Search Results for “vaccine” – Page 37 – media

Beyfortus® Approved in China for the Prevention of Respiratory Syncytial Virus Infections in Infants

On January 2, 2024, AstraZeneca and Sanofi announced that the long-acting monoclonal antibody Beyfortus® (Nirsevimab/nisevizumab) has been officially approved for marketing by the State Drug Administration of China (SDA) for the prevention of Lower Respiratory Tract Infections (LRTIs) caused by Respiratory Syncytial Virus (RSV) in newborns and infants. The drug is indicated for newborns and infants who are entering or born during the first season of RSV infection. Nisevizumab is expected to be available in China during the 2024-2025 RSV infection season. Nisevizumab is the first and only* approved prophylaxis in China to protect the broader infant population against RSV infection, covering healthy term infants, preterm infants, and infants vulnerable to serious RSV infection due to specific health conditions. Nisevizumab was approved in China based on the results of three pivotal clinical trials and the Chinese clinical development program. For all clinical trial endpoints, a single injection of nisevizumab demonstrated ...
- Source: drugdu
- 127
- January 4, 2024
After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer

In 2022, fueled by its powerhouse COVID products, Pfizer became the first company in the history of the biopharma industry to top $100 billion in annual revenue. What would the New York drugmaker do for an encore? In 2023, Pfizer went from generating the most sales in the industry to gaining the most approvals. With seven FDA nods in 2023, Pfizer had more than double that of any other company. It’s also more than twice as many as every drugmaker over each of the last three years. You need to go back to 2019, when Novartis scored six approvals, to find a company that approached what Pfizer accomplished in 2023. Pfizer’s splurge included four approvals in a dizzying five weeks in May and June. And all but one of the seven products has been pegged by analysts as a potential blockbuster. Two of the newly approved Pfizer treatments were acquired ...
- Source: drugdu
- 224
- January 4, 2024
Sanofi’s ‘SR604 Injection’ Approved in China, ‘Yipian Lida’ Supports Lipid Management with ‘Dual Standards’

Sanofi announced that its rosuvastatin and ezetimibe tablets (I) (Yipian Lida®) have been approved by the National Medical Products Administration (NMPA) of China for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) patients. As the first approved and marketed combination formulation of rosuvastatin and ezetimibe in China, Yipian Lida® marks the beginning of a new era in potent combination lipid-lowering therapy. A single dose achieves a greater than 50% reduction in low-density lipoprotein cholesterol (LDL-C), effectively and continuously lowering LDL-C to target levels, supporting ‘Dual Standards’ in lipid management, and providing a new and powerful option for patients with lipid abnormalities. Academician Ge Junbo from Zhongshan Hospital, affiliated with Fudan University, stated, “In the face of the increasingly serious burden of cardiovascular diseases, effective control and management of risk factors are crucial. Only by controlling LDL-C to ideal levels early can we reduce the incidence of adverse events and ...
- Source: drugdu
- 173
- January 1, 2024
AstraZeneca to buy China’s Gracell Biotechnologies in $1.2 billion deal

Dec 26 (Reuters) – AstraZeneca (AZN.L) said on Tuesday it will buy Gracell Biotechnologies (GRCL.O) for up to $1.2 billion as the Anglo-Swedish pharma company furthers its cell therapy ambitions and boosts its presence in China, the world’s second-largest pharmaceuticals market. The cash deal, which adds several experimental therapies to AstraZeneca’s portfolio, values Gracell at $2 per ordinary share, or $10 per American Depository Share, of Gracell, representing a premium of 61.6% from its last close on Dec. 22. The shareholders will also receive a non-tradable contingent value right of $0.30 per ordinary share, if certain regulatory milestones are met. Shares of China-headquartered Gracell surged 60% in premarket trading in the United States. Gracell’s CAR-T cell therapy works by extracting disease-fighting white blood cells known as T-cells from a patient, re-engineered to attack cancer and infused back into the body. H.C. Wainwright analyst Emily Bodnar said this could be AstraZeneca’s ...
- Source: drugdu
- 183
- December 28, 2023
Big Pharma reworks China strategy, and job cuts are part of it

Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country. In the last few months of 2023, Pfizer, GSK, Sanofi and Biogen have each tapped local partners to help commercialize their products in China. With marketing responsibilities shifting to other firms, job cuts were expected at each of those large drugmakers. It’s not a new approach for foreign drugmakers to tap local partners in China, Justin Wang, head of L.E.K. Consulting’s China practice, pointed out in an email interview with Fierce Pharma. But these deals are on the rise lately, Wang explained, partly because “there is increasing pricing and competitive pressure in the market, especially for mature products, leaving reduced [return on investment] for in-house commercial resources.” Pfizer in November unveiled a deal with Keyuan Pharma, ...
- Source: drugdu
- 196
- December 27, 2023
Previously unrecognized class of antibodies can broadly neutralize multiple virus strains

Researchers have identified a previously unrecognized class of antibodies-;immune system proteins that protect against disease-;that appear capable of neutralizing multiple forms of flu virus. These findings, which could contribute to development of more broadly protective flu vaccines, will publish December 21st by Holly Simmons of the University of Pittsburgh School of Medicine, US, and colleagues in the open access journal PLOS Biology. A flu vaccine prompts the immune system to make antibodies that can bind to a viral protein called hemagglutinin on the outside of an invading flu virus, blocking it from entering a person’s cells. Different antibodies bind to different parts of hemagglutinin in different ways, and hemagglutinin itself evolves over time, resulting in the emergence of new flu strains that can evade old antibodies. New flu vaccines are offered each year based on predictions of whatever the most dominant strains will be. Extensive research efforts are paving the ...
- Source: drugdu
- 215
- December 25, 2023
Glass specialist Schott Pharma touts 2023 sales growth, Serbia expansion and hiring plans

Following an IPO and ahead of its fiscal 2023 earnings release next month, German drug containment and delivery specialist Schott Pharma is trumpeting its recent momentum. Over the course of its 2023 fiscal year, Schott Pharma charted a 9% year-over-year revenue boost to €899 million (about $986 million), the company said Tuesday. For comparison, the company pulled down €821 million in fiscal year 2022. Schott credited the gains to the expansion of its production capabilities, especially as they pertain to drug delivery systems and new production lines for prefillable polymer syringes in Germany. Schott partners with a range of drugmakers in the biopharma industry. The company and its products are involved in several significant trends, such as the GLP-1 treatments from Novo Nordisk and Eli Lilly, plus mRNA vaccines from Moderna. Schott’s revenue win comes more than a year after the company set out on its own. Back in August ...
- Source: drugdu
- 133
- December 25, 2023
China updates guidelines for vaccination practices

BEIJING — China has released new vaccination guidelines to enhance standardized immunization management, according to the National Disease Control and Prevention Administration. The updated guidelines, a revision of the 2016 version, mandate standardized requirements for vaccination practices, including vaccine-use management, the monitoring and handling of suspected adverse reactions, as well as vaccination-rate surveillance. According to the guidelines, disease control agencies and vaccination centers should implement a routine vaccine inspection system. This involves monthly checks on factors such as vaccine quantity, source, packaging, storage temperature and expiration date, with records maintained. In China, vaccines are categorized into immunization plan vaccines, mandated by government regulations, and non-immunization plan vaccines, which residents voluntarily choose, excluding those specified in the official immunization plan. http://english.nmpa.gov.cn/2023-12/18/c_948768.htm
- Source: drugdu
- 156
- December 22, 2023
Amid BioNTech legal fight, CureVac takes a loss as German court invalidates patent

A German court has dealt the first blow against CureVac amid the company’s heated COVID-19 vaccine patent fight with fellow German mRNA specialist BioNTech. The German Federal Patent Court ruled that one of eight CureVac patents involved in the litigation is invalid, the company said in a Tuesday release. The patent in question covers a process that improves the expression of mRNA in cells, Juve Patent reports. The ruling came as a surprise to CureVac, which noted that the court in April issued a preliminary opinion in favor of the patent’s validity. Still, CureVac believes its “pioneering role in mRNA technology and continuing innovation in the field made essential contributions to safe and efficacious COVID-19 vaccines,” CEO Dr. Alexander Zehnder said in a statement. The company will “continue to defend our claim for recognition and fair compensation and will take appropriate action by appealing this decision,” Zehnder added. CureVac’s appeal ...
- Source: drugdu
- 93
- December 21, 2023
Signing ceremony between the Municipality of Bogotá, Colombia and SINOVAC for the official launch of the joint venture BogotáBio

On December 18th, local time in Colombia, a signing ceremony was held between the Municipality of Bogotá and SINOVAC. Claudia López Hernández, Mayor of Bogota, and Weidong Yin, Chairman, President and CEO of SINOVAC, signed the cooperation agreement on behalf of the two parties for the Bogota Vaccine Plant Project and announced the official launch of BogotáBio, a joint venture company jointly funded by the two parties. The Bogotá Vaccine Factory project will promote the localized production of a variety of vaccines in Colombia as well as the research and development of new vaccines and innovations, thereby enhancing the local capacity to respond to infectious diseases and prepare for the next pandemic. The signing ceremony was attended by Colombian Foreign Minister Álvaro Leyva Durán, Chinese Ambassador to Colombia Zhu Jingyang, Colombian Deputy Minister of Trade, Industry and Tourism Quintero, and nearly 60 guests from the Colombian central government, Bogota city ...
- Source: drugdu
- 146
- December 21, 2023

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