Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. Thanks to a new FDA approval, a continuous immunotherapy regimen for use on both sides of surgery is now available for certain patients. The approval, for Merck’s Keytruda, clears the PD-1 inhibitor to be used both as part of a neoadjuvant regimen before surgery and as an adjuvant therapy after surgery in patients with resectable NSCLC. Patients also take chemotherapy during presurgical treatment. In a coveted win for Merck, Keytruda’s updated label (PDF) already includes data showing that, compared with neoadjuvant chemo alone, the addition of perioperative Keytruda significantly cut the risk of death by 28% in the Keynote-671 study. Patients who took neoadjuvant chemo alone lived a median 52.4 months, while the median result for the Keytruda arm wasn’t reached by the time of the analysis, ...
What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer (NSCLC) could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Keytruda. Using Keytruda both before and after surgery significantly extended the lives of patients with stage 2 to 3b NSCLC in a phase 3 trial, Merck said Tuesday. The Keytruda regimen was pitted against presurgical chemo alone, while Keytruda recipients also received chemotherapy before surgery. The Keynote-671 trial marks the first time an immunotherapy has shown a statistically significant overall survival benefit for certain patients with early-stage NSCLC, Marjorie Green, M.D., head of late-stage oncology development at Merck Research Laboratories, said in a statement. The positive readout comes right before the FDA is expected to decide—by Monday—on Keytruda’s perioperative use as a continuous neoadjuvant-plus-adjuvant therapy in early-stage NSCLC. The trial previously met its other dual primary endpoint, showing Keytruda could reduce ...
Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024. By FRANK VINLUAN An Alnylam Pharmaceuticals drug developed to treat a rare disease’s potentially fatal effects on the heart has fallen short in its bid for FDA approval, costing the company a chance to immediately challenge a Pfizer product that has become a blockbuster seller in the indication. But the biotech still has another chance with a different drug in late-stage development that could offer patients a better alternative. Alnylam was seeking approval of its drug, Onpattro, as a treatment for cardiomyopathy caused by hereditary transthyretin amyloidosis (hATTR). According to the Cambridge, Massachusetts-based company, the FDA’s complete response letter said ...
After the Centers for Medicare & Medicaid Services revealed the list of drugs set to face the first round of price negotiations under the Inflation Reduction Act (IRA), the drugmakers responsible for marketing them are confronting a series of deadlines. First up, the companies need to tell CMS by Sunday whether they’ll participate in the process or exit the Medicare and Medicaid programs entirely. In a statement to Fierce Pharma, an AstraZeneca representative said the company plans to “participate in the process outlined by CMS to communicate the value of Farxiga to people covered by Medicare” as part of its commitment to ensuring access. BMS plans to begrudgingly participate in the process, a spokesperson told Fierce Pharma in an emailed statement. “If we did not sign, we’d be required to pay impossibly high penalties unless we withdraw all of our medicines from Medicare and Medicaid,” the spokesperson said. “That is ...
Ionis Pharmaceuticals’ olezarsen has Phase 3 results showing the therapy handily beat a placebo at reducing fat levels in the blood due to a rare, inherited metabolic disorder with no FDA-approved drugs. Ionis plans early 2024 submissions for what could become the first medicine it commercializes without a partner. By FRANK VINLUAN Ionis Pharmaceuticals has revenue from commercialized medicines, but those products reached the market in the hands of biopharma industry partners. The genetic medicines company does have wholly owned assets, and one of them now has preliminary Phase 3 data that put it on the path for an FDA submission. The drug, olezarsen, is a potential treatment for familial chylomicronemia syndrome, or FCS. The rare, inherited disease leads to the inability to break down triglycerides, which are fats consumed from food. High triglyceride levels can lead to acute pancreatitis, severe inflammation of the pancreas that can become fatal. Patients ...
On a €1 billion quest to build a global mRNA network, Merck KGaA’s MilliporeSigma has rounded out its service offerings to include all key stages of mRNA development, manufacturing and commercialization.Tuesday, MilliporeSigma christened two new mRNA drug substance manufacturing sites in Darmstadt and Hamburg, Germany. The company has invested €28 million in the sites, where it plans to hire 75 new staffers, MilliporeSigma said in a release. The new facilities will be able to tackle a full range of mRNA services, from pre-clinical to commercial-scale projects, MilliporeSigma said. Those offerings will include analytical development and biosafety testing specifically designed for mRNA technologies, the company added. The facilities fall under the umbrella of MilliporeSigma’s €1 billion investment to advance mRNA technologies and build its global mRNA network. Employing 27,000 worldwide, MilliporeSigma sells life sciences companies the tools and tech needed for testing and manufacturing. It also operates a contract testing, development ...
Merck KGaA has announced two new strategic partnerships with Benevolent AI and Exscientia to support its artificial intelligence (AI)-driven drug discovery plans. Benevolent and Exscientia plan to leverage Merck KGaA’s expertise in oncology and neuroinflammation under the collaboration. As part of the agreement, the companies have collectively selected three potential first-in-class and best-in-class targets. The partnership will focus on finding viable small molecule candidates for development that Merck KGaA will choose for further preclinical and clinical development. In this deal, announced on 20 September, BenevolentAI will be eligible for payments of up to $594 million, including a low double-digit million-dollar immediate payment. Further payments will be made according to future discovery, development and commercial milestones. Also, the London, UK-based company could receive tiered royalties on net sales of any commercialised products. BenevolentAI is already collaborating with AstraZeneca and Eli Lilly for AI-driven drug discovery. In May, BenevolentAI announced intentions to ...
Mere hours after it surfaced that Lonza’s CEO, Pierre-Alain Ruffieux, will step down, the Swiss CDMO has lost another major executive. And this time, the exec is jumping ship to U.S. contract manufacturing rival Catalent. Monday, Catalent named Lonza’s David McErlane group president of its biologics segment. McErlane, who most recently served as Lonza’s senior vice president and head of the bioscience business, will take up his post at Catalent on Sept. 25, a source familiar with the matter told Fierce Pharma. McErlane’s hiring represents one of the first major strategic grabs since Catalent caved in to activist investor Elliott Management last August. The New Jersey CDMO is now working to rejuvenate its business after a difficult stretch of manufacturing snares, executive turnover and dwindling revenues. Before joining Catalent, McErlane led a Lonza department that provides specialty raw materials and technology solutions for cell and gene therapies, injectable drugs, vaccines ...
IBM has announced a data breach of Janssen’s CarePath platform and has started informing affected customers. The Janssen CarePath portal provides patients and healthcare professionals in the US with information regarding insurance coverage, out-of-pocket costs, and prescribing information at no cost to the users. The number of highest grossing Janssen drugs are included in the platform such as Darzalex (daratumumab) and Stelara (ustekinumab) which generated $2.5bn and $3.2bn in US sales in H1 2023, respectively, as per the company’s Q2 2023 financial report. Data breaches at the top pharma companies are nothing new, as companies such as Merck & Co (MSD), Roche, and AstraZeneca have all been hacked in the past. Data breaches cost the companies an average of $5m to remediate, as per IBM’s 2020 data breach report. The Janssen CarePath systems provider, IBM, indicated that the stolen data may have contained information provided as part of the Janssen ...
Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act (IRA). But now that the Centers for Medicare & Medicaid Services (CMS) has released the first 10 drugs set for governmental bargaining, the company is ready to abandon its litigation. When CMS last week revealed its list of the first 10 drugs eligible for Medicare price negotiations, Astellas’ Xtandi did not make the cut. This surprised some pharma watchers, who had expected the Pfizer-partnered cancer blockbuster to be among the first drugs to face the controversial new process. Now, without Xtandi on the list, Astellas is pulling its lawsuit, Reuters reports. The 10 drugs on the CMS’ list are blockbusters marketed by Johnson & Johnson, Bristol Myers Squibb, Merck & Co., Novartis, Eli Lilly, AstraZeneca, Novo Nordisk and Amgen. Many of the companies whose drugs made the cut had already filed ...
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