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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.

Who is GSK’s next CEO Luke Miels?

British drugmaker GSK (GSK.L), opens new tab named insider Luke Miels as its CEO designate on Monday to succeed Emma Walmsley, who will step down after nine years in the role. Miels will be tasked with leading a new phase for the company and delivering GSK's sales target of more than 40 billion pounds ($53.78 billion) by 2031. He will assume full responsibilities as CEO on January 1. REMUNERATION: Miels' starting annual base salary will be 1.38 million pounds, below Walmsley's current salary, GSK said. Walmsley's 2025 salary is 1.43 million pounds, according to GSK's annual report. He will also receive an on-target yearly bonus of 150% and a long-term incentive grant 7.25 times his salary. WHO IS MIELS? Miels, 50, joined GSK as its chief commercial officer in 2017, managing its global medicines and vaccines portfolio, with annual sales topping 20 billion pounds across over 100 countries. The Australian national holds a biology degree from Flinders University and an MBA from Macquarie University in Australia. From his beginnings as a sales representative at AstraZeneca, he went on to assume senior roles at global pharmaceutical giants such as Sanofi and Roche. CAREER PATH: AstraZeneca * 1995 – 2000: Held various sales and marketing roles Sanofi-Aventis (SASY.PA), opens new tab * 2004 – 2006:...

GSK’s Walmsley to step down early as insider Luke Miels named next CEO

British drugmaker GSK (GSK.L), opens new tab said on Monday Emma Walmsley will step down as CEO after nine years in the role and will be replaced by insider Luke Miels in January. Since taking over in 2017, Walmsley has returned GSK to growth, with a focus on cancer and infectious diseases to counter a combination of patent expiries and declining revenue from its best-selling medicines by 2030. "2026 is a pivotal year for GSK to define its path for the decade ahead, and I believe the right moment for new leadership," Walmsley said. Miels will be tasked with leading a new phase of the company and delivering GSK's sales target of more than 40 billion pounds ($53.76 billion) by 2031. Miels, 50, joined GSK in 2017 and is currently the drugmaker's chief commercial officer, overseeing the company's global medicines and vaccines portfolio. He will assume full responsibilities as chief executive on January 1. "He has outstanding global biopharma development and commercial experience, together with a deep understanding of the company," GSK Chairman Jonathan Symonds said in a statement. GSK's shares have fallen nearly 6% since Walmsley took over as CEO. Under her leadership, GSK also demerged consumer healthcare group Haleon (HLN.L), opens new tab...

Amgen lays out $650M to grow Puerto Rico manufacturing campus, add hundreds of jobs

Big Pharma's U.S. manufacturing investment pledges continue to pile up on the mainland and beyond. In the industry's latest nine-figure capital investment project, Amgen plans a $650 million expansion of its sprawling site in Juncos, Puerto Rico. The company, which boasts a multidecade history on the island, plans to create hundreds of new jobs with the Puerto Rico expansion, according to a Sept. 26 release. Amgen's expansion in Juncos will support increased drug production at the biologics site. Amgen first established its Juncos site in 1993 and has significantly expanded it along the way. A 30-year celebration of the site's history, posted on Amgen's website in 2022, shows that the manufacturing complex started with just one building and about 30 staffers. By 2022, the facility grew to more than 20 buildings with thousands of employees. In 2003, Amgen revealed plans to splash out $800 million for new plants, quality labs, packaging infrastructure and more in Juncos. In 2005, the company touted the facility as boasting 1 million square feet. Nowadays, Amgen's expansion plans coincide with the Trump administration's onshoring push for the pharmaceutical industry. In a Thursday evening post on the social media site Truth Social, President Donald Trump said that starting Oct....

Sanofi Set to Offer Insulin Products at $35 Per Month for All US Patients

-French drugmaker Sanofi said on Friday it would offer a month's supply of any of its insulin products for $35 to all patients in the U.S. with a valid prescription, regardless of insurance status. The program, originally meant for uninsured diabetes patients, would now include those with commercial insurance or Medicare, the drugmaker said. Global drugmakers have ramped up efforts, such as direct-to-consumer programs, to lower U.S. drug prices as President Donald Trump presses them to align the cost of their medicines with what other comparable high-income countries pay. "Our announcement builds on an idea first championed by President Trump to lower costs for American patients at the pharmacy counter," said Adam Gluck, head of U.S. Corporate Affairs, Sanofi. Patients will be able to purchase any combination, type, and quantity of Sanofi insulins with a valid prescription for the fixed monthly price of $35, starting January 1. Sanofi is one of the three largest insulin makers with Novo Nordisk and Eli Lilly. Lilly and Novo also have similar programs through which they offer insulin products for $35 a month for U.S. patients regardless of whether the patients have insurance. An estimated 8.4 million people with diabetes in the United States rely on insulin to survive, according...

Bristol Myers to sell psoriasis drug at over 80% discount to some US patients

Bristol Myers Squibb (BMY.N), opens new tab said on Thursday it will sell its psoriasis drug Sotyktu directly to cash-paying U.S. patients at a more than 80% discount to its list price amid pressure from the Trump administration. President Donald Trump has been pressuring drugmakers to lower the cost of medicines, demanding that they align domestic prices with the lowest levels paid by comparable high-income countries under the "most-favored-nation" policy. The program would cut Sotyktu's monthly cost to $950, or about 86% discount to the current list price of $6,828, the company said. Bristol will start selling the drug through its new direct-to-patient platform BMS Patient Connect from January, the drugmaker said. The program, which would bypass traditional pharmacy benefit managers and insurers, targets a small percentage of patients on Sotyktu who are uninsured or underinsured. Sotyktu is approved to treat moderate-to-severe plaque psoriasis in adults. Bristol and partner Pfizer (PFE.N), opens new tab also sell their blockbuster blood thinner, Eliquis, directly to cash-paying patients at a more than 40% discount to its list price.