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Subcutaneous Injection Articles & Analysis

21 news found

CD Bioparticles Announces Advanced Capabilities in Customized Liposomes for Targeted Delivery

CD Bioparticles Announces Advanced Capabilities in Customized Liposomes for Targeted Delivery

FDA-approved Comirnaty, 113-O12B showed significantly lower mRNA expression in the liver and higher expression in the lymph nodes after subcutaneous injection. Another example is FPD-Lipid Nanoparticles (Catalog: CDCLP24-003-L). ...

ByCD Bioparticles


MorphoSys’ Licensing Partner Roche Provides Update on Phase 3 GRADUATE Program for Gantenerumab in Early Alzheimer’s Disease

MorphoSys’ Licensing Partner Roche Provides Update on Phase 3 GRADUATE Program for Gantenerumab in Early Alzheimer’s Disease

Gantenerumab was well tolerated, including the subcutaneous administration. The GRADUATE Phase 3 program evaluated the safety and efficacy of gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimer’s and mild Alzheimer’s dementia over 27 months. 1,965 study participants across 30 countries were randomized 1:1 to receive gantenerumab or placebo by ...

ByMorphoSys AG


Alnylam Announces FDA Approval of Supplemental New Drug Application for OXLUMO® (lumasiran) in Advanced Primary Hyperoxaluria Type 1

Alnylam Announces FDA Approval of Supplemental New Drug Application for OXLUMO® (lumasiran) in Advanced Primary Hyperoxaluria Type 1

Food and Drug Administration (FDA) approved a label expansion for OXLUMO® (lumasiran), an RNAi therapeutic administered via subcutaneous injection, now indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate (UOx) and plasma oxalate (POx) levels in pediatric and adult patients. ...

ByAlnylam Pharmaceuticals, Inc.


FDA Emerging Technology Program

FDA Emerging Technology Program

Broomfield Colorado 6/16/2022. Aktiv Pharma Group (Aktiv) announced today the acceptance of its novel glass-free, film-based flexible primary drug container (PDC) technology for sterile injectables named ARCH, into the US Food and Drug Administration (FDA) Emerging Technology Program (ETP). The ETP is a collaborative effort which supports the FDA’s mission to facilitate modernization in ...

ByAktiv Pharma Group, Inc


Alnylam Receives Approval in Europe for AMVUTTRA® (vutrisiran) for the Treatment of Hereditary Transthyretin-mediated (hATTR) Amyloidosis in Adult Patients with Stage 1 or Stage 2 Polyneuropathy

Alnylam Receives Approval in Europe for AMVUTTRA® (vutrisiran) for the Treatment of Hereditary Transthyretin-mediated (hATTR) Amyloidosis in Adult Patients with Stage 1 or Stage 2 Polyneuropathy

– AMVUTTRA Demonstrated Halting or Reversal in Neuropathy Impairment with Subcutaneous Administration Once Every Three Months – – Decision Follows Positive Opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2022 – CAMBRIDGE, ...

ByAlnylam Pharmaceuticals, Inc.


AIVITA Biomedical Announces Publication of Phase 1 and Phase 2 Trial Results of its COVID-19 Vaccine Candidate

AIVITA Biomedical Announces Publication of Phase 1 and Phase 2 Trial Results of its COVID-19 Vaccine Candidate

IRVINE, Calif. – AUG. 29, 2022 – AIVITA Biomedical, Inc., a biotech company specializing in innovative cell applications, today announced the publication of safety and efficacy results from Phase 1 and Phase 2 clinical trials investigating its anti-SARS-CoV-2 vaccine candidate AV-COVID-19 that is made at point-of-care by third-party personnel. The results were published in the article ...

ByAIVITA Biomedical, Inc.


Rani Therapeutics Unveils High-Capacity RaniPill Device for Oral Delivery of Biologics

Rani Therapeutics Unveils High-Capacity RaniPill Device for Oral Delivery of Biologics

” Today, biologics are predominantly delivered via injection or intravenous infusion, which limits long-term treatment adherence, often leading to suboptimal patient outcomes. ...

ByRani Therapeutics


TikoMed AB reports positive phase II clinical data for the treatment of Amyothropic Lateral Sclerosis in data published by PLOS ONE

TikoMed AB reports positive phase II clinical data for the treatment of Amyothropic Lateral Sclerosis in data published by PLOS ONE

” TikoMed’s phase II open label clinical trial conducted at Sahlgrenska University Hospital in Gothenburg, Sweden, evaluated the safety, tolerability and possible efficacy of subcutaneous injections of ILB in the treatment of thirteen patients (of both sexes) with ALS of intermediate severity. ...

ByTIKOMED AB


Gerresheimer and Portal enter strategic partnership to treat chronically ill patients with innovative needle-free drug-delivery solution

Gerresheimer and Portal enter strategic partnership to treat chronically ill patients with innovative needle-free drug-delivery solution

Together, the partners aim at transforming the administration of injectable medicines and improving the patient’s experience, especially for those with chronic diseases. Portal develops technology which allows for needle-free and high-speed subcutaneous injection of medicine and – via connectivity –adherence monitoring along ...

ByPortal Instruments, Inc.


Dupixent (dupilumab) Approved by European Commission for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation

Dupixent (dupilumab) Approved by European Commission for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation

Dupixent is also approved in one or more of these indications in more than 60 countries around the world, and more than 400,000 patients have been treated globally. Dupixent is an injection under the skin (subcutaneous injection) at different injection sites. ...

ByRegeneron Pharmaceuticals Inc.


FDA Accepts Dupixent (dupilumab) for Priority Review in Patients Aged 12 Years and Older with Eosinophilic Esophagitis

FDA Accepts Dupixent (dupilumab) for Priority Review in Patients Aged 12 Years and Older with Eosinophilic Esophagitis

Asthma: injection site reactions, pain in the throat (oropharyngeal pain), high count of a certain white blood cell (eosinophilia), and parasitic (helminth) infections. ...

ByRegeneron Pharmaceuticals Inc.


The European Medicines Agency accepts application to extend the Buvidal indication to include treatment of chronic pain

The European Medicines Agency accepts application to extend the Buvidal indication to include treatment of chronic pain

Camurus (NASDAQ STO: CAMX) today announces that the European Medicines Agency (EMA) has accepted the company’s submission of a Type II variation application for Buvidal (buprenorphine) prolonged release injection to include treatment of chronic pain. “We are pleased that the review procedure has been initiated. ...

ByCamurus AB


Qprotyn achieves viscosity of 14 cP for 250mg/mL of Bevacizumab using its HILOPRO technology

Qprotyn achieves viscosity of 14 cP for 250mg/mL of Bevacizumab using its HILOPRO technology

Upgrading Bevacizumab from IV to subcutaneous (SubQ) administration may now be possible with Qprotyn's HILOPRO technology. ...

ByQprotyn Inc


Micron Biomedical Initiates First-Ever Microneedle Vaccine Clinical Trial in Children

Micron Biomedical Initiates First-Ever Microneedle Vaccine Clinical Trial in Children

The trial will assess the safety, tolerability and immunogenicity of an MR vaccine delivered using Micron’s technology, compared with delivery via standard subcutaneous injection, in adults and children. The Company-sponsored Phase 1/2 trial will be conducted at the Medical Research Council Unit The Gambia (“MRCG”) under the leadership of Ed ...

ByMicron Biomedical, Inc.


Raising Awareness on the Challenges of Hormone Replacement Injections

Raising Awareness on the Challenges of Hormone Replacement Injections

Injectable testosterone is usually prescribed intramuscularly, though studies have shown that subcutaneous injections are just as effective at maintaining testosterone levels as the intramuscular ...

ByPortal Instruments, Inc.


TIKOMED’S ILB® resolves inflammatory scarring and promotes functional tissue repair in data published in npj Regenerative Medicine

TIKOMED’S ILB® resolves inflammatory scarring and promotes functional tissue repair in data published in npj Regenerative Medicine

TIKOMED’s study, conducted at the School of Biomedical Sciences, Institute of Clinical Sciences, University of Birmingham, UK is the first to demonstrate that subcutaneous injections of ILB®, which has already demonstrated safety in humans, can resolve inflammation and arising/established fibrosis in both rodent and human models of inflammation and ...

ByTIKOMED AB


Clinical Trial Phase I “Safety and Tolerability of Escalating Doses of Subcutaneous Elafin (Tiprelestat) Injection in Healthy Normal Subjects” completed.

Clinical Trial Phase I “Safety and Tolerability of Escalating Doses of Subcutaneous Elafin (Tiprelestat) Injection in Healthy Normal Subjects” completed.

tiakis Biotech AG (formerly Proteo Biotech AG) has attained another milestone in its Pulmonary Arterial Hypertension (PAH) development program by receiving the final clinical phase 1 trial report demonstrating the very good safety profile of Tiprelestat (no severe adverse occurred). tiakis’s research partners and investigators at Stanford University School of Medicine, Dr. Marlene ...

Bytiakis BIOTECH AG


Update regarding our Amyotrophic Lateral Sclerosis (ALS) study conducted at Sahlgrenska University Hospital in Gothenburg, Sweden

Update regarding our Amyotrophic Lateral Sclerosis (ALS) study conducted at Sahlgrenska University Hospital in Gothenburg, Sweden

Our Phase IIa clinical trial evaluating the safety, tolerability and possible efficacy of subcutaneous injections of ILB® in ALS is finalized and has been reported to the Swedish Medical Products Agency. ...

ByTIKOMED AB


Allovate Therapeutics Appoints Bob Pomrenke as CEO

Allovate Therapeutics Appoints Bob Pomrenke as CEO

By coupling a daily oral care activity with allergy immunotherapy, OMIT, delivered using Allerdent®, can help address the issues associated with poor adherence that limits the use and effectiveness of other forms of allergy immunotherapy, such as subcutaneous injections. Allovate® retains the global rights to develop products based on the OMIT platform ...

ByAllovate Therapeutics


tiakis (formerly Proteo Biotech AG) Elafin Enters the Clinic For Subcutaneous Use In Pulmonary Arterial Hypertension

tiakis (formerly Proteo Biotech AG) Elafin Enters the Clinic For Subcutaneous Use In Pulmonary Arterial Hypertension

tiakis BIOTECH AG today announced the start of the clinical development for the subcutaneous use of tiakis lead investigational drug candidate Elafin (INN: Tiprelestat). ...

Bytiakis BIOTECH AG

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