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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
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
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
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
Hey Jane Expands Virtual Services Beyond Abortion Care into Reproductive, Sexual Health

As the tension around reproductive health grows, one company is expanding its reproductive and sexual health offerings to provide more support for patients. New York City-based Hey Jane, a virtual abortion provider, announced last week that it is now offering vaginal infections treatment. This includes treatment for urinary tract infections, bacterial vaginosis and herpes. It is also offering birth control and emergency contraception. Patients complete an intake form, are connected with a provider on Hey Jane and then are able to discuss their needs with the provider via text, phone or video. The company chose to expand beyond abortion services after hearing a need from its current patients, said Alyssa Wagner, DNP, RN, APRN, WHNP-BC, head of medical at Hey Jane. She added that it was a natural step for the company. “All abortion is is reproductive health, just like yeast, just like herpes, just like birth control,” Wagner said ...
- Source: drugdu
- 150
- August 19, 2023
Federal Appeals Court Rules for Tighter Restrictions on Abortion Pill

By Tristan Manalac Pictured: U.S. Supreme Court building in Washington, DC/ iStock, SeanPavonePhoto A U.S. federal appeals court on Wednesday imposed restrictions on access to the abortion pill mifepristone, though this ruling will not take effect immediately as its effectivity is pending the Supreme Court’s review. While it did not rule that mifepristone had to be taken off the market completely, the U.S. 5th Circuit Court of Appeals in its 93-page decision upheld a lower court’s ruling that disallowed telemedicine prescriptions for the drug and its delivery by mail. “In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” Judge Jennifer Walker Elrod wrote for the court, adding that the regulator also did not consider the “cumulative effect” of lifting several safeguards simultaneously. “And it failed to gather evidence that affirmatively showed that mifepristone could ...
- Source: drugdu
- 206
- August 19, 2023
With trial win, Seagen’s breast cancer drug Tukysa boosts Roche’s Kadcyla—and Pfizer’s $43B buyout

Pfizer is shelling out $43 billion to acquire Seagen primarily for the Seattle biotech’s antibody-drug conjugate (ADC) capabilities. But a trial win for a small-molecule cancer drug makes the deal more attractive. Seagen on Wednesday said a phase 3 trial testing a combination of its Tukysa and Roche’s Kadcyla has hit its main goal in patients with previously treated HER2-positive breast cancer. Compared with Kadcyla and placebo, the combo significantly reduced the risk of tumor progression or death, Seagen said. Data on patient survival remain immature. Seagen plans to share the detailed results from the HER2CLIMB-02 trial at a medical meeting and will discuss them with the FDA, the company’s R&D chief, Roger Dansey, said in a statement. The positive results further de-risk the Seagen acquisition by Pfizer, Leerink Partners analysts said in a Wednesday note. Since securing FDA approval in 2020, Tukysa has been used alongside trastuzumab (Herceptin) and ...
- Source: drugdu
- 149
- August 19, 2023

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