Wednesday, April 3, 2024

Biden and Senator Sanders to Highlight Efforts Lower Cost of Asthma Inhalers

(4/3, Jarrett Renshaw, Reuters) ...U.S. President Joe Biden will host a White House event with U.S. Senator Bernie Sanders on Wednesday to highlight their efforts to cut the cost of inhalers for asthma suffers. Sanders and other lawmakers in January criticized four manufacturers of inhalers sold in the U.S. — AstraZeneca, Boehringer, Teva Pharmaceuticals, and GSK, — over prices that were much higher in the U.S. than in other countries... Full

Biden, Sanders to Take Victory Lap After Drugmakers Cap Cost of Inhalers

(4/3, The Hill) ...The president, alongside Sen. Bernie Sanders (I-Vt.), will give remarks at the White House to highlight the crackdown on the cost of inhalers. They will also be joined by health care advocates and experts, according to a White House official...The announcements also came after Sanders earlier this year led a letter from a group of Senate Democrats to the CEOs of the four biggest manufacturers of inhalers sold in the United States — AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Teva — demanding information and documents on the costs involved in the manufacturing of inhalers, among other issues... Full

UroGen Pharma Files Patent Infringement Action Against Teva Pharmaceuticals

(4/3, UroGen Pharma Ltd.) ...UroGen Pharma Ltd., a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 ("the '074 patent") and 9,950,069 ("the '069 patent"). Both patents are listed in the U.S. Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) for JELMYTO® (mitomycin) for pyelocalyceal solution... Full

Teva, Viatris Revive Patent Challenge On J&J's Long-Acting Schizophrenia Blockbuster Invega Sustenna

(4/2, Fraiser Kansteiner, Fierce Pharma) ...After incurring a loss in New Jersey federal court in 2021, Teva and Viatris have successfully resurrected challenges to the last remaining U.S. patent on a lucrative Johnson & Johnson schizophrenia drug. On Monday, the U.S. Court of Appeals for the Federal Circuit sided with Teva and Viatris' argument that the last FDA-registered patent on Invega Sustenna, dubbed the ‘906 patent, may be invalid... Full

Federal Court Gives Teva and Viatris Another Chance to Invalidate J&J's Last Patent for Invega Sustenna

(4/2, Katherine Lewin, Endpoints News) ...Johnson & Johnson only has one last patent covering its long-acting blockbuster schizophrenia drug Invega Sustenna, and now Teva and Viatris have another opportunity to challenge it following a federal circuit panel decision...Teva's representative said that it's looking forward to providing the drug to patients "as soon as possible" and that it's "pleased" with the court's decision, "affording us the opportunity to prove Janssen's patent is invalid."... Full

Teva Wins Fed Circ Appeal Over J&J's Schizophrenia Drug

(4/2, Sarah Speight, Life Sciences Intellectual Property Review) ...The decision gives appellants Teva Pharmaceuticals and Mylan Laboratories (now part of Viatris) a fresh chance to launch their own generic versions. In its decision delivered yesterday, April 1, the US Court of Appeals for the Federal Circuit vacated and remanded a lower court's decision to grant validity to Janssen's last remaining Orange Book patent for Invega Sustenna, used to treat schizophrenia in adults... Full

Teva, Viatris Again Challenge J&J Patent for Schizophrenia Drug with Appeals Court Win

(4/2, Tristan Manalac, BioSpace) ...The case will now go back to a New Jersey federal court, where Teva will have another chance to make its case that J&J's patent, which protects a certain dosing regimen of Invega Sustenna, is invalid because it is obvious to experts knowledgeable in the field. "The district court will need to reassess the significance of the secondary considerations as part of its renewed obviousness analysis," Monday's ruling stated. If Teva ultimately emerges victorious, it could open Invega Sustenna up to generic competition, which in turn could lower drug prices for patients... Full

Teva and Launch Thera to Work Together On Respiratory Candidate

(4/2, The Pharma Letter) ...A new collaboration has been agreed between Israel's Teva Pharmaceutical Industries and Launch Therapeutics, related to the candidate TEV-248, which combines fluticasone and albuterol. A short-acting beta-agonist, the candidate is being developed for adults and children, to be delivered via Teva's proprietary breath-activated, multi-dose dry powder inhaler...At the same time as the new research collaboration, Teva has announced a strategic funding from Abingworth, part of global investment firm Carlyle... Sub. Req'd

CNN Exclusive: Adderall Prescriptions Have Been Filled Less Often Amid Ongoing Shortage in the US

(4/2, Deidre McPhillips, CNN) ...In an exclusive analysis for CNN, data from the health data platform Truveta shows that the prescription fill rate for amphetamine/dextroamphetamine medications fell from nearly 49% in October 2022 to a low of less than 41% in February 2023. Overall, the average monthly prescription fill rate was 11% lower in the first half of 2023 than it was in the first half of 2022, and it did not show steady signs of improvement through the end of 2023... Full

More Americans Forgoing ADHD Meds As Shortages Drag On

(4/3, Tina Reed, Axios) ...The drop is "quite striking," said Truveta vice president of research Nick Stucky, whose team analyzed de-identified records of more than 336,000 ADHD patients...Patients struggling to find ADHD drugs have aired their frustrations in thousands of comments filed to the Federal Trade Commission, which is studying possible factors driving shortages. "I have not been able to fill my prescription at any pharmacy I've been to including Costco, CVS, Publix, Walmart, and local discount pharmacies," wrote a man who identified himself as a medical student in the Miami area... Full

Eli Lilly's Popular Diabetes Drug Mounjaro to Face Continued Supply Squeeze Through April, FDA Says

(4/2, Zoey Becker, Fierce Pharma) ...The FDA on Monday extended its estimated shortage duration for the drug in its 15-mg, 12.5-mg, 10-mg and 7.5-mg dose strengths to reflect "limited availability" through the end of this month. The shortage for several strengths was previously expected to persist through March... Full

Zepbound Pen Shortage Has Patients Clamoring for Vials of Drug

(4/2, Madison Muller, Bloomberg Law) ...Zepbound isn't in short supply because there's a lack of medicine — but rather the pre-filled pens that patients use to inject the right dose of the drug...But there's another way to administer the drug: Lilly could ditch the pen and sell Zepbound in vials. That would require patients to fill a syringe on their own, but ease the drugmaker's production woes. Lilly is already turning to vials outside the US, and increasingly popular compounded versions of the drug also come packaged that way... Sub. Req'd

US FDA Approves Vanda's Drug for Treatment of Bipolar Disorder

(4/2, Christy Santhosh and Vaibhav Sadhamta, Reuters) ...The U.S. FDA approved Vanda Pharmaceuticals' drug to treat manic and mixed episodes associated with a type of bipolar disorder, the company said on Tuesday, marking the second approval for the treatment...Fanapt, which was initially approved in 2009 as a treatment for schizophrenia, faces a potential loss of exclusivity in 2027. The decision could help revive prescriptions for Fanapt, which has seen sales declining in recent quarters due to increased competition... Full

Ipca Strikes Biosimilar Technology Transfer Amid Rising Ambitions In The Space

(4/2, Dean Rudge, Generics Bulletin) ...Ipca Laboratories has entered into a technology transfer agreement with fellow Indian firm Omexa Formulary, granting Omexa non-exclusive rights to research, develop, manufacture and market an oncology biosimilar for the global market. "This agreement shall enable Omexa to develop this anti-cancer biosimilar from early stage of development to clinical trials and subsequent commercial launch," Ipca noted, adding that it would also "strengthen Omexa's capability of biosimilar development."... Global Sub. Full

Apotex to Acquire Searchlight Pharma, a Canadian Specialty Branded Pharmaceutical Leader

(4/2, Apotex) ...For nearly five decades, Apotex has leveraged its strong Canadian footprint into adjacent verticals, and building on its recent transaction with Harrow, Inc. for the exclusive rights to certain branded ophthalmic products, with the addition of Searchlight, is positioned to become the partner of choice for pharmaceutical licensing and acquisition opportunities in the Americas. The acquisition further accelerates Apotex's growth within the specialty branded pharmaceutical market, adding a diverse portfolio of over 60 products and a full-service branded pharmaceutical platform, as well as established business development networks in Canada and internationally... Full

Pharma is Betting Big On Connecting Potential Patients to its Medications. It's Just The Beginning

(4/2, Beth Snyder Bulik, Endpoints News) ...There are nearly a dozen pharma brand websites with direct telehealth links, by Endpoints' count. Along with Lilly, AstraZeneca and Phathom, Pfizer and AbbVie offer "talk to a doctor now" options for oral migraine drugs Nurtec and Ubrelvy, respectively. Two GI drugmakers, Salix with Trulance and AbbVie and Ironwood with Linzess, also offer telehealth connections, as does Currax Pharmaceuticals for its prescription weight loss med Contrave. Experts agree the adoption of telehealth in pharma is still in its early stages, and also that it's not for every biopharma company or health condition... Full

Additional Drugmakers Flag Risks Of Working With WuXi Amid Heightened US Scrutiny

(4/2, Jared Whitlock and Zachary Brennan, Endpoints News) ...More drug companies are disclosing the potential for clinical trial delays and drug shortages if the US government blacklists a family of WuXi companies used across the biopharma industry. The disclosures come from companies large and small, including Merck, Cabaletta Bio and Kyverna Therapeutics. Through securities filings, Endpoints News identified nearly three dozen companies that rely on WuXi and have flagged the risk of a crackdown... Full

Aurobindo's Eugia Recalls One Lot of Muscle Relaxant Because of Possible Contamination

(4/2, Joseph Keenan, Fierce Pharma) ...Eugia, a unit of India's Aurobindo, issued a voluntary recall of one lot of methocarbamol injection after a customer complained about finding white particles inside a vial...The company said it hasn't received any reports of patient problems related to the recall. Methacrarbamol is typically used to treat discomfort related to musculoskeletal conditions... Full

More Providers Could Start Offering the Generic Version of Expensive Treatments for Things Like Cancer

(4/2, Kaylyn Izzo, ABC News 10) ...We know that generic drugs are designed to work the same way as name brand drugs, but for a lower price. An emerging group of medications called biosimilars are aiming to do the same thing for biologic drugs..."If you think about all the money that the U.S. healthcare system spent on all drugs, all simple molecules, all generics, every medicine— biologic medications accounted for almost half of that. And not that many people take these biologic medicines," said Fran Gregory, the vice president of emerging therapies at Cardinal Health. "This is kind of why biosimilars have come to market. They cost on average, about 50% less than reference products or brand products, but some can cost up to 85% less."... Full

US Takes Next Step in Medicare Drug Price Negotiations with Pharma Companies

(4/2, Ahmed Aboulenein, Reuters) ...The Biden administration said on Tuesday it has responded to offers from the manufacturers of 10 high-cost drugs selected for the U.S. Medicare program's first-ever pricing negotiations, but provided no details... Full

US Responds to Drugmakers' IRA Counteroffers as Medicare Price Negotiations Continue

(4/2, Nicole DeFeudis, Endpoints News) ...CMS wants further discussions with pharma companies that are participating in IRA price negotiations, HHS announced on Tuesday. The agency said it has responded to counteroffers proposed by all of the participating manufacturers, but declined to comment further. According to CMS' guidelines, the agency will now hold up to three negotiation meetings with the companies before negotiations end Aug. 1. Drugmakers have largely kept quiet about the talks. Endpoints News reached out to participating companies on Tuesday, all of which declined to comment or did not respond... Full

The White House Has a Plan to Stem Drug Shortages

(4/2, John Wilkerson, STAT Plus) ...The White House at long last published a plan to stem drug shortages, and it involves basing Medicare pay to hospitals on whether hospitals adopt business practices that avoid shortages...The plan would create two nongovernmental organizations that the government would accredit. One would rate drugmakers on how well they maintain resilient supply chains. The other would rate hospitals on their performance... Sub. Req'd

Biden Plan Calls for Hospitals to Pay More for Drugs to Head Off Shortages

(4/2, Riley Griffin, Bloomberg) ...US health officials met with congressional leaders Tuesday to lay out their vision for legislation that would set standards for hospitals to follow when purchasing medicines, including key generic drugs. Costing as much as $5.11 billion over 10 years, the plan aims to pressure the market to ensure Americans have reliable supplies of high-quality medicines...The administration wants to "address the market failure that currently exists, which is that there is no entity that's accountable to supply chain," Neera Tanden, President Joe Biden's domestic policy adviser, said in an interview... Full

HHS Releases White Paper Focused on Preventing Drug Shortages

(4/2, U.S. Department of Health and Human Services) ...Today, the U.S. Department of Health and Human Services released a white paper highlighting steps HHS has taken to prevent and mitigate drug shortages and proposing additional solutions for policymakers to consider...With today's white paper, HHS offers solutions and stands ready to work with Congress to ensure no patient faces the devastating consequences of drug shortages or goes without needed medicines... Full

Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States

(4/2, Office Of The Assistant Secretary For Planning And Evaluation) ...This paper describes policy concepts for consideration, including collaboration with the private sector to develop and implement a Manufacturer Resiliency Assessment Program and a Hospital Resilient Supply Program...This paper focuses on generic sterile injectable medicines used in inpatient settings, given their importance to acute inpatient care, and their relative risk of supply disruptions—though HHS recognizes that these challenges affect other products, and therefore, the solutions described here may be applicable in other markets... Full

America's Life-Threatening Drug Shortages Reach Record Highs

(4/2, Jeff Ferry, The Washington Times) ...The problem is not with branded prescription drugs, where treatments can cost thousands of dollars a month. America's drug shortage problem is with generic medicines and some over-the-counter medicines. These products are now so inexpensive that supply is overly dependent on only a few sources, most of which are offshore. The long-term solution is to ensure there are enough suppliers and enough redundancy in the system to eliminate shortages. However, the immediate problem is reducing America's dependence on China and India. Ms. Tenney's PILLS Act would be a good start to address this... Full

Editorial: Probe Medicine Shortage

(4/3, The Intelligencer) ...News that the Federal Trade Commission is launching a probe of companies that help buy and distribute the bulk of medicines sold to U.S. hospitals is welcome — and hopefully will unravel and inject transparency into a procurement and maintenance process upon which few Americans reflect until they are affected directly by a medicine not being available. Hopefully, what is uncovered will help end medicine shortages or reduce them dramatically, when stacked against supply records compiled perhaps a decade or two ago...The inquiry will be shining a spotlight on a little-noticed corner of the drug-supply chain — the "drug middlemen," as FTC Chair Lina Kahn described them... Full

Biden Summons Bernie Sanders to Help Boost Drug-Price Campaign

(4/3, Dan Diamond, The Washington Post) ...Biden and Sanders plan to discuss their joint efforts to lower the out-of-pocket cost of inhalers for tens of millions of Americans who rely on the devices to treat asthma and other conditions, speaking to an audience of about 75 health policy experts and advocates, according to White House officials who previewed the remarks. Wednesday's event is part of a broader election-year push by Biden to highlight Democrats' efforts to lower drug prices, including a law that caps seniors' out-of-pocket costs at $2,000 a month starting next year and a Federal Trade Commission crackdown on drug industry patents that they say have stifled competition... Sub. Req'd

Sanders' Pressure On Novo Nordisk Fuels Ozempic Pricing Debate

(4/3, Nyah Phengsitthy, Bloomberg Law) ...Novo Nordisk Chief Executive Officer Lars Fruergaard Jørgensen has yet to publicly respond to Sanders' (I-Vt.) request to meet this week after the Senate Health, Education, Labor, and Pensions Committee chairman called on the Danish drug company to lower the list price of its drug Ozempic, a weekly injectable used to treat diabetes..."It's just a piece of the pricing pressure that is building," said Ted Kyle, principal and founder of ConscienHealth, a group that works to advance approaches to health and obesity. "The combination of political pressure and market forces will sooner or later, without a doubt, lead to adjustments in the prices. The timing on that, though, is unpredictable," Kyle said... Full

Bernie Sanders: Novo Nordisk's New Weight-Loss Drug "Ozempic" Could Cost $1 Per Month

(4/2, Tim Hains, RealClearPolitics) ...MSNBC's Ana Cabrera reports on a new study suggesting Wegovgy and Ozempic could be profitably manufactured in bulk at a cost of about $1 per month per patient...[Bernie Sanders] My reaction to the study is that Novo Nordisk has got to substantially lower the price they're charging Americans for two reasons. Number one, you're going to have millions of Americans who are dealing with diabetes, dealing with obesity, not being able to afford this medicine that could really help them. And number two, Ana, if we don't get a handle on this price, Medicare and Medicaid are going to be spending enormous sums of money which are going to pull back on the taxpayers of this country... Full

Medicare Coverage of Weight Loss Drugs Could Save the U.S. Billions of Dollars

(4/3, Dana P. Goldman and Alison Sexton Ward, STAT) ...There is something government can do. It could begin by allowing coverage of weight loss drugs in Medicare Part D plans and Medicare Advantage plans. Research at the USC Schaeffer Center, which we are affiliated with, shows that Medicare coverage of weight loss therapies alone — with no additional impacts on private insurance coverage — would generate almost $1 trillion in social benefits over the next 10 years. If private insurance were to follow Medicare's lead, as it often does, the benefits would be even greater, as people would be able to treat their obesity before it leads to costly chronic health conditions... Full

Matrix Global Advisors Touts Biosimilar Interchangeability Proposal in Biden Administration Budget – SSR Health: Biosimilar Competition Leads to Significant Decline in Net Prices on Brand Humira

(4/2, PCMA) ...Recently, Alex Brill, founder and CEO of Matrix Global Advisors, published a new blog, "Biden Budget Proposes a Step Toward Biologic Drug Competition," highlighting how the proposed budget will help bring more biosimilars to market. Brill writes: "Specifically, the President's budget proposes eliminating the two-tiered approval of biosimilar drugs (competitors to branded biologic "reference" drugs) by ending the interchangeability designation and deeming all approved biosimilars to be interchangeable with their reference biologic”... Full

PBM Rebate Schemes to Suppress Biosimilar Humira Cost U.S. Patients $6 Billion

(4/2, Biosimilars Council) ...Today, the Biosimilars Council, the leading trade association representing manufacturers of biosimilar medicines, released a new analysis of IQVIA data revealing health plans and patients missed out on savings up to $6 billion as a result of rebate schemes by pharmacy benefit managers. The report highlights the strategy created by pharmacy benefit managers to protect $2 billion in profits by suppressing adoption of lower-cost versions of the brand drug Humira®, once the best-selling drug in the world... Full

FDA Turns Attention to Data Integrity Lapses at Testing Sites in New Guidance

(4/2, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration has issued a draft guidance outlining how manufacturers can ensure the data integrity of bioavailability and bioequivalence studies to support investigational new drug application, new drug applications, and abbreviated new drug applications, and certain biologic license applications... Full

FDA Tells Congress What It Wants, What it Really Really Wants (It Really Really Really Wants a Zigazig-Ah)

(4/3, Sara W. Koblitz, FDA Law Blog) ...In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients...Finally, in response to the GSK and Teva litigation, FDA continues to ask for a legislative fix. Specifically, FDA asks to add a "safe harbor" from patent infringement liability for applicants for generic applicants marketing with a "skinny label" due to Agency concern that induced infringement litigation threats will impact the "timely availability" of generic drugs... Full

Prescription Drug Affordability Boards Do More Harm Than Good

(4/2, Jen Laws, Chicago Sun Times) ...State lawmakers across the country are telling patients they're working to reduce out-of-pocket costs for prescription drugs. However, in response to calls to better serve patients, many states are looking to use an unproven tool that simply is not going to get the job done and could worsen challenges patients face today to access medications... Full

EU Rules Drive Pharma Backers to the US, Says Irish Investment Chief

(4/3, Jude Webber and Andy Bounds, Financial Times) ...Michael Lohan, chief executive of IDA Ireland, the foreign direct investment promotion agency, told the Financial Times that new rules proposed by Brussels last year risk further widening the gap between the US and the EU when it comes to cutting-edge technologies. While the US regulatory system "has become more agile, more responsive", he said, "the European system, one could argue, has moved in the opposite direction"... Full

EU Regulators Explain How To Ensure Transitioned Trials Align With CTR

(4/2, Vibha Sharma, Pink Sheet) ...Members of the EU's Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents. EU regulators have issued guidance explaining what the next steps are for sponsors who moved their ongoing studies that were approved under the erstwhile Clinical Trials Directive to the Clinical Trials Information System on the basis of a "minimum dossier."... Sub. Req'd

Proposed EU HTA Methods Pose Challenges For Cancer Therapies, Warns EFPIA

(4/2, Eliza Slawther, Pink Sheet) ...Proposed methods for conducting EU-level joint clinical assessments could result in such a broad range of comparator therapies that companies are unable to fulfill scoping requirements, according to a report commissioned by industry federation EFPIA. Guidelines for implementing forthcoming EU-level joint clinical assessments "do not offer the required flexibility and pragmatism" to address the challenges posed by "highly dynamic" disease areas such as oncology, warns the R&D-based pharmaceutical industry body EFPIA... Sub. Req'd

Reports Claiming Significant Rise in Medicine Prices Are Misleading: Ministry of Health

(4/3, ANI) ...The Government has debunked media reports that medicine prices will witness a significant hike by up to 12 percent from April 2024, the Ministry of Health and Family Welfare clarified that these reports of price hikes are fake and misleading...The statement by the Ministry clarified that the NPPA's measures to regulate medicine prices ensure that citizens can continue to access essential medications without experiencing any significant financial burden... Full

Australia Cuts Regulatory Burden Of Product Recalls

(4/2, Ian Schofield, Pink Sheet) ...The Australian government is beginning the second phase of a reform program intended to reduce the regulatory burden on drug and medical device companies when carrying out product recalls while retaining a "strong emphasis on public safety." More flexible reporting timelines, greater clarity on the requirements for immediate recalls, and the removal of outdated guidance are among the changes that have been made to the Uniform Recall Procedure for Therapeutic Goods... Sub. Req'd

China's First Biosimilar Ozempic Drug Applies for Approval

(4/3, Andrew Silver, Reuters) ...Hangzhou Jiuyuan Gene Engineering said on Wednesday in a post on its official social media account that the application for the drug it calls Jiyoutai was for usage to control blood sugar in patients with type 2 diabetes. An approval of Jiyoutai would make the injectible China's first locally developed biosimilar semaglutide drug. A biosimilar drug has a structure that closely mimics an existing drug but is not exactly alike... Full

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