Friday, May 16, 2025

Moody's Investor Services Upgrades Teva to Ba1

(5/15, The Fly) ...Teva Pharmaceuticals "announced that Moody's Investor Services has raised the company's corporate credit rating to Ba1, outlook stable; from Ba2, outlook positive. Moody's report cites the Company's strengths which include significant global scale, ongoing growth in the company's branded franchises, stabilization of the company's generics business, focus on debt reduction and resolution of various legal liabilities."... Full

Moody's Ratings Upgrades Teva's CFR to Ba1; Outlook Stable

(5/15, Moody's Ratings) ..."The ratings upgrade reflects meaningful improvement in Teva's credit metrics, supported by ongoing growth in the company's branded franchises, along with stabilization of the company's generic business," stated Vladimir Ronin, Moody's Ratings' Vice President-Senior Analyst. "Furthermore, Teva's credit profile has benefited from conservative financial policies with focus on debt reduction, along with progress in resolution of various legal liabilities. Over the next 2-3 years we expect Teva to benefit from product launches across both branded and biosimilar portfolios, as well as ongoing cost saving initiatives, which will support further strengthening of the company's credit profile," continued Ronin... Full

Bristol Myers CEO Says America's Biopharma Pole Position is Not Guaranteed

(5/15, Max Gelman, Endpoints News) ...Bristol Myers Squibb CEO Chris Boerner said America's role as the global biopharma leader is at a "pivot point" as the Trump administration aims to remake the country's institutions and Chinese innovation is increasingly competitive...While Boerner acknowledged that trying to make government more efficient is a venerable goal, he noted that the complex nature of the pharma industry means any changes should be thoughtful and deliberate... Sub. Req’d

Bristol CEO Boerner Says Other Countries Should 'Pay More' for US Pharma Innovation

(5/15, Jonathan Block, Seeking Alpha) ...Bristol Myers Squibb CEO Christopher Boerner on Thursday said that foreign countries should pay more for drugs as a way to more fairly support research and development conducted by U.S. pharma companies whose costs are largely borne by American consumers...Boerner also addressed the increasing amount of R&D being done in China and the consequences of that for innovation in the U.S... Full

Bayer US Head Says FDA Chief Reassured Pharma Executives of Timely Reviews

(5/15, Bhanvi Satija, Michael Erman, Reuters) ...Bayer Pharmaceuticals' chief operating officer said the head of the top U.S. drug regulator recently reassured industry executives that the Food and Drug Administration would meet its targets for reviews despite recent job cuts and a restructuring. "We're looking at an FDA and scientific review staff that is stable, engaged and meeting its deadlines," Sebastian Guth, who oversees Bayer's U.S. operations, said in an interview... Full

Merck KGaA Cites Trump Tariffs, Funding Cuts as it Scales Back 2025 Contracting Forecast

(5/15, Fraiser Kansteiner, Fierce Pharma) ...The decision to scale back from a previous forecast of 9.1 billion euros to 9.8 billion euros can be blamed in large part on the "current uncertainties around tariffs," Merck said in a Thursday press release. "In response to the challenging global backdrop, we've slightly adjusted our guidance but continue to remain confident that we are well-positioned to achieve sustainable growth for 2025 and beyond," the company's CEO, Belén Garijo, said in a statement...While pharmaceutical-specific tariffs have yet to touch down, Merck KGaA has already had to factor trade duties into its operations this year by adding a surcharge to life science orders for customers in China... Full

Celltrion Chief Backs Trump's PBM Crackdown as ‘Biosimilar Boost,' But Halves Zymfentra Forecast

(5/15, Kim Ji-hye, Korea Biomedical Review) ...Speaking Thursday morning in what he described as an unscripted briefing, [Celltrion Chief, Seo Jung-jin] spent more than an hour dismantling what he called the "exaggerated uncertainty" surrounding the U.S. directive. The threat, he argued, had been overstated. The real issue, he said, lay not with pharmaceutical manufacturers, but with the intermediaries that stand between them and patients. "None of the drugs we sell in the U.S. are priced higher than in Europe," he said. "But the margin is mostly captured by PBMs" -- a reference to the pharmacy benefit managers now squarely in the crosshairs of Trump's policy shift... Full

Celltrion Pharm Posts Record 1st Quarter Profit of 10.7 Billion Won, Up 191%

(5/15, Heo Ji-yoon, ChosunBiz) ...Celltrion Pharm reported on the 15th that its first-quarter revenue increased by 16% compared to the same period last year, reaching 112.5 billion won, while operating profit soared 191% to 10.7 billion won. The operating profit margin for the first quarter rose by more than 5 percentage points to 9.5%. The company noted that it achieved "the largest quarterly revenue in history," stating, "Despite the increase in workforce and research and development expenses, we expanded our profit margin through reduced commissions and in-house production."... Full

US FDA Approves Amneal's Self-Administered Migraine Treatment

(5/15, Mariam Sunny, Reuters) ...The treatment, branded as Brekiya, delivers a single dose of the drug called dihydroergotamine mesylate via an autoinjector. It is approved for the treatment of acute cases of migraine and severe, one-sided pain in the head called cluster headaches in adults, the drugmaker said on Thursday...Brekiya will be available in the U.S. by the second half of the year and Amneal will disclose price details close to the launch, it said... Full

Lupin Receives US FDA Nod for Blood Clot Drug Rivaroxaban

(5/15, Ajay Vaishnav, CNBC TV-18) ...These tablets are bioequivalent to Xarelto® tablets (10 mg, 15 mg, and 20 mg) by Janssen Pharmaceuticals. The product will be manufactured at Lupin's state-of-the-art facility in Aurangabad, India. The medication is prescribed for the treatment of deep venous thrombosis (DVT), a condition where harmful blood clots form in the veins, commonly in the legs... Full

Biocon's Subsidiary Get US FDA Nod for Anticoagulant Medication Rivaroxaban

(5/16, Business Standard) ...Biocon said that its subsidiary Biocon Pharma has received approval for its ANDA for Rivaroxaban Tablets USP from the United States Food and Drug Administration, for various strengths. Rivaroxaban is a prescription medication used in the treatment of deep vein thrombosis and pulmonary embolism, to reduce the risk of stroke and systemic embolism in nonvalvular atrial fibrillation... Full

Eisai Says Leqembi is Headed for 'Demand Expansion Phase' in US

(5/15, Nicole DeFeudis, Endpoints News) ...Monthly Leqembi revenue reached a "record high" last month, Eisai's US executive VP Katsuya Haruna said on the company's fourth-quarter earnings call on Thursday, according to a translated transcript. "In May, growth [has] continued," he said. Leqembi's fiscal 2024 sales totaled 44.3 billion yen ($304 million), which the company said is up from its prior expectation of 42.5 billion yen ($291 million). However, Eisai projected roughly flat revenue for its 2025 fiscal year, which ends in March 2026... Sub. Req’d

Hyloris Strikes New Deals With AFT And QliniQ Over Novel Valacyclovir Formulation

(5//15, Adam Zamecnik, Generics Bulletin) ...The Belgian value-added medicines specialist company struck two commercialization deals over its novel valacyclovir oral suspension that span three continents, marking a further milestone in the product's development...AFT will handle the drug's commercialization in Australia, Canada, and New Zealand, while QliniQ will sell the product in the Netherlands. Hyloris will receive up to 50% of the gross margin post deduction of certain expenses... Global Sub. Full

Amgen Could Owe Regeneron More Than $400M After Defeat in Cholesterol Drug Antitrust Suit

(5/15, Fraiser Kansteiner, Fierce Pharma) ...A federal jury in Delaware has determined that Amgen violated U.S. antitrust laws by engaging in a bundling scheme with pharma middlemen that unfairly advantaged its cholesterol-lowering drug Repatha over Regeneron's PCSK9 counterpart Praluent. In turn, the jury has put Amgen on the hook to pay Regeneron $135.6 million in compensatory damages and another $271.2 million in punitive damages, according to a verdict form filed Thursday... Full

Follow-On Biologics Poised to Expand Global Health Care Access and Lower Costs

(5/15, Cameron Santoro, The Center For Biosimilars) ...Follow-on biologics, including biosimilars, biobetters, and bioparallels, hold significant promise for creating a more equitable and accessible global health care landscape by driving down costs and enabling budget-neutral expansion of treatment options, according to Ivo Abraham, PhD, director, center for health outcomes and pharmacoeconomic research at The University of Arizona Cancer Center... Full

'Go Ahead and Do It': Top RFK Jr. Deputy Dares Drugmakers that Might Pull Manufacturing Over New Price Pressure

(5/15, Max Gelman, Endpoints News) ...Calley Means, a special White House employee and top advisor to HHS Secretary Robert F. Kennedy Jr., effectively dared Roche to pull its US investment after the company said it would consider doing so in response to President Donald Trump's "most favored nations" plan. "I think that is morally reprehensible. Go ahead and do it," Means said... Sub. Req’d

HHS Launches AI, Informatic Projects To Shore Up Domestic Drug Production

(5/15, Gabrielle Wanneh, Inside Health Policy) ...The Trump administration on Thursday (May 15) launched four projects aimed at bolstering manufacturing for eight sterile injectable and oral medications, as well as their active ingredients, within the United States between now and next spring, using a mix of artificial intelligence, machine learning, and information science and technology to revolutionize how drugs are produced domestically...The projects are a part of a program known as Equip-A-Pharma, spearheaded by HHS, Administration for Strategic Preparedness and Response (ASPR), Defense Advanced Research Projects Agency (DARPA) and the private sector... Sub. Req’d

Hospitals Could Make More Drugs In-House Under Trump Proposal

(5/15, Jessica Nix, Bloomberg) ...The partnership between some of the nation's top health agencies and a handful of companies, including the Mark Cuban Cost Plus Drug Company, is intended to use artificial intelligence and other tools to make eight drugs in the places where people actually get medical care. The treatments include generic drugs such as levetiracetam, which treats epilepsy, the local anesthetic lidocaine, the chemotherapy carboplatin, albuterol sulfate for asthma and the antibiotic linezolid... Sub. Req’d

Will International Prices Influence Medicare Price Negotiation?

(5/15, Cathy Kelly, Pink Sheet) ...The Trump Administration likely will not incorporate international reference pricing into the Medicare price negotiation program because of operational and legal challenges, a former CMS official suggested. The policy more likely would be implemented as a demonstration project at the Center for Medicare and Medicaid Innovation. Some stakeholders are confident CMS will consider international pricing in the process to justify deeper price reductions... Global Sub. Full

Trump's US Drug-Pricing Plan Would Cost the Rest of the World

(5/16, Naomi Kresge and Ashleigh Furlong, Bloomberg) ...US President Donald Trump's effort to reduce drug prices for Americans relies on a practice long employed in Europe: aligning costs with lower prices paid elsewhere. If he succeeds, the knock-on effect could hit Europe hard...Drugmakers will never willingly compromise their profits in the US to maintain sales in smaller, less important markets like Greece, said the Center for Global Development's Rachel Bonnifield and her colleagues in a blog post. Companies would be more likely to raise the Greek price to the US level, she said... Sub. Req’d

Pharmaceutical Tariffs Will Cost Consumers In Terms of Price, Reliability

(5/16, Ike Brannon, RealClearMarkets) ...If President Trump follows through on his executive order to encourage U.S. drug manufacturing and imposes tariffs on drug imports, patients like me could face not only higher costs but also reduced access to medications. Most drugs taken by people in the U.S. are generic drugs--the FDA estimates that proportion is over 90 percent. These medications are already highly affordable--typically just a few dollars per prescription--and they save health plans enormous sums. That translates into lower premiums and--for those insured through their employer--lower employer healthcare costs and ultimately higher wages. Tariffs would jeopardize that system... Full

Trump Is Taking Aim at US Drug Prices. Here's Why They're So High.

(5/15, Robert Langreth, Bloomberg) ...Americans spend more on prescription and over-the-counter drugs than anyone else in the world. It's true that they take a lot of pills. But what really sets the US apart is how much drugs cost. Unlike in most other countries, their prices are established without direct government intervention. Modest changes under President Joe Biden reduced the expense of some medicines for senior citizens. Now, his successor Donald Trump has vowed to slash US drug prices and bring them in line with those in other wealthy countries... Full

Trump's Drug Price Controls Are the Wrong Prescription for a Real Problem

(5/16, Tiana Lowe Doescher, Washington Examiner) ...Other countries have not been "screwing" the U.S. by selling its consumers goods they demand, by turning its trade deficit into a capital surplus with the dominance of the American bond market, or by maintaining its dollar's esteemed status as the world's reserve currency. However, even the U.S.'s allies have mooched off its medical R&D for too long, and Trump should indeed make them pay for the privilege... Full

Administration Releases Medicare Drug Price Negotiation Program Draft Guidance For 2028

(5/15, Rachel Sachs and Kristi Martin, Health Affairs) ...In this article, we first explain what policies have changed from previous cycles of the DPNP. In general, differences from previous cycles are quite modest. Then, we analyze key elements of the program's more significant expansion to include Part B and renegotiation in 2028. Throughout, we place these policies in context with broader drug pricing reform efforts. Importantly, we do not attempt to analyze every change associated with the draft guidance, and we give particularly short shrift to operational issues included within the Medicare Transaction Facilitator portion of the document. Our goal here is to identify and analyze particularly notable policy-relevant changes and developments... Full

AARP Calls On Congress to Protect Medicare Drug Price Negotiation

(5/15, Rachel Nania, AARP) ...For the first time in history, Medicare has the power to negotiate the price it pays for some of the costliest and most-used prescription drugs in the U.S., passing the savings on to taxpayers and the millions of older adults who rely on these life-saving medications. But drug companies are pushing for legislation that would disrupt this process and delay cost savings for beneficiaries, many of whom already struggle to afford their prescription drugs. AARP is fighting back and urging lawmakers to protect the Medicare prescription-drug negotiation program and patients' pockets... Full

PBM Limits Could Finally Pass, If Congress Moves its Tax-Cut Bill

(5/16, Michael McAuliff, Modern Healthcare) ...Greg Lopes, a spokesman for the Pharmaceutical Care Management Association criticized both sets of provisions. "Eliminating spread pricing in Medicaid reduces states and health plans' options to contract with PBMs in ways that meet the health care needs of their enrollees," Lopes said in a statement. "The delinking policy is windfall profit giveaway to Big Pharma on the backs of Medicare beneficiaries and taxpayers."... Sub. Req’d

Makary Talks FDA Priorities, Says Recent Cuts Addressed Redundancies

(5/15, Joanne S. Eglovitch, Regulatory Focus) ...Leveraging artificial intelligence in product reviews and postmarketing surveillance is a top policy priority for the US Food and Drug Administration (FDA), FDA Commissioner Martin Makary said at the Food and Drug Law Institute (FDLI) Annual Conference on Thursday. He also said the agency will roll out a new framework for communicating about vaccines and again confirmed that the agency is not planning a major reorganization of its product centers... Full

Makary, Prasad Promise ‘Gold Standard And Common Sense' At FDA

(5/15, Jessica Karins, Inside Health Policy) ...FDA Commissioner Marty Makary and newly appointed biologics center head Vinay Prasad are aiming to send a positive message about their controversial leadership at the agency, with Makary telling an industry audience Thursday morning (May 15) they want to show appreciation for FDA staff and promising a "gold standard" approach to regulation. Makary also said a new vaccine framework is days away... Sub. Req’d

‘Tectonic' Arkansas PBM Legislation May Upend Industry

(5/15, Tim Casey, Pink Sheet) ...A new Arkansas law barring PBMs from owning or operating pharmacies in the state could radically change the industry as other states states or the federal government could attempt to pass similar legislation. Experts said the law seems to tap into growing concerns about conflicts of interests and other problems in the pharmacy industry. But because PBMs are expected to fight hard against other state attempts to pass similar legislation, other states may not quickly follow with similar laws... Global Sub. Full

UK's International Recognition Procedure: EU Dossier Faster Than US Or Canada

(5/15, Eliza Slawther, Pink Sheet) ...Companies using the UK's International Recognition Procedure to apply for marketing authorizations can expect faster timelines when they use the EU as a reference regulator rather than the US or Canada. This is because EU dossiers are more likely to be eligible for the type A pathway under the IRP, as the requirements for granting a marketing authorization are similar to those of the UK. The UK MHRA is also looking at a new pilot project focused on the acceptance of approval decisions from the US Food and Drug Administration, which is set to be announced this year... Global Sub. Full

Polish Presidency Eyes Early June Breakthrough in EU Pharma Package Talks

(5/15, Paulina Mozolewska, Euractiv) ...A decisive breakthrough in negotiations on the landmark EU pharmaceutical package is within sight. The Polish presidency of the Council of the EU aims to secure a mandate to open trilogue talks with Parliament and the Commission by the beginning of June. Sources close to the process say that almost all elements of the proposed agreement have been settled, but the main sticking point remains the length of the exclusivity period for new medicines... Full

Position of the Polish Pharmaceutical Sector on the Reform of Pharmaceutical Legislation in the European Union

(5/16, Bartek Czyczerski and Krzysztof Kopec, Euractiv) ...EU is facing shortages of medicines, and dependence on supply of ingredients for their production from Asia has reached 80%. Building the strategic resilience of the EU and its economic development requires restoration of production of the most needed medicines and their ingredients. In the current geopolitical situation and financial challenges associated with increasing the EU's military potential, strengthening competition that optimizes healthcare spendings in the European pharmaceutical market becomes crucial... Full

Irish Exports Reached Record Level in March, Due to Threat of Trump Tariffs

(5/15, John Surns, Irish Independent) ...The stockpiling is most obvious in the pharma sector, which is operating under the threat of a tariff of up to 25pc. According to trade figures released by the Central Statistics Office, the exports of medical and pharma products rose by €16.7bn, or 243pc, to €23.6bn in March. The exports would include the active pharmaceutical ingredient (API) in Mounjaro, the weight-loss drug produced by Eli Lilly, one of the world's leading pharma companies which employs over 3,500 people in Ireland across three sites... Full

Govt Invites Fresh Applications Bulk Drugs PLI

(5/15, Manu Kaushik, Financial Express) ...To boost the production of bulk drugs, the department of pharmaceuticals (DoP) has invited fresh applications from the entities under the performance-linked incentive (PLI) scheme. Under the fifth round of the scheme, the DoP is seeking interest from the industry on 11 product categories to promote domestic manufacturing of active pharmaceutical ingredients (APIs), key starting materials (KSMs) and drug intermediates... Full

Generic Pharma Companies Unlikely to Be Impacted by Trump's Order to Cut Rx Drug Prices: Report

(5/16, ANI) ...Generic drug companies in India are not expected to be affected by US President Donald Trump's new order to bring the prices for prescription (Rx) drugs in line with other developed nations, according to a report by HDFC Securities. The report stated that the order aims to reduce the cost of prescription medicines in the US by matching them with the prices paid by other developed countries... Full

US Tariffs On Pharmaceuticals Could Hit Chinese Export Firms' Profit Margins: Analysts

(5/16, Sylvia Ma, South China Morning Post) ...Trump signed an executive order on Monday to lower US drug prices to align with levels paid in other countries. But duties on imports are likely to remain - even at the risk of increased costs - as Washington seeks to reshore manufacturing and reduce dependence on supply chains in countries like China, according to health experts interviewed by the Post... Full

Industry Group Updates Standards for Responsible Antibiotic Manufacturing

(5/15, Chris Dall, MA, CIDRAP) ...The AMR Industry Alliance announced this week that it has updated its Antibiotic Manufacturing Standard to be more aligned with World Health Organization (WHO) antibiotic manufacturing guidelines...The AMR Industry Alliance says the update version of the Standard reflect the latest science and best practices and incorporates provisions for waste management, active pharmaceutical ingredient discharge limits, and transparency in supplier practices laid out in the WHO's 2024 Guidance for Responsible and Sustainable Manufacturing of Antibiotics... Full

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