Search Results for “Sanofi” – Page 3 – media

Senate Democrats press Sanofi and AZ for answers as ‘unprecedented’ demand spurs shortage of RSV antibody Beyfortus

The shortage of Sanofi and AstraZeneca’s new respiratory syncytial virus (RSV) antibody Beyfortus continues to confound doctors and patients, with the Centers for Disease Control and Prevention (CDC) last week fast-tracking tens of thousands of extra doses into circulation to deal with a tough RSV season. Now, several Senate Democrats are pressing the drugmakers to get to the bottom of the issue. In a letter sent to the drugmakers Friday, Sen. Tammy Duckworth, D-Illinois, lamented that Sanofi and AZ “seem to have vastly underestimated” the amount of Beyfortus—also known nirsevimab—needed to protect young kids during this disease season. The partners’ immunization, approved back in July, has quickly run into supply problems, with the CDC last month issuing an advisory for doctors to prioritize available Beyfortus 100-mg doses for infants at the highest risk of severe RSV. At the time, Sanofi attributed the shortfall to “higher than anticipated demand,” which has ...
- Source: drugdu
- 199
- November 22, 2023
CDC rushes extra doses of Sanofi, AZ’s Beyfortus to ease supply shortfall

In response to a supply squeeze for Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody Beyfortus, the U.S. Centers for Disease Control and Prevention (CDC) is fast-tracking tens of thousands of extra doses into circulation. More than 77,000 additional doses will be distributed “immediately” to physicians and hospitals through the CDC’s Vaccines for Children program and commercial routes, the agency said in a Thursday statement. Alongside the FDA, the CDC plans to maintain “close contact” with manufacturers to secure availability of extra supply through the end of this year and early 2024, the CDC added. The supply strain began last month despite Sanofi’s “aggressive” plan that was designed to “outperform past pediatric vaccine launches,” the company said at the time. The company said it was working with AstraZeneca to “explore a number of actions” to extend the manufacturing network. AZ handles manufacturing under the duo’s Beyfortus partnership. Sanofi previously noted ...
- Source: drugdu
- 138
- November 21, 2023
Sanofi Issues Update on Shortages of Beyfortus for Respiratory Syncytial Virus

Pharmaceutical Executive Editorial Staff Due to a higher than anticipated demand, Sanofi is carefully managing distribution of 50 mg doses of Beyfortus in the private market to fulfill existing orders and provide equitable access to remaining doses for the vaccine that protects infants against respiratory syncytial virus. Sanofi has announced that a higher than expected demand for nirsevimab-alip (Beyfortus) 50 mg and 100 mg injection to protect infants against respiratory syncytial virus (RSV) has caused a change in the company’s distribution plan. Sanofi said it developed an aggressive supply plan to outperform prior launches of pediatric vaccines, but the demand exceeded the supply. Image credit: MargJohnsonVA | stock.adobe.com “We previously communicated that new orders for the 100 mg dose were no longer being accepted, as the demand exceeded the available supply for the season,” Sanofi said in a statement.1 “Currently, due to demand, we are carefully managing distribution of the ...
- Source: drugdu
- 96
- November 9, 2023
Bloomberg

Sanofi appears to be considering a buyout of cancer drugmaker Mirati Therapeutics, according to Bloomberg reporting on Thursday, citing sources familiar with the matter. Deliberations surrounding the potential acquisition are ongoing and there is no certainty that Sanofi will push through with the deal, Bloomberg noted. Still, the possibility of the buyout has energized the market and Mirati was trading 45% higher Thursday afternoon in reaction to the rumors. A Sanofi spokesperson declined to confirm or deny the acquisition in a statement to Reuters, saying that the company does not comment on market rumors. Mirati was likewise tight-lipped about the matter. This is not new territory for Mirati. In October 2021, Merck had expressed interest in acquiring Mirati, according to people briefed on the matter. In November 2022, Mirati was attracting “fresh takeover interest” from large pharma companies, also reported by Bloomberg. At the time, the California-based biotech was still ...
- Source: drugdu
- 213
- October 8, 2023
Sanofi, Teva Ink Deal to Develop Inflammatory Bowel Disease Treatment

Collaboration to focus on ulcerative colitis and Crohn’s disease. Image Credit: Adobe Stock Images/SciePro Sanofi and Teva Pharmaceuticals, a US subsidiary of Teva Pharmaceutical Industries Ltd., announced in a company press release plans to partner on development and commercialization of TEV’574, currently in Phase IIb clinical trials for the treatment of ulcerative colitis and Crohn’s disease, two types of inflammatory bowel disease. Under terms of the collaboration, Teva will receive an initial payment of $500 million with the potential to earn up to $1 billion in development and launch milestones. “This is a new era for Teva, and our robust, innovative pipeline is key to our Pivot to Growth strategy,” said Richard Francis, president, CEO, Teva, in the aforementioned release. “This collaboration further validates the great science that Teva has to offer with our internally developed anti-TL1A. We are honored to partner with Sanofi to bring their proven capabilities, leadership, ...
- Source: drugdu
- 122
- October 7, 2023
Sanofi Sells 11 CNS Assets to Pharmanovia including Frisium and Gardenal

By Tristan Manalac Pictured: Sanofi’s Germany office at night/iStock, Panama7 Sanofi on Monday offloaded 11 brands in its central nervous system portfolio to U.K-based company Pharmanovia, including epilepsy drugs Frisium and Gardenal. The companies did not disclose specific terms of the agreement, but revealed that the medicines span four therapeutic areas—all with ongoing unmet need: psycholeptics, anxiolytics, anti-epileptics and anti-psychotics. Though not all these drugs are approved in every market, they still have “clear synergy” with Pharmanovia’s existing portfolio and will fit well with the company’s “core sub-therapy focuses of mental health and epilepsy, where there continues to be significant unmet need,” CEO James Burt said in a statement. Among the divested drugs are several brands of the benzodiazepine clobazam, including Sentil, Urbanol, Noiafren, Castilium and Frisium. All of these are for the treatment of anxiety in certain patient subgroups; Frisium can also be used as an adjunctive treatment in ...
- Source: drugdu
- 187
- September 21, 2023
Sanofi and Ad Scientiam partner to assess MS disability progression

Sanofi and Ad Scientiam have partnered to launch an international, multicentre, longitudinal study to evaluate the ability of medical software, MSCopilot, to assess disability progression in people with multiple sclerosis (MS). The main objective of the MS-DETECT study, which explores digital biomarkers of MS, is to determine whether the MSCopilot software can effectively identify subtle and early signs of disability worsening. MS is a chronic immune-mediated, neurodegenerative disease of the central nervous system that currently affects 2.8 million people globally. The study will include 314 people with MS and will be conducted in the US, Canada, Germany, Italy, Spain, Denmark and France. Coordinating investigator and chairman of the study steering committee, professor Patrick Vermersch, believes that “these novel digital biomarkers are key to helping clinicians make appropriate treatment decisions and, ultimately, improve patients’ care.” As part of the agreement, the study will draw upon Ad Scientiam’s expertise in MS and ...
- Source: drugdu
- 204
- September 19, 2023
First Wave plans to repurpose Sanofi’s capeserod as GI therapy

First Wave BioPharma has acquired Sanofi’s capeserod with plans to repurpose it as a gastrointestinal (GI) disease therapy. Following the news, First Wave’s stock skyrocketed by over 80% in pre-market trading. The US-based company has a market cap of $3.112m. The agreement includes a $500,000 upfront payment, with developmental and commercial milestone payments of up to $46m and $235m, respectively. Additionally, Sanofi would have the right of first refusal on any capeserod sublicensing agreement and would be entitled to a percentage of any licensing payments. Sanofi also reserves the first refusal right to reacquire capeserod during development. Capeserod is a selective partial agonist of the serotonin type 4 (5-HT4) receptor. In the GI tract, these receptors perform various functions, including gastric emptying, decreasing oesophageal reflux, and promoting intestinal peristalsis. Sanofi had previously evaluated capeserod in Alzheimer’s disease and urinary incontinence but had since terminated the drug development. However, Fist Wave ...
- Source: drugdu
- 214
- September 18, 2023
Novartis Scores Phase III Chronic Hives Wins as Sanofi Challenges

By Kate Goodwin Pictured: Novartis Building/iStock, JHVE Photo With Xolair’s patents set to expire over the next year, Novartis has been looking to strengthen its grip on the chronic spontaneous urticaria market. Thursday, the Swiss pharma shared positive Phase III results for chronic hives with its BTK inhibitor and announced plans to submit for regulatory approval next year. In two late-stage studies, remibrutinib met the primary endpoint of change from baseline in a weekly urticaria activity score at week 12. While studies will continue for a full year, the BTK inhibitor demonstrated a rapid onset, improving patients’ symptoms in as little as two weeks. Patients with chronic spontaneous urticaria (CSU) deal with chronic hives that can last for six weeks or longer. The trigger is internal, as opposed to allergen exposure. While antihistamines are the first line of treatment, around 60% of patients’ symptoms are inadequately controlled with antihistamines alone. ...
- Source: drugdu
- 213
- August 11, 2023
Sanofi Expects Infant RSV Shot to Roll Out Before Respiratory Virus Season This Fall

Sanofi expects its infant RSV shot to roll out in the U.S. before respiratory virus season this fall, a company spokesperson said Friday. The Food and Drug Administration on Monday approved Beyfortus, a monoclonal antibody that is administered as a single dose to infants before or during their first respiratory syncytial virus season. The Sanofi spokesperson said the company does not expect any challenges with manufacturing or capacity to meet demand this RSV season. The French drugmaker jointly developed Beyfortus with AstraZeneca , which is based in England. A panel of independent advisors to the Centers for Disease Control and Prevention will meet on Aug. 3 to make recommendations about how the shot should be administered. Sanofi is working with the panel to place Beyfortus on the U.S. childhood immunization schedule, the company spokesperson said. The Affordable Care Act requires most private insurance to cover ...
- Source: drugdu
- 125
- July 25, 2023

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