 trial at the American Academy of Ophthalmology (AAO) annual meeting, Dr Wykoff set aside some time to go into further detail with pharmaphorum about how the r

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FDA Grants EUA to Roche's Real Time PCR Test for Monkeypox Virus

Pharmacy Times

cobas MPXV targets 2 different regions of the monkeypox virus genome that are less prone to mutations than other parts of the genome.

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The scientist behind Pfizer’s Covid vaccine says a flu pandemic is only a matter of time

STAT

BOSTON — Even after leading the charge combating the worst pandemic in a century, vaccine researcher Kathrin Jansen doesn’t feel that she can relax. Another pandemic — this one based on an influenza virus — is inevitable, Jansen said at the annual STAT Summit on Tuesday. “Before SARS-CoV-2, we had worried about pandemic flu.

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ElevateBio and Affini-T collaborate to develop T cell therapies

Pharmaceutical Technology

ElevateBio has entered a partnership with Affini-T Therapeutics to progress the latter’s engineered TCR-T therapies focused on Kirsten rat sarcoma viral oncogene homolog (KRAS), a dominant oncogenic driver mutation in solid tumours. Under the deal, the LentiPeak lentiviral vector technology platform and cell therapy production expertise of ElevateBio BaseCamp will be used by Affini-T to develop its investigational oncogenic driver programmes in the clinic.

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In country after country, primary care doctors report high burnout and degraded patient care

STAT

The increased stress doctors have faced throughout the Covid-19 pandemic is making some feel like they are providing worse patient care, according to a new survey of primary care physicians from 10 wealthy countries. Younger doctors also reported higher rates of feeling distressed and burned out — a finding that was broadly consistent across the countries included.

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How to prevent—and treat—high blood pressure during pregnancy

The Checkup by Singlecare

Maintaining a healthy blood pressure is a key marker of overall health, and one of the most important vital signs monitored at each pregnancy visit. High blood pressure, also known as hypertension, can cause serious health problems in people when they are not pregnant—and complications in both the mother and child when it occurs during pregnancy. Hypertensive complications range from more frequent monitoring and medication to life-threatening for both the mother and baby.

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After decades of setbacks, scientists make strides toward the holy grail of male birth control

STAT

The headlines spelled the end of a short-lived scientific hope: “Male birth control study nixed after men can’t handle side effects women face daily,” USA Today announced. “Men Back Out of Male Birth Control Study Because They Couldn’t Handle the ‘Changes in Mood,’” proclaimed People. It was a high-profile — and highly embarrassing — end to a clinical trial that researchers hoped would usher in a new era of birth control.

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As resistant tuberculosis rises, GSK says trial backs novel antibiotic

pharmaphorum

With cases of drug-resistant tuberculosis on the rise again around the world, GSK has sparked hopes of a new treatment option after reporting phase 2a data with a novel antitubercular drug for the disease. The study of GSK3036656 – an inhibitor of the bacterial enzyme leucyl t-RNA synthetase (LeuRS) – showed that 14 days’ treatment with a low once-daily dose showed it was able to kill Mycobacterium tuberculosis in patients with drug-susceptible pulmonary tuberculosis , with no serious adve

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Covid-19 vaccines were a success, but mRNA still has a delivery problem. Two startups have an unorthodox solution

STAT

This story has been adapted from the STAT Report “The future of messenger RNA: Covid-19 vaccines are just the beginning.” W hile billions of vaccine doses administered during the pandemic have generated reams of data about the safety and effectiveness of mRNA, they haven’t answered one of the field’s biggest questions: How do you send messenger RNA exactly where it needs to go in the body?

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NICE rejects five COVID drugs and backs three on price, efficacy data

pharmaphorum

NICE has recommended that three COVID-19 therapies can continue to be used to treat patients – Pfizer’s Paxlovid, Roche’s RoActemra and Eli Lilly’s Olumiant – but turned down another five in draft guidance published this week. The health technology assessment (HTA) agency has turned down five other COVID-19 therapies, notably AstraZeneca’s Evusheld (tixagevimab plus cilgavimab) – which patient organisations in the UK have been clamouring for access to, as it is an alterna

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Why doesn’t the U.S. have more Black doctors?

STAT

BOSTON — When LaShyra “Lash” Nolen was learning about how to recognize signs of Lyme disease in a class at Harvard Medical School, a fellow Black classmate pointed out that all the examples featured people with white skin. ”How would I recognize these on someone’s skin who looked like mine?” her classmate asked.

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NICE gives thumbs-down to 5 COVID-19 drugs including AZ's Evusheld and Merck's Lagevrio

Fierce Pharma

NICE gives thumbs-down to 5 COVID-19 drugs including AZ's Evusheld and Merck's Lagevrio. kdunleavy. Wed, 11/16/2022 - 09:44.

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STAT+: Lilly CEO concedes Twitter flap over insulin costs shows there’s ‘more work to do’

STAT

After a tweet from a fake corporate account last week claimed Eli Lilly would give insulin away for free, the drugmaker’s chief executive officer acknowledged the need to do a better job of widening access to the life-saving diabetes treatment and change perceptions of its existing efforts to do so. “It probably highlights that we have more work to do to bring down the cost of insulin for more people,” David Ricks said at the STAT Summit, where he made his first public remar

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Which states have the most overweight, obese populations?

Drug Store News

Colorado has the lowest percentage of obese adults, 25%, which is 1.6 times lower than in West Virginia, the state with the highest at 40.7%.

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