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Phase I clinical drugs can bypass the FDA and go directly to market

Recently, the Montana legislature passed a bill that allows medical institutions to sell drugs that have only passed Phase I clinical trials without the need for U.S. FDA approval. The legislation was promoted by a group of people committed to extending human life span, including scientists, libertarians and opinion leaders. They hope that Montana can become a testing ground for medical innovation, providing more options for patients, especially those with terminal illnesses or those who are ineffective with existing treatments, so that they can have earlier access to some experimental drugs that may have potential therapeutic effects. What exactly does this bill include? First, doctors can apply for a license to open an experimental treatment clinic to recommend and sell non-FDA-approved therapies to patients. #No FDA approval required At the same time, these clinics must disclose all treatment effect and adverse event data to patients and regulators, and publish treatment ...
- Source: drugdu
- 38
- May 22, 2025
Gut bacteria help ease chemotherapy side effects and aid recovery

Intestinal microbes that survive chemo can rid the gut of excess chemo drugs and produce a vitamin that helps to stem nausea. Chemotherapy doesn’t just kill cancer cells. It also affects the microbes in the digestive tract. Researchers at UC San Francisco have discovered that some gut bacteria can reduce the side effects of these potent treatments, and that one family of cancer drugs may actually boost these protective bacteria. The phenomenon could help physicians to predict the severity of a patient’s side effects and points the way to supplements that could help those whose guts aren’t sufficiently protecting them. Clearing drugs from the body Turnbaugh’s team found that colorectal cancer patients taking a class of chemotherapy drugs known as fluoropyrimidines had much less diverse microbiomes in their digestive systems. But the surviving bacteria did something amazing. “They were able to gobble up the chemotherapy and chemically transform it ...
- Source: drugdu
- 40
- May 22, 2025
What to Know

|In a major policy shift, federal health officials anticipate the shots will be made available to adults 65 and older as well as children and younger adults who have one or more risk factors that make them more vulnerable to severe COVID-19. The Trump administration on Tuesday unveiled a new plan for updated COVID-19 shots that will likely significantly limit the number of Americans who have access to the vaccines in the fall. Federal health officials anticipate the shots will be available to adults 65 and older as well as children and younger adults who have one or more risk factors – like cancer, lung disease or obesity as measured by body mass index – that make them more vulnerable to severe COVID-19. For other Americans, the Food and Drug Administration will require an additional clinical trial before signing off on their shots. FDA Commissioner Marty Makary and FDA vaccine ...
- Source: drugdu
- 40
- May 22, 2025
Pfizer has been granted authorization for the dual drug of Sansheng Guojian; Huashen Technology Received Administrative Supervision Measures Decision from Sichuan Securities Regulatory Bureau | Medical Early Reference

NO.1 Sancheng Guojian Dual Anti Drug Authorization Pfizer SanSheng Guojian, an innovative pharmaceutical company on the Science and Technology Innovation Board, announced that the company and its affiliates SanSheng Pharmaceutical and Shenyang SanSheng Pharmaceutical Co., Ltd. have jointly granted Pfizer the exclusive development, production, and commercialization rights for the PD-1/VEGF bispecific antibody SSGJ-707 worldwide (excluding mainland China). It is reported that Pfizer will pay a non refundable and non deductible down payment of $1.25 billion, up to $4.8 billion in development, regulatory approval, and sales milestone payments, as well as a double-digit percentage gradient sales share calculated based on authorized regional product sales. Comment: The “$1.25 billion down payment” of this authorization transaction once again breaks the record for the down payment amount of domestic innovative drugs going abroad, and also marks the recognition of the R&D strength of innovative drug companies on the Science and Technology Innovation Board ...
- Source: drugdu
- 51
- May 22, 2025
Health News Daily | Chinese disease control experts respond to the changes in clinical severity of COVID-19 infection; Sansheng Guojian and Pfizer have reached an agreement on a bispecific antibody

Chinese disease control expert: the clinical severity of COVID-19 infection has not changed significantly At the press conference held by the National Health Commission on May 20, An Zhijie, a researcher from the China Center for Disease Control and Prevention, said that the recent COVID-19 epidemic in some countries and regions has shown a slight upward trend, but the clinical severity of the disease has not changed significantly. To prevent respiratory infectious diseases, it is important to maintain good personal hygiene habits in daily life, wash hands frequently, and ensure adequate ventilation; It is recommended that people with weaker immunity, such as young children, the elderly, and chronic disease patients, receive relevant vaccines to prevent respiratory infectious diseases. Medical device approval Changshan Medicine Nadroparin Calcium Injection Obtained Belarus Drug Registration Certificate On May 20th, Changshan Pharmaceutical announced that the company had recently received notice that its drug nadroparin calcium ...
- Source: drugdu
- 45
- May 22, 2025
Hospital Expo

Organiser: Indonesian Medical Industry Association Time：September 25 – September 28, 2025 address：Jl. Jend. Gatot Subroto, RT.1/RW.3, Gelora, Kecamatan Tanah Abang, Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta 10270, Indonesia Exhibition hall：Balai Sidang Jakarta Convention Center Product range: Medical Products: Medical equipment and instruments, medical consumables, ambulance equipment, surgical equipment, diagnostic equipment and supplies, analysis and control devices, monitoring equipment, surgical devices, preventive medicine equipment, ophthalmic instruments and equipment, ENT (Ear, Nose, and Throat) devices, dental supplies and equipment, radiological medical equipment, medical reagents and devices, prosthetics and rehabilitation equipment, medical healthcare products and devices, technical equipment for medical institutions and laboratories, medical information and technology exchange, hospital engineering telecommunications and data transmission equipment, medical sterilization equipment, waste disposal equipment, cold storage equipment, ambulances and supporting equipment, beauty instruments, medical textiles, medical construction technology, healthcare services, and medical publications, etc. Pharmaceutical Products: Various traditional Chinese medicines, Western medicines, new drugs,特效药 ...
- Source: drugdu
- 41
- May 22, 2025
Changshan Pharmaceutical’s Nadroparin Calcium Injection Obtains Belarus Drug Registration Certificate

On May 20, Changshan Pharmaceutical(300255) announced that the company’s drug Nadroparin Calcium Injection has obtained the drug registration certificate issued by the Belarusian drug administration department. Nadroparin calcium injection is an injection with specifications of 0.4ml and 0.6ml. This drug is mainly used to treat moderate or high-risk venous thrombosis, prevent venous thromboembolic diseases, treat established deep vein thrombosis, and be used in combination with aspirin to treat unstable angina and acute stage of non-Q wave myocardial infarction; and prevent blood clot formation in extracorporeal circulation during hemodialysis. In the first quarter of 2025, Changshan Pharmaceutical achieved revenue of 259 million yuan and net profit attributable to shareholders of the parent company of 3.78 million yuan. https://finance.eastmoney.com/a/202505203409519560.html
- Source: drugdu
- 41
- May 21, 2025
Beihai Kangcheng’s Velaglucerase β for Injection is Approved for Marketing in China

Beihai Kangcheng announced that its independently developed injectable velaglucerase beta (Gorinin, CAN103) has been approved for marketing by the China National Medical Products Administration on May 15, 2025 for the treatment of type I and type III Gaucher disease. Gaucher disease is an autosomal recessive genetic disease caused by a deficiency of glucocerebrosidase, which leads to the accumulation of glucocerebroside in the body and causes a variety of symptoms. Gorenin is the first independently developed long-term enzyme replacement therapy in China suitable for adolescents aged 12 years and above and adults with type I and type III Gaucher disease. https://finance.eastmoney.com/a/202505203409423342.html
- Source: drugdu
- 69
- May 21, 2025
FDA filing is about to start, and one medical device has completed its first human clinical trial

Recently, Duke Herrell, CEO of Virtuoso Surgical, announced that the robotic endoscope system developed by the company has successfully completed the first batch of human clinical trials. This milestone event marks an important technological innovation in the field of minimally invasive surgery. It is reported that from May 12 to 13, the VIABLE clinical trial was performed by Professor Yuanjin Zhang of the Chinese University of Hong Kong, who successfully performed en bloc resection of bladder lesions on 6 patients, treating a total of 11 lesions. Professor Yuanjin Zhang is not only a top surgical expert in the field of bladder cancer, but also the pioneer of the “en-bloc” technique, which can significantly improve the completeness and accuracy of tumor resection. According to Virtuoso, the system is equipped with two needle-shaped robotic arms that pass through a sheath with a diameter of less than 1 cm and perform surgical operations ...
- Source: drugdu
- 41
- May 21, 2025
Phase I clinical drugs can bypass the FDA and go directly to market

Recently, the Montana legislature passed a bill that allows medical institutions to sell drugs that have only passed Phase I clinical trials without the need for U.S. FDA approval. The legislation was promoted by a group of people committed to extending human life span, including scientists, libertarians and opinion leaders. They hope that Montana can become a testing ground for medical innovation, providing more options for patients, especially those with terminal illnesses or those who are ineffective with existing treatments, so that they can have earlier access to some experimental drugs that may have potential therapeutic effects. What exactly does this bill include? First, doctors can apply for a license to open an experimental treatment clinic to recommend and sell non-FDA-approved therapies to patients. #No FDA approval required At the same time, these clinics must disclose all treatment effect and adverse event data to patients and regulators, and publish treatment ...
- Source: drugdu
- 40
- May 21, 2025

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