Search Results for “Sanofi” – Page 18 – media

FDA, citing safety concerns, places partial hold on Merck KGaA’s MS drug

Dive Brief: The Food and Drug Administration told Merck KGaA not to give an experimental drug for multiple sclerosis to new patients and to pause treatment for study participants who have been on it for less than 70 days amid concerns about possible liver damage. Regulators acted after laboratory tests suggested the livers of two patients might have been adversely affected by the drug, known as evobrutinib. However, neither patient exhibited symptoms and their liver enzyme levels returned to normal after they stopped taking the medicine, Merck KGaA said Wednesday. The German drugmaker had already fully enrolled a Phase 3 study known as Evolution, and that program will continue as planned because all the patients have already had received the medication for at least 70 days. Results are still expected in the fourth quarter. Dive Insight: Evobrutinib is part of a class of drugs known as BTK ...
- Source: drugdu
- 198
- April 13, 2023
Brazil’s ANVISA approves Takeda’s dengue vaccine Qdenga

Qdenga’s approval is supported by the data obtained from 19 clinical trials, and follows similar decisions in other countries. The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda’s tetravalent dengue virus vaccine, Qdenga. The vaccine, previously known as TAK-003, has received approval for preventing dengue disease in people aged four years to 60 years. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these. Qdenga is purported to be the only dengue vaccine approved in Brazil for use in people without the need for pre-vaccination testing and regardless of previous exposure. ANVISA’s approval follows similar decisions by the European Commission in December, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) last month. The company continues to advance regulatory filings in other dengue-endemic countries in Asia and Latin America. In ...
- Source: drugdu
- 139
- March 17, 2023
China’s Import and Export Market Report of Diabetes Drugs

Diabetes is one of the most common chronic diseases and is mainly classified into type 1 diabetes, type 2 diabetes, gestational diabetes and others. Worldwide, 90% of diabetic patients suffer from type 2 diabetes, which greatly promotes the development of the diabetes drug market.
- Source: Ddu
- 49,911
- August 25, 2021
Ddu College Diabetes Drugs
Positive topline results for nirsevimab in RSV

Sanofi and AstraZeneca’s (AZ) monoclonal antibody (mAb) nirsevimab reached its primary endpoint in a Phase III trial, demonstrating protection against respiratory syncytial virus disease (RSV) in healthy infants. Nirsevimab, an investigational extended half-life mAb is designed to protect infants entering their first RSV season, when they are at a higher risk for developing severe RSV disease. In the Phase III MELODY trial, nirsevimab reduced lower respiratory tract infections (LRTI) requiring medical attention due to RSV in healthy preterm and term infants. There were no clinically meaningful differences observed in the safety results between the nirsevimab and placebo groups, with the overall safety profile for nirsevimab in the trial remaining consistent with previously reported results. “Respiratory syncytial virus is the leading cause of hospitalisations in all infants,” said Jean-François Toussaint, global head of research and development, Sanofi Pasteur. “In fact, most hospitalisations occur in otherwise healthy infants born at term. It’s ...
- Source: drugdu
- 111
- April 26, 2021
nirsevimab
Four medicines accepted for use by NHS Scotland

The Scottish Medicines Consortium (SMC) has approved NHS funding for four new medicines, including treatments for multiple myeloma and severe migraine in its April 2020 decisions. Firstly, Sanofi’s Sarclisa (isatuximab) has been accepted by the SMC for the treatment of relapsed or refractory multiple myeloma, in combination with two other medicines – pomalidomide and dexamethasone. This treatment was accepted following consideration through the SMC’s Patient and Clinician Engagement (PACE) process, which is used for medicines for end of life and rare conditions. Another medication developed by Sanofi – Dupixent (dupilumab) – was also accepted for use on NHS Scotland, for the treatment of a subgroup of patients with severe asthma. Dupixent will be offered as an option for patients with severe asthma who do not fully respond to standard treatment and require more intensive therapies, such as oral corticosteroids, to control their symptoms. “This is a very positive day for ...
- Source: drugdu
- 220
- April 14, 2021
Scotland
PFIZER AND BIONTECH ANNOUNCE VACCINE CANDIDATE AGAINST COVID-19 ACHIEVED SUCCESS IN FIRST INTERIM ANALYSIS FROM PHASE 3 STUDY

Monday, November 09, 2020 – 06:45am Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis Analysis evaluated 94 confirmed cases of COVID-19 in trial participants Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201109005539/en/ NEW YORK & MAINZ, GERMANY–(BUSINESS WIRE)– Pfizer Inc. (NYSE: ...
- Source: drugdu
- 1,236
- November 10, 2020
Covid-19 Pfizer
Testing Set to Begin on a Coronavirus Vaccine

In different parts of the world, scientists are racing to develop a vaccine for coronavirus (COVID-19). A lot is at stake as governments worldwide are in a frenzy to prevent the spread of the virus in key hotspots.
- Source: drugdu
- 495
- May 27, 2020
CORONAVIRUS Covid-19 MASKS vaccines
GlaxoSmithKline, Seqirus roll out First flu Vaccines for Coming Season

Flu vaccine producing pharma giants plan to supply millions of additional doses produced using futuristic manufacturing processes instead of conventional egg-based procedures, as they ship their first doses of flu-vaccine for the impending season.
- Source: FiercePharma
- 721
- August 17, 2018
Company Insight flu shot vaccines
Xolair Gets FDA Approval for Food Allergy Treatment

Xolair of Novartis and Roche has been declared as a breakthrough therapy for food allergies including eggs, milk and peanuts by the Food and Drugs Administration (FDA).
- Source: FiercePharma
- 977
- August 15, 2018
FDA food allergies New Approvals
HitGen and Merck Collaborates For DNA Library Screening

HitGen and Merck have updated their licensing agreement to a full-fledged drug discovery collaboration in order to screen DNA-encoded libraries for new small-molecule assets.
- Source: FierceBiotech
- 987
- August 8, 2018
biotech China Company Insight Merck

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