Tuesday, June 25, 2024

Teva Launches Generic Version of Novo Nordisk's Diabetes Drug Victoza

(6/24, Mariam Sunny, Reuters) ...Teva Pharmaceuticals said on Monday it had launched a generic version of Novo Nordisk's Victoza to treat patients with type 2 diabetes, making it the first generic GLP-1 drug in the United States where the drug class has seen overwhelming demand... Full

Teva Pharmaceuticals Launches Generic Version of Diabetes Drug

(6/24, Dean Seal, Dow Jones) ...The company said Monday that its generic liraglutide medication injection is the U.S. marketplace's first-ever generic GLP-1, a class of drugs that have recently become popular for weight-loss and related uses. Teva said its new injectable can be used to treat type 2 diabetes by helping lower blood sugar in adults and children over the age of 10... Full

Generic Liraglutide (Victoza) Becomes First Generic GLP-1 Receptor Agonist

(6/24, Abigail Brooks, HCPLive) ...Teva Pharmaceuticals has announced the launch of an authorized generic of liraglutide (Victoza) in the United States for patients with type 2 diabetes, making it the first-ever generic glucagon-like peptide-1 (GLP-1) receptor agonist...According to a release from Teva, liraglutide had annual sales of $1.656 billion as of April 2024... Full

Teva Announces Launch of Authorized Generic of Victoza in the U.S.

(6/24, The Fly) ..."By launching an authorized generic for Victoza, we are providing patients with type 2 diabetes another option for this important treatment," said Ernie Richardsen, SVP, Head of U.S. Commercial Generics at Teva. "In addition to strengthening Teva's diverse complex generics portfolio, we are providing the first generic GLP-1 product to the U.S. marketplace, demonstrating once again our ability to sustain a generics powerhouse."... Full

Teva Launches First Generic GLP-1

(6/24, Jakob Emerson, Becker's Hospital Review) ...Teva Pharmaceuticals is launching the first authorized generic of Victoza, the first generic GLP-1 product available in the United States...The launch comes as insurers, health systems, state health plans and self-funded employers have grappled with how to cover the high cost of weight loss drugs, with some groups moving to drop coverage entirely. PBMs such as Express Scripts have noted the low competition and supply facing the GLP-1 market, alongside high consumer demand and prices that can reach upward of $15,000 annually... Full

Novo Nordisk Budgets $4.1B for New US Manufacturing Site as it Abandons Plans for Irish Build

(6/24, Anna Brown, Endpoints News) ...Novo Nordisk is further boosting manufacturing in the US for its obesity drugs as it injects $4.1 billion for a second fill-finish facility in Clayton, NC. But the Danish company is pulling back elsewhere. Novo has canceled plans for a new build in Ireland that was also intended to bolster GLP-1 production, a spokesperson confirmed to Endpoints News... Full

Roche's OCREVUS Subcutaneous Administration Approved by European Commission, As First and Only Twice-a-Year Injection for Relapsing and Primary Progressive Multiple Sclerosis

(6/25, Roche) ...Roche announced today that the European Commission has granted marketing authorisation for OCREVUS® (ocrelizumab) subcutaneous for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis. OCREVUS SC is a 10-minute injection that maintains the same twice-yearly schedule as the previously approved intravenous infusion. More than 350,000 people with multiple sclerosis have been treated with OCREVUS IV globally... Full

Rallying in RSV Vaccine Race, Pfizer Gains Contract Win Over GSK in the UK

(6/24, Kevin Dunleavy, Fierce Pharma) ...The U.K. government has selected Pfizer to supply 5 million doses of its RSV shot Abrysvo over the next two years...On Monday morning, the U.K. introduced its RSV immunization program, with instructions on how patients can receive their shots of Abrysvo. The vaccine is expected to become available in early August, the U.K. said... Full

US Rejected Drug Odronextamab Among 11 EU Marketing Hopefuls

(6/24, Neena Brizmohun, Pink Sheet) ...The European Medicines Agency is this week deciding whether to recommend pan-EU marketing authorization for a number of new drugs, including odronextamab, Regeneron Pharmaceuticals' investigational treatment for blood cancers that the US regulator rejected for marketing earlier this year. The agency is also expected to formally reject the marketing authorization application for masitinib, AB Science's treatment for amyotrophic lateral sclerosis... Sub. Req'd

Sun Pharma Completes Taro Merger to Make it a Wholly-Owned Private Company

(6/24, Financial Express) ...As part of this merger, Sun Pharma acquired all outstanding ordinary shares of Taro other than the shares already held by Sun Pharma or its affiliates. As a result of the merger, Taro is now a private company and wholly-owned by Sun Pharma, the company announced. According to Sun Pharma's statement, the combined entity is better positioned to compete in the increasingly competitive generics industry... Full

ANI Scoops Up Alimera, 2 Approved Ophthalmology Meds for $381M-Plus

(6/24, Eric Sagonowsky, Fierce Pharma) ...Over the years, ANI Pharmaceuticals has grown itself in part through a series of strategic acquisitions. Now, the company has inked a sizable deal to get its hands on ophthalmology specialist Alimera Sciences and its two approved commercial drugs... Full

Merck Shares Drop 10% As Pharma Giant Scraps Trial Of Promising Cancer Drug

(6/25, Louis Goss, The Wall Street Journal) ...Merck & Co's Frankfurt-listed shares fell 10% on Tuesday morning after the pharmaceutical giant said it had decided to call off a Phase III trial of its cancer drug Xevinapant, in an unexpected turn that threatens to undermine confidence in the company's research abilities...Jeffries' analysts added that Merck's failed trial could now see investors start "calling into question the company's R&D abilities, particularly given the recent Evobrutinib study failure," which saw the Phase III trial of the multiple sclerosis drug called off in December 2023... Sub. Req'd

Exploring Innovative Targeted Therapies for Relapsed SCLC

(6/24, Pharmacy Times) ...Pharmacy Times interviewed Jordyn B. Higgins, PharmD, BCOP, a thoracic and head and neck clinical pharmacist at Duke University Medical Center, on the emerging treatment landscape for patients with small cell lung cancer at the 2024 Oncology Pharmacists Connect conference. Higgins shares the latest advancements and implications of new therapies for relapsed SCLC, which can offer patients with poor prognoses new opportunities for treatment... Full

A Ketamine Pill May Help Hard-to-Treat Depression with Fewer Side Effects, Early Research Suggests

(6/24, Brenda Goodman, CNN) ..."It's very logistically involved. You have to come in and be observed for a couple hours," said Dr. Brian Barnett, clinical director of the Psychiatric Treatment Resistance Program at the Cleveland Clinic, who was not involved in the study. "The field has really been looking for a way to take advantage of ketamine for depression but let patients take this at home in the form of a pill."... Full

US Law Firm Motley Rice Appeals $396 Mln Opioid Fee Award

(6/24, Brendan Pierson, Reuters) ...U.S. law firm Motley Rice is appealing its award of $396 million for its work on litigation against the drug industry over the opioid crisis that resulted in $46 billion in nationwide settlements...The fees stem from settlements that local and Native American tribal governments have reached with drugmakers Johnson & Johnson, AbbVie and Teva Pharmaceutical Industries; distributors Cencora, McKesson and Cardinal Health; and pharmacies CVS, Walgreens Boots Alliance and Walmart... Full

Exploitation of Supply Chain Monitoring Loopholes Fueled US Opioid Epidemic, Study Finds

(6/24, Indiana University) ...New research from the Indiana University Kelley School of Business explains how pharmaceutical companies were able to saturate the country with massive quantities of opioids, despite efforts by the Drug Enforcement Administration to regulate their supply. The research identifies a loophole in the DEA's monitoring system exploited by some pharmaceutical companies, leading to an oversupply of opioid drugs in communities. The hallmark of this activity was high supply chain complexity, such as pharmacies with dozens of distributors across the country... Full

Novo Nordisk CEO To Testify Sept. 24 On Ozempic, Wegovy Prices

(6/24, Gabrielle Wanneh, InsideHealthPolicy) ...Senate health committee chair Bernie Sanders (I-VT) has set Sept. 24 as the date for a high-profile hearing that will feature testimony from Novo Nordisk global CEO Lars Fruergaard Jørgensen on why the company has priced Ozempic and Wegovy dramatically higher in the United States than in other countries. The hearing announcement comes after Jørgensen willingly agreed to participate on a solo panel, prompting Sanders to drop his initial threat to subpoena the company's U.S. president to appear... Sub. Req'd

Sanders Targets ‘Unacceptable' Price of Weight-Loss Drugs Ozempic and Wegovy

(6/24, Jessica Glenza, The Guardian) ..."Prices vary all over the world, but we are paying far, far, far more for the same products than other countries," Sanders told the Guardian in an interview..."What we're focusing on right now is what may end up being one of the best-selling pharmaceutical products in the history of humanity, and that is Ozempic and Wegovy," said Sanders. "These are very important gamechangers helping people with diabetes and obesity."...In response to questions from the Guardian, a Novo Nordisk spokesperson said Fruergaard Jørgensen, "[looks] forward to discussing solutions that ensure access and affordability for all patients within the complex US healthcare system"... Full

US Medicare Agency Reconsidering Proposed Accelerated Approval Payment Demo

(6/24, Laura Helbling, Pink Sheet) ...The US Medicare agency is not moving forward with a proposal to cut payments for drugs with accelerated approval status pending further discussions with the FDA about whether new regulatory authorities have addressed concerns about timely completion of confirmatory trials... Sub. Req'd

Rep. Susan Wild Joins Local Leaders, Advocates to Highlight New $35 Cap On Inhalers

(6/24, Congresswoman Susan Wild) ...On Tuesday, Congresswoman Wild joined local health care providers and advocates, including Andrea Wittchen from Lehigh Valley Breathes, Dr. Matt McCambridge, a pulmonary and critical care physician with Lehigh Valley Health Network, and Allentown resident Susan Rego, who suffers from asthma, to celebrate the impact of the $35 price cap on inhalers enacted by two of the four major inhaler producers in the United States...Congresswoman Wild will continue to push for Teva, the fourth leading inhaler producer, to follow suit... Full

Hidden Markups at Mail-Order Pharmacies Make Drugs More Costly for Employers

(6/25, Jared S. Hopkins, The Wall Street Journal) ...Unity Care NW, a nonprofit health clinic in Washington state, forecasts the cost of medical and drug benefits for its 365 employees and their family members will increase this year by 25% to more than $3 million. A big reason: Drugs delivered by mail are costing multiples more than those picked up at a store counter. Markups were as much as 35 times higher than what other pharmacies charged, according to a recent analysis of millions of prescriptions in Washington state... Sub. Req'd

US Patent Office Plan To Expand Settlement Disclosure Requirements Welcomed By FTC

(6/24, Cathy Kelly, Pink Sheet) ...The Federal Trade Commission supports a US Patent and Trademark Office proposal that would require patent settlement agreements be disclosed even if they are reached before a Patent Trial and Appeal Board proceeding...PhRMA argued the plan threatens to expose confidential information and should be more fully vetted in a separate rulemaking before advancing, while AAM maintains the policy is unnecessary... Sub. Req'd

Making Adjustments to Reimbursement Models Impacting Patient Therapies in the Biosimilar Space

(6/24, Nicholas Saraceno, Pharmaceutical Commerce) ...In an interview with Pharma Commerce Editor Nicholas Saraceno, Fran Gregory, PharmD, Vice President of Emerging Therapies, Cardinal Health, discusses ways that changes made to reimbursement models are affecting patient therapies in the biosimilar space... Full

ASCO Posters Reflect On Reimbursement Trends, Combination Therapies Involving Biosimilars

(6/24, Skylar Jeremias, The Center For Biosimilars) ...Two posters from the American Society of Clinical Oncology Annual Meeting examined Medicare reimbursement trends for both originator and biosimilar biologics,1 as well as the use of a combination therapy incorporating a pegfilgrastim biosimilar in patients with advanced hepatocellular carcinoma... Full

Who Is Responsible for the High Cost of Prescription Drugs? One Advocate Weighs In

(6/24, Marissa Plescia, MedCity News) ...According to Merith Basey, executive director of Patients for Affordable Drugs, multiple stakeholders are to blame. Patients for Affordable Drugs is a patient advocacy organization focused on lowering the cost of prescription drugs. The primary actors are pharmaceutical companies, which abuse the "patent system to maintain monopolies and keep drug prices high," Basey declared in a recent interview... Full

Pharma, Insurance Groups Ask FDA To Nix CO Drug Importation Plan

(6/24, Luke Zarzecki, InsideHealthPolicy) ...Pharmaceutical and insurance industry groups are asking FDA not to authorize Colorado's application to start a state drug importation program, saying the proposal has procedural issues, does not satisfy criteria for authorization, and presents a risk to patients living in the state and to the confidentiality of information requested from manufacturers... Sub. Req'd

House Committee Presses FDA On Signs Of Inconsistent Inspections in China and India

(6/24, Zachary Brennan, Endpoints News) ...Republican leaders on the House Energy and Commerce Committee are raising more questions about the FDA's inspections in India and China after finding inconsistencies in the way some inspectors have operated, including signals that some were considerably more lenient than their peers... Full

US Lawmakers Questions FDAs Drug Inspection Programme in India and China

(6/25, Press Trust Of India) ..."The results of this analysis were surprising, revealing tremendous variation in inspection outcomes. Some FDA inspectors found compliance issues during all or almost all of their inspections. Other inspectors rarely reported finding a single compliance issue. Two inspectors never found a single compliance issue throughout a combined 24 inspections in India," they wrote... Full

Arkansas Sues 2 Pharmacy Benefit Managers, Accusing Them Of Fueling Opioid Epidemic in State

(6/24, Andrew Demillo, Associated Press) ...Arkansas on Monday sued two pharmacy benefit managers that oversee coverage for insurers, employers and other large clients, accusing them of fueling the opioid crisis in the state. Attorney General Tim Griffin filed the lawsuit against Express Scripts Inc. and Optum Inc., and their subsidiaries, in state court... Full

Optum, Express Scripts Sued by Arkansas Over Opioid Epidemic

(6/24, Nyah Phengsitthy, Bloomberg Law) ...Optum in a statement said it "did not cause the opioid crisis or make it worse" and will defend itself in the litigation. "Optum takes the opioid epidemic seriously and has taken a comprehensive approach to fight this issue, including the Opioid Risk Management Program available to all Optum Rx clients, to address opioid abuse and promote patient health," the company wrote in an email... Sub. Req'd

Nevadans Would Benefit from Pharmacy Benefit Manager Reform

(6/25, Kaylyn Karadavani, Las Vegas Sun) ...As Congress and our legislature continue to work to lower drug prices, they should support legislation that would tie patient co-pays to the lower prices PBMs pay, as well as end links between higher cost drugs and higher PBM fees. Both reforms would lower prices and expand accessibility to treatments... Full

Divisional Patents Remain Divisive In Europe

(6/25, David Wallace, Generics Bulletin) ...Speaking at the conference, George Moore – Viatris' assistant general counsel for Europe intellectual property and ex-North America IP litigation – acknowledged that divisionals were a perennial problem for the off-patent industry...Welcoming the suggestion of European Commission guidelines on divisional patents – and acknowledging that action was still ongoing in the case of Teva's Copaxone (glatiramer acetate), where the firm had been targeted for allegedly "strategically filing and withdrawing" divisional patents to repeatedly delay the market entry of a generic competitor, after the basic patent covering glatiramer acetate expired in 2015 – Moore said that "anything that can stop the enforcement of divisionals or divisional abuse in this way has got to be something."... Global Sub. Full

More Cracks Appear In EU Pharma Reform As Ministers Debate RDP Proposals

(6/25, Ian Schofield, Pink Sheet) ...Most of the 27 member states support the European Commission's proposal for a "modulated" system – which includes a cut in baseline RDP – provided it is "clear and predictable" and "respects the need for innovation," according to Belgian health minister Frank Vandenbroucke. However, a "very notable minority" of countries would prefer to retain the current system – eight years of RDP followed by two years of market exclusivity, plus one more year for a new indication – Vandenbroucke told the meeting, which was the last to be held under the Belgian presidency of the council... Sub. Req'd

England's NICE Not Planning To Include Societal & Genericization Factors In HTAs – For Now

(6/24, Eliza Slawther, Pink Sheet) ...Some health economists have argued that NICE should take into account the impact of generic competition on drug prices and the societal benefits of a drug during HTAs. The researchers acknowledge that calculating the impact of generic competition on drug prices would be complex, but still argue in favor of this approach. NICE has justified its current approach and said it has enough flexibility to account for societal benefits, but did not rule out a change to its processes in the future... Sub. Req'd

Elara Securities' Positive Outlook On Indian Pharma Sector with Emphasis On US Generics Market

(6/25, Sonia Shenoy and Prashant Nair, CNBC TV 18) ...Elara Securities has expressed an optimistic view on India's pharmaceutical sector, particularly focusing on the exports to US generics market. Speaking to CNBC-TV18, Bino Pathiparampil, Pharma Analyst and Head of Research at brokerage Elara Securities, highlighted a notable uptick in the US generics business over the last few quarters. He noted that pricing pressures have eased and stabilised, creating a conducive environment for growth... Full

Government Study Reveals Korea's Generic Drug Prices Up to 10 Times Higher Than Overseas

(6/24, Choi Mun-hee, Business Korea) ...A recent government research study has revealed that the prices of generic drugs in South Korea are up to 10 times higher than in major overseas countries, sparking concerns over the financial stability of the national health insurance system...The government plans to initiate reforms to the generic drug pricing system within the year based on this study. The lack of proper price competition in the generic market is seen as a threat to the financial stability of the national health insurance system... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: Registration is required to access FirstWord and Generics Bulletin. Click on the links below to register. If you have any questions or issues with access, contact InfoNOW or visit InfoNOW's Industry News page for more details regarding these subscriptions.

                                                         

FirstWord Pharma Plus: Enter your work email address on the Registration page along with your contact information in order to receive access.

  

Generics Bulletin by Informa:

•      Registration: Click on "Sign In" (link on the upper right side of the page). Enter your work email address in the "username" box and press the "Tab" button on your keyboard or click out of the box. You will then be automatically logged into the Informa news resource (no password required). You may be redirected to the Account Settings page to update your contact information.                                

•       Subsequent Access: If you're not automatically logged in, click on "Sign In" (link on the upper right side of the page). Enter your work email address. You will be automatically logged in (no password is required).

•      Note: You must be on the Teva Network (in a Teva location or connected via VPN) in order to access the Informa news resources. You can toggle between the Informa news resources by clicking the news resource on the top.