Friday, April 11, 2025

6 Drugs Now in Shortage

(4/10, Alexandra Murphy, Becker's Hospital Review) ...Lanthanum carbonate chewable tablet: Exelan and Teva have reported shortages of multiple strengths of lanthanum carbonate chewable tablets. Both companies have not provided specific reasons for the shortages. Exelan expects resupply in the second half of 2025, while Teva anticipates early April 2025...Liraglutide injection: Multiple presentations of liraglutide injection, marketed under Victoza and Saxenda, are facing limited availability. Novo Nordisk cited demand increases and shipping delays as causes. Distributed by Teva, other 6-milligram/milliliter formulations remain available... Full

Pfizer's Nurtec Approved in Korea, Intensifying CGRP Migraine Treatment Competition

(4/11, Kim Chan-hyuk, Korea Biomedical Review) ...The Korean approval of Pfizer's Nurtec, an oral calcitonin gene-related peptide (CGRP) targeting drug for both acute and preventive treatment, is expected to further intensify competition in the domestic migraine treatment market...So far, CGRP monoclonal antibodies (mAbs) like Emgality (galcanezumab, Lilly Korea), Ajovy (fremanezumab, Handok Teva), and the CGRP receptor antagonist Aquipta (atogepant, AbbVie Korea) have been introduced in Korea... Full

AAN 2025: Lundbeck Highlights Sustained Efficacy of Vyepti for Migraine Prevention

(4/10, Clinical Trials Arena) ...Long-term sustained efficacy data and demonstration of meaningful benefit for patients, such as was presented for Vyepti at AAN 2025, are likely to further cement the case for first-line adoption of the anti-CGRP mAbs; however, given the comparative costs of the oral preventives and the mAbs, whether this recommendation will be implemented by insurance companies remains to be seen. Vyepti faces significant competition from three other anti-CGRP mAbs: Amgen's Aimovig (erenumab), Eli Lilly's Emgality (galcanezumab), and Teva's Ajovy (fremanezumab). Additional competition also comes from two orally administered gepants: Pfizer's Nurtec (rimegepant) and AbbVie's Qulipta (atogepant)... Full

Henlius And Outlook Move Forward With Ophthalmic Bevacizumab

(4/10, Dave Wallace, Generics Bulletin) ...Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing... Global Sub. Full

US FDA Approves Syringe Version of Argenx's Immune Disorder Drug

(4/10, Mariam Sunny and Kamal Choudhury, Reuters) ...The U.S. Food and Drug Administration has approved a prefilled syringe version of Netherlands-based Argenx SE's blockbuster immune disorder drug, Vyvgart, giving patients a more convenient option of at-home self administration, the company said on Thursday...Argenx said the Vyvgart Hytrulo prefilled syringe will be available within the next two weeks and that it would have a comparable price to the subcutaneous vial... Full

Jazz Agrees To Fork Out $145M To Resolve Most Xyrem ‘Pay-For-Delay' Claims

(4/11, Dean Rudge, Generics Bulletin) ...Previously facing the prospect of a jury trial beginning next month, Jazz Pharmaceuticals has agreed in principle to pay $145m to resolve certain allegations that its US patent-litigation settlement agreements with generics manufacturers for Xyrem (sodium oxybate) violated antitrust, consumer protection and unfair competition laws... Global Sub. Full

Samsung Bioepis Projects $580 Mil. in EU Cost Savings As Stelara Biosimilar Gains Ground

(4/10, Kim Ji-hye, Korea Biomedical Review) ...With patent walls down on the blockbuster immunology drug Stelara, Samsung Bioepis is making its move. Backed by a courtroom win in Europe and new budget impact data, the Korean biosimilar maker is projecting more than €526 million ($580 million) in cost savings across Germany, the U.K., and Sweden over three years by switching to its ustekinumab biosimilar, Pyzchiva... Full

‘Gamechanging' Breast Cancer Pill to Be Offered On NHS in England and Wales

(4/10, Andrew Gregory, The Guardian) ...As many as 3,000 women every year could benefit from capivasertib for hormone receptor (HR)-positive HER2-negative breast cancer that has certain genetic mutations and has spread. The drug, also known as Truqap and made by AstraZeneca, blocks an abnormal protein molecule AKT that drives cancer cells to multiply – helping to slow or stop the spread of the disease. Claire Rowney, the chief executive of charity Breast Cancer Now, welcomed the green light from the National Institute for Health and Care Excellence (Nice) but said its initial rejection of the pill had led to treatment delays... Full

Aurobindo Pharma's Aurolife Plant in North Carolina Faces US FDA Scrutiny, Gets Form 483 with 11 Observations

(4/11, Poonam Behura, CNBC TV-18) ...At the conclusion of the inspection, the US FDA issued a Form 483, listing 11 observations. Aurobindo Pharma characterised these observations as "procedural in nature." The company has stated that it will submit a comprehensive response to the US FDA within the stipulated timeframe, addressing each observation with appropriate corrective and preventive actions... Full

New I-MAK Report Exposes Patent Abuse and Market Monopolization Behind GLP-1 Drug Prices

(4/10, Initiative for Medicines, Access, and Knowledge) ...The report highlights how branded pharmaceutical companies are cornering the GLP-1 market through aggressive and systemic misuse of the U.S. patent system. By building vast "patent thickets," these companies delay the entry of more affordable generics and biosimilars - keeping prices high and competition at bay. "The potential revenue earning capability of these drugs is astronomical compared to some of the best-selling drugs we've seen in the last decade," said Tahir Amin, Co-Founder and CEO of I-MAK. "The iPhone earned $260 billion in its first decade - these drugs are going to exceed that by 77%."... Full

Novo, Lilly Patent Moves Keep GLP-1 Prices High, Report Says

(4/10, Christopher Yasiejko, Bloomberg Law) ...I-MAK, a nonprofit advocate for affordable access to medicines, said the extended GLP-1 monopolies allow Novo and Lilly to maintain drug prices at roughly $1,000 per month, placing them "out of reach" for many Americans—especially low-income, Black communities disproportionately affected by diabetes and obesity...The GLP-1 market is projected to reach $130 billion annually by 2030, I-MAK's report said. Both Novo and Lilly are using follow-on patents to extend their legal monopolies on the blockbuster products beyond 2040, the group wrote... Sub. Req’d

UC Tracks ‘Evolving' Opioid Epidemic Across US

(4/10, Michael Miller and Email Michael, UC News) ...In a study published in the journal The Lancet Regional Health, epidemiologists at the University of Cincinnati tracked the epicenter of this life-shattering epidemic over space and time across the country, driven largely by a move from prescription opiates to heroin to synthetic substances like fentanyl. Researchers say this geographic shift can be narrowed between 2013 and 2016 as lawmakers implemented stricter regulations limiting access to opioids and law enforcement began prosecuting doctors for allegedly prescribing them irresponsibly. In the absence of a legal remedy, many people with substance use disorder began turning to illicit drugs such as heroin and fentanyl, UC College of Arts and Sciences Professor Diego Cuadros said... Full

Pharma Tariffs: Here's What a Potential Rollout Could Look Like

(4/10, Anna Brown, Endpoints News) ...Leerink analysts believe Trump could announce pharma tariffs as soon as next week. It's likely Trump is planning a "dual track" approach to target pharmaceuticals, using the 232 investigation and the International Emergency Economic Powers Act, which could see the levy placed very quickly, they said in a Thursday note...Another question on the tariff rollout is if pharma tariffs could be stacked on top of Trump's preexisting levies. This is likely to be the case for countries like China, whose tariffs have been stacked multiple times reaching a total of 125%, [Mollie Sitkowski, a trade compliance partner at US law firm Faegre Drinker,] added. As it stands, it looks like all pharmaceutical goods, including API, will be levied. This would be a major blow to China — especially if tariffs are stacked — since it's a major supplier of API to the US... Full

Novartis Plans to Invest $23 Billion in US Sites As Trump Renews Drug Tariff Threats

(4/10, Patrick Wingrove, Reuters) ...Swiss drugmaker Novartis said on Thursday it plans to spend $23 billion to build and expand 10 facilities in the U.S., as it grapples with renewed threats of drug import duties from the Trump administration...The announcement comes two days after President Donald Trump said the U.S. will soon announce a "major" tariff on pharmaceutical imports, sending shares of drugmakers plunging. "We believe we can manage the tariffs - though of course they will be very painful - so while that is a factor (behind this investment), it's not the driving factor," Novartis Chief Executive Vas Narasimhan said in an interview, adding that it aims to produce all the drugs it sells to Americans in the U.S. rather than import them... Full

Following Pledges from Lilly and J&J, Novartis Unveils $23B US Investment to Beef Up Manufacturing, R&D

(4/10, Fraiser Kansteiner, Fierce Pharma) ...The outlay is the latest in a series of moves seemingly spurred on by the threat of import tariffs on pharmaceuticals under the second Trump administration. On the production front, Novartis will build four new manufacturing facilities in "soon-to-be-determined states," plus establish new radioligand therapy plants in Florida and Texas. The company will also expand existing radioligand manufacturing facilities in Indiana, New Jersey and California... Full

1 Big Thing: Pharma's Volatile Reality

(4/11, Caitlin Owens, Axios) ...The future of the pharmaceutical industry is looking — at least for now — pretty bleak, thanks to a growing pile of threats...President Trump said this week that pharmaceutical tariffs are still coming, and the prevailing consensus among analysts and investors seems to be that if they do, it'll be chaos. Wednesday, he seemed to signal in remarks to reporters that such tariffs could range from 50% to 200% — much higher rates than generally expected... Full

3. About Those Pharma Tariffs ...

(4/11, Caitlin Owens, Axios) ...For generics, "tariff pressure ... will test their already low margins, potentially leading to product discontinuations or cost cutting that erodes quality," and shortages are also a risk, argues Brookings' Marta Wosinska in a paper exploring pharma tariffs' impact..."We believe sustained tariffs would drive up U.S. drug prices for consumers, because even if companies were to redomicile manufacturing, it will take years and cost more than ex-U.S. manufacturing," Leerink analysts wrote in a separate recently published note... Full

2. On An Island

(4/11, Caitlin Owens, Axios) ...Any one of today's threats to pharma would be cause for alarm from the industry on its own — look no further than the freakout over the IRA when it initially passed, despite how watered-down the policy had become from the original version...The bottom line: Yes, this week's big topic — tariffs — has a much bigger direct impact on drug companies' wallets than last weeks' massive changes to the federal health bureaucracy. But ultimately the consequences could end up in the same place... Full

Editorial: Trump's Pharmaceutical Tariff Plan Would Put American Lives in Danger

(4/11, Las Vegas Sun) ...Generic medicines — which account for over 90% of all prescriptions filled in the U.S. — have helped keep some semblance of affordability in our deeply flawed health care system. But tariffs threaten to upend that fragile equilibrium, hitting working-class and elderly Americans the hardest... Full

Senators Hassan, Paul, Hickenlooper, Lee Reintroduce Bill to Lower Prescription Drug Prices by Streamlining Generic Drug Approval Process

(4/10, United States Senator for New Hampshire Maggie Hassan) ..."Skyrocketing prescription drug prices are forcing too many Granite Staters to choose between their health and their financial security," said Senator 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

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

(4/10, Cathy Kelly, Pink Sheet) ...Coverage of GLP-1 drugs for obesity are expanding in Medicaid even though coverage for the indication still is almost nonexistent in Medicare Part D, according to recent MMIT data. The data suggest the Trump Administration's recent decision to drop the Biden-era proposal to expand obesity drug coverage in the programs may be more disappointing to Part D beneficiaries. Cost likely was the key reason for the decision, especially as the administration appears poised to implement significant cuts in the Medicaid program, former CMS official John Coster said... Global Sub. Full

How Job Cuts at the FDA Are Set to Slow Down Crucial Drug Reviews

(4/10, Lizzy Lawrence, Matthew Herper, and Elaine Chen, STAT+) ...Biotech industry leaders including Peter Kolchinsky of RA Capital and former Alnylam CEO John Maraganore published a letter to the senator on Thursday morning, detailing specific breakdowns their colleagues are already experiencing in interactions with the FDA, including, they said, a case in which a dispute resolution process was ended because senior staff were not available to review it and another where no senior FDA employee was available to resolve conflicting feedback from reviewers... Sub. Req’d

Biotech CEOs to Cassidy: We're Already Seeing the Effects of FDA's Staff Cuts

(4/10, Zachary Brennan, Endpoints News) ...The group of CEOs' letter from Wednesday raised concerns that the institutional knowledge "that makes the FDA the world's leading regulatory body will be irretrievably lost" due to the cuts and retirements. The agency has lost many of its senior staff since the Trump administration took over, including the heads of CDER and CBER, the chief medical officer, the principal deputy commissioner and the head of the Office of New Drugs... Full

FDA Official Says Data Integrity Issues Are the Main Reason for ANDA Delays

(4/10, Joanne S. Eglovitch, Regulatory Focus) ...Data integrity issues were the primary reason for the US Food and Drug Administration's (FDA) delay in approving abbreviated new drug applications (ANDAs) past their review goal date, according to Darby Kozak, deputy director of the Office Generic Drugs (OGD) at the Center for Drug Evaluation and Research (CDER)... Full

Arkansas May Force Companies to Choose Between Running a PBM or Pharmacies

(4/10, Ed Silverman, STAT+) ...The bill is designed to eliminate what state — and some federal — lawmakers have called a conflict of interest that has forced residents to pay more for medicines and hastened the demise of independent pharmacies. And it arrives as scrutiny of pharmacy benefit managers and their role in the opaque pricing of prescription drugs has increased dramatically. A spokesman for Sanders declined to say whether she would sign the bill and, if so, when... Sub. Req’d

Assembly Committee Holds First Hearing to Examine Impact of Pharmacy Benefits Managers On Drug Price

(4/10, New Jersey Assembly) ...Today's meeting included testimony from experts on PBMs' function, including Michael Carrier, Rutgers University Law Professor Michael Carrier, and Dr. Geoffrey Joyce, Director of Health Policy at the University of Southern California Schaeffer Center. "PBMs are meant to make sure that necessary medications are both accessible and affordable," said Assemblyman Freiman (D-Hunterdon, Mercer, Middlesex, Somerset). "However, PBMs may now be contributing to higher prescription prices and reduced medication access."... Full

Pharma Companies On Edge Over Trump Tariff Tantrum: ‘Will He, Won't He?'

(4/11, Ashish Agrawal, Mint) ...However, the threat of tariff imposition is higher for formulations/ biosimilars as, unlike generics, the US does not have a very high import dependency for these. "Our base case (ditto for companies and investors) is that any high tariffs in pharma, particularly for generics, are unlikely to sustain, as those will drive higher outlays for US patients and drug shortages," said Kotak in a report dated April 3...For now, the 90-day pause brings short-term relief. But uncertainty looms. "We expect uncertainty to prevail not just till the formal announcement on pharma but also post that, as then the focus will be on trade treaties and subsequent timing/extent of any rollback," said Kotak... Sub. Req’d

'Pharma Companies Need to Look Beyond US Market'

(4/11, Swati Bharadwaj, The Times of India) ...The US market dominates India's pharma exports, accounting for over 30% ($9 billion) of the total $28 billion in FY24, while the European Union stands as the second-largest market at around $4 billion. "The industry was relieved when Trump did not announce any tariff earlier and put a 90-day pause on tariffs after earlier stating his intention to impose tariffs on pharma, but the situation is still very dicey," said an industry source...Prescribing an 'America Plus' strategy for the Indian pharma sector, former Pharmaceuticals Export Promotion Council of India (Pharmexcil) Director General Ravi Uday Bhaskar said there are significant opportunities in the global generic drug market, which is projected to grow from $430 billion currently to $790 billion by 2030... Full

Why Indian Pharma Majors Can't Easily Escape Tariff Impact

(4/11, Surabhi Upadhyay and Nigel D'Souza, CNBC TV-18) ...Companies like Dr Reddy's Laboratories, Cipla, Sun Pharmaceutical Industries, and Aurobindo Pharma could see pressure on their margins if tariffs are imposed. While the cost may be passed on to US consumers, it won't be entirely without impact for Indian drugmakers. "There could be a small part of it which may hit the margins of the generic company manufacturers." Moving production to other geographies is not a quick fix either... Full

Trump's Tariff War with Beijing is Part of a Multi-Prong Strategy to Secure America from a Much Broader Threat

(4/10, Rebekah Koffler, FOX News) ...Today, the U.S. relies on China in key industries, including in pharmaceutical drugs and four manufacturing areas: electronics, clothing and textiles, plastics products, medical products, and healthcare supplies...A large portion of over-the-counter drugs in America are imported from China. Ninety-one percent of prescriptions filled in the U.S. are generic drugs – 95% of ibuprofen supply and 45% of penicillin supply come from China. Our critical and dangerous reliance on China in the medical industry was clearly demonstrated during the COVID-19 pandemic, when we experienced massive shortages of basic products like masks and hand sanitizers... Full

Japan Looks To Build Domestic Capacity In New Modalities

(4/11, Lisa Takagi, Pink Sheet) ...METI has now budgeted a further JPY5.8bn to assist the R&D of biopharma manufacturing technologies in Japan, which is separate from another JPY38.3bn allocation to a new project designed to support the development of domestic contract development and manufacturing organizations (CDMOs) specialized in cell and gene therapies (CGTs), a ministry official told CPHI Japan in Tokyo on April 9...The Japanese government is still measuring the impact of the new and ever-changing tariff policies from the US, which initially imposed a 24% tariff on the country then set a 90-day hiatus as of April 10...While its automobile sector is likely to be hard hit, with US President Donald Trump directly criticising Japanese firms, several large pharma companies in the country including Takeda, Daiichi Sankyo and Astellas saw their stock prices plunge after the broad tariff announcement... Global Sub. Full

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