injectable treatments News
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Braeburn receives new Complete Response Letter for Brixadi in the US
Camurus AB (NASDAQ STO: CAMX) today announced that its US licensee Braeburn has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its updated New Drug Application (NDA) for Brixadi (buprenorphine) extended-release injections for the treatment of opioid use disorder. The CRL is a result of continued quality related deficiencies at Braeburn’s US ...
By Camurus AB
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Amivas (US), LLC Announces FDA Approval of Artesunate for Injection for Treatment of Severe Malaria
Artesunate for Injection 110 mg, powder and solvent for solution is approved by FDA for initial treatment of severe malaria in adult and pediatric patients. Artesunate for Injection is in a group of drugs known as “artemisinin derivatives” and is on the World Health Organization Model List of Essential Medicines. Since 2007, Investigational Intravenous (IV) Artesunate has been ...
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Amivas (US), LLC Announces U.S. Launch of Artesunate for Injection for Initial Treatment of Severe Malaria
Artesunate for Injection 110 mg, powder and solvent for solution is launching in the U.S. for initial treatment of severe malaria in adult and pediatric patients. From 2007 until today, the product was available in the U.S. only through an expanded access investigational new drug (IND) program managed by the Centers for Disease Control and Prevention (CDC). Amivas (US), LLC is now the sole ...
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Cara Therapeutics Announces Biomarker Data from KALM-1 and KALM-2 Trials of KORSUVA (difelikefalin) Injection Selected for Presentation at National Kidney Foundation Spring Clinical Meetings 2022
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced biomarker data from the KALM-1 and KALM-2 clinical trials evaluating KORSUVA™ (difelikefalin) injection for the treatment of chronic kidney disease-associated pruritus in patients undergoing ...
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Relievant Medsystems Announces Publication of New INTRACEPT Trial Data Showing Sustained Relief from Chronic Low Back Pain 12 Months Post-Procedure
Relievant Medsystems, a privately held medical device company transforming the treatment of Chronic Low Back Pain (CLBP), today announced 12-month results from a Level 1, prospective, randomized, multi-center trial that demonstrated the effectiveness and superiority of the Intracept® Procedure for vertebrogenic CLBP compared to standard care treatments. The INTRACEPT study randomized 140 ...
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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. There is a high unmet medical need in chronic pain, particularly among ...
By Camurus AB
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Clearside Biomedical Enters into Non-Dilutive Financing Agreement with HealthCare Royalty Partners for up to $65 Million
Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today it has entered into a Royalty Interest Purchase and Sale Agreement (the agreement) with HealthCare Royalty Partners (HealthCare Royalty). Clearside intends to use the proceeds from the agreement to ...
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Cara Therapeutics Announces Difelikefalin (KORSUVA) Injection Achieves Positive Topline Results in Phase 3 Clinical Study in Japan for the Treatment of Pruritus in Hemodialysis Patients
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that its licensing partner Maruishi Pharmaceutical Co., Ltd., and its sublicensee Kissei Pharmaceutical Co., Ltd., confirmed the primary endpoint was achieved in a Japanese Phase 3 clinical study ...
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Shifa Launches with Seed Financing to Address Cardiovascular Disease by Developing Orally Bioavailable Drugs for the Treatment of Dyslipidemia - PharmiWeb.com
MALVERN, Pa.--(BUSINESS WIRE)--#Cardiovascular--Shifa Biomedical Corporation (Shifa), a drug discovery company developing an oral small molecule PCSK9/low density lipoprotein-cholesterol receptor (LDLR) antagonist, P-21, to treat dyslipidemia, today announced their launch with a seed investment from Xontogeny, LLC to advance their lead program through IND-enabling research. “We are excited ...
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Kadimastem Receives Grant for a Total Budget of $3.1 million from the Israeli Innovation Authority
NESS ZIONA, ISRAEL, March 3, 2022 – Kadimastem Ltd. (TASE: KDST), a clinical stage cell therapy company developing a treatment for ALS and a potential cure for diabetes, has received a grant from the Israel Innovation Authority (IIA) for a total budget of NIS 10 million ($3.1 million) and a net grant of NIS 4 million ($1.25 million). The funds will be used to advance the filing of an IND ...
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KiOmed Pharma and moveUP Partner to Develop and Market a Companion Healthcare Application for Personalised Treatment of Osteoarthritis
Belgian biotech company KiOmed Pharma and digital therapeutics company moveUP are pleased to announce the signature of an exclusive agreement for the development and licensing of a unique mobile health companion application dedicated to personalised conservative intra-articular treatment for patients suffering from osteoarthritis. This application is to be developed by moveUP, while exclusive ...
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UNITY Biotechnology Completes Enrollment in BEHOLD, the Phase 2 Study of Senolytic Candidate UBX1325 in Diabetic Macular Edema
12-week safety and efficacy data anticipated by mid-year 2022 24-week safety and efficacy data anticipated before year-end 2022 UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, has completed enrollment for the BEHOLD study, its Phase 2 clinical trial of UBX1325 in patients with ...
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Frontier Biotechnologies` First Long-acting Injectable (Aikening(R), in a Two Drug Regimen for HIV, Proves Safe and Efficacious for Patients
The TALENT study (TALENT) findings, which were presented at the 11th International AIDS Society (IAS) Conference on HIV Science, showed that a two-drug regimen was as effective and safe as multi-drug therapies TALENT is the world's first phase III clinical trial of the new long-acting HIV-1 fusion inhibitor, Aikening® (generic name: Albuvirtide [ABT]) in an all-Asian population TALENT ...
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GC Pharma Taps Small Molecule AI Expert Atomwise to Expand Hemophilia Franchise
Atomwise, the leader in using artificial intelligence (AI) for small molecule drug discovery, announced today a partnership with GC Pharma (KRX: 006280), a South Korean biopharmaceutical company formerly known as Green Cross Corporation, to discover and develop novel hemophilia therapies. GC Pharma is a pioneer in vaccines and protein therapeutics and has long been dedicated to research and ...
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Showcase
Aktiv Pharma Group Receives Grant Funding to Develop Tranexamic Acid Autoinjector
Broomfield Colorado 6/25/2022. Aktiv Pharma Group (Aktiv) announced today a grant award from the U.S. Department of Defense (DOD) Defense Health Agency (DHA) Joint Program Committee 6/Combat Casualty Care Research Program (JPC-6/CCCRP) [1] for the continued development of a tranexamic acid (TXA) autoinjector, targeting proposed indications related to prehospital treatment of severe bleeding. ...
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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, Mass.--(BUSINESS WIRE)--Sep. 20, 2022-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), ...
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U.S. FDA approves Xarelto to treat venous thromboembolism (VTE) and to prevent VTE in children
Xarelto is the only Factor Xa anticoagulant FDA approved for pediatric patients and offers a flexible weight-based dosing Xarelto is available in both oral tablet and liquid suspension formulations for use in appropriate children less than 18 years of age Convenient liquid formulation advances standard of care for children; alleviates administration challenges found with injectable ...
By Bayer AG
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TikoMed AB reports positive phase II clinical data for the treatment of Amyothropic Lateral Sclerosis in data published by PLOS ONE
A new study with TikoMed’s platform lead clinical drug candidate ILB®, provides positive safety and tolerability results and the first clinical evidence of encouraging clinical efficacy of ILB® in the treatment of Amyotrophic Lateral Sclerosis (ALS). The study was published in PLOS ONE today. In a phase II study of ILB administered to patients with ALS for five weeks, the ...
By TIKOMED AB
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NYMOX Receives RTF letter from FDA
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) Nymox reports today that it has received a Refusal to File (“RTF”) letter from FDA on Friday May 20th at 2:48 pm EST, with regard to the Company's New Drug Application (“NDA”) for Fexapotide Triflutate. Nymox’s position is that clarifications remain to be resolved at a follow-up meeting and that some significant ...
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Ocular diseases and the rise of Biologics in the field of Ophthalmology
Speaking at the American Academy of Optometry 2021 annual meeting in Boston, Anthony DeWilde, OD, FAAO, discussed biologics, which hold promise for the treatment of ophthalmic diseases. Original Post can be read here. A wide range of articles cover the use of biologics in oncology. Apart from oncology, biologics have been successful in various therapeutic indications as listed in Annexure A. ...
By Qprotyn Inc
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