Search Results for “FDA” – Page 151 – media

BMS Seeks Another Indication for Camzyos

The FDA will release its verdict on June 16 regarding Bristol Myers Squibb‘s sNDA proposing to use its heart drug Camzyos (mavacamten) to lower the need for septal reduction therapy (SRT) in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Currently, many patients suffering from HCM need to undergo SRT, Roland Chen, senior vice president and head of cardiovascular development, Global Drug Development at BMS, said in a statement upon the FDA’s acceptance of the sNDA. SRT is either an open-heart surgical procedure or a catheter-based operation. BMS supported Camzyos’ sNDA with data from the Phase III VALOR-HCM study, a randomized, double-blinded and placebo-controlled trial that enrolled 112 patients with symptomatic obstructive HCM. All participants were qualified for SRT and had been referred for the operation. VALOR-HCM’s primary endpoint was a composite between the number of patients who decided to push through with SRT by week 16 and the number of ...
- Source: drugdu
- 132
- June 14, 2023
Johnson & Johnson inks another Stelara patent settlement, this time with Alvotech and Teva

Another biosimilar product copying Johnson & Johnson’s top-selling drug Stelara may enter the U.S. market without a patent infringement challenge by early 2025 thanks to a new settlement.J&J has signed an agreement granting Alvotech and Teva a license for their proposed Stelara biosimilar, AVT04, in the U.S. The settlement allows the biosimilar makers to launch their version no later than Feb. 21, 2025, the companies said Monday. The new Stelara biosim deal follows another one J&J recently inked with Amgen, which gives the latter a license to launch its copycat no later than Jan. 1, 2025. Like Amgen, Alvotech and Teva haven’t gotten the FDA’s blessing for AVT04. The pair in January said the FDA had accepted its application with a decision targeted for the second half of this year. A verdict for Amgen’s version is expected by the end of the third quarter. Settling those biosimilar entry dates is ...
- Source: drugdu
- 125
- June 14, 2023
Similar symptoms, biological abnormalities underlie long COVID and chronic fatigue syndrome

Long COVID and myalgic encephalomyelitis/chronic fatigue syndrome are debilitating conditions with similar symptoms. Neither condition has diagnostic tests or treatments approved by the Food and Drug Administration (FDA) and each cost the United States billions of dollars each year in direct medical expenses and lost productivity. Doctors and researchers have wondered what are the underlying biological abnormalities that may cause symptoms, and whether these abnormalities are similar in the two illnesses. A review article authored by senior investigators at Brigham and Women’s Hospital and Harvard Medical School, and the Mailman School of Public Health and Vagelos College of Physicians and Surgeons of Columbia University, addresses these questions. In it, the authors review 559 scientific publications. The authors compared the symptoms of both conditions, noting their great similarity, and then showed that very similar underlying biological abnormalities have been found in both conditions, abnormalities involving the brain, immune system, heart, lungs, ...
- Source: drugdu
- 127
- June 13, 2023
Ipsen/Albireo Look to Add Rare Genetic Disease to Bylvay’s Label

In February 2023, the FDA accepted an sNDA submitted by Albireo, seeking to add the rare genetic disease Alagille syndrome to Bylvay (odevixibat)’s label. The target action date is June 15. Albireo entered into an agreement in January to be acquired by Ipsen Alagille syndrome is a heritable condition characterized by the lack of bile ducts that drain the liver, leading to the accumulation of bile, which ultimately causes organ damage. The disease can also affect the heart, skeleton, eyes, kidneys and central nervous system. Common symptoms include yellow skin or eyes, stunted growth and severe pruritus. Bylvay’s Alagille bid is supported by data from the Phase III ASSERT study, a double-blinded, randomized and placebo-controlled trial that enrolled more than 50 participants across 32 trial sites in North America, the Middle East, Europe and the Asia-Pacific region. In the study’s main analysis, Bylvay significantly reduced pruritus after 6 months of ...
- Source: drugdu
- 113
- June 13, 2023
Ironwood Pushes Gut Drug to Pediatric Setting

By Tristan Manalac On June 14, the FDA is set to release its verdict on Ironwood Pharmaceuticals’ supplemental New Drug Application (sNDA), in which the company proposes to use Linzess (linaclotide) for the treatment of functional constipation in kids and teens aged 6–17 years. Ironwood is developing and commercializing Linzess in collaboration with AbbVie, following a 2015 agreement with Allergan. AbbVie acquired Allergan in 2019. Linzess is a guanylate cyclase-C (GC-C) agonist that works by binding to the GC-C receptor within the intestinal epithelium, which in turn increases fluid secretion, faster transit and lower pain-sensing in the intestine. The drug won the FDA’s approval in August 2012 to treat patients with chronic idiopathic constipation and irritable bowel syndrome with constipation in adults. Linzess’s label bears a boxed warning for risk of serious dehydration when used in children under two years of age. Ironwood supported Linzess’ sNDA with data from a ...
- Source: drugdu
- 225
- June 13, 2023
In shift away from toxic ethylene oxide, Colorado firm offers ‘green’ chlorine dioxide sterilization

Dive Brief Boulder Sterilization is introducing contract chlorine dioxide sterilization services this summer to provide medical device manufacturers with an alternative to ethylene oxide (EtO). The rollout of the service will make Boulder Sterilization, a division of Boulder iQ, part of a small group of companies to offer medtech sterilization using the gas and, it claims, the only provider to offer both EtO and chlorine dioxide services. Boulder Sterilization’s addition of chlorine dioxide capabilities comes as the industry races to find alternatives to EtO ahead of restrictions on the use of the carcinogenic gas. Dive Insight Interest in using chlorine dioxide to sterilize medical devices dates back decades. A patent filed in 1982 described the use of chlorine dioxide to “sterilize surfaces, especially the gas impermeable surfaces of implements commonly employed in the medical sciences.” Yet, while some sterilization companies such as ClorDiSys Solutions have deployed the approach, EtO has ...
- Source: drugdu
- 123
- June 11, 2023
’ Seagen CEO talks about his next stop, Pfizer deal and the ADC landscape

David Epstein’s short tenure as Seagen’s CEO will likely end soon with the antibody-drug conjugate specialist’s sale to Pfizer. After a rich career spanning companies of various sizes, Epstein is keeping an open mind about where he might head next.“I will hopefully make new drugs somewhere else,” Epstein said in a recent interview on the sidelines of the American Society of Clinical Oncology’s annual meeting. “I don’t know where that will be.” Throughout his time in biopharma, Epstein has worn many hats. He’s known for building Novartis’ oncology unit and leading the Swiss giant’s larger global pharma business. He fostered startups for five years at Flagship Pioneering before taking the reins at Seagen in November. Those roles have given him experience in almost every therapeutic area and in both drug development and commercialization. That kind of resume opens a lot of possibilities—although going back to Flagship isn’t his plan right ...
- Source: drugdu
- 187
- June 10, 2023
Johnson & Johnson, Legend file for expanded use of Carvykti after key trial win

Legend Biotech and Johnson & Johnson are moving fast in their efforts to forward their CAR-T standout Carvykti.Two days after presenting remarkable data from a phase 3 trial in multiple myeloma at the American Society of Clinical Oncology annual meeting, the companies have filed with the FDA for expanded use of the cell therapy. After gaining approval 16 months ago for Carvykti to treat multiple myeloma patients following four or more lines of therapy, the companies hope to get the U.S. regulator to sign off on its use at an earlier stage of treatment. Specifically, Legend and J&J submitted an application seeking an approval to treat patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a protease inhibitor, such as Takeda’s Velclade, and an immunomodulatory agent, such as Bristol Myers Squibb’s Revlimid. With such an approval, Carvytki could leapfrog BMS’ multiple ...
- Source: drugdu
- 108
- June 9, 2023
Biosimilars ‘Fulfilling Their Promise’ of Lowering Biologic Prices

By Tristan Manalac Pictured: Cancer patient in bed looking out window / iStock, Ridofranz The entry of biosimilars promotes healthy market competition. It can reduce the prices of branded biologic medicines, according to a new study from the University of Southern California’s Leonard D. Schaeffer Center for Health Policy & Economics. The study, published online Tuesday in the journal Health Affairs, focused on Genentech’s (Roche) breast cancer treatment Herceptin (trastuzumab) and its five biosimilar competitors that entered the U.S. market starting in 2019: Amgen’s Kanjinti, Viatris’ Ogivri, Pfizer’s Trazimera, Teva’s Herzuma and Organon’s Ontruzant. Study results showed that when Herceptin’s first biosimilar competitor—Kanjinti—hit the market, its average price dropped around 21%, from $101 to $80 per 10 mg. By the second quarter of 2022, toward the end of the study’s analysis period, biosimilars maintained an average sales price of 28% to 58% of Herceptin’s pre-competition average sales price. “Trastuzumab is ...
- Source: drugdu
- 202
- June 9, 2023
Lawmakers worry Medicare Alzheimer’s plan won’t ensure access to new treatments

Two Democratic lawmakers are calling on Medicare to provide more information on how the program will make good on its promise to cover Alzheimer’s treatments for seniors. Rep. Anna Eshoo, the ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Barragan said Medicare has failed to answer basic questions about how its coverage plan will work. The lawmakers told Chiquita Brooks-LaSure, who heads the Centers for Medicare and Medicaid Services (CMS), in a letter Monday that it is still “very unclear” how seniors will access the new treatments. Medicare has promised to cover Alzheimer’s antibody treatments on the same day the medications receive full approval by the Food and Drug Administration. The federal health program will cover the treatments through Part B of the program for seniors. Part B typically covers treatments that seniors can’t administer at home on their own, such as infusions. Under this policy, seniors ...
- Source: drugdu
- 168
- June 8, 2023

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