media – Page 308 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

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
- 151
- 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
- 213
- 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
- 238
- 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
Pfizer Bispecific Drug Wins FDA Accelerated Approval for Multiple Myeloma

By Tristan Manalac Pictured: Pfizer office at its South San Francisco campus/iStock, hapabapa The FDA on Monday granted accelerated approval to Pfizer’s bispecific antibody elranatamab, to be marketed as Elrexfio, for the treatment of relapsed or refractory multiple myeloma. Elrexfio’s label covers patients who had been treated with at least four prior lines of therapy, including an anti-CD38 antibody, an immunodulatory agent and a proteasome inhibitor. According to Pfizer’s announcement, Monday’s approval makes Elrexfio the first off-the-shelf, ready-to-use fixed-dose subcutaneous therapeutic that targets the BCMA protein. “With significant responses in a patient population with highly refractory disease, we believe Elrexfio is poised to potentially become the new standard of care for multiple myeloma,” Pfizer Chief Commercial Officer Angela Hwang said in a statement, adding that the company will continue the treatment’s clinical development through its broad MagnetisMM program. The FDA’s approval was supported by data from the Phase II MagnetisMM-3 ...
- Source: drugdu
- 216
- August 17, 2023
Researchers publish early results with new interleukin-targeting antibody

An academic group has published preclinical results with a new antibody that has greater activity and fewer side effects than existing biological therapies for inflammatory conditions. This could translate into a clinical benefit for patients living with rheumatoid arthritis (RA), psoriasis, or inflammatory bowel disease (IBD). Researchers from the University of Birmingham in the UK and the University of Naples Federico II in Italy revealed promising results after designing an antibody that targets a 20-long amino acid sequence in interleukin-17 (IL-17) – a protein important in inflammatory pathways. According to the team, they demonstrated for the first time that this sequence activates the release of cyto-chemokines. The antibody, which has been called Ab-IPL-IL-17, targets this sequence in both IL-17A and IL-17F. In cell studies, it demonstrated an ability to reduce the production of cyto-chemokines and white blood cell migration to inflammation-primed tissue. When the researchers compared it to existing therapies ...
- Source: drugdu
- 230
- August 17, 2023
UK government allocates £250m for more NHS hospital beds in England

The government has announced a fund of £250m to provide another 5,000 NHS England hospital beds this winter, to relieve pressure on hospitals and reduce waiting times. As part of the NHS Urgent and Emergency Care Recovery Plan, over 30 NHS organisations across England will benefit from the investment in urgent and emergency care services. Over 900 new hospital beds, including 60 intermediate care beds, should be ready by January 2024 to increase capacity on hospital wards and A&E to 100,000. The scheme will also improve assessment spaces and cubicles in A&E. Health and social care secretary, Steve Barclay, said: “Creating additional hospital capacity will support staff to provide the best possible care and treat patients more quickly, helping us to improve waiting times and cut waiting lists – one of the government’s top five priorities.” Trusts including Hull Royal Infirmary, James Cook University Hospital and Worthing Hospital will develop ...
- Source: drugdu
- 116
- August 17, 2023
Sandoz says its biosimilar matches Eylea in another threat to Regeneron’s blockbuster

With its blockbuster eye drug Eylea, Regeneron is already juggling between a recent FDA rejection and new competition. Meanwhile, biosimilar players are also eying a piece of the pie. Tuesday, Novartis’ Sandoz said its biosimilar to Eylea showed no clinically meaningful differences with the originator in a phase 3 trial in patients with wet macular degeneration. The two versions were therapeutically equivalent in improving the best vision that patients can achieve. Sandoz now expects to file the Eylea biosimilar in the U.S. and EU in the coming months. The Sandoz drug is only the latest copycat to be closing in on Eylea. Viatris was the first to file an Eylea biosimilar in the U.S. in 2021. That asset now belongs to Biocon Biologics through a $3 billion transaction. In addition, the partnership between Formycon and Coherus BioSciences filed its biosimilar in June, followed on the heels by a separate filing ...
- Source: drugdu
- 148
- August 17, 2023
Stada in ‘exploratory talks’ about possible sale, CEO says, but nothing is certain

Speculation that Stada Arzneimittel may be looking for a buyout has largely been confirmed after the company’s CEO said as much in a recent German-language news story. Responding to recent acquisition rumors, Stada CEO Peter Goldschmidt told the German Press Agency, “Whether and when STADA might be sold is solely the decision of our owners; Bain Capital and Cinven.” From the company’s view, Goldschmidt said, “our owners are in an orientation phase in which initial exploratory talks are taking place.” A Stada press representative emailed a translated version of the remarks early Tuesday along with the company’s second-quarter results. Goldschmidt added that he doesn’t expect a decision before 2024. Additionally, the company’s investors “have no pressure to sell,” the CEO pointed out. “What speaks in favor of a sale process is that it is common for financial investors to exit after five to six years,” Goldschmidt opined. Early this month, ...
- Source: drugdu
- 115
- August 17, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.