Wednesday, November 27, 2024

Please note: Teva Daily News will not publish November 28 & 29 in observance of the U.S. Thanksgiving Holiday. Publication will resume on Monday, December 2.

Defining an Orange Book 'Drug'

(11/26, An Nguyen, LexBlog) ...In late 2023, Teva filed a complaint for patent infringement in response to Amneal's ANDA filing seeking to make and sell a generic version of ProAir HFA (albuterol sulfate) Inhalation Aerosol ("ProAir"). Teva holds an approved NDA for ProAir in addition to five patents listed in the Orange Book as covering the product, all of which were asserted in the lawsuit. The patents claim variations of a metered dose inhaler and dose counter. In its answer, Amneal asserted counterclaims requesting delisting of all five asserted patents in the Orange Book for failure to comply with the statutory requirements under the FD&C Act... Full

Amphastar Continues To Push Proprietary Portfolio With Focus On Baqsimi

(11/26, Adam Zamecnik, Generics Bulletin) ...Amphastar is continuing in its shift towards a more proprietary portfolio through the development of new products with different delivery systems, as discussed in a fireside chat at this year's Jefferies Healthcare Conference – which took place in London in late November – in which members of Amphastar's management focused on the company's latest results and recent efforts... Global Sub. Full

Amgen's Weight-Loss Drug Fails to Impress in Study; Shares Plunge

(11/26, Bhanvi Satija, Deena Beasley, Reuters) ...Amgen's experimental drug MariTide helped overweight or obese patients shed up to 20% of their body weight in a mid-stage trial, but the results failed to meet lofty investor expectations and shares of the biotech company fell 4.8% on Tuesday. The year-long trial involving 592 people tested several different doses of the drug as a monthly or bi-monthly injection. Amgen said it also planned to study quarterly dosing... Full

Alvotech's Eylea Biosimilar ‘Keeps In Mind' US Patent Landscape

(11/26, Dean Rudge, Generics Bulletin) ...Alvotech believes that the company's chosen formulation of its proposed biosimilar to Regeneron's Eylea (aflibercept) 2mg "might give us a very interesting opportunity," especially in the US where the Icelandic firm plans to launch "as soon as we feel it is feasible."...Alvotech is eyeing a European marketing authorization for its AVT06 proposed biosimilar to Eylea (aflibercept) 2mg in the third quarter of next year after the Icelandic firm's application was accepted for filing by the European Medicines Agency in August. However, the firm would adopt a more cautious approach in the US, where Alvotech's partner Teva is yet to disclose a filing... Global Sub. Full

Glenmark Pharma Launches Travoprost Ophthalmic Solution in US

(11/27, CNBC TV-18) ...Glenmark Pharmaceuticals on Wednesday, November 27, announced the launch of the Travoprost Ophthalmic Solution USP, 0.004%, by its subsidiary Glenmark Pharmaceuticals Inc., USA...In addition to its in-house pipeline, Glenmark actively seeks external development partnerships to enhance and expedite the growth of its product offerings, reaffirming its commitment to innovation and customer-focused solutions... Full

Dr. Reddy's, Senores Pharmaceuticals Launch Generic Stromectol

(11/26, Sandra Levy, Drug Store News) ...Dr. Reddy's and Senores Pharmaceuticals are offering ivermectin tablets, 3 mg, which is the generic of Merck Sharp and Dohme's Stromectol...Ivermectin tablets, 3 mg brand and generic products had a market value of roughly $20 million for the 12 months ending in September 2024, per IQVIA... Full

Celltrion Sets Annual Sales Target at 5 Tln Won Next Year: Chairman

(11/27, Kim Na-young, Yonhap News) ...South Korean drugmaker Celltrion Inc. plans to achieve annual sales of 5 trillion won (US$3.58 billion) next year, driven by the growth of its biosimilar products and a new treatment for autoimmune diseases, its chairman said Wednesday... Full

Novartis Plots More Than 100 Layoffs in New Jersey as Part of Rework to Xolair, Cancer Combo Field Sales Teams

(11/26, Fraiser Kansteiner, Fierce Pharma) ...Novartis confirmed the staff reductions via email, with a company spokesperson noting that the moves will primarily affect commercial field sales associates working on the brands Xolair, for asthma and allergies, and the oncology combo made up of kinase inhibitors Tafinlar and Mekinist (Taf+Mek)...Nevertheless, the company has set its sights on launching some 15 new drugs over the next three years. In turn, the planned changes to Xolair and Taf+Mek promotion are expected to "help ensure that we can bring forward this new wave of innovation and offer the appropriate education and support required to realize the full potential of these medicines for the patients they serve," Novartis' spokesperson said... Full

Sanofi Boosts Preparedness With $600 Million Singapore Plant

(11/27, Karoline Kan, Bloomberg) ...The facility, named Modulus, came up at investment of S$800 million (nearly $600 million) at Tuas Biomedical Park in the city-state, according to a statement. It can be adapted to manufacture up to four vaccines or biopharmaceuticals at the same time, and will be fully operational in mid-2026 and create 200 skilled jobs in Singapore. Modulus can also be reconfigured within a few days to transform between technological platforms, a process which traditionally takes months or years, the company said. It can house the equivalent of 34 standardized production modules... Full

Omalizumab Biosimilar Shows Equivalent Efficacy as Multiple Sclerosis Treatment

(11/26, Skylar Jeremias, The Center For Biosimilars) ...The biosimilar ocrelizumab candidate (Xacrel) was found to be equivalent to the originator product (Ocrevus) in reducing the annualized relapse rate and showed comparable safety and efficacy over 96 weeks in patients with relapsing multiple sclerosis (RMS), as confirmed in a randomized trial... Full

Kentucky Attorney General Targets Another Big Pharmacy Benefit Manager in Opioid-Related Lawsuit

(11/26, Bruce Schreiner, Associated Press) ...OptumRx has been added as a new defendant in the suit that was filed two months ago, Attorney General Russell Coleman said Tuesday. His claims against Optum and its affiliated organizations are similar to those initially made against Express Scripts, which remains a defendant in the case. The Republican attorney general accused Optum of playing a central role in what he called the reckless promotion, dispensing and oversupply of opioids... Full

Proposed Rule Addresses Formulary Placement, Drug Negotiation & OOP Payment Plan

(11/26, Gabrielle Wanneh, Maaisha Osman, InsideHealthPolicy) ...For contract year 2026, CMS hopes to ensure Part D plans' formulary policies provide patients with access to generic and biosimilars, bolster transparency from plans and pharmacy benefit managers when they are working with contracted pharmacies, and add forms of dementia beyond Alzheimer's to the condition list plans must use to identify beneficiaries with multiple chronic diseases, according to a proposed policy and technical changes rule for Medicare Advantage and Part D released Tuesday (Nov. 26)... Sub. Req’d

Consolidated Lawsuit Challenges GLP Makers On Adverse Events, Marketing

(11/26, Jessica Karins, InsideHealthPolicy) ...As CMS takes a bold step by proposing Medicare and Medicaid cover GLP-1s to treat obesity as a chronic disease, over a thousand patients are simultaneously asking the courts to force GLP-1 makers to update their labels to warn of dangerous adverse events and arguing the drug makers pushed the argument that obesity is a disease and that their drugs are the proper treatment through inappropriate marketing... Sub. Req’d

Medicare, Medicaid Coverage Of Obesity Drugs Would Add $40Bn In Government Spending

(11/26, Cathy Kelly, Pink Sheet) ...A CMS proposed rule requiring Medicare and Medicaid to cover obesity drugs would cost the federal government $25bn over 10 years in Medicare and federal and state governments $15bn in Medicaid, according to the agency. The policy involves a ‘reinterpretation' of the law informed by recent advances in obesity treatments. The incoming Trump Administration will decide whether to finalize the rule... Global Sub. Full

Jim O'Neill Selected to Lead HHS Alongside RFK Jr. as Deputy

(11/26, Tara Suter, The Hill) ...President-elect Trump's choice for deputy secretary of Health and Human Services is Jim O'Neill, an investor and historically close associate of billionaire Peter Thiel, the president-elect said Tuesday. "I am very pleased to nominate Jim O'Neill to serve as the Deputy Secretary of Health and Human Services to work alongside Robert F. Kennedy Jr.," Trump said in a Tuesday statement. "He will oversee all operations and improve Management, Transparency, and Accountability to, Make America Healthy Again."... Full

How the Incoming Administration Could Impact FTC's Approach to Pharma M&A

(11/26, Kelly Bilodeau, PharmaVoice) ...Pharma leaders hoping for a friendlier merger environment after the Trump administration grabs the keys to the White House may be sorely disappointed. Once the president-elect is sworn in, the higher level of scrutiny from the Federal Trade Commission that ramped up under the Biden administration isn't likely to ease up, according to David Balto, an antitrust lawyer and former assistant director of policy and evaluation at the FTC... Full

Bristol Myers Sues HHS Over Rebate Model in Drug Discount Plan

(11/26, Nyah Phengsitthy, Bloomberg Law) ...Bristol Myers Squibb Co. is challenging a federal health agency for denying its plan to implement a rebate model for its blood thinner Eliquis to health providers that treat low-income and uninsured patients rather than through an up-front discount...Bristol Myers said, at least to start, it intended to implement the model exclusively for Eliquis, which is one of the 10 drugs selected for the first round of the Medicare Drug Price Negotiation Program... Sub. Req’d

Carter, Schmidtknecht: The Human Cost of Inaction On PBM Reform

(11/26, Buddy Carter and Bil and Shanon Schmidtknecht, Scottsdale Independent) ...The roadmap to a better, more sensible prescription drug pricing system is right before us. Break the linkage between drug prices and PBM profits. End a system where middlemen can steer patients to the drugs that generate the greatest profits for them and block access to medicines that may be best for patient health. Pay the PBMs a fair but flat market-based fee for their services and get them out of the business of conflating prescription drug access with the need to please their shareholders... Full

PBM Private Labeling: A Boon or Bane to Biosimilar Drug Makers?

(11/26, Stanton Mehr, Biosimilars Review & Report) ...Some very knowledgeable people I've spoken to believe the floodgates of adalimumab biosimilar utilization will open wide in January. I am more skeptical about the prospects. To date, none of the biosimilar makers who have not signed a deal with a PBM "pseudomanufacturer" gained any significant market share. In other words, if you're not chosen to play for one of the three teams, you may never see the ballfield... Full

Unlocking The Full Potential Of Generic Drugs For Patients

(11/26, Beth Boyer and Tanisha Carino, HealthAffairs) ...Generic drug repurposing is an underused but promising tool for finding new, affordable therapies. Creating a pull incentive can spur developers to finally explore the untapped potential in these drugs... Full

It Might Be Now or Never for the BIOSECURE Act

(11/27, John Wilkerson, STAT Plus) ...BIOSECURE has strong bipartisan support, as lawmakers look to signal that they're tough on China, and it could be added to either must-pass defense budget legislation, which is viewed as the most likely vehicle, or a government-funding bill. But if it doesn't pass this year, one of the bill's few opponents could gain leverage to potentially kill it. Sen. Rand Paul (Ky.), the ranking Republican on the homeland security committee, cast the sole vote against BIOSECURE during its March markup by that panel... Sub. Req’d

Compounding, Unapproved Drugs, and Pricing—Nothing New Here But Still a Conundrum

(11/26, Bob Pollock, Lachman Consultants) ...Having been around the block more than a few times, the position of the FDA regarding pricing is clear. The Agency is not supposed to take pricing considerations into drug approval or enforcement decisions. However, there is controversy swirling around the FDA's recent decision on the drug shortage for GPL-1 obesity medications and the practice of compounding during drug shortages... Full

FDA Updates Warning for All NSAIDs; Other Drugs to Come?

(11/26, Bob Pollock, Lachman Consultants) ...For those of you who follow the daily approvals page (here), on November 21, 2024, there was a flurry of supplemental labeling approvals listed for drug products that contain non-steroidal anti-inflammatory drugs (NSAIDs), from aspirin to Zipsor (diclofenac potassium). In today's CDER Drug Safety-related Labeling Changes (SrLC), the new, revised warning that must be included was made more obvious; see example below for indomethacin... Full

‘Hard Truths' For Sentinel: US FDA Scales Back Active Surveillance Ambitions

(11/26, Grace Moser, Pink Sheet) ...The FDA plans to focus on meeting existing mandates for its Sentinel surveillance system, rather than adding new capabilities. CDER Director Patrizia Cavazzoni attributed the decision to funding issues, saying the program had to be responsive to "the realities of our budgets." Ideally, the program will be able to scale up when needed, such as during the COVID-19 pandemic, Cavazzoni said... Global Sub. Full

Align Pharma Reform with EU's Competitiveness Focus, Says Roche Pharma Chief

(11/27, Christoph Schwaiger, Euractiv) ...The EU's pharma reform must be viewed from a fresh perspective in the context of the new EU mandate's focus on competitiveness, Roche Head of Pharma International, Padraic Ward, told Euractiv...Negotiations are still ongoing, but various industry leaders have flagged that adopting the current plans without some tweaks may undermine Europe's ability to compete on the global market... Full

Navigating The Uncharted Waters Of EU HTA

(11/26, Alexander Natz and Matias Olsen, Pink Sheet) ...Ground breaking new procedures in Europe for assessing the relative effectiveness of new drugs at an EU-level are due to go live from January 2025 and companies must be ready. In this article, The European Confederation of Pharmaceutical Entrepreneurs' Alexander Natz and Matias Olsen set out what companies need to know, from understanding which new oncology products will be exempt from the assessments and how best they can engage clinician and patient experts in line with conflict of interest rules... Global Sub. Full

How India Can Catch the Next Wave of Growth in Biosimilars, Biologics, and Vaccines

(11/27, Manoj Panicker, Hindustan Times) ...India's biopharma industry is primed to expand into biosimilars, biologics, and vaccines and is ready to solidify its global influence. Through concerted efforts in research and development, infrastructure development, innovation ecosystems, regulatory compliance, industry expansion, and talent development, India can chart a path to sustainable growth and continue to cement its position as a key player in the global pharmaceutical landscape... Full

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