PharmaFocus Today – Page 345 – media

Intercept’s latest NASH bid in jeopardy after FDA questions drug’s efficacy, safety

An industry-first FDA approval for a nonalcoholic steatohepatitis (NASH) therapy may still be a ways off.After reviewing Intercept Pharmaceuticals’ latest application for obeticholic acid (OCA), the agency appears all but ready to reject the drug in NASH-related pre-cirrhotic liver fibrosis, according to a briefing document released ahead of an expert panel meeting set for Friday. Citing a long list of safety risks and the practical hurdle for patients to undergo a liver biopsy—coupled with “modest” efficacy—the FDA said it “cannot justify OCA use in NASH subjects with stage 2 or 3 fibrosis.” The FDA’s negative review could once again thwart Intercept’s bid to win the first NASH approval in the U.S. If members of the FDA’s Gastrointestinal Drugs Advisory Committee side with the FDA and the agency follows through with its own staff’s analysis, it would mark the second rejection for OCA in NASH. Intercept’s stock price was down more ...
- Source: drugdu
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- May 19, 2023
Wearable Children’s Thermometer May Cause Skin Burns

The penguin-shaped Walnut Thermometer, intended for continuous chest temperature monitoring of children ages 6 and under, has been recalled due to reports of injuries, including skin burns. Amanda Pedersen | A popular children’s thermometer has been recalled after the manufacturer received reports of injuries such as skin burns. Hauppauge, NY-based BearCare initiated a voluntary recall of its rechargeable Walnut Wearable Smart Thermometer. The wearable device is intended for continuous chest temperature monitoring of children up to age 6. The device has a silicone exterior designed to resemble a cartoon penguin. The thermometer was sold and distributed from December 2022 to April 2023 through Amazon, Walmart (online), and www.walnutcares.com. If users of the thermometer observe any substance leaking from the device’s exterior, any corrosion near the smart sensor on the back of the device, diminished battery life, or connectivity issues with the Walnut app, these are indicators of a failing device, ...
- Source: drugdu
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- May 19, 2023
Allergan’s new skin-smoothing product gets FDA nod—with novel delivery mechanism

AbbVie’s aesthetics unit is growing its product catalog once again with a new FDA approval.The product, called Skinvive, nabbed an FDA nod this week and falls within Allergan’s Juvederm dermal filler collection. Skinvive works by injecting hyaluronic acid (HA), plus a small amount of lidocaine, into facial skin to increase hydration while smoothing. The delivery mechanism is the first of its kind and “flows easily into the skin,” creating a “lasting glow,” Allergan said in a recent release. Skinvive got the green light for use in adults over the age of 21 with all Fitzpatrick skin types I-VI covered, a skin classification scale that ranges from light to dark. Its effects last six months and the procedure requires little to no downtime, according to the company. The approval was supported by a pivotal clinical study in which 58% of patients saw their skin improve by more than one point on ...
- Source: drugdu
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- May 19, 2023
BCBS Massachusetts Adds 3 Physician Groups To Primary Care Network

Blue Cross Blue Shield of Massachusetts (BCBS Massachusetts) is expanding members’ access to primary care by adding Eden Health, On Belay Health Solutions and VillageMD to its network, the insurer announced Tuesday. New York City-based Eden Health offers primary care, telemedicine and insurance navigation. On Belay Health Solutions, based in Boston, works with independent primary care physicians and helps them engage in value-based contracts. Chicago-based VillageMD is a primary care provider that is majority owned by Walgreens Boots Alliance. These primary care physician groups will provide both virtual and in-person care for BCBS Massachusetts members. “Research shows that patients who have an established primary care physician achieve better health outcomes than those who don’t,” said Dr. Ashley Yeats, vice president of medication operations at BCBS Massachusetts. “These additional physician groups each offer a wide-range of services — including care navigation support, chronic disease care, mental health support — both in-person ...
- Source: drugdu
- 114
- May 19, 2023
Roche’s fenebrutinib shows promise in relapsing forms of MS

Roche has announced positive new data from a mid-stage study of fenebrutinib in adults with relapsing forms of multiple sclerosis (MS). The phase 2 FENopta study met its primary and secondary endpoints, the company said, with oral fenebrutinib significantly reducing MRI markers of MS disease activity in the brain compared to placebo. MS is a disabling, neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. The disease affects approximately 2.8 million people worldwide. Relapsing forms of MS are characterised by clearly defined, but unpredictable, attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared to 15% with progressive forms of the disease. Roche and Genentech’s fenebrutinib belongs to a class of drugs known as Bruton’s tyrosine ...
- Source: drugdu
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- May 19, 2023
Pfizer to raise $31 billion in debt offering to fund Seagen acquisition, SEC filing shows

Pfizer plans to raise $31 billion through a debt offering to fund its proposed acquisition of cancer drug maker Seagen, for what would be its largest takeover since 2009, according to a new filing with the Securities and Exchange Commission. Pfizer expects to complete the $43 billion Seagen buyout later this year or in early 2024. The debt offering is expected to close Friday, according to a prospectus supplement New York-based Pfizer filed with the SEC late Tuesday. The pharma giant’s debt offering would be the biggest since CVS Health sold $40 billion of bonds in 2018 to finance its acquisition of health insurer Aetna. Pfizer’s move comes as other corporations including Apple, T-Mobile and Merck rush to tap the U.S. bond market ahead of a potential spike in borrowing costs sparked by the debt ceiling standoff. Pfizer’s stock price dropped slightly on Wednesday. The company said it will secure ...
- Source: drugdu
- 125
- May 19, 2023
Is Parkinson’s a Military Base’s Toxic Legacy?

F. Perry Wilson, MD, MSCE This transcript has been edited for clarity. Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine. The thing to realize about this story is that even if it were just a problem for the military, it would be a huge problem. But although this is a story about the military, in the end, it may affect a much larger segment of the population. It’s a story about a military base, Camp Lejeune, and the toxins that leached into the water system there, poisoning the base residents for decades. It is about the most rapidly growing neurologic disease in the country. And it is very much about a simple molecule, trichloroethylene (TCE). TCE was first synthesized in 1864 and quickly became a sensation as an early anesthetic. Less toxic to ...
- Source: drugdu
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- May 19, 2023
A major stem cell variant in lungs of patients with idiopathic pulmonary fibrosis

A pair of internationally renowned stem cell cloning experts at the University of Houston is reporting their findings of variant cells in the lungs of patients with Idiopathic Pulmonary Fibrosis (IPF) which likely represent key targets in any future therapy for the condition. IPF is a progressive, irreversible and fatal lung disease in which the lungs become scarred and breathing becomes difficult. The rapid development and fatal progression of the disease occur by uncertain mechanisms, but the most pervasive school of thought is that IPF arises from recurrent, subclinical lung injury that imparts changes to epithelial and stromal cells, which, in turn, compromise lung repair and favor fibrosis. To dig deeper into the cause of IPF, Frank McKeon, professor of biology and biochemistry and director of the Stem Cell Center, and Wa Xian, research associate professor at the center, used single cell cloning technologies to generate libraries of basal stem ...
- Source: drugdu
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- May 19, 2023
Reduction in neighborhood-related stress leads to improvement in kids’ asthma symptoms

Children whose families participated in a program that helped them move from distressed neighborhoods to areas with lower rates of poverty and better public resources like schools and parks experienced significant improvements in severe asthma episodes, according to a new study led by a researcher at Dell Medical School at The University of Texas at Austin. The study, published today in the Journal of the American Medical Association, involved 123 children, ages 5 to 17, with persistent asthma whose families took part in a six-year housing mobility program in Baltimore. Before moving, for every 100 children, there were approximately 88 severe asthma attacks per year. After moving, there were approximately 40 severe attacks per year, a reduction of more than 50%. In fact, researchers found that the reduction in neighborhood-related stress was responsible for between 20% and 35% of the improvement in asthma exacerbations and symptoms. The number of symptom ...
- Source: drugdu
- 124
- May 18, 2023
Moderna hits back at Alnylam’s ‘baseless’ patent infringement claims

The United States’ COVID-19 health emergency might be over, but vaccine-related lawsuits are moving forward in full force. After Alnylam levied patent infringement claims against Moderna last year, the mRNA specialist is hitting back. In a pair of countersuits, Moderna claims Alnylam “baselessly seeks to profit” from Moderna’s inventions. Alnylam first sued Moderna in March 2022, claiming patent infringement on its so-called ‘933 patent. The patent covers delivery technology that Alnylam says is infringed by Moderna’s popular vaccine Spikevax. Alnylam later claimed violations on another patent that it received in July. The company did not seek to stop sales of the lucrative mRNA vaccine but instead requested damages and royalties. But Moderna isn’t having it. “Alnylam played no role in Moderna’s significant accomplishments,” the company said in a pair of countersuits, filed last week. The Spikevax maker says that it had been pioneering mRNA technologies for a decade before the ...
- Source: drugdu
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- May 18, 2023

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