PharmaFocus Today – Page 328 – media

Scientists develop universal donor stem cell therapy to treat degenerative brain diseases in a preclinical study

Scientists at City of Hope have developed universal donor stem cells that could one day provide lifesaving therapy to children with lethal brain conditions, such as Canavan disease, as well as to people with other degenerative diseases, such as Alzheimer’s and multiple sclerosis. The study was recently published in Advanced Science. “The off-the-shelf approach City of Hope is taking can easily be extended to improve the quality of life of cancer patients who are experiencing cognitive impairment or impaired motor function as a side effect of chemotherapy or radiation,” said Yanhong Shi, Ph.D., chair of the Department of Neurodegenerative Diseases and the Herbert Horvitz Professor in Neuroscience at Beckman Research Institute of City of Hope. Shi has been working on this research for 12 years. This is the first time stem cells have been engineered to become universal donors for cell therapy targeting diseases of the central nervous system, Shi ...
- Source: drugdu
- 139
- June 17, 2023
AbbVie Files Patent Infringement Lawsuit Against BeiGene’s Brukinsa

By Alejandra Manjarrez www.biospace.com Pictured: Judicial gavel and scales of justice/iStock AbbVie has filed a lawsuit accusing China-based BeiGene’s new blood cancer drug Brukinsa (zanubrutinib) of infringing on its patent for Imbruvica (ibrutinib). Imbruvica was co-developed by J&J’s Janssen and AbbVie’s Pharmacyclics and approved in 2014 by the FDA as a treatment for chronic lymphocytic leukemia. Brukinsa, which gained its FDA approval in January 2023, had its patent issued on Tuesday. Through its complaint, filed that same day in federal court in Delaware, AbbVie is seeking a declaratory judgment of infringement plus damages, Bloomberg Law reported. BeiGene’s shares in Hong Kong and mainland China have fallen more than 10% since the announcement. Both Brukinsa and Imbruvica are BTK inhibitors designed as oral medications to treat the slow-growing blood cancers chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). They are different forms of the same disease and account for about ...
- Source: drugdu
- 116
- June 17, 2023
FDA Puts Mersana’s Ovarian Cancer Trials on Partial Clinical Hold

By Tristan Manalac www.biospace.com Pictured: FDA Building/courtesy of Grandbrothers/Adobe Stock The FDA has placed Mersana Therapeutics’ UP-NEXT and UPGRADE-A trials on partial clinical hold, the company announced Thursday. Both studies evaluate Mersana’s investigational antibody-drug conjugate upifitamab rilsodotin in platinum-sensitive ovarian cancer. The regulatory pause was triggered by an aggregate safety report containing information from around 560 patients who had received upifitamab rilsodotin (UpRi). Mersana’s data showed a higher rate of serious bleeding events, though most of these episodes were low-grade. Still, five cases of serious bleeding were fatal. The exact causes of bleeding are still unknown and are currently being investigated. Mersana’s stocks fell 60% in pre-market trading Thursday in response to the news. The FDA has yet to provide Mersana with a formal written communication regarding the partial clinical hold. However, the company expects the regulator to request a more comprehensive evaluation of UpRi’s safety data. Mersana is working ...
- Source: drugdu
- 104
- June 17, 2023
Blue Water Biotech shores up portfolio with purchase of six FDA-approved treatments

Blue Water Biotech has expanded its commercial portfolio with the purchase agreement of six assets from WraSer. The agreement includes an $8.5m cash payment and the offering of one million restricted shares. Blue Water’s deal includes treatments across cardiology, otic infections, and pain management indications and will see Zontivity (vorapaxar), Trezix (acetaminophen-caffeine-dihydrocodeine), Nalfon (fenoprofen calcium), Conjupri (levamlodipine), Otovel (ciprofloxacin and fluocinolone acetonide) and Cetraxal (ciprofloxacin) all exchange hands to Blue Water’s ownership. All six treatments are US Food and Drug Administration (FDA) approved. At market open, shares in Blue Water surged 90% higher than the previous day’s (13 June) market close. The company has a market cap of $20m. Blue Water’s major purchasing agreement comes at a time when pharma mergers and acquisitions are beginning to pick up after a slow start to 2023. Included in the agreement are the patents related to Zontivity – a medication for patients with ...
- Source: drugdu
- 106
- June 17, 2023
Phastar’s DIA 2023 Global Inspire Award for Community Engagement winner to present at this year’s conference

A statistics manager at specialist biometrics contract research organization (CRO) Phastar, has been chosen to receive the DIA 2023 Global Inspire Award for Community Engagement. Stephen Corson said it was a ‘fantastic bonus’ to be recognized by the DIA community and says it is already privilege enough to share his knowledge. The award recognizes outstanding contribution of DIA Community Chairs who ‘consistently drive engagement and promote knowledge sharing, while advancing thought leadership within the membership community’. He said: “The DIA Community is such a constructive, collaborative space with everyone inspired by their work which can really benefit people. It already feels a privilege to be able to share what knowledge I can bring to the table, so it is a fantastic bonus to be recognized by the DIA community. “Education around data science is crucial to making clinical trial processes more efficient and I get such a buzz from working ...
- Source: drugdu
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- June 17, 2023
House Democrats press Walmart, Costco, Kroger to sell abortion pill mifepristone

House Democrats on Thursday called on Walmart, Costco, Kroger, Safeway and Health Mart to publicly commit to sell the prescription abortion pill mifepristone at their retail pharmacies. Pending lawsuits have jeopardized mifepristone’s approval in the U.S. For now, it is the most common method to terminate a pregnancy in the country. The five companies have been silent for months on whether they will get certified to sell mifepristone under a Food and Drug Administration program that monitors how the medication is distributed and used by patients. “It is unconscionable that five of the largest retail pharmacies in the country are refusing to declare whether they will receive certification to provide basic, legal, FDA-approved medication abortion health care for Americans,” Rep. Dan Goldman, D-NY, said in a statement Thursday. Goldman and Rep. Judy Chu, D-Calif., sent a letter asking the companies’ CEOs to confirm by June 23 whether their pharmacies will ...
- Source: drugdu
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- June 17, 2023
Health insurance stocks slide after UnitedHealth warns more surgeries will drive up medical costs

Health insurer stocks dropped Wednesday after UnitedHealth Group warned of higher medical costs as older Americans start to catch up on surgeries they delayed during the Covid-19 pandemic. Shares of UnitedHealth, the largest U.S. health-care provider by market value, closed around 6% lower. Medicare-focused insurer Humana declined 11%. Elevance Health closed roughly 7% lower, and CVS Health, which owns insurer Aetna, slid nearly 8%. Insurance companies have benefited in recent years from a delay in nonurgent procedures due to hospital staffing shortages and the pandemic, which saw hospitals inundated with Covid patients. Hospitals at that time were widely seen as too risky to enter for elective procedures. But on Tuesday, UnitedHealth executives indicated that trend may be reversing. The company has recorded “strong outpatient care activity” throughout April, May and the early part of June, Chief Financial Officer John Rex said at a Goldman Sachs health-care conference. Most of the ...
- Source: drugdu
- 106
- June 17, 2023
Merck’s efinopegdutide shows promise in nonalcoholic fatty liver disease

Merck & Co – known as MSD outside the US and Canada – has said its investigational GLP-1/glucagon receptor co-agonist, efinopegdutide (MK-6024), has demonstrated promising results in nonalcoholic fatty liver disease (NAFLD). NAFLD is a chronic and progressive condition in which fat builds up in the liver. It is known as a silent disease with few or no symptoms, however, certain health conditions such as obesity, metabolic syndrome and type 2 diabetes, increase the likelihood of developing NAFLD. There is not currently any approved medicine that can treat NAFLD, with treatment options focused on managing the problems associated with the condition. The findings, which will be presented at the European Association for the Study of the Liver (EASL) annual congress, include new data from a phase 2a randomised, open-label study evaluating the compound’s efficacy in liver fat reduction and safety against Novo Nordisk’s semaglutide in NAFLD patients. The candidate was ...
- Source: drugdu
- 130
- June 16, 2023
New in-ear device promises to predict fainting, help understand dizziness and brain fog

Digital health startup STAT Health has designed a device to help people better understand why they’re experiencing symptoms like dizziness, fainting and brain fog. STAT Health on Tuesday announced its new in-ear wearable, the STAT, which measures blood flow to the head. When users stand up, the earpiece automatically tracks changes in their heart rate, blood pressure trend and blood flow, which are useful insights for patients who commonly experience dizziness and fainting spells as a result of illnesses like long Covid and postural orthostatic tachycardia syndrome (POTS), among others. Users can track their metrics in an app on their cellphone and glean insights into how their lifestyle choices affect their symptoms. The STAT earpiece has also proven to predict fainting minutes before it happens, according to peer-reviewed findings published in Journal of the American College of Cardiology this year. STAT Health CEO Daniel Lee said the wearable is not ...
- Source: drugdu
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- June 16, 2023
Illumina acquisition of Grail wins support from GOP lawmakers, state AGs as FTC tries to block it

Republican lawmakers, state attorneys general and several advocacy groups have voiced their support for Illumina’s acquisition of cancer-test developer Grail while the Federal Trade Commission fights to unwind the deal. The groups filed 14 amicus briefs Monday urging the U.S. 5th Circuit Court of Appeals to reverse an FTC order that would have Illumina undo the $7.1 billion Grail deal over concerns that it stifles competition. Last week, the San Diego-based DNA-sequencing company appealed the agency’s ruling. Proponents of the deal argued in the court filings that the FTC overstepped its authority in trying to unwind the tie-up that closed nearly two years ago. They added that blocking the companies from merging could harm the development of life-saving technology. “Unaccountable federal agency power undermines liberty, and overzealous, unfair agency enforcement impedes technological advancements benefitting citizens’ wellbeing,” attorneys general from 12 states said in one of the briefs. Those states are ...
- Source: drugdu
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- June 16, 2023

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