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Swiss pharma giant Roche is looking to put its biologics manufacturing facility in Vacaville, California, on the auction block or shutter it by 2029, Reuters reports. In a statement to Reuters, the company didn’t directly respond to the prospect of selling or closing the facility but said it no longer needs large volumes of the products being manufactured at the site. However, internal emails sent to employees and obtained by the news agency indicated that if a buyer weren’t identified, Roche would begin winding down operations at Vacaville and shutter the plant between 2028 and 2029, Reuters reports. The plant, which employs about 800 people, produces monoclonal antibodies, according to the news service. Roche is currently staving off challenges to its revenue flow thanks to biosimilar challengers to its big-selling cancer drugs Herceptin, Avastin and Rituxan. This has forced the company to rely on newer products to deliver growth. Roche ...
- Source: drugdu
- 121
- June 4, 2023
Former Novartis execs cleared of Greek bribery charges after yearslong investigation

After a yearslong investigation involving politicians and medical professionals alike, Novartis is looking to close the books on its Greek bribery imbroglio. The probe into allegations that the company paid kickbacks between 2006 to 2015 has culminated in Greece’s Council of Misdemeanor Courts clearing four former Novartis executives and a former politician of bribery charges, Greece’s Kathimerini reports. Former Novartis Greece Vice President Konstantinos Frouzis, alongside three other Novartis execs and former Health Ministry adviser Nikos Maniadakis, couldn’t be charged of bribing nonpolitical individuals due to the expiration of the statute of limitations, according to the publication. Ten other politicians were investigated, but no evidence was found to prove passive bribery, according to Kathimerini. Meanwhile, 15 doctors who allegedly received financial benefits for prescribing Novartis drugs have been charged for passive bribery and money laundering, according to the publication. Novartis did not immediately reply to Fierce Pharma’s request for comment. ...
- Source: drugdu
- 135
- June 4, 2023
Novartis receives EC approval for Cosentyx in hidradenitis suppurativa

Novartis’ Cosentyx (secukinumab) has been approved by the European Commission (EC) to treat adults with active moderate to severe hidradenitis suppurativa (HS). Cosentyx, which is now the first new treatment option for the inflammatory skin disease in nearly a decade, is specifically indicated for patients who have had an inadequate response to conventional systemic therapy. There are currently around 200,000 people in Europe living with moderate to severe stages of HS, which causes boil-like abscesses that can burst, creating open wounds and irreversible scarring. Until now, there has only been one approved biologic treatment for HS, with around half of patients potentially losing response to this. Surgery is usually considered in advanced cases to remove abscesses and prevent the disease from spreading further, which Novartis describes as an invasive procedure that frequently results in additional scarring. Currently approved to treat a range of inflammatory conditions such as psoriatic arthritis and ...
- Source: drugdu
- 131
- June 4, 2023
Medicare details plan to cover Alzheimer’s treatments

Medicare Part B will cover treatments for Alzheimer’s disease that receive U.S. Food and Drug Administration approval, according to the federal agency that administers the program for seniors. Anyone who has Medicare Part B and meets “eligibility criteria” will be covered for new antibody treatments such as Leqembi once the FDA approves them, said Chiquita Brooks-LaSure, the administrator of the Centers for Medicare & Medicaid Services, on Thursday. Part B is an optional part of the Medicare program for seniors that typically covers the costs of drugs patients cannot administer themselves, such as infusions. The new policy will provide broader access to treatments, such as Leqembi, that slow cognitive decline. But patients will have to participate in so-called registries that collect real-world data on how the drugs work. Brooks-LaSure said the expanded coverage will go into effect on the same day the FDA approves an Alzheimer’s antibody treatment. The FDA ...
- Source: drugdu
- 115
- June 4, 2023
Amgen centers cancer patients’ voices in new YouTube series

Beth Snyder Bulik Senior Editor In Amgen’s new oncology video series, patient Gina calls her colorectal cancer diagnosis “the best worst thing that’s ever happened to me.” She goes on to talk about her Stage IV diagnosis and initial, terminal prognosis four years ago, but also describes her strong family support system and a group created by her husband around a healing star theme. Gina is one of seven “Patient Points of View” in Amgen Oncology’s new YouTube series, debuting today, and an example of the personal, forthright and unscripted perspectives each person offers. The unbranded campaign includes people with non-small cell lung cancer, small cell lung cancer and gastric cancer as well. Amgen’s goal is to “give them the microphone” to tell their stories for self-empowerment, but also for employees and others who can learn from them, said Michelle Carrillo, executive director of advocacy at Amgen. Several of the ...
- Source: drugdu
- 113
- June 4, 2023
Sandoz plans to stay local after Novartis separation, selecting new HQ in Basel

Paul Schloesser Associate Editor Sandoz, a generics maker that Novartis plans to spin off later this year, has picked its new headquarters — and it’s only 2.4 miles away from its current digs on the Novartis campus. The Novartis unit said Thursday that it plans to move to an office building in Basel called Elsässertor sometime in mid-2024. Sandoz CEO Richard Saynor said in a news release that the location in the heart of Basel “will allow us to create a working environment that meets our business needs,” citing the talent pool in the Swiss city. Sandoz added that the workspace is designed to allow for “closer collaboration and teamwork.” Sandoz did not immediately respond to queries from Endpoints News. Novartis announced back in August that it planned to spin out Sandoz as its own independent company, which is set to be listed on the SIX Swiss Exchange. Amid concerns ...
- Source: drugdu
- 114
- June 4, 2023
Memory killer cells can improve survival for melanoma patients

Our skin contains specialized long-lived killer cells that protect against intruders. Researchers at Karolinska Institutet in Sweden have now identified how these cells are formed, and shown that high levels of memory killer cells in cancer tissue correlate with a better survival rate in people with melanoma. The study is published in the journal Immunity. Certain immune T cells called tissue-resident memory cells are formed locally in the skin and other tissue, and protect against infections that they have encountered before. Some of them express proteins that enable them to kill infected cells. These “memory killer cells” can also contribute to the inflammatory skin disorders vitiligo and psoriasis. Recent research has shown that they are also involved in the body’s immune response to various cancers. Varying responses to treatment The memory killer cells have been shown to respond to immunotherapy, a Nobel Prize-winning cancer therapy involving the tweaking/activation of the ...
- Source: drugdu
- 108
- June 4, 2023
Children with drug-resistant epilepsy live longer after cranial surgery, large study finds

Survival rate beyond 10 years in children with drug-resistant epilepsy (DRE) was highest after cranial epilepsy surgery and lowest when treated only with antiseizure medications, according to a study published in The Lancet Child and Adolescent Health. This large, retrospective study was the first to compare long-term survival in children with DRE among cohorts treated with medications only, vagus nerve stimulation plus medications, and cranial epilepsy surgery plus medications. Results show that risk of early death was reduced by over 80% after surgery and by 40% after vagus nerve stimulation, compared to medication-only treatment. People with epilepsy have increased mortality rates compared to the age-matched population. Epilepsy is one of the most common neurological conditions, affecting at least 3.4 million people in the United States. Among children with epilepsy, an estimated 20% have DRE. “We provide critical evidence for healthcare decision making for pediatric patients with drug-resistant epilepsy,” said senior ...
- Source: drugdu
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- June 4, 2023
AZ, Merck’s Lynparza wins FDA nod in prostate cancer subgroup following advisory committee vote

After a panel of independent experts endorsed a narrow approval for AstraZeneca and Merck’s Lynparza in metastatic castration-resistant prostate cancer (mCRPC), the FDA has followed suit.Lynparza can now be used in combination with Johnson & Johnson’s Zytiga and a corticosteroid to treat patients with mCRPC whose tumors have BRCA mutations. The approval limits Lynparza’s use in the mCRPC population to about 10% of patients. The FDA’s decision comes after agency staffers and a committee of outside experts argued that the drug only showed a favorable risk-benefit in that population. Results from the phase 3 PROpel trial showed that the combo cut the risk of disease progression or death by 34% compared with solo Zytiga in newly diagnosed mCRPC patients regardless of mutation status. However, the FDA noted a “significant design flaw” with the trial in its briefing documents ahead of the meeting. Specifically, the FDA argued that the study didn’t ...
- Source: drugdu
- 146
- June 3, 2023
eXmoor pharma raises $35m to boost cell and gene therapy production

eXmoor pharma has received an investment of around $35m in its Series A round to support the expansion of its cell and gene therapy production capability. The fundraise saw the participation of new and existing investors Kineticos Ventures and MVM Partners, respectively. Kineticos Ventures president and CEO Frank Lis is joining eXmoor board as a result of the financing. The investment will allow eXmoor to launch its Cell and Gene Therapy Centre, a 65,000ft2 good manufacturing practice (GMP) facility. The purpose-built facility will help the firm to develop and produce autologous and allogeneic cell therapies in addition to viral vectors. It will see eXmoor leveraging around two decades of in-house facilities design, strategic cell and gene therapy (CGT) process development and transformation of its consultancy experience to become a comprehensive CGT contract development and manufacturing organisation (CDMO). Planned to be opened in Bristol, UK in this July, the facility will ...
- Source: drugdu
- 101
- June 3, 2023

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