Wednesday, February 12, 2025

The Teva Turnaround: Steering a Company Comeback

(2/11, Michael Christel, PharmExec.com) ...Over the course of his first 10 weeks, [Teva CEO Richard Francis] and the leadership group conducted a detailed and honest appraisal of all things Teva, conceiving and constructing the steps and machinations of what would become the drugmaker's "Pivot to Growth" strategy, which it officially unveiled that spring..."There was no, ‘let's just gently move in this direction,' because I don't think time was on our side; and once you decide what direction to go, then, to me, it's just about execution," says Francis... Full

Teva Deals Early On US Auvelity Generic, Agreeing To At Least 13-Year Freeze

(2/11, Dean Rudge, Generics Bulletin) ...Teva will have to wait until the end of the next decade to launch its proposed generic version of Axsome Therapeutics' Auvelity treatment for MDD...Nevertheless, in a same-day note, William Blair described the Teva settlement as a material win for the originator, given both the clarity on timelines of potential generic market entry and timelines that are "significantly delayed from patents expiring November 2034 that would have been the next tier of protection had Teva been successful in paragraph IV proceedings against the 2040 and 2043 patent families."... Global Sub. Full

Gilead Provides Upbeat 2025 Forecast, Shares Rise 4%

(2/11, Deena Beasley, Reuters) ...Gilead Sciences posted fourth-quarter results that exceeded Wall Street expectations and forecast 2025 earnings above analyst estimates on Tuesday, sending the biotech company's shares up 4%... Full

Drugmaker Biogen Forecasts 2025 Profit Below Expectations

(2/12, Manas Mishra, Reuters) ...Biogen forecast 2025 profit below Wall Street expectations on Wednesday, hurt by a strong dollar and fierce competition for its drugs to treat multiple sclerosis. Investors sold Biogen shares in 2024 as a slow US launch of Leqembi, the Alzheimer's disease drug it sells with Japan's Eisai, exacerbated worries of slowing sales growth... Full

Eisai Execs Flag Leqembi 'Expansion Phase' On the Horizon as Alzheimer's Med Grows Slowly

(2/11, Fraiser Kansteiner, Fierce Pharma) ...All told, Leqembi brought home around 13.3 billion Japanese yen ($87 million) in the third quarter of Eisai's 2024 fiscal year, which will wrap up on March 31. In the U.S. specifically, Leqembi grew roughly 30% quarter-over-quarter to 7.7 billion yen (nearly $51 million), Eisai said in a recent earnings presentation... Full

Profits at Irish Arm of Roche Pharma Climb by 17%

(2/11, Gordon Deegan, Irish Examiner) ...The lengthy timelines to reimburse medicines in Ireland must be reduced to improve standards of care and patient outcomes, the directors of the Irish arm of pharma giant Roche have stated. The directors for Roche Products (Ireland) Ltd make the statement in new accounts which show that pre-tax profits at the Irish operation increased by 17% to €5.3m in 2023. This followed revenues increasing by 7% from €116.3m to €124.68m. The directors report that the company "delivered a solid level of sales growth in 2023"... Full

U.S. FDA Approves Celltrion's AVTOZMA® (Tocilizumab-Anoh), A Biosimilar to ACTEMRA®

(2/11, Celltrion) ...The intravenous (IV) formulation of AVTOZMA® (tocilizumab-anoh) is expected to be available in the U.S. in August 2025. Approval was received for multiple indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and COVID-19. AVTOZMA® becomes Celltrion's fifth immunology biologic and seventh biosimilar approved by the FDA... Full

Natco Pharma Gets USFDA Approval for Bosentan 32mg Tablets

(2/12, IIFL Capital) ...Natco Pharma Ltd has received final approval from the USFDA to market Bosentan 32mg tablets. This drug, Bosentan 32mg tablets is used for the treatment of pulmonary arterial hypertension (PAH). This drug is usable for children aged 3 years and above. This provides an opportunity for the company to market a generic equivalent of Tracleer, a drug produced by Actelion Pharmaceuticals US Inc... Full

Lilly, Novo Skew Overall Pharma Trends With Colossal GLP-1 Sales Growth

(2/12, Annalee Armstrong, BioSpace) ...In a recent analysis, William Blair predicted that revenue among the top 15 pharmas will increase 6.1% in 2025. This is a great forecast—more than double the 2.7% compound annual growth rate in the five years leading up to the pandemic—but when you take out Lilly and Novo, the number falls to what the firm called a more modest 3.7%. That's because Lilly and Novo are expecting double-digit growth of 27.9% and 20.3%, respectively, this year thanks to their in-demand weight loss drugs Zepbound and Wegovy... Full

Compounded GLP-1s For Obesity: Is The Genie Out Of The Bottle?

(2/11, Cathy Kelly, Pink Sheet) ...The business of GLP-1 drug compounding has progressed to a point that will be hard to reverse. Patient demand will continue, even if semaglutide is removed from the US FDA's drug shortage list and compounding is curtailed. A high-profile Super Bowl ad may increase momentum to align advertising rules for compounded products with those for FDA-approved prescription drugs... Global Sub. Full

MSN Pushes for Rehearing On Revival of Novartis' Entresto Patent

(2/11, Christopher Yasiejko, Bloomberg Law) ...MSN Laboratories Pvt. Ltd. urged the Federal Circuit to reconsider a three-judge panel's January ruling that revived a patent for Novartis AG's blockbuster heart-disease drug Entresto..."The panel's decision ignored the full scope requirement of Section 112(a)"—the requirement that a patent fully describe the invention—"and should be reversed," MSN argued in its petition... Sub. Req’d

Wegovy and Ozempic Stars Dim Amid Overuse Concerns

(2/11, Tina Reed, Axios) ...The luster is starting to wear off GLP-1 weight-loss drugs including Wegovy and Ozempic as more clinicians warn patients about side effects and other potential risks stemming from their surging demand...Research showing the drugs not only work for obesity but could lower the risk of heart attacks, stroke, some cancers and even Alzheimer's disease has overshadowed the substantial cost and the fact that many patients can't stay on them... Full

FDA Puts Two Chinese API Makers On Import Alert After Failed Inspections

(2/11, Anna Brown, Endpoints News) ...Chinese API manufacturers Wuhu Nuowei Chemistry and Chengdu Innovation Pharmaceutical have been placed on US import alert over issues with their quality control and testing methods. The import alerts mean that the FDA has the right to detain any future products shipped to the US from either of the two companies... Full

Amazon's RxPass Shown to Improve Days' Supply, Refills, and Out-of-Pocket Costs for Common Medications

(2/11, Kennedy Ferruggia, Pharmacy Times) ...RxPass, Amazon Pharmacy's subscription service for common medications, has demonstrated significant improvements in medication adherence and out-of-pocket cost reductions, according to research published in JAMA Network Open. However, RxPass could disrupt traditional retail pharmacies, making it difficult to compete with Amazon Pharmacy's business model... Full

Lawmakers Press for Quick Action On PBM Bills

(2/11, Michael McAuliff, Modern Healthcare) ..."We're going to continue to push for PBM reform. It's extremely important," said Rep. Dr. Marianette Miller-Meeks (R-Iowa), a member of the Energy and Commerce Committee. That panel has jurisdiction over a huge swath of the healthcare system, including Medicaid, Medicare and programs from the Affordable Care Act of 2010. "We've got to. We've got to make that happen," said Rep. Rick Allen (R-Ga.), another committee member who said he is "absolutely" pushing to add the previous package to one of the big spending bills... Sub. Req’d

Health of the Biosimilars Industry, Getting Rid of Clinical Trials, PBMs As Obstacles and Other Biosimilar Topics | Q&A With Craig Burton, MBA

(2/11, Peter Wehrwein, Managed Healthcare Executive) ...As part of Managed Healthcare Executive's coverage of biosimilars and managed care in 2025, we will be reaching out to leaders in industry and managed care, and outside experts and analysts who can provide insight and understanding into biosimilars and their market dynamics. Managing Editor Peter Wehrwein spoke recently with Craig Burton, MBA, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances for the Association for Accessible Medicines. The Biosimilars Council is part of the association, a trade association of generic and biosimilar distributors and manufacturers... Full

Senator Reverend Warnock Introduces Legislation to Cap the Cost of Prescription Medication

(2/11, U.S. Senator for Georgia Reverend Raphael Warnock) ...The legislation would lower prescription drug costs for millions of Americans by placing annual caps on out-of-pocket costs for prescription drugs at $2,000 for individuals and $4,000 for families with private insurance. The Senator's bill builds on the success of the Inflation Reduction Act, which includes the Senator's provision capping prescription drug cost-sharing for Medicare Part D beneficiaries, extending the savings to the commercial health care market... Full

Senator Warnock Introduces New Bill Focused On Limiting Medication Costs for Families

(2/11, Hayley Boland, WTOC) ...The "Capping Prescription Costs Act" limits the annual out-of-pocket drug costs per year to $2,000 per individual and $4,000 for families. This cap would apply for both group health plans and marketplace health plans. It would expand the cap already in place for seniors through the Inflation Reduction Act... Full

Addressing Rapidly Changing Biosimilar Dynamics at Access 2025

(2/10, Stanton Mehr, Biosimilars Review & Report) ...The bulk of the discussion at this year's ACCESS 2025 conference fell into four buckets: (1) the effect of the Trump administration's tariffs on the active pharmaceutical ingredient (API) supply chain, (2) the magnitude of the potential lost opportunity for biosimilars that are not developed (or the "biosimilar void"), (3) the effect of the Department of Government Efficiency (DOGE)'s early retirement initiative, and (4) the effect of the new private-label channel in the biosimilar marketplace. In the initial installment of a two-part report, we cover the first two topics... Full

Top California Democrats Clash Over How To Rein In Drug Industry Middlemen

(2/12, Christine Mai-Duc, California Healthline) ...A California bill awaiting its first hearing would subject drug industry intermediaries known as pharmacy benefit managers, or PBMs, to licensing by the state Department of Insurance. And it would require them to pass along 100% of the rebates they get from drug companies to the health plans and insurers that hire them to oversee prescription drug benefits... Full

Depemokimab & Tzield Among 10 New EU Filings

(2/11, Neena Brizmohun, Pink Sheet) ...GSK's depemokimab, if approved, could become the first ultra-long-acting drug for treating asthma and chronic rhinosinusitis with nasal polyps. Meanwhile, Sanofi's teplizumab, which the US approved as the first disease-modifying therapy for type 1 diabetes in 2022, has now been filed for review by the European Medicines Agency... Global Sub. Full

Tariffs Can Make Pharma Go Slow on Off-Patented Drugs

(2/11, Sangeetha G, Deccan Chronicle) ...India may lose the chance to grab the Rs 12,000 crore opportunity of US drugs going off-patent in the coming years if US President Donald Trump imposes tariffs on pharma imports. Automobile component manufacturers too may find it tough to export products to the US... Full

'Ineffective' Generic Drugs Fuel Rare Public Anger in China

(2/11, Koh Ewe, BBC News) ...Public anger in China over concerns raised by doctors that generic drugs used in public hospitals are increasingly ineffective has led to a rare response from the government. Doctors say they believe the country's drug procurement system, which incentivises the use of cheap generic drugs over original brand-name pharmaceuticals, has led to costs being cut at the expense of people's safety... Full

Takeda's Market Exit and Return of Vonoprazan Raise Stakes in Korea's Drug Pricing Battle

(2/12, Kim Ji-hye, Korea Biomedical Review) ...The timing was too perfect to be a coincidence. Just three months before its mandatory post-marketing surveillance (PMS) period was set to expire, Takeda Korea pulled its acid reflux drug, Vocinti (vonoprazan), from the market...For Takeda, the maneuver may have been calculated, a move to reposition the drug under more favorable conditions. For generic drugmakers, it was an unexpected roadblock... Full

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