Monday, April 14, 2025

Anti-CGRP Drug Reduces Episodic Migraine in Kids

(4/12, Susan Jeffrey, MedPage Today) ...Fremanezumab (Ajovy) cut monthly migraine days in children and adolescents with episodic migraine, according to the SPACE trial. The phase III study showed a reduction in monthly migraine days in patients (mean age about 13 years) with fremanezumab treatment versus placebo (-2.5 vs -1.4 days per month, P=0.0210), said Christina Szperka, MD, of Children's Hospital of Philadelphia... Full

Celltrion's Yuflyma Gains FDA Interchangeability Approval, Challenging Humira's Market Dominance

(4/14, Choi Mun-hee, Business Korea) ...South Korean biopharmaceutical company Celltrion announced a significant milestone in the pharmaceutical industry on April 14,: the U.S. Food and Drug Administration (FDA) has granted interchangeability approval for its biosimilar Yuflyma with the original drug Humira. This approval marks a pivotal moment for patients suffering from autoimmune diseases, as it allows them to access Yuflyma at pharmacies without needing a doctor's prescription under the U.S. interchangeability system... Full

Biocon Celebrates Long-Awaited FDA Approval For Bevacizumab Biosimilar

(4/14, Urte Fultinaviciute, Generics Bulletin) ...The day has finally come. Biocon Biologics has received approval for its bevacizumab biosimilar from the US Food and Drug Administration, after being delayed for several years due to facility inspections. Bevacizumab-nwgd, which will be marketed in the US under the name Jobevne, was deemed highly similar to originator Roche's Avastin, with no clinically meaningful differences in terms of pharmacokinetics, safety, efficacy, and immunogenicity... Global Sub. Full

Aurobindo Pharma Gets USFDA Nod for Generic Xarelto 2.5mg, Eyes $447 Million US Market

(4/13, Ajay Vaishnav, CNBC TV-18) ...Aurobindo Pharma Ltd has received final approval from the United States Food & Drug Administration (USFDA) to make and sell Rivaroxaban Tablets USP, 2.5mg — the generic equivalent of Janssen Pharmaceuticals's blockbuster drug, Xarelto 2.5mg. The Hyderabad-based pharma major has announced plans to launch the product in the first quarter of the financial year 2025-26... Full

Emcure's Subsidiary Tillomed Boosts Portfolio With $20m+ Manx Deal

(4/11, Adam Zamecnik, Generics Bulletin) ...Tillomed Laboratories has acquired a product portfolio from the UK-based pharmaceutical company Manx Healthcare for an upfront payment of £6.2m ($7.9m), boosting the company's armamentarium with further products. The deal hands over the portfolio of Manx Healthcare and its subsidiaries Manx Pharma and Manx Generics for a total amount of £19.7m, which includes the aforementioned £6.2m upfront payment... Global Sub. Full

Amgen Pads Imdelltra's Case in Tough-to-Treat Lung Cancer Subtype with Phase 3 Survival Win

(4/11, Zoey Becker, Fierce Pharma) ...Nearly a year after winning an accelerated approval for its DLL3-targeting small cell lung cancer (SCLC) therapy Imdelltra, Amgen is further proving the drug's worth with overall survival data from an interim analysis of a phase 3 study... Full

In a Blow to its Obesity Pipeline, Pfizer Drops Oral Drug After Liver Injury Case

(4/14, Elizabeth Cairns, Endpoints News) ...Pfizer has discontinued its once-daily obesity pill danuglipron after a patient in one of its clinical trials had a liver injury that may have been drug-induced. A Pfizer spokesperson told Endpoints News that the case occurred during rapid dose titration of one of the formulations being studied. The study participant was asymptomatic, and their liver enzymes recovered rapidly after treatment discontinuation... Full

Weight is Over! Pharma Companies Race to Make Weight-Loss Drug Semaglutide

(4/12, Teena Thacker and Vikas Dandekar, The Economic Times) ...Indian drugmakers, including Dr. Reddy's and Zydus Lifesciences, are investing heavily in manufacturing capabilities to launch generic versions of Novo Nordisk's Wegovy and Ozempic as patents expire. These companies are developing novel technologies and aligning capacities for delivery pens, targeting both the Indian market and exports. Indian drug makers such as Dr Reddy's Laboratories, Zydus Lifesciences and MSN Labs are setting up new manufacturing capacities as they race to launch copies of blockbuster anti-diabetes and weight-loss drugs Wegovy and Ozempic... Full

Sandoz Files U.S. Antitrust Lawsuit Against Amgen Over Arthritis Drug

(4/14, Abinaya Vijayaraghavan, Mike Scarcella and Oliver Hirt, Reuters) ...Swiss generic drug manufacturer Sandoz said on Monday it had filed an antitrust lawsuit in the United States against Amgen over the alleged entrenchment of the market position of its blockbuster medicine, Enbrel (etanercept). Sandoz alleges Amgen blocked competition from more cost-effective biosimilar competitors, including Sandoz etanercept biosimilar, Erelzi, by unlawfully purchasing and using certain patent rights to entrench its dominant market position... Full

Glenmark, Sun Pharma, Zydus Recall Products in US Over Compliance Issues

(4/13, CNBC TV-18) ...Drug manufacturers Glenmark, Sun Pharma, and Zydus are recalling multiple products in the US due to manufacturing-related issues, according to the latest Enforcement Report by the US Food and Drug Administration (USFDA)... Full

Pridopidine Shows Promise in Subgroup of Huntington's Patients

(4/13, Susan Jeffrey, MedPage Today) ..."Pridopidine shows long-term sustained efficacy up to 2 years, and there's significant long-term benefit confirmed compared to a matched cohort in ENROLL-HD and in TRACK-HD," both observational cohort studies, said Andrew Feigin, MD, of New York University Grossman School of Medicine in New York City...Language from the FDA label for deutetrabenazine (Austedo), for example, which is used to treat chorea in Huntington's disease, notes that it can cause clinical worsening, adverse effects that may cause worsening in mood, cognition, rigidity, and functional capacity, "and it may be difficult to distinguish between adverse reactions and progression of disease," he noted... Full

The Global Biosimilar Development and Approval of Yesintek With Elena Wolff-Holz, MD

(4/13, Cameron Santoro and Elena Wolff-Holz, MD, The Center For Biosimilars) ...Elena Wolff-Holz, MD, global head of clinical development at Biocon Biologics, discussed the approval of BMAb-1200, a biosimilar to reference ustekinumab for psoriasis, highlighting comparable efficacy and safety data while noting challenges in global patient recruitment and regulatory navigation... Full

Pharma Tariffs to Arrive 'In the Next Month or Two,' Commerce Secretary Says

(4/14, Anna Brown, Endpoints News) ...Commerce Secretary Howard Lutnick has indicated more specific timelines as to when pharma tariffs could surface, noting they are "coming in the next month or two."..."President Trump has called out pharmaceuticals and semiconductors and autos – he called them sectoral tariffs – and those are not available for negotiation. They are just going to be part of making sure we reshore core national security items," Lutnick added during an interview with ABC News... Full

Trump Smartphone Tariff Pause is Temporary - Measures 'Coming Soon,' Lutnick Says

(4/13, Cybele Mayes-Osterman, USA TODAY) ...In a Sunday interview on ABC This Week, Lutnick said separate tariffs on the products were "coming soon." "They're exempt from the reciprocal tariffs, but they're included in the semiconductor tariffs, which are coming in probably a month or two," he told host Jonathan Karl..."There was no Tariff 'exception' announced on Friday," Trump wrote. "These products are subject to the existing 20% Fentanyl Tariffs, and they are just moving to a different Tariff 'bucket.'" Lutnick said pharmaceutical products would also be hit with their own separate tariff rate, to come within months... Full

AstraZeneca Chairman Says Drug Tariffs Would Harm Patients

(4/11, Ashleigh Furlong, Bloomberg) ...Tariffs on pharmaceuticals would hurt patients and drugs should be exempt from these levies, AstraZeneca Plc' Chairman Michel Demaré said..."Medicines should be exempted from any kind of tariffs because at the end this is just harming patients, health systems and restricting health equity," Demaré said at Astra's annual general meeting on Friday... Sub. Req’d

GSK CEO Says She's Already Tariff-Proofing Britain's Global Drugmaker

(4/11, Ashleigh Furlong and Ruth David, Bloomberg) ...In her eight-year tenure as chief executive officer of GSK Plc, Emma Walmsley has seen off a combative activist investor, navigated multi-billion dollar litigation in the US and spun out a consumer health company, Haleon Plc. Her latest challenge is preparing the drugmaker for the looming threat of getting dragged into President Donald Trump's trade war...Walmsley spoke to Bloomberg in London about how GSK is hoping for the best but positioning for the worst on tariffs, why she's not panicking about the stock's lackluster performance, and where she's looking for the industry's next transformative drug development. The transcript has been edited for brevity... Sub. Req’d

America's Generic-Drug Crisis Can Be Fixed in Two Words: Pharma Tariffs

(4/14, Jon Toomey, MarketWatch) ...The U.S. has an investment in branded drugs. But rebuilding America's generic drug manufacturing base will require short-, medium- and long-term objectives. In the short term, the U.S. government must move urgently to shore up supply-chain vulnerabilities in critical drug categories - starting with antibiotics. Amoxicillin, a drug that is hard to find in the U.S., has been deemed critical by the FDA and is almost always facing supply issues... Sub. Req’d

Trump Pharma Tariff Threat Raises Specter of Shortages, Price Hikes

(4/14, Nathaniel Weixel, The Hill) ...Experts and industry stakeholders have said if Trump follows through, the impact would be felt hardest on generics, which make up about 90 percent of the medicines prescribed in the country and many of which rely on ingredients made in China and India...Patients will likely be hit hard no matter which drugs they take. "We use generics and spend on brands," Marta Wosinska, a senior fellow at the Brookings Institution, wrote in a paper last month... Full

Trump Says Pharma Tariffs Will Entice Back Drug Production. They Won't.

(4/14, Mari Eccles and Hanne Cokelaere, Politico) ...It's true that the branded pharmaceuticals — the household names that left the U.S. for Ireland and its favorable tax regime — need a continued presence in the U.S. because it's such a big market for pharma, and due to its "relatively short time-to-market for innovative medication," according to analysts at ING. "Given their presence all over the globe and their higher margins, some shuffling in their supply chains as a result of tariffs is likely," they wrote in a briefing... Full

Millions in the U.S. Take This Drug. Tariffs Might Complicate Their Care.

(4/11, Sabrina Malhi, The Washington Post) ...The U.S. domestic supply chain is not equipped to meet national heparin demand. Building a self-sufficient supply would require substantial investment in processing infrastructure, a reliable source of animal tissue and regulatory support. Unless that capacity expands, the United States will remain reliant on international suppliers to meet the bulk of its needs. "There is a chokehold of China on many of those" active ingredients, "so from a geopolitical perspective we've been over-relying on China, which has allowed for cheaper prices, but also a greater risk," said Mark R. Kennedy, a former congressman from Minnesota and the director of the Wahba Institute for Strategic Competition, a research institute in Washington... Sub. Req’d

HHS To GAO: Coordinated Drug Shortage Response Ends Next Month

(4/11, Jessica Karins, Inside Health Policy) ...In its newest report, GAO intended to recommend the coordinator document how recommended practices will be used for coordination on drug shortages across the federal government. But HHS responded to a draft of the report by informing GAO the coordinator position will end in May when funding designated for the purpose expires... Sub. Req’d

Drug Shortages Remain Steady, Down From 2024 All-Time High

(4/11, Luke Zarzecki, Jessica Karins, Inside Health Policy) ...The American Society of Health-System Pharmacists (ASHP) found that the number of active drug shortages is at 270, essentially unchanged for the past three quarters but down from the first quarter of 2024 which was at an all-time high of 323...Of reasons reported by manufacturers for the 2024 shortages, -- 55% are unknown, 17% are due to manufacturing issues, 9% are due to hurricanes, 9% due to business decisions, 8% due to supply and demand and 2% are due to a raw materials issue. "Workload required to manage shortages, including work to change pharmacy automation and electronic health records, adds to the challenges of pharmacy staff shortages," the report says... Sub. Req’d

‘Most-Favored Nation' Drug Pricing Has Three Significant Problems

(4/14, Darius Lakdawalla and Dana P. Goldman, STAT) ...The administration is exploring so-called "most-favored nation" (MFN) pricing, which pegs U.S. drug prices to the lowest level paid by comparable countries. At the end of his first term, President Trump ordered Medicare to implement such an MFN policy, only to have the order blocked by the Biden administration. MFN falls short on several fronts, but three are particularly important... Full

Is the "Price Is Right" Game Over for Many Generic Drugs?

(4/11, Bob Pollock, Lachman Consultants) ...The proposed legislation would eliminate the guessing game and endow the FDA with authority to provide accurate Q1 Q2 data to ANDA applicants upon request, saving both the FDA and industry the scarcest of all resources, time. Also, it will enable certain generic drug products to be brought to market sooner, which will save money for the American consumer... Full

US Bill Recap: Senate Judiciary Committee Offers Fresh Start For Reintroduced Off-Patent Drug Bills

(4/11, Urte Fultinaviciute, Generics Bulletin) ...The US Senate Judiciary Committee has passed six bills aimed at lowering drug prices by addressing patent abuse and market competition-limiting tactics used by pharmaceutical companies. "These bills won't just level the playing field for smaller companies. They'll help make prescription drugs more affordable for the people who need them," said the Committee's chairman senator Chuck Grassley (R-Iowa)... Global Sub. Full

RFK Jr. Says Deep State ‘Is Real,' Called FDA Employees ‘Sock Puppet' of Industry

(4/11, Adam Cancryn, Lauren Gardner and David Lim, Politico) ...HHS Secretary Robert F. Kennedy Jr.'s visit to the FDA Friday was supposed to introduce him as a trusted leader to agency employees. It did anything but. Over the course of 40 minutes, Kennedy, in largely off-the-cuff remarks, asserted that the "Deep State" is real, referenced past CIA experiments on human mind control and accused the employees he was speaking to of becoming a "sock puppet" of the industries they regulate... Full

Inside U.S. Health Agencies, Workers Confront Chaos and Questions as Operations Come Unglued

(4/11, STAT) ...With bare-bones procurement departments to rely on and administrative staff axed, lab leaders at the National Institutes of Health are scrambling to buy food for the animals kept in their facilities. Some scientists have been hoarding and rationing the reagents that they have stockpiled. Because of imposed restrictions, for months they haven't been able to purchase supplies like culture media to nourish cells or dyes to track experiments. For a brief period, one investigator reported not even being able to get anything that comes on dry ice; in the case of at least one institute, the entire warehouse department was laid off, briefly shutting down all shipments of various supplies... Full

Tennessee Officials Find Express Scripts Violated Law Governing Commercial Pharmacy Claims

(4/13, Ed Silverman, STAT+) ...In an unusual move, an audit of commercial health plans by Tennessee officials found that Express Scripts, one of the largest pharmacy benefit managers in the United States, violated state laws in its dealings with pharmacies, according to newly released documents... Sub. Req’d

AbbVie Brings New Suits Against State Pharmacy Contract Laws

(4/11, Ganny Belloni, Bloomberg Law) ...Pharmaceutical giant AbbVie issued a new slate of challenges this week against states with laws requiring drugmakers to offer discounted medications to an unlimited number of contract pharmacies. The four lawsuits filed this week by Kirkland & Ellis in federal district courts in Nebraska, North Dakota, South Dakota, and Utah allege that all four states have laws that violate the drugmakers' constitutional rights... Sub. Req’d

Canada Launches Antitrust Probe into Cigna's Express Scripts Unit

(4/11, Sneha S K, Reuters) ...Canada's Competition Bureau said on Friday it has started an investigation into Cigna's pharmacy services unit Express Scripts' alleged anti-competitive conduct that could prevent or limit competition in the country's drug retail market. The agency said it is looking into Express Scripts' alleged "patient steering" to make people use pharmacies owned or associated with its Canada unit, instead of a drugstore of the patient's choice... Full

Trump Tariffs Unnerve Locals in Irish 'Pharma' Hub

(4/11, Peter Murphy, AFP) ...Pharmaceuticals are now the motor of Ireland's economy, accounting for around 100 billion euros ($114 billion) in 2024, almost half of all Irish exports, and up around 30 percent from the previous year. The sector also provides an estimated 20,000 well-paid jobs in County Cork, most of them around Ringaskiddy and the neighbouring commuter town of Carrigaline, and flushes a corporate tax bounty into the Irish exchequer. But local people are sweating that the good times could end as Ireland has found itself in the crosshairs of the US president's tariff war... Full

Medicines Must Be Protected from Customs Duties, Says Sweden's Lif

(4/14, The Pharma Letter) ...According to the country's trade group LIF, Sweden must be a driving force in the European Union (EU) to ensure that pharmaceuticals continue to be exempt from tariffs and that a negotiated solution with the US must be reached. That was the message when the Lif and other export industries met with the government last week... Sub. Req’d

Any Tariffs On Pharma Sector Would Be Counterproductive for Americans: Wockhardt Chairman Habil Khorakiwala

(4/12, ANI) ...Habil Khorakiwala, Chairman of pharma company Wockhardt on Friday indicated that any imposition of tariffs on pharma products by the US administration would be counterproductive for the Americans... "The whole approach would be counterproductive for the American people, mainly because when it is not easier to switch, for medicine, because the approval process by USFDA takes several years," the pharma company boss said... Full

"Who's Going to Pay Price to Bring Back Manufacturing in US", Asks Biocon MD Amid Possibility of Tariffs On Pharma

(4/11, ANI) ...Siddharth Mittal, CEO and Managing Director of Biocon Limited, on Friday questioned who would pay the price to shift their establishments to the US where pharma manufacturing costs are higher than in India and China. "I think we all know that manufacturing for all segments moved to China, which was a cost arbitrage over decades. And now you're trying to reverse it. So, there's a price to pay," Siddharth Mittal said, speaking at the Carnegie Global Technology Summit... Full

US-China Trade War: How India Can Turn Crisis into Opportunity

(4/13, Pranjal Chaturvedi and Suhasini, Firstpost) ...If the tariff standoff remains consistent, taking a long-term goal, the concern of electronics import reliance could be addressed with faster PLI (Production Linked Incentive) scheme execution. The Pharma API dependence could be reduced by boosting domestic API (Active Pharmaceutical Ingredient) production via PLI. The issue of textile, steel, and auto part dumping would have to be tackled by stricter anti-dumping duties and local sourcing mandates vis-à-vis incentivising synthetic fibre production in India... Full

Trump's Imminent Drug Tariffs Spark Alarm in Korean Pharma

(4/12, Kim Hae-yeon, The Korea Herald) ...US President Donald Trump announced Tuesday that his administration will soon impose tariffs on imported pharmaceuticals, which had previously been exempt from major "reciprocal" tariff measures, raising alarm across Korea's pharmaceuticals and biotech industries. According to multiple foreign news outlets, Trump made the statement during a dinner hosted by the National Republican Congressional Committee in Washington. There, he suggested that pharmaceuticals companies would likely "relocate operations" to the US, given the size and importance of the American market... Full

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