Sandoz drugs Jubbonti and Xgeva are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies. By FRANK VINLUAN A blockbuster Amgen antibody that treats bone conditions is set to face its first biosimilar competition. The FDA on Tuesday approved two Sandoz drugs as interchangeable with and approved for all uses of the Amgen products. The Amgen antibody, denosumab, is marketed as Prolia for the treatment of osteoporosis. A different dose of the antibody is marketed as Xgeva for preventing bone problems in multiple myeloma patients as well as those whose solid tumors have metastasized to the bones. Sandoz’s biosimilar for the osteoporosis indication will be marketed under the name Jubbonti. For cancer, the Sandoz product will be called Wyost. The Amgen and Sandoz drugs work by binding to a ...
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain patients with multiple myeloma. The agency determined the following grounds for withdrawal were met: (1) the confirmatory study conducted as a condition of accelerated approval did not confirm Pepaxto’s clinical benefit, and (2) the available evidence demonstrates that Pepaxto is not shown to be safe or effective under its conditions of use. The final decision was issued by the FDA’s Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D., as the Commissioner’s designee. The decision is effective immediately. The FDA plans to publish a Federal Register notice announcing the availability of today’s decision and remove Pepaxto from the Orange Book. It is the FDA’s ...
The Senate Health, Education, Labor, and Pensions (HELP) Committee grilled the CEOs of major pharmaceutical companies on what chairman Senator Bernie Sanders labelled “the outrageously high cost of prescription drugs” in the US. Despite intense interrogation, the CEOs made no solid commitments to improve drug prices in the US. The February 8 hearing allowed US senators to question the CEOs of Merck & Co (MSD), Bristol Myers Squibb (BMS) and Johnson & Johnson (J&J) about their drug prices in the US and potential solutions to target high costs. Sanders highlighted price discrepancies between the US and other countries, pointing out that the list price for MSD’s Keytruda (pembrolizumab) is approximately $191,000 in the US, but $112,000 in Canada. On the issue of differential pricing in different countries, BMS CEO Chris Boerner said that the lower prices in countries such as Canada reduced access to essential medications. He said that patients ...
In a move to enhance patient access to complex generic drugs, the FDA’s Office of Generic Drugs (OGD) and the EMA have joined forces in a new pilot programme. This initiative, an extension of the original parallel scientific advice (PSA) programme, homes in on complex generics, also known as ‘hybrid medicines’ as per EMA terminology.Launched in 2005, the original programme offers a means for sponsors of new medicines to seek guidance from regulatory agencies in both the US and EU, regarding scientific matters related to product development. The new voluntary programme aims to facilitate concurrent discussions between generic drug manufacturers and regulatory bodies, with the ultimate goal of improving patient access to harder-to-develop generic drugs. To participate in the PSA programme, applicants must submit requests to the EMA and FDA. Examples of suitable candidates for this programme include proposals for single bioequivalence studies, approaches with common comparators, and the use ...
Eli Lilly’s attempt to wrestle a leukemia market from companies including AbbVie, AstraZeneca, BeiGene and Johnson & Johnson has analysts purring, with the GlobalData team tipping the drugmaker to capture 60% of demand and deliver $3 billion in annual sales. The GlobalData report covers the use of BTK inhibitors in the treatment of chronic lymphocytic leukemia (CLL). Pharmacyclics, now part of AbbVie, and J&J created the market with Imbruvica but now face a sea of threats, with the Inflation Reduction Act, increased competition and the looming prospect of generics pointing to a downward trajectory. AstraZeneca’s Calquence began challenging Imbruvica for the CLL market in 2019 and BeiGene’s Brukinsa joined the party last year. But the GlobalData analysts expect Lilly to come from behind to become the dominant force in CLL in the coming years. Lilly won accelerated FDA approval for Jaypirca in CLL last month. While the drugmaker, which acquired Jaypirca in its $8 billion ...
It took 17 years for Sun Pharmaceutical and Taro Pharmaceutical to finally tie the knot. On Thursday, the companies revealed their long-awaited merger, with Sun of Mumbai, India, agreeing to purchase outstanding shares in the Israeli drugmaker for $43 each. The deal nets out to $348 million for a 48% premium on Taro’s share price of $29. Taro, which manufactures generics, over-the-counter drugs and APIs, will be delisted on the New York Stock Exchange and become a privately held subsidiary within Sun, which already had a 78.5% stake in the company. The companies expect the deal to close in the first half of this year. In its most recent financial report, Taro posted revenue of $593 million for the 12 months ending on Sept. 30, 2023, for a 4% increase year over year. Taro’s annual revenue has generally been in decline since maxing out in 2016 at $951 million. Sun ...
CEO Bill Anderson said despite prior cost-cutting measures, Bayer still has too many layers of management and bureaucracy. A new restructuring will come with layoffs but the corporate shakeup plan does not yet include a separation of Bayer’s business units. By FRANK VINLUAN Bayer is implementing a corporate restructuring that will slash an unspecified number of jobs, particularly within management. But the strategy does not include a breakup of the conglomerate—at least not yet. In announcing its new strategy late Wednesday, Bayer said it aims to reduce hierarchies and eliminate bureaucracy in the company. The job cuts will happen over the coming months and will be completed by the end of next year at the latest, the company said. Bayer’s corporate shakeup is not entirely a surprise. CEO Bill Anderson, who joined Bayer last June after serving as the chief executive of Roche’s pharmaceuticals division, has been critical of bloat ...
Speaking to Sina Finance in Davos, NOVARTIS Global CEO Vas Narasimhan said he is optimistic about the global economy and the company’s next steps, which are characterized by enormous business opportunities despite many challenges. Vas said he was impressed by the continued upgrading and improvement of China’s healthcare system. China is NOVARTIS’ second-largest and fastest-growing market in the world. Overall, I feel very optimistic,” Wansheim said of his experience at Davos. One of the interesting things about Davos is that it brings together so many people who are passionate about improving the world, and so many new ideas in one place.” “As we know, we face many challenges, both in terms of the geopolitical situation and the global economy. But at the same time, I think there are also tremendous opportunities. We are gaining insights into how AI can impact many aspects of life and improve our productivity. At the ...
“Pull incentives such as high cost of therapy and longer exclusivity periods, similar to those granted for orphan drugs, are needed to promote the development of new antimicrobials” says Severin Schwan, chairman of the board of directors of Roche. Schwan was speaking about the threat of antimicrobial resistance (AMR) at the World Economic Forum Annual Meeting taking place from 15–19 January 2024 in Davos, Switzerland. Shyam Bishen, head of the Centre for Health and Healthcare at the World Economic Forum, noted at the same discussion that AMR is the third leading cause of death globally and is forecasted to be responsible for 10 million deaths annually in 2050. Schwan said most companies have left the antimicrobial sector as they perceive that there is no sustainable business model. “The research and development subsidiaries offered by various governments to develop antimicrobials are a waste of money and are not worth it to ...
After many months of shortages affecting attention-deficit/hyperactivity disorder (ADHD) drugs, it was hoped that new generics to Takeda’s Vyvanse would ease the supply situation. But according to a letter from the Association for Accessible Medicines (AAM), production limits on the drug’s active ingredient—set by the government—are at least partly to blame for the shortage that has spread to the generics. Generic drugmakers haven’t been able to obtain enough raw material to “launch their products at full commercial scale,” AAM wrote to the Drug Enforcement Administration (DEA), according to Bloomberg. The DEA sets specific restrictions on production to avoid an excess of supply that could spread to the black market due to Vyvanse’s status as a controlled substance. The agency sets its limits based on past production levels and future sales commitments, which poses a problem given that some companies are cleared to launch the generics but haven’t sold any so ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.