Search Results for “Novo Nordisk” – Page 15 – media

Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study

Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond. By FRANK VINLUAN Accelerated approval offers a way to more quickly bring patients drugs for diseases that have few treatment options. But that speedy path to the market comes with the understanding that the FDA can take its regulatory blessing away—unless the company takes its drug away first. That is what Takeda Pharmaceutical has decided to do with its cancer drug, Exkivity. Following discussions with the FDA, the Japanese pharmaceutical giant is voluntarily withdrawing Exkivity from the market. Exkivity treats non-small cell lung cancer by targeting epidermal growth factor (EGFR). That cancer protein must have exon 20 mutations—the same genetic signature addressed by Johnson & Johnson’s Rybrevant. ...
- Source: drugdu
- 197
- October 10, 2023
Ozempic, Wegovy drug prescriptions hit 9 million, surge 300% in under three years

U.S. health care providers wrote more than nine million prescriptions for Ozempic, Wegovy and similar diabetes and obesity drugs during the last three months of 2022, according to a new analysis released Wednesday. The report, from analytics firm Trilliant Health, shows that quarterly prescriptions for those drugs increased 300% between early 2020 and the end of last year. Novo Nordisk ’s weekly diabetes injection Ozempic accounted for more than 65% of total prescriptions as of the end of 2022, and was primarily prescribed off-label for its ability to help patients lose weight. The data further confirms the rise in demand for that group of drugs, which have fueled a frenzy among Americans and on Wall Street for their ability to cause significant weight loss. Those treatments, known as GLP-1s, mimic a hormone in the gut to suppress a person’s appetite. But the rate of future prescription volumes will largely depend ...
- Source: drugdu
- 109
- September 30, 2023
Meitheal partners with Chinese company for US licencing of insulin biosimilars

Meitheal Pharmaceuticals has signed an exclusive licensing agreement with the China-based Tonghua Dongbao Pharmaceutical to commercialise three insulin biosimilars in the US. The insulin biosimilars include two rapid-acting insulins, namely insulin lispro and insulin aspart, and the long-acting insulin glargine. The rights were acquired by Meitheal’s parent company Nanjing King-Friend Biochemical Pharmaceutical. Eli Lilly reported global sales of $440.4m for the branded version of insulin lispro Humalog in n Q2 2023, while Sanofi’s Lantus (insulin glargine) had global sales of $353m in the same period, as per the company’s Q2 financials. Meitheal will have exclusive US marketing rights after the insulin biosimilars are approved by the US Food and Drug Administration (FDA), which is expected in 2026. As part of the agreement, both Tonghua Dongbao and Nanjing King-Friend Biochemical would be responsible for the development and supply of all three insulin biosimilars. All three companies will also share the royalties ...
- Source: drugdu
- 97
- September 30, 2023
Will Big Pharma engage in Medicare price negotiations? AZ, BMS say they will

After the Centers for Medicare & Medicaid Services revealed the list of drugs set to face the first round of price negotiations under the Inflation Reduction Act (IRA), the drugmakers responsible for marketing them are confronting a series of deadlines. First up, the companies need to tell CMS by Sunday whether they’ll participate in the process or exit the Medicare and Medicaid programs entirely. In a statement to Fierce Pharma, an AstraZeneca representative said the company plans to “participate in the process outlined by CMS to communicate the value of Farxiga to people covered by Medicare” as part of its commitment to ensuring access. BMS plans to begrudgingly participate in the process, a spokesperson told Fierce Pharma in an emailed statement. “If we did not sign, we’d be required to pay impossibly high penalties unless we withdraw all of our medicines from Medicare and Medicaid,” the spokesperson said. “That is ...
- Source: drugdu
- 106
- September 29, 2023
Lilly Sues Pharmacies, Spas and Wellness Centers Over Unapproved Mounjaro Copycats

By Matt Olszewski Pictured: Eli Lilly headquarters in Indianapolis/iStock, jetcityimage Eli Lilly on Tuesday announced it has taken legal action against U.S. medical spas, wellness centers and compounding pharmacies for selling products with tirzepatide, the active ingredient in its blockbuster drug Mounjaro. Approved by the FDA to treat type 2 diabetes, Mounjaro is commercially available only through Lilly. The medication is also only available in prefilled single-dose pens. “Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product. Because of this, Lilly filed lawsuits to protect patient safety and stop the unlawful marketing and sale of non-FDA approved compounded products fraudulently claiming to be Mounjaro (tirzepatide) by medical spas, wellness centers and compounding pharmacies,” the company said in a statement In four different lawsuits filed in Florida and Texas federal courts, Lilly is seeking to ban Better Life Pharmacy, ReviveRX, ...
- Source: drugdu
- 100
- September 23, 2023
In warning letters, FDA tells 8 companies to stop selling illicit eye drugs

Eight companies are finding themselves in hot water for allegedly churning out illicit eye drugs, the FDA said Tuesday. The drugs are unapproved and illegally marketed, the FDA said, which is especially risky considering that medications administered through the eye bypass some of the body’s natural defenses. The illegal therapies are purportedly used to treat diseases such as pink eye, cataracts, glaucoma and more, according to the agency’s release. The companies in the warning letter sweep are: Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance. Consumers using the illicit products should talk to a doctor, according to the FDA. The companies, for their part, must respond within 15 days of receiving the FDA’s warning letters. CVS appears to be responding quickly. Reuters reports the company said it has stopped the sale of its Pink Eye Relief Eye Drops and that customers who ...
- Source: drugdu
- 104
- September 14, 2023
Astellas withdraws IRA lawsuit after avoiding CMS’ price negotiations list

Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act (IRA). But now that the Centers for Medicare & Medicaid Services (CMS) has released the first 10 drugs set for governmental bargaining, the company is ready to abandon its litigation. When CMS last week revealed its list of the first 10 drugs eligible for Medicare price negotiations, Astellas’ Xtandi did not make the cut. This surprised some pharma watchers, who had expected the Pfizer-partnered cancer blockbuster to be among the first drugs to face the controversial new process. Now, without Xtandi on the list, Astellas is pulling its lawsuit, Reuters reports. The 10 drugs on the CMS’ list are blockbusters marketed by Johnson & Johnson, Bristol Myers Squibb, Merck & Co., Novartis, Eli Lilly, AstraZeneca, Novo Nordisk and Amgen. Many of the companies whose drugs made the cut had already filed ...
- Source: drugdu
- 189
- September 8, 2023
Weight-loss drug firm becomes Europe’s most valuable

By Mariko Oi The maker of weight-loss drug, Wegovy, has become Europe’s most valuable firm dethroning the French luxury conglomerate LVMH. Shares rose after the Danish pharmaceutical giant, Novo Nordisk, launched the popular drug in the UK. At the close of trading on Monday, the firm had a stock market valuation of $428bn (£339bn). The drug is now available in the UK public healthcare system and also on the private market. Wegovy is an obesity treatment that is taken once a week which tricks people into thinking that they are already full, so they end up eating less and losing weight. Famous personalities such as Elon Musk are among the reported users of the drug, which has captivated Hollywood and the public more widely since it was approved by regulators in the US in 2021. Wegovy and Ozempic – a diabetes treatment with similar effects – have been described as ...
- Source: drugdu
- 228
- September 6, 2023
US announces first ten drugs up for Medicare price negotiation

Medicare will soon be able to negotiate the prescription drug prices for the first time, under US President Joe Biden’s Inflation Reduction Act (IRA), which was enacted last year. Earlier today, the US Department of Health and Human Services (HHS) released a list of ten drugs that will be up for price negotiations. Aimed at driving down healthcare costs and increasing patient power, the IRA allows the Centers for Medicare and Medicaid Services (CMS), the US Government’s national insurance programme, to provide drugs at reduced prices. The price negotiation process will consider elements like the drug’s clinical benefit, the unmet clinical need, and the costs associated with the drug’s production. The negotiations with manufacturing companies will occur in 2023 and 2024, with any price changes rolling in by 2026. Blockbuster drugs are aplenty on the list. Bristol-Myers Squibb (BMS) and Pfizer’s co-developed drug Eliquis (apixaban) and Amgen’s Enbrel (etanercept) are ...
- Source: drugdu
- 103
- August 31, 2023
CMS

The day drugmakers have been dreading has arrived: Tuesday, the Centers for Medicare & Medicaid Services (CMS) unveiled its list of 10 drugs up for the first price negotiations under the Inflation Reduction Act (IRA). The drugs that made the price negotiation cut are Johnson & Johnson’s Imbruvica, Stelara and Xarelto plus Bristol Myers Squibb’s Eliquis, Merck & Co.’s Januvia, Novartis’ Entresto, Eli Lilly’s Jardiance, AstraZeneca’s Farxiga, Novo Nordisk’s Fiasp and Amgen’s Enbrel. Together, the drugs accounted for more than $45 billion in Medicare Part D spending from June 2022 to May 2023, according to a CMS fact sheet (PDF). Next up, these companies will get a chance to submit data and information on their medications to CMS by Oct. 2. Meanwhile, many of the companies are challenging the legality of the IRA in court. It remains to be seen whether any of those efforts can stop the IRA process ...
- Source: drugdu
- 94
- August 31, 2023

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