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【EXPERT Q&A】What is a pharmaceutical intermediate?

Drugdu.com expert’s response: A pharmaceutical intermediate is a substance that is produced during the synthesis of an active pharmaceutical ingredient (API) and is used in the further production of the API. These intermediates are crucial compounds in the drug manufacturing process, acting as pivotal building blocks that are transformed through various chemical reactions to form the final active ingredient. Pharmaceutical intermediates can vary widely in their complexity and are often produced in controlled conditions to ensure purity and quality. These intermediates are integral to the pharmaceutical industry, allowing for the efficient and cost-effective production of APIs. They play a significant role in the development of new drugs and formulations, providing flexibility and innovation in drug synthesis and design. The quality and control of pharmaceutical intermediates are vital, as they directly affect the efficacy, safety, and stability of the final pharmaceutical products. Manufacturers of pharmaceutical intermediates must adhere to strict regulatory ...
- Source: drugdu
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- December 15, 2023
intermediate
Bristol Myers Squibb to Pay Up to $8.4 Billion to Codevelop Antibody-Drug Conjugate With SystImmune

Pharmaceutical Executive Editorial Staff Bristol Myers Squibb will pay $800 million upfront to SystImmune for the rights to codevelop and sell a potentially first-in-class bispecific antibody-drug conjugate that has shown promise treating non-small cell lung cancer and breast cancer. Bristol Myers Squibb (BMS) has reached an agreement with SystImmune for the rights to codevelop and sell a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC) in a deal that could exceed $8 billion. As part of the agreement, BMS will pay $800 million upfront to SystImmune and up to $500 million in contingent near-term payments.1 Should certain developmental, regulatory, and sales performance milestones be achieved, SystImmune would be eligible for additional payments that would bring the total for the agreement to approximately $8.4 billion.1 “Our collaboration with SystImmune allows us to strengthen our leadership in oncology and is consistent with our strategy to diversify beyond immuno-oncology to transform patient care,” said ...
- Source: drugdu
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- December 14, 2023
AstraZeneca’s Icosavax M&A Deal Helps It Stand Out in Multivalent Vaccines Chase

AstraZeneca is acquiring Icosavax, which has technology well-suited for multivalent vaccines. Icosavax’s pipeline includes a Phase 3-ready program that protects against two pathogens that cause severe respiratory infections in older adults. By FRANK VINLUAN AstraZeneca is already in the respiratory syncytial virus market with two products, including the drug Beyfortus, approved earlier this year. An M&A deal will give AstraZeneca an RSV vaccine candidate based on technology that could help the company compete where new vaccines are going. AstraZeneca is acquiring clinical-stage Icosavax for $800 million up front, the pharmaceutical giant announced Tuesday. Under the deal terms, AstraZeneca will pay $15 for each Icosavax share, which is a nearly 43% premium to the stock’s closing price on Monday. AstraZeneca could pay an additional $5 per share depending on the progress of Icosavax’s vaccine candidates. That payout could bring the value of the deal to $1.1 billion. The vaccines of Seattle-based ...
- Source: drugdu
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- December 14, 2023
Automated Device for Non-Invasive Measurement of Cells’ Electrical Properties to Advance Cancer Diagnosis

Effective monitoring of cancer cells is crucial for physicians in guiding treatment and managing the disease, potentially reducing cancer-related mortality. Non-invasive diagnostic platforms that measure the electrical properties of cancer cells show promise for early detection of drug resistance and metastasis in cancer. Earlier studies have found that the type of cancer and its drug resistance status can be understood from cellular permittivity and conductivity data. As a result, there is a growing need for analytical methods that can quickly measure these electrical properties of cells. Electrorotation (ROT) is one method that can capture these cellular properties by analyzing permittivity and conductivity based on how a cell moves in an electric field. This method characterizes cell types and states by profiling their frequency-dependent rotational movement under a modulated electric field. However, traditional ROT methods have limitations, primarily the cumbersome process of capturing, measuring, and replacing cells, which reduces the throughput ...
- Source: drugdu
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- December 14, 2023
HPV DNA Test Using Lymphatic Fluid Collected After Surgery Could Predict Risk of Cancer Recurrence

Head and neck cancer, previously linked to heavy drinking and smoking, has seen a significant shift due to human papillomavirus (HPV). In fact, HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) has become the most prevalent HPV-related cancer, surpassing cervical cancer, with increasing cases globally. Despite treatments, up to 30% of head and neck cancer patients face recurrences, often due to elusive cancer cells that treatments miss. Recently, the focus has shifted to liquid biopsy for detecting cancer recurrences post-treatment. Liquid biopsies search for cancer indicators in body fluids like blood and urine. Now, a new study has found that liquid biopsy of lymphatic fluid, which is commonly thrown away post-surgery, could be key in tailoring treatments for HPV-driven head and neck cancer. The groundbreaking study by researchers at University of Pittsburgh (Pittsburgh, PA, USA) and Washington University School of Medicine in St. Louis (WUSTL, St. Louis, MO, USA) revealed that HPV ...
- Source: drugdu
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- December 14, 2023
CanSino Biologics completed the first subject enrollment in Phase I clinical trial of its component diphtheria-tetanus and pertussis combined vaccine for adolescents and adults

Recently, CanSino Biologics’ adsorbed acellular (component) diphtheria-tetanus combination vaccine (hereinafter referred to as “Tdcp for adolescents and adults”) officially launched Phase I clinical trials and completed the enrollment of the first subject. Tdcp for adolescents and adults is suitable for people aged 6 years and above. It is a booster vaccine for adolescents and adults. This randomized, blinded, controlled phase I clinical trial will initially evaluate the safety and immunogenicity of the vaccine. Whooping cough, diphtheria and tetanus, also known as diphtheria, are serious diseases caused by bacteria. Since the protective effect of immunity triggered by the main antigen of pertussis gradually decreases after vaccination, the incidence and mortality of pertussis gradually increase in the post-vaccination population. The domestic market is in urgent need of a DPT vaccine with longer-lasting immune protection and higher safety. Major developed countries have included this vaccine in their regular vaccination plans, but there is ...
- Source: drugdu
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- December 14, 2023
CanSinoBIO Kicks-off the Polio VLP Vaccine Cooperation

December 1, 2023 – CanSino Biologics Inc. (“CanSinoBIO” or “the Company”) kicked off its innovative Polio VLP Vaccine Cooperation that aims to eradicate polio worldwide today as representatives from The Bill & Melinda Gates Foundation (the foundation) visited the facility. Dr. Xuefeng Yu, Chairman and CEO, Dr. Shoubai Chao, Chief Operating Officer, Dr. Tao Zhu, Chief Scientific Officer, and Ms. Jing Wang, Chief Commercial Officer and representatives from CanSinoBIO gave warm welcome to the foundation delegation. Dr. Xuefeng Yu expressed his gratitude to the foundation for their support over the past years that enabled CanSinoBIO to play a vital role in the global polio eradication efforts. CanSinoBIO is committed to continuously focusing on this fight against the vaccine-preventable disease and make a greater impact on global public health. CanSinoBIO has been actively participating in the World Health Organization (the WHO) polio eradication strategy to eliminate the disease, and has been ...
- Source: drugdu
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- December 14, 2023
National Resilience lines up 440 new jobs at former AstraZeneca plant in Ohio

After multiple expansion forays overseas this year, biomanufacturing outfit National Resilience is returning to its American roots with plans to beef up production and add hundreds of new jobs at a recently purchased plant in Ohio. Resilience is expanding operations at the West Chester, Ohio, facility it bought from AstraZeneca in January, the technology-focused contract manufacturer said Monday. In turn, the company expects to create some 440 new jobs with an associated annual payroll of nearly $29 million over the next three years. The project represents a partnership between Resilience, JobsOhio and Cincinnati’s Regional Economic Development Initiative (REDI), the company noted. All told, the plan is set to nearly double Resilience’s current presence in West Chester, according to JobsOhio president and CEO J.P. Nauseef. In the company’s press release, Resilience’s CEO Rahul Singhvi pointed out that the West Chester site serves as the CDMO’s global center of excellence for commercial ...
- Source: drugdu
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- December 14, 2023
After leak of neurotoxin, Sanofi plant in France is under scrutiny again

A Sanofi manufacturing facility in France, which was temporarily closed five years ago for emitting dangerous emissions, is under the microscope again after a recent leak caused the release of the same neurotoxin, bromopropane. The plant, which produces epilepsy drug Depakine (sodium valproate), released 75 times the allowable amount of bromopropane in mid-November, according to a report in the French news outlet Le Monde. The facility, located in Mourenx, stopped production “immediately” after noting “inconsistent measurements” of bromopropane emissions, according to a Sanofi spokesperson. “We quickly identified that this isolated and very brief event was linked to the degradation of the treatment unit’s activated carbons following the bad weather and heavy rains that had affected the region in the preceding days,” Sanofi said. “The coals were replaced and bromopropane emissions returned to normal, enabling production to resume after approval from the authorities.” Bromopropane—which is used in the production of Depakine—is ...
- Source: drugdu
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- December 14, 2023
Genentech elevates interim CEO Ashley Magargee to full-time leadership position

Genentech’s brief leadership interregnum is coming to an end as the company’s interim chief executive, Ashley Magargee, prepares to take a permanent place on the throne. Magargee, who was tapped to temporarily steer the Roche subsidiary in November, will don the mantle of full-time CEO on Jan. 1, 2024, Genentech said Tuesday. Magargee, who most recently headed up Genentech’s commercial portfolio in addition to her interim CEO duties, is taking the place of Alexander Hardy. Hardy hit the exit back in November and now serves as CEO of BioMarin. Having served at Genentech since 2004, Magargee is no stranger to the South San Francisco-based drugmaker. In terms of her leadership pedigree, Magargee has operated in senior management positions at both Roche and Genentech across life cycle management, digital customer experience and market access, Genentech said in a release. Genentech and its Swiss parent Roche have been locked in a complicated ...
- Source: drugdu
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- December 14, 2023

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