Monday, April 21, 2025

The Top 20 Pharma Companies by 2024 Revenue

(4/21, Kevin Dunleavy, Fierce Pharma) ...Under CEO Richard Francis, Teva's turnaround has been swift and pronounced, with multiple wins coming in last year across both the company's bread-and-butter generics business and its burgeoning innovative medicines division...As for 2025, Teva expects to generate between $16.8 billion and $17.4 billion in total sales for the year—with Austedo tipped to account for between $1.9 billion and $2.05 billion of that sum. The company is looking for its adjusted earnings per share to land between $2.35 and $2.65, a range that came in below analyst expectations when Teva announced its guidance in late January... Full

Where Drug Ingredients Are Made

(4/18, David Lim and Lauren Gardner, Politico) ...The report — which excludes intravenous solution API — finds India is the largest maker of API for generic drugs, producing 35 percent of the global supply. The European Union produces 18 percent of API for generic medicines, followed by the U.S. at 12 percent of the global supply. Meanwhile, the European Union is the largest maker of API used for brand drugs, with 43 percent of global production. The USP report notes countries such as Norway and Switzerland, which are not in the EU, are also major players in brand-drug API manufacturing. But China — which makes only 8 percent of the total volume of API — is a noteworthy player in the building blocks of active pharmaceutical ingredients known as key starting materials, according to the USP report... Full

Cardinal Looks Ahead To A New Decade For US Biosimilars

(4/20, Dave Wallace, Generics Bulletin) ...Cardinal Health recently published a report to mark 10 years since the first biosimilar hit the US market, covering areas including physician and patient adoption, overcoming market barriers, sustainability, the launch of biosimilars into new therapeutic areas, and evolving federal and state legislation related to biosimilars. In the wake of the report, Dracey Poore – director of biosimilars, emerging therapies at Cardinal Health – spoke to Generics Bulletin for an exclusive Q&A... Global Sub. Full

Lilly Promises to Make Weight-Loss Pill in US in Reshoring Push

(4/18, Madison Muller, Bloomberg) ..."We're going to make this medicine here in the United States," Chief Executive Officer Dave Ricks said Friday in an interview with Fox Business Network's Mornings With Maria. "We'll be proud to make this medicine at that site and ship it around the world from our country."...By making its pill in the US, Lilly may be able to avoid the impact of Trump's sweeping tariffs, including potential levies on pharmaceutical products. Lilly had already announced in February that it would spend at least $27 billion to build four new domestic manufacturing plants. The pill still needs to be submitted to US regulators for review and approval, meaning it likely won't reach patients until at least 2026, the company has said... Sub. Req’d

Fresenius Divests Brazilian Sites To EMS Amid Structural Streamlining

(4/20, Adam Zamecnik, Generics Bulletin) ...Fresenius Kabi is handing over parts of its business in Brazil to local pharmaceutical player EMS for an undisclosed sum as part of the company's wider streamlining efforts. This includes the company's production site in Anápolis, with generic injectable manufacturing capacities, alongside a development center and a warehouse found at the same location. Additionally, the company is also letting go of its logistics operations in Goiânia...According to Fresenius' spokesperson, this divestment represents another step taken by the firm to reduce its complexity and optimize utilization in its global manufacturing network... Global Sub. Full

JB Chemicals & Pharma Receives USFDA Approval for Bisoprolol Tablets

(4/21, Business Standard) ...JB Chemicals & Pharmaceuticals announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Bisoprolol Tablets USP, 5 mg, and 10 mg. The approved product is the generic version of Zebeta (marketed by Teva Pharmaceuticals) and is indicated for the management of hypertension... Full

FDA Approves Dupixent for Hives, Rejects New Eylea Dosing Schedule

(4/20, Max Gelman, Endpoints News) ...The approval came for Dupixent, the megablockbuster Regeneron develops and sells with Sanofi. Regulators approved it to treat chronic spontaneous urticaria, also known as chronic hives. The second decision was a rejection of a new dosing regimen for Eylea. Regeneron was attempting to extend the dosing interval for the 8 mg Eylea dose to up to every 24 weeks, across all of its approved indications. But the agency said it didn't agree with pushing dosing beyond the maximum 16 weeks currently indicated... Full

Impressive Phase III Results for Enhertu Plus Pertuzumab

(4/21, The Pharma Letter) ...The companies noted that positive high-level results from a planned interim analysis of the DESTINY-Breast09 Phase III trial showed Enhertu in combination with pertuzumab demonstrated a highly statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) compared to a taxane, trastuzumab and pertuzumab (THP) as a first-line treatment for patients with HER2-positive metastatic breast cancer. The PFS improvement was seen across all pre-specified patient subgroups with Enhertu in combination with pertuzumab... Sub. Req’d

Viatris Files Supplemental New Drug Applications to Japan's Ministry of Health, Labor and Welfare for the Approval of EFFEXOR® for the Treatment of Generalized Anxiety Disorder

(4/21, Viatris) ...Viatris Inc., a global healthcare company, today announced it has filed applications to the Ministry of Health, Labor and Welfare (MHLW) for approval of Effexor SR Capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI) to treat adults with generalized anxiety disorder (GAD), an indication for which no other treatment option is currently approved in Japan... Full

Amneal Pharma Recalls Ropivacaine Hydrochloride Injection

(4/21, RTT News) ...Amneal Pharmaceutical LLC is recalling two lots of Ropivacaine Hydrochloride Injection Infusion bags to the hospital/user level as they may contain an inert fiber identified as polypropylene fibers from the IV bag, according to the U.S. Food and Drug Administration... Full

Cipla's Goa API Facility Receives VAI status from USFDA

(4/21, Business Standard) ...Cipla announced that its wholly-owned subsidiary, Medispray Laboratories, has received a voluntary action indicated (VAI) classification from the U.S. Food and Drug Administration (USFDA) for its API manufacturing facility located in Goa... Full

More Pharmacies Offer to Speed Prescription Deliveries to Customers

(4/20, Tom Murphy, Associated Press) ...Amazon and Walmart are undergoing national expansions in same-day prescription deliveries. They're joining a trend that has gained momentum since the COVID-19 pandemic, with drugstore chains and companies like Instacart and DoorDash rushing to deliver prescriptions as soon as possible. Fast prescription delivery options are growing as traditional drugstores close and more people use telemedicine or subscription-based care that encourages regular deliveries. But this trend may run into limits in the complicated U.S. health care system, where drug costs and coverage can outweigh convenience for consumers, some of whom still like visiting a store... Full

US Tariffs On Pharmaceuticals Risk Shortages of Lower-Cost Generic Drugs

(4/21, Hannah Kuchler and John Reed, Financial Times) ...John Murphy, chief executive of the Association for Accessible Medicines, a US lobby group, said tariffs would not benefit patients or improve the security of the healthcare system. He said older injectables, such as chemotherapy for cancer, were "particularly vulnerable"...Murphy said he was lobbying the White House for the industry to be treated differently, arguing that there were other ways to encourage more onshoring of production, and that imposing costs on an industry that was already struggling with capital investment would not work... Sub. Req’d

When Should Six Drugs Count as One? The Answer Could Be a Big Deal for Pharma Companies

(4/21, John Wilkerson, STAT+) ...Novo argues that the federal government should be forced to negotiate the price for six of its insulin products separately, even though they all contain the same active ingredient. The government says that the law allows it to lump all these products together...The back and forth between the judges and lawyers seemed abstract at times, but the court's ruling could have an impact that is concrete and significant. That's in part because, although the lawsuit focuses on insulin products from the first year of the program, Medicare also lumped together three of Novo's blockbuster diabetes and weight loss products — Ozempic, Rybelsus, and Wegovy — in the second round of negotiations. Semaglutide is the active ingredient in all of them... Sub. Req’d

Deregulation Is The Pathway To Greater Pharmaceutical Innovation

(4/20, Wayne Winegarden, Forbes) ...Surveys confirm that most Americans recognize the value of prescription drugs. But the same surveys also show that Americans are worried that they will be unable to afford needed medicines...Unlike price controls, there are many potential regulatory changes that will improve drug affordability without diminishing the hope of patients who are waiting for an effective treatment to be developed. An Executive Order (EO) signed on April 15th is a solid first step toward achieving this goal... Sub. Req’d

Hickenlooper, Colleagues Reintroduce Bill to Lower Prescription Drug Costs

(4/18, U.S. Senator Hickenlooper) ..."Skyrocketing prescription drug prices are forcing too many Granite Staters to choose between their health and their financial security," said Hassan. "This commonsense, bipartisan legislation will help address a critical obstacle in the generic drug approval process that keeps affordable alternatives off of pharmacy shelves. By requiring more transparency from the FDA and streamlining the drug approval process, this bill will help deliver lower-cost medications to Americans faster."... Full

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

(4/18, Sarah Karlin-Smith, Pink Sheet) ...FDA Commissioner Martin Makary suggested combining all of FDA's adverse event reporting systems, currently divided by product area into separate systems, into one. While many FDA experts have called for improvements to the agency's post-market surveillance capabilities, this particular change called for by Makary was not seen as adding much value to FDA and could cause some problems, experts said. Makary also falsely argued in the April 17, interview with The Megyn Kelly Show that FDA did not properly investigate certain adverse events tied to COVID vaccines... Global Sub. Full

FDA's Drug Office Handling Disputes, Complaints Goes Dark

(4/18, Nyah Phengsitthy, Bloomberg Law) ...The office, known as the Center for Drug Evaluation and Research Ombuds, receives questions and investigates complaints from regulated industry, law firms, and health-care providers to informally resolve disputes between those entities and the FDA's drug reviewers. Bloomberg Law received an automated email Friday from CDER Ombuds that said its "services are currently unavailable at the Food and Drug Administration." "We recommend that you email us again in May, at which time we hope to have more information," the email said. A source familiar with the matter also confirmed that staff in that office were part of the reduction-in-force and placed on administrative leave... Sub. Req’d

East Texas Pharmacists Fear Tariffs Could Lead to Shortages, Price Hikes in Prescription Meds

(4/19, Robert De La Garza, CBS 19) ...From factory to pharmacy, every stage of the supply chain is expected to grow more costly, with the burden falling hardest on those who depend on daily medications. "Every level of the chain of prescription drugs will be affected," Rose City Pharmacy owner Sonny Krezdorn said...East Texans who rely on prescription medications are expected to feel the impact at the counter, as rising costs turn routine purchases into difficult decisions, Krezdorn said. "We're already in a situation where many people have to make hard choices about whether they're going to take a medication that's prescribed by their doctor or go without," he said... Full

Arkansas PBM Law Could Spur Lookalike Restrictions

(4/21, Tina Reed, Axios) ...Among the states that might follow suit is Indiana, which is weighing legislation that would ban PBMs from owning pharmacies or having ownership ties with health carriers. Mississippi is working on a measure that would end the practice of "spread pricing," in which PBMs charge an insurer more than they pay a pharmacy for a drug, and pocket the difference. The bill also would restrict patient steering to affiliates and require mandatory data reporting to the state. Connecticut, Iowa, Maryland, New Hampshire, Oklahoma and Virginia also have bills pending... Full

Illinois Looks to Rein in Drug Intermediaries Over High Costs, But Legislation is Unresolved and Industry Says the Efforts Are Flawed

(4/20, Lisa Schencker, Dan Petrella, Chicago Tribune) ...Many Illinois pharmacists say the practices of PBMs have made it difficult to stay in business. "They're just middlemen. They don't care for any patients. They don't dispense prescriptions except at pharmacies they own," said Michelle Dyer, who owned three pharmacies in central Illinois. "All they do is take money out."...For a time, business went well. But then certain PBM fees began to soar and reimbursements for medications dropped, she said. She said it costs pharmacies $12, on average, to fill a prescription, including the costs of paying employees, rent and utilities. For some medications, she'd get reimbursed only 50 cents, she said, which "doesn't even cover the cost of my vial."... Sub. Req’d

In Ireland, A Global Hub for the Pharma Industry, Trump Tariffs Are a Source of Deep Worry

(4/21, Andrew Joseph, STAT+) ...Even if tariffs compelled companies to manufacture more in the U.S., experts say, any new facilities wouldn't even open until Trump's out of office. "It can take up to six years to commission, design, construct, equip, and validate a biopharmaceutical manufacturing facility — it is not easy to stand up manufacturing capacity quickly," said Rory Mullen, the head of biopharma and food at IDA Ireland, an economic development agency tasked with attracting international investment. "If there were tariffs charged at the point of entry to the U.S., it wouldn't be possible to manufacture those products in the U.S. immediately." Still, Trump's plans have set off deep concerns in Ireland. It isn't that drugmakers will suddenly close up shop on their existing sites, local boosters say... Sub. Req’d

Trump Tariffs Bring Furrowed Brows to Ireland's Botox Town

(4/19, Jude Webber and Hannah Kuchler, Financial Times) ...The US president this past week stepped up his criticism of American companies' Irish operations. His threats to impose tariffs to encourage investors to reshore are weighing on the 7,000 people of Westport: some 1,500 of them are employed by AbbVie to make the wrinkle-erasing drug...Besides Botox - which leaves Westport as vials of powder to be mixed with saline solution before injection into celebrity foreheads or to treat cerebral palsy or muscle spasms - factories in Ireland churn out active ingredients for drugs including Viagra, weight-loss remedy Mounjaro and statins for high cholesterol... Sub. Req’d

NHS Cancer Patients Denied Life-Saving Drugs Due to Brexit Costs, Report Finds

(4/20, Andrew Gregory, The Guardian) ...Brexit has "damaged the practical ability" of doctors to offer NHS patients life-saving new drugs via international clinical trials, according to the 54-page report obtained by the Guardian. In some cases, the cost of importing new cancer drugs for Britons has nearly quadrupled as a result of post-Brexit red tape. Some trials have had shipping costs alone increase to 10 times since Brexit. The extra rules and costs have had a "significant negative impact" on UK cancer research, creating "new barriers" that are "holding back life-saving research" for Britons, the report says... Full

Tariffs Will Positively Impact India; Pharma, Metals Attractive Sectors: Anshul Saigal

(4/21, The Economic Times) ...Saigal Capital's founder, Anshul Saigal, anticipates tariffs positively impacting India, presenting buying opportunities post-volatility. He sees value in companies benefiting from volume and price increases, particularly in pharma (CDMO) and metals. Despite tech's potential, high valuations make it currently less appealing, with uncertainty creating opportunities in specific sectors like textiles... Full

Indian Pharma Can't Survive On Prescriptions Alone. It Must Now Build Brands

(4/21, Prof. [Dr.] Kiran Mahasuar, Business Today) ...Indian pharma must now acknowledge the limits of the branded generics model that has long driven domestic growth. Chronic therapies like cardiology and diabetes remain volume drivers, but competitive intensity and the rise of trade generics are compressing margins and eroding brand loyalty. To stay ahead, firms need to redirect capital and capabilities toward faster growing, consumer-centric segments. Dermatology, for instance, is witnessing a surge in demand for biologics and aesthetic solutions in urban markets... Full

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