PharmaFocus Today – Page 266 – media

Insulin pump-makers grapple with questions about GLP-1s

Insulin pump-makers face questions about whether a new category of weight loss drugs will affect their long-term growth prospects. Companies including Insulet and Tandem Diabetes Care saw their stock prices fall after a small study showed that GLP-1 agonists — which include the branded drugs Ozempic, Wegovy and Mounjaro — allowed people with Type 1 diabetes to reduce or stop insulin injections. Shares of Insulet have declined 22% in the last month to $173.90, and shares of Tandem have declined 20% to $23.14. However, physicians surveyed by analysts were skeptical the drugs would change the long-term outlook for diabetes, noting that the study only included 10 patients who started GLP-1s within three months of being diagnosed. William Blair analyst Margaret Kaczor cited interviews with three physicians, including Insulet Medical Director Trang Ly, who all said there was no evidence GLP-1s reverse damage to the insulin-producing beta cells in the pancreas. ...
- Source: drugdu
- 101
- September 16, 2023
BMS Culls Two Mid-Stage, Four Early-Stage Clinical Programs

By Connor Lynch Pictured: Bristol Myers Squibb in New Jersey/iStock, arlutz73 Bristol Myers Squibb has trimmed its development pipeline, announcing at an R&D Day on Thursday that the company would be cutting two mid-stage and four early-stage clinical programs for efficacy and safety reasons. Two Phase II clinical programs were on the BMS chopping block, including an investigational asset targeting heat shock protein 47 (HSP47), a small interfering RNA (siRNA) for nonalcoholic steatohepatitis (NASH), which was licensed from Nitto Denko for an upfront payment of $100 million in 2016. The compound inhibits expression of the heat shock protein, which is associated with excessive collagen buildup such as occurs in NASH, which is the most severe form of fatty liver disease. In 2019, BMS completed a Phase II trial investigating two different doses of the siRNA in 61 patients with scar tissue buildup post-hepatitis C infection. Neither dose performed better than ...
- Source: drugdu
- 204
- September 16, 2023
AbbVie Passes on License Option for Harpoon’s TriTAC Multiple Myeloma Program

By Tristan Manalac Pictured: AbbVie corporate office in California/iStock, vzphotos AbbVie will not exercise its exclusive licensing option for Harpoon Therapeutics’ HPN217 program, being developed for the treatment of multiple myeloma, the immuno-oncology biotech announced Wednesday. Harpoon will retain exclusive ownership over HPN217, for which it is running a Phase I clinical trial. The company will complete the study and plans to advance the candidate through its next phases of development. Despite AbbVie’s decision, Harpoon CEO Julie Eastland said in a statement that the biotech remains “confident in HPN217’s potential” to offer multiple myeloma patients “a differentiated treated option.” The company will share interim results from the candidate’s Phase I study at the upcoming International Myeloma Society (IMS) Annual Meeting, scheduled for Sept. 28, Eastland said. Developed using Harpoon’s proprietary TriTAC technology, HPN217 targets the B-cell maturation antigen, a protein highly and specifically expressed on myeloma cells. TriTAC, which stands ...
- Source: drugdu
- 107
- September 16, 2023
AbbVie shares positive results from head-to-head study of Skyrizi in Crohn’s disease

AbbVie has shared positive top-line results from a head-to-head study of its interleukin-23 inhibitor Skyrizi (risankizumab) in Crohn’s disease. The late-stage study, SEQUENCE, has been evaluating the drug against Johnson & Johnson’s Stelara (ustekinumab) in patients with moderately to severely active disease who have failed one or more traditional anti-TNF agents. Skyrizi was shown to match Stelara in terms of clinical remission at week 24, with remission rates of 59% in the Skyrizi group and 40% in the Stelara cohort. On the second primary endpoint of endoscopic remission at week 48, Skyrizi demonstrated superiority to Stelara, with remission rates of 32% and 16%, respectively. All secondary endpoints achieved statistical significance for superiority versus Stelara, AbbVie said, and safety results were consistent with the overall safety profile of Skyrizi. Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain. It is ...
- Source: drugdu
- 148
- September 15, 2023
HHS argues Merck ‘lacks standing’ to sue over Medicare price negotiations

Merck & Co. was the first drugmaker to sue over the controversial Medicare price negotiation provisions in last year’s Inflation Reduction Act (IRA). But the New Jersey drug giant “lacks standing” to challenge the law in court, the Biden administration argued in a new filing. Monday, the Department of Health and Human Services (HHS) argued that Merck can’t sue the agency because it isn’t the primary manufacturer for the diabetes med Januvia—one of 10 medications up for the first round of price negotiations in 2026. Simply put, HHS argues a Merck subsidiary is the company set to face the negotiation process, not Merck itself. Merck has argued it stands to suffer harm from the price negotiations because it developed and markets Januvia. But that assertion is “incorrect,” according to HHS, because a “non-party” to the lawsuit, Merck Sharp & Dohme, holds the FDA license to Januvia. “Accordingly, [the Centers for ...
- Source: drugdu
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- September 15, 2023
FDA to start review of subcutaneous Entyvio for Crohn’s disease

The US Food and Drug Administration (FDA) has accepted Takeda’s biologics license application (BLA) for the company’s investigational subcutaneous administration of Entyvio (vedolizumab) for the treatment of Crohn’s disease. The BLA, which is for maintenance therapy of moderate to severe active forms of the disease after induction therapy with IV vedolizumab, will now be reviewed by the FDA alongside a separate BLA submitted by Takeda for the same formulation indicated for ulcerative colitis treatment. Dr Vijay Yajnik, vice president and head of US Medical for Gastroenterology at Takeda said in a statement: “With two applications for a subcutaneous option of Entyvio now under FDA review, we remain firm in our commitment to the inflammatory bowel disease community—adults with ulcerative colitis or Crohn’s disease—and the healthcare professionals actively managing their care.” Takeda submitted the most recent BLA with data from a Phase III clinical trial demonstrating that Entyvio led to a ...
- Source: drugdu
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- September 15, 2023
Avalo drops three rare disease assets amid ongoing challenges

Avalo Therapeutics will divest three compounds in its rare disease AVTX-800 series to AUG Therapeutics, marking a further development in the company’s tumultuous past months that included a negative trial readout and a default. The divestment is expected to be completed in Q4 2023, according to a 12 September press release. AUG will make an upfront payment of $150,000 for each of the three compounds bought from Avalo. This includes AVTX-801 (D-galactose), AVTX-802 (D-mannose) and AVTX-803 (L-fucose). In addition to the upfront payment, AUG will make a contingent payment of $15m if the first US Food and Drug Administration (FDA) approval is for an indication that is not a rare paediatric disease. AUG will also assume up to $150,000 of certain liabilities incurred before the agreement, based on the 12 September press release. Avalo’s AVTX-801 is a therapeutic dose of D-galactose that was developed for the treatment of the rare ...
- Source: drugdu
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- September 15, 2023
TB deaths prompt FDA warning on reducing transmission risk

Dive Brief The Food and Drug Administration has issued advice on how to mitigate the risk of cell and tissue products transmitting tuberculosis. The recommendations follow a report from the Centers for Disease Control and Prevention that showed two recipients of bone matrix products died. In July, Aziyo Biologics, now rebranded as Elutia, recalled its viable bone matrix (VBM) products after two patients developed post-surgical infections. Elutia withdrew all of its VBM products and pivoted to drug-eluting biomatrices in response to its second link to tuberculosis since 2021. The FDA’s advice covers the role of the responsible person and donor screening. While the FDA has yet to authorize a donor screening test, it is “evaluating the risks and appropriate mitigation strategies including testing.” Dive Insight Elutia, then called Aziyo, found itself at the center of reports of tuberculosis cases in June 2021. At the time, the company voluntarily recalled a ...
- Source: drugdu
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- September 15, 2023
Alnylam Wins Adcomm’s Support for Heart Disease Drug Despite FDA Concerns

By Hayley Shasteen Pictured: FDA headquarters, iStock, GrandbrothersT he FDA’s Cardiovascular and Renal Drugs Advisory Committee on Wednesday voted 9-3 in favor of Alnylam Pharmaceuticals’ patisiran on whether its benefits outweigh its risks for the treatment of adults with cardiomyopathy induced by transthyretin amyloidosis. In the company’s announcement on Wednesday, Alnylam CMO Pushkal Garg said the “positive outcome” of the adcomm meeting is “supported by the efficacy and safety data observed in the APOLLO-B Phase III study and is another step toward bringing patients with the cardiomyopathy of ATTR amyloidosis a novel treatment option that addresses the underlying cause of disease and has the potential to meaningfully benefit patients’ functional capacity and quality of life.” The decision came after the panel’s day-long meeting in which adcomm members discussed whether the treatment effects demonstrated by data from Alnylam’s Phase III APPOLLO-B clinical trial were clinically meaningful for patients with cardiomyopathy induced ...
- Source: drugdu
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- September 15, 2023
AbbVie’s Skyrizi Outperforms J&J’s Stelara in Late-Stage Crohn’s Disease Trial

By Tristan Manalac Pictured: AbbVie headquarters in California/iStock, Michael Vi Topline data from the Phase III SEQUENCE trial showed that AbbVie’s Skyrizi (risankizumab) matched, and could potentially even outpace, Johnson & Johnson’s Stelara (ustekinumab) in patients with Crohn’s disease. SEQUENCE was designed to establish the non-inferiority of Skyrizi compared to Stelara in terms of clinical remission. AbbVie’s IL-23 inhibitor not only met this bar, but also demonstrated signals of superiority: 59% of Skyrizi-treated patients achieved remission, as opposed to only 40% among Stelara comparators. Remission, the study’s primary endpoint, was defined as scores lower than 150 in the Crohn’s Disease Activity Index, measured at week 24. “These head-to-head data reinforce SKYRIZI is an effective treatment option for patients living with Crohn’s disease,” Roopal Thakkar, AbbVie’s chief medical officer and senior vice president of development and regulatory affairs, said in a statement. SEQUENCE’s results also highlight the role Skyrizi can play ...
- Source: drugdu
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- September 15, 2023

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