Noah AI Industry News

Delivers real-time biopharma news and signals — powered by AI, curated for professionals.

Heidelberg Pharma Faces Setback: Missed Royalty Payment Leads to Drastic Workforce Reduction

Heidelberg Pharma Faces Setback: Missed Royalty Payment Leads to Drastic Workforce Reduction

Heidelberg Pharma, a German biopharmaceutical company, has announced a significant restructuring plan following a missed royalty payment, highlighting the volatile nature of the pharmaceutical industry's financial landscape.Ladenburg, Germany-based Heidelberg Pharma revealed plans to lay off approximately 75% of its workforce after failing to secure an expected $70 million royalty payment from HealthCare Royalty. The payment was contingent upon FDA approval of TLX250-CDx, a radiolabeled antibody for clear cell renal cell carcinoma, developed in partnership with Telix Pharmaceuticals.

NoahAI News9/27/2025
SS Innovations Appoints New CFO as Global Expansion Accelerates

SS Innovations Appoints New CFO as Global Expansion Accelerates

SS Innovations International, a surgical robot developer, has announced the appointment of Naveen Kumar Amar as its new Chief Financial Officer. This strategic move comes as the company prepares to expand its global footprint, particularly in Europe and the United States.

NoahAI News9/27/2025
FDA Approves Eli Lilly's Oral SERD Inluriyo for Advanced Breast Cancer

FDA Approves Eli Lilly's Oral SERD Inluriyo for Advanced Breast Cancer

Eli Lilly has secured FDA approval for Inluriyo (imlunestrant), marking a significant advancement in the treatment of advanced breast cancer. The oral selective estrogen receptor degrader (SERD) is now cleared for use in adult patients with ER-positive, HER2-negative advanced or metastatic breast cancer who carry ESR1 mutations and have progressed after at least one line of endocrine therapy.

NoahAI News9/27/2025
FDA Clears EssilorLuxottica's Groundbreaking Eyeglasses for Childhood Myopia Control

FDA Clears EssilorLuxottica's Groundbreaking Eyeglasses for Childhood Myopia Control

The U.S. Food and Drug Administration (FDA) has granted a landmark clearance to EssilorLuxottica for its Essilor Stellest lenses, designed to slow the progression of nearsightedness in children aged 6 to 12. This groundbreaking development marks a significant milestone in addressing the growing global epidemic of myopia, which is expected to affect half the world's population by 2050.

NoahAI News9/27/2025
Biogen Discontinues AAV Gene Therapy Programs, Shifts Focus to High-Potential Modalities

Biogen Discontinues AAV Gene Therapy Programs, Shifts Focus to High-Potential Modalities

Biogen, a leading biotechnology company, has announced the discontinuation of all gene therapy programs utilizing adeno-associated virus (AAV) capsids. This strategic move, part of the company's ongoing efforts to restructure its R&D pipeline and allocate capital more efficiently, marks a significant shift in Biogen's approach to rare and genetic diseases.

NoahAI News9/27/2025
ARPA-H Launches Nine-Figure Programs to Advance Personalized Gene Editing Treatments

ARPA-H Launches Nine-Figure Programs to Advance Personalized Gene Editing Treatments

The Advanced Research Projects Agency for Health (ARPA-H) has unveiled two groundbreaking funding opportunities aimed at revolutionizing the development and delivery of custom gene editing therapies. These programs, representing a significant investment from the Department of Health and Human Services (HHS), seek to build upon recent successes in personalized genetic medicine and expand access to potentially life-saving treatments for patients with rare genetic diseases.

NoahAI News9/27/2025
Pharmaceutical Industry Advances: New Drug Approvals, Gene Therapy Initiatives, and Manufacturing Expansions

Pharmaceutical Industry Advances: New Drug Approvals, Gene Therapy Initiatives, and Manufacturing Expansions

Crinetics Pharmaceuticals has received FDA approval for Palsonify (paltusotine), the first once-daily oral therapy for acromegaly. The drug is cleared for adult patients who are not eligible for corrective surgery or have not adequately responded to it. With a broad label and an annual list price of $290,000, Palsonify is poised to compete with established treatments from pharmaceutical giants like Novartis and Pfizer. Leerink Partners analyst Joseph Schwartz predicts peak annual sales of $375 million in the U.S. and Europe.

NoahAI News9/27/2025
Dreem Health Secures $29M to Revolutionize Sleep Care with AI and Digital Solutions

Dreem Health Secures $29M to Revolutionize Sleep Care with AI and Digital Solutions

The Sunrise Group, a leader in sleep health technology, has raised $29 million to expand its recently acquired digital sleep clinic, Dreem Health. This significant investment aims to address the growing concern of sleep disorders and their associated health risks, while leveraging artificial intelligence to enhance sleep medicine.

NoahAI News9/27/2025
Eye Injection of Fatty Acid Shows Promise in Restoring Vision in Elderly Mice

Eye Injection of Fatty Acid Shows Promise in Restoring Vision in Elderly Mice

A groundbreaking study published in Science Translational Medicine has revealed that injecting a specific fatty acid into the eyes of elderly mice can significantly improve their vision for up to a month. This discovery opens up new possibilities for treating age-related vision conditions in humans and has sparked excitement in the ophthalmology research community.

NoahAI News9/27/2025
Hansa Biopharma's Imlifidase Achieves Phase III Success, Eyes FDA Approval for Kidney Transplants

Hansa Biopharma's Imlifidase Achieves Phase III Success, Eyes FDA Approval for Kidney Transplants

Hansa Biopharma, a Swedish biopharmaceutical company, has reported positive top-line results from its U.S. Phase III ConfideS trial of imlifidase, an antibody-cleaving enzyme designed to improve kidney transplant outcomes in highly sensitized patients. The success of this late-stage study marks a significant milestone for the company as it prepares to file for FDA approval, potentially unlocking a substantial market opportunity in the United States.

NoahAI News9/26/2025
Amgen Announces $650 Million Expansion in Puerto Rico, Bolstering U.S. Manufacturing Presence

Amgen Announces $650 Million Expansion in Puerto Rico, Bolstering U.S. Manufacturing Presence

Amgen, a leading biotechnology company, has unveiled plans for a significant expansion of its manufacturing operations in Puerto Rico. The $650 million investment will enhance the company's Juncos facility, creating hundreds of new jobs and increasing drug production capabilities. This move comes as part of a broader trend in the pharmaceutical industry to strengthen domestic supply chains and respond to potential regulatory pressures.

NoahAI News9/26/2025
Pharmaceutical Industry Roundup: Major Acquisitions, FDA Decisions, and Global Partnerships

Pharmaceutical Industry Roundup: Major Acquisitions, FDA Decisions, and Global Partnerships

In a significant move to bolster its U.S. presence and mitigate tariff impacts, South Korean biopharmaceutical company Celltrion has announced the acquisition of Eli Lilly's drug substance plant in Branchburg, New Jersey. The deal, valued at approximately $330 million, is set to close by the end of the year. Celltrion plans to retain all current employees and continue existing CDMO contracts at the site, signaling a smooth transition and immediate operational readiness.

NoahAI News9/26/2025
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