Wednesday, August 13, 2025

Teva Pharmaceutical Continues Gains for Seven Straight Sessions

(8/12, Seeking Alpha) ..."The company is delivering better results, raising guidance and slowly changing the narrative but most investors still don't buy it. I think this is a setup where patient investors can get in before the crowd catches on," noted Seeking Alpha analyst Motti Sapir... Full

Trump's Proposed 200-250% Tariff On Pharma Imports to Lead to Drug Shortages and Higher Prices, Says GlobalData

(8/12, GlobalData) ...While the tariffs are set to be announced soon, a grace period of 12 to 18 months has been indicated before they take effect. Even with this delay, production costs are likely to rise, potentially leading to drug shortages and higher consumer prices, says GlobalData, a leading data and analytics company. Kathryn Kinch, Senior Pharma Product Manager at GlobalData, comments: "Historically exempt from tariffs due to their essential nature, pharmaceuticals are now under scrutiny for perceived unfair pricing, prompting major firms like Novartis and Eli Lilly to invest in US operations."... Full

Tariff Effects On Drug Shortages May Be Tough to Trace: ASHP

(8/12, Alexandra Murphy, Becker's Hospital Review) ..."I think the FDA does a pretty strong job of tracking discontinued products, but you never know the true underlying reason of why a product was discontinued," Michael Ganio, PharmD, senior director of pharmacy practice and quality at the ASHP, said in an interview with Becker's. "So if a tariff goes into effect, the manufacturer may choose just to stop making the drug, but they may never disclose that the reason for discontinuing it is because of tariffs."... Full

Tariffs Won't Cure What Ails U.S. Drug Prices

(8/12, Tony Losasso, PhD, MedPage Today) ...High drug prices demand serious solutions. While tariffs aim to address these issues head-on, they may not deliver the intended relief. By prioritizing competition and transparency, we can harness U.S. strengths to deliver affordable, secure medicines, thus achieving the administration's goals without unintended hardships... Full

US Tariffs Could Undo Generic Drugmakers' Efforts to Be Less Reliant On Chinese Raw Materials, Experts Say

(8/13, Anna Brown, Endpoints News) ...The US has been encouraging drugmakers to source APIs and starting materials from India instead of China, Wosinska said. But with potentially high US tariffs on India, there is pressure on Indian drugmakers to cut costs and sourcing APIs for as cheaply as possible - most likely from China - becomes attractive, [Marta Wosinska, senior fellow of economic studies at The Brookings Institution,] said. "How do they cut costs further? Probably by going where they can find the cheapest," she added... Sub. Req’d

Big Pharma Puts Profits Over President Trump's Agenda

(8/12, Debbie Dooley, Inside Sources) ...Republicans should be championing greater competition in the prescription marketplace to lower drug costs for the American people, not encouraging policies that give big drug companies a massive government handout and the government more control over our health care system and markets—and that directly go against policies from the President to put America First... Full

As the FDA Goes AI-First, Biopharma Must Rethink Regulatory Operations

(8/12, The Pharma Letter) ...The FDA's rapid integration of AI into its review processes marks a significant moment for regulatory affairs in biopharma. While this transition introduces new operational challenges, it also creates opportunities for companies willing to modernize how they manage, prepare, and submit regulatory data. Success in this new environment won't be achieved through short-term workarounds or by waiting for detailed guidance. It will come to those prepared to rethink operational processes, improve data management practices, and strengthen cross-functional collaboration to keep pace with faster, more automated review cycles... Sub. Req’d

Eli Lilly Pledges Vigorous Defense as Texas Sues Over Alleged Drug Kickbacks

(8/12, Fraiser Kansteiner, Fierce Pharma) ...Paxton and Health Choice Alliance are now accusing Lilly of plying Texan medical providers with "illegal incentives" to induce prescriptions of the company's drugs. Many of those medications were covered by Medicaid, allegedly causing millions of dollars in claims to the state program to be "tainted by Eli Lilly's illegal marketing and quid pro quo arrangements," according to a press release from Paxton's office...Eli Lilly, for its part, will "vigorously defend against these allegations," a company spokesperson said over email. "Multiple courts and the federal government have rejected claims by this same corporate relator against Lilly as meritless," the spokesperson continued, alluding to Health Choice Alliance... Full

Biogen Sees Potential in Combining Alzheimer's and Obesity Drugs

(8/12, Gerry Smith, Bloomberg) ...Biogen's looking to the growth of its Alzheimer's drug Leqembi to offset the decline of its multiple sclerosis franchise, which is facing competition from cheaper generic drugs. Biogen's new Alzheimer's drug is already facing competition from Eli Lilly & Co.'s Alzheimer's drug, which was approved in the US last year and has since captured around 30% of the market, according to analysts... Sub. Req’d

Senores Pharma to Buy Two ANDAs from Teva, Its Third US Transaction this Year

( 8/13, PT Jyothi Datta, The Hindu BusinessLine) ...In its third US-related transaction in six months, Senores Pharmaceuticals has agreed to buy two Abbreviated New Drug Applications from Teva Pharmaceuticals USA Inc...The latest Teva transaction will be funded through the proceeds from Senores's Initial Public Offer (IPO), and is in line with its Red Herring Prospectus, the company said. Speaking recently to businessline on the uncertainty involving US tariffs, Swapnil Shah, Senores Pharma Managing Director said, "we make products locally, especially for (the) US market, which is 70 per cent of our revenue. So we can be a little more insulated compared to other players… So I would say we are better placed. How better, we don't know yet."... Full

Senores Pharma Gains On US ANDA Acquisition from Teva

(8/13, Business Standard) ...Senores Pharmaceuticals rose 2.16% to Rs 687.75 after its US arm signed a deal to acquire two USFDA-approved ANDAs from Teva Pharmaceuticals USA, targeting a market size of up to $120 million... Full

Lupin Couples Up With Sandoz For Global Lucentis Biosimilar Deal

(8/13, Urte Fultinaviciute, Generics Bulletin) ...Lupin and Sandoz have entered a licensing agreement for the global commercialization of Lupin's ranibizumab biosimilar, granting Sandoz rights across various regions, including Europe and several Asia-Pacific countries. In the US, Lupin filed the biosimilar a few months ago, with the goal date set in June 2026. Meanwhile, Sandoz paused sales of its Lucentis rival in April... Global Sub. Full

Lupin Launches Generic Version Of Lilly's Discontinued Glucagon In The US

(8/12, Urte Fultinaviciute, Generics Bulletin) ...Alongside biosimilars, Lupin sees injectable products as one of the key growth drivers in the US, as competition for two of its "material" drugs and proposed tariffs are looming over the firm... Global Sub. Full

Hikma Rides Price Gap as Novo's Ozempic, Wegovy Costs Climb

(8/13, Dean Rudge, Generics Bulletin) ...Hikma is witnessing increased demand for its generic version of Victoza (liraglutide) following the recent ban on semaglutide compounding, which has led to higher prices for Novo Nordisk's Ozempic and Wegovy. The UK-listed firm's generics division experienced a slight revenue drop of 1% to $523m, primarily due to pricing pressures. Increased R&D investments were emphasized as critical for the division's future growth. Hikma projects a growth rate of 4%-6% for group revenue in 2025, with ambitions of reaching $5bn in sales by 2030... Global Sub. Full

Lilly Launches Mounjaro Pen in India at $160 for Starting Dose, Stepping Up Novo Rivalry

(8/13, Rishika Sadam and Kashish Tandon, Reuters) ...Eli Lilly on Wednesday launched the easy-to-use injector pen of its blockbuster weight-loss drug Mounjaro for 14,000 rupees (nearly $160) for its starting dose of 2.5 mg in India, stepping up competition with Novo Nordisk... Full

AbbVie Plans $195M API Plant in Illinois as Part of US Investment Campaign

(8/12, Eric Sagonowsky, Fierce Pharma) ...Tuesday, the Illinois pharma giant revealed plans to spend $195 million to expand its manufacturing presence in North Chicago. Specifically, the company plans to begin construction on a facility to produce active pharmaceutical ingredients in the fall and have the site be fully operational in 2027. The plant, which is part of the company's $10 billion plan to invest in the U.S., will help the drugmaker produce current and next-gen therapies in neuroscience, immunology and oncology, AbbVie said in an Aug. 12 release... Full

To Stay On Weight-Loss Drugs, US Patients Cut Doses and Maybe Vacations

(8/13, Deena Beasley, Reuters) ...Doctors advise most patients on GLP-1 obesity drugs such as Wegovy and Zepbound to stay on them to keep the weight off, but as more U.S. insurers restrict coverage people are trimming costs by stretching doses or forgoing expenditures like vacations to pay for the medication out of pocket. A half dozen doctors who spoke with Reuters said insurance coverage has tightened in 2025 as many employers drop it for the expensive GLP-1 drugs. While patients on these medications are counseled on proper diet and exercise, clinical trials show that people who stop taking these drugs are apt to regain weight... Full

EU: Pharma Tariffs Impact On Countries and Companies Will Vary

(8/13, The Pharma Letter) ..."Despite the increased risks associated with future pharmaceutical tariffs, or other non-tariff measures, we expect the credit impact on EU countries to remain manageable, and we will continue to assess the economic and fiscal implications over time," said Javier Rouillet, senior vice president, Morningstar DBRS, Global Sovereign Ratings, adding: "Ireland is by far the EU country with the highest exposure to the pharma tariffs; however, Ireland's dynamic economy and the strong starting point of its public finances will help mitigate the impact on the credit profile."... Sub. Req’d

Lilly and UK Government Launch Joint Obesity Care Innovation Program

(8/12, The Pharma Letter) ...The program will be run with Innovate UK, the national innovation agency. The UK government has pledged up to £50 million ($65 million), while Lilly will contribute as much as £35 million, including a £10 million allocation for projects in the devolved nations. Both parties stressed the funding is not intended to influence prescribing decisions involving Lilly's medicines. Obesity costs the UK economy an estimated £74 billion a year, including £11 billion in direct NHS spending. The program's backers say that new models of care — whether digital, community-based, or through pharmacies — could improve quality of life while easing strain on health services... Sub. Req’d

Indian Pharma Sector Will Not Suffer Any Loss Due to Trump Tariff: Former ICMR Chief

(8/12, IANS) ...The Indian pharma sector, which supplies 80 per cent of the world's generic medicines, will not suffer any loss due to tariffs imposed by US President Donald Trump, the ICMR's former Director General, Dr N.K. Ganguly said..."If any country in the world increases tariffs, it does not benefit them because the loss is suffered by that country only. India is a country that provides medicines at cheap rates and also exports them," Ganguly told IANS. The noted microbiologist said that whether it is Europe or North America, the prices of drugs are very high in foreign countries... Full

Tariff Showdown: US Trade Politics Threaten the World's Affordable Medicine Supply

(8/13, Manuel Freire-Garabal y Núnez, The Times Of India) ...Strip away the trade jargon, and this comes down to a simple question: do we believe access to essential medicines should be dictated by election cycles and tariff schedules? History tells us what happens when healthcare becomes part of a political bargain — the poorest pay the most, and the longest. India has both the opportunity and the responsibility to frame this debate for what it is: a global health issue, not just a bilateral trade spat. Affordable medicine is not a luxury. It’s a basic human right... Full

Japanese Study Provides Postapproval Insights Into Biosimilar Quality Attributes

(8/12, Skylar Jeremias, The Center For Biosimilars) ...Japan's slow uptake of therapeutic monoclonal antibody (mAb) biosimilars—despite more than a decade of regulatory approval—has led researchers to examine whether quality concerns are a factor. In a recent study, scientists analyzed the quality characteristics of biosimilar mAbs and their reference products approved in Japan, assessing multiple product lots to measure variation and lot-to-lot consistency. The findings aimed to inform clinically acceptable quality ranges and strengthen public confidence in biosimilars... Full

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