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Delcath Gets FDA Approval for Cancer Drug-Device Combo 10 Years After Rejection

By Tristan Manalac Pictured: Cancer cells growing on the liver/iStock, Rasi Bhadramani The FDA on Monday approved Delcath Systems’ Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma, capping a nearly decade-long effort to secure regulatory approval. Hepzato’s label covers metastatic uveal melanoma (mUM) patients with unresectable hepatic metastases that afflicts less than 50% of their liver and who do not show signs of extra-hepatic disease. Hepzato can also be used in cases of extra-hepatic spread, provided it is limited to the bone, lymph nodes, subcutaneous tissues or lungs. Monday’s approval makes Hepzato “the only liver-directed therapy that can treat the whole liver,” Delcath Chief Medical Officer Vojislav Vukovic said in a statement. The approved product comes with a boxed warning for severe peri-procedural complications, such as hemorrhage and hepatocellular injury, as well as myelosuppression. To manage these risks, the company will implement a Risk Evaluation ...
- Source: drugdu
- 112
- August 18, 2023
Seagen Touts Phase III Data for Breast Cancer Combo Therapy

By Connor Lynch Pictured: Cancer patient in bed looking out window/iStock, Ridofranz Biotech Seagen announced promising Phase III results Wednesday for its tyrosine kinase inhibitor Tukysa (tucatinib), in combination with Genentech’s antibody-drug conjugate Kadcyla (ado-trastuzumab emtansine), which met its primary endpoint of progression-free survival in HER-2 breast cancer patients. The HER2CLIMB-02 trial was investigating the efficacy of Tukysa in combination with Genentech’s Kadcyla to treat locally advanced or metastatic HER-2 breast cancer that had received previous treatment with taxane and trastuzumab. While the trial met the primary endpoint of PFS, the study’s data on its secondary endpoint of overall survival “were not yet mature,” Seagen Chief Medical Officer Roger Dansey said in a statement. The combination arm of the trial also resulted in more discontinuation “due to adverse events,” but also noted that “no new safety signals emerged for the combination.” Serious adverse reactions occurred in the study in 26% ...
- Source: drugdu
- 205
- August 18, 2023
Diffusion Pharma’s stockholders support merger with EIP Pharma

The stockholders of Diffusion Pharmaceuticals have approved a merger with EIP Pharma, which is on track to close on 16 August. Diffusion’s stockholders approved all proposals as part of a special meeting, including the issuance of Diffusion Common Stock and a reverse stock split of outstanding Diffusion Common Stock, based on the 15 August press release. Specifically, 71% of stockholders voted in favour of the transaction, while 73% voiced their support for the Reverse Split. The combined company is expected to have cash runway through the trial until the end of 2024, based on a 30 March press release. If all goes ahead, the soon-to-be merged companies will begin trading as CervoMed under the trading symbol CRVO when NASDAQ opens on 17 August. The merger’s approval marks a further development in Diffusion’s strategic review process. In October 2022, Diffusion authorised the evaluation of additional strategic opportunities, which included joint ventures, ...
- Source: drugdu
- 196
- August 18, 2023
Wegovy could prevent up to 1.5 million heart attacks, strokes over 10 years, study says

Novo Nordisk’s blockbuster weight loss injection Wegovy could prevent up to 1.5 million heart attacks, strokes and other cardiovascular events in the U.S. over 10 years, according to a study released this week. Researchers from the University of California, Irvine, also found that Wegovy could result in 43 million fewer Americans with obesity over a decade. Notably, the study was partly funded by Novo Nordisk. The study results complement the initial data the Danish company released last week from a large clinical trial, which found that Wegovy slashed the risk of serious heart problems and heart-related death by 20%. Novo Nordisk’s trial studied overweight or obese patients with established cardiovascular disease, while UC Irvine’s study examined similar patients, albeit without the disease. Together, the results suggest that Wegovy and, likely, similar obesity drugs have significant health benefits beyond shedding unwanted pounds. Physicians and Wall Street analysts hope that could eventually ...
- Source: drugdu
- 201
- August 18, 2023
Legend exec

Johnson & Johnson and Legend Biotech’s Carvykti continues to grow in multiple myeloma despite the introduction of a more convenient option. Carvykti generated $117 million in the second-quarter sales, up from $72 million in the first three months of the year. The increase suggests the two companies’ efforts to ramp up supply are working. Manufacturing capacity has been a limiting factor for Carvykti’s performance since its launch last Spring, and expansion is key as the partners angle for earlier lines of treatment. Under a regular review timeline, the FDA has set April 5, 2024, as the target decision date for Carvykti’s application as a second- to fourth-line myeloma treatment, Legend said Tuesday. The standard review is somewhat disappointing given that industry watchers were expecting a priority review, which might’ve enabled a launch in December. But the longer timeline shouldn’t be much of a problem because J&J and Legend don’t have ...
- Source: drugdu
- 121
- August 18, 2023
Teva’s trial in high-stakes kickbacks case delayed as company pursues rare pretrial appeal

For three years, Teva has been defending against claims from the U.S. government that it paid illegal kickbacks to boost sales of its multiple sclerosis drug Copaxone. Now, with a trial just weeks away, Teva has scored a delay to pursue a unique appeal strategy. The trial was previously scheduled for September but has been postponed because of “substantial ground for difference of opinion” in one important aspect of the case, U.S. District Judge Nathaniel Gorton wrote in a Monday order (PDF) published by Reuters. The case centers on allegations from the government that Teva paid two patient foundations hundreds of millions of dollars to cover Medicare co-pays for patients on Copaxone for many years. The company made payments to the foundations even as it repeteadly raised prices, according to the government. The U.S. also alleges violations of the Anti-Kickback Statute, which prohibits drugmakers from directly funding Medicare co-pays. The ...
- Source: drugdu
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- August 18, 2023
【EXPERT Q&A】For pharmaceutical exports to the United States, after obtaining FDA certification, is there still a need for an import permit from the U.S.?

Drugdu.com expert’s response: To export pharmaceuticals to the United States, in addition to obtaining FDA certification, one must also comply with other U.S. import regulations. After receiving FDA approval, the drug also needs to adhere to the import regulations set by the U.S. Customs and Border Protection (CBP). Sometimes, this may involve obtaining additional import permits or certificates, but the specific requirements can vary based on the type of product and specific circumstances. Before shipping the drug to the U.S., ensure that you are familiar with and compliant with all relevant regulations. Collaborating with local import/export agents might be helpful as they are typically knowledgeable about these regulations and can provide specific guidance.
- Source: drugdu
- 210
- August 17, 2023
FDA approval import permit
Medtronic’s bid to dismiss heart device kickback claims fails, clearing case to advance

“This is a preliminary ruling in the case and Medtronic is confident that the full body of evidence, as the case moves ahead, will demonstrate that the claims have no merit. “Each patient seen at the Robert J. Dole VA Medical Center for a Peripheral Arterial Disease interventional procedure was referred by other doctors because of the patient’s medical condition. Moreover, the physicians performing these procedures used FDA-approved devices from a variety of manufacturers and the physicians were salaried and received no additional compensation for the procedures or using the devices. “Medtronic follows all applicable laws and policies to ensure our interactions with physicians are principled and appropriate.” Dive Brief Medtronic’s attempt to dismiss whistleblower accusations that it violated the False Claims Act has largely failed, with a court ruling on Thursday that most of the claims can advance. The whistleblower accused Medtronic of billing the government for unnecessary medical ...
- Source: drugdu
- 237
- August 17, 2023
Multimillion-dollar NIH grant awarded to develop advanced treatment for diabetic foot ulcers

A team of researchers from the Terasaki Institute for Biomedical Innovation (TIBI) and the University of Nebraska Medical Center (UNMC) has been awarded a multimillion-dollar grant from the National Institutes of Health to develop a superior, multi-pronged wound treatment for diabetic foot ulcers (DFUs). DFUs remain a significant complication resulting from dysregulated internal pathophysiological conditions in diabetic patients. The unresolved diabetic wounds affect patients’ quality of life and can result in amputations or death. More than 6.5 million individuals suffer from diabetic wounds worldwide. Therefore, efforts toward improving current treatment modalities via an innovative approach may promote rapid healing and increased quality of life in patients. Treatment options include growth factors, anti-bacterial agents, protease inhibitors, and anti-inflammatories. Unfortunately, currently available dressings with tiny pores limit granulation tissue formation, prevent cell migration, increase infection rates, and promote scar formation. Johnson V. John, Ph.D., TIBI scientist and principal investigator, said, “The microarchitecture ...
- Source: drugdu
- 126
- August 17, 2023
Galecto Drops Idiopathic Pulmonary Fibrosis Hopeful After Phase II Flop

By Tristan Manalac Pictured: Air sacs inside the lungs/iStock, Ozgu Arslan Galecto’s investigational drug GB0139 fell short of its primary efficacy endpoint in the Phase IIb GALACTIC-1 trial, failing to slow the decline of forced vital capacity in patients with idiopathic pulmonary fibrosis, the company announced Tuesday. Following the failure, Galecto will discontinue the clinical development of GB0139 in idiopathic pulmonary fibrosis (IPF) and instead focus its resources on advancing assets for severe liver diseases, the company said in the announcement. Galecto CEO Hans Schambye said in a statement that results from GALACTIC-1 “do not support the continued development of GB0139 as a new treatment for IPF” and that the company is currently re-evaluating its options and resource allocation plans “with the goal of extending our cash runway into 2025.” Previously granted the FDA’s Orphan Drug Designation, GB0139 was an inhaled small-molecule inhibitor of the galectin-3 protein, which is a ...
- Source: drugdu
- 216
- August 17, 2023

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