Tuesday, April 23, 2024

U.S. Supreme Court Rejects Vanda Pharmaceuticals Case Over Sleep-Drug Patents

(4/22, Blake Brittain, Reuters) ...The U.S. Supreme Court on Monday declined to hear a bid by Vanda Pharmaceuticals to revive patents for its sleep-disorder drug Hetlioz that were previously declared invalid in a dispute with generic drugmakers Teva and Apotex...A Teva spokesperson said that the company was pleased with the Supreme Court's action. Representatives for Apotex did not immediately respond to a request for comment... Full

Supreme Court Denies Vanda's Petition in Hetlioz Patent Case Against Teva

(4/23, Tristan Manalac, BioSpace) ...The U.S. Supreme Court will not hear Vanda Pharmaceuticals' petition in its patent case against Teva Pharmaceuticals regarding its sleep-wake disorder drug Hetlioz (tasimelteon), according to an order list published Monday...Vanda filed its lawsuit in 2018 after Teva announced that it had submitted an Abbreviated New Drug Application to the FDA for a generic version of Hetlioz. At the time, Teva told Vanda that many of its patents covering Hetlioz are "invalid, unenforceable and/or will not be infringed." However, Vanda alleged that Teva had infringed these patent protections... Full

US Supreme Court Rejects Vanda's Bid to Revive Patents On Sleep Disorder Drug Hetlioz

(4/22, Fraiser Kansteiner, Fierce Pharma) ...Vanda first sued Israeli-American pharma Teva and Canada-based Apotex in Delaware back in 2018, alleging the generic drug makers had tread on certain Hetlioz patents after applying to make copycats of the med, which was first approved by the FDA in 2014 to treat non-24-hour sleep-wake disorder...Vanda's total 2023 revenues clocked in at $192.6 million, of which Hetlioz sales accounted for slightly more than 50%. Vanda's Monday share price was down about 4.3% on news of the Supreme Court rejection. Meanwhile, this marks the second major setback for Hetlioz this year... Full

The Comeback Begins? Positive Signs Seen For Humira Biosimilars In US

(4/22, David Wallace, Generics Bulletin) ..."In our view, the optics of Cordavis continuing to pick up share shows there is now a formula to quickly take a good chunk of market share away from AbbVie/branded Humira," Deutsche Bank suggested. The analyst said this was "particularly pressing since Alvotech's Simlandi (adalimumab-ryvk) launch is also looming." Partner Teva plans to introduce the interchangeable 100mg/ml biosimilar imminently. Alvotech has in the last few days announced that it and Teva have signed a "long-term agreement with a strategic partner" to "further enhance access to adalimumab-ryvk in the US market."... Global Sub. Full

ADHD Drugs: FDA Commissioner Blames Inappropriate Prescribing For Shortages

(4/22, Sue Sutter, Pink Sheet) ...Rep. Ashley Hinson, R-IA, asked about ongoing shortages of amphetamine-containing medicines that are used to treat ADHD, such as Teva Pharmaceutical Industries Ltd.'s Adderall (mixed salts of a single-entity amphetamine product) and Takeda Pharmaceutical Co. Ltd.'s Vyvanse (lisdexamfetamine) and their generic versions...The ADHD drug shortages reveal a challenge "at the intersection of regulatory oversight, market dynamics, and then of course, the manufacturing side as well," Hinson said... Sub. Req'd

European Commission Gives Nod to Sandoz's Biosimilar to Treat Autoimmune Disorders

(4/23, Financial Express) ...Sandoz, a key player in generic and biosimilar medicines, announced that the European Commission has granted marketing authorization for Pyzchiva (biosimilar ustekinumab), developed and registered by Samsung Bioepis. According to the company's statement, Pyzchiva is a key biosimilar value driver for the company over the mid-term and this approval is a major step in advancing Sandoz growth strategy... Full

Samsung Bioepis Initiates Phase 3 Clinical Trial for Proposed Pembrolizumab Biosimilar

(4/22, Ashley Gallagher, Pharmacy Times) ...Samsung Bioepis announced the initiation of a phase 3 clinical trial for SB27, a proposed biosimilar referencing pembrolizumab (Keytruda; Merck), according to a press release from the company. "We are thrilled to announce the initiation of [a] phase 3 clinical trial for SB27, after our successful phase 1 clinical trial initiation in February 2024," Ilsun Hong, vice president of Product Evaluation Team Leader of Samsung Bioepis, said in the press release... Full

Novartis Surges After Forecast Boost Beats Expectations

(4/23, Naomi Kresge, Bloomberg) ...Novartis is pushing for growth after years of successive revamps as Chief Executive Officer Vas Narasimhan cut jobs and spun off units. The new forecast is "a significant positive surprise" that offers "much needed hopes for a return to beat-and-raise," Peter Welford, an analyst at Jefferies, wrote in a note...A more favorable outlook on coming competition from generic drugs is responsible for about a third of the upgrade, Chief Financial Officer Harry Kirsch said... Full

Endo's Par Pharma Issues Recall of Blood Pressure Med Over Possible Contamination

(4/22, Joseph Keenan, Fierce Pharma) ...Par has issued a voluntary recall of seven lots of the injectable high blood pressure medication treprostinil due to the possible contamination of silicon particles in the solution. Treprostinil for injection, which is approved for pulmonary arterial hypertension, is a generic to United Therapeutics' Remodulin, which has been marketed for over 20 years... Full

Eli Lilly to Acquire Manufacturing Facility from Nexus Pharma

(4/22, Christy Santhosh, Reuters) ...Eli Lilly said on Monday that it will acquire a manufacturing facility from Nexus Pharmaceuticals to produce injectable medicines. Lilly expects production at the facility based in Pleasant Prairie, Wisconsin, to begin at the end of 2025...Soaring demand for GLP-1 agonists, a class of highly effective diabetes and obesity drugs which suppress appetite and promote a feeling of fullness, has led to constrained supply for drugmakers such as Lilly and Danish drugmaker Novo Nordisk... Full

Sanofi to Pay $100 Million to Settle Zantac Cancer Lawsuits

(4/22, Jef Feeley, Bloomberg) ...Sanofi will pay more than $100 million to settle about 4,000 lawsuits accusing the French drugmaker of failing to warn users that its Zantac heartburn medicine could cause cancer, according to people familiar with the deal. The settlement was announced earlier this month, but the amount was not made public at that time... Full

Cardinal Health Loses OptumRx Contract to McKesson

(4/22, Katherine Lewin, Endpoints News) ...Cardinal Health's distribution contract with pharmacy benefit manager OptumRx will expire at the end of June and it will not be renewed, the company said. McKesson has won the contract, investment bank Leerink Partners said in a note on Monday. Leerink analysts said they confirmed with management that McKesson won the contract, which begins July 1. Analysts added that the contract gives McKesson "additional drug volumes and earnings growth" and "more cushion for long-term growth."... Full

Mark Cuban Cost Plus Drug Company and Vivid Clear Rx Team Up to Increase Access to Low-Priced Prescriptions

(4/22, Vivid Clear Rx) ...Now, eligible Vivid Clear Rx members have direct access to purchase affordable prescriptions and have them shipped through Cost Plus Drugs using their pharmacy benefit plan. Cost Plus Drugs' online pharmacy provides individuals with complete transparency into the drug pricing process. All medications are priced at cost with a 15% markup. Similarly, Vivid Clear Rx also provides transparent pricing, offering a 100% pass-through model and no spread pricing or hidden fees. By collaborating together, Cost Plus Drugs and Vivid Clear Rx aim to control drug costs for health plans and patients nationwide... Full

Sustainable Biosimilar Markets Achieve Widespread Market Uptake Through Collective Action

(4/22, Cameron Santoro, The Center For Biosimilars) ...Despite current challenges in biosimilar market growth due to stakeholder disagreements, a recent commentary proposes that applying collective action theory can achieve widespread biosimilar market uptake by fostering collaboration for long-term benefits. Collective action theory was a proposed solution for stakeholder disagreements stalling biosimilar uptake because it fosters collaboration and achieves widespread biosimilar use for long-term benefits... Full

Drug Price Program Legal Fight Shifts Focus to Property Rights

(4/23, Nyah Phengsitthy, Bloomberg Law) ...A recent US Supreme Court ruling on landowner property fees is getting drawn into the fight against a government drug price-setting program as drugmakers seek out additional defense against the negotiation scheme...The pharmaceutical giants have long argued the price-setting scheme violates the takings clause enshrined in the Fifth Amendment because it seizes their property without paying just compensation. Their patented drugs are "protected from uncompensated takings," they say... Sub. Req'd

PBMs Highlight Rural Partnerships Amid Continued Calls For Reform

(4/22, Gabrielle Wanneh, InsideHealthPolicy) ...While the leading lobbying group for pharmacy benefit managers highlights the role of PBMs in rural pharmacy access, pharmacists' groups remain steadfast in urging Congress to pass comprehensive legislation that would prohibit PBMs from engaging in business practices they say lead to higher prescription drug costs for patients and payers and pose a threat to the sustainability and operations of independent community pharmacies... Sub. Req'd

Refreshed Drug Discount Dispute Process to Face Wave of Claims

(4/22, Nyah Phengsitthy and Ian Lopez, Bloomberg Law) ...The HHS's Health Resources and Services Administration's new swing at an administrative dispute resolution process for the federal 340B drug discount program seeks to lay out an administratively feasible and timely process for manufacturers and health-care providers. The revised action comes after the Biden administration pulled the plug on a previous resolution process put forth by the Trump administration... Full

Trump Surrogates Hint at How He Could Reshape U.S. Health Care Policy

(4/23, Sarah Owermohle, STAT) ...STAT spoke with six former officials and people close to Trump's orbit who emphasized his interest in reshaping Medicare's drug pricing policies and taking on ACA markets, but downplayed a renewed "repeal and replace" threat... Full

FDA Outlines Its Role As Drug Shortages Reach All-Time High

(4/22, Urte Fultinaviciute, Generics Bulletin) ...The FDA's Drug Shortage Staff said it aims to resolve long-term, not just short-term, issues with drug supplies, as the country sees the highest-ever levels of drug shortages. The ongoing drug shortage crisis in the US has reached new heights. In the first quarter of 2024, 323 medicines were in short supply, making it the highest level since 2001 or when the American Society of Health-System Pharmacists started tracking these trends... Global Sub. Full

Government Price Setting Won't Help Patients in Illinois

(4/22, Stami Williams, PhRMA) ...Patients in Illinois face high health care costs and coverage barriers, but a price-setting board like the one proposed in HB 4472 is not the solution...PDABs in Maryland and Colorado are spending millions of dollars creating new bureaucratic positions and red tape — without helping one patient or saving one cent since 2019. Illinois shouldn't be another open checkbook along the way to waste funds on misguided schemes. Several patient groups across the country have publicly shared their concern that PDABs may reduce access to medicines... Full

Dem Lawmakers Push for Action On Prescription Drug Board Bills

(4/22, Kyle Davidson, Michigan Advance) ...Four Democratic House members are renewing the call for action on prescription drug affordability, sharing support for three bills awaiting action on the House floor. During a Friday town hall in Royal Oak, state Reps. Sharon MacDonell (D-Troy), Natalie Price (D-Berkley), Helena Scott (D-Detroit) and Regina Weiss (D-Oak Park) spoke in favor of creating a prescription drug affordability board, which would be able to set upper limits on drug costs in the state... Full

EU Countries Offered Funding To Contribute to African Regulatory Strengthening

(4/22, Ian Schofield, Pink Sheet) ...More support for regulatory strengthening in Africa has come after the European Medicines Agency published a call to EU countries asking them to help build up national and regional systems in Africa and get the new African Medicines Agency off the ground. The EMA has a total budget of €450,000 ($480,000) available to offer EU regulators grants to train African regulatory personnel across the whole medicines lifecycle, from development through market authorization to post-marketing surveillance... Sub. Req'd

High-Priced Drugs and Little Evidence is a ‘Toxic Combination'

(4/23, Jessica Davis Plüss, Swissinfo.ch) ...As the global debate intensifies over whether multi-million-dollar drugs are worth the money, big pharma needs to improve transparency over the pricing and therapeutic value of potentially life-saving new medicines, says law and medicine expert Kerstin Noëlle Vokinger... Full

Pharma Companies Need to Explore Various Pricing Strategies for Optimum Utilisation of Patent-Cliff: DoP Study

(4/23, Pharmabiz.com) ...Indian pharma companies need to explore various pricing strategies to ensure optimum returns while coming up with generic drugs to utilise the patent cliff opportunities where over 20 drugs with sales worth $251 billion are going off-patent in the current decade, according to a study by the Department of Pharmaceuticals (DoP)... Full

DoP Study Asks Indian Companies to Address Challenges to Grab $251 Billion Opportunities from Patent Cliff

(4/22, Pharmabiz.com) ...The study observes that in the years between 2022-30, the pharmaceutical sector in India will undergo landmark changes as a number of drugs are expected to go off-patent and provide an opportunity for the entry of generic products. Expiry of patents is very promising for the Indian generic drug market as it is expected to expand and grow further with inclusion of these new drugs... Full

Import Alerts, Warning Letters, Drug Recalls — Why ‘Pharmacy to the World' is Facing US FDA Heat

(4/23, Sumi Sukanya Dutta, ThePrint) ...These observations, according to the FDA, are made when investigators come across conditions or practices indicating that any food items, drugs, devices or cosmetics have been adulterated. Additionally, action is also initiated, if in their judgment, these products are being prepared, packed, or held under conditions in which they might become adulterated or rendered injurious to health... Full

Hungary Wants New Approach to Manage Growing Drug Shortages

(4/22, Zsolt Kopári, Euractiv) ...Hungary's Minister of State for Health, Péter Takács, has said a new approach is needed to allow Hungary to choose medicines better suited to the national health budget...Addressing medicines shortages, the State Secretary underlined, "Although the pharmaceutical package contains good suggestions, there cannot be a safe supply of medicines without strong European manufacturing capacities, and especially active ingredient manufacturing capacities. We therefore expect further actions taken by the Commission."... Full

GP with Chronic Migraine Pushes for Greater Power to Prescribe Medicare-Subsidised Medication

(4/22, Daniel Miles, ABC News) ...GP Andrew Leech wants primary care doctors to have access to injectable migraine prevention medications like Ajovy. Dr Leech says prescribing restrictions and long waits to see neurologists are causing painful wait times for sufferers. What's next? The Health Department says initial Ajovy prescriptions are handled by specialists, but subsequent care can also be managed by Gps... Full

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