Friday, May 2, 2025

Cigna Raises Full-Year Profit Forecast, Latest to Beat Medical Cost Estimates

(5/2, Manas Mishra and Sneha S K, Reuters) ...Cigna on Friday raised its full-year earnings forecast and beat estimates for quarterly profit, helped by strong performance in its pharmacy benefit management business and lower-than-expected medical costs in its insurance arm...The company benefited from increased adoption of biosimilars of AbbVie's blockbuster arthritis drug, Humira. Biosimilars are cheaper versions of biologic drugs... Full

Eli Lilly Downplays CVS Move to Drop Zepbound Coverage, Shares Plunge

(5/1, Bhanvi Satija, Patrick Wingrove, Reuters) ...Lilly CEO Dave Ricks said most customers affected by CVS's move would be smaller employers that do not tend to cover obesity drugs. Still, "it seems like the wrong idea to reduce choice," he said, adding that the company will watch the market's reaction...CVS CEO David Joyner said in an interview that he was unsure if the negotiated price for Wegovy will dramatically increase the number of health plans providing weight-loss coverage. "But certainly as we're bringing the cost down, we're going to end up bringing more clients into a covered benefit."... Full

Obesity Drug Price Wars Heat Up as CVS Picks Novo Over Lilly

(5/1, Robert Langreth, Madison Muller and Ike Swetlitz, Bloomberg) ...Novo's starting off with a higher price. Its obesity drug Wegovy costs $1,349 for a month's supply, while Lilly's Zepbound is $1,086. Contrary to typical consumer economics, that higher price helps Novo compete by giving it more wiggle room to offer discounts..."In the past, it was really about very high list prices and relatively deep discounts to leverage PBM access, and we have been very vocal about trying to move away from that," Lilly Chief Executive Officer David Ricks said on the call. The company is disappointed with the decision, which "limits doctors' choice and patient access," it said in a statement... Sub. Req’d

After Years of Sales Declines, 'A New Biogen' Emerges as Launches Take Flight: CEO

(5/1, Zoey Becker, Fierce Pharma) ...There's one company, a multiple sclerosis (MS)-centered drugmaker, with a portfolio that has been gradually declining, with its sales falling 11% during the first quarter. But now with 45% of Biogen's revenue coming from medicines outside of its MS franchise, "there's a new Biogen emerging," according to Viehbacher. The fresh start is hallmarked by Alzheimer's disease med Leqembi, postpartum depression (PPD) treatment Zurzuvae and Friedreich's ataxia therapy Skyclarys, all of which helped drive Biogen to a 6% revenue increase during the first quarter of 2025. Overall, the company generated $2.4 billion during the period... Full

Amgen Says FDA Hold is Lifted On its Phase 1 Obesity Candidate as MariTide Enters Phase 3

(5/1, Andrew Dunn, Endpoints News) ...Amgen has emerged with one of the leading efforts in attempting to disrupt the duopoly that Eli Lilly and Novo Nordisk have had on the obesity market. The California drugmaker's lead candidate, MariTide, is now enrolling in two Phase 3 studies, with plans to launch additional Phase 3 trials throughout the year. In its first-quarter earnings report released Thursday, Amgen also said an earlier-stage candidate is no longer under a recently announced FDA clinical hold... Sub. Req’d

Nasal Powder for Acute Migraine Gets FDA Nod

(5/1, Judy George, MedPage Today) ...The FDA approved dihydroergotamine (DHE) nasal powder (Atzumi) 5.2 mg to treat acute migraine with or without aura in adults, Satsuma Pharmaceuticals announced Wednesday. The product is the only DHE nasal powder for acute migraine, Satsuma said. It uses the Simple MucoAdhesive Release Technology (SMART) platform which combines proprietary powder and device technology to simplify DHE delivery... Full

AstraZeneca's 'Smoker's Lung' Therapy Meets Main Goals of Late-Stage Asthma Trials

(5/2, Pushkala Aripaka, Reuters) ...The Anglo-Swedish drugmaker's therapy, already approved for the treatment of Chronic Obstructive Pulmonary Disease or "smoker's lung", was being compared with a dual-combination maintenance treatment in the trials. The results come as AstraZeneca targets $80 billion in revenue by 2030, after first-quarter sales this week missed expectations on weaker oncology drug performance... Full

Alembic Gets USFDA Nod for Generic Drug

(5/2, Press Trust Of India) ...Alembic Pharmaceuticals secured USFDA approval to market generic Ticagrelor tablets, 90 mg, aimed at preventing heart attack and stroke. They also received tentative approval for the 60 mg version. The approved drug is equivalent to AstraZeneca's Brilinta, with the 90 mg tablet having a market size of over USD 1 billion... Full

J&J Denied Injunction Over Private-Label Ustekinumab In US

(5/1, Dave Wallace, Generics Bulleitn) ...J&J is attempting to block Samsung Bioepis and Sandoz from marketing a private-label Stelara (ustekinumab) biosimilar through a PBM in the US. A New Jersey district court has denied J&J's request for an injunction while the case is ongoing. J&J has immediately filed a notice to appeal the district court decision to the US Court of Appeals for the Third Circuit... Global Sub. Full

MSN Asks Federal Circuit to Revive Entresto Patent Delisting Bid

(5/1, Christopher Yasiejko, Bloomberg Law) ...MSN is asking the Federal Circuit to overturn Judge Richard G. Andrews' April 1 final judgment and his April 29 denial of its post-trial motions, including a request to vacate the judgment and remove Novartis' US Patent No. 8,101,659 from the FDA's Orange Book, according to a notice filed Wednesday in the US District Court for the District of Delaware. Andrews, ruling from the bench this week, called MSN's delisting argument "too late" and rejected its claim that the Federal Circuit's January revival of the patent made the issue newly ripe... Sub. Req’d

Emergent BioSolutions Reinforces Commitment to Opioid Emergency Preparedness Efforts in Canada Through Multi-Year Contract with Ontario Ministry of Health

(5/1, Emergent BioSolutions Inc.) ...Today, Emergent BioSolutions Inc. announced a maximum three-year agreement with a value of approximately $65 million to supply the Ontario Ministry of Health with NARCAN® Nasal Spray for the Ontario Naloxone Program. Since 2018, Emergent has supported the Ontario Ministry of Health to provide access to NARCAN® Nasal Spray across the province. NARCAN® Nasal Spray is designed to reverse the effects of an opioid poisoning in minutes and is the only 4 mg, intranasal naloxone spray in Canada with a shelf life of four years (48 months)... Full

Trump Hints at Tariff Reprieve for Pharma Companies that Bring Operations Back to US

(5/1, Lisa O'Carroll, The Guardian) ...[Trump] reiterated at a meeting of pharma, tech and industry bosses in the White House that if companies moved their operations to plants in the US they would face no tariffs, but he suggested that they would get "a lot of time" to make the switch before facing levies...However, in a rambling, carrot-and-stick speech on Wednesday evening, he suggested that he would give companies such as Johnson & Johnson the time they needed to repatriate some manufacturing with new or expanded operations in the US before they would face a "tariff wall"... Full

Lilly CEO Urges Trump Admin to 'Level the Playing Field' by Negotiating Trade Deals, Striking Down Tariffs

(5/1, Fraiser Kansteiner, Fierce Pharma) ...Take Eli Lilly helmsman Dave Ricks, for example. Despite the Indianapolis pharma making a $27 billion U.S. production pledge in late February, Ricks took his company's first-quarter earnings call Thursday to argue against trade levies as the best policy for supporting local industry. "We support the U.S. government's goals to increase domestic investment," the CEO said on the call. "However, we don't believe tariffs are the right mechanism." Rather, "enhanced" tax incentives—or an extension of the Tax Cuts and Jobs Act—are "better tools" to spur U.S. growth, Ricks contended... Full

'Declare Victory and Move On': Eli Lilly CEO On Trump Tariff Threat

(5/1, Anjalee Khemlani, Yahoo! Finance) ...Trump's Department of Commerce is looking into what it calls national security threats from overseas drug manufacturing, and Eli Lilly CEO David Ricks has personally met with President Trump in recent weeks to discuss the matter. He and CFO Lucas Montarce spoke with Yahoo Finance Thursday about how the company is planning for potential tariffs...Ricks, meanwhile, pointed out that the investigation is focused on the national security threat rather than the overall global network of drug manufacturing and said there is reason to consider that threat... Full

Eli Lilly CEO Says Company Can Help 'Respond' to National Security Concerns Around Essential Drugs as Tariffs Loom

(5/1, Annika Kim Constantino, CNBC) ...Eli Lilly CEO Dave Ricks said the drugmaker can help "respond" to national security concerns around cheaper essential medicines as pharmaceutical-specific tariffs loom. The Trump administration has opened an investigation into how importing certain pharmaceuticals into the U.S. affects national security – a move widely seen as a prelude to initiating tariffs on drugs. Ricks said reshoring manufacturing capacity for older essential medicines is "a valid thing," adding that Eli Lilly is "happy to help the country if we're in need."... Full

Amgen Posts Profit, Says Tax Policy More Effective Than Tariffs

(5/1, Deena Beasley, Reuters) ...Amgen on Thursday said its first-quarter profit rose 24%, driven by product sales, and said that while it is premature to speculate on the impact of U.S. tariffs, tax policy would be a more effective way to influence U.S. manufacturing. President Donald Trump's administration has opened a national security investigation into pharmaceuticals in a bid to demonstrate why the U.S. needs tariffs to increase domestic manufacturing. "We agree with our peers that the most effective answer is not tariffs, but tax policy," Amgen CFO Peter Griffith said on a conference call... Full

Baxter International, Deerfield-Based Maker of IV Fluid and Pharmaceuticals, Expects Tariff Impact of $60 to $70M

(5/1, Lisa Schencker, Chicago Tribune) ...Baxter expects to see most of the impact from increased tariffs in the second half of the year, said Joel Grade, Baxter executive vice president and chief financial officer. Baxter makes IV fluids, a number of pharmaceuticals and other hospital products...Baxter is considering a number of strategies to mitigate the impact of tariffs, including carrying additional inventory, identifying alternative suppliers, alternative shipping routes and "targeted pricing actions," Grade said. Baxter is also working with its trade association partners to advocate for possible exemptions, he said... Sub. Req’d

CSRXP: Pharma-Backed PERA and PREVAIL Act Would Further Enable Patent Abuse, Undermine Bipartisan Progress Toward Greater Competition

(5/1, The Campaign for Sustainable Rx Pricing) ..."Big Pharma's egregious abuse of the U.S. patent system allows brand name drug manufacturers to continually hike prices on their best-selling products, block competition from lower-cost alternatives and set increasingly high launch prices on new products entering the market, often outpacing the current rate of inflation," said CSRxP executive director Lauren Aronson. "We respectfully urge lawmakers on the U.S. Senate Committee on the Judiciary to reject these proposals, backed by the pharmaceutical industry, that would further enable Big Pharma to game the patent system to extend monopoly pricing on blockbuster products."... Full

Senators Coons, Tillis, Colleagues Introduce Bipartisan, Bicameral Bill to Foster American Innovation by Modernizing the Patent Trial and Appeal Board

(5/1, U.S. Senator Chris Coons) ..."Whether you have the backing of a huge company or are tinkering in your garage, you should be confident that your ideas and innovation will be protected. That's what the Patent Trial and Appeal board was intended to do," said Senator Coons. "Unfortunately, bad actors ranging from multinational corporations to overseas grifters have spent the last decade exploiting the PTAB to harass innovators and prevent them from profiting off their creations. With the bipartisan PREVAIL Act, we restore fairness to the patent process and let America get back to inventing and innovating."... Full

New Analysis: Fewer Treatments and Cures Under the IRA's Pill Penalty

(5/1, Brianna Allen, PhRMA) ...The pill penalty, which allows the government to set the price of pills and other small molecule treatments years before other drugs, is already driving investors away from funding the early development of these vital medicines, according to a report by health consulting firm Vital Transformation. The report, which was published in the Journal Therapeutic Innovation and Regulatory Science, analyzed the impact of the IRA on investment in drug development since the law's introduction in 2021... Full

Cassidy's Proposed 340B Reforms Echo Many Aims Of Previous Bills

(5/1, Gabrielle Wanneh, Inside Health Policy) ...The 340B reforms Senate health committee chair Bill Cassidy (R-LA) says are most needed after finishing his years-long probe of the drug discount program -- chiefly improving transparency, clarifying the program's intent, requiring patients directly benefit from discounts, imposing annual reporting requirements for select covered entities, potentially changing the definition of eligible 340B patients and clarifying use of contract pharmacies' fees and the inventory replenishment model -- encompass reforms included in myriad other bills introduced last Congress... Sub. Req’d

Republicans for Price Controls

(5/1, Kimberley A. Strassel, The Wall Street Journal) ...But tackling the problem by taking it out on the innovators—by importing other countries' backward policies—will only harm the world's greatest producer of cures and replicate those countries' failing systems. Europe's price controls have reduced its once-thriving pharmaceutical industry to dust, while Europeans (and Australians and Canadians) have access to far fewer new drugs than are available to Americans, including breakthrough cancer treatments. Those nations also show how a lack of innovation leads to even higher healthcare costs in the longer run... Sub. Req’d

FDA to Rehire Fired Staffers Who Booked Inspection Trips, But Other Workers Remain in Limbo

(5/1, Matthew Perrone, Associated Press) ...For the second time in recent months, the Food and Drug Administration is bringing back some recently fired employees, including staffers who handle travel bookings for safety inspectors. More than 20 of the agency's roughly 60 travel staff will be reinstated, according to two FDA staffers notified of the plan this week, who spoke on condition of anonymity to discuss confidential agency matters... Full

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

(5/1, Joseph Haas and Nielsen Hobbs, Pink Sheet) ...Delays stemming from FDA layoffs could push out criterial development milestones that would have driven M&A activity. Firms must develop "worst-case" scenarios "with respect to deadlines and interactions with the FDA." Biopharma is challenged by potential review delays, as well as macroeconomic factors, such as interest rates and tariffs... Global Sub. Full

Raising Drug Prices In The EU Could Take Years, Even If Pharma Effort Succeeds

(5/1, Cathy Kelly, Pink Sheet) ...Major pharma companies are publicly touting efforts to persuade European Union countries to pay higher drug prices that are more aligned with the US. The initiative could begin a more serious conversation about a topic that pharma has been pushing for decades, but the change could take years to implement. Companies also may engage the Trump Administration to use its tools, possibly including tariffs, to pressure the EU... Global Sub. Full

Trump's Tariffs Are Just One Worry for Belgium's Pharma Industry

(5/2, Charles Cohen and Emma Pirnay, Euractiv) ...On the outskirts of Antwerp, workers at one of Pfizer's lesser known plants may yet suffer from the imposition of US tariffs. But, even without Donald Trump, the pharma industry is already grappling with some serious problems. The factory in Puurs is the American multinational's second-largest production site worldwide...If imposed, the Section 232 tariffs could affect around 10% of the Puurs Pfizer location over two years, said Paul Schoeters, secretary for the chemical and pharmaceutical sector at Belgium's CSV-ACV labour union. But tariffs are just one of a range of concerns created by the US for the Belgian pharma sector, he said, and moving production elsewhere couldn't happen overnight... Full

No Brand Names, Prescribing Generic Drugs Should Be A Must: Supreme Court

(5/1, Ashish Kumar Bhargava, NDTV) ...Doctors should only prescribe generic medicines and not any particular brand, as has been ordered in Rajasthan, the Supreme Court remarked today while hearing a petition seeking regulation of unethical marketing practices by pharmaceutical companies...The petition contended that pharmaceutical companies are bribing doctors so they prescribe excessive or irrational drugs and push for over-priced brands. Not only does it bring up medical costs for the common man, it ca also lead to overuse of drugs which has negative effects, or create drug dependence... Full

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