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WuXi debuts first vaccine CDMO site in China, where it plans to employ more than 500

Amid a global expansion spree at WuXi Biologics, the company’s immunization-focused subsidiary has christened its inaugural CDMO site in China. Tuesday, WuXi Vaccines launched its first standalone vaccines contract manufacturing facility in Suzhou. With the plant, the company adds drug substance and drug product capacity for projects in various stages of development. WuXi Vaccines is a contract development and manufacturing organization that helps its partners tackle clinical- and commercial-stage vaccine projects across a range of modalities, including protein-, virus- and mRNA-based shots. The new site’s drug substance production area houses two cell culture lines and one purification line, teeing up drug substance production scales ranging from 50 liters to 1,000 liters, according to a release. WuXi Vaccines says it will also maintain 2,000 liters of reserve capacity at the facility. Meanwhile, the drug product facility is equipped with an automatic vial washing, sterilizing, filling and capping line, which can support ...
- Source: drugdu
- 114
- September 28, 2023
Merck KGaA’s MilliporeSigma pumps €28M into 2 new mRNA production plants

On a €1 billion quest to build a global mRNA network, Merck KGaA’s MilliporeSigma has rounded out its service offerings to include all key stages of mRNA development, manufacturing and commercialization.Tuesday, MilliporeSigma christened two new mRNA drug substance manufacturing sites in Darmstadt and Hamburg, Germany. The company has invested €28 million in the sites, where it plans to hire 75 new staffers, MilliporeSigma said in a release. The new facilities will be able to tackle a full range of mRNA services, from pre-clinical to commercial-scale projects, MilliporeSigma said. Those offerings will include analytical development and biosafety testing specifically designed for mRNA technologies, the company added. The facilities fall under the umbrella of MilliporeSigma’s €1 billion investment to advance mRNA technologies and build its global mRNA network. Employing 27,000 worldwide, MilliporeSigma sells life sciences companies the tools and tech needed for testing and manufacturing. It also operates a contract testing, development ...
- Source: drugdu
- 195
- September 28, 2023
Morphic’s Ulcerative Colitis Pill Misses Expectations in Mid-Stage Study, Stock Falls

By Tristan Manalac Pictured: Woman grasping her stomach in pain/iStock, Doucefleur New data from the Phase IIa EMERALD-1 study showed that Morphic Therapeutic’s investigational ulcerative colitis pill MORF-057 induced endoscopic improvement, the company announced Friday. However, investors were underwhelmed with the candidate’s new efficacy findings and Morphic’s stock price dropped around 25% after the data was released. The new data, presented in a moderated poster session at the United European Gastroenterology Week (UEGW) 2023, showed that at 12 weeks, 25.7% of treated patients demonstrated endoscopic improvement. Clinical response, measured using the modified Mayo Clinic Score (mMCS), was documented in 45.7% of participants at 12 weeks. The UEGW data follow a prior readout from EMERALD-1, posted in April 2023, which showed that patients treated with MORF-057 saw a significant 6.4-point improvement in the Robarts Histopathology Index, a validated tool that measures histological disease activity in ulcerative colitis. This was accompanied by ...
- Source: drugdu
- 164
- September 27, 2023
AbbVie Ends I-Mab Deal for CD47 Antibody Compounds, Products

By Tristan Manalac Pictured: AbbVie headquarters in California/iStock, Michael Vi AbbVie has terminated its license and collaboration agreement with I-Mab, the Maryland- and Shanghai-based biotech announced in an SEC filing posted Friday. As a result, I-Mab will regain the global rights to develop and commercialize all CD47 compounds covered by the deal, including the monoclonal antibody lemzoparlimab. The termination will take effect on Nov. 20, 2023 and will not affect the $200 million in upfront and milestone payments that I-Mab had already received from AbbVie. According to I-Mab’s SEC document, AbbVie is pulling away from the partnership as a “strategic decision,” though a prior program discontinuation also factored into its decision. AbbVie and I-Mab first entered into their global agreement in September 2020. For an upfront payment of $180 million and the promise of up to $1.74 billion in success-based milestones, AbbVie earned exclusive rights—outside of the greater China area—to ...
- Source: drugdu
- 179
- September 27, 2023
Boston Scientific expects ‘dramatic shift’ to pulsed field ablation to fuel fast growth through 2026

Dive Brief Boston Scientific has set bullish growth targets for 2024 to 2026, according to analysts. The company is forecasting that a “dramatic shift” to pulsed field ablation will increase its organic revenues by 8% to 10% over the period. Analysts went into Boston Scientific’s investor day expecting 7% to 9% growth. Some analysts left the event speculating that Boston Scientific can exceed its 10% target after being convinced that PFA and left atrial appendage closure can power the company toward its goal. Boston Scientific forecast that the global atrial fibrillation ablation market will grow from $5 billion today to $8 billion in 2026 and $11 billion by 2028. PFA’s share of the market is predicted to rise from less than 5% today to 40% to 60% in 2026 and 60% to 80% in 2028. Dive Insight Boston Scientific forecast an 8% to 10% organic sales compound annual growth rate ...
- Source: drugdu
- 243
- September 25, 2023
Photobiomodulation in sleep has more therapeutic effects for Alzheimer’s disease than in wakefulness

It is well known that sleep is the best medication. However, it is still unknown why the brain recovers better in sleep and whether these processes can be controlled. Recent discoveries have shown that the lymphatic system of the brain is activated during sleep, which contributes to the removal of metabolites, toxins and unnecessary molecules from its tissues. Sleep disturbance contributes to the deposition of metabolites in the central nervous system (CNS). For example, sleep is a biomarker for the development of Alzheimer’s disease. This is due to the fact that the toxic metabolite beta-amyloid is excreted from brain tissue during sleep. Sleep deprivation leads to the accumulation of toxin in the CNS, which over time can lead to the development of Alzheimer’s disease. In this pilot study, the researchers have shown that non-invasive sleep photobiomodulation technology can effectively increase lymphatic excretion of beta-amyloid from the brain tissues of mice ...
- Source: drugdu
- 215
- September 25, 2023
Takeda settles antitrust lawsuit over gout drug Colcrys after trial kicked off

Takeda has managed to close one of the antitrust cases that have been hanging over the company. The Japanese pharma giant has inked a settlement with drug wholesalers who accused the company of using anti-competitive deals to delay generic entry to its gout drug Colcrys, a court filing shows. The exact terms of the deal were unclear. Takeda declined to comment. The lawsuit lasted for about two years. A group of wholesalers, including big names such as AmerisourceBergen, filed the antitrust claims in federal court in Pennsylvania in August 2021. The case centers on patent settlements that Takeda reached in 2015 and 2016 with several generic drug manufacturers around their generic versions of Colcrys. Other defendants in the lawsuit include Endo’s Par Pharmaceutical, Amneal and Teva, through its acquisition of Watson Laboratories. Rather than selling its own product, Par agreed to make an authorized generic Colcrys by paying Takeda royalties, ...
- Source: drugdu
- 206
- September 25, 2023
Lilly Sues Pharmacies, Spas and Wellness Centers Over Unapproved Mounjaro Copycats

By Matt Olszewski Pictured: Eli Lilly headquarters in Indianapolis/iStock, jetcityimage Eli Lilly on Tuesday announced it has taken legal action against U.S. medical spas, wellness centers and compounding pharmacies for selling products with tirzepatide, the active ingredient in its blockbuster drug Mounjaro. Approved by the FDA to treat type 2 diabetes, Mounjaro is commercially available only through Lilly. The medication is also only available in prefilled single-dose pens. “Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product. Because of this, Lilly filed lawsuits to protect patient safety and stop the unlawful marketing and sale of non-FDA approved compounded products fraudulently claiming to be Mounjaro (tirzepatide) by medical spas, wellness centers and compounding pharmacies,” the company said in a statement In four different lawsuits filed in Florida and Texas federal courts, Lilly is seeking to ban Better Life Pharmacy, ReviveRX, ...
- Source: drugdu
- 102
- September 23, 2023
CMS leader defends breakthrough device reimbursement proposal at House hearing

Dive Brief An acting director at the Centers for Medicare and Medicaid Services has defended contentious aspects of the planned breakthrough reimbursement pathway. At a hearing that lasted almost three hours, CMS’ Dora Hughes made the case for restricting the Transitional Coverage for Emerging Technologies (TCET) pathway to five reviews a year and discussed the exclusion of in vitro diagnostics from the program. Hughes is the agency’s acting chief medical officer and the acting director at its center for clinical standards and quality. Some lawmakers, while voicing support for TCET, joined medtech trade groups in calling for the CMS to expand the scope of the pathway to cover diagnostics before the plan is finalized. Dive Insight Hughes spent Tuesday morning at a House health subcommittee hearing fielding questions about how to improve seniors’ access to innovative drugs, medical devices and technology. TCET, a pathway that the CMS proposed for consultation ...
- Source: drugdu
- 100
- September 22, 2023
U-M receives CDC grant to establish new center to improve public health response to disease outbreaks

The University of Michigan is among 13 institutions that will receive funding from the Centers for Disease Control and Prevention to be part of a national network of centers focused on predicting and responding to future disease outbreaks. U-M will receive a $17.5 million grant over five years to establish the Michigan Public Health Integrated Center for Outbreak Analytics and Modeling, or MICOM. Housed within the U-M School of Public Health, MICOM is a partnership with the Michigan Department of Health and Human Services and a national collaboration among institutions’ experts, who represent a wide variety of disciplines. At U-M, researchers from the College of Engineering, School of Information, Medical School and College of Literature, Science, and the Arts will also lend their expertise to the effort. Marisa Eisenberg, director of MICOM and associate professor of epidemiology and complex systems, “This center is a remarkable opportunity to build on the ...
- Source: drugdu
- 137
- September 22, 2023

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