PharmaFocus Today – Page 367 – media

Neuralink competitor Paradromics gets one step closer to FDA approval for its brain implant

A growing team of nearly 50 employees at the neurotech startup Paradromics is working on a brain implant that sounds like the work of science fiction. And it has caught the attention of federal regulators. Paradromics, founded in 2015, is developing a device that could help patients with severe paralysis regain their ability to communicate by deciphering their neural signals. And on Thursday, the Austin, Texas-based company announced that it has received the Breakthrough Device designation from the Food and Drug Administration for its flagship system, called the Connexus Direct Data Interface. CEO Matt Angle said the designation, in addition to a $33 million funding round the company also announced Thursday, will help Paradromics bring its device to market. Paradromics is part of the emerging brain-computer interface, or BCI, industry. A BCI is a system that deciphers brain signals and translates them into commands for external technologies. Experts believe the ...
- Source: drugdu
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- May 21, 2023
AbbVie nabs seventh FDA approval for Rinvoq, adds Crohn’s disease indication

Beth Snyder Bulik Senior Editor AbbVie picked up another indication for blockbuster Rinvoq on Thursday, this time for Crohn’s disease. The seventh FDA approval for the JAK inhibitor is specifically for use in moderate to severe Crohn’s patients who have had inadequate response or intolerance of at least one TNF blocker. While there are several other biologics already on the market to treat moderately to severely active Crohn’s including J&J’s Stelara, Takeda’s Entyvio and AbbVie’s own Skyrizi, the FDA noted that Rinvoq is the first oral drug. The approval was based on results from three studies, the U-EXCEED and U-EXCEL initial trial and the U-ENDURE maintenance trial, determining statistical significance in the co-primary endpoints of endoscopic response and clinical remission. AbbVie consultant and gastroenterologist Edward Loftus, who was a U-EXCEL investigator, said in a news release, “Based on the clinical trial results, treatment with RINVOQ shows both early and long-term ...
- Source: drugdu
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- May 21, 2023
Blood Test Taken After Miscarriage Can Predict Future Risk of Pregnancy Loss

By LabMedica International staff writers www.labmedica.com/ Image: Early blood test may unravel secrets of pregnancy loss (Photo courtesy of Freepik) Approximately 10% of women experience pregnancy loss, a percentage that is higher in regions where pregnancies frequently occur later in a woman’s reproductive years. Various factors contribute to pregnancy loss, including hormonal imbalances, endocrine disorders, clotting issues, or lifestyle-related factors. Despite the fact that one in four pregnancies results in a miscarriage, little has been done to investigate the underlying causes, with the primary focus being on the process of uterus evacuation post-miscarriage. Now, a new study has found that a post-miscarriage blood test as early as the fifth week of pregnancy could shed light on the cause and, in some instances, guide preventative treatment strategies. These findings could potentially help prevent 5% of the annual 30 million miscarriages worldwide. In the study, a team of researchers at Hvidovre Hospital ...
- Source: drugdu
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- May 21, 2023
Mustang bucks some partnered cell and gene therapy work

Mustang Bio is galloping away from a few City of Hope-partnered cell therapy programs and pausing a gene therapy trial to funnel resources toward a lead asset developed in collaboration with Fred Hutch. A pipeline reprioritization has led the company to ax work on a CD123-targeted CAR T as well as three other cell therapies targeting HER2, CS1 and PCSA, respectively, according to a release Thursday. Mustang will continue work on an IL13Rα2-targeting cell therapy combined with an oncolytic virus—MB-108—that’s been developed alongside City of Hope and Nationwide Children’s Hospital. And that’s not all; Mustang is halting “bubble boy disease” gene therapy after a review of data from an ongoing investigator-sponsored trial spurred a pause in enrollment. The company says no safety concerns have been raised and “no insertional mutagenesis or malignancy has been detected” in either investigator-sponsored trial. Mustang is awaiting more data from its partner on a new ...
- Source: drugdu
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- May 21, 2023
In a new look at Novo’s Wegovy data, researchers spell out weight loss for teens

Kyle LaHucik May Associate Editor A few months after the FDA approved the weight loss drug Wegovy for adolescents, researchers are out with a post-hoc look at the late-stage data, this time finding that 45% of the teens taking Novo Nordisk’s drug dipped below the clinical cutoff for obesity. The analysis, presented by University of Minnesota pediatrics professor Aaron Kelly at this week’s European Congress on Obesity in Dublin, gives new insight into the popular drug, which is part of the ballooning obesity R&D field that has Novo and Eli Lilly in the lead and biopharmas like Amgen and Boehringer Ingelheim racing to catch up. The results from the same study, the STEP TEENS trial, were published in the New England Journal of Medicine last December, shortly before the FDA expanded the original 2021 label for adults to include teens 12 years old and older. Almost three-quarters (74%) of teens ...
- Source: drugdu
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- May 21, 2023
US drug overdose deaths, fueled by synthetic opioids, hit a new high in 2022

By Deidre McPhillips, CNN Maryland on February 25, 2023. Michael S. Williamson/The Washington Post/Getty Images CNN — Nearly 110,000 people died from drug overdoses in the United States in 2022, according to early estimates from the US Centers for Disease Control and Prevention.Overdose deaths surged during the first two years of the pandemic, exacerbating a years-long steady increase. Monthly updates to the provisional data suggest that overdose deaths have leveled off in 2022, but they still ended slightly higher than the year before. The 109,680 overdose deaths in 2022 are the highest recorded in a calendar year, compared with 109,179 in 2021. However, the data published by the CDC on Wednesday is subject to change, as death certificates are reviewed and records are assessed. Final data on drug overdose deaths won’t be available for months. Fentanyl, the powerful synthetic opioid, has been a significant factor in the rise of deadly ...
- Source: drugdu
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- May 21, 2023
SCOTUS hands win to Sanofi, Regeneron in long-running PCSK9 feud with Amgen

After numerous twists and turns, a highly divisive patent infringement case between Amgen and partners Sanofi and Regeneron has come to an end at the U.S. Supreme Court.The nine justices voted unanimously to uphold (PDF) a lower court ruling invalidating a pair of patents on Amgen’s PCSK9 cholesterol med Repatha. The case stretches back to 2014, when Amgen first sued Sanofi and Regeneron for allegedly treading on Amgen intellectual property with their rival PCSK9 drug Praluent, under development at the time as alirocumab. Praluent and Amgen’s Repatha won U.S. approvals just weeks apart in 2015. Both drugs work to help lower “bad” LDL cholesterol by blocking the protein PCSK9. In 2019, a judge ruled that certain claims of two Amgen patents covering Repatha were invalid. Amgen took that loss to federal appeals court, where it was rejected. The company ultimately petitioned the U.S. Supreme Court to hear the case in ...
- Source: drugdu
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- May 21, 2023
Cambrex wraps up expansion of Snapdragon API plant in Massachusetts

CDMO company Cambrex completed the second phase of an expansion at its Snapdragon Chemistry API production facility in Waltham, Massachusetts.The project added 51,000 square feet to the facility’s footprint, the company said in a May 16 press release. Among the new features at the plant are process R&D labs with 100-liter and 60-liter glass-lined steel reactors plus a 10-liter plug flow reactor, the company said. Cambrex didn’t reveal its total investment in the project. The company expects the new suites to be operating in June. “The capabilities and capacity added in Waltham are designed to support the industry’s most complex chemical development needs, consistent with Snapdragon’s expertise and history,” Tom Loewald, Cambrex chief executive, said in the release. Cambrex acquired Snapdragon for an undisclosed sum in November as part of its strategy to expand API offerings. With the deal, Cambrex picked up two Snapdragon facilities in Waltham. Prior to the ...
- Source: drugdu
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- May 20, 2023
Abbott wins FDA spinal cord stimulation approval to challenge Nevro for back pain market

Dive Brief The U.S. Food and Drug Administration has approved Abbott’s spinal cord stimulation devices for the treatment of non-surgical back pain. Abbott landed the label expansion after showing its BurstDR spinal cord stimulation technology improved outcomes more than conventional medical management in people with chronic back pain who were ineligible for surgery. The label expansion comes 16 months after Nevro won FDA approval in non-surgical refractory back pain and four months after Boston Scientific released data on its rival device in the setting. Dive Insight: Abbott competes with Boston Scientific, Medtronic and Nevro for the spinal cord stimulation market and the four players are continually looking to expand into new areas where they are free from the intense competition that characterizes the core indications. Nevro unlocked an opportunity early last year, when it said it was the only company with specific labeling to treat non-surgical refractory back pain. Now, ...
- Source: drugdu
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- May 20, 2023
US Appeals Court Panel Questions FDA Due Diligence on Abortion Pill

By Lisa Munger Pictured: Scales of justice/Kanizphoto, iStock A three-judge panel in Louisiana’s 5th Circuit Court of Appeals proffered probing questions during oral arguments Wednesday about whether the FDA had done due diligence before it made changes in recent years that made the abortion pill, mifepristone, more accessible. This comes after the U.S. Supreme Court granted the FDA’s application for a stay in April, effectively maintaining access to mifepristone as the case goes through the appeals process. Anti-abortion groups sued the FDA in November 2022, arguing that its approval of mifepristone in 2000 was flawed and subsequent changes to its usage lacked solid scientific evidence. The three-judge panel, consisting of Jennifer Walker Elrod, James C. Ho and Cory T. Wilson, raised questions about the FDA’s role in reviewing and approving medications during Wednesday’s hearing. “I don’t understand this theme [that] ‘the FDA can do no wrong.’ That is basically the narrative ...
- Source: drugdu
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- May 20, 2023

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