media – Page 287 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

Roche hits FDA delay with subcutaneous version of Tecentriq amid manufacturing process changes

It’s looking like Roche may not receive an on-time FDA decision for the subcutaneous version of its cancer immunotherapy Tecentriq.The FDA was supposed to dole out a verdict on subcutaneous Tecentriq by next week. But Roche now needs to update the therapy’s manufacturing processes, the Swiss pharma’s drug delivery technology partner Halozyme Therapeutics said in a securities filing Thursday. “These updates are expected to be completed in 2023 and are expected to support a potential launch of Tecentriq SC in the U.S. in 2024,” Halozyme said. Roche is making the changes in response to the FDA’s evolving requirements, a spokesperson with the company’s Genentech unit told Fierce Pharma. The spokesperson confirmed that the company now expects to receive an FDA approval in 2024. Roche filed the under-the-skin formulation to both the FDA and the European Medicines Agency in November. It’s targeting all existing indications of the original intravenous Tecentriq. Last ...
- Source: drugdu
- 162
- September 9, 2023
BMS sought bogus patents, filed sham lawsuits and more to protect Pomalyst, lawsuit says

After 10 years on the market, the Bristol Myers Squibb and Celgene blockbuster multiple myeloma treatment Pomalyst has landed in some legal hot water.In a new lawsuit (PDF), Blue Cross and Blue Shield of Louisiana claims Celgene used an illegal scheme to protect the drug’s monopoly, causing purchasers to overpay by “hundreds of millions, if not billions” of dollars over the years. BMS did not immediately respond to Fierce Pharma’s request for comment. The company acquired Pomalyst in its $74 billion buyout of Celgene in 2019. In the suit, Blue Cross and Blue Shield of Louisiana says Celgene sought fraudulent patents, abused the federal judicial system and shared some of its “illicitly acquired” profits with generic drug makers to keep competition at bay. Specifically, Celgene knowingly secured certain patents using information that was already in the public domain, Blue Cross argues. To protect these patents, Celgene initiated lawsuits against would-be ...
- Source: drugdu
- 202
- September 9, 2023
J&J dumps high-dose Opsumit trial upon failure in rare type of pulmonary hypertension

Johnson & Johnson’s plan to expand decade-old pulmonary hypertension med Opsumit has hit a snag.J&J’s Janssen has decided to stop a phase 3 trial for a 75-mg dose of macitentan in patients with chronic thromboembolic pulmonary hypertension (CTEPH). The company pulled the plug after an independent data monitoring committee performed an interim analysis and figured the trial wouldn’t succeed. Macitentan, given at 10 mg daily, won approval in 2013 under the brand name Opsumit for treating pulmonary arterial hypertension (PAH). PAH and CTEPH are slightly different diseases, but both feature abnormally high blood pressure in the arteries of the lungs. The results from the high-dose trial, dubbed MACiTEPH, won’t affect the marketed product, J&J said. Separately, J&J is trying to show that the higher dose works better than the FDA-approved 10-mg version in PAH. That study, coded UNISUS, remains ongoing with an estimated primary completion date next month, according to ...
- Source: drugdu
- 99
- September 9, 2023
BlueWhale Bio surfaces with $18M on mission to overhaul cell therapy production

University of Pennsylvania spinout BlueWhale Bio has surfaced on a mission to smash bottlenecks in cell and gene therapy manufacturing.The new company uncloaked Thursday with news it has raised $18 million in seed financing. The funding round was led by the ventures arm of Danaher Corporation with contributions from the likes of Novalis LifeSciences and Marshall Wace as well. Concerned that demand for cell therapy products is outstripping supply, BlueWhale aims to develop a technology platform and product portfolio that could bring the benefits of cell therapy to more patients “faster and at lower costs,” the company said in a press release. BlueWhale will be based in Philadelphia and led by CEO Peter Keller. The company’s scientific team is spearheaded by immunotherapy pioneers Carl June, M.D., the Richard W. Vague professor in immunotherapy at Penn’s Perelman School of Medicine, and James Riley, Ph.D., a professor of microbiology at Penn. “With ...
- Source: drugdu
- 118
- September 9, 2023
BMS Accused by HMO of Patent Fraud to Allegedly Sustain Pomalyst Monopoly

By Tristan Manalac Pictured: BMS office in California/iStock, hapabapaBlue Cross and Blue Shield of Louisiana on Tuesday filed a class action lawsuit against Bristol Myers Squibb, accusing the pharma giant of unlawfully extending the market exclusivity for its multiple myeloma drug Pomalyst (pomalidomide), according to Reuters. The Baton Rouge-based health maintenance organization is being joined by HMO Louisiana, a subsidiary of Blue Cross and Blue Shield of Louisiana. The plaintiffs are representing a proposed class of entities in the U.S. and its territories that paid for or reimbursed Pomalyst from October 2020. In the 151-page complaint, the not-for-profit health insurance company alleged that BMS and its subsidiary Celgene committed patent fraud by misrepresenting and concealing data regarding Pomalyst’s properties, formulations and uses that had already been publicly available. The pharma companies also “abused the federal judicial system” by launching a barrage of “sham lawsuits” against generics companies that were trying ...
- Source: drugdu
- 175
- September 9, 2023
Idorsia reacquires aprocitentan rights from Janssen for $343m

Idorsia has decided to reacquire the global rights for the oral endothelin receptor antagonist aprocitentan almost six years after they were sold to Janssen. The news comes after Idorsia announced potential layoffs, and cost-reduction initiatives, including the sale of its Asia Pacific operations, in July due to “lower than anticipated” sales in H1 2023. The reacquisition of aprocitentan is expected to provide a much-needed boost to Idorsia’s profits. GlobalData forecasts aprocitentan to generate $241m in sales in 2029. Idorsia CEO Jean-Paul Clozel said: “Aprocitentan has demonstrated significant and clinically meaningful sustained blood pressure lowering benefits with a good safety profile, particularly suited to the high-risk patient population with resistant hypertension.” Aprocitentan is currently under review with the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) set for 19 December. An EU approval application was filled with the European Medicines Agency (EMA) in January. Idorsia ...
- Source: drugdu
- 110
- September 8, 2023
GSK invests over $270m in vaccine manufacturing ahead of RSV vaccine launch

GSK has announced it is investing over £270m to build a new vaccine manufacturing facility at its Wavre campus in Belgium. The investment follows the launch of the company’s new respiratory syncytial virus (RSV) vaccine, Arexvy. Designed to increase the efficiency of manufacturing processes and reduce environmental impact, the new unit will handle freeze-dried vaccines, including Arexvy, as well as the company’s fast-growing shingles vaccine, Shingrix, and its malaria vaccine, Mosquirix. The plant will contain two wings: one for producing the UK company’s ‘non-live’ vaccines, and the other for making ‘live’ vaccines, which include Varilrix for chickenpox and Priorix for measles. A spokesperson from GSK said: “The ambition is to have tens of millions of doses lyophilized each year.” “The new centre will feature several cutting-edge technological innovations designed to increase the efficiency of manufacturing processes and reduce environmental impact,” the spokesperson added. In May, Arexvy became the first RSV ...
- Source: drugdu
- 199
- September 8, 2023
Astellas withdraws IRA lawsuit after avoiding CMS’ price negotiations list

Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act (IRA). But now that the Centers for Medicare & Medicaid Services (CMS) has released the first 10 drugs set for governmental bargaining, the company is ready to abandon its litigation. When CMS last week revealed its list of the first 10 drugs eligible for Medicare price negotiations, Astellas’ Xtandi did not make the cut. This surprised some pharma watchers, who had expected the Pfizer-partnered cancer blockbuster to be among the first drugs to face the controversial new process. Now, without Xtandi on the list, Astellas is pulling its lawsuit, Reuters reports. The 10 drugs on the CMS’ list are blockbusters marketed by Johnson & Johnson, Bristol Myers Squibb, Merck & Co., Novartis, Eli Lilly, AstraZeneca, Novo Nordisk and Amgen. Many of the companies whose drugs made the cut had already filed ...
- Source: drugdu
- 186
- September 8, 2023
J&J’s patient assistance program suffers data breach, IBM says

A technical flaw has resulted in “unauthorized access” to personal information at Johnson & Johnson’s Janssen CarePath patient assistance program, IBM reported on Wednesday. After an internal investigation, IBM was unable to determine how many accounts were affected, or the exact information that may have been compromised. The company is reaching out to all Janssen CarePath customers “out of an abundance of caution,” the tech giant said in a statement. The Janssen program helped more than 1.16 million U.S. patients access medications in 2022 alone, according to the drugmaker’s website. The free initiative facilitates access by helping patients navigate health insurance, plus provides information to get patients started on and stay on treatment. The program also provides options to manage out-of-pocket costs. By IBM’s account of events, J&J first became aware of a technical loophole in the Janssen CarePath system. Once informed, IBM, which manages the service, “promptly remediated the ...
- Source: drugdu
- 111
- September 8, 2023
Oral health worsens in morbidly obese people before and after bariatric surgery

Oral health deteriorates in morbidly obese people on a diet in preparation for bariatric surgery and patients who have undergone the procedure, with increasing caries, gingivitis and periodontitis. This is the conclusion of a study conducted by researchers at the Federal University of São Paulo (UNIFESP) in Brazil. Articles on the study are published in the Journal of Oral Rehabilitation and Clinical Oral Investigations, stressing the importance of participation by a dentist in the assessment of bariatric patients. The study was funded by FAPESP (projects 17/26400-6 and 16/10940-9), following 100 patients divided into two groups (dietary counseling and gastroplasty) at the Bariatric Clinic in Piracicaba, São Paulo state. The clinic performs some 50 such operations per month, mainly under the auspices of the SUS (“Sistema Único de Saúde”), Brazil’s national health service. Questionnaires, oral examinations, saliva samples and cheek swabs were analyzed to determine dietary changes, weight loss, inflammatory markers, ...
- Source: drugdu
- 118
- September 8, 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.