Search Results for “EC” – Page 339 – media

Important Factors Differentiating Prescription Versus OTC Hearing Aids

It is important to understand that the performance of over-the-counter hearing aids can vary widely from prescription hearing aids due to a number of factors. By DR. CLIFF OLSON In October 2022, new Food and Drug Administration guidelines brought notable changes to the hearing aid market. The guidelines, which were mandated by the Over-the-Counter Hearing Aid Act of 2017, aim to improve hearing aid adoption rates by increasing the accessibility and affordability of hearing aid devices. Under the guidelines, direct-to-consumer (DTC) hearing devices that have been available for years will now be regulated by the federal government as over-the-counter (OTC) hearing aids. One of the specific measures implemented by the FDA guidelines was the establishment of “prescription hearing aids” and “over-the-counter hearing aids” as two distinct hearing aid categories. Given that OTC hearing aids can now be obtained without a hearing aid evaluation, they can be purchased at a lower cost from retail ...
- Source: drugdu
- 99
- November 14, 2023
Novo Pumps $6B into Manufacturing to Help Meet Sky-High Wegovy Demand

By Tristan Manalac Pictured: Novo Nordisk signage outside its office in California/iStock, Sundry Photography Novo Nordisk on Friday announced that it is investing more than $6 billion to boost manufacturing capacity in its home country of Denmark to meet current and future demand for products targeting serious chronic diseases. The Danish company will start rolling out the investment this year, with an initial $3.6 billion capital tranche and will continue to invest over the next six years. The additional funding will be channeled into facilities in Denmark, where the pharma giant currently has more than 23,000 employees—most of whom work at production sites. The multibillion-dollar manufacturing boost comes as Novo is struggling to keep up with the staggering demand for its weight-loss medication Wegovy (semaglutide). Manufacturing issues have also hounded the GLP-1 agonist, forcing the company to restrict the U.S. supply of the lower doses of the therapy. Novo will ...
- Source: drugdu
- 93
- November 14, 2023
EU regulator changes its mind on Mirati’s KRAS inhibitor Krazati with a thumbs-up following initial snub

Mirati Therapeutics’ KRAS inhibitor Krazati’s EU prospects weren’t looking good after an initial rejection from Europe’s drugs regulator. Now, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has come around on the drug after taking a second look. The CHMP first rebuffed the med back in July, finding that it didn’t meet certain requirements for a conditional marketing authorization, despite acknowledging its positive risk-benefit profile. Mirati, disagreeing, filed for a formal re-examination that ultimately resulted in the recent positive opinion. Now, European patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) will soon have a new treatment option in Mirati’s flagship drug. The company was already supplying the therapy to eligible patients in the EU based on “individual requests” from healthcare professionals, it said in July. This will be good news for Bristol Myers Squibb, which last month put $5.8 billion on the table ...
- Source: drugdu
- 91
- November 14, 2023
Bristol Myers Squibb’s CAR-T Breyanzi wins FDA priority review

The US Food and Drug Administration (FDA) has granted priority review for Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) to treat patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). The Prescription Drug User Fee Act (PDUFA) goal date for the therapy is now 14 March 2024. BMS submitted a supplemental biologics licence application (sBLA) to the FDA for the expanded use of Breyanzi for the treatment of patients with CLL and SLL who have previously received a Bruton tyrosine kinase inhibitor (BTKi) and a B-cell lymphoma 2 inhibitor (BCL2i). The application is based on results from the Phase I/II TRANSCEND CLL 004 study, which demonstrated clinical benefit with a CD19-directed CAR T cell therapy in patients with relapsed or refractory CLL after prior treatment with BTKi and BCL2i. In May 2023, BMS received approval from the European Commission (EC) for Breyanzi to treat relapsed ...
- Source: drugdu
- 93
- November 14, 2023
Valneva’s chikungunya vaccine approved by FDA for adults at increased exposure risk

Valneva’s chikungunya vaccine has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in individuals ages 18 years and older who are at an increased risk of exposure to the mosquito-borne disease. The decision makes Ixchiq, which is administered as a single intramuscular injection, the world’s first licensed chikungunya vaccine. Chikungunya often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. Infection leads to symptomatic disease in up to 97% of people after three to seven days following the mosquito bite, with clinical symptoms including fever, joint and muscle pain, headache, nausea and rash. “Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. He added: ...
- Source: drugdu
- 94
- November 14, 2023
FDA Amends Approved Indication for Keytruda in Gastric Cancer

FDA restricts use of pembrolizumab (Keytruda) combination in the treatment of gastric cancer to patients with certain tumor types. The FDA has amended the currently approved indication for pembrolizumab (Keytruda) plus trastuzumab (Herceptin), fluoropyrimidine, and platinum-containing chemotherapy in the treatment of gastric cancer. The agency’s updated indication remains under accelerated approval regulations, but restricts the use of Keytruda to patients whose tumors express PD-L1 with a combined positive score (CPS) of one or more as determined by an FDA-approved test for the treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. The FDA also approved the Agilent PD-L1 immunohistochemistry 22C3 pharmDx companion diagnostic device to help identify patients with gastric or GEJ adenocarcinoma whose tumors express PD-L1. Keytruda is an anti-PD-1 therapy that has been found to increase the immune system’s ability to detect and fight tumor cells. The humanized monoclonal antibody inhibits the interaction ...
- Source: drugdu
- 112
- November 13, 2023
FDA Approves Takeda’s Treatment for Rare Blood Clotting Disorder

Adzynma is the first approved genetically engineered protein product for the treatment of patients with congenital thrombotic thrombocytopenic purpura. The FDA has approved Takeda’s Adzynma as the first genetically engineered protein medication for the preventative treatment or for on-demand enzyme replacement therapy in patients with congenital thrombotic thrombocytopenic purpura (cTTP). Image credit: olegganko | stock.adobe.com The FDA granted the application for Adzynma with a Rare Pediatric Disease Priority Review Voucher, as well as Priority Review, Fast Track, and Orphan designations. cTTP affects fewer than 1,000 individuals in the United States. “The FDA remains deeply committed in our efforts to help facilitate the development and approval of safe and effective therapies for patients with rare diseases,” said FDA Director of the Center for Biologics Evaluation and Research Peter Marks, MD, PhD, in a press release.1 “Without treatment, cTTP is ultimately fatal. Today’s approval reflects important progress in the development of ...
- Source: drugdu
- 98
- November 13, 2023
Eli Lilly reiterates POINT acquisition plans with tender offer extension

Eli Lilly has substantiated its desire to acquire radiopharmaceutical company POINT Biopharma by extending the expiration date of the tender offer. The offer, which will now give POINT until 5:00 pm ET on 16 November to accept or terminate proceedings, outlined Lilly’s proposal to purchase shares at $12.5 per share in cash, with the condition to purchase a majority of POINT’s outstanding shares. The offer was previously scheduled to expire one minute after 11.59 pm ET on 9 November. As of 8 November, Lilly reported that nearly 15 million shares had been presented and not properly withdrawn. These shares constituted about 14.16% of the issued and outstanding shares of POINT as of the same date. The transaction is making waves at POINT where it has been met by a wall of opposition. As per an amended tender offer statement filed with the SEC on 8 November, POINT has received several ...
- Source: drugdu
- 103
- November 13, 2023
Spinal stimulation implant offers new hope for Parkinson’s disease treatment

Researchers from the French National Institute of Health and Medical Research, the French National Center for Scientific Research and the University of Bordeaux in France, along with Swiss researchers and neurosurgeons, have successfully designed and tested a spinal stimulation implant to treat Parkinson’s disease. Conducted in collaboration with the Swiss Federal Institute of Technology in Lausanne and the Lausanne university and hospital (UNIL CHUV), the implant was tested to correct disabling gait disorders, which are associated with 90% of people living with advanced Parkinson’s and are often resistant to treatment. Parkinson’s disease is a neurodegenerative condition which progressively damages and leads to a loss of nerve cells in parts of the brain. Gait disorders are commonly caused by weakness of the hip and lower extremity muscles, such as cerebral palsy, muscular dystrophy and spinal muscular dystrophy. The implant directly stimulates nerve cells in the spinal cord responsible for controlling leg ...
- Source: drugdu
- 94
- November 13, 2023
Janssen reveals positive results for nipocalimab in rheumatoid arthritis

Janssen, a Johnson & Johnson company, has announced positive results from a mid-stage study of its investigational FcRn inhibitor in rheumatoid arthritis (RA). The phase 2a IRIS-RA trial has been evaluating nipocalimab in adults with moderate-to-severe RA who have tested positive for anti-citrullinated protein antibodies (ACPAs) or rheumatoid factor (RF) and had an inadequate response or been intolerant to at least one anti-TNF therapy. Approximately 13 million people worldwide are affected by RA, a chronic inflammatory disease that causes joint pain, swelling and stiffness, and in some cases, permanent damage and deformity in structural joint elements such as cartilage and bone. The presence of autoantibodies is a distinctive feature of RA, with ACPAs and RF being two autoantibody systems commonly used as aids for diagnosing and classifying the disease. Results from IRIS-RA showed that nipocalimab reduced levels of circulating IgG antibodies, including ACPAs, indicating they may play a key role ...
- Source: drugdu
- 100
- November 13, 2023

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