News Briefs

05/24/2022

O Positiv debuts menopause supplement

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o positiv meno

With its latest product, Meno, O Positiv is looking to help alleviate common symptoms of menopause.

Meno is an all-natural and hormone-free capsule formulated with such ingredients as black cohosh, ashwagandha, chaste berry, vitamin D3 and vitamin B6, the company said.

“Following a hysterectomy, menopause hit me like a ton of bricks,” said co-founder Mary Kay. “I was desperate to find a natural, hormone-free menopause solution, but there was nothing available. The effective, premium ingredients in Meno have truly helped me feel like myself again. It's possible to be unaffected by menopause symptoms, live your life and feel great — that’s the reason why we created Meno!”

Designed to help combat hot flashes, night sweats, occasional sleepiness and mood swings, Meno also may aid in improving sexual function, promoting calcium absorption and immunity support, the brand said.

Available in a bottle that contains 30 servings, O Positiv’s Meno retails for $34.99 online.

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05/24/2022

Amphastar receives FDA OK for generic Lexiscan

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The Food and Drug Administration has given Amphastar the green light for regadenoson injection 0.08 mg/ml, 5 ml single-dose pre-filled syringe.

Regadenoson, indicated for radionu lide myocardial perfusion imaging in patients unable to undergo adequate exercise stress, is the generic of Astellas Pharma’s Lexiscan.

“We are excited with the FDA's approval of our Regadenoson injection as this broadens our portfolio of products, highlighting our capabilities in combination product development, while providing patients and healthcare providers with another important option. Both the finished product and active pharmaceutical ingredient will be manufactured in the United States," said Jack Zhang, Amphastar's CEO and president.

Lexiscan had a market value of approximately $650 million for the 12 months that ended March 31, 2022, according to IQVIA.

The timing of the commercialization of Amphastar's regadenoson product is subject to the confidential settlement terms agreed to between the company and Astellas.

 

05/24/2022

Hikma’s CEO to depart

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Hikma announced that Siggi Olafsson has resigned as CEO, as well as from its board of directors, to pursue other opportunities.

Said Darwazah, Hikma’s executive chairman and former CEO, will assume all CEO responsibilities. Olafsson will remain available to the group until he departs on June 24, 2022.

Darwazah will continue to work closely with the executive committee, including Hikma’s three divisional presidents. 

Hikma’s board has initiated the process to identify a new CEO.

“On behalf of Hikma’s board and the entire group, I would like to thank Siggi for his leadership over the past four years. Together with the executive committee, he has worked tirelessly to drive strategic momentum across all three businesses, especially during the challenging days of the pandemic. Hikma is on a strong footing and well positioned for future growth, and we wish Siggi well for the future,” Darwazah said.

“It has been a privilege to work for Hikma, and I am proud of what the entire team has achieved during my tenure. I would like to thank the board for their confidence in me throughout the past four years. I would also like to thank my colleagues around the world for their exceptional hard work and commitment,” Olafsson said. “I believe that Hikma has an exciting future and I look forward to seeing the business go from strength to strength.”

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05/23/2022

AAM, Biosimilars Council submit comments to FTC request for information on PBMs

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The Association for Accessible Medicines and its Biosimilars Council have submitted a comment letter to the Federal Trade Commission in response to its request for information on “the ways that large, vertically integrated Pharmacy Benefit Managers are affecting drug affordability and access.”

The FTC sought information on a wide range of issues in the PBM market, including contract terms, rebates, fees, pricing policies, steering methods, conflicts of interest and consolidation.

“A distinct set of PBM business practices have resulted in higher prices and delayed access to generics and biosimilars for patients,” said AAM CEO Dan Leonard. “These business practices directly cause consumer harm, undermine the long-term viability of the generics and biosimilars industry, and imperil billions in annual savings for taxpayers and the U.S. healthcare system.”

AAM said that its submission details how PBMs force patients to overpay for generic medicines through co-pays that do not reflect their decreasing costs and how PBMs prefer high-cost brand drugs to the detriment of lower-cost biosimilar competition.

“Generics and biosimilars are lower-cost options, but too often PBMs do not encourage their use. And when they do, they can force patients to pay more than necessary,” said Biosimilars Council executive director Christine Simmon. “We look forward to working with the Federal Trade Commission to investigate how PBMs contribute to ever-increasing costs in the pharmaceutical supply chain and on approaches to meaningfully reduce the costs of prescription drugs for America’s patients.”

An additional docket submission signed by several patient, consumer, taxpayer and other groups bolstered AAM and the council’s position by highlighting the negative impact these PBM practices have on their constituents, calling on the FTC to investigate.

“Every day, allergy and asthma patients bear the brunt of anticompetitive PBM business practices. By restricting access to more affordable generic and biosimilar alternatives, PBMs are forcing the majority of allergy and asthma patients to pay for expensive brand-name medicines just to manage their conditions,” said Tonya Winders, president and CEO of the Allergy & Asthma Network, a signatory of the letter. “It is critical that the FTC investigate how PBMs are inflating pharmaceutical prices, and take swift action to promote competition and provide savings to patients who need these medicines most.”

05/23/2022

Aurobindo receives FDA OK for generic Aromasin

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Aurobindo has obtained the Food and Drug Administration’s nod for exemestane tablets in a dosage strength of 25 mg.

The product is the generic of Pfizer’s Aromasin.

Exemestane tablets are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer and treatment of advanced breast cancer in postmenopausal women, whose disease has progressed following tamoxifen therapy.

Exemestane tablets 
have a market value of roughly $29 million for the 12 months ending March 2022, according to IQVIA.

05/20/2022

Lenny & Larry’s packs protein, probiotics in The Complete Kickstart Bar

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Lenny & Larry’s Complete Kickstart Bar

Lenny & Larry’s wants to help consumers get a jump-start on their morning nutrition with a breakfast bar that’s packed with protein and probiotics.

Complete Kickstart Bar, a soft and chewy breakfast bar, contains 8 g of plant-based protein, probiotics for immune support and 14 g of whole grains. In addition, the vegan and kosher bar is Non-GMO Project Verified and made without the use of high fructose corn syrup, artificial sweeteners or sugar alcohols, the company said.

“We’re thrilled to present a new breakfast option for consumers based on the market’s demand for plant-based protein and immunity support,” said Lenny & Larry’s CEO Jolie Weber. “Lenny & Larry’s continues to be an innovative brand that creates new products based on unmet consumer needs. Receiving feedback from our consumers is crucial to our business and part of our brand’s commitment to research and development, setting us apart from others in the category.”

The bar is available in four flavors — blueberry lemon, apple cinnamon, banana chocolate chip and cranberry white chocolate-flavored chip. Consumers can find the apple cinnamon and blueberry lemon flavors on the company’s website in a four-count box that retails for $5.49. Kroger will also carry the two flavors beginning June 12.