News Briefs


SkinnyDipped rolls out strawberry lemonade almonds

skinnydipped strawberry lemonade almonds

SkinnyDipped is debuting its new refreshingly tangy, limited-edition flavor.

Strawberry lemonade almonds are thin-dipped in lightly sweetened yogurt and kissed with real lemon and berry, the Seattle-based company said.

Made without the use of artificial ingredients, the almonds are gluten free, non-GMO, kosher and contain almonds sourced from certified bee-friendly farms.

In addition to launching this new variety, SkinnyDipped is releasing a Beach, Don’t Kill My Vibe bundle, which includes strawberry lemonade and lemon bliss almonds, a tote bag, and branded stickers.

“Strawberry lemonade is the perfect extension for us since we’re all about creating amazingly delicious flavors that are both familiar and unique,” said Breezy Griffith, SkinnyDipped’s CEO and founder. “It’s an even more summery and nostalgic riff on lemon bliss, which people go crazy for! We’re already seeing a ton of excitement and can't wait for more people to try it.”

Consumers can find the strawberry lemonade almonds in a 3.5-oz. pouch that retails for $4.99 at such locations as HelloFresh, Kroger, H-E-B and Hungryroot. The Beach Don’t Kill My Vibe bundle retails for $14.99 at Amazon.


O Positiv debuts menopause supplement

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.


Amphastar receives FDA OK for generic Lexiscan

generic vial teaser

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.



Hikma’s CEO to depart

company departure teaser

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.”


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

a close up of a sign

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.”


Aurobindo receives FDA OK for generic Aromasin

generic pills teaser

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.