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News and Trends 11 Oct 2022

Accelerated application for drug to help immunodeficiency submitted by Pharming

A marketing authorization application (MAA) has been submitted by Dutch company Pharming Group, to the European Medicines Agency (EMA) for a rare, primary immunodeficiency in adults and adolescents 12 years and older. Activated phosphonide 3-kinase delta syndrome (APDS), first discovered in 2013, is caused by genetic variants in either one of two identified genes known […]

October 11, 2022 - 4 minutesmins - By Liza Laws

News and Trends 11 Oct 2022

License granted to EnteroBiotix for manufacture of microbiome product candidates

Microbiome therapeutics company, EnteroBiotix Limited has been granted a manufacturer’s license for a GMP manufacturing facility for Investigational Medicinal Products (IMP) to make microbiome product candidates for clinical trials. It was given by the Medicines and Healthcare Products Regulatory Agency (MHRA) and also incorporates an in-house QC hub and analytical department. EnteroBiotix’s manufacturing capabilities include […]

October 11, 2022 - 2 minutesmins - By Liza Laws

News and Trends 11 Oct 2022

Gedea Biotech reports results from bacterial vaginosis trial

Gedea Biotech has reported top-line results from a clinical study, NEFERTITI, of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV). NEFERTITI is a placebo-controlled, double blind clinical trial performed in Sweden and UK in 150 patients. Treatment details The treatment is a vaginal tablet taken once daily for six […]

October 11, 2022 - 4 minutesmins - By Jim Cornall

News and Trends 11 Oct 2022

Muna Therapeutics gets $4.9M grant for Parkinson’s disease research

Muna Therapeutics has been awarded a $4.9 million grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF). The grant will be used to support ongoing preclinical research and development of novel, brain-exposed, small molecule potassium channel type 1.3 (Kv1.3) blockers to abrogate neuroinflammation driven by disease-associated microglia and enhance neuroprotection as a disease-modifying […]

October 11, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 11 Oct 2022

Positive results from NMD Pharma myasthenia gravis trial

NMD Pharma A/S has reported positive top-line results from its phase I/IIa clinical trial of NMD670, recently granted orphan drug designation by the FDA for treatment of myasthenia gravis (MG). NMD670 was safe and well tolerated in healthy volunteers and patients. Administration of single doses of NMD670 was associated with clinically significant improvements in the […]

October 11, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 11 Oct 2022

Clinical Microbiomics expanding with €10M million investment

Danish microbiome research company Clinical Microbiomics A/S has received €10 million ($9.7 million) in funding from Seventure Partners. Clinical Microbiomics, founded in 2015, is a microbiome analysis company, which includes work on clonal-level microbiome profiling. The company is working with food and consumer health companies and is supporting the pharmaceutical industry in phase 3 clinical […]

October 11, 2022 - 2 minutesmins - By Jim Cornall

More News! 10 Oct 2022

Positive data indicates likely therapeutic effect of Alzheimer’s drug

Positive phase 2a clinical data from an Alzheimer’s disease (AD) biomarker study, has been announced today (October 10). Actinogen Medical Limited shared the news that its study validates its planned program for Xanamem, a potential drug for the disease. The biomarker study was conducted in 72 patients with available blood biomarker samples from the prior […]

October 10, 2022 - 3 minutesmins - By Liza Laws

News and Trends 10 Oct 2022

Fast track designation for Nanoscope Therapeutics’ retinitis pigmentosa treatment

Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, says the U.S. Food and Drug Administration (FDA) has granted fast track designation (FTD) to MCO-010. MCO-010 is an ambient-light activatable multi-characteristic opsin (MCO) optogenetic monotherapy to restore vision in blind patients, for the treatment of retinitis pigmentosa (RP) via intravitreal […]

October 10, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 10 Oct 2022

JW Therapeutics receives approval for relapsed or refractory follicular lymphoma drug

China’s National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for JW Therapeutics’ anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection. Also known as relma-cel, the product has the trade name Carteyva. It is used for the treatment of adult patients with follicular lymphoma that is […]

October 10, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 10 Oct 2022

Evonik and Phathom Pharmaceuticals partner on novel acid-blocker vonoprazan

Evonik has entered into a long-term supply agreement with Phathom Pharmaceuticals, a U.S. biopharma company developing and commercializing new treatments for gastric acid-related diseases. Evonik will produce large-scale volumes of vonoprazan at its FDA-inspected manufacturing sites in Tippecanoe, Indiana, U.S., and Dossenheim, Germany. “The manufacture of vonoprazan requires multi-step syntheses involving complex chemistries. We are […]

October 10, 2022 - 2 minutesmins - By Jim Cornall

More News! 10 Oct 2022

RadioMedix announces a $40 million series A financing for targeted alpha therapy platform

A company committed to advancing treatments for rare and aggressive cancers has received a series A funding of $40 million. Clinical stage biotech, RadioMedix, Inc. announced the agreement with an entity related to Portland Investment Counsel Inc. (Portland), on Friday (October 7). RadioMedix is committed to the advancement of a targeted alpha therapy (TAT) pipeline […]

October 10, 2022 - 3 minutesmins - By Liza Laws

News and Trends 10 Oct 2022

Trial starts for treatment of warm autoimmune hemolytic anemia

China-based Hutchmed has started a phase 2/3 trial of sovleplenib in adults with a disorder called warm antibody autoimmune hemolytic anemia (wAIHA). The autoimmune disorder can lead to anemia and currently has limited treatment options. It causes premature destruction of healthy red blood cells and the rate of production of new cells in the bone […]

October 10, 2022 - 2 minutesmins - By Liza Laws

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News and Trends

Accelerated application for drug to help immunodeficiency submitted by Pharming

License granted to EnteroBiotix for manufacture of microbiome product candidates

Gedea Biotech reports results from bacterial vaginosis trial

Muna Therapeutics gets $4.9M grant for Parkinson’s disease research

Positive results from NMD Pharma myasthenia gravis trial

Clinical Microbiomics expanding with €10M million investment

Positive data indicates likely therapeutic effect of Alzheimer’s drug

Fast track designation for Nanoscope Therapeutics’ retinitis pigmentosa treatment

JW Therapeutics receives approval for relapsed or refractory follicular lymphoma drug

Evonik and Phathom Pharmaceuticals partner on novel acid-blocker vonoprazan

RadioMedix announces a $40 million series A financing for targeted alpha therapy platform

Trial starts for treatment of warm autoimmune hemolytic anemia

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The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

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