Search Results for “Roche” – Page 3 – media

Roche’s subcutaneous Tecentriq recommended by CHMP for multiple cancer types

Roche has announced that an injectable form of its PD-L1 inhibitor Tecentriq (atezolizumab) has been recommended by the European Medicines Agency’s human medicines committee for multiple cancer types. The subcutaneous (SC) formulation of Tecentriq can cut treatment time by approximately 80%, the company said, with most injections taking between four to eight minutes compared with 30 to 60 minutes for an intravenous (IV) infusion. The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that Tecentriq SC be authorised for use in all indications in which the drug’s IV form has previously been approved, including certain types of lung, liver, bladder and breast cancer. The committee’s decision will now be reviewed by the European Commission and, if approved, Tecentriq SC will be the first injectable PD-L1 cancer immunotherapy in the EU. Levi Garraway, Roche’s chief medical officer and head of global product development, said: “Tecentriq has helped to ...
- Source: drugdu
- 171
- November 18, 2023
Roche Cuts Pipeline as COVID, Currency Headwinds Impact Q3 Results

Pictured: Roche tower in Switzerland/iStock, olli0815 Roche is eliminating four clinical programs amid drooping sales brought about by a sharp decline in demand for COVID-19 products and a strong Swiss franc, the pharma group announced Thursday morning in its third-quarter earnings results. According to a development pipeline document released alongside the quarterly report, Roche will end a Phase I solid tumor trial for its investigational CEA/CD3 bispecific antibody cibisatamab. The company will also stop Phase II trials of its antipsychotic drug candidate ralmitaront in schizophrenia and the developmental cannabinoid receptor agonist vicasinabin in diabetic retinopathy. Roche discontinued the mid-stage study of ralmitaront after it failed a Phase II trial in May 2023, unable to elicit significant improvements on negative symptoms in a preliminary analysis. The vicasinabin and cibisatamab programs were likewise scrapped following underwhelming reviews of their efficacy in their respective studies. However, in a media call Thursday morning, a Roche spokesperson said that these two ...
- Source: By Tristan Manalac
- 141
- October 31, 2023
Roche announces positive phase 3 results for Alecensa in early-stage lung cancer

Roche has shared new results from a late-stage study of its anaplastic lymphoma kinase (ALK) inhibitor Alecensa (alectinib) in early-stage lung cancer. The phase 3 ALINA study has been evaluating the targeted drug as an adjuvant therapy in patients with completely resected stage 1B to 3A ALK-positive non-small cell lung cancer (NSCLC). Alecensa was shown to reduce the risk of disease recurrence by 76% compared with platinum-based chemotherapy, Roche said. A clinically meaningful improvement of central nervous system disease-free survival was also observed in those receiving Alecensa, and the safety and tolerability of the therapy were consistent with previous trials in the metastatic setting. Overall survival data was immature at the time of this analysis and the company has outlined that follow-up is ongoing to “report a more mature estimate”. Levi Garraway, Roche’s chief medical officer and head of global product development, said: “By reducing the risk of recurrence or ...
- Source: https://www.pmlive.com/pharma_news/roches_alecensa_shows_promise_in_phase_3_early-stage_lung_cancer_trial_1502267
- 122
- October 30, 2023
Royalty Boosts Struggling PTC with Additional $1B for Royalties on Roche’s Evrysdi

Pictured: Handshake over a deal/iStock, PeopleImages Biopharma’s biggest royalties buyer is upping its stake in a popular spinal muscular atrophy drug. Royalty Pharma announced Thursday a $1 billion upfront payment to beleaguered PTC Therapeutics for additional royalties in Evrysdi, licensed and marketed by Roche. Royalty initially bought into Evrysdi in July 2020, just before its approval by the FDA. The drug has already been used to treat over 11,000 patients worldwide. Spinal muscular atrophy (SMA) is a rare and often fatal genetic disease that typically presents in infants and young children. The deal increases Royalty’s ownership of the Evrysdi royalty from 43% to 81%, equating to 13% of the royalties Roche pays on worldwide net product sales. Roche reported $801.4 million in sales for the first half of 2023. GlobalData predicts sales to rise to just under $3 billion in 2029. In Thursday’s announced deal, PTC has the option to sell the remainder of the Evrysdi royalty to Royalty for up ...
- Source: Kate Goodwin
- 120
- October 21, 2023
Roche’s Subcutaneous Ocrevus Rivals IV Formulation in Phase III MS Trial

By Kate Goodwin Pictured: Roche Building in Pleasanton/iStock, JHVEPhoto Roche’s Genentech claimed victory for the subcutaneous formulation of its multiple sclerosis blockbuster Ocrevus on Wednesday, with plans to submit Phase III data for regulatory approval. In the OCARINA II study, twice-yearly, 10-minute subcutaneous injections of Ocrevus were pitted against the currently approved IV formulation for multiple sclerosis (MS). The subcutaneous dosing proved as effective in patients with relapsing or primary progressive MS over a 24-week period as the IV version on pharmacokinetic, biomarker and MRI measures. Ocrevus works by targeting and removing a type of B cells that attack the myelin covering around the brain and spinal cord nerve cells. In the Phase III study, the subcutaneous injection provided rapid and sustained B-cell depletion similar to the IV infusion—97% and 98%, respectively, had levels of 5 cells/µL or less at two weeks, which was sustained over 24 weeks. Both formulations ...
- Source: drugdu
- 116
- October 13, 2023
Roche presents positive results for spinal muscular atrophy treatment Evrysdi in babies

Roche has presented positive results from an ongoing study evaluating its spinal muscular atrophy (SMA) treatment Evrysdi (risdiplam) in babies aged from birth to six weeks with pre-symptomatic disease. SMA is a severe and progressive neuromuscular disease affecting approximately one in every 10,000 babies. Those living with the condition have insufficient levels of the SMN protein, which is essential to the function of nerves that control muscles and other functions such as swallowing, speaking, breathing and movement. Roche’s Evrysdi, which can be administered at home in liquid form by mouth or by feeding tube, is designed to treat the disease by increasing and sustaining the production of SMN protein in the central nervous system and peripheral tissues. Clinical studies have shown that the loss of motor neurons may begin before symptoms start, so beginning treatment early is seen as critical for improved outcomes. Results from the ongoing RAINBOWFISH study, which ...
- Source: drugdu
- 207
- October 10, 2023
Roche condemns ‘act of counterfeiting’ as authorities in Pakistan crack down on unapproved Avastin use

After several diabetic patients received a sham version of Roche’s Avastin and lost their sight, the Drug Regulatory Authority of Pakistan (DRAP) is halting the sale or distribution of the drug until it can verify quality, the agency said in a release Sunday.The affected patients received “altered/dispensed/diluted Avastin” to treat diabetic retinopathy, despite the drug only being approved in Pakistan to treat colorectal and other metastatic carcinomas, the regulator said. Roche itself isn’t being blamed for the issue. Rather, DRAP singled out Genius Advanced Pharmaceutical Services, which it accused of altering, dispensing, diluting and selling unlicensed Avastin made under unhygienic and non-sterile conditions. In response to Genius’ actions, Pakistan’s regulatory field force raided the company’s facility, according to the DRAP release. “The premises have been sealed and legal proceedings have been initiated against the personnel involved,” DRAP said. Roche “strongly condemns” the “criminal act of counterfeiting,” the company said in ...
- Source: drugdu
- 127
- October 6, 2023
Roche scores—again—in hemophilia drug patent case against Takeda

In a patent case centered on two rival hemophilia medicines, Roche’s Genentech unit has scored its second straight win. After a U.S. district court last year ruled in favor of Roche and invalidated a patent held by Takeda’s Baxalta unit, the U.S. Court of Appeals for the Federal Circuit reaffirmed the ruling. In the decision, U.S. Circuit Judge Timothy B. Dyk wrote that in order to be valid, patents must describe inventions “in such full, clear, concise and exact terms” so that any skilled person can make and use the same product “without undue experimentation.” In this case, Baxalta’s patent describes an antibody that binds to a protein that’s key to enable blood clotting. In its appeal, Baxalta argued that skilled practitioners can use a screening process that doesn’t amount to undue experimentation. But the circuit court shot down this argument, supporting the decision that the patent should be invalidated. ...
- Source: drugdu
- 188
- October 1, 2023
Roche hits FDA delay with subcutaneous version of Tecentriq amid manufacturing process changes

It’s looking like Roche may not receive an on-time FDA decision for the subcutaneous version of its cancer immunotherapy Tecentriq.The FDA was supposed to dole out a verdict on subcutaneous Tecentriq by next week. But Roche now needs to update the therapy’s manufacturing processes, the Swiss pharma’s drug delivery technology partner Halozyme Therapeutics said in a securities filing Thursday. “These updates are expected to be completed in 2023 and are expected to support a potential launch of Tecentriq SC in the U.S. in 2024,” Halozyme said. Roche is making the changes in response to the FDA’s evolving requirements, a spokesperson with the company’s Genentech unit told Fierce Pharma. The spokesperson confirmed that the company now expects to receive an FDA approval in 2024. Roche filed the under-the-skin formulation to both the FDA and the European Medicines Agency in November. It’s targeting all existing indications of the original intravenous Tecentriq. Last ...
- Source: drugdu
- 165
- September 9, 2023
Following in Tecentriq’s footsteps, Alecensa gives Roche another win in early-stage lung cancer

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 ...
- Source: drugdu
- 116
- September 6, 2023

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