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Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations
RARITAN, N.J., February 28, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of niraparib in combination with abiraterone acetate, in the form of a dual-action tablet (DAT), plus prednisone, for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). If approved, this will be the first DAT formulation available in the U.S. to patients with mCRPC with BRCA mutations, which are a type of homologous recombination repair (HRR) gene alt...
Source: Johnson and Johnson - March 1, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Janssen Receives Positive CHMP Opinion for AKEEGA ® (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer
BEERSE, Belgium, 24 February 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for AKEEGA® (niraparib and AA), in the form of a DAT, given with P or prednisolone, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.[1]Niraparib is a highly selective poly adenosine diphosphate-ribose polymerase (PARP) inhibi...
Source: Johnson and Johnson - February 27, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

European committee: Regulators should deny Merck's Lagevrio
A European medical committee says regulators should reject Merck’s COVID-19 treatment Lagevrio for European Union use. The drugmaker said that a European Medicines Agency committee has recommended marketing authorization refusal for the antiviral pill. More than two dozen countries have already…#merck #iv #fda #lagevrio (Source: Reuters: Health)
Source: Reuters: Health - February 24, 2023 Category: Consumer Health News Source Type: news

Janssen Presents Updated Data Demonstrating Improved Outcomes from the Use of Niraparib in Combination with Abiraterone Acetate Plus Prednisone as a First-Line Therapy in Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
SAN FRANCISCO, February 16, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated results from the Phase 3 MAGNITUDE study evaluating the investigational use of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) with or without specific homologous recombination repair (HRR) gene alterations, including BRCA mutations. Results will be featured today in a Rapid Abstract Session (Abstract #170) at the American Society of Clinica...
Source: Johnson and Johnson - February 16, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

New phase III data show Roche ’s Vabysmo rapidly improved vision and reduced retinal fluid in people with retinal vein occlusion (RVO)
Vabysmo met its primary endpoint in two clinical trials, BALATON and COMINO, showing non-inferior visual acuity gains compared toafliberceptMoreVabysmo patients showed an absence of blood vessel leakage in the retina compared toaflibercept in a pre-specified exploratory endpointIf approved, RVO would be the third indication forVabysmo in addition toneovascular or ‘wet’ age-related macular degeneration and diabetic macular edemaBasel, 10 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive new data from two global phase III studies, BALATON and COMINO, evaluating Vabysmo ® (faricimab) in macular ...
Source: Roche Investor Update - February 10, 2023 Category: Pharmaceuticals Source Type: news

New phase III data show Roche ’s Vabysmo rapidly improved vision and reduced retinal fluid in people with retinal vein occlusion (RVO)
Vabysmo met its primary endpoint in two clinical trials, BALATON and COMINO, showing non-inferior visual acuity gains compared toafliberceptMoreVabysmo patients showed an absence of blood vessel leakage in the retina compared toaflibercept in a pre-specified exploratory endpointIf approved, RVO would be the third indication forVabysmo in addition toneovascular or ‘wet’ age-related macular degeneration and diabetic macular edemaBasel, 10 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive new data from two global phase III studies, BALATON and COMINO, evaluating Vabysmo ® (faricimab) in macular ...
Source: Roche Media News - February 10, 2023 Category: Pharmaceuticals Source Type: news

Janssen Reports Positive Topline Phase 2 Results for Nipocalimab in Pregnant Individuals at High Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
SPRING HOUSE, PENNSYLVANIA, February 6, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive topline results from the proof-of-concept Phase 2 open-label UNITY clinical trial for the treatment of pregnant adults at high risk for severe hemolytic disease of the fetus and newborn (HDFN). HDFN is a serious and rare condition which can cause life-threatening anemia in the fetus. It occurs when the blood types of a pregnant individual and their fetus are incompatible.1 The trial met the primary endpoint, with the majority of pregnant patients who received nipocalimab achieving a live b...
Source: Johnson and Johnson - February 8, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

CHMP recommends Bayer ’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus ADT in combination with docetaxel for marketing authorization in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). (Source: World Pharma News)
Source: World Pharma News - January 30, 2023 Category: Pharmaceuticals Tags: Featured Bayer Business and Industry Source Type: news

EMA: No Bivalent-Stroke Link; Presley's Cause of Death 'Deferred'; Handshakes Return
(MedPage Today) -- Note that some links may require subscriptions. The European Medicines Agency said it has not seen any signal of a possible stroke risk related to the Pfizer-BioNTech bivalent COVID-19 vaccine. (Reuters) Funds from pandemic... (Source: MedPage Today Infectious Disease)
Source: MedPage Today Infectious Disease - January 19, 2023 Category: Infectious Diseases Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche ’s Tecentriq plus Avastin is the first treatment combination to reduce the risk of cancer returning in people with certain types of early-stage liver cancer in a Phase III trial
Pivotal Phase III IMbrave050 study investigatingTecentriq plusAvastin in people with early-stage hepatocellular carcinoma (HCC) at high risk of recurrence following surgery met primary endpoint of recurrence-free survivalNew adjuvant treatments are urgently needed as an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery1Data will be discussed with health authorities globally, including the US Food and Drug Administration and the European Medicines Agency to inform the next regulatory steps, and presented at an upcoming medical meetingBasel, 19 January 2023 - Roche (SIX: RO, ROG;...
Source: Roche Investor Update - January 19, 2023 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche ’s Tecentriq plus Avastin is the first treatment combination to reduce the risk of cancer returning in people with certain types of early-stage liver cancer in a Phase III trial
Pivotal Phase III IMbrave050 study investigatingTecentriq plusAvastin in people with early-stage hepatocellular carcinoma (HCC) at high risk of recurrence following surgery met primary endpoint of recurrence-free survivalNew adjuvant treatments are urgently needed as an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery1Data will be discussed with health authorities globally, including the US Food and Drug Administration and the European Medicines Agency to inform the next regulatory steps, and presented at an upcoming medical meetingBasel, 19 January 2023 - Roche (SIX: RO, ROG;...
Source: Roche Media News - January 19, 2023 Category: Pharmaceuticals Source Type: news

EMA Seeks to Issue Guidance on Liver Damage From Gene Therapy EMA Seeks to Issue Guidance on Liver Damage From Gene Therapy
The European Medicines Agency said it plans to issue advice for physicians using Novartis AG ' s Zolgensma, calling on them to monitor patients for any liver injury after treatment.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 13, 2023 Category: Consumer Health News Tags: Gastroenterology News Source Type: news

Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above
Xofluza is now approved in the EU for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza in children aged one year and above, and in adolescents and adultsXofluza is the first influenza antiviral with a new mechanism of action in almost 20 years, stopping viral replication faster thanoseltamivirSingle-doseXofluza helps reduce the societal burden of influenza by helping patients recover quickly and by preventing infection in individuals following contact with someone with the virusBasel, 12 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC...
Source: Roche Investor Update - January 12, 2023 Category: Pharmaceuticals Source Type: news

Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above
Xofluza is now approved in the EU for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza in children aged one year and above, and in adolescents and adultsXofluza is the first influenza antiviral with a new mechanism of action in almost 20 years, stopping viral replication faster thanoseltamivirSingle-doseXofluza helps reduce the societal burden of influenza by helping patients recover quickly and by preventing infection in individuals following contact with someone with the virusBasel, 12 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC...
Source: Roche Media News - January 12, 2023 Category: Pharmaceuticals Source Type: news

FDA grants priority review to Roche ’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma
If approved,glofitamab would be the first fixed-duration CD20xCD3 T-cell engaging bispecific antibody approved to treat the most aggressive type of non-Hodgkin lymphomaResults from the pivotal phase I/II NP30179 study showedglofitamab induced durable response rates in people with heavily pre-treated large B-cell lymphoma, with 40% achieving a complete responseGlofitamab is part of Roche ’s industry-leading portfolio of T-cell engaging bispecific antibodies, which also includes the newly FDA-approved first-in-classLunsumio to treat follicular lymphomaBasel, 6 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announc...
Source: Roche Investor Update - January 6, 2023 Category: Pharmaceuticals Source Type: news