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Amgen to sell cholesterol drug at 60% discount direct to US consumers

Amgen on Monday launched direct-to-consumer U.S. sales of its cholesterol medication Repatha at a discounted cash price, becoming the latest pharmaceutical company responding to U.S. political pressure to lower drug prices. The injected drug, with sales of $2.2 billion last year, will have a monthly price of $239, or nearly 60% below its current U.S. list price, the company said. It said the price matches the lowest it now receives in any economically developed country. Amgen was one of 17 major drug companies that received a letter from President Donald Trump in July demanding they charge U.S. patients the same price as people in other high-income countries, create direct-to-consumer channels and increase investment in the U.S. Trump threatened to impose 100% tariffs on branded drugs. In response, Pfizer last week agreed to reduce prescription drug prices for Medicaid, which covers low-income people, to match lower prices overseas and said it would launch direct-to-consumer sales of a handful of its drugs. Pfizer also said it would offer most-favored-nation pricing on new drugs launched in the U.S., and Trump flagged that other drugmakers would follow suit. The Trump administration said it plans to launch, likely early next year, a website called TrumpRx that will help consumers...

AstraZeneca and Daiichi’s Datroway boosts overall survival in breast cancer trial

(Reuters) -AstraZeneca and Daiichi Sankyo's precision drug Datroway improved survival prospects in patients with an advanced form of breast cancer in a late-stage trial, the drugmakers said on Monday, paving the way for broader approvals. The trial was for patients with a type of aggressive and advanced breast cancer for whom immunotherapy was not an option, AstraZeneca said. The treatment was given early and compared with chemotherapy. The company added that Datroway was the first therapy to significantly improve overall survival in this group, and that it also significantly improved progression-free survival and met the dual main goal of the study. "We expect today's results will mark an inflection point in the treatment of these patients who have the poorest prognosis of any type of breast cancer and urgently need better options," said Susan Galbraith, AstraZeneca's executive vice president, Oncology Haematology R&D. Datroway belongs to a class of medicines called antibody-drug conjugates, also known as "guided-missiles" because they are designed to target only cancer cells while sparing healthy cells, unlike conventional chemotherapy. It works by targeting the TROP2 protein found on the surface of tumour cells of many types of cancer, and is already approved for treating a form of breast cancer and a...

Eli Lilly to invest over $1 billion in India to expand manufacturing capacity

will invest more than $1 billion in India in the coming years to boost manufacturing and supply through local drugmakers, the company said on Monday, as it seeks to tap into skilled workforce to bolster its global manufacturing expansion. The collaborations aim to increase the availability of Lilly's key drugs, including those for obesity, diabetes, Alzheimer's, cancer and autoimmune conditions, the company said. "We are making significant investments to increase manufacturing and medicine supply capacity around the world," Patrik Jonsson, president of Lilly International, said, adding, India is a hub for capability building within its global network. The company, which launched its blockbuster weight-loss drug Mounjaro in India this year, currently does not operate its own manufacturing facility in the country, which hosts several firms that develop and manufacture complex drugs, vials, injectables for larger pharmaceuticals on a contract basis. "Lilly is actively engaging with contract manufacturers in India," the company told Reuters, but did not divulge any further details. Lilly's investment plans in India come at a time when global drugmakers are rushing to bolster U.S. manufacturing capacity after the Trump administration imposed a 100% tariff on imported branded and patented drugs from October 1. Last month, Lilly announced a $5 billion investment in...

Novo plans online launch for obesity pill once approved, Bloomberg News reports

Danish drugmaker Novo Nordisk said it plans to make its new obesity pill available through telehealth platforms like Ro and WeightWatchers once it gets U.S. approval, Bloomberg News reported on Friday. The pill uses the same active ingredient as Novo's popular weight-loss injections Ozempic and Wegovy, and could be available in early 2026, the report said. Novo did not immediately respond to a Reuters request for comment. The company is also considering a subscription model where patients commit to six or 12 months of treatment at a discounted price, the report added.

Rocket Pharmaceuticals withdraws US application for blood disorder gene therapy

-Rocket Pharmaceuticals said on Friday it has withdrawn its application for U.S. approval of its experimental gene therapy for a rare inherited blood disorder. The therapy RP-L102 was being tested in patients with Fanconi anemia, characterized by impaired bone marrow function which leads to a decrease in the production of blood cells. The company said the move was driven by business strategy and not by concerns about the treatment safety or efficacy. Rocket said it will consider external partnership opportunities for RP-L102.

Novo, Lilly weight-loss drugs should be first option obesity treatments, European doctors say

-Novo Nordisk's and Eli Lilly's blockbuster weight-loss drugs should be the first medicines doctors reach for to treat obesity and its complications, a major European medical association advised on Thursday. Semaglutide, the active ingredient in Novo’s Wegovy and Ozempic, and tirzepatide, sold as Zepbound and Mounjaro by Lilly, are so effective that they should be the first choice in almost all cases when substantial weight loss is necessary, according to a new guideline from the European Association for the Study of Obesity published in Nature Medicine. When a lesser degree of weight loss is required, other medications can be considered, including liraglutide, an older, less effective drug from the same class, naltrexone–bupropion, and phentermine-topiramate, the guideline says. The EASO guidelines are non-binding on individual countries. Semaglutide, tirzepatide, and other drugs from the class known as GLP-1 agonists are completely transforming care of obesity and its complications, coauthor Dr. Andreea Ciudin of Vall d’Hebron University Hospital in Barcelona said in a statement. Although no treatment algorithm can replace the nuanced clinical judgment necessary for comprehensive patient care, the new guidelines can serve to support therapeutic decision-making in obesity, she said.

GoodRx expands tie-up with Kroger to offer branded drugs at discounted price

-GoodRx said on Wednesday it has partnered with Kroger’s healthcare unit to expand its prescription savings services for branded drugs, including Novo Nordisk’s popular weight-loss drug Wegovy. The retail tie-up, RxSmartSaver, could help customers access GoodRx savings services for branded treatments at nearly 2,200 Kroger pharmacies across the U.S. as well as help drug manufacturers expand the reach of their direct-to-consumer programs, the telehealth firm said. Patients can use GoodRx services to check what discounts are available for a drug at a particular pharmacy. "It is a new channel for us getting close to the point of pick up, where most discussions around how much a prescription costs happen is right at the pharmacy counter," David Graziano, head of retail network at GoodRx said, adding that it is also a "flexible branding opportunity". The company said it has also launched the program with a smaller retailer Hy-Vee and plans to roll it out with additional retailers in the coming months. The initiative also strengthens GoodRx’s relationship with its retail partners, Graziano said, adding that it ensures the "distribution mechanism for a large majority of prescriptions stays intact". The savings program also includes Dexcom’s continuous glucose monitor Dexcom G7, Sanofi’s long-acting insulin Lantus among others, the...

Enanta’s RSV treatment helps speed up recovery in study, shares surge

Enanta Pharmaceuticals (ENTA.O), opens new tab said its experimental respiratory syncytial virus treatment significantly quickened recovery in a mid-stage study of adults at high risk of complications from the infection. The Monday announcement boosted shares of the drug developer by 40%. The oral drug, zelicapavir, however, failed to meet the main study goal of improving the time taken to resolve certain symptoms of lower respiratory tract disease associated with RSV infection. RSV is a common respiratory virus that causes seasonal infections such as the flu. It is a major cause of pneumonia and death in infants and older adults. All RSV symptoms in patients on zelicapavir resolved 2.2 days faster than a placebo, and 6.7 days faster in the high-risk group, which had people who either had congestive heart failure, chronic obstructive pulmonary disease or were aged 75 or above, the company said. "We believe the trial results validate there is a high likelihood that Zelicapavir is an approvable RSV therapeutic product," said H.C. Wainwright analyst Brandon Folkes. With an estimated two to three million cases of RSV annually among high-risk adults in the U.S., even modest market penetration translates to a very significant commercial opportunity, Folkes said. The drug met several other secondary goals of the study,...

Novartis’ skin disease drug gets US approval

-The U.S. Food and Drug Administration has approved Novartis' oral treatment for patients with type of chronic inflammatory skin disease, the Swiss drugmaker said on Tuesday. The twice-daily pill, Rhapsido, is approved for patients with symptoms of chronic spontaneous urticaria (CSU) despite standard therapies. CSU is a long-term skin condition without a known cause, characterized by recurring hives - itchy, red welts - and sometimes swelling, lasting six weeks or more. Rhapsido will cost $4,521 in the U.S. for 30 days and will be available to patients in the coming days, a company spokesperson told Reuters in an email. The approval is based on results from two late-stage studies in which Rhapsido showed statistically significant improvements over placebo in itch severity, hive count and overall disease activity, Novartis said. Patients achieved well-controlled disease as early as week 2, with about one-third experiencing complete relief from itches and hives by week 12, the company said. The drug, chemically known as remibrutinib, works by inhibiting a protein called BTK, which plays a crucial role in triggering the body's allergic response, and thus help prevent symptoms by calming overactive immune cells. Rhapsido showed safety profile that requires no lab monitoring, Novartis said. "This convenient new oral therapy offers a promising...

Metsera’s obesity drug shows promising weight loss in mid-stage trials

Metsera (MTSR.O), opens new tab said on Monday that its experimental obesity drug showed significant weight loss and favorable tolerability in mid-stage studies. The drug, MET-097i, led to a placebo-adjusted weight loss of up to 14.1% after 28 weekly doses in a mid-stage study, the company said. MET-097i also showed tolerability in patients without type 2 diabetes who are overweight or have obesity. Pfizer (PFE.N), opens new tab said last week that it would buy Metsera in a deal valued at up to $7.3 billion, including future payments, as it seeks a foothold in the fast-growing obesity treatment market.