“Commanders of the resistance groups received the message of borderless confrontation with the enemy and have put it into practice,” he said.
https://www.iranintl.com/en/202611047377
Speaking at a news conference on Wednesday, foreign ministry spokeswoman Mao Ning said preventing another round of fighting was China's most urgent diplomatic objective in the region.
"The top priority is to avoid the resumption of hostilities in the Middle East that would bring disaster to the region's people," Mao said, adding that Beijing would also support efforts to reach a political settlement in Yemen.
Another patient has died after taking Neurocrine Biosciences’ Prader-Willi syndrome therapy Vykat, leading to analyst inquiries during the biotech’s third-quarter earnings call on Monday afternoon.
Clinicians and patient advocates have been sounding the alarm about serious safety events that have occurred in patients who took the product, which was approved for the rare disorder in 2025 and picked up by Neurocrine in April as part of the $2.9 billion acquisition of Soleno Therapeutics.
Neurocrine this week confirmed the newly reported death and reiterated confidence in the drug’s safety profile, urging appropriate monitoring and patient selection.
“We are confident in the benefit-risk profile of Vykat XR and believe the FDA-approved label provides clear guidance on how to use the medicine safely and effectively in the indicated patient population,” a spokesperson told BioSpace in a Monday evening statement.
Prader-Willi syndrome is a rare disease that causes an insatiable desire to eat plus a slow metabolism that together can lead to significant weight gain. The condition can also cause cognitive disabilities and behavioral challenges. Before Vykat was approved, patients had few options.
Neurocrine reported third-quarter earnings on Monday, with the investor call focusing on the safety profile of Vykat. Analysts wondered about the real-world safety reports and a recent letter from a clinician warning of safety risks associated with the drug.
“Neurocrine remains committed to the benefits of Vykat XR in the right patients with the right monitoring, and the franchise was resilient this quarter,” William Blair said in a Tuesday morning note.
Indeed, Vykat took home $107 million for the third quarter, helping Neurocrine to reach $1.1 billion in total revenue.
To help ease concerns, Neurocrine is planning a new study in 2027 to explore dosing and safety in patients with Prader-Willi who have complex health issues.
“We clarified on the call that this was not an FDA request, despite Neurocrine’s collaboration with the agency,” William Blair said. “There is no doubt that education and data is needed to extract value from the Soleno acquisition and return Vykat XR to a true rare disease growth product, but the cards are in place now and Neurocrine is not hiding.”
Clinicians have raised concerns in the Prader-Willi community, warning about seven deaths and more than 100 serious adverse events that have occurred in patients who received Vykat. Yesterday’s report would being the number of deaths to eight.
Most of the events were associated with edema, respiratory and cardiac complications. The most serious incidents occurred in patients who had complex medical issues, used other medications or had pre-existing obesity.
The events have not been definitively linked to Vykat, clinicians have noted, and patients with Prader-Willi have complex needs. The clinicians therefore warned prescribers of heightened risk among patients with obesity, severe breathing issues, underlying heart problems and other conditions.
The safety concerns have spurred BMO Capital Markets to temper expectations for Vykat growth.
“Recent concerns over product safety and patient deaths could lead to some increased patient discontinuations in 4Q26 and early 2027,” BMO said in a Monday evening note. “Over time, we expect Neurocrine will be able to further establish the safety and optimal dose titration of Vykat XR through additional studies, but until this time, we expect patient persistence to be somewhat negatively impacted.”
Neurocrine pledged to build the base of evidence that will give prescribers, patients and advocates confidence in the profile of Vykat. Executives on the earnings call insisted that the current label is sufficient to warn of the potential risks associated with the drug.
“We continue to closely monitor the safety of VYKAT XR, evaluate all available information, and work with the FDA as clinical and real-world experience with the medicine grows,” Neurocrine’s statement added.
https://www.biospace.com/business/neurocrine-defends-prader-willi-drug-after-another-patient-death
Pfizer is getting its first taste of the obesity business with partner Sciwind Biosciences as the weight loss drug Ecnoglutide breaks into the Chinese market. But the idea of a consumer-driven market is not new territory for the storied New York pharma, if you look back to erectile dysfunction blockbuster Viagra.
“We are learning a lot, and we are very happy that we are entering this market because I think it is cut for our capabilities,” Pfizer CEO Albert Bourla said on a third quarter earnings call Tuesday morning.
He pointed to Pfizer’s work with Viagra, the drug that took on a life of its own and—Bourla claimed—became the first drug available on the internet.
“There are a lot of similarities, people are willing to pay out of pocket for products that they value, irrelevant if they are reimbursed or not,” Bourla said. “That creates dramatically different size in the international markets.”
Pfizer snagged mainland China licensing rights to Sciwind’s GLP‑1 receptor agonist injection Ecnoglutide in February for $495 million in upfront and potential milestone payments. The drug had already been cleared for use in the Asian country, finally giving Pfizer an approved obesity product—at least in part of the world.
Eli Lilly and Novo have been the clear obesity leaders for several years now, despite Pfizer’s efforts—both internal and external—to gain a foothold. Pfizer fought Novo in a bidding war for Metsera in 2025, buying a pipeline of assets that are still years from the market in the U.S. But the Sciwind deal allowed Pfizer to dip its toes into the obesity world while Metsera’s assets and other projects weave through the clinic.
Ecnoglutide isn’t the first drug for which Pfizer has drawn on its Viagra experience to market, Bourla said, pointing out that self-pay customers in China can now access migraine medicines like Nurtec or COVID treatment Paxlovid. With that model a success, it was only natural for the pharma to extend it to Ecnoglutide.
Chief International Commercial Officer Alexandre de Germay said things have been going smoothly since the April launch, providing a glimpse at the market segments that Pfizer still needs to address.
“The things that we are clearly understanding is there are very different segments within these overall chronic weight management categories,” de Germay said on Pfizer’s call.
Some patients are looking to lose weight with a more “aesthetic-driven purpose,” he continued, while others have significant weight to lose. The latter group is more willing to accept the side effects that come with weight loss medications but in turn want significant efficacy, de Germay said.
“It is confirming our strategy that if we want to be successful in chronic weight management, you need to have a portfolio,” he added. “You will need to activate all those different channels and the cost of activations of those channels will be amortized across the portfolio.”
The Ecnoglutide launch also marks a pivot for Pfizer—launching a new drug in China first rather than the typically more lucrative U.S. market. Specific to the Chinese market, de Germay said the company had to pursue a diabetes indication for Ecnoglutide in order to have access to more patients via the hospital markets. That was secured at the end of October, with an indication for type 2 diabetes.
Pfizer is also awaiting a review by Chinese regulators that would provide reimbursement for Ecnoglutide for its approved indications. This is a key milestone since rival products already have access to those, de Germay said.
With the China launch underway, Pfizer still has its eyes on the global market, particularly with the products acquired with Metsera last year. Leading the charge is berobenatide, for which Pfizer is advancing 10 pivotal studies.
“Our goal is initially to establish berobenatide as a potentially best-in-class monthly subcutaneous GLP-1 for obesity, and this is globally,” said Chris Boshoff, chief scientific officer and president of R&D, during the earnings call.
Phase 3 studies have advanced in knee osteoarthritis and obstructive sleep apnea, with initial readouts expected in the coming months, Boshoff said. Pfizer is also testing whether patients can switch from one of the existing weekly injectable GLP-1s to monthly berobenatide.
Also in development is an amylin analog called PF3945, which is being tested in combination with berobenatide in a Phase 1/2a trial.
Pfizer’s Valneva-partnered Lyme disease vaccine is nearing a regulatory submission, with interest in preventative options against the tick-borne disease rising around the world. But the FDA won’t be its first stop. Rather, Europe will likely become the launching pad for the new highly-anticipated preventive, executives said.
But it won’t be the only market for the vaccine, they emphasized on a third quarter earnings call Tuesday. “Awareness of the disease, of course, in the U.S., it’s skyrocketing right now because we do have an increase of severity and incidence,” CEO Albert Bourla said.
Pfizer confirmed on the call that discussions are ongoing with the FDA about a regulatory submission for PF-07307405 as executives expressed excitement over the ongoing regulatory process for the shot, which was developed in partnership with Valneva. Analysts have suggested that the FDA filing could be completed by the end of the year. An update on regulatory discussions in the U.S. will occur sometime this quarter, according to Chris Boshoff, Pfizer’s chief scientific officer and president of R&D.
As for the European launch, executives declined to pinpoint a timeline but said regulators on the other side of the pond have commenced their review after the European Medicines Agency (EMA) confirmed receipt of Pfizer’s application in August. The Committee for Medicinal Products for Human Use (CHMP), which recommends new medicines for approval in Europe, is set to deliver its verdict in 2027.
Meanwhile, the vaccine has been filed in Canada as well.
Europe is a natural place for Pfizer to start with the Lyme disease vaccine, since Pfizer owns a tick-borne encephalitis (TBE) vaccine portfolio marketed there from a long-ago acquisition, Chief International Commercial Officer Alexandre de Germay said.
“We know how to activate tick-borne populations in those endemic areas because we have a sales force, we have a commercial play with pharmacies, and so we are very excited with the opportunity,” de Germay said.
Lyme is much more known than TBE, which will help with the commercialization strategy, de Germay added.
Amgen is racing toward readouts for its GLP-1 program, reaffirming plans for the candidate in its third quarter earnings report and beginning a study to support launching the product as an autoinjector.
The injectable drug candidate, MariTide, is differentiated on paper from incumbent GLP-1 products sold by Eli Lilly and Novo, notably by a half-life that Amgen believes can support dosing as infrequently as four times per year. In practice, however, “MariTide differentiation [is] still more of a show-me story,” BMO Capital Markets analysts said in a Nov. 3 note to investors.
“Management emphasized monthly dosing, potentially extending to four or six annual doses, and described gastrointestinal symptoms as generally short-lived despite prolonged pharmacologic activity,” BMO analysts said. “These observations are encouraging, but do not substitute for Phase 3 tolerability data.”
Amgen is expected to publish the first Phase 3 MariTide data next year. Ahead of the readouts, tolerability and maintenance, not weight loss, are driving the debate, Truist Securities analysts said in a Nov. 3 note, writing that they see “dose-escalation tolerability, durability and maintenance as key to validating differentiation.”
With pivotal data approaching, Amgen recently began another Phase 3 trial to study the home-based self-administration of subcutaneous MariTide using an autoinjector. The study has a primary completion date in June 2027, per ClinicalTrials.gov, leading TD Cowen analysts to predict in a Nov. 3 note that the trial could enable Amgen to launch MariTide as an autoinjector.
Amgen has been “pretty consistent in sharing that MariTide is expected ultimately to be delivered in a patient-friendly single-chamber handheld autoinjector,” Jay Bradner, executive vice president of R&D at the company, said on the third quarter earnings call. Amgen has “significant experience” with the delivery devices and has “taken a fairly standard approach,” Bradner added.
CFO Thomas Dittrich reaffirmed that Amgen expects capital expenditures of about $2.6 billion this year to scale manufacturing capacity for commercial growth and to prepare for a potential MariTide launch. Asked by an analyst whether biosimilar production capacity could support MariTide, CEO Robert Bradway said Amgen considers all options but feels confident it can continue to be a reliable biosimilar supplier.
A series of readouts will determine how much manufacturing capacity Amgen needs for MariTide. The biotech’s Phase 3 MARITIME program features 10 trials, and two more studies are scheduled to start this year. Amgen recently completed enrollment in two Phase 3 sleep apnea studies and a cardiovascular outcome trial, according to the earnings release.
Beyond MariTide, Amgen’s schedule for 2026 includes the completion of a Phase 3 dazodalibep study in symptomatic Sjogren’s disease. A Phase 3 trial of the CD40L antagonist in systemic Sjogren’s met its primary endpoint in September, but it is hard to read through from the successful trial to the ongoing study because the patient populations are different, Bradner said.
Amgen provided the pipeline updates as part of third quarter earnings in which revenues increased 8% to $10.4 billion. Key Amgen brands, including Repatha, Uplizna, Evenity, Blincyto and Imdelltra, continue to outperform, William Blair analysts said in a Nov. 4 note.
Big Pharma leaders presenting earnings this week largely shrugged off the potential of renewed risk ahead for drug pricing, with President Donald Trump’s Most Favored Nation initiative already embedded into assumptions.
Even with Democrats regaining control of Congress during Tuesday’s mid-term elections, executives were steadfast. Novo’s Mike Maziar Doustdar, reporting from Copenhagen Wednesday morning, was the first to speak to U.S. policy points after the blue wave.
“There’s always been a strong bipartisan support from both sides of the aisle for what we do,” Doustdar said. “We improve health at scale—whether you’re Republican or Democrat, you welcome that for your constituents.” He pledged to work closely with either party on “making sure that we can be a meaningful partner” to the U.S.
Leerink Partners warned that the Democrats could renew a push to lower drug prices but would likely have bigger issues to tackle first as they take control in Washington.
“Democrats likely have ‘bigger fish to fry’ than drug pricing in the near-term, in our view. But we do expect investigations related to drug pricing,” the firm wrote.
These investigations could focus on the confidential negotiations the administration conducted around MFN offering pharmas a chance to avoid tariffs, Leerink suggested.
While 2027 may not bring much change, Leerink warned that Trump himself has also suggested that he may seek to renegotiate MFN in 2028. America will also return to the polls that year to select a new president.
“Since the Trump administration’s voluntary tariff-avoidance deals with drug companies expire in December 2028, we have been assuming that President Trump could demand “a better bargain” from drug companies going into the November 2028 elections,” Leerink wrote.
BMO Capital Markets warned that the markets could be volatile for the industry today. “While Novo’s commercial beat is strong, we could see BioPharma shares face headwinds at open on U.S. Democrat ‘blue wave’ in midterms,” the firm wrote early Wednesday morning.
A day earlier, Pfizer CEO Albert Bourla similarly signaled that little would change even if Democrats took control of Congress.
“We are waiting to see what will happen today in the election,” Bourla said during his company’s earnings call on Tuesday. “But I think that in any case, it looks like we will have a split government, so I don’t think that many things can move legislation-wise.”
Bourla’s election outcome prediction was proven right. In a rebuke to Trump, Democrats retook both houses of Congress, flipping multiple key seats.
Bourla does not expect any changes this year for the MFN agreements, which Pfizer and other pharmas secured in order to avoid tariffs in 2025. But he admitted the policy woes of last year still weighed on him.
“It’s a very big contrast vis-a-vis what I was telling you a year ago. In 2025, I was really scared about the implications that either tariffs or MFN could have,” Bourla said.
But the CEO is confident that in working through those issues with the administration, there will not be any major policy surprises.
“Through the successful navigation of those issues, we brought the stability that is now projected to last and has brought, I think, this confidence back to the investor to invest in the in the industry in our sector,” Bourla said.
While most Big Pharmas have secured an MFN deal with the Trump administration, Bayer, for one, has not done so yet.
“We expect to have a good resolution that’s good for America, good for Bayer,” CEO Bill Anderson said on a Tuesday morning call with media.
The negotiations are particularly key for Bayer as the company gets nearer to a launch for the stroke medicine asundexian, which was accepted for FDA priority review in October.
“Our mission … is health for all, it doesn’t say health for people with private insurance,” Anderson said. “So [we’ve] got to work on that. And we’re going to fight really hard with everything we have to make sure that this medicine is covered broadly.”
Stefan Oelrich, president of the Pharmaceuticals Division and member of Bayer’s board of management, confirmed during an investor call later that morning that Bayer is still potentially exposed to tariffs without an MFN deal.
“We’re one of the companies that has not signed a deal on this,” Oelrich said. “So right now, that would mean we would be exposed to potential tariff impact and potential GUARD and GLOBE impact. And this is something that we’re currently discussing still.”
GUARD and GLOBE are trial programs being developed by the Centers for Medicare and Medicaid Services to embed MFN drug pricing into the government healthcare programs.
Bayer has been working to boost its U.S. footprint, with a $2.2 billion investment in an Ohio manufacturing plant announced in October. Trump promised leniency to pharmas who onshored manufacturing efforts during his initial MFN push last year.
“The Ohio investment clearly is a sign of our strategy of renewed focus on the U.S. market really coming through,” Oelrich said. “That includes bringing manufacturing to where our biggest markets are in the world that we live in now.”
Oelrich promised an update on the MFN negotiations when Bayer reports first quarter earnings and offers guidance for the year ahead.
