The Pharmaceutical Research and Manufacturers of America (PhRMA) China Office announced that Mr. Leo Lee, President and Managing Director of Novartis China, has joined the PhRMA China Executive Liaison Group. Mr. Lee, a long-time veteran of the biopharmaceutical industry who has held senior management positions in a number of multinational corporations and has extensive experience in strategy development and implementation, business development and operational management, joins PhRMA’s China Executive Liaison Group and expresses its confidence that Mr. Lee will bring invaluable experience to the group, as well as its appreciation to the member companies for their continued support of PhRMA. Novartis is a member of the Pharmaceutical Research and Manufacturers of America (PhRMA). About the PhRMA China Executive Liaison Group The China Executive Liaison Group (CELG) consists of the China General Managers of PhRMA member companies. As an important bridge between PhRMA China Office and member companies in China, the ...
Dive Brief Dexcom will lay off 535 employees in California, adding to the medical device industry’s long list of job cuts this year. The expected first date of separation is July 26, and the layoffs are connected to one site in San Diego, according to a Worker Adjustment and Retraining Notification filing with California. “Dexcom has decided to centralize its [U.S.] manufacturing operations in Mesa, Arizona, and refocus our San Diego operations as a Global Center of Excellence for Product Innovation,” company spokesperson James McIntosh wrote in an emailed statement. He added that Dexcom is offering support for employees, such as allowing them to apply for similar roles at another U.S. site with relocation assistance. Dive Insight The layoffs continue the consistent stream of job cuts in the medtech industry over the past 18 months. This year alone has seen numerous layoffs from top medical technology companies, including Medtronic, Zimmer ...
A new study found that eating a snack of baby carrots just three times a week significantly increased skin carotenoids in young adults. Levels of these phytonutrients were boosted even more when this healthy snack was combined with a multivitamin containing the carotenoid beta carotene. Carotenoids, which are responsible for the bright red, orange and yellow colors of many fruits and vegetables, can be measured in the skin to gauge fruit and vegetable consumption since diet is the only source of these pigments. Higher levels of skin carotenoids are associated with increased antioxidant protection and a lower risk of chronic diseases such as heart disease and certain cancers. This marker also reflects improved skin health and immune function. Mary Harper Simmons, Master of Science in Nutrition student at Samford University, said, “Previous studies have demonstrated that skin carotenoid levels can be increased by consuming three times the recommended serving of ...
Don Tracy, Associate Editor Ohtuvayre is the first inhaled product with a novel mechanism of action for chronic obstructive pulmonary disease to be approved in 20 years. The FDA has approved Verona Pharma’s Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Classified as a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), the treatment combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. According to the company, this marks the first time in 20 years that an inhaled product with a novel mechanism of action has been approved for COPD maintenance.1 “The approval of Ohtuvayre is a significant advance in COPD care, and we believe Ohtuvayre’s novel profile can change the treatment paradigm for COPD,” said David Zaccardelli, PharmD, president, CEO, Verona Pharma, in a press release. “We plan to launch Ohtuvayre in the third quarter 2024, ensuring Ohtuvayre ...
Don Tracy, Associate EditorThe inclusion of Vaxelis in the CDC’s preferential recommendations is expected to influence vaccine administration strategies and public health policies in high-risk populations moving forward. Haemophilus influenzae bacteria, 3D illustration. Image Credit: Adobe Stock Images/Dr_Microbe Image Credit: Adobe Stock Images/Dr_Microbe The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has unanimously voted to add Vaxelis to its preferential recommendations for the treatment of American Indian and Alaska Native infants with invasive Hemophilus influenzae type B (Hib). Developed as a collaboration between Merck and Sanofi, Vaxelis is the only hexavalent combination vaccine available in the United States. Vaxelis could potentially offer the advantage of reducing the number of injections needed in the first year of life compared to other vaccine schedules. Moving forward, the recommendation has the potential to significantly influence vaccine administration strategies and public health policies, especially in high-risk populations.1 “We ...
Biotech startup incubator Curie.Bio has secured $380m in funding for its latest investment pool aimed at nurturing early-stage companies advancing towards clinical trials. The fundraising round – which boosts Curie.Bio’s total funds raised to nearly $1bn – specifically targets Series A investments in companies within its accelerator programme, focusing on advancing companies towards clinical proof-of-concept studies. The Massachusetts-based biotech investor launched with $520m in its pocket in February 2023, with investments from GV, ARCH Venture Partners, and Leaps by Bayer. The investor operates through two parts: one provides seed-stage funding to startups, while the other offers essential services to help advance scientific projects. Amid macroeconomic pressures, private biotech venture financing saw a significant downturn in 2022 and 2023. During 2023, funding decreased by 43.2% compared to 2022 and by 52.3% compared to 2021, as investors became more cautious and focused on existing portfolios. Curie.Bio was started by Alexis Borisy, Zach ...
On June 24, Yuan Lin, Director of Drug Safety of State Drug Administration, and his delegation went to Sinopharm for investigation, Zhao Bingxiang, Deputy Secretary of Party Committee and General Manager of Sinopharm, hosted the reception, and the two sides held a symposium on drug regulation and high-quality development. The meeting was presided over by Zhou Le, Deputy Director of the Department of Drug Administration. Director Yuan Lin and relevant comrades of the Department of Drug Registration and the Department of Drug Administration listened to the special reports on children’s medicines, vaccines and blood products, special medicines, traditional Chinese medicines injections and formula granules, and drug business of Sinopharm Group’s scientific and technological research and development, industrial manufacturing, and trading and circulation subsections, focusing on the research and development of medicines, manufacturing, supply management, quality assurance, informationization construction, modernization and logistics construction, and so on. Informatization construction, modern logistics construction ...
Lennox-Gastaut syndrome affects up to 5% of children living with paediatric epilepsy A new study sponsored by University College London (UCL) has begun, making it the UK’s first ever deep brain stimulation (DBS) trial for children with epilepsy. In collaboration between Great Ormond Street Hospital, UCL, King’s College London, the University of Oxford and Amber Therapeutics, the Children’s Adaptive Deep brain stimulation for Epilepsy Trial (CADET) pilot intends to recruit three additional patients living with Lennox-Gastaut syndrome (LGS). Affecting around 50 million people worldwide, epilepsy is a neurological condition where sudden bursts of electrical activity in the brain cause seizures or fits. Affecting up to 5% of children with paediatric epilepsy, LGS is a rare and severe form of epilepsy that is characterised by repeated seizures that begin early in life. The study will investigate the safety of a cranially-mounted DBS device called the Picostim with software called DyNeuMo-1, manufactured ...
The initiative’s proposals aim to tackle current challenges in health research and innovation The Innovative Health Initiative (IHI) has launched a new call for proposals, which include topics on cardiovascular disease (CVD) and arthritis, as part of the total budget worth €96.5m to tackle challenges in health research and innovation. As part of the total budget, Horizon Europe, the EU’s research and innovation programme, has contributed €47.6m, while an additional €40.9m comes from the IHI’s industry members, as well as €8.1m from IHI contributing partners. Dr Niklas Blomberg, executive director, IHI, commented: “This call for proposals is an excellent opportunity to be part of ambitious projects tackling major challenges in health research and innovation.” The IHI aims to identify and create models, interventions and best practices to improve the management of CVD in Europe’s cities, covering healthcare delivery, individual lifestyle changes and the living environment. It will include five pilot ...
Dive Brief The Food and Drug Administration published draft guidance on Wednesday for diversity action plans intended to increase enrollment of underrepresented groups in clinical trials. A year-and-a-half after Congress passed legislation requiring clinical trial diversity action plans, the agency explained which device trials must meet the requirements and presented a timeline for implementation. The draft is open for feedback for 90 days, giving sponsors a chance to comment on the FDA’s interpretation of legal requirements such as the need to share enrollment goals in the plans. Dive Insight Congress passed a law in 2022 that would require drug- and device-makers to submit diversity action plans to the FDA. Per the law, the FDA was required to publish draft guidance clarifying the format and content of the diversity action plans by Dec. 29, 2023. In the draft, the FDA says that, while the Act “refers to clinical studies broadly,” it ...
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