G.I.

Ironwood Announces Publication in The Lancet Gastroenterology & Hepatology of New Linaclotide Phase III Data in Children and Adolescents Aged 6-17 Years with Functional Constipation

Retrieved on: 
Tuesday, January 9, 2024

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced that new data from the Phase III study that evaluated linaclotide in children and adolescents aged 6-17 years with functional constipation were published in The Lancet Gastroenterology & Hepatology.

Key Points: 
  • Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced that new data from the Phase III study that evaluated linaclotide in children and adolescents aged 6-17 years with functional constipation were published in The Lancet Gastroenterology & Hepatology.
  • Functional constipation in children is defined as a condition with hard, infrequent bowel movements that are often difficult or painful to pass1.
  • Linaclotide (marketed as LINZESS®) 72mcg is available in the U.S. for the treatment of functional constipation for pediatric patients aged 6-17 years old.
  • “The publication of these results in The Lancet Gastroenterology & Hepatology adds to the body of knowledge about linaclotide and helps close the unmet needs gap in pediatric patients ages 6- 17 with FC.”

Fans of the SPAM® Brand Come Together to Support Maui Relief Efforts

Retrieved on: 
Wednesday, November 1, 2023

AUSTIN, Minn., Nov. 1, 2023 /PRNewswire/ -- When the August wildfires first broke out on the island of Maui, the team behind the SPAM® brand responded with a donation of cash and product with a retail value of more than $1,000,000 to directly help those impacted by the devastation. The donation included more than five truckloads of SPAM® products — totaling over 264,000 cans — to help feed people in need.

Key Points: 
  • The donation included more than five truckloads of SPAM® products — totaling over 264,000 cans — to help feed people in need.
  • As those truckloads were being delivered, the brand team also began selling specially designed T-shirts on its website , pledging 100% of all proceeds to the Aloha United Way Maui Fire Relief Fund .
  • To date, shirt sales have produced $160,000 in total proceeds, all of which were recently donated to the Aloha United Way and its Maui Fire Relief Fund.
  • "We have an incredible fan base and knew they would want to help support the people of Maui with us," said Jennesa Kinscher, senior brand manager of the SPAM® brand.

Elbit Systems Awarded a $95 Million Contract to Supply Canister Configuration SkyStriker Loitering Munitions to a European Country

Retrieved on: 
Monday, September 18, 2023

HAIFA, Israel, Sept. 18, 2023 /PRNewswire/ -- Elbit Systems Ltd. (NASDAQ: ESLT) (TASE: ESLT) ("Elbit Systems" or the "Company") announced today that it was awarded a $95 million contract to supply SkyStriker loitering munitions (LM) to a European country.

Key Points: 
  • HAIFA, Israel, Sept. 18, 2023 /PRNewswire/ -- Elbit Systems Ltd. (NASDAQ: ESLT) (TASE: ESLT) ("Elbit Systems" or the "Company") announced today that it was awarded a $95 million contract to supply SkyStriker loitering munitions (LM) to a European country.
  • As part of the contract Elbit Systems will provide several hundred SkyStriker units.
  • Elbit Systems' SkyStriker LM is a fully autonomous loitering munition that can locate, acquire and engage operator designated targets with a warhead of up to 10 Kg, enabling high-precision performance.
  • SkyStriker can be launched from a variety of ground and aerial platforms, including from a dedicated canister on Elbit Systems' PULS™ (Precise and Universal Launching System) rocket artillery systems.

The Makers of the SPAM® Brand Sending Resources to Aid Maui Wildfire Response

Retrieved on: 
Thursday, August 17, 2023

AUSTIN, Minn., Aug. 17, 2023 /PRNewswire/ -- In response to the devastating wildfires on Maui, Hormel Foods Corporation and the makers of the SPAM® brand — whose special relationship with the Hawaiian community spans decades — is sending resources to aid the disaster-relief efforts.

Key Points: 
  • AUSTIN, Minn., Aug. 17, 2023 /PRNewswire/ -- In response to the devastating wildfires on Maui, Hormel Foods Corporation and the makers of the SPAM® brand — whose special relationship with the Hawaiian community spans decades — is sending resources to aid the disaster-relief efforts.
  • Hormel Foods and its SPAM® brand have made a product donation to support the efforts on Maui.
  • In all, the SPAM® brand has donated cash and product with a retail value of more than $1,000,000 to directly help those impacted by the wildfires.
  • The brand has also created a specially designed "SPAM® Brand Loves Maui" T-shirt available on SPAM.com, with 100% of proceeds to be donated to Aloha United Way's Maui Fire Relief Fund for relief efforts in the area.

Ardelyx Reports Second Quarter 2023 Financial Results and Provides 2023 IBSRELA Net Sales Revenue Guidance

Retrieved on: 
Wednesday, August 2, 2023

WALTHAM, Mass., Aug. 02, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the second quarter ended June 30, 2023 and provided a business update.

Key Points: 
  • The May 2023 LaunchDynamix report published in Q2 by Spherix reports significant increases in awareness and experience with IBSRELA, while continuing to rate the product highly, 12-months post-launch.
  • R&D Expenses: Research and development expenses were $8.3 million for the quarter ended June 30, 2023, compared to $9.7 million for the quarter ended June 30, 2022.
  • Net Loss: Net loss for the quarter ended June 30, 2023 was $17.1 million, or $(0.08) per share, compared to net loss of $26.9 million, or $(0.19) per share, for the quarter ended June 30, 2022.
  • Ardelyx currently expects full-year 2023 net product revenue for IBSRELA to be between $72.0 and $77.0 million.

Elbit Systems Awarded $150 Million Contract to Supply PULS Rocket Artillery Systems to an International Customer

Retrieved on: 
Tuesday, July 18, 2023

HAIFA, Israel, July 18, 2023 /PRNewswire/ -- Elbit Systems Ltd. (NASDAQ: ESLT) (TASE: ESLT) ("Elbit Systems" or the "Company") announced today that it was awarded a $150 million contract to supply PULS™ (Precise and Universal Launching Systems) rocket launchers and a package of precision-guided long-range rockets to an international customer.

Key Points: 
  • HAIFA, Israel, July 18, 2023 /PRNewswire/ -- Elbit Systems Ltd. (NASDAQ: ESLT) (TASE: ESLT) ("Elbit Systems" or the "Company") announced today that it was awarded a $150 million contract to supply PULS™ (Precise and Universal Launching Systems) rocket launchers and a package of precision-guided long-range rockets to an international customer.
  • Elbit Systems' PULS provides a comprehensive and cost effective solution, that can launch unguided rockets, precision guided munitions and missiles with an effective range of up to 300km.
  • The PULS launcher is fully adaptable to existing wheeled and tracked platforms, enabling a significant reduction in maintenance and training costs.
  • This contract provides an additional vote of confidence in Elbit Systems' PULS rocket artillery solutions."

Press release - MEPs want better protection for quality agricultural products

Retrieved on: 
Friday, June 2, 2023

Geographical indications -intellectual property rights that identify products having qualities, characteristics or a reputation due to natural and human factors linked to their place of origin- should be better protected online, MEPs say.

Key Points: 
  • Geographical indications -intellectual property rights that identify products having qualities, characteristics or a reputation due to natural and human factors linked to their place of origin- should be better protected online, MEPs say.
  • An alert system monitoring the registration of domain names should be set by the EU Intellectual Property Office (EUIPO) for this purpose.
  • Parliament demands that GIs should be better protected in processed products.
  • According to MEPs, the Commission has unique agricultural expertise and should therefore continue administering the GIs system, rather than the EUIPO.

Despite Last Minute Change, UnitedHealthcare's Policy for Virtually All Colonoscopies and Endoscopies Lays Groundwork for Delays, Disruptions, and Denials of Life-saving Services

Retrieved on: 
Thursday, June 1, 2023

WASHINGTON, June 1, 2023 /PRNewswire/ -- While the American Gastroenterological Association (AGA) accepts that UnitedHealthcare (UHC) backed off its disastrous decision to begin imposing prior authorization on gastroenterology endoscopy services for all commercial plans starting June 1, AGA remains extremely concerned that the advance notification program UHC is rolling out instead is a temporary patch likely to have significant repercussions for patient access in the coming months. UHC's advance notification program, hastily announced to reporters late yesterday, only temporarily postpones prior authorization requirements set to impact the insurance giant's 27 million commercial beneficiaries while increasing the administrative burden on providers. Clear to the AGA from discussions last Friday, UHC does not currently have data demonstrating any significant overutilization of critical endoscopy and colonoscopy procedures that would justify this program or prior authorization. Since colorectal cancer is the #2 cancer killer and rates are rising in younger adults, now is not the time to increase barriers for patients who need GI care.

Key Points: 
  • The nebulous advance notification program UHC announced late last night will impact virtually all endoscopies and colonoscopies for UHC's commercial plans.
  • The poorly defined "advance notification program" would ostensibly require physician practices to input copious amounts of highly complex and granular patient data prior to performing colonoscopies and endoscopies.
  • These services are critical for the early diagnosis of life-threatening diseases such as colorectal cancer and for monitoring patients' disease progression.
  • This new policy comes despite immense pressure from physicians, patients, lawmakers, and regulators to crack down on abusive prior authorization policies.

Press release - Deal on geographical protection for local craft and industrial products

Retrieved on: 
Wednesday, May 3, 2023

This new mechanism will not just help with raising the awareness of traditional products from less-developed regions, attract tourists and create jobs.

Key Points: 
  • This new mechanism will not just help with raising the awareness of traditional products from less-developed regions, attract tourists and create jobs.
  • Background
    The protection of geographical indications for agricultural products at EU level has been in place for many years.
  • MEPs already called for the EU-wide protection of locally manufactured products in 2015.
  • In 2019, they reiterated their call following the EU accession to the Geneva Act, allowing for the global recognition of local non-food products.

Press release - New EU mechanism to protect local craft and industrial products

Retrieved on: 
Tuesday, February 28, 2023

With 19 votes in favour, MEPs from the Legal Affairs Committee (JURI) adopted unanimously on Tuesday a draft negotiating mandate on legislation introducing a geographical indication (GI) protecting the names of local craft and industrial products.

Key Points: 
  • With 19 votes in favour, MEPs from the Legal Affairs Committee (JURI) adopted unanimously on Tuesday a draft negotiating mandate on legislation introducing a geographical indication (GI) protecting the names of local craft and industrial products.
  • Producers’ applications would first be examined by national and local authorities, then the EU Intellectual Property Office (EUIPO) would decide on the registration.
  • Quote
    Following the committee vote, rapporteur Marion Walsmann (EPP, DE) said: “It is time to create an EU-wide mechanism to protect specific European local skills and traditions relating to craft and industrial products.
  • In 2019, they reiterated their call following the EU accession to the Geneva Act, allowing for international recognition of local non-food products.