Tuesday, April 15, 2025

Cipla Welcomes Abraxane ANDA Approval After Tackling Goa Compliance Issues

(4/14, Dean Rudge, Generics Bulletin) ...According to a filing with India's BSE exchange, Cipla could begin shipping its AB-rated Abraxane generic in the next few months, with launch expected during the firm's current financial first half ended September 30. It has been approved to treat metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas...The FDA has approved two other AB-rated Abraxane ‘therapeutic equivalents', both through the 505(b)(2) hybrid new drug application pathway. Daiichi Sankyo affiliate American Regent received the first in July 2022, with Teva following with its own NDA approval in May 2023... Global Sub. Full

J&J Earnings Beat Estimates On Strong Cancer Drug Sales

(4/15, Patrick Wingrove, Bhanvi Satija, Reuters) ...J&J lowers 2025 profit forecast, excluding forex impact, due to tariffs and Intra-Cellular deal. Sales of psoriasis drug Stelara fall more than 33%, still beat analysts' estimates. Cancer drug Darzalex sales increase 20%, boosting pharma revenue... Full

Sanofi Progressing Pipeline Across Respiratory Indications

(4/15, The Pharma Letter) ...Sanofi is confident that the fully human non-T cell depleting monoclonal antibody that blocks OX40-Ligand, a key immune regulator, has the potential to be a first- or best-in-class treatment for a range of immune-mediated diseases and inflammatory disorders...These results demonstrate that amlitelimab can improve key disease outcomes in asthma patients with continued unmet need. A Phase III program is currently being planned. Meanwhile, lunsekimig is being explored in a broad population of asthma patients, regardless of their inflammation and severity status... Sub. Req’d

Biocon Biologics Secures Market Entry for Yesafili in US

(4/15, Press Trust Of India) ...Biocon Biologics has reached a settlement and licensing agreement with Regeneron, clearing the way for the US commercialization of Yesafili, its biosimilar to Eylea. The agreement allows Biocon Biologics to launch Yesafili in the US by the second half of 2026, or earlier under certain conditions. Yesafili, already approved by the USFDA, is intended for treating various ophthalmology conditions... Full

AbbVie and Sandoz Agree to Drop Court Spat Over Rinvoq Patents

(4/14, Nicole DeFeudis, Endpoints News) ...AbbVie and Sandoz have resolved their patent dispute over AbbVie's blockbuster immunology drug Rinvoq. Sandoz admitted the Rinvoq patents asserted against it are "enforceable, valid, and would be infringed" by its proposed generic extended-release tablets, according to an order filed Friday in the US District Court for the District of Delaware. Judge Maryellen Noreika signed off on the order, which dismissed "all other claims, counterclaims, and defenses asserted by the parties against each other."... Full

Eli Lilly's Mounjaro Launch in India Ignites Wave of Weight-Loss Enquiries

(4/14, Rishika Sadam, Reuters) ...The India launch of Eli Lilly's popular weight-loss drug Mounjaro has triggered a huge wave of patient enquiries about its availability, with some Indian doctors fielding hundreds of calls about the medicine, according to a Reuters survey. The survey of 18 doctors, patients and weight-loss clinic operators follows the U.S. drugmaker's market entry ahead of Danish obesity drug rival Novo Nordisk into a nation expected to have the second-largest population of overweight or obese people by 2050... Full

What's Pfizer's Next Move After Shelving its Oral Obesity Drug Danuglipron?

(4/14, Elizabeth Cairns, Endpoints News) ..."In a development landscape as extensive as obesity, we think Pfizer could be better served by looking outside," Stifel analysts wrote in a note to investors after the news...A Pfizer spokesperson told Endpoints News that the company is interested in developing "oral small molecules and differentiated combinations with both validated and/or well understood [mechanisms], as well as new mechanisms of action," in the obesity field. Pfizer would not want to bring an undifferentiated product into the established injectable GLP-1 market, they said... Full

Merck Explores Potential of Oral Peptides in Deal with Austrian Biotech

(4/15, Ayisha Sharma, Endpoints News) ...The large pharma is licensing a drug delivery platform from Austrian biotech Cyprumed in a pact worth $493 million in upfront and potential milestone payments. The technology is designed to develop oral formulations of peptide drugs, which could include Merck's GLP-1 candidate...Just weeks prior to that announcement, Merck CEO Rob Davis said of GLP-1s that the company is focused on opportunities for oral formulations that can be combined with other drugs to address obesity alongside a range of comorbidities... Full

Novo Nordisk Warns Consumers About Counterfeit Versions of Ozempic in US

(4/14, Sriparna Roy, Reuters) ...Danish drugmaker Novo Nordisk said on Monday several hundred counterfeit units of its diabetes drug Ozempic were being distributed outside its authorized supply chain in the United States. The country's health regulator seized the counterfeit injections on April 9 and is investigating them... Full

Aurobindo Gets Form 483 Scolding from FDA at North Carolina Inhaler Plant

(4/14, Joseph Keenan, Fierce Pharma) ...Aurobindo's subsidiary Aurolife Pharma received a Form 483 from the FDA outlining 11 observations at a U.S. production plant, the Indian drugmaker said in a filing late last week. The exact nature of the infractions remain unclear, as the FDA has not published the document...The facility produces inhalers and dermatology products..."We do not expect this development to have any material impact on the current business operations or existing supplies from this facility," Aurobindo said... Full

US Steps Up Probes into Pharmaceutical, Chip Imports, Setting Stage for Tariffs

(4/15, Patrick Wingrove, David Lawder, Reuters) ...The Trump administration is proceeding with probes into imports of pharmaceuticals and semiconductors as part of a bid to impose tariffs on both sectors on grounds that extensive reliance on foreign production of medicine and chips is a national security threat, Federal Register filings on Monday showed...The notices published on Monday showed the investigations will include both pharmaceuticals and pharmaceutical ingredients as well as other derivative products... Full

Trump Pharma Tariffs Inch Closer as Administration Confirms US Trade Probe

(4/14, Max Bayer, Endpoints News) ..."President Trump has long been clear about the importance of reshoring manufacturing that is critical to our country's national and economic security," White House spokesperson Kush Desai said in a statement to Endpoints News...A spokesperson for the trade group PhRMA didn't immediately respond to a request for comment and a spokesperson for BIO referred to a previous statement from CEO John Crowley describing "the negative consequences of these proposed tariffs."  Drugmakers have warned that tariffs could raise prices... Full

Trump Administration Launches Probe into Pharmaceutical Imports

(4/14, Ed Silverman, STAT+) ...But tariffs are widely expected to eventually raise prices for consumers. Depending on the specifics of any White House plan, some experts predict generic drugs, many of which are made in India and have low profit margins, will cost more in coming months. In some cases, shortages might occur if generic manufacturers find tariffs too costly...A raft of financial analysts and economists are trying to sort out the implications for pricing and availability as they calculate the extent to which drugmakers are able to revamp production to appease Trump and absorb costs... Sub. Req’d

White House Launches National Security Investigation into Pharma, Semiconductors

(4/14, Nathaniel Weixel, The Hill) ...The probe will examine specific issues, including current and projected demand for pharmaceuticals and pharmaceutical ingredients in the U.S.; the role of foreign supply chains, particularly of major exporters, in meeting U.S. demand for pharmaceuticals; the concentration of imports from a small number of suppliers and any associated risks; and the feasibility of increasing domestic capacity for pharmaceuticals and ingredients... Full

Trump Initiates Chips and Drug Probes, Ahead of More Tariffs

(4/14, Madison Muller and Jennifer A. Dlouhy, Bloomberg) ...The probes, which began April 1 and were ordered under Section 232 of the Trade Expansion Act, could play out for months. Under the law, the Commerce Secretary is expected to deliver the results of his investigation within 270 days, though Trump and other officials have signaled these efforts could conclude more quickly... Full

Commerce Says Pharmaceutical Tariffs Coming In ‘Next Month Or Two,' Launched Import Probe April 1

(4/14, Maaisha Osman, Inside Health Policy) ..."President Trump has long been clear about the importance of reshoring manufacturing that is critical to our country's national and economic security... entire administration is committed to working on Trump Time to secure our economic future and restore American Greatness," Kush Desai, White House deputy press secretary told Inside Health Policy Monday (April 14)... Sub. Req’d

AAM Comments On Section 232 Investigation On Pharmaceuticals

(4/14, AAM) ..."AAM and the generics and biosimilars industry look forward to working with the Commerce Department and the White House to engage constructively on ways to incent more domestic investment in the medicines supply chain," said John Murphy III, President and CEO of the Association for Accessible Medicines. "As we have said countless times: a resilient and reliable generic medicines supply chain is critical to patient health, U.S. healthcare and national security interests. Tariffs, however, will only amplify the problems that already exist in the U.S. market for affordable medicines"... Full

New Research Reveals the Devastating Impact of the Inflation Reduction Act's "Pill Penalty" On Small Molecule Medicines

(4/14, We Work For Health) ...Vital Transformation's research found that aggregate small molecule investments by companies valued at less than $2 billion dropped by 68% since the Inflation Reduction Act was introduced. Further, the study also found a 74% drop in the median size of aggregate investments into indications specifically targeting the Medicare-aged population, with a significant decrease in investments in small molecules compared to large molecules after the IRA was introduced. The peer-reviewed research was first published in the journal Therapeutic Innovation and Regulatory Science... Full

Imminent Actions Discussed at Generic Drug Forum, With Clarity On IA Report Metric!

(4/14, Bob Pollock, Lachman Consultants) ...It has been quite some time since issuance of the GDUFA III commitment letter, which discussed a few new enhancements to the ANDA review and approval process, among other things. One such enhancement was Imminent Action (IA)...This would be in lieu of issuing a complete response letter (CRL) to meet the goal date... Full

OGD Officials Offer Advice On ANDAs, Post-CRL Scientific Meetings

(4/14, Joanne S. Eglovtich, Regulatory Focus) ...Arun Agrawal, a pharmacologist at the Office of Bioequivalence in the Office of Generic Drugs (OGD). Agrawal and colleagues offered advice to sponsors on abbreviated new drug applications (ANDAs) and reviewed common practices to avoid having their Form 356h rejected during FDA's Generic Drugs Forum on 10 April in Bethesda, MD... Full

US FDA Staff's Union President Calls For More Support From Industry

(4/14, Sarah Karlin-Smith, Pink Sheet) ...The industries that the US Food and Drug Administration regulates should be more vocal in calling out the harms of mass layoffs that took place on April 1, the chapter president of the union that represents agency staffers told Pink Sheet. "The industry, for the most part, has been silent on what is going on here, and they are definitely going to be impacted by a [reduction-in-force] of 3,500 people," National Treasury Employees Union (NTEU) Chapter 282 President Anthony Lee said in an interview... Global Sub. Full

FDA Reorganization Proposal A ‘Mindless Approach To Centralization,' Woodcock Says

(4/14, Sue Sutter, Pink Sheet) ...The proposal for a reorganized FDA that is being circulated by the Trump Administration "is a really, really bad idea," former Acting Commissioner and Principal Deputy Commissioner Janet Woodcock said at the recent Biopharma Congress, presented by Prevision Policy and Friends of Cancer Research. Woodcock suggested the reorganization proposal was devised by someone who does not understand how the agency operates... Global Sub. Full

FDA's Union Readies Negotiations with HHS Over Some Fired Staff

(4/14, Zachary Brennan, Endpoints News) ...An NTEU spokesperson confirmed to Endpoints News that 2,453 of their HHS members received a "reduction in force" (RIF) notice announcing their layoffs. It remains unclear when another round of staff cuts might occur, and how many employees HHS may end up bringing back, the spokesperson said...A former FDA attorney who's a member of the NTEU and received one of the RIF notices told Endpoints he was told HHS is willing to negotiate, but hasn't heard anything yet from their side — or heard anything from other colleagues... Full

Q&A: Douglas Hoey On PBM Reform, Optum Rx Cost-Plus Announcement | AAP 2025

(4/14, Killian Meara and B. Douglas Hoey, RPh, MBA, Drug Topics) ...Drug Topics® sat down with [Douglas Hoey, RPh, MBA, CEO NCPA] at the American Associated Pharmacies (AAP) Annual Conference, held April 10 to 12 in Austin, Texas, to discuss if he is hopeful that PBM reform will be passed under the new administration, what needs to be done to get PBM reform passed, and his take on Optum Rx's announcement that it plans to introduce a cost-plus prescription reimbursement model... Full

Attorneys General Want Congress to Prohibit PBMs from Owning Affiliated Pharmacies

(4/14, Ed Silverman, STAT+) ...Dozens of state attorneys general are urging Congress to pass a law prohibiting pharmacy benefit managers from simultaneously owning pharmacies, arguing such a move would boost competition and create more affordable prescription drug prices for Americans... Sub. Req’d

MD Prescription Board's Power Expanded, But Wait for Cost Caps Continues

(4/14, Jack Hogan, Maryland The Daily Record) ...Gov. Wes Moore is expected to sign the bill expanding the Prescription Drug Affordability Board's authority into law in the next month or so, but the board appears to be more than a year away from potentially implementing caps on prescription prices outside of those purchased by state and local governments, including for correctional facilities, public hospitals, health clinics at public colleges and universities, employee health benefit plans and Maryland Medicaid... Full

Teamsters Union Plan Sues Arkansas Over Pharmacy Ownership Law

(4/14, Lauren Clason, Bloomberg Law) ...The Central States, Southeast and Southwest Areas Health and Welfare Fund and participant Charles A. Whobrey sued Arkansas Insurance Commissioner Alan McClain April 11, arguing a law requiring health plans to report pharmacy cost data and pay pharmacies a minimum amount violates the Employee Retirement Income Security Act... Sub. Req’d

'Inappropriate' for US to Hit Pharma Sector Amid EU Trade Talks - Harris

(4/15, David Murphy and Tony Connelly, RTE) ...EU trade commissioner Maroš Šefcovic held meetings in Washington yesterday with Trump administration officials following the US President's decision last week to pause sweeping "reciprocal" tariffs for 90 days. Ahead of Mr Šefcovic's meeting with US Commerce Secretary Howard Lutnick, Mr Harris told RTÉ News: "It would be inappropriate if during that time, the United States was to take further action on a sectoral basis, including towards pharma... Full

Martin: Pharmaceutical Sector Must Be Part of Trade Negotiations

(4/15, Tadgh McNally, Paul Hosford, Eoin English, and Ronan Smyth, Irish Examiner) ...Pharmaceutical and semiconductor manufacturing must form part of EU-US talks on trade, Taoiseach Micheál Martin has said. His comments come as it was confirmed Ireland is the second biggest pharma exporter in the EU, with exports reaching a record €313.4bn last year... Full

Ireland Ranked as Second Largest Pharma Exporter in EU Last Year

(4/14, Ronan Smyth, Irish Examiner) ...Ireland has ranked second in the EU, only behind Germany, for the volume of medicinal and pharmaceutical products exported out of the bloc during 2024, data from Eurostat shows. According to Eurostat's data, overall EU export of medicinal and pharmaceutical products increased by 13.5% compared with 2023, reaching €313.4bn. At the same time, imports only recorded a modest increase of 0.5%, amounting to €119.7bn. As a result, the EU's trade surplus in medicinal and pharmaceutical products came to a total of €193.6bn, marking a record high... Full

Belgium's Pharma Hub Still Resilient Despite US Investment Surge

(4/15, Nicole Verbeeck, Euractiv) ...A recent $150 million investment by Johnson & Johnson and Legend Biotech in CAR-T cell therapy production in Belgium highlights the country's resilience in the global ATMP landscape. "We are expanding our footprint in EMEA and are committed to providing CAR-T cell therapy to every patient who is eligible to receive it. At this time, trade policies do not impact that effort. We plan to supply EMEA with our Belgium site and the US from our Raritan site," Legend Biotech told Euractiv...The question of whether highly specialised products like ATMPs will be exempt from potential pharmaceutical tariffs remains unresolved. "This is unclear at this time," Deloitte noted... Full

French Bill Could Improve Clinical Research, But Further Action Is Required

(4/14, Francesca Bruce, Pink Sheet) ...A bill in France that aims to cut bureaucracy for businesses in general includes favorable provisions for clinical research. The bill would make it easier to conduct research in patients' homes and make it easier to export and import samples used in research. Industry association, Leem, says more could be done in this area to make France more competitive with respect to clinical research... Global Sub. Full

Pharma Companies May Feel Heat of US Tariffs On China

(4/15, Teena Thacker, The Economic Times) ...India's drug industry may face the unintended fallout of a potential disruption to the global pharmaceutical supply chain due to lofty US tariffs on Chinese goods. Industry experts say China may eventually move to recover the extra cost burden from buyers by raising prices of key starting materials and Active Pharmaceutical Ingredients (APIs) including to Indian companies. "China is badly hit and faces huge tariffs. It may pass this on to its buyers, in this case India, which is totally dependent on China for APIs, intermediates and key starting materials," said an industry expert. "The supply chain disruptions are likely, which may lead to higher costs."... Full

Tariff Wars to Hit Popular US-Made Drugs in China, Regulator Data Shows

(4/15, Andrew Silver, Reuters) ...Big pharmaceutical companies including AstraZeneca, Sanofi, GSK and Eli Lilly have at least one U.S. manufacturing site for their drugs sold in China, records from China's National Medical Products Administration showed...In response to Reuters queries about China's tariffs and their effects, a spokesperson for Eli Lilly said it was "continuing to examine the detail" and declined to comment further... Full

China Plans Clinical Data Protection By Product Category For First Time

(4/15, Xu Hu, Pink Sheet) ...After on-and-off efforts to implement a scheme for clinical trial data exclusivity over the past eight years, China's top drug regulator, the National Medical Products Administration (NMPA), recently released a draft of new Implementation Measures for Trial Data Protection. Along with the draft, the agency also published the working procedures for drugmakers and NMPA's Center for Drug Evaluation on applying for and reviewing data protection applications. The regulator is also seeking comments on the draft from the public by May 18, and it is not yet clear what the possible implementation date would be... Global Sub. Full

Eli Lilly Issues Warning for Australia as Trump Signals Pharma Tariffs

(4/15, Michael Smith, Financial Review) ...Eli Lilly says it could pull tens of millions of dollars invested in Australian clinical trials unless the federal government dramatically cuts the time it takes to put new drugs onto the Pharmaceutical Benefits Scheme. The warning from one of the drugmaker's top executives, visiting Australia this week, builds on pressure from the powerful pharmaceutical lobby for better deals for the medicines they sell domestically and comes at the same time as Donald Trump prepares to place tariffs on drug imports... Full

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