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FDA Action Alert: Regeneron, BioMarin, Eton and Amneal

Biospace news - Mon, 06/26/2023 - 02:00
FDA Action Alert: Regeneron, BioMarin, Eton and Amneal 6/26/2023

Opinion: Cracking the Code—Solving the Economic Puzzle of Leqembi

Biospace news - Mon, 06/26/2023 - 02:00
Opinion: Cracking the Code—Solving the Economic Puzzle of Leqembi 6/26/2023

Magdeburg researchers discover a new mechanism of cancer immune defense

World Pharma News - Fri, 06/23/2023 - 10:00
Modern immunotherapies boost the body's own defenses against cancer. They activate killer T cells of the immune system that can specifically recognize and destroy cancer cells. In many patients, however, cancer cells adapt and become invisible to killer T cells so that the treatment is no longer effective. An interdisciplinary team of researchers from Magdeburg has now discovered a new mechanism that enables the immune system to also eliminate such invisible cancer cells.

States Back FTC in Lawsuit Seeking to Block Amgen-Horizon Deal

Biospace news - Fri, 06/23/2023 - 02:00
States Back FTC in Lawsuit Seeking to Block Amgen-Horizon Deal 6/23/2023

Intercept Cuts All NASH Investments, One-Third of Staff After Second FDA Rejection

Biospace news - Fri, 06/23/2023 - 02:00
Intercept Cuts All NASH Investments, One-Third of Staff After Second FDA Rejection 6/23/2023

Apogee Files for IPO with Promising Preclinical Immuno Asset

Biospace news - Fri, 06/23/2023 - 02:00
Apogee Files for IPO with Promising Preclinical Immuno Asset 6/23/2023

Medicare Provides Further Details About Planned Coverage of Leqembi

Biospace news - Fri, 06/23/2023 - 02:00
Medicare Provides Further Details About Planned Coverage of Leqembi 6/23/2023

Roivant Reports Positive Results in Phase II Ulcerative Colitis Trial

Biospace news - Fri, 06/23/2023 - 02:00
Roivant Reports Positive Results in Phase II Ulcerative Colitis Trial 6/23/2023

Sarepta Shares Fall due to Concerns Over Elevidys’s Potential for Label Expansion

Biospace news - Fri, 06/23/2023 - 02:00
Sarepta Shares Fall due to Concerns Over Elevidys’s Potential for Label Expansion 6/23/2023

Jubilant’s Precision Medicines Offer Safety, Therapeutic Advantages in Cancer, Immunology

Biospace news - Fri, 06/23/2023 - 02:00
Jubilant’s Precision Medicines Offer Safety, Therapeutic Advantages in Cancer, Immunology 6/23/2023

FDA approves first gene therapy for treatment of certain patients with Duchenne muscular dystrophy

World Pharma News - Thu, 06/22/2023 - 10:00
Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who do not have a pre-existing medical reason preventing treatment with this therapy.

Tourmaline Bio, Talaris Therapeutics Announce Reverse Merger in Stock Deal

Biospace news - Thu, 06/22/2023 - 02:00
Tourmaline Bio, Talaris Therapeutics Announce Reverse Merger in Stock Deal 6/22/2023

FDA Rejects Aldeyra’s Eye Cancer Injection, Citing Lack of Well-Controlled Studies

Biospace news - Thu, 06/22/2023 - 02:00
FDA Rejects Aldeyra’s Eye Cancer Injection, Citing Lack of Well-Controlled Studies 6/22/2023

US Government Seeks New Judgment, Trial After Gilead’s HIV PrEP Victory

Biospace news - Thu, 06/22/2023 - 02:00
US Government Seeks New Judgment, Trial After Gilead’s HIV PrEP Victory 6/22/2023

Novartis-Backed Tagworks Raises $65M Series A to Further ADC, Click-to-Release Tech

Biospace news - Thu, 06/22/2023 - 02:00
Novartis-Backed Tagworks Raises $65M Series A to Further ADC, Click-to-Release Tech 6/22/2023

FY22 Drug Recalls Highest in Five Years: FDA Report

Biospace news - Thu, 06/22/2023 - 02:00
FY22 Drug Recalls Highest in Five Years: FDA Report 6/22/2023

Expanding ALS Trial Eligibility Could Benefit Patients, Therapeutic Progress

Biospace news - Thu, 06/22/2023 - 02:00
Expanding ALS Trial Eligibility Could Benefit Patients, Therapeutic Progress 6/22/2023

Worried About Productivity? Studies Suggest Taking More Breaks

Biospace news - Thu, 06/22/2023 - 02:00
Worried About Productivity? Studies Suggest Taking More Breaks 6/22/2023

Pfizer's TALZENNA® in combination with XTANDI® receives U.S. FDA approval

World Pharma News - Wed, 06/21/2023 - 12:00
Pfizer (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved TALZENNA (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI (enzalutamide), for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

The first year of the Long COVID project: What has been achieved?

World Pharma News - Wed, 06/21/2023 - 10:00
Since the 1st of June 2022, the Long COVID Consortium, led by HUS Helsinki University Hospital, is working to elucidate the predisposing factors and mechanisms for the development of Long COVID Syndrome (LCS). This is essential to be able to develop and improve the care of patients suffering from the long-term effects of COVID-19 infection.