PharmaFocus Today – Page 279 – media

GenScript and T-MAXIMUM partner for CAR-T cell therapy development

Genscript Biotech has formed a strategic collaboration agreement with T-MAXIMUM Biotech to develop CAR-T cell therapy. Leveraging GenScript’s CRISPR nucleic acid re-agents, the partnership will focus on developing T-MAXIMUM’s CAR-T cell therapy. GenScript research and development (R&D) and manufacturing vice-president Dr Li Hong stated: “Our R&D-to-GMP-level sgRNA will support their UCAR-T products for solid tumours. While CAR-T cell therapies have made remarkable strides in haematological tumours, addressing the unmet need for solid tumours remains crucial.” T-MAXIMUM will receive a number of CRISPR re-agents from GenScript. These will support the development of T-MAXIMUM’s universal CAR-T products from discovery to commercialisation. GenScript’s partnership with T-MAXIMUM will drive the latter’s strategic development plan, advancing products into Phase II clinical research and enabling market delivery up to 2027. T-MAXIMUM is currently focused on the development of its universal CAR-T cell therapy product, MT027, to treat recurrent high-grade gliomas. T-MAXIMUM CEO Dr Shang Xiaoyun stated: ...
- Source: drugdu
- 169
- August 21, 2023
Amazon Pharmacy to provide automated discounts for insulin in the US

Amazon has announced that its online healthcare business, Amazon Pharmacy, will provide automated manufacturer-sponsored coupons for over 15 insulin and diabetes medicines to help patients access discounts pledged by the drug industry. The company said that patients will not need to search for and manually enter coupons using the new automatic coupon programme for three insulin makers: Novo Nordisk, Eli Lilly and Sanofi, lowering costs to as little as $35 a month. In March 2023, Novo, Lilly and Sanofi announced that they would be lowering their insulin prices by around 70% by or in 2024. A report published in July by Senator Elizabeth Warren said that some patients were struggling to get already discounted generic insulin from pharmacies at the guaranteed lower price. After Lilly lowered its Insulin Lispro list price in May to $25 per vial, patients were still being quoted up to $330 for the medicine and were ...
- Source: drugdu
- 121
- August 20, 2023
FDA again slams Biocon’s troubled plant in Malaysia, citing 8 manufacturing shortfalls

Biocon’s troubled Malaysia manufacturing facility has been slammed once again by the FDA. After a recent inspection, the regulator cited the plant for eight observations. The latest citation follows an FDA visit to the site from July 10 to July 20. Afterward, the FDA wrote up its findings in a Form 483 filing that highlights inadequate corrective and “repeat” problems that it observed on previous visits. In a letter posted on the FDA’s website, Biocon was cited for a number of ongoing issues such as scissors stored in non-sterile holders being used to open “bags of sterile components,” improper blockage of air filters, insufficient cleaning of sterile machinery and numerous problems with batch testing and record-keeping. The filing, which contained numerous redactions, also cited Biocon’s failure to lay out detailed, written guidelines for some manufacturing operations. “Specifically, your firm has no written procedures on what corrective actions are to be ...
- Source: drugdu
- 167
- August 20, 2023
Lilly’s $13.5M insulin pricing settlement gets pushback from 9 states

Nine states are saying not so fast to a proposed $13.5 million settlement that would get Eli Lilly out of hot water over claims it jacked up the price of its lucrative insulin product Humalog. The states argue Lilly is trying to use the deal to ward off future lawsuits by U.S. states. In a Tuesday filing in New Jersey federal court, lawyers for Arizona, Mississippi and Minnesota urged U.S. District Judge Brian Martinotti to delay approval of the deal unless it’s altered to make sure states can still file their own lawsuits over insulin prices. The states joined Illinois, Nebraska, Utah, Arkansas, Kansas and Montana in making their objections known this week. In a separate filing Monday, the group of six states argued that in light of local insulin price caps, Lilly was trying to settle claims valued at about $1 billion by offering price reductions that are already ...
- Source: drugdu
- 141
- August 20, 2023
Moderna says new Covid vaccine was effective against Eris variant in early trial

Moderna’s new Covid vaccine generated a robust immune response against the now-dominant Eris variant and another rapidly spreading strain of the virus in an early clinical trial, the biotech company said Thursday. The updated shot is designed to target omicron subvariant XBB.1.5, but the results suggest that the jab may still be effective against newer variants of the virus that are gaining ground nationwide. That includes Eris and another variant nicknamed Fornax, both of which are also descendants of the omicron virus variant. Moderna’s vaccine and new shots from Pfizer and Novavax are slated to roll out within weeks, pending potential approvals from the U.S. Food and Drug Administration. Meanwhile, Covid-related hospitalizations fueled by Eris and other variants continue to accelerate but remain below the summer peak that strained hospitals this time last year. Eris, also known as EG.5, accounted for 17.3% of all cases as of earlier this month, ...
- Source: drugdu
- 105
- August 20, 2023
Healthy diet and organized sports linked to better reasoning skills in children

Reasoning skills are crucial skills in learning, academic performance, and everyday problem-solving. According to a recent study conducted at the University of Eastern Finland, improved overall diet quality and reduced consumption of red meat, as well as increased time spent in reading and organised sports enhanced reasoning skills among children over the first two school years. Sehrish Naveed, Doctoral Researcher, University of Eastern Finland, said, “Children with healthier eating habits showed greater cognitive development than other children. Specifically, better overall diet quality, lower red meat consumption, and higher low-fat dairy product intake were linked to better reasoning skills.” Children who spent more time in reading and organised sports showed better reasoning skills than their peers. On the other hand, excessive time spent on a computer and unsupervised leisure-time physical activity were associated with poorer reasoning skills. Screen time, active school transportation, recess physical activity, and physical activity intensity were not ...
- Source: drugdu
- 115
- August 19, 2023
Inherent Biosciences, Inc. Advances Fertility Solutions with Transformative Grant Funding from the NIH

A Leap Forward for Patients, A Promising Opportunity for Investors, and a Revolutionary Tool for Physicians Salt Lake City, Utah – Inherent Biosciences, Inc., a commercial-stage life science company, is at the forefront of innovation with its epigenetic diagnostic tools designed to enhance and support the reproductive journey. The company has secured a $1.9M Fast-Track SBIR grant from the National Institutes of Health (NIH) to further its mission of raising the standard of care in reproductive health. Inherent Biosciences is driven by a vision to transform trial and error medicine and restore hope for patients. The company’s Sperm Quality Test (SpermQT), marketed under the brand Path Fertility (pathfertility.com), offers a cutting-edge assessment of male fertility. This grant will bolster the development of the company’s second test, targeting the needs of approximately 40 million men worldwide affected by azoospermia, a condition where there is an absence of sperm in the ejaculate, ...
- Source: drugdu
- 154
- August 19, 2023
MSF, trying to secure supplies of ViiV’s Apretude, calls out new clauses in purchasing contract

As GSK’s ViiV Healthcare looks to widen the reach of its HIV franchise, Médecins Sans Frontières (MSF) has been working to secure access to the company’s long-acting HIV prevention drug, Apretude, for more than a year. Now, the organization is airing grievances about the negotiation process with an open letter to ViiV’s executive team. MSF is calling on the company to take out what it says are problematic new amendments to the proposed purchase agreement. Since last June, MSF has been stuck in contract negotiations with ViiV for Apretude, according the letter from Sidney Wong, executive co-director of MSF’s access campaign, and Philip Aruna, team leader for MSF’s southern Africa region. The sides almost reached a deal in December, but ViiV subsequently changed the terms because of supply limitations, Wong and Aruna wrote. Thanks to last-minute edits that deviate from standard MSF purchase agreements, the new contract more closely resembles ...
- Source: drugdu
- 125
- August 19, 2023
Bayer pledges $500K in drugs and cash relief to Maui following devastating wildfires

In the aftermath of devastating wildfires on Maui, Bayer is standing up as one of the first pharmaceutical companies to offer relief. The German conglomerate is providing a cash donation of $250,000 to the island, plus a donation of essential healthcare products also worth $250,000. Bayer has operated in Maui for more than half a century, the company said in a Wednesday release. The company said it “stands in solidarity with those impacted and offers heartfelt condolences for the losses endured.” The fire in Lahaina, Hawaii, is now the deadliest in more than a century, according to the U.S. Fire Administration and CNN. To date, some 2,200 structures have been destroyed or damaged, 86% of which are residential, the state’s governor, Josh Green, has said. The death toll was 110 as of Wednesday. Of Bayer’s cash donation, $150,000 will go to the Hawaii Community Foundation’s Maui Strong program, which is ...
- Source: drugdu
- 182
- August 19, 2023
GSK stays a step ahead in RSV vaccine battle as Arexvy becomes available at US pharmacies

As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. In May, the U.K. company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna. And now—well in advance of the fall and winter RSV season—Arexvy is available in major U.S. retail pharmacies, GSK said Thursday. Under the Inflation Reduction Act, Medicare Part D patients will pay no out-of-pocket expenses for the shot, GSK said. Additionally, under the Affordable Care Act, patients with commercial insurance may be covered when Arexvy is administered in-network, GSK said. In June, the Advisory Committee on Immunization Practices (ACIP) recommended that people 60 and older decide in consultation with their healthcare provider whether to receive the RSV vaccine. As people age, their immune systems can become compromised, making them more vulnerable to ...
- Source: drugdu
- 170
- August 19, 2023

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