European Medicines Agency (EMA) News 
This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.
This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.AbbVie secures positive CHMP opinion for atogepant for the preventive treatment of adults with migraine
AbbVie (NYSE: ABBV) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have four or more migraine days per month. If approved, AbbVie will be the only company to offer a once daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment spanning both episodic and chronic migraine in the European Union (EU). (Source: World Pharma News)
Source: World Pharma News - July 11, 2023 Category: Pharmaceuticals Tags: Featured AbbVie Business and Industry Source Type: news
E.U. investigates Ozempic, Saxenda after suicidal thoughts reported
The European Medicines Agency is investigating Novo Nordisk’s diabetes drug Ozempic and weight-loss treatment Saxenda after Iceland’s health regulator flagged three cases of patients thinking about suicide or self-harm. Shares of the Danish drugmaker fell 1% on Monday following the news. An…#novonordisks #saxenda #iceland #danish #ema #ozempic #novo #novonordisk #fda #sanofi (Source: Reuters: Health)
Source: Reuters: Health - July 10, 2023 Category: Consumer Health News Source Type: news
Four-year follow up data for Roche ’s Evrysdi show continued increase in number of children with a severe form of spinal muscular atrophy (SMA) able to sit, stand and walk
Data from ongoing FIREFISH study confirm long-term efficacy and safety profile ofEvrysdi in children with Type 1 SMANinety-one percent of children were alive at month 48More than 95% maintained the ability to swallow- without treatment they would have required feeding support and majority would have died within 2 yearsEvrysdi is now approved in 99 countries with more than 8,500 patients treated globallyBasel, 30 June 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new long-term data for Evrysdi ® (risdiplam) from the open-label extension (n=50) of the pivotal FIREFISH study, reinforcing its sustained efficacy an...
Source: Roche Investor Update - June 30, 2023 Category: Pharmaceuticals Source Type: news
Four-year follow up data for Roche ’s Evrysdi show continued increase in number of children with a severe form of spinal muscular atrophy (SMA) able to sit, stand and walk
Data from ongoing FIREFISH study confirm long-term efficacy and safety profile ofEvrysdi in children with Type 1 SMANinety-one percent of children were alive at month 48More than 95% maintained the ability to swallow- without treatment they would have required feeding support and majority would have died within 2 yearsEvrysdi is now approved in 99 countries with more than 8,500 patients treated globallyBasel, 30 June 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new long-term data for Evrysdi ® (risdiplam) from the open-label extension (n=50) of the pivotal FIREFISH study, reinforcing its sustained efficacy an...
Source: Roche Media News - June 30, 2023 Category: Pharmaceuticals Source Type: news
FDA accepts Pfizer & #039;s application for hemophilia B gene therapy fidanacogene elaparvovec
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B. In parallel, the European marketing authorization application (MAA) for fidanacogene elaparvovec has also been accepted and is under review by the European Medicines Agency (EMA). (Source: World Pharma News)
Source: World Pharma News - June 27, 2023 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news
The COVID-19 Vaccine Is Likely Getting an Update
In a unanimous vote, the 21 members of the U.S. Food and Drug Administration (FDA)’s vaccine committee recommended an update to the COVID-19 vaccine to better match the viral strains currently circulating in the country and around the world.
The panel voted to move away from the current bivalent vaccine, which is designed to tackle the original virus and BA.4 and BA.5 variants, to a vaccine that is better able to protect against the XBB family of variants. The half a dozen different versions of XBB viruses account for nearly all new infections in the U.S., with two—XBB.1.5 and XBB.1.16—currently dominatin...
Source: TIME: Health - June 15, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news
The COVID-19 Vaccine Is Getting an Update. Here ’ s What to Know
In a unanimous vote, the 21 members of the U.S. Food and Drug Administration (FDA)’s vaccine committee recommended an update to the COVID-19 vaccine to better match the viral strains currently circulating in the country and around the world.
The panel voted to move away from the current bivalent vaccine, which is designed to tackle the original virus and BA.4 and BA.5 variants, to a vaccine that is better able to protect against the XBB family of variants. The half a dozen different versions of XBB viruses account for nearly all new infections in the U.S., with two—XBB.1.5 and XBB.1.16—currently dominatin...
Source: TIME: Health - June 15, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news
TREMFYA ® (guselkumab) Provides Sustained Improvements Across All Minimal Disease Activity Domains for Adults Living with Active Psoriatic Arthritis in Phase 3b Trial
SPRING HOUSE, PENNSYLVANIA, May 31, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 3b COSMOS clinical trial showing that treatment with TREMFYA® (guselkumab) provided sustainable improvements in all minimal disease activity (MDA)a domains through week 48 in adults living with active psoriatic arthritis (PsA) who previously had an inadequate response to one to two tumor necrosis factor inhibitors (TNFi-IR).[1] In a separate post-hoc analysis of the Phase 3 DISCOVER-1 and DISCOVER-2b clinical trial findings, TREMFYA was shown to be associated with prompt and su...
Source: Johnson and Johnson - May 31, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
FDA accepts application for Roche ’s Vabysmo for the treatment of retinal vein occlusion (RVO)
Acceptance based on two phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting primary endpoint of non-inferiority compared to afliberceptApplication was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluidIf approved, RVO would be the third indication for Vabysmo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME)Vabysmo is currently approved in 60 countries to treat nAMD and DME, with nearly one million doses distributed globallyBasel, 9 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY...
Source: Roche Investor Update - May 9, 2023 Category: Pharmaceuticals Source Type: news
FDA accepts application for Roche ’s Vabysmo for the treatment of retinal vein occlusion (RVO)
Acceptance based on two phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting primary endpoint of non-inferiority compared to afliberceptApplication was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluidIf approved, RVO would be the third indication for Vabysmo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME)Vabysmo is currently approved in 60 countries to treat nAMD and DME, with nearly one million doses distributed globallyBasel, 9 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY...
Source: Roche Media News - May 9, 2023 Category: Pharmaceuticals Source Type: news
European CHMP recommends approval of use of Spikevax (previously COVID-19 Vaccine Moderna) in younger patients, European Medicines Agency
The CHMP has adopted an extension to the existing indication to include use of Spikevax bivalent Original/Omicron BA.4-5 as a booster in children aged 6 to 11 years [currently licensed only for use in individuals aged 12 years and older]. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - May 2, 2023 Category: Consumer Health News Source Type: news
GSK's RSV Vaccine First to Get EU Regulator's Nod GSK's RSV Vaccine First to Get EU Regulator's Nod
The European Medicines Agency (EMA) on Wednesday recommended authorization of GSK ' s Arexvy vaccine for respiratory syncytial virus in adults aged 60 and older.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 27, 2023 Category: Consumer Health News Tags: Infectious Diseases News Source Type: news
CHMP recommends EU approval of Roche ’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
Once approved,Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphomaThe recommendation is based on results from the phase I/II NP30179 study, whereColumvi given as a fixed course induced early and long-lasting complete responses in people with heavily pre-treated or refractory diffuse large B-cell lymphoma1Columvi is part of Roche ’s industry-leading CD20xCD3 T-cell-engaging bispecific developmentprogramme, which aims to transform the treatment experience for people with blood cancers using off-the-shelf and fixed-duration optionsBasel, 26 ...
Source: Roche Investor Update - April 26, 2023 Category: Pharmaceuticals Source Type: news
CHMP recommends EU approval of Roche ’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
Once approved,Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphomaThe recommendation is based on results from the phase I/II NP30179 study, whereColumvi given as a fixed course induced early and long-lasting complete responses in people with heavily pre-treated or refractory diffuse large B-cell lymphoma1Columvi is part of Roche ’s industry-leading CD20xCD3 T-cell-engaging bispecific developmentprogramme, which aims to transform the treatment experience for people with blood cancers using off-the-shelf and fixed-duration optionsBasel, 26 ...
Source: Roche Media News - April 26, 2023 Category: Pharmaceuticals Source Type: news
New Vabysmo data suggest greater retinal drying versus aflibercept in nAMD and DME
Post-hoc analyses from four phase III studies indicate Vabysmo dried retinal fluid faster with fewer injections in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME)More Vabysmo patients with nAMD had absence of retinal fluid at 12 weeks in a post-hoc analysis from the phase III TENAYA and LUCERNE studiesDME patients treated with Vabysmo had less blood vessel leakage in the macula at 16 weeks in a post-hoc analysis from the phase III YOSEMITE and RHINE studiesBasel, 25 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that post-hoc data indicate treatment with Va...
Source: Roche Investor Update - April 25, 2023 Category: Pharmaceuticals Source Type: news
