Drug Topics

JANUARY 27, 2023

Though, unvaccinated people are at much greater risk for severe outcomes than folks the same age who are caught up on boosters.

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STAT

JANUARY 27, 2023

After weeks of deliberation, Pfizer was scolded by a U.K. pharmaceutical industry trade group after its chief executive officer made misleading statements in a media interview about the need to vaccinate young children against Covid-19. The fracas began when the Pfizer chief, Albert Bourla, gave an interview to the BBC and discussed the idea of vaccinating children between five and 11 years old, a course of action that had not yet been approved by regulators in the U.K.

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Vaccines 145

Drug Topics

JANUARY 27, 2023

A study aims to quantify the burden of current childhood asthma in the United States in association with smoke from indoor gas stoves.

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pharmaphorum

JANUARY 27, 2023

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. Evusheld (tixagevimab and cilgavimab) was cleared by the FDA towards the end of 2021, becoming the first antibody to be authorised for prevention of COVID-19 infection, and it rapidly found use among people with compromised immune systems, such as cancer chemothe

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FDA Chemotherapy Immunization Vaccines 135

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.

FDA

Drug Topics

JANUARY 27, 2023

Recommendations from the unanimous vote must be adopted by the FDA and CDC.

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FDA Vaccines 187

Pharmacy Times

JANUARY 27, 2023

The FDA has approved elacestrant (Orserdu) for the treatment of postmenopausal women or adult men with estrogen receptor–positive (ER+), HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy.

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FDA 123

Pharmacy Times

JANUARY 27, 2023

The FDA has approved pirtobrutinib (Jaypirca) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma following at least 2 lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.

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FDA 123

Drug Topics

JANUARY 27, 2023

SPL026 with supportive therapy sees positive results in patients with major depressive disorder.

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pharmaphorum

JANUARY 27, 2023

The emergence of COVID-19 resulted in staffing challenges that have continued to have a sustained, negative impact on clinical trial workflows. In fact, 76% of healthcare professionals have recently cited feelings of burnout, leading to a turnover rate twice as high as before the pandemic and increased levels of vacant positions across clinical research sites.

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Medical Records Patient Care Hospitals 111

Drug Topics

JANUARY 27, 2023

The agency intends to work with Congress to create a pathway that balances the desire for access with regulatory oversight and risk management.

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FDA 98

pharmaphorum

JANUARY 27, 2023

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. Having previously spoken with Dr Mullen three years ago when she was country medical director for the UK & Ireland at GSK – on the topic of patient centricity and embedding that focus within the core of a pharmaceutical company – our recent interview provided some interesting insights into the changing landscape of the indus

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Pharmaceutical Companies Pharmaceutical Companies Vaccines Patient Care 111

Fierce Healthcare

JANUARY 27, 2023

SDOH startup Spatially Health partners with Florida ACO amid new CMS rules on equity agliadkovskaya Fri, 01/27/2023 - 13:40

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STAT

JANUARY 27, 2023

LOS ANGELES – California cities are supposed to be cracking down on sales of flavored vapes, which are now illegal across the state. But even cities that have banned such vapes for years are unwilling — or unable — to police the sellers. STAT visited 24 vape shops earlier this month in Oxnard, Ventura, Pasadena, El Monte, Carson and West Hollywood — all of which have had bans on flavored vapes on the books for at least a year; most for two or more years.

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FDA 105

pharmaphorum

JANUARY 27, 2023

Johnson & Johnson has been cleared to continue a lawsuit filed last year against drug benefit programme SaveOnSP, which claims it defrauded a payment assistance programme for patients out of “at least $100 million.” The complaint – originally filed in May 2022 in a New Jersey federal court – alleges that SaveOnSP took advantage of J&J’s Janssen CarePath programme, which covers eligible patients’ out-of-pocket expenses for 44 of its more expensive prescription drug

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Specialty Pharmacies Health Insurance Companies Insurance Documentation 105

STAT

JANUARY 27, 2023

A panel of federal advisers voted unanimously Friday to advance a set of proposals to bolster government oversight of pathogen research that could make viruses more transmissible. The advisers, a collection of biosecurity, ethics and infectious disease experts, united to vote the set of proposals through with minor changes. But some of the scientists who attended the public meeting balked at language that they said could accidentally hinder relatively low-risk gain-of-function research, which ma

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pharmaphorum

JANUARY 27, 2023

As the legendary investor Warren Buffett once said, forecasts about the future usually tell you more about the forecaster than they do about the future. It’s wise advice from the “Sage of Omaha”; indeed, one highly respected financial newspaper began its 2023 predictions by conceding that it had been wrong on five major counts for 2022. Still, pretty much every business decision is based on some kind of forecast, or scenario; the alternative would be to do nothing, ever.

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Vaccines Packaging 105

Fierce Healthcare

JANUARY 27, 2023

CVS Health launches initiative with Meharry Medical College, Sinai Chicago aiming to reduce disparities in marginalized communities agliadkovskaya Fri, 01/27/2023 - 12:25

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STAT

JANUARY 27, 2023

After nearly a year of public silence and private speculation over Eric Lander’s next act, his return to the Broad Institute of MIT and Harvard is now official. Starting in February, the former White House science adviser will resume his position as a core institute member as well as his tenured faculty positions at MIT and Harvard. But the founding director will not be back at the helm of the Cambridge, Mass., biomedical research powerhouse, a role he held from 2003 to 2021, when he was

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Fierce Healthcare

JANUARY 27, 2023

Majority of patients repeatedly provide duplicate health information, Carta Healthcare survey finds aburky Fri, 01/27/2023 - 16:21

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The Checkup by Singlecare

JANUARY 27, 2023

Dealing with a case of strep throat while pregnant is no fun at all. If you develop strep throat symptoms, such as a sore throat and pain while swallowing—or if you’ve recently tested positive for strep—you are probably wondering what happens next. Is strep throat dangerous for pregnant women? Will it harm the pregnancy? And what treatment options are effective and pregnancy-safe?

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Immunization Hospitals 98

pharmaphorum

JANUARY 27, 2023

Ipsen has suffered rather a setback in its marathon effort to bring palovarotene to market for ultra rare disease fibrodysplasia ossificans progressiva (FOP), after EU advisors recommended against approval. The EMA’s human medicines committee delivered a negative opinion on palovarotene , making it very unlikely that the drug will be approved by the European Commission, although Ipsen says it will be requesting a re-examination of the marketing application.

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FDA 98

STAT

JANUARY 27, 2023

WASHINGTON (AP) — The U.S. is moving to ease restrictions on blood donations from gay and bisexual men and other groups that traditionally face higher risks of HIV. The Food and Drug Administration on Friday announced draft guidelines that would do away with the current three-month abstinence requirement for donations from men who have sex with men.

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FDA 98

Drug Store News

JANUARY 27, 2023

The law change removes the federal requirement for practitioners to have a DATA-Waiver registration to prescribe buprenorphine for the treatment of opioid use disorder.

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STAT

JANUARY 27, 2023

Legend Biotech said Friday that its CAR-T therapy Carvykti kept multiple myeloma patients’ cancer in check for longer than conventional therapy in a Phase 3 trial. Carvykti was approved last year, on the basis of an early trial that showed the cell therapy substantially diminished the number of cancer cells in 97% of patients, all of whom had already tried most of the other options available.

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Fierce Healthcare

JANUARY 27, 2023

'I cry and no one cares': Medscape survey shows doctor burnout, depression is getting worse agliadkovskaya Fri, 01/27/2023 - 15:35

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Pharmaceutical Technology

JANUARY 27, 2023

The European Union (EU) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (trastuzumab deruxtecan) as monotherapy to treat unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer adult patients. Enhertu has been approved for patients who have previously received chemotherapy in the metastatic setting or who have seen disease recurrence during or in six months after adjuvant chemotherapy.

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Chemotherapy 94

STAT

JANUARY 27, 2023

After months of anticipation, the first biosimilar version of Humira will become available next week — a pivotal moment in the long-running debate about whether cheaper copies of pricey biologics can lower soaring U.S. health care costs. For years, Humira dominated the market for treating rheumatoid arthritis and other autoimmune disorders.

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Fierce Healthcare

JANUARY 27, 2023

FDA panel approves path toward one-shot yearly COVID vaccine fdiamond Fri, 01/27/2023 - 09:17

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FDA Vaccines 128

The Thyroid Pharmacist

JANUARY 27, 2023

There are common underlying root causes in Hashimoto’s, including nutrient deficiencies , food sensitivities , an impaired ability to handle stress, intestinal permeability, chronic infections , and an impaired ability to handle toxins. [1] Many people have more than just one root cause, and addressing all of these elements can help us feel better.

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Immunization Packaging 91

Fierce Healthcare

JANUARY 27, 2023

HCA Healthcare closes out 2022 with revenue gains, lingering capacity constraints dmuoio Fri, 01/27/2023 - 12:42

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Fierce Pharma

JANUARY 27, 2023

J&J, Legend's Carvykti hits goal in earlier myeloma, escalates CAR-T showdown with Bristol Myers' Abecma aliu Fri, 01/27/2023 - 11:02

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Fierce Healthcare

JANUARY 27, 2023

Cigna sues CVS, former exec Amy Bricker over noncompete agreement pminemyer Fri, 01/27/2023 - 12:20

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Pharmafile

JANUARY 27, 2023

The FDA is calling on the US Congress to work with them on a new regulatory pathway for cannabidiol (CBD). CBD is the non-psychoactive ingredient from the cannabis plant generally considered to have wellness properties. According to the FDA, there have been some safety concerns around CBD, especially with its long-term use. The concerns around the substance relate to its potential to harm the liver, possibilities that it may be detrimental to the male reproductive system as well as the way it in

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FDA Communication 88

Fierce Healthcare

JANUARY 27, 2023

Senators introduced bills to reform PBMs after stalling out in last Congress rking Fri, 01/27/2023 - 15:23

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STAT

JANUARY 27, 2023

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Drug Store News

JANUARY 27, 2023

The Food as Medicine program gives qualified participants access to nutritious food and encourages them to make healthy lifestyle choices.

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