PharmaFocus Today – Page 6 – media

FDA Warns of Heart Risk With Pfizer, Moderna COVID Vaccines

THURSDAY, May 22, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) has ordered Pfizer and Moderna to expand their warning labels on COVID-19 vaccines. The updated warnings highlight a rare risk of heart inflammation in teen boys and young men, CBS News reported. The warning applies to males ages 16 to 25 and is based on new data from FDA safety monitoring and a 2023 study. This includes both Pfizer’s Comirnaty and Moderna’s Spikevax vaccines. The updated label will note that “the highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age.” Myocarditis is inflammation of the heart muscle, while pericarditis is inflammation of the lining around the heart. For every million doses in 16- to 25-year-old males, there were 38 cases of these heart conditions, the warning adds. For all people under 65, the rate was about 8 cases per ...
- Source: drugdu
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- May 26, 2025
It is expected that blockbuster vaccine varieties will resume sales growth trend in 2025 under a low base

Xinhua Finance Beijing May 22nd CITIC Construction InvestmentThe research report pointed out that the overall number of vaccine batches issued in the first quarter of 2025 was 697, a year-on-year decrease of 14% .Vaccines, diphtheria, pertussis and hepatitis vaccines increased significantly year-on-year, while polio vaccines, herpes zoster vaccines, rotavirus vaccines and HPV vaccines decreased significantly year-on-year. In terms of research and development, tumor therapeutic vaccines have become a hot area for the expansion of vaccine indications, and domestic research and development is in its infancy; while there are many domestic companies with traditional blockbuster vaccine pipelines, and the competition landscape is becoming fierce. It is expected that in 2025, blockbuster vaccine varieties will resume sales growth on a low base, driving corporate performance improvements. The continuous advancement of innovative vaccine pipelines will bring companies greater market space and potential overseas opportunities in the future. https://finance.eastmoney.com/a/202505223411350774.html
- Source: drugdu
- 60
- May 26, 2025
Moderna withdraws its application for the launch of the new crown/influenza combined vaccine, and its share price fell more than 6% during the session

On Wednesday, Eastern Time, American vaccine manufacturer Moderna announced that it had withdrawn its vaccine for COVID-19 and influenza.The company is considering filing a marketing authorization application for its combined vaccine, pending more efficacy data for its vaccine. Affected by the news, its stock price fell more than 6% during the session. Moderna said it will resubmit its application later this year with effectiveness data from its standalone flu vaccine in a large-scale trial, which is expected to be released this summer. Earlier this month, Moderna claimed, largely as expected, that it did not expect regulators to approve the vaccine until 2026 because more data on its flu vaccine was needed. It is worth noting that the day before Moderna made this decision, the United States tightened the approval requirements for the new crown vaccine. The U.S. Food and Drug Administration (FDA) said that the approval of new crown vaccines ...
- Source: drugdu
- 51
- May 26, 2025
Subsidiary obtains medical device registration certificate

Zhonghong Medical announced on the evening of May 22 that Shenzhen Medrena Biotechnology Co., Ltd., a subsidiary of Zhonghong Pulin Medical Supplies Co., Ltd., recently obtained the ” Medical Devices of the People’s Republic of China” issued by the Guangdong Provincial Food and Drug Administration.The registration certificate for enteral nutrition pump and injection pump medical devices submitted by Medrina has been approved. From January to December 2024, the operating income structure of Zhonghong Medical is as follows: the medical device industry accounted for 100.0%. https://finance.eastmoney.com/a/202505223412056092.html
- Source: drugdu
- 47
- May 26, 2025
Removal bag products are certified by Health Canada to expand overseas market potential

China Securities Intelligence Finance Weili Medical(603309) announced on the evening of May 22 that the company recently received a Class 2 medical device certificate issued by the Canadian Ministry of HealthProduct registration certificate, the company’s product extraction bag (Extraction Bag) has been certified by the Canadian Ministry of Health. 　　This product has two registration certificates because of the differences in design structure and working principle of different models. Product name: Extraction Bag. The certificate numbers are 113343 and 113348 respectively; the models/specifications are Type A (200ml, 400ml, 800ml), Type B (300ml, 550ml, 800ml), and Type C (300ml, 550ml, 800ml). The certification date is May 20, 2025. 　　The announcement stated that the certification obtained from the Canadian Ministry of Health indicates that it can be legally sold in the Canadian market, which will play a positive role in promoting and selling the product in overseas markets. 　　According ...
- Source: drugdu
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- May 26, 2025
Bodybuilding Linked To Sudden Cardiac Deaths

By Dennis Thompson HealthDay ReporterWEDNESDAY, May 21, 2025 (HealthDay News) — Bodybuilders spend countless hours in the gym to create a heart-stopping physique. But their efforts place their own hearts at risk of stopping, a new study says. Sudden cardiac death is responsible for an unusually high proportion of deaths in male bodybuilders, researchers reported today in the European Heart Journal. Further, professional bodybuilders are five times more likely to fall dead from cardiac arrest than amateurs, results show. “The risk of death among male bodybuilders is considerably high,” lead researcher Dr. Marco Vecchiato, a sports medicine specialist at the University of Padova in Italy, said in a news release. “Professional athletes had a markedly higher incidence of sudden cardiac death, suggesting that the level of competition might contribute to this increased risk.” The research was prompted by “a growing number of reports of premature deaths among people involved in ...
- Source: drugdu
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- May 23, 2025
Deaths Waiting For Lung Donation Have Dropped Under New Guidelines

By Dennis Thompson HealthDay ReporterWEDNESDAY, May 21, 2025 (HealthDay News) — New guidelines for allocating donated lungs are saving more lives, a new study says. By prioritizing medical urgency, the guidelines caused a dramatic decline in the number of people who die waiting for a lung transplant, researchers reported Sunday at the American Thoracic Society’s international conference in San Francisco. Patients are now three times less likely to die on the waitlist than before 2017, when a lawsuit kicked off a rethinking of the way donated lungs were allocated, researchers say. The sickest patients on the waitlist saw the greatest benefit, researchers added. “We always want to make sure that any time we make a change to the allocation system that we’re improving outcomes, especially for our sickest patients,” lead researcher Dr. Mary Raddawi, a second-year pulmonary and critical care fellow at Columbia University Irving Medical Center, said in ...
- Source: drugdu
- 61
- May 23, 2025
InnoCare Pharma’s application for marketing approval of Tancitumomab for injection

On May 21, InnoCare Pharma (688428/09969) announced that the company received a notice from the National Medical Products Administration that the application for the marketing approval of tafasitamab combined with lenalidomide for the treatment of relapsed/refractory diffuse large B-cell lymphoma was approved. This is the first CD19 monoclonal antibody approved in China to treat this disease, marking an important progress for the company in the field of hematological tumors. The announcement mentioned that Tancitumomab is a monoclonal antibody targeting CD19 and is suitable for adult patients who are not suitable for autologous stem cell transplantation. In addition, Tancitumomab combined with lenalidomide has also been approved for the treatment of eligible patients in Hong Kong, Macau and Taiwan, China, showing its potential for application in multiple regions. In the first quarter of 2025, InnoCare Pharma achieved revenue of 381 million yuan and net profit attributable to shareholders of the parent company ...
- Source: drugdu
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- May 23, 2025
MicuRx Pharmaceuticals’ new drug application for contezolizumab sodium injection has been accepted

On May 21, Mengke Pharmaceuticals (688373) announced that the company’s new drug marketing authorization application for contezolidinone sodium for injection was accepted by the National Medical Products Administration. The drug is a Class 1 antibacterial drug of the oxazolidinone class independently developed by the company. The previous contezolidinone tablets were approved in 2021 for the treatment of complicated skin and soft tissue infections. The sodium contezolizumab for injection applied for this time is a water-soluble prodrug of contezolizumab. Based on the background that the prodrug has been approved, the company has carried out relevant Phase III clinical trials and successfully achieved the primary efficacy endpoint. Although the new drug marketing authorization application has been accepted, the announcement mentioned that the application still needs to go through review, clinical trial site inspection and approval, and the time and results are uncertain, so it will not have a significant impact on the ...
- Source: drugdu
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- May 23, 2025
Pfizer acquires bispecific antibodies from 3SBio for $6.05 billion

On May 20, 3SBio announced that it had signed an exclusive licensing agreement with Pfizer, granting Pfizer the exclusive rights to develop, produce, and commercialize its independently developed breakthrough PD-1/VEGF bispecific antibody SSGJ-707 worldwide (excluding mainland China). At the same time, it retained the relevant rights of the product in mainland China and granted Pfizer the option to commercialize the product in mainland China. The total amount of this cooperation is as high as US$6.05 billion, including an upfront payment of US$1.25 billion and development, regulatory approval and sales milestone payments of up to US$4.8 billion. In addition, Pfizer will subscribe to 3SBio’s common stock worth US$100 million. SSGJ-707 is a bispecific antibody targeting PD-1/VEGF independently developed by 3SBio based on its proprietary #CLF2 platform. In the Phase II clinical phase analysis, it demonstrated excellent objective response rate (ORR) and disease control rate (DCR) in the treatment of patients with ...
- Source: drugdu
- 60
- May 23, 2025

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