Search Results for “FDA” – Page 53 – media

Perrigo’s OTC birth control pill aces FDA expert meeting

The jury has spoken, giving a unanimous “yes” to push Perrigo’s birth control tablet Opill over the counter. Wednesday, experts from a joint FDA meeting of outside experts voted 17 to 0 in favor of Opill’s over-the-counter approval pivot. If approved later this year by the FDA, Opill would become the first OTC daily hormonal birth control pill cleared in the U.S. The unanimous vote came despite a number of big questions from the FDA about the potential for Opill’s responsible over-the-counter use in the real world. The FDA does not have to follow the advice of its advisory committees when making an approval vote, though it often does. Panelists had one main question to consider. Namely: Was there “adequate information to conclude that consumers will be likely to use [Opill] properly, such that the benefits of making this available for nonprescription use … exceed the risks.” Overall, panelists concluded ...
- Source: drugdu
- 127
- May 12, 2023
GSK’s RSV vaccine approved by FDA for older adults

GSK’s respiratory syncytial virus (RSV) vaccine has been approved in the US for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older. The US Food and Drug Administration’s (FDA) decision makes Arexvy the first RSV vaccine for older adults to be approved anywhere in the world. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease. This is partly due to age-related decline in immunity. RSV can also exacerbate other conditions, including chronic obstructive pulmonary disease, asthma and chronic heart failure. Overall, RSV infections in older adults account for over 170,000 hospitalisations and approximately 14,000 deaths each year in the US. The company’s application was supported by positive results from its phase 3 AReSVi-006 trial, in which the vaccine showed ...
- Source: drugdu
- 145
- May 12, 2023
FDA completes inspection of Nexus’ manufacturing facility in US

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with stringent quality and safety standards. Equipped with advanced isolator technology, the Pleasant Prairie facility adheres to the highest current good manufacturing practice (CGMP) standards. It is designed to manufacture a broad range of injectable medications and will provide hospitals and clinicians access to affordable, safe, and critical-need medicines. Nexus Pharmaceuticals President and CEO Usman Ahmed said: “We are thrilled to receive the EIR for our Pleasant Prairie facility. “This is a major milestone for our company and reflects our commitments to reshoring sterile pharmaceutical manufacturing to the US. “We are proud of our team’s hard work and focus on achieving a ...
- Source: drugdu
- 125
- May 10, 2023
Manufacturing operations for Eli Lilly, Rentschler reprimanded by FDA

After FDA inspectors visited Eli Lilly and Rentschler Biopharma production sites in October 2022 and early 2023, respectively, the U.S.’ drug regulator is making concerns about the facilities public. In Form 483 filings posted this week, the FDA flagged Lilly’s site in Indianapolis for three manufacturing-related shortfalls and Rentschler’s Baden-Wurttemberg, Germany, site for five deficiencies. At Lilly’s site, the regulator said the company’s aseptic technique for an undisclosed drug’s filling operation was “deficient.” Specifically, operators “handled unprotected sterile components” in a way that “may introduce contaminants onto sterile surfaces” in certain areas, the FDA said. Aside from that observation, the FDA flagged “processing areas” for two filling lines as substandard. Again, the FDA flagged sanitization procedures as not meeting its standards. Inspectors visited Lilly’s Indianapolis site from Oct. 17-21, 2022. In parallel to the Indianapolis site inspection and filing, the FDA in April rejected Eli Lilly’s ulcerative colitis prospect mirikizumab over manufacturing-related shortfalls. It isn’t immediately clear whether the ...
- Source: drugdu
- 189
- May 8, 2023
After FDA rejection, Gilead’s Hepcludex looks set for full EU nod

Six months after Gilead got a smackdown in the United States for its drug to treat hepatitis delta virus (HDV), bulevirtide has scored a regulatory win in Europe. The Committee for Medicinal Products for Human Use (CHMP) has given bulevirtide a thumbs up for patients with HDV and compensated liver disease. If the European Commission signs off on the entry inhibitor, it will become the only authorized treatment for HDV in Europe. Known commercially as Hepcludex, the drug received conditional approval in Europe three years ago. Since then, a phase 3 trial has demonstrated the effectiveness and safety of the treatment. Gilead hoped the results of the MYR301 study—which were released in June of last year and showed significant viral declines after 48 weeks of treatment—would pave the way for approval in the U.S. But the FDA sent Gilead a complete response letter (CRL) citing manufacturing and delivery concerns. The regulator did not ask Gilead to conduct another ...
- Source: drugdu
- 411
- May 8, 2023
Protalix, Chiesi challenge Sanofi with EU approval for Fabry disease med as FDA decision looms

Protalix BioTherapeutics and Chiesi Farmaceutici have endured a rejection from the FDA and conducted multiple readouts of a phase 3 trial of their Fabry disease candidate. After many stops and starts, the companies have finally scored a marketing approval in Europe for PRX-102 (pegunigalsidase alfa), an enzyme replacement therapy for the rare, genetic, progressive disorder, which causes an accumulation of fatty deposits in the lysosomes and strikes roughly 1 in 50,000 people. The authorization is based on results from a clinical program that has tested PRX-102 in more than 140 patients with up to 7.5 years of treatment. A head-to-head trial pitting PRX-102 against Sanofi’s Fabrazyme (agalsidase beta) demonstrated noninferior efficacy in controlling the kidney disease that accompanies the disorder. Fabrazyme, which was approved 20 years ago, is the longtime dominant drug in the Fabry disease market, generating sales of 938 million euros ($986 million) last year. Amicus Therapeutics of Philadelphia, which earned an FDA approval for its ...
- Source: drugdu
- 185
- May 8, 2023
Formus Labs’ Hip Surgery Planning Software Expands with FDA Clearance

In order to carry out a seamless joint replacement, surgeons must create a customized preoperative plan for each patient. However, surgeons having to perform multiple operations per day are often too busy to dedicate adequate time to this step. Formus Labs, a New Zealand-based medical technology startup, is on a mission to make the preoperative planning process much quicker. On Wednesday, the company received 510(k) clearance from the FDA for Formus Hip, its fully automated 3D software for hip replacement preoperative planning. The company announced its plans to expand into the U.S. last year. Wednesday’s FDA clearance represents a major milestone, as Formus can now begin to sell its product to surgeons and healthcare providers across the country. Founded in 2017, Formus seeks to solve the problem of patient dissatisfaction and unsustainable costs in joint replacement surgery, said CEO Ju Zhang in a recent interview. “Our approach to solving this ...
- Source: drugdu
- 129
- May 7, 2023
FDA issues new draft guidance on decentralised clinical trials

The US Food and Drug Administration (FDA) has issued new draft guidance on the implementation of decentralised clinical trials (DCTs), in which some or all trial-related activities occur at locations other than traditional investigation sites. This could include carrying out clinical tests at a local facility rather than a research medical centre, or conducting follow-up visits in the participants’ homes using telemedicine. The 16-page document provides recommendations for sponsors, investigators and other stakeholders on the use of these trials, which the agency expects’ will play an important role in addressing public health needs’. ‘By reducing barriers to participation, we expect that DCTs will increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges,’ the FDA said in a statement. The guidance covers recommendations on topics such as DCT design, the use of digital health technologies for remote patient monitoring, ...
- Source: drugdu
- 125
- May 6, 2023
Seres’s Bacteria in a Pill Becomes First FDA-Approved Oral Microbiome Therapy

Recurrent Clostridioides difficile infection can be treated with fecal microbiota transplants. FDA approval of Seres Therapeutics’ Vowst makes it the first oral microbiome therapy. A capsule filled with bacteria is now FDA approved for treating a serious and potentially deadly type of gut infection, making the Seres Therapeutics drug the first oral microbiome therapy to receive the regulatory go-ahead for patients. The infection is caused by Clostridioides difficile (C. difficile or C. diff), a bacterium that’s part of the diverse microbial community in the intestines. When the gut microbiome is disrupted, C. diff can proliferate, releasing toxins that cause frequent diarrhea, abdominal pain, and fever. In severe cases, the infection leads to organ failure and death. Antibiotics can treat C. diff infection, but these bacteria can develop resistance, leading to a recurrence of the infection. When that happens, patients have limited treatment options. According to Centers for Disease Control and Prevention data cited by Seres, about 156,000 cases of ...
- Source: drugdu
- 176
- May 2, 2023
FDA clears Pfizer’s pneumococcal vaccine for infants and children

Pfizer on Thursday gained U.S. approval of its newest pneumococcal conjugate vaccine for use in children and infants, helping it compete with a rival shot from Merck & Co. that won a similar OK last year. Pfizer’s vaccine, called Prevnar 20, is designed to protect against infection by 20 strains of the bacteria — seven more than the company’s prior Prevnar 13 version. It has been approved in adults since 2021. Last July, Merck won approval in children of its Vaxneuvance vaccine, which protects against 15 strains. Both companies could soon face more competition as the market has sparked interest from other drugmakers. While vaccines for the bacterial infection are widely available, thousands of cases still lead to hospitalization and death in the U.S. each year. In response, Pfizer, Merck and others have worked to develop new shots that offer better protection, particularly against strains that weren’t ...
- Source: drugdu
- 232
- May 1, 2023

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