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Wednesday, April 3, 2024

Biden, Xi Discussed TikTok Divestment Push, White House Says

 

  • President has said he would sign bill forcing US sale of app
  • TikTok one of several points of tension between Biden, Xi

President Joe Biden and Chinese leader Xi Jinping on Tuesday discussed efforts to force the sale in the US of TikTok Inc. during a wide-ranging discussion.

“TikTok came up today, yes,” White House spokesman John Kirby told reporters following the call, the first one-on-one conversation between the leaders since November.

https://www.bloomberg.com/news/articles/2024-04-02/biden-xi-discussed-tiktok-divestment-push-white-house-says

Drugmaker seeks approval for China’s first biosimilar Ozempic

A DRUGMAKER in China has developed a biosimilar version of Novo Nordisk’s popular diabetes drug Ozempic and applied for approval to sell it there, in a potential challenge to Novo’s expansion plans in the country.

Hangzhou Jiuyuan Gene Engineering said on Wednesday (Apr 3) in a post on its official social media account that it was seeking approval to sell the drug, which it calls Jiyoutai, to control blood sugar in patients with type two diabetes.

Novo’s patents in China on Ozempic and related drug Wegovy are set to expire in 2026, according to its annual report. 

Approval for Jiyoutai would make the injectible drug China’s first locally developed biosimilar semaglutide drug. A biosimilar drug has a structure that closely mimics an existing biologic drug but is not exactly alike.

The application for approval comes amid surging demand for semaglutide that is far outpacing supply globally.

Jiuyuan Gene, which is majority owned by China’s Huadong Medicine, completed a late-stage clinical trial in China last year comparing its semaglutide injection with Ozempic in 476 patients, according to a clinical trials registry.

The company did not immediately respond to a Reuters request for comment on Jiyoutai’s safety or efficacy data.

Novo did not immediately respond to a request for comment.

https://www.businesstimes.com.sg/companies-markets/consumer-healthcare/drugmaker-seeks-approval-china-s-first-biosimilar-ozempic

Helius Medical Tech Partners with Lovell® Government Services to Expand MS Therapy

 Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced it has partnered with Lovell Government Services (“Lovell”), an SBA-certified Service Disabled Veteran Owned Small Business (“SDVOSB”), to make the Company’s Portable Neuromodulation Stimulator (“PoNS®”) device available to federal healthcare systems. PoNS is indicated in the U.S. for use as a short-term treatment of gait deficit in adults with mild-to-moderate symptoms from MS when used in conjunction with physical therapy.

https://www.globenewswire.com/news-release/2024/04/03/2856799/0/en/Helius-Medical-Technologies-Inc-Announces-Partnership-with-Lovell-Government-Services-to-Expand-Reach-of-PoNS-Therapy.html

Kintara Therapeutics and TuHURA Biosciences Enter into Definitive Merger

 

  • TuHURA is planning to advance a single Phase 3 trial for IFx-2.0 personalized cancer vaccine as adjunctive therapy with Keytruda® in first-line therapy for advanced Merkel cell carcinoma in 2H 2024 under FDA's accelerated approval pathway
  • $31 million subscribed financing by TuHURA in connection with the merger agreement expected to provide cash runway into late 2025
  • TuHURA's first-in-class bifunctional Antibody Drug Conjugates (ADCs) represents potential upside partnering opportunities
  • Companies are to hold a joint conference call and webcast today, Wednesday, April 3 at 8:30 AM ET

The companies plan to hold a joint conference call and webcast today, April 3, 2024 at 8:30 AM ET to discuss the Merger details.

Interested participants and investors may access the conference call and webcast via the Investors section of the Kintara website at www.kintara.com and on TuHURA's website,  tuhurabio.com. A webcast replay will be available following the live event and will be accessible for 90 days.

https://www.prnewswire.com/news-releases/kintara-therapeutics-and-tuhura-biosciences-enter-into-definitive-merger-agreement-302106737.html

ARCA biopharma and Oruka Therapeutics to Merge

 Merger to create a company focused on advancing Oruka’s portfolio of novel biologics that aim to redefine the standard of care for patients with chronic skin diseases

Oruka, the third company founded based on assets generated by Paragon Therapeutics, expects to advance ORKA-001 and ORKA-002, potentially best-in-class antibodies targeting IL-23p19 and IL-17A/F, respectively, into clinical trials in 2025

Pre-closing private financing of approximately $275 million anticipated to fund operations through 2027

Companies to hold conference call on April 3, 2024 at 8:30 AM EDT

he companies plan to hold a joint conference call on April 3, 2024 at 8:30 AM EDT to discuss the merger details.

The dial-in number in the U.S./Canada is (800) 715-9871; for international participants, the number is (646) 307-1963. For all callers, please refer to the Conference ID 4737644.

Live webcast link: https://edge.media-server.com/mmc/p/rnug3oyp

A replay of the conference call will be available for seven business days beginning shortly after the conclusion of the live call, by calling: Toll Free: (800) 770-2030; Toll: (609) 800-9909; Playback ID: 4737644#.

https://www.globenewswire.com/news-release/2024/04/03/2856818/0/en/ARCA-biopharma-and-Oruka-Therapeutics-Announce-Merger-Agreement.html

Lipella FDA Type C Meeting for LP-10 for Hemorrhagic Cystitis

 Lipella Pharmaceuticals Inc. (Nasdaq: “LIPO”) (“Lipella,” “our,” “us” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced that the U.S. Food and Drug Administration (“FDA”) has granted a Type C meeting request to discuss the company’s proposed Phase-2b clinical trial design for the evaluation of LP-10, an intravesical liposomal formulation of tacrolimus, as a potential treatment for moderate to severe hemorrhagic cystitis (HC). Lipella expects to meet with the FDA on May 21, 2024.

HC is a serious, life-threatening form of gross hematuria (i.e. visible blood in urine) caused by cancer treatments including pelvic radiation therapy, and certain chemotherapies including cyclophosphamide and ifosfamide, which are most commonly used for the treatment of breast cancer.

https://www.globenewswire.com/news-release/2024/04/03/2856846/0/en/Lipella-Pharmaceuticals-Announces-FDA-Type-C-Meeting-for-LP-10-for-Hemorrhagic-Cystitis.html

Bidenomics Failure Shows Up At Polls As Gen-Z Revolts Against Democrats

 It is no surprise that a new Gallup poll shows a growing number of Gen-Zers and millennials are becoming increasingly frustrated with the failure of 'Bidenomics' as they struggle with the cost-of-living crisis. 

We didn't need a poll to reveal the frustrations of youngsters working two or three jobs just to afford rent, auto payments, and avocado and toast. The writing has been on the wall, especially on social media feeds of TikTok and X: