News Briefs

05/16/2022

AAM elevates Craig Burton

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craig burton

The Association for Accessible Medicines and its board of directors has promoted Craig Burton to senior vice president of policy and strategic alliances, effective May 30, 2022.

Burton also will become the executive director of the Biosimilars Council, which is the preeminent voice advocating in Washington and the states for policies to improve access to more affordable alternatives to expensive biologic medicines.

With more than 20 years of federal health policy experience, Burton has served in key roles at the center of a range of pressing healthcare debates. Prior to joining AAM in 2017, he was at Avalere Health, where he helped clients anticipate and plan for the impact of change stemming from legislative, regulatory or other market dynamics. He also established and directed the health policy and government relations efforts at two biopharmaceutical companies.

“The AAM board and I are pleased to elevate Craig to senior vice president, where he will continue his work to create and promote policy solutions to ensure that America’s patients have access to the safe, affordable and effective generic and biosimilar medicines that they depend on,” said Dan Leonard, AAM president and CEO. “Craig is nationally recognized as a leading expert in health policy, and his experience in both the executive and legislative branches of government makes him an invaluable advocate for our industry and the patients that it serves.”

Burton also served as deputy assistant secretary for legislation in the U.S. Department of Health and Human Services. In this role, he advised the secretary, senior department leaders and White House officials on legislative strategy to achieve key priorities. He also served in the Senate, where he was health policy advisor to Senate majority leader Bill Frist, and as professional staff on the U.S. Senate Committee on Health, Education, Labor and Pensions.

AAM's long-time executive vice president of policy and head of the Biosimilars Council, Christine Simmon, has just been named president and CEO of the Food and Drug Law Institute, the nonprofit membership organization that offers education, training, publications and professional engagement opportunities in the field of food and drug law.

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05/16/2022

Camber intros generic Atripla

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Camber is offering efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets.

The medication, which is a generic of Gilead's Atripla, is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 88 lbs.

Camber’s generic product is available in 600 mg, 200 mg and 300 mg 30-count bottles.

05/16/2022

P&G launches Super Nature hair care products

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Procter & Gamble is debuting a brand-new hair care line for the natural personal care category.

Super Nature features products formulated with ingredients sourced from nature, including sustainably sourced potent aloe and craft plant-powered cleansers and conditioners to leave hair and the world better than how it was found, the company said.

Made without parabens, sulfates, dyes or mineral oil, the line is PETA-certified cruelty-free, made from 96% naturally derived formulas and is pH balanced.

Products that are part of the line include Gentle Moisture Shampoo and Conditioner, designed to cleanse hair without stripping, nourish and infuse moisture to the hair leaving it healthy, soft and protected from damage, the company said.

Safe for color-treated hair, Super Nature’s products are available exclusively at Costco.

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05/16/2022

FDA grants Sun Pharma approval for generic Pentasa

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Sun Pharma has received the Food and Drug Administration’s permission for mesalamine ER capsules in a dosage strength of 500 mg.

The medication is the generic of Ferring’s Pentasa and is indicated for the induction of remission and for the treatment of adult patients with mildly to moderately active ulcerative colitis.

Pentasa had a market value of roughly $213 million, according to IQVIA March 2022 data.

05/16/2022

Eli Lilly receives FDA green light for Mounjaro

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Eli Lilly has obtained the Food and Drug Administration’s blessing for Mounjaro (tirzepatide) injection to improve blood sugar control in adults with Type 2 diabetes, as an addition to diet and exercise.   

Glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide are hormones involved in blood sugar control. Mounjaro is a first-in-class medicine that activates both the GLP-1 and GIP receptors, which lead to improved blood sugar control, the company said.

"Given the challenges many patients experience in achieving their target blood sugar goals, today's approval of Mounjaro is an important advance in the treatment of Type 2 diabetes," said Patrick Archdeacon, associate director of the division of diabetes, lipid disorders and obesity in the FDA's Center for Drug Evaluation and Research.

"Mounjaro delivered superior and consistent A1C reductions against all of the comparators throughout the SURPASS program, which was designed to assess Mounjaro's efficacy and safety in a broad range of adults with Type 2 diabetes who could be treated in clinical practice," said Juan Pablo Frías, medical director of the National Research Institute and Investigator in the SURPASS program. "The approval of Mounjaro is an exciting step forward for people living with type 2 diabetes given the results seen in these clinical trials."

"Lilly has a nearly 100-year heritage of advancing care for people living with diabetes — never settling for current outcomes. We're not satisfied knowing that half of the more than 30 million Americans living with Type 2 diabetes are not reaching their target blood glucose levels," said Mike Mason, president of Lilly Diabetes. "We are thrilled to introduce Mounjaro, which represents the first new class of Type 2 diabetes medication introduced in almost a decade and embodies our mission to bring innovative new therapies to the diabetes community."

Mounjaro is administered by injection under the skin once weekly, with the dose adjusted as tolerated to meet blood sugar goals. It is expected to be available in the United States in the coming weeks. 

It will be available in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg) and will come in Lilly's well-established auto-injector pen, with a pre-attached, hidden needle that patients do not need to handle or see, the company said.

05/13/2022

MegaFood intros Extra Strength Sleep Melatonin Gummies

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megafood melatonin gummies

MegaFood wants to aid consumers who are having difficulty getting a good night’s sleep.

The latest launch from the Manchester, N.H.-based company is the Extra Strength Sleep Melatonin Gummies.

Featuring 10 g of melatonin per serving in an orange blossom flavor, the gummies are formulated to help consumers fall asleep quickly, the brand said.

Made with chamomile and lemon balm, the product is Non-GMO Project Verified, Certified Glyphosate Residue Free and does not contain high fructose corn syrup or gelatin.

“Sleep plays a critical role in our overall health and wellness, and getting enough sleep at night should never feel unattainable,” said Erin Stokes, a naturopathic doctor and medical director at MegaFood. “Our new Extra Strength Sleep Gummies are intended for occasional use to help you fall asleep faster and support a healthy sleep cycle.”