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New data for Roche ’s Evrysdi (risdiplam) demonstrate long-term efficacy and safety in a broad population of people with spinal muscular atrophy (SMA)
Long-term efficacy data from the pivotal SUNFISH study confirm increases in motor function are sustained at three years while adverse events decreased over the same periodPart 2 of SUNFISH showedEvrysdi demonstrated a marked improvement in, orstabilisation of, motor function after two years compared to an untreated external control groupLatest interim results from the RAINBOWFISH study demonstrate that the majority of babies treated withEvrysdi for at least 12 months were able to stand and walk within timeframes typical of healthy babiesMore than 5,000 patients have been treated withEvrysdi to date, from newborns to people...
Source: Roche Media News - March 16, 2022 Category: Pharmaceuticals Source Type: news

Janssen Seeks Approval of a New Indication for IMBRUVICA ® (ibrutinib) for Use in Patients with Untreated Mantle Cell Lymphoma
BEERSE, BELGIUM, 8 March 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for IMBRUVICA® (ibrutinib) in combination with bendamustine and rituximab (BR) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation (ASCT).Ibrutinib is a once-daily Bruton's tyrosine kinase (BTK) inhibitor that is currently approved for patients with MCL who have received at least one prior lin...
Source: Johnson and Johnson - March 8, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Announces Landmark Agreement to Enable its COVID-19 Vaccine to be Manufactured and Made Available by an African Company for People Living in Africa
NEW BRUNSWICK, NJ (March 8, 2022) – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the completion of a landmark agreement between Janssen Pharmaceuticals, Inc., and manufacturer Aspen SA Operations (Pty) Ltd, based in South Africa, to enable the first COVID-19 vaccine to be manufactured and made available by an African company for people living in Africa, with the goal of increasing COVID-19 vaccination rates across the continent.Expanding global vaccination coverage is critically important to controlling the COVID-19 pandemic and reducing the risk of emergence of new SARS-CoV-2 variants. Currently, only...
Source: Johnson and Johnson - March 8, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news

Roche to present new Evrysdi data at MDA 2022 and highlight expanding neuromuscular disease portfolio
Evrysdi ® (risdiplam) data further confirm long-term efficacy and safety data in a broad range of people with spinal muscular atrophy (SMA)Latest interim results from the RAINBOWFISH study demonstrate that the majority of babies treated with Evrysdi for at least 12 months were able to sit, stand and walk within timeframes typical of healthy babiesNew gene therapy data in boys living with Duchenne muscular dystrophy (DMD) reports encouraging results from early stage study supporting its progress into global pivotal Phase III EMBARK studyBasel, 08 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data...
Source: Roche Media News - March 8, 2022 Category: Pharmaceuticals Source Type: news

Roche to present new Evrysdi data at MDA 2022 and highlight expanding neuromuscular disease portfolio
Evrysdi ® (risdiplam) data further confirm long-term efficacy and safety data in a broad range of people with spinal muscular atrophy (SMA)Latest interim results from the RAINBOWFISH study demonstrate that the majority of babies treated with Evrysdi for at least 12 months were able to sit, stand and walk within timeframes typical of healthy babiesNew gene therapy data in boys living with Duchenne muscular dystrophy (DMD) reports encouraging results from early stage study supporting its progress into global pivotal Phase III EMBARK studyBasel, 08 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data...
Source: Roche Investor Update - March 8, 2022 Category: Pharmaceuticals Source Type: news

EU clears Moderna shot for young kids, Pfizer boosters
The European Medicines Agency said it has authorized Moderna’s coronavirus vaccine for children aged six to 11, in addition to recommending booster shots of Pfizer’s vaccine for those aged 12 and over (Source: ABC News: Health)
Source: ABC News: Health - March 3, 2022 Category: Consumer Health News Tags: Health Source Type: news

U.S. FDA Approves CARVYKTI ™ (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
HORSHAM, Pa., February 28, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has approved CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.1 The approval is based on data from the pivotal CARTITUDE-1 study, which included patients who had received a median of six prior treatment regimens (range, 3-18), and had previously rec...
Source: Johnson and Johnson - March 1, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

SII seeks permission for phase-3 study of Covid vaccine Covovax as booster dose in adults
Covovax is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by WHO. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - February 27, 2022 Category: Pharmaceuticals Source Type: news

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce the Submission of a Marketing Authorization Application to the European Medicines Agency for PRX-102 for the Treatment of Fabry Disease
CARMIEL, Israel and BOSTON, Feb. 24, 2022 -- (Healthcare Sales & Marketing Network) -- Protalix BioTherapeutics, Inc. (NYSE: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeu... Biopharmaceuticals, Regulatory Protalix BioTherapeutics, Chiesi , Fabry disease, pegunigalsidase alfa (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 24, 2022 Category: Pharmaceuticals Source Type: news

Heart Experts Cast Doubt on Claims That Russian Skater ’s Drug Test Was Contaminated by Her Grandfather’s Medicine
The latest revelations about Russian figure skater Kamila Valieva’s doping case raise more questions about the substances found in her sample—and the reasons why the 15-year-old might have failed the drug test. TIME asked leading experts to help make sense of the claims, which have upended the women’s figure skating competition at the Beijing Olympics and cast a larger pall over the sport. At the hearing held on Sunday by the Court of Arbitration for Sport (CAS), anti-doping authorities revealed that Valieva tested positive for three heart treatment drugs, one of which is banned as a performance-enhancer ...
Source: TIME: Health - February 16, 2022 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized 2022 olympics overnight Second click Source Type: news

GE gets clearance for additional uses for stress contrast agent
GE Healthcare has secured clearance from the European Medicines Agency for additiona...Read more on AuntMinnie.comRelated Reading: Supply-chain shortages hit GE revenues in Q4 GE completes BK acquisition, expands ultrasound business GE targets radiology efficiency with new product launches Clinical evaluation begins on GE photon-counting CT scanner FDA clears GE Healthcare's x-ray AI for endotracheal tube placement (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 14, 2022 Category: Radiology Source Type: news

Is approving esketamine as an antidepressant for treatment resistant depression associated with recreational use and risk perception of ketamine? Results from a longitudinal and cross-sectional survey in nightlife attendees - Grabski M, Waldron J, Freeman TP, van Laar M, Curran HV.
BACKGROUND: Esketamine was licensed for use in treatment resistant depression by the European Medicines Agency in December 2019. It is unclear whether this new approval has lowered the risk perception of recreational ketamine use. This is important given a... (Source: SafetyLit)
Source: SafetyLit - February 14, 2022 Category: International Medicine & Public Health Tags: Alcohol and Other Drugs Source Type: news

EU medical watchdog probes link between Pfizer and Moderna's Covid vaccines and irregular periods
The European Medicines Agency's drug safety committee is investigating both cases of heavy bleeding and missed periods following vaccination. (Source: the Mail online | Health)
Source: the Mail online | Health - February 11, 2022 Category: Consumer Health News Source Type: news

Covid vaccine side effects: EU safety committee investigates menstrual disorders
A SAFETY review on the mRNA Covid vaccines is going ahead from Friday, February 11. The European Medicines Agency's safety committee wants to investigate all the reports of menstrual disorders. (Source: Daily Express - Health)
Source: Daily Express - Health - February 11, 2022 Category: Consumer Health News Source Type: news

New two-year data for Roche ’s Vabysmo and Susvimo reinforce potential to maintain vision with fewer treatments for people with two leading causes of vision loss
This study will evaluate the efficacy, safety, and pharmacokinetics of the port delivery system with ranibizumab in participants with diabetic macular edema compared with intravitreal ranibizumab (Pagoda) [Internet; cited January 2022]. Available from:https://clinicaltrials.gov/ct2/show/NCT04108156.[14] ClinicalTrials.gov. A multicenter, randomized study in participants with diabetic retinopathy without center-involved diabetic macular edema to evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered via the port delivery system relative to the comparator arm (PAVILION) [Internet; cited January 2022]. A...
Source: Roche Investor Update - February 11, 2022 Category: Pharmaceuticals Source Type: news