BMS has reported its results for the 2023 financial year (FY), revealing a 2% decrease in revenues of $45bn from $46.2bn reported in 2022. The company saw a decrease in sales of Revlimid (lenalidomide) following the entry of generic versions after its patent loss in 2022. Revlimid generated $6bn in 2023, compared to $12.9bn in 2021 before the loss. BMS’ blockbuster cancer drug Opdivo generated $9bn in 2023, a 9% increase from 2022. The human IgG4 anti-PD-1 monoclonal antibody saw a label expansion, as well as increased demand from patients with gastric, bladder, non-small cell lung cancer (NSCLC) and melanoma. BMS’ top-seller is anti-stroke drug Eliquis (apixaban), generating $12.2bn in 2023, however, Eliquis loses its patent in 2026, with GlobalData predicting that sales will drop to $3bn by 2029.In a strategic move to counteract anticipated revenue declines from upcoming patent expirations on certain BMS drugs in the next few years, ...
Over the years, myriad generic drugmakers have had to ante up fines and settlement fees for allegedly colluding on the prices of copycat drugs. Now, Apotex and two of its generics peers have agreed to settle with direct purchasers of their drugs in a price-fixing case that stretches all the way back to 2017. Apotex plans to settle with the group of direct purchaser plaintiffs for $30 million, while Heritage Pharmaceuticals and Breckenridge Pharmaceutical will hand over $10 million and $5 million, respectively, according to a trio of motions filed Tuesday in the multidistrict litigation in Pennsylvania federal court. Each of the settlement amounts has the potential to increase or decrease, depending on the outcome of the legal proceedings. Apotex, for instance, could have its settlement fund reduced by up to $3.6 million if certain parties opt out of the deal. The case stretches back to 2017, when direct purchasers ...
Taiwan-based CDMO Bora Pharmaceuticals is expanding its business in the United States, acquiring Minnesota generics manufacturer Upsher-Smith Laboratories for $210 million. Upsher-Smith, which was established in 1919, brings two manufacturing facilities that are five miles apart in the suburbs of Minneapolis. These become Bora’s first facilities in the U.S. Bora also has a 170,000 square meter plant in Mississauga, Ontario, which acts as its North America headquarters. Upsher-Smith produces a portfolio of 48 generic products. Its plants can handle packaging and a range of formulations including oral solids, liquids and topical powders. The sites have a total annual capacity of 3.5 billion doses. “This is a significant milestone for Bora Group, marking the most critical expansion of Bora’s presence in the U.S. market and significantly enhancing Bora’s position as a global competitor,” Bora CEO Bobby Sheng said in a release. The acquisition also supports Bora’s commercial prescription business, TWi, which ...
After 16 years on the market, Takeda’s blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. The med, which is also approved for binge-eating disorder, has been in short supply since June due to a “manufacturing delay compounded by increased demand,” the company said in a statement earlier this summer. Now, generics may soon help ease the supply situation. On Aug. 25, the FDA cleared many copycats of the drug. The now-approved generics range in dosage from 10 mg to 70 mg and come in capsule and chewable forms. Manufacturers such as Teva, Sun Pharmaceutical, Actavis, Mylan, Hikma and others have cleared the agency’s regulatory bar with their generics. It’s not clear whether any of the companies have actually launched their copycats in the U.S. Takeda’s patents on its branded version expired Aug. 24. Whenever they debut, the generics will surely be welcomed by patients. A 100-day ...
Swiss-based Novartis announced that the US District Court for the District of Delaware has invalidated the patent covering its cardiac drug Entresto, which expires on 15 July 2025 with the associated paediatric exclusivity. The company said it will now appeal to the US Court of Appeals for the Federal Circuit (CAFC) to further pursue the efforts to validate the combination patent around Entresto. A combination of sacubitril and valsartan, Entresto was first approved by the US Food and Drug Administration (FDA) to treat heart failure with reduced ejection fraction in July 2015. It is also approved to treat symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients. Apart from the patent which was adjudicated by the District Court, additional patents for the combinations of sacubitril and valsartan, including the drug forms and dosages, are listed to expire from November 2026 to May 2036. ...
More than a year ago, eight pharma giants partnered to provide cancer medicines to many of the world’s most needy nations where oncology treatments often are non-existent.On Thursday, the effort took a major step toward fruition as the United Nations-backed Medicines Patent Pool (MPP) signed up four generic drugmakers to produce copycat versions of Novartis’ myeloid leukemia blockbuster Tasigna (nilotinib). The agreement allows BrightGene of Indonesia and three Indian manufacturers—Dr. Reddy’s, Eugia and Hetero—to produce generic nilotinib, even though it remains on patent in the U.S. The generic companies plan to make their copycats in six countries—Egypt, Guatamala, Morocco, Pakistan, the Philippines and Tunisia—and supply it to 44 territories. “We have seen great gains in cancer survival in the richest countries over the last decade, however, the benefit of our innovation is not reaching everyone,” Lutz Hagemann, Novartis’ president of global health and sustainability, said in a release. “Through public-private ...
The new EU Pharmaceutical Strategy, adopted today by the European Commission, is designed to improve and accelerate patients’ access to safe and affordable medicines and address unmet medical needs in the areas of antimicrobial resistance, cancer, and rare diseases. It is also aiming to bolster the competitiveness and the innovative capacity of the EU’s pharma industry. Enhancing crisis preparedness and response mechanisms, and addressing security of supply, drawing lessons from the COVID-19 crisis, are also namechecked as top policy priorities in the strategy, as well as a need to guarantee a strong EU voice on the global stage by promoting a high level of quality, efficacy and safety standards. “The COVID-19 pandemic has, and continues to have, a very serious impact on Europe. Though Europe’s response has demonstrated strengths, existing vulnerabilities have been thrown into sharp focus, including those related to data availability, the supply of medicines or the availability ...
In a potential threat to foreign drugmakers profiting on innovative drugs, the Chinese government on Tuesday issued a new policy package—including tax breaks—to promote generics.
As the world’s largest generics maker, Teva still doesn’t have much of a presence in China, even though it is a country relies heavily on generics. The Israeli company is looking to remedy that by reportedly forming a joint venture with local company Guangzhou Pharma
On the evening of October 24, Hengrui Medicine announced its Q3 performance report for 2024, showcasing steady growth in performance. For the first three quarters of 2024, Hengrui reported an operating revenue of 20.189 billion yuan, marking an increase of 18.67% year-on-year. The net profit attributable to shareholders reached 4.620 billion yuan, an increase of 32.98%, while the net profit after deducting non-recurring gains and losses was 4.616 billion yuan, reflecting a 37.38% increase, demonstrating robust development momentum. According to the report, Hengrui’s R&D expenditures reached 4.549 billion yuan in the first three quarters of 2024, marking a significant increase of 22% year-on-year. This ongoing high-intensity investment in R&D is providing strong momentum for the transformation of the company’s innovative achievements. As a result of these sustained investments, Hengrui is seeing a continual emergence of innovative outcomes. During the reporting period, Hengrui launched its self-developed Class 1 new drug, Fuhuanqi ...
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