News Briefs

08/08/2022

RXBAR debuts chocolate cinnamon brownie flavor

Image
Rx bar

RXBAR is launching a new flavor, RXBAR Chocolate Cinnamon Brownie, for a limited time only.

Chocolate Cinnamon Brownie has an indulgent chocolate flavor and features 12 grams of protein, simple ingredients, no added sugar and most importantly, No B.S., the company said.

Containing simple ingredients — including dates, egg whites, almonds and cashews — Chocolate Cinnamon Brownie is a decadent, limited-time addition to the RXBAR portfolio to offer fans more taste variety. With crunchy whole almonds, deliciously rich chocolate chunks and fragrant cinnamon spice, the bar nods to the nostalgic senses of homemade brownies from the oven.

"RXBAR consumers seek variety, so we're constantly innovating to deliver delicious new flavors made with only simple ingredients," said Eileen Flaherty, senior brand manager, RXBAR. "Adding Chocolate Cinnamon Brownie to our portfolio of No B.S. bars allows us to surprise and delight our fans, while offering them something new to enjoy for a limited time."

The new RXBAR Chocolate Cinnamon Brownie is available now through December at RXBAR.com and select retailers nationwide.

Advertisement
08/08/2022

Lilly intros citrate-free Taltz

Image
generic vials teaser

Eli Lilly is unveiling a new, citrate-free formulation of Taltz (ixekizumab) injection 80 mg/ml.

The new formulation, approved by the Food and Drug Administration in May, includes the same active ingredient as the original formulation. The new formulation significantly reduces injection site pain experienced by some people immediately following injection as shown by an 86% decrease in a visual analog scale of pain versus the original formulation, the company said.

Taltz is approved to treat adults and children 6 years old and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, adults with active psoriatic arthritis, active ankylosing spondylitis and active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. 

“Taltz has long delivered effective treatment with a well-established safety profile that addresses symptoms for people living with plaque psoriasis, psoriatic arthritis, AS and nr-axSpA,” said Ashley Diaz-Granados, vice president of U.S. Immunology at Lilly.

“We’re proud of our investment in research that keeps the patient experience at the center. This new formulation provides yet another reason to choose Taltz, and we look forward to introducing it to patients who have not yet tried Taltz and providing a seamless transition for those already enjoying the medicine’s benefits,” she said. 

“Today is an exciting milestone for the nearly 30 million people around the world who live with the challenging symptoms of these autoimmune diseases that affect the skin and joints,” said April Armstrong, professor of dermatology and associate dean of clinical research at the Keck School of Medicine at the University of Southern California.

“In my six years of prescribing Taltz, I’ve seen firsthand the significant impact Taltz has had for patients across multiple indications,” she said. “The availability of Taltz as a citrate-free formulation represents an important advance in patient care that will allow more patients to experience less injection-site pain.”  

08/08/2022

Myovant Sciences, Pfizer gain FDA approval for new indication of Myfembree

Image
The FDA building

Myovant Sciences and Pfizer have obtained the Food and Drug Administration’s blessing for Myfembree (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months.

Myfembree also is approved for heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. Myovant Sciences and Pfizer will continue to jointly commercialize Myfembree in the United States, with the product available immediately.

“Endometriosis is a painful, chronic disease with limited therapies to manage symptoms,” said Juan Camilo Arjona Ferreira, chief medical officer of Myovant Sciences.

“The new Myfembree indication helps advance our mission to redefine care for women by helping address a disease with high unmet need, giving women and physicians a new meaningful treatment option to manage moderate to severe pain associated with endometriosis,” he said.

“This approval is an important milestone reflecting Pfizer and Myovant’s commitment to women’s health in areas of significant unmet need,” said James Rusnak, senior vice president, chief development officer, internal medicine and hospital, global product development at Pfizer. “We look forward to making Myfembree available to women with endometriosis and broadening their options in managing this complex disorder.”

Advertisement
08/08/2022

FDA gives Daiichi Sankyo approval for Enhertu

Image
Binder with FDA Approved

Daiichi Sankyo has received permission from the Food and Drug Administration for Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable (unable to be removed) or metastatic (spread to other parts of the body) HER2-low breast cancer.

This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer.

Todays approval highlights the FDAs commitment to be at the forefront of scientific advances, making targeted cancer treatment options available for more patients, said Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research. Having therapies that are specially tailored to each patient's cancer subtype is a priority to ensure access to safe and innovative treatments.

HER2 receptors, which are proteins made by the HER2 gene, are important in determining a patient's treatment. HER2-negative includes hormone receptor positive and triple negative breast cancers. HER2-low is a new classification of the HER2 subtype. It describes a new subtype of breast cancer that has some HER2 proteins on the cell surface, but not enough to be classified as HER2-positive.

Patients with HER2-low breast cancer are eligible for Enhertu if they have received a prior chemotherapy in the metastatic setting, or their cancer returned during, or within six months of completing, adjuvant chemotherapy.

08/03/2022

ThermaMEDx releases EverTears

Image
evertears teaser

ThermaMEDx, based in Atlanta, is debuting EverTears instant heat eye compress + moist cleaning pad for dry eye and stye relief.

EverTears features patented ThermaMEDx technology to instantly heat to the temperature needed to help unblock eyelid glands responsible for most dry eye symptoms. This moist heat also activates the natural power of a proprietary cleaning formula made with essential coconut extracts and fatty acids. When you feel the soothing warmth on your eyelids, EverTears is already working to provide sustained relief of dry eye symptoms with regular use, the company said.

EverTears was inspired by world-renowned doctor and research scientist Michel Guillon. “The ThermaMEDx team is passionate about bringing sustainable relief to patients suffering from dry eye symptoms related to Meibomian gland dysfunction,” the company said.

“Based on over 30 years of research, Guillon patented the world's first self-heating eye compress, featuring a pre-moistened cloth cleaning pad to deliver the two therapies most recommended by doctors in one convenient medical device,” the company said. “EverTears is designed to provide relief from dry eye symptoms while also helping your eyes retain more of your natural protective tear film.”

The product helps restore natural tear film and reduces reliance on artificial tears.

08/03/2022

Amber Specialty Pharmacy to dispense Pfizer's oncology portfolio

Image
generic vial teaser

Amber Specialty Pharmacy, a subsidiary of Hy-Vee, will begin dispensing 13 Pfizer oncology products.

The pharmacy’s comprehensive service model will support patients, caregivers and oncology specialists throughout the country.

The Pfizer portfolio of oncology products now supported by Amber Specialty Pharmacy includes:

  • Besponsa (inotuzumab ozogamicin);
  • Bosulif (bosutinib);
  • Braftovi (encorafenib);
  • Daurismo (glasdegib);
  • Ibrance (palbociclib);
  • Inlyta (axitinib);
  • Lorbrena (lorlatinib);
  • Mektovi (binimetinib);
  • Mylotarg (gemtuzumab ozogamicin);
  • Sutent (sunitinib malate);
  • Talzenna (talazoparib);
  • Vizimpro (dacomitinib); and
  • Xalkori (crizotinib).

Amber Specialty Pharmacy is licensed to ship prescription medication to all 50 states in the United States, as well as Puerto Rico.