PharmaFocus Today – Page 262 – media

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
- 204
- 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
- 100
- 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
- 98
- 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
- 135
- September 22, 2023
FDA Rejects ARS Pharmaceuticals’ Needle-Free EpiPen Alternative

Agency cites a need for more research to be completed. ARS Pharmaceuticals revealed in a company press release that the FDA issued a complete response letter (CRL) regarding its new drug application (NDA) for neffy, a potential nasal spray alternative to the EpiPen. According to the response, the agency stated that it needed more research before agreeing to approval. The denial comes amid an initial advisory committee vote to approve the treatment back in May. “We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive Advisory Committee vote. In fact, multiple Committee members highlighted the favorable profile of neffy in our completed single-dose nasal allergy challenge study and that any decline in exposure 20 minutes after dosing, after the expected response ...
- Source: drugdu
- 201
- September 22, 2023
CDMOs SK pharmteco, Oxford Biomedica make cell and gene therapy manufacturing M&A plays

It’s a boom time in the cell and gene therapy market, with manufacturers making moves to secure a larger piece of the pie. Wednesday, two CDMOs revealed acquisitions that will bolster their production capabilities and increase their global presence. Korean manufacturer SK pharmteco has taken a controlling stake in the Philadelphia-based Center for Breakthrough Medicines (CBM) for an undisclosed sum. Meanwhile, England’s Oxford Biomedica said it is in talks with Institut Mérieux to buy out its subsidiary, ABL Europe, for 15 million euros ($16 million). SK’s move comes after it invested $350 million in CBM in January of last year. As part of the agreement, SK had an option to increase its stake, which it exercised, becoming its largest stockholder. CBM was established in 2019 at a former GSK site. The prior funding allowed CBM to begin building end-to-end manufacturing capabilities. SK boasted that the site will be the world’s ...
- Source: drugdu
- 103
- September 22, 2023
Merck KGaA links with BenevolentAI and Exscientia to expand AI capabilities

Merck KGaA has announced two new strategic partnerships with Benevolent AI and Exscientia to support its artificial intelligence (AI)-driven drug discovery plans. Benevolent and Exscientia plan to leverage Merck KGaA’s expertise in oncology and neuroinflammation under the collaboration. As part of the agreement, the companies have collectively selected three potential first-in-class and best-in-class targets. The partnership will focus on finding viable small molecule candidates for development that Merck KGaA will choose for further preclinical and clinical development. In this deal, announced on 20 September, BenevolentAI will be eligible for payments of up to $594 million, including a low double-digit million-dollar immediate payment. Further payments will be made according to future discovery, development and commercial milestones. Also, the London, UK-based company could receive tiered royalties on net sales of any commercialised products. BenevolentAI is already collaborating with AstraZeneca and Eli Lilly for AI-driven drug discovery. In May, BenevolentAI announced intentions to ...
- Source: drugdu
- 115
- September 22, 2023
Researchers discover how neurons die in Alzheimer’s disease

Scientists from the UK’s Dementia Research Institute at University College London (UCL) and VIB-KU Leuven have discovered the cause of the death of neurons in Alzheimer’s disease (AD), opening up potential avenues to develop new treatments for the condition. The researchers found that a programmed form of cell death, known as necroptosis, is initiated when neurons are exposed to amyloid plaques and tau tangles. The researchers created a new model to replicate and connect AD hallmark features – amyloid plaques, tau tangles, and death of neurons – by implanting both healthy human and mouse neurons into the brains of AD mouse models. They discovered that only human neurons displayed Alzheimer’s features, including tau tangles and neuronal cell loss. These findings suggest that humans have specific factors that play in Alzheimer’s that standard mouse models cannot replicate, as their neurons are more resilient to amyloid pathology. Upon further research, the team ...
- Source: drugdu
- 107
- September 22, 2023
kICR researchers develop new test to help identify future cancer treatments

Researchers from the Institute of Cancer Research’s (ICR) Centre for Cancer Drug Discovery have developed a new test, RKD2, which makes the early stages of drug discovery for cancer more efficient. Funded by Cancer Research UK, the researchers created an investigative procedure that can help scientists identify new biologically active compounds to be used to develop effective medications. Fragment-based drug discovery uses various techniques to screen libraries of compounds, or fragments, with a low molecular weight. During the initial stage, scientists introduce a potential anti-cancer target and see which fragments interact with it. Previously, researchers could only determine that ‘yes, an interaction occurred’ or ‘no, there was no interaction’. However, it was difficult to apply this to weak interactions, and the team could not rule out nonspecific interactions. The new RKD2 test allows researchers to quantify interactions by determining their strength, identifying those that are truly active and worth following ...
- Source: drugdu
- 143
- September 22, 2023
FDA Rejects ARS’ Epinephrine Nasal Spray Despite Adcomm Support

By Tristan Manalac Pictured: FDA signage outside its office in Maryland/iStock, hapabapa The FDA on Tuesday turned down ARS Pharmaceuticals’ application for its epinephrine nasal spray neffy for the treatment of type I allergic reactions in adults and children weighing at least 30 kg. In its Complete Response Letter (CRL), the regulator asked ARS to conduct an additional pharmacokinetic and pharmacodynamic study that evaluates repeated neffy doses compared with repeat administrations of an epinephrine injection in participants with allergen-induced allergic rhinitis. According to the company’s announcement on Tuesday, the FDA is making this request despite aligning with ARS in August 2023 regarding the need to conduct this study as a post-marketing requirement. The regulator and the company have also already settled on the final physician’s labeling for the product. In May 2023, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 16-6 that neffy’s risk-benefit profile was favorable in adults. The ...
- Source: drugdu
- 118
- September 22, 2023

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