Wednesday, April 23, 2025

Samsung Biologics Reports Record Q1 Revenue of 1.3 Trillion Won, Driven by Biosimilars

(4/23, Yeom Hyun-a, ChosunBiz) ...Subsidiary Samsung Bioepis recorded sales of 400.6 billion won and operating profit of 128 billion won thanks to the expansion of biosimilar product sales in the global market. Despite this growth, Samsung Biologics maintained the growth rate guidance it provided earlier in January for the total sales outlook for 2025, projecting a growth rate of 20-25% compared to the previous year. The company explained that it considered uncertainties due to changes in the global economic environment and exchange rate fluctuations... Full

Celltrion Celebrates Interchangeability Designation For Humira Biosimilar In The US

(4/22, Urte Fultinaviciute, Generics Bulletin) ...The study demonstrated similar outcomes in terms of pharmacokinetics, efficacy, safety, and immunogenicity in patients with moderately to severely active plaque psoriasis who received reference adalimumab continuously and those who alternated between reference product and Yuflyma during the dosing interval of week 25-27... Global Sub. Full

Xbrane Approves Deal Giving Away Cimzia Rival To Alvotech

(4/22, Adam Zamecnik, Generics Bulletin) ...Xbrane has approved its deal with Alvotech that will hand over the company's Swedish R&D facilities and in-development Cimzia (certolizumab pegol) biosimilar, as part of an extra general meeting. Last month, the Icelandic company Alvotech struck a SEK275m ($27m) deal with Xbrane, which traded away Xbrane's research facilities at Campus Solna in Sweden's Karolinska Institute together with the rights to a Cimzia biosimilar, XB003. The R&D facilities include approximately 40 employees and all of Xbrane's laboratory equipment... Global Sub. Full

Aurobindo Pharma Shares Gain Nearly 3% After Getting USFDA Nod for Leukemia Drug

(4/23, Juviraj Anchil, CNBC TV-18) ...Aurobindo Pharma gained nearly 3% in trade on Wednesday, April 23, after it said its wholly-owned subsidiary, Eugia Pharma Specialities Limited, received the final approval from the US Food & Drug Administration to manufacture and market Dasatinib Tablets...Dasatinib is expected to be launched in the first quarter of the financial year 2026... Full

Roche's Genentech Builds Autoimmune Repertoire with Deal Worth Up to $765M

(4/23, Darren Incorvaia, Fierce Biotech) ...Flagship Pioneering-backed Repertoire will leverage its immune-modeling platform in efforts to discover new targets in an undisclosed autoimmune condition, after which Genentech will take over preclinical and clinical development plus any potential commercialization activities, according to an April 23 release... Full

Bristol Myers' Cobenfy Fails to Meet Main Goal as Add-On Treatment for Schizophrenia

(4/22, Sriparna Roy, Reuters) ...Bristol Myers Squibb said on Tuesday its drug Cobenfy failed to show a statistically significant difference in a keenly watched late-stage trial that would help expand its use, sending its shares down nearly 5% in after-market trade. The drug, which was approved last year, failed to meet the main goal in a trial that was testing Cobenfy in patients with schizophrenia who have stopped responding to their current antipsychotic treatments... Full

Facing Added Pressure from Eli Lilly, Novo Nordisk Submits for FDA Approval of Oral GLP-1 Obesity Drug

(4/22, Kevin Dunleavy, Fierce Pharma) ...Nearly two years after reporting successful results from a phase 3 trial of its oral version of injected obesity treatment Wegovy, Novo Nordisk has asked the FDA to approve it. A company spokesperson confirmed the FDA submission, which was reported Monday by BioPharma Dive. Novo plans to provide more information during its quarterly results presentation May 7, the spokesperson said...On Tuesday, a company spokesperson said that Novo was "awaiting the results from the entire OASIS program to include a full package for submission."... Full

Novo Nordisk to Phase Out Key Drug, Insulin Cos Spot Big Biz Opportunity

(4/23, Rica Bhattacharyya and Vikas Dandekar, The Economic Times) ...Novo Nordisk is set to discontinue some forms of its Mixtard insulin, including pen and cartridge versions, in India, coinciding with the anticipated launch of its weight-loss drug Wegovy. This move has prompted other major insulin manufacturers like Lupin, Eris, and Eli Lilly to increase their production capabilities to address the potential supply gap...Confirming the development, a Novo Nordisk spokesperson said, "In order to meet increasing patient demand and ensure a stable supply of our medicines, we have decided to consolidate our insulin portfolio, as this will create space needed in our global manufacturing network. Hence, in this process, we are phasing out the penfill."... Full

Eli Lilly Sues Four Telehealth Companies Selling Compounded Tirzepatide

(4/23, Shelby Livingston, Endpoints News) ...In four separate complaints, Lilly alleged that the telehealth companies deceive customers and make false claims about their compounded tirzepatide drugs, including that the medications are safe and effective and personalized for each individual patient. The companies include Henry Meds, Mochi Health, Willow Health Services as well as Fella Health and Delilah, which are separate brands under the same entity. Each advertises and prescribes compounded GLP-1 medications online... Sub. Req’d

Dose of Reality: Big Pharma's Patent Abuse Extending Monopolies, Keeping Prices High On GLP-1s

(4/22, The Campaign for Sustainable Rx Pricing) ...A new report from the Initiative for Medicine, Access and Knowledge (I-MAK) highlights how Big Pharma giants Novo Nordisk and Eli Lilly are gaming the U.S. patent system to extend monopolies and keep prices high on blockbuster GLP-1 drugs like Ozempic, Wegovy and Mounjaro...The report found that "the main compound patent for semaglutide as used in the three drugs was set to expire in March 2026, it said, but regulatory extensions have lengthened Novo's exclusivity until December 2031." I-MAK estimates that this five-year period will grant Novo Nordisk an additional $166 billion... Full

Regeneron, Biocon Settle Patent Suit On Biosimilar of Eylea Drug

(4/22, Christopher Yasiejko, Bloomberg Law) ...Judge Thomas S. Kleeh approved the stipulation and order Tuesday in the US District Court for the Northern District of West Virginia, resolving Regeneron's disputes with Mylan Pharmaceuticals Inc., a unit of Viatris Inc., and Biocon Ltd., which will market its own macular degeneration drug in the US. The order vacated the permanent injunction and dismissed all claims and counterclaims, closing the door on both sides' chances to renew allegations... Sub. Req’d

How Takeda's CEO Transformed the Company into a Global Pharma Powerhouse

(4/22, Christine Tan, CNBC) ...Takeda Pharmaceuticals, Japan's largest drugmaker, has undergone a sweeping transformation under CEO Christophe Weber, emerging as one of the world's leading pharmaceutical companies...Now operating in approximately 80 countries, Takeda is focusing its efforts on high-impact therapeutic areas such as oncology, rare diseases, gastroenterology and neuroscience. As it enters its next phase of growth, the company is committed to scaling its innovation capabilities and reinforcing its role in shaping the future of global healthcare... Full

Dr Reddy's, Lupin Recall Products in US Due to Manufacturing Errors: USFDA

(4/22, Press Trust Of India) ...Dr Reddy's Laboratories and Lupin are recalling products in the US market due to labelling and manufacturing errors, respectively, according to the US health regulator. As per its latest Enforcement Report, US Food and Drug Administration said a US-based subsidiary of the Hyderabad-based drug major is recalling certain batches of a generic antiepileptic drug in the US market... Full

Mark Cuban Cost Plus Drugs Provides More Cost Savings for Dermatology Prescription

(4/22, Brian Nowosielski, Drug Topics) ...Mark Cuban Cost Plus Drug Company (CostPlus) demonstrated significantly higher savings for dermatology drugs when compared with GoodRx, according to a study published in JMIR Dermatology. While both companies' models provided patients with savings, CostPlus was much more successful, demonstrating better savings even when compared to GoodRx's lowest-priced products... Full

Optum Rx Reduces Over 10% of Overall Pharmacy Prior Authorizations, Impacting Dozens of Drugs

(4/22, Luke Halpern, Pharmacy Times) ...Optum Rx, the pharmacy benefit manager (PBM) of UnitedHealth Group Inc., has announced in a news release that it is reducing up to 25% of reauthorizations, comprising over 10% of overall pharmacy prior authorizations, for a list of 80 medicines that will be expanded over time through collaboration with pharmacists and other treatment providers. The policy change is a significant development for patients and their providers, who have in recent years increased their criticism of prior authorization, claiming it produces avoidable harm and waste... Full

Patient Hit With $250,000 Bill Over Plan to Access Cheap Drugs

(4/22, John Tozzi, Bloomberg) ...Drugmakers have long offered subsidies for uninsured patients, and also help defray out-of-pocket costs for insured people with copay cards or other support. Health plans, in turn, develop elaborate programs to maximize how much of that funding they can capture. That's where alternative funders come in. If health-plan sponsors remove insurance coverage for certain medications, alternative funders make the case to drugmakers that patients should get the medicines for free or at a discount. Payer Matrix says coverage decisions are entirely up to the plan, and that it doesn't decide which drugs are covered... Full

Drugmakers Stockpile Inventory in the US, Seeking to Get Ahead of Trump Tariffs

(4/22, Drew Armstrong, Endpoints News) ...Large pharmaceutical companies that make drugs around the world have begun to ship and stockpile products inside US borders, in an effort to blunt the impact of the Trump administration's expected tariffs on the industry, multiple companies told Endpoints News. The moves are a temporary solution that will at most provide a few quarters worth of respite, said the companies, which spoke to Endpoints on condition of anonymity. Many are also looking at longer-term plans to reorient current and future manufacturing plans, including possibly expanding manufacturing operations in the US... Sub. Req’d

2 Years After Leaving PhRMA, AstraZeneca Opts Back In

(4/22, Kevin Dunleavy, Fierce Pharma) ...Two years ago, the Pharmaceutical Research and Manufacturers of America (PhRMA) trade group faced a mini-exodus as several drugmakers opted to pick up stakes and leave the association. Now, with global trade winds swirling harsher, one of those companies is making its official return...Now, after an administration change, the landscape has shifted. President Donald Trump is considering changes to the IRA and other measures—such as tariffs, antitrust enforcement and reform of the pharmacy benefit manager system—which could have major impacts for the biopharma industry... Full

Proposed HHS Budget Would Eliminate Medicare Negotiation Program Start-Up Funding

(4/22, Cathy Kelly, Pink Sheet) ...An internal and preliminary White House FY 2026 federal budget proposal would eliminate the $3bn appropriated in the Inflation Reduction Act for implementing the Medicare price negotiation program. Cutting the funding could disrupt the ongoing implementation, which includes development of a complex Medicare Transaction Facilitator to effectuate the negotiated prices. The potential reduction emerged after President Trump issued an Executive Order directing "improvements" to the negotiation program... Global Sub. Full

An ‘Insane' Calculus: A Pharma Company Raised Price for a Rare Disease Drug 150% to Cover Medicaid Rebates

(4/22, Ed Silverman, STAT+) ...Four months ago, a small pharmaceuticals company bought a medicine used to combat a rare growth disorder in children and quickly raised the list price by 150%. Such a dramatic boost — from $5,882 to $14,705 per vial — is the sort of move that often draws attention at a time when many Americans complain about rising drug costs. But the company, Eton Pharmaceuticals, argues there is no other way to keep its treatment on the market and make a profit. But its decision involves a calculated twist: a willingness to take a hefty loss on each Medicaid patient... Sub. Req’d

GDUFA III and DMF Assessments

(4/22, Rebecca Welton, Lachman Consultants) ...On Day 2 of the Generic Drugs Forum (GDF), there were a couple of sessions on Drug Master Files (DMFs) that provided some helpful information. The first presentation, from Dr. Jayani Perera, Senior Chemist in the Division of Product Quality Assessment (DPQA) XIX, provided some insight into the GDUFA III impact on DMF Assessments and DMF Prior Assessments and it is the topic of this blog... Full

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

(4/22, Michael McCaughan, Pink Sheet) ...The Office of Generic Drugs is committed to meeting user fee goal dates despite layoffs and restructuring, FDA officials pledged during the annual Generic Drugs Forum. Former Office of Regulatory Operations Director Ted Sherwood said reviewers hope to approve an application, not just meet the deadline. OGD Deputy Director Darby Kozak included starting the GDUFA IV negotiation process on his closing list of 2025 plans for OGD... Global Sub. Full

Recent FDA Staff Cuts to Delay Drug Hearing Decision by Months, Agency Tells Vanda

(4/22, Zachary Brennan, Endpoints News) ...The firings affected the "offices assigned to lead the review and draft the written response to this Vanda matter," the agency said in its letter to Vanda, including leadership at the FDA's Center for Drug Evaluation and Research, as well as "access to relevant subject matter experts, administrative support staff, library staff, and academic journal subscriptions."...In a response sent Thursday, Vanda claimed that the agency is "repeatedly violating Vanda's rights" with its proposed delays over its tradipitant review and hearing, and that the agency already had an entire year to review Vanda's application. It's asking that the hearing be conducted no later than May 7... Sub. Req’d

High Cost of Naloxone Prompts Rural Arkansas Pharmacists to Keep Life-Saving Medicine Behind Counter

(4/22, Mary Hennigan, Arkansas Advocate) ...The life-saving medicine naloxone was approved for nonprescription sale more than two years ago, but many rural Arkansas pharmacies still keep the overdose-reversal kit behind the counter. Of 15 pharmacies the Advocate contacted for this article, all but two kept naloxone behind the counter. Pharmacists and business owners said requests for the drug have been low or nonexistent among their clientele, and they haven't thought of moving it to a different area. Others cited shoplifting and the drug's expense as a concern; several said more insurance providers should cover the cost... Full

As a Result of PBM Reform, CVS Will Close Over 20 Pharmacies in Arkansas

(4/22, Brian Nowosielski, Drug Topics) ...CVS plans to close up to 23 of its pharmacy locations in Arkansas as a result of the signing of HB1150, which bans pharmacy benefit managers (PBMs) from owning pharmacy storefronts. This statewide event could serve as a precursor to significant change in the US pharmacy industry if similar federal bills are signed into law...While many experts believe this move will result in greater medication access and lower drug prices, CVS representatives believe the opposite... Full

European Pharma Companies Push for Higher Drug Prices in EU Amid U.S. Tariff Threats

(4/23, Maggie Fick, Reuters) ...European drugmakers are urging the EU to allow higher medicine prices, warning that without stronger investment incentives, the bloc would fall further behind the U.S., where tariff threats have triggered a wave of pharma investment announcements... Full

Pharma Bosses Call for Higher Drug Prices in EU to Counter Tariff Threat

(4/23, Hannah Kuchler and Alice Hancock, Financial Times) ...In a letter to the Financial Times, Novartis chief executive Vas Narasimhan and Paul Hudson, his counterpart at Sanofi, say the European Commission should set a spending target for medicines and vaccines to "fairly reward innovation"...The European chief executives say in their letter: "Against a backdrop of waning European biopharma competitiveness, the uncertainty of tariffs is further reducing incentives to invest in the EU."... Sub. Req’d

Letter: Brussels Must Get the Incentives Right for Pharma Investment

(4/22, Vas Narasimhan and Paul Hudson, Financial Times) ...China, now the second largest biopharma market, has expanded its position by attracting multinationals and creating a vibrant biotechnology environment. In response, the European Commission is seeking to reduce bureaucracy and simplify regulations. We fully support this, but it is very far from enough. Europe's largest issue is failing to properly value innovation. The US pharmaceutical market is twice the size of Europe's, despite a smaller population. In the new world context, Europe's pharmaceutical model of producing in Europe and exporting to the US cannot continue. It needs to strengthen its domestic market... Sub. Req’d

PHARMAP 2025 Brings Together Global Pharma Leaders to Discuss Innovation and Drug Safety

(4/23, Express Pharma) ...PHARMAP 2025, Europe's premier pharmaceutical congress, brought together over 300 senior leaders from major global pharma companies, including Bayer, Roche, Johnson & Johnson, AstraZeneca, Novartis, Novo Nordisk, Pfizer, Takeda, and more. The congress showcased the industry's evolving trends, such as the integration of digital twins in manufacturing and advancements in sustainable packaging solutions. These trends highlighted the pharmaceutical sector's shift towards connected, data-driven, and patient-centric models... Full

Medicines for Ireland Announces Managing Director of Clonmel Healthcare, Donagh O'Leary as New Vice Chairperson

(4/22, Medicines for Ireland) ...Medicines for Ireland (MFI), the representative body for the suppliers of the majority of medicine in Ireland has today (22.04.25) announced Mr Donagh O'Leary as its new Vice Chairperson. Mr O'Leary will join MFI Chairperson, Paul Neill in leading the association as it enters a period of strategic significance for the industry and patients... Full

Russian Drugmakers Call for New Criteria for Strategically Important Drugs

(4/23, The Pharma Letter) ...The Russian pharma trade group Innovative Pharma (Inpharma) has sent an official letter to the Ministry of Industry and Trade of Russia with proposals for revising the criteria for including drugs in the list of strategically important drugs, The Pharma Letter's local correspondent reports... Sub. Req’d

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