News Briefs

03/23/2022

ANI welcomes new board member

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ANI is welcoming Renee Tannenbaum to its board of directors.

Tannenbaum has over 35 years of management experience in the pharmaceutical industry.

“We are honored to bring Dr. Tannenbaum’s vast biopharmaceutical commercial experience and expertise to our board of directors. With her many accomplishments and proven track record of developing and implementing innovative commercial strategies, and driving growth, Dr. Tannenbaum will be a great asset to the company, especially as we move forward with our commercialization of Purified Cortrophin Gel,” said Patrick Walsh, chairman of the board of ANI.

With her appointment, which is effective immediately, ANI’s board of directors has nine members, the company said. 

Tannenbaum is a strategic advisor for several biopharmaceutical and device companies and serves on the Cardiff Oncology board of directors and as a board advisor to Aerami Therapeutics. She was previously vice president of global partnering at Halozyme and head of global customer excellence at AbbVie, where she was responsible for building commercial capabilities for the organization.

“I am thrilled to join the board of directors at this pivotal point in ANI’s trajectory. With the Novitium acquisition completed, and the launch of Cortrophin Gel underway, the company has many exciting years ahead, and I look forward to providing my perspectives to management along the way,” Tannenbaum said.

Previously, she served as president of Myrtle Potter & Co., a global life sciences consulting and advisory firm and executive vice president and chief commercial officer at Elan Pharmaceuticals, where she was responsible for, among other things, revenue generation for Elan’s marketed products, preparing for the commercialization of the company’s pipeline and strengthening the company’s overall commercial capabilities.

Prior to her role at Elan, Tannenbaum was at Novartis Pharma AG, where she led the Global Commercial Operations organization. She also spent nine years at Bristol Myers Squibb and 16 years at Merck where she held a variety of leadership positions.

Tannenbaum previously served on the boards of Zogenix, Nordic Nanovector ASA, Cipher Pharmaceuticals, Sharps Compliance and Immune Pharmaceuticals, and retains a faculty position at the University of the Sciences’ Mayes College of Healthcare Business and Policy. She received her Doctor of Pharmacy degree from the Philadelphia College of Pharmacy and Sciences, her MBA from Temple University, and her Bachelor of Science degree in Pharmacy from the University of Connecticut.

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03/22/2022

Marinus receives FDA OK for Ztalmy

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An illustration with check mark in an envelope.

Marinus Pharmaceuticals has received the green light from the Food and Drug Administration for Ztalmy (ganaxolone) oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder, a rare form of genetic epilepsy, in patients aged 2 years old and older. 

“Today is a historic milestone not only for Marinus but for CDD patients, families and caregivers who have long been navigating the unpredictable, often devastating reality of living with uncontrolled seizures,” Scott Braunstein, CEO of Marinus, said. “The approval of Ztalmy would not have been possible without the patients, caregivers and investigators who participated in the clinical trials to develop this important new therapy. We are grateful and humbled by the opportunity to bring the first and only FDA approved treatment for seizures associated with CDD to this community.”

The medication is the first FDA-approved treatment specifically for CDD, is a neuroactive steroid that acts as a positive allosteric modulator of the GABAA receptor, and is expected to be available through a designated specialty pharmacy in July 2022, the company said. 

“There has been a great unmet medical need for treatments that address seizures associated with CDKL5 deficiency disorder given their prominent role and profound impact on patients,” principal investigator for the Marigold trial and neurologist and clinical director of Precision Medicine at Children’s Hospital Colorado, Scott Demarest, said. “To date, antiseizure treatment decisions have been based on very limited clinical evidence in this patient population and the resulting outcomes underscore the need for therapies that further improve seizure control. Thanks to our research and this trial, we now have the first treatment specifically approved for seizures associated with CDKL5 deficiency disorder that was shown to have a positive benefit-risk profile.”

“As the mother of a daughter living with CDD, I’ve experienced first-hand the devastating impact seizures can have on these patients,” Karen Utley, president and co-founder of the International Foundation for CDKL5 Research, said. “This approval is monumental for the CDD community—bringing not only the first approved treatment option specifically for CDD patients, but renewed hope to those who have struggled to find medications that are effective in significantly reducing the number of seizures these patients experience on a daily basis.”

03/22/2022

Mayne Pharma adds board member

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a long table in a room

Mayne Pharma is welcoming Ann Custin to its board, effective March 23, 2022.

Custin, a United States resident, has almost 40 years of experience in the healthcare sector. Most recently, she was a board director and CFO of Siemens Medical Solutions, now Siemens Healthineers, a leading medical technology company with EUR20b in revenues.

“We are delighted to welcome Ann to the Board of Mayne Pharma,” Mayne Pharma’s chair Frank Condella, said. “She is an experienced executive with a wealth of healthcare commercial experience across the U.S., Europe and Asia. She has extensive experience in strategy, financial planning and reporting, portfolio management, sales operations, manufacturing, risk management, business and corporate development.”

Previously, Custin was chief operating and financial officer of Scient’x Group and president and CEO of USA Draeger Medical Systems.

“I look forward to applying my skills and experience in guiding Mayne Pharma strategically and realizing the potential of its asset base established in both product and pharma service end markets,” Custin said. “I am particularly excited about supporting the board to unlock the value of Mayne Pharma’s businesses for the benefit of shareholders and ensure the company delivers sustainable profitable growth into the future.”

Custin is currently a director of two women’s health-focused companies, Volpara Health and Establishment Labs. She has a Bachelor of Accounting from Queens College and was a Certified Public Accountant.

In addition, she also will join Mayne Pharma’s Audit and Risk Committee, the company said.

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03/22/2022

Cirrus Healthcare intros EarPlanes+

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earplanes teaser

Earplanes, known best for their use in helping consumers prevent ear pain while traveling, is adding a brand new feature.

Cirrus Healthcare, the parent company of the brand, announced the launch of the EarPlanes+ companion app, which looks to actively monitor cabin pressure with the smartphone’s barometer.

In addition, the app also sends a notification when pressure is rapidly changing on a flight and gives consumers the knowledge to know when they may need ear protection, the company said.

Available for free, the EarPlanes+ app also gives Cirrus the ability to engage with its consumers directly to help generate in-store sales for its retailers, which include CVS Pharmacy, Target and Walgreens.

03/22/2022

Pop-Tarts unveils cookie-inspired snickerdoodle flavor

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pop-tarts snickerdoodle

There’s a new Pop-Tarts flavor in town.

The Battle Creek, Mich.-based company announced the launch of its newest flavor, which is inspired by bakery classics.

Snickerdoodle Pop-Tarts feature a snickerdoodle-flavored filling with crunchy cinnamon sugar topping to create a melt-in-your-mouth moment, the company said.

“We know our fans love a ‘dessert for breakfast’ moment, so Pop-Tarts continues to deliver crazy-good flavors that capitalize on this trend with our pie, donut and cake-themed lineups already on shelves,” David Greci, senior brand manager at Pop-Tarts said. “This spring, we’ll complete the cookie trifecta with this delicious new snickerdoodle flavor. Besides, who needs a cookie jar when you've got a toaster and a box of Pop-Tarts?”

Joining the previously launched chocolate chip and cookies and crème varieties, the snickerdoodle Pop-Tarts will be available for purchase in May in an eight-count box that retails for $3.19 at retailers nationwide.   

 

03/21/2022

Padagis debuts generic Tobradex

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Padagis is introducing a generic version of Tobradex ophthalmic suspension.

The medication is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Tobradex ophthalmic suspension had a market value of roughly $106 million for the 12 months ending January 2022, according to IQVIA.

"This FDA approval and launch demonstrates our commitment to bringing complex, specialized products to patients and customers nationwide who are in search of high quality, affordable specialized healthcare products. The Padagis team partnered with Rafarm to leverage their unique sterile manufacturing skillset in combination with our regulatory and commercial expertise with the overall goal to deliver this important product to the market," Padagis President and CEO Sharon Kochan said.