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Neuropsychiatric treatment is on the verge of a major transformation. Historically, treatment options have been limited, with patients relying on daily medications that have minimal efficacy and troublesome side effects. “We call this phenomenon ‘event-driven pharmacology.”
1] [2] Adverse effects The US Food and Drug Administration prescription label for fitusiran contains a boxed warning for thrombotic events (blood clotting) and gallbladder disease (with some recipients requiring gallbladder removal). [2] Fitusiran 1711.0g/mol, 1] It is an antithrombin-directed small interfering ribonucleic acid. [1]
Gibbs — It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA FDA does, however, expect to issue a report on OTC hearing aid adverse events to Congress by August 2024.
Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
Department of Health and Human Services’ (HHS) decision to effectively remove the “X-waiver” requirement for physicians, expanding their ability to utilize medication-assisted treatment (MAT) for patients struggling with opioid use disorder (OUD). Added Dr. Rosenberg, “This is a great day for our patients.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer- BioNTech COVID-19 Vaccine.
The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints. About GDA-201.
FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.
15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China.
Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. iii Current treatment options have limited efficacy in terms of weight loss or are often associated with adverse events. “We
DF6002, Dragonfly’s extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. About DF6002. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies.
1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). .
TOKYO and CAMBRIDGE, England , Dec. Biohaven Forward-looking statements.
Rapid and substantialimprovement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term treatment.
points at Week 6 (primary timepoint), with AXS-05 treatment. points at Week 6 (primary timepoint), with AXS-05 treatment.
NEW YORK, Dec.
(NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the long-term, open-label Phase 3 MOVEMENT trial of AXS-07, Axsome’s novel, oral, multi-mechanistic investigational medicine in the acute treatment of migraine.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].
Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the company’s lead product candidate, PBGM01, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of infantile GM1 gangliosidosis (GM1). chief medical officer of Passage Bio. About PBGM01.
Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.
Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. and Axel Bolte, MSc, MBA, with technology developed by Dr. Braddock and licensed from Yale University.
an international research-focused healthcare Group (Chiesi Group), today announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease. galactosidase-A product candidate under development for the treatment of Fabry disease. nM and 13.81
We are excited to partner with Relay Therapeutics, and we believe that the combination of KRAS G12C and SHP2 inhibitors together represents a promising approach that we hope could become a new treatment option for patients with KRAS G12C mutant tumors.”.
Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. The FDA has granted an Orphan Drug designation for PBFT02 for the treatment of FTD-GRN. PHILADELPHIA, Jan.
Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. (OTCQB: QBIO), announced today that the U.S. billion by 2027.
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. – If Authorized, Lenacapavir Would be the First Capsid Inhibitor and the Only HIV-1 Treatment Option Administered Twice Yearly –. Lenacapavir was generally well-tolerated, with no serious adverse events related to study drug and no study drug discontinuations through the 14-day period, including no discontinuations due to adverse events.
It is also licensed under the brand name Efluelda ® in Europe where it is indicated for adults aged 60 and older. It is also licensed under the brand name Efluelda® in Europe where it is indicated for adults aged 60 and older. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering.
Of 202 treated participants, no safety signals have been identified and of the 4 serious adverse events reported, none were considered to be study drug related. At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data.”.
This innovative technology harnesses the power of sound for the treatment of cellulite. The unique, rapid-pulsed technology safely and comfortably breaks apart the fibrous septa bands beneath the skin that cause cellulite to deliver efficacious results in just one, 40–60-minute treatment.
out of 10. .
We are entering an area with significant unmet medical need since the current treatment paradigm for GBM remains bleak, as this aggressive and currently incurable form of brain cancer continues to claim high mortality rates. These statements relate to future events, future expectations, plans and prospects.
and Shionogi Limited as shareholders, today presented positive long-term data from its global phase IIIb ATLAS-2M study of the first complete, long-acting regimen of cabotegravir and rilpivirine for the treatment of HIV. ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc.
(NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that the Company’s U.S.
About CNS Pharmaceuticals, Inc.
Gilead and Eisai have secured approval for their oral JAK1 preferential inhibitor Jyseleca (filgotinib) from the Japanese Ministry of Health, Labour and Welfare as a treatment for rheumatoid arthritis (RA), it has emerged. Matt Fellows. Source link.
AR-711 was previously shown to be effective in prophylactic as well as therapeutic treatment modes in a SARS-CoV-2 viral challenge study. AR-711 is currently being developed as an inhaled, self-administered treatment for non-hospitalized patients suffering from mild to moderate COVID-19. About Aridis Pharmaceuticals, Inc.
Novartis moment blazoned that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Operation (sBLA) and that the European Medicines Agency (EMA) has validated the type-II variation operation for Beovu ® (brolucizumab) 6 mg for the treatment of diabetic macular edema (DME).
Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis 1 . Showed the annual rate of brain volume loss was not significantly different (MRI-related secondary endpoint) 1. 10% of patients 1,3.
Four #ASCO abstracts Other therapeutics in this space include INBRX-105 (Inhibrx, Inc, discontinued), PRS-344 (Pieris, licensed to Servier BioInnovation LLC), MCLA-145 (Merus Inc, development suspended last week), BH3120 (Hamni Pharmaceutical), ND-021 (Numab), FS222 (invoX, which bought F-Star) and many others. One more question.
SELLAS’ lead product candidate, galinpepimut-S (GPS), is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events.
We are excited to share this new clinical data for naxitamab, which we believe could be a very important new treatment for high-risk neuroblastoma patients, if approved. Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. About Y-mAbs. Contact: Y-mAbs Therapeutics, Inc.
This patent application, filed with the United States Patent & Trademark Office (“U.S.P.T.O.”), is titled: “MEDICATED CBD COMPOSITIONS, METHODS OF MANUFACTURING, AND METHODS OF TREATMENT.”
U.S. is Titled “MEDICATED CBD COMPOSITIONS, METHODS OF MANUFACTURING, AND METHODS OF TREATMENT”. 62/990,709.
BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments in mental disorders and viral infections, announces it has entered into an agreement with Eurofins Discovery for TD-0148A’s U.S. VANCOUVER, Jan.
Access to a replay of the presentation will be available on the Company’s website shortly after the meeting under the archived events. Those interested in attending must register in advance on the Athersys website or at the direct link: [link]. About MultiStem ®.
3 There are currently no HER2-directed therapies approved specifically for the treatment of HER2-mutant NSCLC,4 which occurs in approximately 2-4% of patients with non-squamous NSCLC.4,5. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway. After a median follow-up of 13.1
Roquinimex (Linomide), a drug developed by Pfizer for the treatment of multiple sclerosis, is structurally related to laquinimod. Figure 3: Roquinimex (linomide) Clinical development of both laquinimod and roquinimex was halted due to serious cardiovascular events. Teva Pharmaceuticals licensed laquinimod from Active Biotech.
We share EyePoint’s commitment to rapidly advancing new treatments for ocular disease in attractive markets and look forward to commercial launches in China in the coming year.”. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.
The first one relates to the development of a Pharmaceutical grade version of Tauri-Gum , for nausea regulation (specifically designed to help patients that are subjected to ongoing chemotherapy treatment). is Titled “MEDICATED CBD COMPOSITIONS, METHODS OF MANUFACTURING, AND METHODS OF TREATMENT”. The Patent, filed with the U.S.P.T.O.
Shapiro served as Senior Director of the North America Device Division at Merz, where he successfully led a team of over 60 sales professionals and helped launch Cellfina, a cellulite treatment device which generated $15 million in sales during the first year, along with Ultherapy, an industry leading skin tightening device.
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