A technical flaw has resulted in “unauthorized access” to personal information at Johnson & Johnson’s Janssen CarePath patient assistance program, IBM reported on Wednesday. After an internal investigation, IBM was unable to determine how many accounts were affected, or the exact information that may have been compromised. The company is reaching out to all Janssen CarePath customers “out of an abundance of caution,” the tech giant said in a statement. The Janssen program helped more than 1.16 million U.S. patients access medications in 2022 alone, according to the drugmaker’s website. The free initiative facilitates access by helping patients navigate health insurance, plus provides information to get patients started on and stay on treatment. The program also provides options to manage out-of-pocket costs. By IBM’s account of events, J&J first became aware of a technical loophole in the Janssen CarePath system. Once informed, IBM, which manages the service, “promptly remediated the ...
After a groundbreaking approval for Tecentriq, Roche has another positive early-stage lung cancer trial to celebrate. This time, the honor belongs to a targeted therapy in Alecensa. Alecensa, compared with chemotherapy, reduced the risk of tumor recurrence or death when used after surgery in certain non-small cell lung cancer patients, Roche said Friday. The patients had ALK-positive, stage 1b to 3a tumors that were completely resected before taking Alecensa. The positive readout, from the ALINA trial, makes Alecensa the first ALK inhibitor to show a benefit in early-stage NSCLC in a phase 3 trial, Roche noted. Data on patient survival remain immature. But the Swiss pharma said it’ll submit the results to the FDA and the European Medicines Agency for a potential label expansion. “If approved, Alecensa has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure,” Roche’s chief ...
By Kate Goodwin Pictured: 3D rendering of antibody-drug conjugate/iStock, Love Employee BioNTech’s licensed antibody-drug conjugate is moving on to Phase III testing in a potential effort to challenge AstraZeneca and Daiichi Sankyo’s blockbuster Enherto in a heavily treated breast cancer subpopulation. DualityBio, BioNTech’s partner and the ADC’s creator, posted the trial plans Wednesday. BioNTech added the ADC, DB-1303, to its portfolio in April 2023 when it paid China’s DualityBio $170 million upfront for rights to it plus a second preclinical asset. Another $1.5 billion is on the line in milestone payments, plus tiered royalties. DB-1303 will be pitted against chemotherapy in the open-label Phase III for patients with HER2-low, HR+ metastatic breast cancer patients whose disease has progressed despite endocrine therapy. ADC therapy is like a targeted missile for cancer, with an antibody targeted to deliver the cancer killing payload. DB-1303 is a topoisomerase-1 inhibitor. Phase I/II trial results showed ...
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 ...
Pfizer’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) to protect both infants and older adults against RSV-caused lower respiratory tract disease (LRTD). The EC’s decision allows Abrysvo to be given as a single dose to adults aged 60 years and older, and those who are 24 to 36 weeks into their pregnancy to protect their babies from birth until they are six months old. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can cause severe illness in young infants and older adults. In the EU, about 245,000 yearly hospital admissions have been associated with RSV in children aged under five years, while the virus is estimated to cause more than 270,000 hospitalisations in older adults each year. The EC’s decision, which follows a recent recommendation from the European Medicines ...
As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. In May, the U.K. company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna. And now—well in advance of the fall and winter RSV season—Arexvy is available in major U.S. retail pharmacies, GSK said Thursday. Under the Inflation Reduction Act, Medicare Part D patients will pay no out-of-pocket expenses for the shot, GSK said. Additionally, under the Affordable Care Act, patients with commercial insurance may be covered when Arexvy is administered in-network, GSK said. In June, the Advisory Committee on Immunization Practices (ACIP) recommended that people 60 and older decide in consultation with their healthcare provider whether to receive the RSV vaccine. As people age, their immune systems can become compromised, making them more vulnerable to ...
Pfizer is shelling out $43 billion to acquire Seagen primarily for the Seattle biotech’s antibody-drug conjugate (ADC) capabilities. But a trial win for a small-molecule cancer drug makes the deal more attractive. Seagen on Wednesday said a phase 3 trial testing a combination of its Tukysa and Roche’s Kadcyla has hit its main goal in patients with previously treated HER2-positive breast cancer. Compared with Kadcyla and placebo, the combo significantly reduced the risk of tumor progression or death, Seagen said. Data on patient survival remain immature. Seagen plans to share the detailed results from the HER2CLIMB-02 trial at a medical meeting and will discuss them with the FDA, the company’s R&D chief, Roger Dansey, said in a statement. The positive results further de-risk the Seagen acquisition by Pfizer, Leerink Partners analysts said in a Wednesday note. Since securing FDA approval in 2020, Tukysa has been used alongside trastuzumab (Herceptin) and ...
By Tristan Manalac Pictured: Janssen headquarters in California/iStock, Sundry Photography The FDA on Friday signed off on Janssen Pharmaceutical’s niraparib and abiraterone acetate tablets, now to be marketed as Akeega, for the treatment of metastatic castration-resistant prostate cancer in patients carrying the BRCA mutation. According to Janssen’s announcement, Akeega is the first dual-action tablet that combines the activity of a PARP inhibitor with abiraterone acetate, an androgen biosynthesis inhibitor sold by the company under the brand name Zytiga. Janssen is a subsidiary of Johnson & Johnson. The approval covers a combination regimen of Akeega with prednisone and is based on data from the Phase III MAGNITUDE study, a randomized, double-blinded and placebo-controlled trial with 765 participants. Compared with Zytiga plus prednisone, the Akeega-based regimen significantly improved radiographic progression-free survival by 47% in BRCA-positive patients. Akeega also led to a trend toward better overall survival, though this effect fell short of ...
GSK has won the first FDA approval for an immunotherapy to treat certain patients with newly diagnosed endometrial cancer. But the industry-first go-ahead is tempered with a label limitation. The FDA has cleared Jemperli as an add-on to chemotherapy for patients with primary advanced or recurrent endometrial cancer, GSK said Monday. To be eligible for the therapy, the patient’s tumor must be mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), both terms that describe a type of genetic abormality. The approval comes nearly two months ahead of schedule and puts Jemperli ahead of Merck & Co.’s rival PD-1 inhibitor Keytruda, which is also gunning for the first-line endometrial cancer use. But the dMMR/MSI-H restriction comes as a bit of a disappointment for the GSK drug. By GSK’s estimate, about 15% to 20% of the roughly 60,000 new cases of endometrial cancer each year in the U.S. will be diagnosed at an advanced ...
The UK’s Medicines and Healthcare products Regulatory Agency said Wednesday that it is reviewing a class of drugs used for obesity and diabetes treatment after reports of self-injury and suicidal thoughts in patients. The probe by the MHRA comes shortly after the European Medicines Agency (EMA) expanded its own investigation into the GLP-1 receptor agonist class of drugs. This includes medications like Saxenda (liraglutide), Wegovy (semaglutide) and Ozempic (semaglutide) produced by Danish pharma company Novo Nordisk. According to reporting by Reuters, the MHRA also confirmed AstraZeneca’s Bydureon (exenatide), Sanofi’s lixisenatide, and Eli Lilly’s dulaglutide were also being included in the review. Novo Nordisk told Reuters that it had received a request from the MHRA about the investigation. “The review is ongoing and a response will be provided within the requested timelines,” Novo Nordisk said in a statement. The MHRA review kicked off July 12, though the agency could not specify when it would ...
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