Wednesday, January 29, 2025

Teva Pharm Q4 Tops Estimates On Strong Sales of its Own Drugs

(1/29, Steven Scheer, Reuters) ...Teva Pharmaceutical Industries reported a slightly larger than expected rise in fourth-quarter profit, helped by double-digit sales gains in a trio of its branded drugs to treat migraines, Huntington's disease and schizophrenia...Teva noted that in the fourth-quarter of 2023 its revenue was boosted by a $500 million upfront payment from Sanofi related to their collaboration on developing a treatment for inflammatory bowel disease... Full

9 Drugs in Shortage

(1/28, Alexandra Murphy, Becker's Hospital Review) ...Verapamil hydrochloride capsule: Teva Pharmaceuticals has discontinued the 120 mg, 180 mg, 240 mg and 360 mg extended release formulations of Verapamil hydrochloride capsules, a medication used to treat hypertension and angina. The decision to discontinue the presentations is based on commercial considerations... Full

Reddy's Reveals Strategy For Denosumab To ‘Facilitate' Abatacept Opportunity

(1/28, Dean Rudge, Generics Bulletin) ...Dr Reddy's Laboratories has divulged plans for its in-licensed denosumab biosimilar to "facilitate" its proposed launch of a biosimilar to the highly-complex Orencia (abatacept) in the US, as the Indian firm expressed confidence that it would succeed in developing and launching a biosimilar to the novel fusion protein where others have failed. Revealing insights during the firm's financial third quarter, the Indian firm's management confirmed that Reddy's denosumab biosimilar – in-licensed in the US and Europe from Alvotech – had been filed with both the US Food and Drug Administration and the European Medicines Agency... Global Sub. Full

Kashiv Looks To Phase III Trial On Orencia Biosimilar, Setting Up Reddy's Race

(1/29, Dean Rudge, Generics Bulletin) ...Not to be outdone by recent disclosures from Dr Reddy's Laboratories, Kashiv Biosciences has announced successful results from a Phase I clinical trial for the firm's proposed biosimilar to Orencia (abatacept), which the firm privately-owned company is developing in both subcutaneous and intravenous formulations. Kashiv's KSHB002 abatacept candidate has successfully met the primary endpoints in its Phase I clinical trial, demonstrating that both maximum serum concentration (Cmax) and area under the concentration-time curve from time zero to infinity (AUC0–8) were within the 80%-125% bioequivalence range, confirming pharmacokinetic equivalence... Global Sub. Full

Ahead of Earnings, Lilly Culls Mid-Stage Drug for Heart Failure and Chronic Kidney Disease

(1/28, Kyle LaHucik, Endpoints News) ...Eli Lilly is discontinuing a Phase 2 relaxin treatment candidate for heart failure and chronic kidney disease, a spokesperson for the company confirmed to Endpoints News. The drug, an under-the-skin injection known as volenrelaxin, was being tested in an approximately 450-patient trial in people with worsening chronic heart failure who have preserved ejection fraction, or HFpEF... Full

Piramal Pharma Q3 Results | Net Profit Tanks 63% to 4 Crore, Revenue Climbs 13% to 2,204 Crore

(1/28, Jomy Jos Pullokaran, CNBC TV-18) ...Piramal Pharma Ltd on Tuesday (January 28) reported a 63.4% year-on-year (YoY) decline in net profit at ?3.7 crore for the third quarter that ended December 31, 2024...The Contract Development and Manufacturing Organization (CDMO) business showed high-teen revenue growth for 9MFY25, driven by continued traction in on-patent commercial manufacturing and the generic API business. The business benefited from timely capacity expansions and targeted business development efforts, leading to year-on-year growth in requests for proposals (RFPs)... Full

Amneal Celebrates FDA Approvals For Generic Namzaric And Afinitor Disperz

(1/28, Urte Fultinaviciute, Generics Bulletin) ...Amneal builds on its affordable medicines business with three FDA approvals – two final and one tentative – for generic rivals referencing AbbVie's Namzaric, Novartis' Afinitor Disperz, and Bausch Health's Xifaxan...Other generic competitors, such as Teva, Sandoz, And Sun Pharma, have settled with Bausch, picking up US launch dates of January 1, 2028... Global Sub. Full

Celltrion Settlement Puts Prolia And Xgeva Biosimilars On Ice – But Only Until June

(1/28, Dean Rudge, Generics Bulletin) ...Celltrion looks set to be able to launch a biosimilar to Amgen's Prolia/Xgeva (denosumab) in the US beginning on June 1, 2025 after settling patent-litigation proceedings with the originator – although, crucially, the firm is yet to pick up US Food and Drug Administration approval for its CT-P41 denosumab candidates... Global Sub. Full

Amgen Settles Prolia Patent Suit with Celltrion, Teeing Up Potential Biosimilar Launch in June

(1/28, Fraiser Kansteiner, Fierce Pharma) ...While Sandoz appears poised to hit the scene with its biosimilars first, the fact that Celltrion holds claim to the next launch window while lacking an FDA approval somewhat muddies the waters in terms of overall launch staging for off-brand denosumab. Apart from Sandoz and Celltrion, Organon, Teva, Fresenius Kabi and Samsung Bioepis have also filed applications for Prolia and Xgeva biosimilars with the FDA. As of October, Amgen had filed patent infringement lawsuits against Sandoz, Celltrion, Samsung Bioepis and Fresenius Kabi over their proposed copycats, online sources show... Full

AZ, Daiichi's Enhertu Nabs 7th FDA Nod, Including in 'HER2-Ultralow' Use, in Breast Cancer First

(1/28, Kevin Dunleavy, Fierce Pharma) ...After breaking through in 2022, with an endorsement for Enhertu to become the first treatment for HER2-low metastatic breast cancer, the question became: How low could Enhertu go? The FDA's answer came on Tuesday. In addition to becoming the first treatment for those whose tumors show a lower level of the HER2 protein biomarker, the nod moves Enhertu up a notch in the treatment line for patients with HER2-low metastatic breast cancer. It can now be used following one or more failed endocrine therapies... Full

Bringing Drugs to Market Has ‘Never Been More Challenging,' and Pharma is Learning to Adapt

(1/28, Michael Gibney, Pharma Voice) ...In an industry as heavily regulated and closely scrutinized as biopharma, the policies driven by agencies like the FDA and HHS, as well as foundational shakeups like a massive patent cliff, shape how companies define their strategies. Confronted with major change like Medicare's price negotiation or competition from biosimilars, for instance, drugmakers are adapting to the evolved landscape. And although sweeping change is occurring in many facets of the industry, companies are still making the system work for them. Just ask Joachin Duato, CEO of J&J, which is staring down several headwinds, notably the entry of biosimilars to compete with its megablockbuster Stelara... Full

Long-Term Data Support Use of Eculizumab Biosimilar as Soliris Alternative in PNH

(1/28, Skylar Jeremias, The Center For Biosimilars) ...Eculizumab biosimilar Elizaria showed long-term safety and efficacy comparable with the reference agent in patients with paroxysmal nocturnal hemoglobinuria (PNH), according to a recent study. The open-label, prospective, multicenter ECU-PNH-III-X study (NCT04679103) published in Acta Haematologica, was conducted as part of the clinical development process for Elizaria, with the cohort being recruited from a previous phase 3 clinical trial (NCT04463056) what demonstrated noninferiority of the biosimilar vs the originator (Soliris)... Full

Tris Builds Clinical Case for Opioid Alternative by Showing its Pain Drug is Less Likely to Be Abused

(1/28, James Waldron, Fierce Biotech) ...Having shown last week that its opioid alternative can reduce post-surgery pain, Tris Pharma is back with another slice of clinical data to show that the drug is less likely to be abused. The phase 1 study gave adult non-dependent recreational opioid users a single crushed dose of either Tris' cebranopadol, the common opioid oxycodone or placebo to snort. The dose of cebranopadol was 1000 µg, which is 2.5 times higher than the dose that Tris is planning to use as a pain treatment, the biotech noted. Abuse potential was determined based on a patient-provided score of the drugs' likeability... Full

West Virginia Top Court Urged to Revive Landmark Opioid Case Against Distributors

(1/29, Brendan Pierson, Reuters) ...A West Virginia city and county on Tuesday urged the state's top court to revive their $2.5 billion lawsuit accusing the three largest U.S. drug distributors of fueling the opioid epidemic, asking it to rule that opioid sales can give rise to a public nuisance under state law... Full

Vizient: Expect 3.84% Increase in Hospital Pharmacy Spend

(1/28, Paige Twenter, Becker's Hospital Review) ...Health systems and ambulatory surgery centers should plan to increase their pharmacy budgets by 3.84% between July 1, 2025, and June 30, 2026, according to Vizient. Vizient's latest spend management outlook, which the company has published biannually since 2010, predicts specialty and personalized medicines will be the primary drivers of growing pharmaceutical costs... Full

Novo Nordisk Asks Third Circuit to Expedite IRA Case as Participation Deadline Looms

(1/28, Nicole DeFeudis, Endpoints News) ...Novo Nordisk is asking a federal appeals court to make haste on its case challenging the Inflation Reduction Act's drug pricing provisions...The company argued during the first round of negotiations that CMS erred by grouping its NovoLog and Fiasp insulin products together, but its case was rejected in New Jersey federal court last July. In a court document filed Monday, the company said the government has "again defied" the law by grouping its weight loss and diabetes products for the next cycle... Full

Patient Advocates To Petition Drug Makers To Scrap IRA Lawsuits

(1/28, Gabrielle Wanneh, Inside Health Policy) ...Patient and consumer advocacy groups will hold a demonstration Wednesday (Jan. 29) to publicly press drug companies to drop their ongoing lawsuits against the Medicare drug price negotiation program. The groups, spearheaded by Patients for Affordable Drugs (P4AD), have collected more than 200,000 signatures for a petition to be presented to the drug companies' CEOs...Currently, seven lawsuits are awaiting further movement at the appellate level in the Second, Third, Fifth and Sixth Circuits, while Merck is waiting on a decision from a Washington, D.C. court and Teva Pharmaceuticals filed a new suit this month with the same court... Sub. Req’d

Carter To Revive Bill Giving Congress More Control Over CBO Health Panel

(1/28, Jalen Brown, Inside Health Policy) ...Rep. Buddy Carter (R-GA) plans to reintroduce a bill previously opposed by Democrats that would give congressional Budget Committee leaders more control over who sits on the Congressional Budget Office's (CBO) health advisory panel, whose insights shape the scoring of bills and ultimately influence their chances of passage -- an effort spurred by Republican concerns over the agency's scoring of the Inflation Reduction Act's (IRA) drug price negotiation provision... Sub. Req’d

Trump Order Signals Shake-Up in Drug Pricing Innovation Through Medicare and Medicaid

(1/29, Gabrielle M. Etzel, Washington Examiner) ...In doing so, Trump pulled the plug on three drug pricing test models that respectively would have lowered the costs of gene and cell therapies for Medicaid patients, capped certain generic drug prices for Medicare beneficiaries to $2 monthly out of pocket, and accelerated the Food and Drug Administration approval process for drugs designed to address unmet medical needs... Full

US FDA Acting Commissioner Tells Staff She's Ready To MAHA

(1/28, Sarah Karlin-Smith, Pink Sheet) ...Acting FDA Commissioner Sara Brenner's first memo is generally a boiler plate intro to agency staff, but also includes the political slogan "Make America Healthy Again!" Using the slogan associated with HHS Secretary nominee Robert F. Kennedy Jr. could be polarizing at the FDA, in part because Kennedy and the MAHA movement have sometimes backed discredited ideas about health. Kennedy's MAHA agenda also is not particularly pharma industry friendly... Global Sub. Full

Stakeholders Ask FDA to Harmonize Oligonucleotide-Based Therapeutics Guidances

(1/28, Ferdous Al-Faruque, Regulatory Focus) ...In November, FDA published a draft guidance on nonclinical safety assessments of oligonucleotide-based therapeutics (ONT) detailing its expectations for pharmacology and pharmacokinetic characteristics and conducting different toxicity studies. In response, several stakeholders have written to the agency recommending that it not only harmonize the guidance with a recent FDA final guidance, but also with international guidelines... Full

Approvals The US FDA Is Not Talking About: A Communication Freeze Calendar

(1/28, Bridget Silverman, Pink Sheet) ...A Pink Sheet chart tracks FDA user fee goal dates falling during the HHS public communication freeze, which lasts at least until February 1. FDA approvals not posted online include significant new indications for Daiichi Sankyo/AstraZeneca's Enhertu and Novo Nordisk's Ozempic, and medac/Medexus' novel conditioning agent for stem cell transplant. Upcoming goal dates include Vertex's much-anticipated non-opioid acute pain drug suzetrigine and PTC Therapeutics' much-debated Translarna for nonsense mutation Duchenne muscular dystrophy... Global Sub. Full

Nebraska Joins Multi-State Settlement Against Biohaven Pharmaceutical for Kickback Allegations

(1/28, News Channel Nebraska) ...Attorney General Mike Hilgers announced Tuesday, Nebraska has joined the United States, 37 other states, and Puerto Rico to settle kickback allegations against Biohaven Pharmaceutical Holding Company Ltd., a subsidiary of Pfizer, Inc. Hilgers said that Biohaven will pay over $59 million to resolve claims of submitting false claims to Medicaid and other federal healthcare programs... Full

EU Offers Funding To Safeguard Innovation Under New Health Data Sharing Rules

(1/28, Eliza Slawther, Pink Sheet) ...Europe's public-private Innovative Health Initiative is seeking contenders for two research projects relevant to pharmaceuticals, one relates to the incoming European Health Data Space Regulation and the other focuses on reducing exposure to medicines containing per- and polyfluoroalkyl substances... Global Sub. Full

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