Search Results for “FDA” – Page 148 – media

Novo Nordisk Brings New Round of Lawsuits Against Compounded Versions of Ozempic and Wegovy

As demand skyrockets for GLP-1 drugs that can trigger significant weight loss, unauthorized versions of the treatments have started to fill pharmacies. In late May, the FDA warned of illegal knockoffs of Novo Nordisk’s Ozempic and Wegovy. Now, five weeks later, the Danish company has filed its second wave of lawsuits against pharmacies in the U.S. that are producing the copycats. Thursday, in federal courts in Florida and Tennessee, the company accused four companies of making compounded versions of its products that are not approved by the FDA. “Testing new drugs and obtaining the regularly acquired regulatory approval to sell them are time-consuming and very costly,” Novo said in its complaints. “Ignoring drug-approval requirements provides defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk. Worse, it puts patients at risk by exposing them to drugs that have not been shown to be safe or effective.” The defendants are compounding ...
- Source: drugdu
- 130
- July 11, 2023
Cipla Pulls 6 Batches of Asthma Med Albuterol After Inhaler Leak Complaint

Cipla, which was recently hit with a 23-page Form 483 filing from the FDA, is adding to the albuterol supply strain with a U.S. recall of six batches of the asthma med.The company’s voluntary recall of albuterol sulfate inhalation aerosol is a result of a container defect, Cipla said in a filing with the Bombay Stock Exchange. Specifically, a market complaint flagged leakage in one inhaler, the company said. The leak was spotted in the inhaler valve, leading Cipla to pull all of the lots of the drug that used that same batch of valves from U.S. shelves. The company made the move “out of an abundance of caution,” it noted in the release. The lots were manufactured in November of 2021 and expire this November. “Cipla maintains stringent quality processes to assess quality defects and safety issues,” the company said in the filing. “Cipla conducts regular investigation and assessment by committees consisting ...
- Source: drugdu
- 143
- July 11, 2023
EU grants full marketing authorisation for Novavax’s Covid-19 vaccine

US-based Novavax received its first full marketing authorisation for its Covid-19 vaccine Nuvaxovid (NVX-CoV2373) in the EU. Nuvaxovid is now fully authorised as a primary series vaccine for general Covid-19 prevention for individuals aged 12 years and older and as a booster dose in adults aged 18 years and older. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in May 2023, surrounding the vaccine’s full approval. The full authorisation comes a few years after the European Medicines Agency (EMA) granted the prophylactic a conditional marketing authorisation, in December 2021. At the time, Nuvaxovid was the fifth vaccine recommended for Covid-19 prevention in the EU. Novavax has authorised its vaccine in more than 40 markets worldwide. Nuvaxovid is a novel Matrix-M adjuvant protein-based vaccine that has received a US Food and Drug Administration (FDA) emergency use authorisation but has not yet received full ...
- Source: drugdu
- 109
- July 10, 2023
Cipla Issues Voluntary Nationwide Recall of Six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) due to Container Defect

WARREN, N.J., July 6, 2023 /PRNewswire/ — Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”), today announced that its wholly-owned subsidiary Cipla US is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 to the consumer level. Sr. No Product Name Batch No Expiry Date 1 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20045 Nov.2023 2 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20055 Nov.2023 3 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20056 Nov.2023 4 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20057 Nov.2023 5 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20059 Nov.2023 6 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20072 Nov.2023 Risk Statement: There is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of acute asthma exacerbations such as wheezing coughing, shortness of breath and ...
- Source: drugdu
- 101
- July 10, 2023
GSK’s ViiV explores novel pathway to bring long-acting HIV med Cabenuva to tough-to-treat patients

GSK’s Cabenuva made history in 2020 as the world’s first complete, long-acting HIV regimen. But the injectable drug is approved in various countries only as a switch therapy for patients who already have undetectable HIV levels in the blood. Trying to reach tough-to-treat patients who have difficulty controlling the virus with existing daily oral therapies, GSK’s ViiV Healthcare is getting creative. To seek an approval for Cabenuva in patients who aren’t virologically suppressed while on oral drugs, GSK’s ViiV is exploring running a clinical trial using a historical control group. This would replace the standard practice of randomizing some patients in the study to receive standard-of-care oral meds, ViiV’s R&D head Kimberly Smith, M.D., said during a recent interview. The FDA in February unveiled draft guidance laying out the considerations for the use of external control groups in clinical trials to prove a drug’s safety and efficacy. The gist is, ...
- Source: drugdu
- 105
- July 9, 2023
Transcenta Received Approvals from China CDE and South Korea MFDS to Initiate TranStar 301 Global Phase III Pivotal Trial of Osemitamab (TST001)

SUZHOU, China, July 7, 2023 /PRNewswire/ — Transcenta Holding Limited (“Transcenta”) (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it has received approvals from China CDE (Center for Drug Evaluation) and South Korea MFDS (Ministry of Food and Drug Safety) to initiate TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy for the first-line treatment of patients with HER2 negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma. In addition, we are in the process of EU and FDA regulatory interaction. Gastric cancer (GC) is the 4th leading cause of cancer death worldwide, accounting for about 7.7% of all cancer related mortality. The five year survival rate for gastric cancer is still around 30%. Nivolumab, an anti-PD-1 antibody, has been approved globally for the first line treatment ...
- Source: drugdu
- 178
- July 9, 2023
Safety Concerns About New Weight Loss Drugs Brew as Demand Soars

By Heather McKenzie Pictured: Physician with notepad/iStock, Everyday better to do everything you love The European Medicines Agency recently flagged a safety signal regarding the potential for glucagon-like peptide-1 receptor agonists to cause thyroid cancer. The documentation—the first step taken by the regulator toward investigation of potential adverse events in approved products—comes as demand for the popular diabetes and weight loss drugs reaches a fever pitch. The safety signal reported by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in April covers a range of glucagon-like peptide-1 receptor (GLP-1) agonists, including semaglutide, the key ingredient in Novo Nordisk’s Wegovy, Ozempic and Rybelsus. Supplemental information was also requested from Eli Lilly, Sanofi and AstraZeneca, all of which manufacture drugs in this class. GLP-1 is a hormone that stimulates insulin secretion after eating, enabling a feeling of fullness and regulating blood sugar. GLP-1 agonists mimic the effects of this hormone, making them an ...
- Source: drugdu
- 112
- July 9, 2023
With full Alzheimer’s approval in hand, Eisai and Biogen kick off Leqembi’s launch in earnest

It’s official: Roughly half a year after the FDA granted an accelerated nod to Eisai and Biogen’s new Alzheimer’s disease med lecanemab, the companies have converted that green light into a full-fledged, traditional approval. Now, the drug—also known as Leqembi—is set to unshackle itself from a strict coverage determination by the Centers for Medicare & Medicaid services (CMS). With a full approval in hand, Leqembi has become the first treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in adults with Alzheimer’s under the traditional approval pathway, Eisai Executive Vice President Alex Scott, who oversees government affairs, said in an interview. Those benefits stand across a “broad patient group that’s generalizable to the whole Medicare population,” he added. Leqembi won an accelerated FDA approval in January based on its ability to reduce amyloid beta plaque, a marker of Alzheimer’s disease that’s believed to be ...
- Source: drugdu
- 112
- July 8, 2023
Clinics ration supplies as cancer drug shortages proliferate

Drug shortages have been in the news for several years, but they worsened during the Covid-19 pandemic, and several pharmacy, regulatory, and physician organisations, in the US and Europe, have recently issued alerts in response. In May, the American Cancer Society declared that chemotherapy drugs were among the top-five drug classes affected by shortages, and numerous oncology medications are currently in short supply according to data from the US Food and Drug Administration (FDA). “The shortages of oncology drugs are primarily in the generic drug market,” says Dr. Kevin Shulman, a professor of medicine and clinical hospitalist at the Clinical Excellence Research Center at Stanford University. There is no financial incentive for big pharma to manufacture older generic medications that are critical to the treatment of several common cancers and very few companies invest in doing so, says Dr. Kristen Rice, medical oncologist with a practice in San Diego, California. ...
- Source: drugdu
- 104
- July 7, 2023
Sandoz launches high-concentration biosimilar of AbbVie’s Humira in the US

Sandoz, a Novartis division, has announced the US launch of its citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz) – a biosimilar version of AbbVie’s Humira (adalimumab). Hyrimoz HCF (100mg/mL) is approved to treat all indications that are no longer covered by the reference medicine regulatory exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Biosimilars, according to the US Food and Drug Administration (FDA), are biological products that are highly similar to an existing FDA-approved reference product. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower healthcare costs. Hyrimoz was approved by the FDA in 2018 at a concentration of 50mg/mL. The HCF offers a 50% reduction compared to the original concentration and can decrease the number of injections required for people who need at least 80mg ...
- Source: drugdu
- 116
- July 7, 2023

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