Monday, March 17, 2025

Drugmakers Agree to Participate in Second Round of Price Negotiations

(3/14, Bhanvi Satija and Sneha S K, Reuters) ...All drug manufacturers, including Novo Nordisk and Teva Pharmaceuticals, whose medicines are part of the second round of price talks have agreed to participate in the negotiation process, a federal health agency said on Friday... The U.S. government has said that it plans to aim for "greater transparency" in Medicare drug price negotiations under Trump, following criticism from the pharmaceutical industry for the Biden-era law. The Centers for Medicare & Medicaid Services said on Friday that the negotiations "will include robust engagement with drug companies and the public."... Full

CMS Announces Manufacturer Participation in Second Cycle of Medicare Drug Price Negotiation

(3/14, CMS) ...Today, the Centers for Medicare & Medicaid Services (CMS) announced that agreements have been signed with manufacturers of the 15 drugs covered under Medicare Part D selected for the second cycle of the Medicare Drug Price Negotiation Program (Negotiation Program). This is an important step in the process which initiates the negotiation period between the manufacturer and CMS. All 15 drugs selected for the second cycle of the Negotiation Program and the associated manufacturers are listed below:... Austedo; Austedo XR, Teva Branded Pharmaceutical Products R&D, Inc... Full

The Top 10 Drugs Losing US Exclusivity in 2025

(3/17, Eric Sagonowsky, Angus Liu, Fraiser Kansteiner, Andrea Park, Kevin Dunleavy, Zoey Becker, Fierce Pharma) ...Now, however, the floodgates are open. The first Stelara biosim launched bright and early on the first of the year, courtesy of Amgen...In the wake of Wezlana's approval, six more Stelara biosim rivals have so far earned FDA green lights and plotted their own 2025 launch dates. February alone heralded the rollouts of Teva Pharmaceutical and Alvotech's Selarsdi, Sandoz and Samsung Bioepis' Pyzchiva and Biocon Biologics' Yesintek... Full

KC Law Firms Help Secure $73.5M EpiPen Settlement for Wholesaler Buyers

(3/14, James Dornbrook, Kansas City Business Journal) ...Two teams of Kansas City lawyers participated in the latest chapter in a long-running legal dispute about the EpiPen: a $73.5 million settlement of a case in Kansas federal court...The complaint accused EpiPen owner Mylan Pharmaceuticals Inc., Pfizer Inc. and Meridian Medical Technologies of conspiring with Teva Pharmaceuticals USA Inc. to delay its release of a generic version of EpiPen. In return, Mylan was accused of agreeing to delay its release of a generic version of Nuvigil, a major drug owned by Teva... Sub. Req’d

The Value of Listening and Proximity to the Humanizing Health Awards 2025 – Viviana Persiani's Blog

(3/16, Jack Wiliams, The Vermilion) ...When we talk about care, it does not refer only to drugs and therapies, but also to empathy, listening and closeness. With this spirit, today, the sixth edition of the Humanizing Health Awards award was officially presented, an initiative that confirms the commitment in the field of the humanization of care by Teva, a leading pharmaceutical company in the market..."Teva's commitment does not end in the research and production of high quality drugs – says Giordana Cortinovis, Marketing and Communication Director of Teva Italia – Taking care also means recognizing the importance of emotional support in the patient's path"... Full

Pfizer Has a New Playbook for Reviving Sales—and It's Starting to Pay Off

(3/17, Jared S. Hopkins, The Wall Street Journal) ...Doctors weren't prescribing its migraine drug Nurtec because they assumed insurance coverage would be too much of a hassle. So last year the company created a phone line for doctors and patients to call Pfizer directly for help. Pfizer now credits that and other changes for a 31% increase in Nurtec's U.S. sales last year...Pfizer made a big bet on Nurtec. The drug was the crown jewel of an $11.6 billion deal that closed in 2022. Analysts estimated the medicine would ring up $4 billion in yearly sales by 2030, revenue Pfizer was counting on as sales from older products faded... Sub. Req’d

Biocon Biologics Teams Up With Civica On US Insulin Production

(3/14, Dave Wallace, Generics Bulletin) ...The collaboration is in addition to Biocon Biologics' own insulin aspart drug product for the US, which is currently under US Food and Drug Administration review. Biocon Biologics CEO and managing director Shreehas Tambe said that "as a fully integrated global biologics company, Biocon Biologics is uniquely positioned to drive commercial success through tailored go-to-market strategies that create lasting value for all stakeholders. Our collaboration with Civica reflects this commitment, enabling us to expand patient access to insulin aspart in the US while reinforcing our dedication to serving the growing needs of people living with diabetes."... Global Sub. Full

Zydus Life Receives Final Approval from USFDA for Eluxadoline Tablets

(3/16, CNBC TV-18) ...Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) to manufacture Eluxadoline Tablets, 75 mg and 100 mg. Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea... Full

Federal Circuit Ruling Allows Amgen's Eylea Biosimilar to Stay On the Market

(3/14, Zachary Brennan, Endpoints News) ...The US Court of Appeals for the Federal Circuit on Friday ruled against Regeneron in a closely-watched patent infringement case involving the New York biotech's blockbuster eye drug Eylea and Amgen's competing biosimilar Pavblu, which launched last November. Regeneron did not establish "a likelihood of success on the merits of its infringement allegations and the district court did not abuse its discretion in denying its motion for a preliminary injunction," Circuit Judge Alan Lourie wrote in his opinion on Friday... Full

Eisai Still Considering Next Steps After Australia Again Rejects Alzheimer's Drug Leqembi

(3/14, Anabel Costa-Ferreira, Pink Sheet) ...Eisai is continuing to explore its options on how to enable Australian patients to, access its early Alzheimer's disease drug, Leqembi (lecanemab), after the Therapeutic Goods Administration again refused to approve the product, which is already authorized for marketing in the US, Japan and many other countries...Eisai told the Pink Sheet on March 12, that it remained "committed to finding a path forward, including potentially seeking review by the Administrative Review Tribunal."... Global Sub. Full

Big Pharma Mergers Unlikely in Near Future: Dr Reddy's MD GV Prasad

(3/16Vikas Dandekar, The Economic Times) ...GV Prasad, co-chairman and managing director, Dr Reddy's Laboratories says large mergers and acquisitions in the Indian pharmaceutical market are unlikely in the near future due to various uncertainties. With revenue of 28,000 crore in FY24, Prasad is steering Dr Reddy's towards a diversified portfolio amid challenges in the global markets for generic drugs. In an interview to Vikas Dandekar, he says India has an obesity problem and Dr Reddy's will have a play in it... Full

Sun Pharma, Zydus Recall Products in US: USFDA Report

(3/16, Press Trust Of India) ...Sun Pharma and Zydus Pharmaceuticals are recalling products in the US market due to manufacturing issues, according to the US Food and Drug Administration (USFDA). The New Jersey-based Sun Pharmaceutical Industries, Inc is recalling 9,840 bottles of Morphine Sulfate extended-release tablets for "Failed Dissolution Specifications", the US health regulator stated in its latest Enforcement Report... Full

Parkinson's Disease Numbers Set to Rise Dramatically in Coming Decades

(3/17, Hannah Docter-Loeb, The Washington Post) ...By 2050, there will be an estimated 25.2 million people living with Parkinson's disease worldwide, a 112 percent increase from 2021, according to a new study published in the journal BMJ...The study's authors called for more research, citing "the upward trend [in Parkinson's diagnoses] being more pronounced in men, in East Asia" and in "moderately developed countries." "An urgent need exists for future research to focus on the development of novel drugs, gene engineering techniques and cell replacement therapies that are aimed at modifying the course of the disease and improving patients' quality of life," the researchers wrote in a news release... Full

Healthcare Industry Must Brace Itself for Deluge of Cyberattacks in 2025 | Viewpoint

(3/16, Michael Marcotte, Chief Healthcare Executive) ...Healthcare is the most afflicted industry by cyberattacks, with around 90% of institutions reporting at least one security breach in the last few years. In fact, 2024 recorded the highest number of cyberattacks for the industry – an increase of 300% since 2015. This trend could worsen this year, with high-profile AI-driven hacks showing no sign of abating. And it's clear to me that the industry isn't prepared for this onslaught... Full

FBI and Other Agencies Investigate Fire at Bayer Executive's New Jersey Home: Reports

(3/14, Fraiser Kansteiner, Fierce Pharma) ...While details on what exactly went down at the Bayer executive's Madison home are slim, the incident once again raises safety concerns for biopharma and healthcare leaders that were thrust into the spotlight following the murder of UnitedHealthcare CEO Brian Thompson on Dec. 4... Full

Oz Vows To Defend Medicare Price Negotiations In Court Challenges, Open To Reference Pricing

(3/14, Maaisha Osman, Inside Health Policy) ...Mehmet Oz, President Donald Trump's nominee to head CMS, told senators he would defend Medicare's drug price negotiation program in court challenges, signaled an openness to international reference pricing and said pharmacy benefit managers' practices need to be reformed. He also acknowledged -- but did not outright condemn -- the growing influence of private equity in health care during his Senate Finance Committee confirmation hearing Friday (March 14)... Sub. Req’d

Novartis is Watching US Reciprocal Tariff Policy 'Very Carefully', CEO Says

(3/17, Rocky Swift, Reuters) ...Swiss pharmaceutical giant Novartis will watch "very carefully" how the reciprocal tariff policy proposed by the United States unfolds in early April, Chief Executive Vas Narasimhan said on Monday..."The real key is to see what are the policies that are actually implemented versus what's being said in the rhetoric," Narasimhan told reporters at a briefing in Tokyo. "And then we're just going to have to respond appropriately."... Full

Trump Tariffs and Drugs: How a Trade War with China Could Worsen Medicine Shortage

(3/15, Ken Alltucker, USA TODAY) ...Health analysts and generic drug manufacturers said the 20% levy from two rounds of tariffs on goods imported from China - a major supplier of medical equipment and prescription drugs for the United States - could shrink inventories and raise prices. Hospitals, doctors and consumers filling prescriptions at their local pharmacy might feel the effects, though not immediately, pharmaceutical supply and pricing experts told USA TODAY... Full

Ireland's Profits From Weight-Loss Drugs Draw Trump's Attention

(3/17, Jennifer Duggan and Madison Muller, Bloomberg Law) ...If Washington slaps broader levies on EU goods of even 10%, which is at the lower end of the spectrum floated, they would still be unprecedented for Ireland, said Dan O'Brien, chief economist with the Institute of International and European Affairs in Dublin. "The impact on the Irish economy, which is by a distance the largest per capita goods exporter to the US in Europe, would be strongly negative," said O'Brien. "The only real question is how much damage they would do... Sub. Req’d

Bipartisan Bill Would Give President New Authority On Medical Good Trade Deals

(3/14, Dave Muoio, Fierce Healthcare) ...A bipartisan, bicameral group of senators have introduced legislation that would give the president new authority to negotiate and strike trade deals—which include the handling of tariffs—with foreign countries for medical goods such as drugs and devices. The bill, also backed by industry pharmaceutical and group purchasing organizations, aims to strengthen the country's medical supply chain, which lawmakers said became strained during the COVID-19 pandemic... Full

Cornyn, Blumenthal, Grassley, Durbin Introduce Bill to Lower Drug Costs

(3/14, United States Senator for Texas John Cornyn) ..."Patent thickets stifle innovation, hinder generic drugs from entering the marketplace, and raise prices for consumers," said Sen. Cornyn. "This legislation would help end these abusive and anti-competitive practices to ensure Texans can access the treatments and life-saving medications they need without breaking the bank." "For too long, pharmaceutical companies have been allowed to abuse the patent system, stifling innovation and driving up costs for consumers. This legislation cracks down on drug companies' manipulative and exploitative practices, promoting competition and lowering prescription drug costs for patients," said Sen. Blumenthal... Full

CSRXP Applauds U.S. Senate Reintroduction of Bipartisan, Market-Based Solutions to Lower Drug Prices by Addressing Big Pharma's Patent Abuse

(3/14, The Campaign for Sustainable Rx Pricing) ..."We applaud Senators Cornyn and Blumenthal for their commitment to lowering prescription drug prices for American patients by addressing Big Pharma's egregious abuse of the patent system," said CSRxP executive director Lauren Aronson. "Big Pharma's patent abuse tactics, like patent-thicketing and product-hopping, extend monopolies, block competition from more affordable alternatives and keep drug prices high."... Full

Wyden, Sanders Blocked From Attempt to Pass Stand-Alone Health Package

(3/14, Nathaniel Weixel, The Hill) ...Sens. Ron Wyden (D-Ore.) and Bernie Sanders (I-Vt.) were blocked Friday from passing a package of health policies, including changes to the pharmacy benefit manager (PBM) industry that was left out of December's government spending bill...The package included reauthorizations of the opioid-fighting SUPPORT Act and the Pandemic and All Hazards Preparedness Act. The pandemic legislation had historically been bipartisan, but its initial inclusion in the spending bill late last year sparked a wave of online misinformation amplified by Musk... Full

We Should Stop Acting as if Big Pharma is the Big Villain in American Health Care

(3/17, Erick Erickson, The Boston Globe) ...A free-market system could and should provide a saner, more streamlined, and affordable system. But the public, like the political parties, is divided over more or less government control and fewer or more mandates. The government cannot provide clarity or direction for private insurance and medical and pharmaceutical costs because Americans themselves cannot agree... Sub. Req’d

Industry Welcomes Critical Medicines Act But With Mixed Responses

(3/14, Urte Fultinaviciute, Generics Bulletin) ...The proposed legislation aims to provide an industrial toolkit to ensure two overarching goals: security of supply; and the availability of critical medicines and accessibility and availability of other key medicines. To bolster supply-chain security and accessibility, the act splits into four key elements: strategic projects, public procurement, collaborative procurement, and strategic partnerships. "Medicine shortages and structural dependencies in our pharmaceutical supply chains put the health of Europeans at risk," commented Olivér Várhelyi, commissioner for health and animal welfare... Global Sub. Full

Last Chance For Pharma To Respond To EU Strategy For Reforming Ecosystem For SMEs

(3/14, Eliza Slawther, Pink Sheet) ...The European Commission is developing a new strategy for start-ups and scale-ups, which will address financial, regulatory and administrative obstacles that slow down their progress. Pharmaceutical firms that want to help shape the framework can respond to a public consultation, which is open until March 17. Industry representatives including EUCOPE have highlighted how the strategy should address challenges specific to the pharmaceutical sector... Global Sub. Full

Ireland Welcomes Draghi-Infused Critical Medicines Act

(3/14, Brian Maguire, Euractiv) ...A spokesperson for Ireland's Department of Health (DoH) told Euractiv that, "Ireland was one of many Member States who called for such a legislative initiative by giving support to Belgium's 2023 non-paper "Improving the security of medicines supply in Europe." Oliver O'Connor, Chief Executive of the Irish Pharmaceutical Healthcare Association told Euractiv that Ireland's pharmaceutical sector welcomes the European Commission's proposal of the CMA so early in its new mandate... Full

Rate of Pharma's UK Payments ‘Undermining' Life Sciences Ambitions

(3/14, The Pharma Letter) ...The UK government plans to raise the Statutory Scheme payment rate for newer branded medicines from 15.5% to 32.2% of subject companies' National Health Service (NHS) sales in the second half of 2025. This payment rate is the amount of revenue that companies are required to hand back to government on their sales of branded medicines to the NHS and is an additional charge to the taxes paid by companies... Sub. Req’d

U.K. Plan to Require Drugmakers to Pay Higher Rebates Draws Criticism from Industry Group

(3/15, Ed Silverman, STAT+) ...At issue is a program called the statutory scheme, which was created several years ago and is one of two initiatives in which the government uses rebates to cap the cost of brand-name medicines for the NHS. However, the programs have grown controversial, partly because the rebates had historically been in the single-digit percentages but rose sharply during the Covid-19 pandemic... Sub. Req’d

AI-Driven Drug Discovery, Precision Medicine, and Sustainable Manufacturing Can Redefine the Pharma Industry

(3/17, Viveka Roychowdhury, Express Pharma) ...Ramandeep Singh, Vice President, Life Sciences and Healthcare, India, Clarivate, discusses the latest innovative R&D, generics, biosimilars and healthcare manufacturing and the vital challenge of integrating patient-centric innovation in today's evolving market in an interview with Viveka Roychowdhury... Full

Indian Pharma Ramps Up US Acquisitions Amid Regulatory and Market Shifts

(3/14, Aishwarya Kumar, The Hindu BusinessLine) ...Indian pharmaceutical companies are aggressively expanding their US presence through a wave of acquisitions, likely as a hedge against future uncertainties. Leading players like Sun Pharma, Syngene, Senores, and Zydus have all made strategic purchases, reflecting a broader industry shift. Analysts and insiders see this trend as a move to scale operations, optimise costs, and maintain profitability amid tightening USFDA regulations. Additionally, the rising demand for biosimilars and specialty drugs has also encouraged acquisitions, as companies seek to reduce their dependence on traditional generics... Full

India First vs America First: The High-Stakes Tug-Of-War Over the US-India Trade Deal'

(3/16, Joe Mathew, Fortune India) ...On March 14, two separate social media messages — one from India's Commerce Minister Piyush Goyal and the other from the US Trade Representative (USTR) Jamieson Greer — hinted at the complexity and shared goals of the ongoing India-US bilateral efforts towards a quick Free Trade Agreement (FTA)... Full

China's Biotech is Redrawing the Global Pharma Map; What India Can Learn

(3/16, Vikas Dandekar and Rica Bhattacharyya, The Economic Times) ...The world looked on in awe as DeepSeek, a tiny artificial intelligence (AI) star tup in Hangzhou, overnight shook the foundation of Silicon Valley giants. Something equally momentous is happening in China though it has not got the sensational public attention the AI model received. China's biotech research is redrawing the global map. The axis of innovation is tilting from the West to Beijing. Scores of small biotech startups, which have sprung up across China over the last decade, are coming up with medical breakthroughs. Impressed by the speed of drug research and new treatment modalities, global pharmaceutical companies are throwing princely sums to buy leads, which have the potential to be drugs... Full

How America Ripped off Australia with 'Free Trade'

(3/15, ABC News) ...This week, US President Donald Trump trashed that 2005 agreement after imposing tariffs on Australian steel and aluminium exports to America. Already, there are hints that agricultural goods may be next in line along with Australian pharmaceuticals... Full

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