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. ...
The FDA turned down the closely watched eye med because of manufacturing problems the agency spotted at a third-party drug filler, Regeneron said in a release. The FDA didn’t flag any issues with the med’s efficacy and safety or its labeling and drug substance manufacturing and didn’t request additional clinical data, the company said. In a race against Roche’s Vabysmo, Regeneron and its partner Bayer’s application for the 8 mg Eylea (aflibercept) version was accepted in February, hoping for approval in wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. Despite the hurdle, Regeneron remains “committed to working closely with the FDA and the third-party filler” to introduce the high-dose drug, the company said. A Regeneron spokesperson declined to comment on the identity of the filler or where it’s located. Elsewhere, the FDA recently published a Form 483 against an Eli Lilly plant in Indianapolis after an inspection in ...
By Tristan Manalac Pictured: BioMarin headquarters/iStock, Michael Vi The FDA has approved BioMarin Pharmaceutical’s valoctocogene roxaparvovec-rvox, to be marketed as Roctavian in the U.S., for the treatment of adult patients with severe hemophilia A, the company announced Thursday. Roctavian, a one-time single-dose infusion, is authorized for use only in adults without antibodies against the adeno-associated virus serotype 5 (AAV5), as determined by an FDA-approved test. It is also the first gene therapy approved for hemophilia A, according to BioMarin’s news release. In an investor call Thursday afternoon, BioMarin Chief Commercial Officer Jeff Ajer said that “the product profile of Roctavian presents tremendous value to patients, including bleed control, good safety profile and freedom from the burden of chronic therapy.” Roctavian is “priced at a wholesale acquisition cost, or WAC, that equates to $2.9 million for the typical patient for this one-time, single-dose treatment,” Ajer said. Hemophilia A is an inherited ...
The Centers for Disease Control and Prevention on Thursday recommended that adults ages 60 and above receive a single dose of RSV vaccines from Pfizer and GSK after consulting their doctors. Outgoing CDC Director Rochelle Walensky signed off on the recommendation, which an advisory panel of outside experts made last week. That endorsement says seniors should work with their health-care providers to decide if taking a shot is right for them. The CDC said the shots are expected to be available to the public this fall, when respiratory syncytial virus – along with Covid and the flu – typically begins to spread at higher levels. “These vaccines provide an opportunity to help protect older adults against severe RSV illness at a time when multiple respiratory infections are likely to circulate,” the CDC said in a statement. The virus is a common respiratory infection that usually causes mild, cold-like symptoms, but ...
After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.The FDA has cleared Roctavian as a one-time therapy for adults with severe hemophilia A, BioMarin said Thursday. The news comes seven months after the FDA greenlighted CSL Behring’s hemophilia B gene therapy Hemgenix, which bears a list price of $3.5 million and is currently the most expensive drug in the world. BioMarin is pricing Roctavian at a wholesale acquisition cost of $2.9 million, BioMarin’s chief commercial officer Jeff Ajer said during a call Thursday. It’s also setting up an outcomes-based warranty program. The warranty will reimburse government and commercial payers up to the full cost if Roctavian doesn’t live up to its treatment expectations. Partial reimbursement will be granted if an individual loses response to the therapy in the first four ...
Dive Brief: Regeneron Pharmaceuticals is facing a delay for a much-anticipated new version of its best-selling eye medicine after failing to win U.S. approval on Tuesday because of a manufacturing issue. The Food and Drug Administration issued a complete response letter for the high-dose version of Eylea, citing inspection findings at a third-party facility that fills vials of the medication. Regeneron said it’s working with the FDA and the third party to resolve the issues “as quickly as possible.” Importantly, the FDA did not cite any issues with the drug’s safety or efficacy and isn’t asking for new clinical trials. The agency also did not find any issues with the labeling or manufacturing of the actual drug substance, Regeneron said. Dive Insight: While the issue sounds relatively minor, any delay is significant for Regeneron, and the company’s shares tumbled around 11% during trading sessions on Tuesday and Wednesday. Eylea is ...
Merely a month into an FDA approval, AbbVie and Genmab’s bispecific drug Epkinly has chalked up a positive readout that might enable an expansion in blood cancer, although the exact regulatory path remains unclear. Epkinly significantly beat back tumors in 82% of patients with relapsed or refractory follicular lymphoma in a phase 1/2 trial, the companies said Tuesday. The patients had received a minimum two—and a median three—prior lines of systemic therapy. The median duration of response hasn’t been reached in Epkinly’s study, and investigators are still following patients. The companies also didn’t disclose the complete response rate. Full results from the study will be shared at a future medical meeting. Epkinly snagged an FDA approval for previously treated diffuse large B-cell lymphoma (DLCLC) in May, and AbbVie and Genmab said they will talk to regulators about next steps in FL, an indolent form of lymphoma. If approved in the ...
For many people, the day doesn’t start until their coffee mug is empty. Coffee is often thought to make you feel more alert, so people drink it to wake themselves up and improve their efficiency. Portuguese scientists studied coffee-drinkers to understand whether that wakefulness effect is dependent on the properties of caffeine, or whether it’s about the experience of drinking coffee. “There is a common expectation that coffee increases alertness and psychomotor functioning,” said Prof Nuno Sousa of the University of Minho, corresponding author of the study in Frontiers in Behavioral Neuroscience and Field Chief Editor of the journal. “When you get to understand better the mechanisms underlying a biological phenomenon, you open pathways for exploring the factors that may modulate it and even the potential benefits of that mechanism.” A caffeine kickstart The scientists recruited people who drank a minimum of one cup of coffee per day and asked ...
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 ...
Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.Right now, Bayer’s Nubeqa leads the charge in the company’s oncology department, with its sales projected to peak at more than 3 billion euros. In addition, the company’s acquisitions of Vividion Therapeutics, BlueRock Therapeutics and Noria Therapeutics in recent years have bolstered its research capabilities. “We’ve done a lot of activity to fill our early pipeline,” Roth said in an interview with Fierce Pharma on the sidelines of the American Society of Clinical Oncology’s 2023 annual meeting. “But if we want to achieve that top 10 spot in the next four to six years, it’s going to take the right midsize acquisition to get there.” Roth agreed ...
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