FDA clears gel-e Flex for OTC use
Gel-e announced on Friday that the U.S. Food and Drug Administration has green lighted the company’s expansion of its OTC label with the approval of gel-e Flex for OTC use of its first flowable hemostat.
This new clearance expands the company’s label that now includes the use of gels and bandages in the local management of bleeding, such as lacerations and minor bleeding. These products are specifically designed to create rapid hemostasis through easy-to-use applications for professional healthcare providers, parents, coaches, adult caregivers and even patients themselves. Gel-e Flex also complements the company’s already FDA-cleared vascular closure device, Vascular gel-e, as it can be worn home by patients to manage any residual bleeding from an out-patient diagnostic or interventional procedure.
“This clearance is the next step in expanding our OTC product line, and will be a key component of gel-e’s 21st Century First Aid Kit,” said Matthew Dowling chief scientific officer at gel-e. “We are continuing to develop a tool kit that will provide the best possible options for all manner of chronic and acute wounds. The versatility of these flowable and bandage formats represents an important progression towards our next-generation kit and eventually to products that can be used in surgery.”
Novartis to spinoff Alcon eye care business
Novartis announced on Friday its intention to spinoff its eye care division, Alcon, into a separately traded standalone company.
The planned spinoff would enable Novartis and Alcon to focus fully on their respective growth strategies. Completion of the transaction is subject to general market conditions, tax rulings and opinions, final board of directors endorsement and shareholder approval at the 2019 AGM in line with Swiss corporate law.
“Our strategic review examined all options for Alcon ranging from retention, sale, IPO to spinoff. The review concluded that a spinoff would be in the best interests of Novartis shareholders and the board of directors intends to seek shareholder approval for a spinoff at the 2019 AGM. This transaction would allow our shareholders to benefit from potential future successes of a more focused Novartis and a standalone Alcon, which would become a publicly traded global medtech leader based here in Switzerland, said Joerg Reinhardt, chairman of Novartis.
Novartis also announced that it will initiate a share buyback of up to $5 billion to be executed by the end of 2019, which will largely be funded through the proceeds of the divestment to GSK of the consumer health joint venture stake, net of the AveXis acquisition payments.
When Novartis acquired Alcon in 2011, the business included surgical, vision care and ophthalmic pharmaceuticals. In January 2016, Novartis began the process of creating two businesses with the transfer of Alcon’s ophthalmic pharmaceuticals to the Novartis Innovative Medicines Division. The ophthalmology pharmaceuticals business will continue to develop as part of Novartis, with 2017 sales of $4.6 billion and the potential blockbuster medicine RTH258 (brolucizumab) in development for neovascular AMD and diabetic macular edema. The Alcon division is now fully focused on surgical and vision care.
Added Vas Narasimhan, CEO of Novartis, “We continue to execute our strategy to focus Novartis as a leading medicines company. Alcon has returned to a position of strength and it is time to give the business more flexibility to pursue its own growth strategy as the world’s leading eye care devices company. We will work to ensure a smooth transition for Alcon and Novartis associates while preparing for the launch of RTH258 and building our leading ophthalmology pharmaceuticals business.”
Commenting on the share buyback, Narasimhan said, “The share buyback is fully aligned with our strategic capital allocation priorities, reflects our strict financial discipline and our confidence in future top line growth and margin expansion.”
Playtex Simply Gentle Glide heroes simplicity with relaunch, video spoof
Edgewell’s feminine care brand Playtex has launched a short video featuring actress comedian D’Arcy Carden spoofing the fact that, despite the influx of “extras” in today’s society, simple is all you need when it comes to tampons.
“It’s funny how extra things have gotten in everything – from diet crazes, new technology and apps launching seemingly every day, even down to the fem care category. I don’t need a tampon to balance my flora, I need one to absorb my period flow and I love that Playtex Simply Gentle Glide is reminding women to get back to the simple things,” Carden said.
Relaunching in June, the Playtex Simply Gentle Glide line now comes with a clear applicator free from colors, dyes and BPA.
“We felt it was time to speak to our customers with a fresh take on the current conversation happening around feminine care,” said Devon Driscoll, brand manager at Playtex Simply Gentle Glide. “This campaign heroes simplicity and is a reminder to simplify our lives a bit – because, at the end of the day, women want a tampon that is safe, gentle and reliable, and that’s what we offer.”