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Diamond Pharma Services Supports GenSight Biologics in Submitting Its First Marketing Authorisation Application, for Ocular Gene Therapy LUMEVOQ

  • Diamond Pharma Services has provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight, leading to the Marketing Authorisation Application for LUMEVOQ

  • LUMEVOQ is a gene therapy to treat vision loss due to the rare, mitochondrial genetic disease, Leber Hereditary Optic Neuropathy

Diamond Pharma Services (“Diamond”), a leading technical services and regulatory affairs consulting group, has announced that it provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight Biologics (“GenSight”), including the preparation, authoring support, agency communication and submission of GenSight’s first Marketing Authorisation Application to the European Medicines Agency (EMA), for its novel ocular gene therapy LUMEVOQ®. The EMA decision is expected in H2 2021.

LUMEVOQ (Lenadogene nolparvovec) is a gene therapy to treat vision loss due to the rare, mitochondrial genetic disease, Leber Hereditary Optic Neuropathy (LHON) caused by mutation in the ND4 mitochondrial gene. LHON mainly affects young males, and the ND4 mutation results in the worst visual outcomes, with most patients becoming legally blind. There is a high unmet medical need for LHON patients, of which there are 800-1200 in the EU and the US annually.

Headquartered in Paris, France, GenSight is a biopharma company focused on developing and commercialising innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. Diamond has provided GenSight with regulatory, pharmacovigilance, quality and compliance support for LUMEVOQ leading up to the MAA assessment.

Maureen Graham, Managing Director, Regulatory, Diamond Pharma Services, said: “We are pleased GenSight Biologics chose to work with our team of experts at Diamond to provide European Regulatory, Pharmacovigilance, Quality and Compliance support for LUMEVOQ, its first MAA submission, and the first for a gene therapy treating a mitochondrial disease. It has been a personal ambition of mine to have the opportunity to work on a gene therapy within the ophthalmic arena, and GenSight has allowed Diamond that opportunity and that privilege.

This submission adds to Diamond’s broad experience in providing support to companies developing advanced therapy medicinal products (ATMPs), which includes over 50 programmes at various stages of development, and two MAA approvals – Glybera® and Yescarta®.”

View source version on businesswire.com: https://www.businesswire.com/news/home/20201005005339/en/

Contacts

Katie Odgaard
Zyme Communications
Tel: +44 7787 502 947
E-mail: [email protected]

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Catholic Chaplains Corps supports patients, hospital workers in Montgomery County during pandemic

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When members of The Woodlands-Conroe branch of the Catholic Chaplains Corps could no longer enter the local hospitals to support patients and staff due to the pandemic, they got to work on other ways they could help.

The Catholic Chaplains Corps is a program of the The Archdiocese of Galveston-Houston. Bishop John Markovsky, of the Diocese of Galveston-Houston, began the program to support the Texas Medical Center in 1967 to better serve the sacramental and spiritual needs of Catholic patients and families. The TMC was just too large for the priests to make visits to all patients.


A The Woodlands-Conroe branch was launched as a pilot program in February 2018 to provide support to those hospitalized in Montgomery County. The program is carried out in partnership with three Montgomery County Catholic churches including Sacred Heart, St. Anthony of Padua and Sts. Simon and Jude.



Pre-pandemic, trained volunteers with the Catholic Chaplains Corps were able to visit both Catholic and non-Catholic patients in the hospital, nursing home or in a home-bound situations. But COVID-19 halted the volunteers work inside the hospitals.

“They are hungry for ministry. They feel a grief because they were very active in these efforts,” said Nanette Coons, Lay Chaplain for Region One, Conroe and The Woodlands. “They had these intimate encounters with people in their hospitals rooms and nursing homes and now that’s gone.”


Coons said there are 66 trained pastoral visitors in this region who can serve the five Montgomery County hospitals that have approximately 1,600 beds.


She said the pastoral visitors wanted to know what they could do to help when they couldn’t physically enter the hospitals and nursing homes.

Two different ways of assistance emerged.

About six weeks to two months into the pandemic, Houston Methodist The Woodlands

Dickey’s Barbecue Pit Supports Breast Cancer Awareness with First Limited-Edition Pink Big Yellow Cup

A portion of the proceeds from every Tribute Cup sold in October will be donated toward providing first responders with mammography screenings and other breast cancer detection services through The Dickey Foundation

Dallas, TX, Sept. 29, 2020 (GLOBE NEWSWIRE) — Dickey’s Barbecue Pit is joining the fight against breast cancer this October with the debut of its first limited-edition Pink Big Yellow Cup.

In honor of Breast Cancer Awareness Month in October, the world’s largest barbecue concept’s signature Big Yellow Cup will become pink. Throughout the month, Dickey’s will offer the 32-ounce limited-edition collectible Tribute Cup for purchase in all of their locations across the U.S

A portion of the proceeds from every charitable cup sold will be donated to The Dickey Foundation, which provides safety equipment and overall support for first responders. The Dickey Foundation will use the funds raised from the collectible Pink Big Yellow Cup to provide mammograms and other breast cancer detection, treatment and services for local first responders.

“Breast cancer is the most common cancer diagnosed among U.S. women and the second leading cause of death,” said Laura Rea Dickey, CEO of Dickey’s Barbecue Restaurants, Inc. “One in eight women will be diagnosed in their lifetime, and early detection is key to increasing survival rates. As the nation’s largest barbecue brand, Dickey’s is proud to support our local first responders in the battle against breast cancer.”

To learn more, follow Dickey’s Franchise on Facebook, Instagram and Twitter. Download the Dickey’s Barbecue Pit app from the Apple App Store or Google Play.

About Dickey’s Barbecue Restaurants, Inc.

Dickey’s Barbecue Restaurants, Inc., the world’s largest barbecue concept, was founded in 1941 by Travis Dickey. For the past 79 years, Dickey’s Barbecue Pit has served millions of guests Legit. Texas. Barbecue.™ At Dickey’s, all our barbecued meats are smoked onsite in a hickory wood burning pit. Dickey’s proudly believes there’s no shortcut to true barbecue and it’s why they never say bbq. The Dallas-based, family-run barbecue franchise offers several slow-smoked meats and wholesome sides with ‘No B.S. (Bad Stuff)’ included. The fast-casual concept has expanded worldwide with two international locations in the UAE and operates over 500 locations in 44 states. In 2016, Dickey’s won first place on Fast Casual’s “Top 100 Movers and Shakers” list and was named a Top 500 Franchise by Entrepreneur in 2018. Dickey’s Barbecue Pit has also been recognized by Fox News, Franchise Times, The Wall Street Journal, QSR Magazine, Forbes Magazine and Nation’s Restaurant News. For more information, visit www.dickeys.com.

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Attachments

CONTACT: Greer Martin Dickey's Barbecue Restaurants, Inc. 9729713898 [email protected]

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