Thursday, October 16, 2025

Pfizer CEO Touts Trump Drug-Price Deal Amid Vaccine Doubts

(10/15, Kristina Peterson and Madison Muller, Bloomberg) ...Pfizer Inc. Chief Executive Officer Albert Bourla said that vaccines are harder to get approved right now as Health Secretary Robert F. Kennedy Jr. looks to overhaul the country's immunization policies...The FDA had earlier said in May it would only give the green light to shots for older people and those with underlying conditions. The decision meant those who don't qualify for the shots can only get them if their doctor prescribes the vaccine off-label, potentially complicating insurance coverage. Bourla called the situation "an anomaly that will correct itself," adding that US President Donald Trump is proud of the Covid-19 vaccine... Sub. Req’d

Wells Fargo, Pfizer CEOs Warn U.S. Could Lose Out to China Without Innovation

(10/15, Luke Fountain, CNBC) ...Wells Fargo CEO Charlie Scharf said AI is boosting productivity but will likely reduce workforce size. Pfizer CEO Albert Bourla warned China is closing the biotech and pharmaceutical patent gap rapidly and said the U.S. needs to focus on innovation. Speaking at CNBC's inaugural Invest in America Forum, both CEOs agreed that the time is now for new investments in technology and manufacturing to ensure competition in the global economy... Full

America Is Heavily Reliant On China for Raw Materials in Medicines

(10/15, Rebecca Robbins, The New York Times) ...A new analysis found that nearly 700 drugs approved for use in the United States depend on chemicals solely produced in China...The new data, from U.S. Pharmacopeia, a nonprofit that tracks the drug supply, identified the origins of chemicals used to make medicines. The analysis found that China was the sole supplier of at least one chemical in widely used antibiotics, like amoxicillin, and generic drugs for heart problems, seizures, cancer and H.I.V. One example is the allergy-relief medicine best known by the brand name Benadryl... Full

Reliance On Dangerous Foreign Generic Drugs is Killing Americans

(10/15, Sen. Rick Scott, R-Fla., The Hill) ...The U.S. currently relies on overseas manufacturers for approximately 75 percent of its essential drug supply, with Communist China and India as two of the largest contributors. Of the top 100 generic medicines consumed in the U.S., 83 percent of them contain no American-sourced Active Pharmaceutical Ingredients (APIs). That means if you look in your medicine cabinet now, there's a good chance you'll find a foreign-made generic drug that includes Active Pharmaceutical Ingredients from overseas... Full

Trump Is Right About So Much, Not So Much On MFN Announcement

(10/15, John Czwartacki, RealClearHealth) ...Americans are innovators, tirelessly working to create a better world. It's in our DNA to take risks and create solutions to the biggest problems. We dominate the world with our bold, creative ideas, not brute force or centralized control. Likewise, we do things our way, blazing our own trails. Especially in technology, science, and medicine. President Donald J. Trump and his Administration are working around the clock to reinstate this belief and confidence in our country. Yet, his "Most Favored Nation" drug pricing policy—which the Administration recently announced is beginning to be implemented—risks the medical miracles that have made me, and countless other patients, survive and live meaningful lives... Full

Waiting On Trump's Go at Medicare Drug Price Talks

(10/15, Lauren Gardner and David Lim, Politico) ...We're still waiting on lawmakers to reach a deal to reopen the government, but the coming weeks could yield news on the prices the Trump administration has negotiated for 15 drugs under the Inflation Reduction Act...While CMS has until the end of November to publicize the negotiated prices it reached, it would not be surprising if the administration announces them sooner, according to Rachel Sachs, a law professor at Washington University in St. Louis who worked as a senior adviser at the HHS's Office of the General Counsel during the Biden administration... Full

Manufacturer Most Favored Nation Deals: How They Could Be Protected From 340B

(10/15, Cathy Kelly, Pink Sheet) ...Most Favored Nation and direct-to-consumer pricing commitments made by Pfizer and AstraZeneca could increase their 340B discount liability by triggering new best prices. But if the companies provide MFN prices to Medicaid through supplemental rebates, they would avoid the new best prices impacting 340B discounts, policy experts said. If CMS determines DTC sales are excluded from the best price, the concessions also would be sheltered from 340B... Global Sub. Full

340B Rebate Model Stalls As Medicare Negotiated Price Implementation Approaches

(10/15, Cathy Kelly, Pink Sheet) ...Progress on advancing the 340B rebate model pilot program has been suspended because HRSA officials responsible for the project are not working due to the US government shutdown. The delay shortens an already aggressive timeline for implementing the model at the same time the first set of Medicare negotiated prices go into effect on Jan. 1. The pilot is intended to help manufacturers avoid giving 340B discounts on drugs already subject to negotiated prices, but is likely to be expanded going forward... Global Sub. Full

340B Abuses Are Fueling Higher Medicare Costs, New BRG Report Shows

(10/15, Molly Jenkins, PhRMA) ...The hidden cost of 340B: The 340B hospital markup program is costing taxpayers an estimated $13.4 billion a year in lost Medicare rebates, according to a new report from Berkeley Research Group (BRG). When hospitals purchase medicines at the 340B price, Medicare cannot collect rebates intended to reduce federal spending. This means that as more tax-exempt hospitals exploit the 340B program as a profit center, Medicare costs also rise. This number is expected to continue to increase due to program growth and additional lost inflation rebates... Full

A Better Way To Lower Prescription Drug Costs

(10/15, Arthur L. Kellermann, Forbes) ...America's approach to drug and medical product development is "perfectly designed to get the results it gets." Rather than bludgeon drugmakers into cutting prices to "most-favored-nation" levels, or threaten to impose high tariffs on any that don't build plants in the U.S., the administration and Congress could revise federal regulations to encourage companies to create high-value, cost-lowering prescription drugs and other healthcare technologies... Sub. Req’d

Republican Senators Press FDA To Suspend Generic Mifepristone Amid Safety Review

(10/16, Dean Rudge, Generics Bulletin) ...Republican senators have called on the FDA to suspend approval of a new generic version of mifepristone, an abortion pill, due to safety concerns and a conflict with state laws. Their letter highlights alarming claims about the drug's safety and warns that mail-order access undermines pro-life regulations established after the Dobbs decision. Signed by 51 senators, the letter asserts that the Biden administration distorted safety data and facilitated access that threatens women's health. They recommend reinstating in-person dispensing rules and halting distribution as an "imminent hazard."... Global Sub. Full

In Shot Across Big Pharma's Bow, California Will Sell Its Own Insulin

(10/16, Rachel Bluth, Politico) ...California will start selling low-cost insulin in January, becoming the first state in the nation to bypass Big Pharma with its own supply of the expensive diabetes drug and marking a notable win in Gov. Gavin Newsom's push to rein in health care costs with state-branded drugs... Full

Actor Pharmaceuticals and Megalabs Become Partners for the Commercialization of Formycon's Eylea® Biosimilar FYB203 (aflibercept) for Australia and Latin America

(10/16, Formycon AG) ...Formycon AG announces that Klinge Biopharma GmbH , the exclusive owner of the global commercialization rights of Formycon's Eylea® biosimilar FYB203 (aflibercept), concluded an exclusive license agreement with Actor Pharmaceuticals Pty. Ltd. for the commercialization of FYB203 in Australia. Furthermore, for Latin America, Klinge has signed an exclusive license agreement with Megalabs S.A... Full

Drug Maker Vimy Pharma Plans to Deliver Made-in-Canada Generic Ozempic

(10/16, Chris Hannay, The Globe and Mail) ...Vimy Pharma says its drug will be available in a vial, which is cheaper to produce and easier to transport than injectable pens – a format that the industry has been moving to in Canada for GLP-1 drugs, particularly Mounjaro from Eli Lilly & Co. Vimy Pharma's generic semaglutide will not be available in January, but the founders say their goal is for the product to be out some time in 2026...Health Canada's public database of generic submissions lists seven companies that have so far applied to produce generic semaglutide...A submission does not mean a company will ultimately produce and sell the drug if it gets approval, although Sandoz and Teva have confirmed to The Globe and Mail they have plans to do so... Sub. Req’d

Biocon Biologics and Civica Expand Partnership and Launch Private-Label Insulin Glargine to Broaden U.S. Diabetes Treatment Options

(10/16, Biocon Biologics) ...The multi-year transformational agreement between Biocon Biologics and Civica creates an exclusive distributorship arrangement where Biocon Biologics will manufacture and supply Insulin Glargine medicine to Civica, and Civica will commercialize under Biocon Biologics' existing marketing approval (a private label agreement). Civica will distribute, promote, and sell the medicine in the United States under a separate Civica label and trade dress, and in California, the product will carry the CalRx brand... Full

Moving Up The Value Chain: Aurobindo's Murali Talks European Strategy

(10/15, Dave Wallace, Generics Bulletin) ...Aurobindo's European CEO, Venugopalan Muralidharan – known as Murali – speaks to Generics Bulletin for an exclusive interview about the firm's strategy. Murali discusses the increasing importance to Aurobindo of more complex products, including injectables and biosimilars, outlining the firm's plans to focus on these areas in the coming years. The Aurobindo executive also sheds light on the firm's plans for future categories of interest, such as GLP-1s and ADCs. He also discusses Aurobindo's M&A strategy and openness to inorganic growth – but only for opportunities that would be complementary and provide minimal overlap... Global Sub. Full

Civica To Launch Long-Acting Insulin Glargine in the US in January 2026

(10/16, Civica) ...Civica insulin glargine will be available in the United States beginning January 1, 2026. In California, the product will carry the "CalRx" brand...Civica plans to distribute its insulin glargine to pharmacies across the United States for $45 for a box of five pens, a significant discount in many cases to current prices. Civica recommends that pharmacies and health plans set a maximum recommended price for consumers of no more than $55. This stable, transparent price contrasts with copay assistance programs offered by other manufacturers, which require patients to register for access to programs that can change at any time... Full

Aspire Looks To Key Milestones For Sublingual Aspirin And Semaglutide

(10/16, Dean Rudge, Generics Bulletin) ...Aspire Biopharma is setting strategic goals for its sublingual drug delivery platform, with plans for a high-dose sublingual aspirin filing with the FDA expected in late 2025. Initial tests of the sublingual aspirin indicated superior absorption and reduced clotting markers compared to traditional tablets. The US-based firm is also eyeing Phase I trials for needle-free semaglutide and a rapid-acting erectile dysfunction medication in 2026... Global Sub. Full

Viatris Completes Acquisition of Aculys Pharma Including Exclusive Rights to Pitolisant in Japan and to Spydia® in Japan and Certain Other Markets in the Asia-Pacific Region

(10/15, Viatris) ...As part of the transaction, Viatris has acquired exclusive development and commercialization rights in Japan for pitolisant, a selective/inverse agonist of the histamine H3 receptor. Based on the strength of recent Phase 3 clinical trial results in Japanese patients and the positive benefit-risk profile established globally, Viatris is on track to file for marketing approval from the Ministry of Health, Labour and Welfare of Japan for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy and for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea syndrome by the end of 2025... Full

Lilly's Oral GLP-1 Racks Up Two More Clinical Wins in Diabetes

(10/15, Elizabeth Cairns, Endpoints News) ...The company said Wednesday that orforglipron beat AstraZeneca's Farxiga at lowering patients' blood sugar levels in one trial, and it topped placebo on the same measure in a different study in patients who were also taking insulin. The data bolster the case for the pill's approval in diabetes that could come next year... Sub. Req’d

AstraZeneca to Spend $445M to Boost Production of Lokelma at Texas Plant

(10/15, Kevin Dunleavy, Fierce Pharma) ...With sales of potential blockbuster Lokelma scaling up, AstraZeneca is bolstering its production of the hyperkalemia treatment with a $445 million injection of funds. The investment will increase the capabilities of AZ's manufacturing facility in Coppell, Texas, which is the company's lone site in the world that produces Lokelma... Full

CEO of GSK Plays Down its Role in FDA Effort to Approve Therapy for Autism-Related Condition

(10/15, Elaine Chen, STAT+) ...The FDA's request that the company update the prescribing information for its decades-old therapy leucovorin is "an administrative request," the CEO, Emma Walmsley, said during a panel discussion at the STAT Summit. "We have no commercial interest, we have no scientific research, and we're not pursuing it," she added. "So it's just the administration at this stage."... Sub. Req’d

Polpharma Prepares For A New CEO As Sieger Steps Down

(10/16, Dave Wallace, Generics Bulletin) ...Markus Sieger has announced that he will be leaving his role as Polpharma CEO at the end of 2025. However, he will still remain close to the company as he plans to join Polpharma's supervisory board from the start of January 2026. Sieger is also currently president of Medicines for Europe, but is expected to pass on his duties to a successor by the end of the year... Global Sub. Full

Don't Give in to Big Pharma On Drug Pricing

(10/15, Simon Dixon, The Guardian) ...While the chief executive of Eli Lilly may lament the UK's drug prices (UK is ‘worst country in Europe' for drug prices, says Mounjaro maker, September 24,), the NHS should celebrate them. The system put in place for evaluating the cost-effectiveness of new drugs is respected the world over and is successful in applying the principle that funding a new product should not damage the NHS as a whole. This principle of cost-effectiveness has led to widespread price reductions for the NHS that have allowed the service as a whole to benefit... Full

From Nobel to Next-Gen: Sweden's Quiet Life Sciences Ascent

(10/16, Robert Barrie, Pharmaceutical Technology) ...While Denmark boasts the headquarters of big pharma players, the diversity of biotechs does not reach Sweden's level. The plethora of Sweden's biopharma startup scene has partly led to the country's high-ranking in the 2025 Global Innovation Index. Measured across various innovation parameters against 138 other countries, Sweden is placed second only to Switzerland. "Sweden has been starved of a big pharma company for many years. Big industry players pull and lift the entire ecosystem. Without that you must roll up your sleeves and do more yourself," says Klaus Langhoff-Roos, CEO of Swedish biotech BioLamina... Full

European Commission Risks Repeating Past Mistakes in Urban Wastewater Treatment Directive Cost Study

(10/15, Medicines for Europe) ...The industries, represented by AESGP, EFPIA and Medicines for Europe, have not been consulted on a study that aims to assess the impact on the concerned sectors. This incomprehensible omission increases our deep concern about the Commission's approach, which disregards repeated calls and recommendations from the European Parliament and the Council of the European Union to ensure a comprehensive and transparent assessment, not just an updated study. The concerns focus on several key points. A study limited to updating costs, correcting for inflation rates, does not constitute a proper sector assessment. It would fail to assess the broader consequences for the impacted sectors and their products... Full

China Biotech Pushes Abroad as Domestic Pricing Tightens

(10/15, The Pharma Letter) ...China's procurement and reimbursement reforms created a crucible that tests resilience. Price compression now appears baked into market access. That reality is pushing companies to prune portfolios, refocus resources on genuine innovation, and look for growth beyond China. The transition is uneven, but the direction is clear... Sub. Req’d

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