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FDA Issues Warning of Contaminated Copycat Eyedrops

Mike Hollan The agency issued the warning against three brands of unapproved eyedrops designed to look like an approved brand. Be careful what you put in your eye. FDA has issued a warning for consumers to be on the lookout for copycat eyedrops.1 Specifically, consumers should be wary of purchasing eye drops that are designed to look like Bausch + Lomb’s Lumify brand. While Lumify is approved for redness relief, the noted brands are not approved by FDA. The brands are as follows: South Moon, Rebright, and FivFivGo. The agency’s warning was posted with an image showing how the three brands packaging and branding is designed to look exactly like Lumify. While each brand is clearly marked with its own name, the box’s all use the same color scheme and each feature the same drawing of a women’s eye with a purple tint to it. The drug information is also ...
- Source: drugdu
- 125
- February 5, 2024
Neuro Biotech Alto Adds $128M in IPO Cash for Biomarker-Based Psych Drugs

Alto Neuroscience will apply the IPO proceeds toward clinical tests of its psychiatric drugs in patients who exhibit certain biomarkers. The company’s two most advanced programs are depression drugs in mid-stage development. By FRANK VINLUAN Matching a drug to a patient’s biology is not a new idea, but it hasn’t caught on in neuropsychiatric disorders, which have high failure rates in drug studies. The technology of Alto Neuroscience brings precision medicine to psychiatric drug research and its IPO has raised $128.6 million to see if this approach can yield better clinical trial results. Alto priced its IPO late Thursday, offering more than 8 million shares for $16 apiece. The Los Altos, California-based company was able to raise more than planned. When Alto set preliminary financial terms earlier this week, it projected offering 6.7 million shares in the range of $14 and $16 each, which would have raised $100.5 million at ...
- Source: drugdu
- 87
- February 5, 2024
CSPC Pharmaceutical Group’s SYS6002’s first human study unveiled at ASCO-GU

From January 25th to 27th local time, the 2024 American Society of Clinical Oncology Urogenital Oncology Branch (ASCO-GU) annual meeting was grandly held in San Francisco. ASCO GU is an academic event in the field of urogenital tumors. The conference will showcase the most innovative scientific progress in this field and discuss the future treatment directions of urogenital tumors. The first human study of SYS6002, a collaboration between CSPC and Fudan University Cancer Hospital’s Professor Ye Dingwei’s team and Professor Zhang Jian’s team – “Evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SYS6002 in patients with advanced solid tumors “An open, single-arm, multi-center phase I clinical trial” – phased research results were presented at the conference in the form of a poster (number B622). Research methods This study is a single-arm, open, multi-center phase I study. Aims to evaluate the safety, tolerability and PK characteristics of SYS6002 in ...
- Source: drugdu
- 137
- February 5, 2024
NHS launches BRCA testing programme for people of Jewish descent

Individuals with Jewish ancestry are six times more likely to carry a genetic fault.The NHS has announced the launch of a new BRCA gene testing programme to identify cancer risk early in individuals with Jewish ancestry. People with Jewish ancestry are about six times more likely to carry a genetic fault, which can increase the risk of developing some cancers, than the general population. Across the next two years, the national NHS Jewish BRCA Testing Programme plans to identify thousands more people carrying faults in the BRCA genes so they can seek early access to surveillance and prevention services. In alignment with the health services drive to catch tumours earlier, when they are easier to treat, anyone over the age of 18 years with Jewish ancestry will be eligible to receive a simple genetic saliva test to look for the presence of BRCA1 or BRCA2 faults. BRCA1 and BRCA2 are ...
- Source: drugdu
- 130
- February 5, 2024
Bristol Myers CEO outlines transition strategy featuring 11 key brands, more dealmaking

In his first earnings call as Bristol Myers Squibb’s CEO, Chris Boerner laid out his plan to quickly navigate the company through a period filled with patent cliffs and new government-mandated pricing pressure in the latter half of the decade. Bristol Myers will have a relatively stable business through 2025 as large legacy products, though declining, continue to generate sizable chunks of revenue. Still, the company’s focus will center on a growth portfolio that includes 11 key brands and about three dozen clinical candidates. Besides commercialization and R&D efforts, the company remains interested in dealmaking, Boerner said. “This, along with pipeline execution, can best position the company into the transition period,” the CEO told analysts Friday. Bristol Myers has “some clear strengths” compared with other companies that have successfully navigated similar periods of patent losses in the past, Boerner figures. The CEO touted the company’s “expanding growth portfolio across multiple ...
- Source: drugdu
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- February 5, 2024
Will the real standard of care please stand up?

One day after Roche said it was starting to establish Vabysmo as the new standard of care in age-related macular degeneration (AMD) and diabetic macular edema (DME), Regeneron clapped back with the same claim about its new treatment—high-dose Eylea. “We continue to see physicians prescribe Eylea HD in both treatment experienced and treatment naïve settings as Eylea HD is increasingly recognized as the new standard of care,” Marion McCourt, Regeneron’s commercial chief, said as the company presented its fourth-quarter and 2023 earnings. Eylea HD is Regeneron’s response to Vabysmo, which hit the market in the first quarter of 2022 as a game-changing, longer-acting treatment. Vabysmo allowed many patients to reduce dosing from six times a year—with Regeneron’s original version of Eylea—to three times a year. Vabysmo has been an immediate hit as illustrated by Roche’s sales figures, which were presented on Thursday. In its first full year on the market, ...
- Source: drugdu
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- February 5, 2024
SINOVAC Influenza Vaccine Exported to Chile for the First Time, Helping to Prevent and Control the 2024 Influenza Season in the Southern Hemisphere

On February 2, 2024, a batch of trivalent influenza vaccine Anflu® produced by SINOVAC arrived in Santiago, Chile. This is the first time that SINOVAC influenza vaccines have exported finished influenza vaccines prepared from the candidate strains recommended by the World Health Organization for influenza vaccines in the southern hemisphere to a country in the southern hemisphere. The vaccine will be distributed to private vaccination centers in Santiago and other major cities across the country for the local 2024 Southern Hemisphere Influenza Season vaccination campaign starting in March. Bárbara Ester Orellana Álvarez, SINOVAC’s Director of Registration in Chile, said the vaccine is now safely stored in cold storage under license from the Chilean Institute of Public Health (ISP). The timely arrival of this shipment demonstrates SINOVAC’s commitment to providing the Chilean people with vaccines of the highest quality and safety standards. “We are confident that this operation will contribute to ...
- Source: drugdu
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- February 5, 2024
Fapon and Bio Farma Sign MOU for Medical Innovations

On February 1, 2024, Fapon, a global leading life science company, and Bio Farma, a state-owned pharmaceutical holding company in Indonesia specializing in vaccines, life science products, and other pharmaceuticals, signed a memorandum of understanding to formalize their commitment to strengthening medical innovations in Indonesia. In doing so, the memorandum will further solidify Fapon’s global ecosystem for diagnostics and medical treatment. Jielun ZHU, Chief Financial Officer and Chief Investment Officer of Fapon, I.G.N. Suharta Wijaya, Finance and Risk Management Director of Bio Farma and Sri Harsi Teteki, Medical, Institutional and Governance Relations Director of Bio Farma attended the official signing ceremony. The partnership between Fapon and Bio Farma focuses on developing biological medicines and technologies, medical devices, and IVD solutions with an emphasis on healthcare localization. The goal is to foster a synergistic collaboration between the two companies, drive medical innovation and technology transfer, and boost the development of healthcare ...
- Source: drugdu
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- February 5, 2024
【EXPERT Q&A】What are the classifications of pharmaceutical intermediates?

Drugdu.com expert’s response: Pharmaceutical intermediates are one or more chemical substances generated during the drug synthesis process, playing a crucial role in the production of the final Active Pharmaceutical Ingredient (API). The variety of pharmaceutical intermediates depends on the chemical structure and synthesis pathway of the target drug. Here are some common types of pharmaceutical intermediates: Benzene Ring Intermediates: Many drugs, especially anticancer and cardiovascular drugs, are based on the benzene ring structure. Heterocyclic Compounds: Such as pyridine, thiophene, imidazole, etc., commonly used in pharmaceutical manufacturing. Amino Acids and Peptides: They are the foundation of many bioactive molecules and drugs, like insulin. Carboxylic Acids and Their Derivatives: Often used in the synthesis of anti-inflammatory drugs and antibiotics. Esters and Ethers: Utilized in the synthesis of various drugs, including painkillers and sedatives. Sulfur Compounds and Thioethers: Play an important role in the synthesis of certain special drugs. Aldehydes and Ketones: Key intermediates ...
- Source: drugdu
- 142
- February 5, 2024
Usability challenges for at-home devices top ECRI’s 2024 hazards list

Dive Brief Medical devices patients can use at home, such as infusion pumps and ventilators, are the top health technology hazard of 2024, a nonprofit patient safety organization said Wednesday. ECRI named at-home devices as the top hazard in response to examples of harms such as medication errors with the use of infusion pumps that suggest products “may be too complex for laypeople to use safely and effectively.” The group identified inadequate or onerous device cleaning instructions as the second biggest hazard of the year, reflecting evidence that reprocessing failures can spread infections. Dive Insight ECRI publishes a list of what it considers the top 10 health technology hazards each year. Devices given emergency authorization during the COVID-19 pandemic and cybersecurity threats topped its lists in 2021 and 2022, respectively, but the nonprofit has since focused on dangers related to at-home products. Last year, Philips’ recall of millions of respiratory ...
- Source: drugdu
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- February 4, 2024

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