Search Results for “EC” – Page 377 – media

FDA Delays PDUFA Date for Valneva’s Chikungunya Shot

By Tristan Manalac Pictured: Sign in front of FDA building/iStock, JHVEPhoto The FDA has delayed its PDUFA action date for Valneva’s investigational chikungunya vaccine VLA1553 to the end of November, the company announced Monday. The original decision was due by the end of August. The regulator extended the review period “to allow sufficient time to align and agree on a phase 4 program,” as required under the agency’s accelerated approval pathway, according to Valneva’s announcement. The FDA did not request additional clinical data to support the application. VLA1553, a live-attenuated investigational shot, could be “the first vaccine candidate to be approved under the accelerated approval pathway in an outbreak disease,” Valneva Chief Medical Officer Juan Carlos Jaramillo said in a statement. This makes its Phase IV plan all the more important as it will set a “future standard” for the industry. Despite the PDUFA delay, Valneva still expects to launch ...
- Source: drugdu
- 107
- August 16, 2023
FDA Approves J&J’s Akeega for BRCA-Positive Prostate Cancer

By Tristan Manalac Pictured: Janssen headquarters in California/iStock, Sundry Photography The FDA on Friday signed off on Janssen Pharmaceutical’s niraparib and abiraterone acetate tablets, now to be marketed as Akeega, for the treatment of metastatic castration-resistant prostate cancer in patients carrying the BRCA mutation. According to Janssen’s announcement, Akeega is the first dual-action tablet that combines the activity of a PARP inhibitor with abiraterone acetate, an androgen biosynthesis inhibitor sold by the company under the brand name Zytiga. Janssen is a subsidiary of Johnson & Johnson. The approval covers a combination regimen of Akeega with prednisone and is based on data from the Phase III MAGNITUDE study, a randomized, double-blinded and placebo-controlled trial with 765 participants. Compared with Zytiga plus prednisone, the Akeega-based regimen significantly improved radiographic progression-free survival by 47% in BRCA-positive patients. Akeega also led to a trend toward better overall survival, though this effect fell short of ...
- Source: drugdu
- 184
- August 16, 2023
Clinigen clears out cancer therapies in line with latest growth strategy

UK-headquartered Clinigen announced the divestment of global rights for four of its cancer therapies from its portfolio, as per a 10 August press release. The company gave away the rights of Cardioxane, Savene, Totect and Ethyol (amifostine), as Clinigen shifts its pharmaceutical strategy. The first three drugs use dexrazoxane to treat cardiotoxicity caused by cancer drugs while Ethyol is used to correct the effects of cancer treatment with cisplatin or radiation. Clinigen announced that the four drugs will join CNX Therapeutics’ pharmaceutical portfolio. Based in the UK, CNX Therapeutics commercialises and distributes pharmaceuticals in 40 countries globally. According to its website, the biotech is “seeking to expand its product portfolio in Europe and selected global markets.” This action follows Clinigen’s January 2023 sale of its kidney cancer treatment Proleukin (aldesleukin) to Iovance Biotherapeutics. This deal included an upfront payment of £166.7m ($211.8m), a milestone-based payment of £41.7m ($53m) upon first ...
- Source: drugdu
- 106
- August 15, 2023
Janssen’s Talvey granted FDA accelerated approval for difficult-to-treat blood cancer

Janssen, a Johnson & Johnson company, has announced that its bispecific antibody has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in certain patients with relapsed or refractory multiple myeloma (RRMM). The authorisation for Talvey (talquetamab-tgvs) specifically applies to adult RRMM patients who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Multiple myeloma is a difficult-to-treat blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. Despite recent advances, Janssen has reported that an unmet need remains for more therapeutic options with different modes of action, including for those treated with prior bispecific or CAR-T cell therapies, to better address the unique characteristics of every patient’s individual needs. Talvey, which is administered as a weekly or bi-weekly subcutaneous injection after an initial step-up phase, ...
- Source: drugdu
- 164
- August 15, 2023
Supreme Court blocks Purdue Pharma’s bankruptcy settlement, threatening immunity to Sackler family

It’s been a rough summer for pharmaceutical companies trying to resolve lawsuits by declaring bankruptcy. Last month, a federal bankruptcy judge denied Johnson & Johnson’s second effort to Texas two-step its way to an $8.9 billion settlement to resolve talc claims. And now, the Supreme Court has blocked (PDF) Purdue Pharma’s bankruptcy settlement, which granted the company’s former owners—the Sackler family—immunity from civil suits related to the opioid crisis. The action is temporary as it allows the court to hear the Justice Department’s claim that a reorganization of a company under Chapter 11 can’t be used to extinguish lawsuits against “third party non-debtors”—in this case, the Sacklers—without consent of the claimants. The court will hear oral arguments in December. “We are confident in the legality of our nearly universally supported Plan of Reorganization, and optimistic that the Supreme Court will agree,” Purdue said in an email. “Even so, we are ...
- Source: drugdu
- 101
- August 15, 2023
Amylyx’s ALS drug Relyvrio gets off the ground as company eyes new brain disorder

Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug Relyvrio continues to wow Wall Street. Approved in the U.S. as Relyvrio and in Canada under a different brand name, the drug brought in $98.2 million in revenue during the second quarter, Amylyx said Thursday. The haul topped analysts’ consensus estimates of below $92 million, according to Mizuho Securities. Having annual revenue now tracking at $400 million after just four quarters of commercialization is no easy feat, Mizuho analyst Graig Suvannavejh, Ph.D., said in a Friday note. Besides, a strong balance sheet—Amylyx had $357 million cash as of June—means the company “faces no existential need to raise capital—an increasingly daunting challenge given a difficult equity capital markets environment,” he said. The beat was fueled by better-than-expected pricing discounts, according to Suvannavejh. New patient starts actually slowed. By the end of June, Relyvrio added 800 more patients compared with the end of March, bringing ...
- Source: drugdu
- 106
- August 15, 2023
74% of Medicare Beneficiaries Concerned About Medicare’s Long-term Sustainability

A majority of current Medicare beneficiaries, or 74%, are worried about the Medicare program’s long-term sustainability, a new survey shows. The survey was published by eHealth, an online marketplace for health insurance. It was conducted in June and included responses from 3,582 Medicare beneficiaries. The report comes after the Medicare Board of Trustees predicted that funding for Medicare Part A will not be able to cover benefits by 2031. About 20% of Medicare beneficiaries are “very worried” about the long-term sustainability of Medicare, 54% are “somewhat worried” and 25% are “not at all worried,” according to eHealth. This concern exists regardless of political opinions: About 74% of Republicans are worried and 76% of Democrats are worried. However, there’s more of a difference based on income: 25% of those with an annual income of less than $25,000 say they’re worried, versus 12% of those with an income of more than $100,000. ...
- Source: drugdu
- 109
- August 15, 2023
ALX Oncology Axes Two CD47 Programs on Disappointing Results

By Connor Lynch Pictured: Doctor holding up hand to stop, courtesy of iStock Clinical-stage oncology company ALX Oncology is dropping trials for two of its anti-CD47 programs after disappointing efficacy findings. In its second-quarter earnings report on Thursday, the San Francisco-based company announced an end to its ASPEN-02 and ASPEN-05 programs, which were evaluating the efficacy of its CD47-inhibitor evorpacept. The protein works by binding to receptors on cancer cells that can potentially enhance the action of both chemotherapy drugs, as well as the body’s natural immune response. The two programs were assessing the effectiveness of evorpacept in concert with chemotherapy drugs to treat myelodysplastic syndrome and acute myeloid leukemia, respectively. Initial findings were promising. The combination of evorpacept and chemotherapy drugs—Bristol Myer Squibb’s azacitidine and AbbVie and Genentech’s venetoclax—proved more effective in combination than apart in early trials for myelodysplastic syndrome, as well as acute myeloid leukemia. However, later ...
- Source: drugdu
- 103
- August 15, 2023
SCOTUS Blocks $6B Purdue Pharma Bankruptcy Settlement

By Tristan Manalac Pictured: Oxycontin bottles on a shelf/iStock, Pureradiancephoto The Supreme Court of the United States on Thursday granted the Department of Justice’s application for a stay on Purdue Pharma’s $6 billion bankruptcy settlement plan shielding the Sackler family from lawsuits related to the opioid epidemic. In the short order, SCOTUS also put any other bankruptcy proceedings against Purdue on hold. The court will schedule a hearing in December 2023 to discuss the legality of a bankruptcy settlement plan reached with state and local governments that traded the Sacklers’ immunity from civil lawsuits for a contribution of up to $6 billion. The issue at hand is whether U.S. bankruptcy laws provide protections for the Sackler family, even though they had not personally declared bankruptcy themselves. The Sacklers were previously the owners of Purdue who are alleged to have fueled the opioid-addiction crisis and required a release from liability as ...
- Source: drugdu
- 115
- August 15, 2023
【EXPERT Q&A】What is the FDA’s drug approval process?

Drugdu.com expert’s response: The FDA drug approval process is both standardized and rigorous. Here’s a detailed breakdown of the entire process: 1.Preclinical Research: This is the first step in the drug approval process. It includes pharmacological and toxicological studies to evaluate the safety and effectiveness of the drug. These studies are usually conducted in laboratories or on animal models. 2.Submission of Investigational New Drug (IND) Application: Once the data from preclinical studies suggest that the drug might be safe, the pharmaceutical company submits an Investigational New Drug (IND) application. The IND contains data from preclinical studies, manufacturing information, clinical trial protocols, and more. 3.Clinical Trials: This is the heart of the drug approval process and it typically encompasses three phases. Phase I primarily tests the drug’s safety and dosage in humans. Phase II focuses on its effectiveness and side effects. Phase III further verifies its effectiveness, monitors side effects, and compares ...
- Source: drugdu
- 208
- August 15, 2023
FDA drug approval

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