Tuesday, July 2, 2024

FTC Opens Investigation into Teva, Escalating Patent Fight with Pharma Industry

(7/1, Dan Diamond, The Washington Post) ...The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals, citing the company's refusal to take down about two dozen patents for its asthma and COPD inhalers, according to confidential agency documents reviewed by The Washington Post..."Our decision to maintain our patent listing comes following serious and thoughtful consideration of the FTC's contentions and our concern for Teva's strict compliance with law," Brian Savage, Teva's general counsel for global litigation, responded to Warren and Jayapal in a June 20 letter shared with The Washington Post... Sub. Req'd

FTC Starts Probe into Teva About Some Products' Patents, Washington Post Reports

(7/1, Gursimran Kaur and Leroy Leo, Reuters) ...The FTC last week ordered Teva to provide internal communications, analysis and financial data related to the contested patents listed in a federal registry known as the Orange Book, according to the report. Teva has to cooperate with the agency's demand by July 24, the report said...In a statement to Reuters, Teva said it "believes that its patents are properly listed in the Orange Book and continues to stand behind the company's intellectual property," it said... Full

Teva Pharmaceutical Said to Face FTC Investigation Over Patents

(7/1, Sabrina Willmer and Ike Swetlitz, Bloomberg) ...Teva confirmed it received a civil investigative demand from the agency last week, according to a company spokesperson, who didn't specify which drugs it involved. "Teva believes that its patents are properly listed," spokesperson Kelley Dougherty said, adding its management "continues to stand behind the company's intellectual property."... Full

FTC Investigates Teva Over Patents, Doubling Down On 'Bogus' Orange Book Listings

(7/1, Nicole DeFeudis, Endpoints News) ...The Federal Trade Commission has turned up the pressure in its patent probe, officially launching a civil investigation into a group of Teva's drug patents that the agency claims are improperly listed in an FDA database. A Teva spokesperson confirmed to Endpoints News on Monday that the antitrust regulator has issued a civil investigative demand. The order requests internal communications and financial data related to the challenged patents, the Washington Post reported earlier based on confidential documents. Teva's deadline to respond is July 24... Full

US Competition Watchdog Probing Teva's Inhaler Patents - Report

(7/2, Shiri Habib-Valdhorn, Globes) ...The US Federal Trade Commission, which is responsible for enforcing competition law, has opened an investigation into Teva Pharmaceutical Industries. According to a report in "The Washington Post", last week, the FTC sent Teva, headed by Richard Francis, a demand for information, including internal correspondence, analyses, and financial data relating to its patents registered in the US on inhalers for treating asthma and COPD (chronic obstructive pulmonary disease)... Full

Teva's Stock Falls After Report FTC Has Opened Probe of Patents

(7/1, Ciara Linnane, MarketWatch) ...Teva Pharmaceuticals Industries Ltd.'s stock fell 2% Monday after a report said the Federal Trade Commission has opened an investigation into the Israeli generics company, citing its refusal to take down roughly two dozen patents for its asthma and COPD inhalers. The report by the Washington Post said the agency last week sent a civil investigative demand, a type of subpoena, to Teva, ordering it to provide it with certain internal communications and data related to the patents, which are listed in a federal registry called the Orange Book... Full

After Months of Warnings, FTC Opens Investigation into Teva Over ‘Improper' Patents

(7/1, Ed Silverman, STAT Plus) ...The U.S. Federal Trade Commission is formally investigating Teva Pharmaceuticals after the company refused to remove approximately two dozen patents for asthma and COPD inhalers from a key federal registry...In a June 20 letter to Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.), Brian Savage, Teva's general counsel for global litigation, argued that, "at no time, did Teva use these patent listings to raise prices or stifle competition by preventing cheaper generic drugs from entering the market," as the lawmakers contended... Sub. Req'd

FTC Launches Probe of Teva Over ‘Improper' Patents; Report

(7/2, Phil Taylor, Pharma Phorum) ...Shares in Teva Pharmaceutical have dipped sharply after reports that the Federal Trade Commission has opened an investigation into the company focusing on improperly listed patents in the FDA's Orange Book...The move is further evidence of increasing scrutiny of the activities of the pharma industry by the FTC, which has also been taking a tougher stance on mergers and acquisitions in the sector and launching investigations into the role of pharmacy benefit managers in the medicines supply chain. Shares in Teva fell almost 3% after the Washington Post's article appeared... Full

On a Mission Against ‘Junk' Patents, FTC Launches Investigation into Teva: Report

(7/1, Elizabeth S. Eaton, FirstWorld Pharma) ...The Washington Post reported Monday that the agency opened an investigation into Teva Pharmaceuticals after the company declined to take down about two dozen patents for its asthma and chronic obstructive pulmonary disease inhalers, citing confidential agency documents...Last week, the agency sent the drugmaker a type of subpoena called a civil investigative demand that requires Teva to provide by July 24 all internal communications, analysis and financial data related to the contested patents listed in the Orange Book... Full

Teva Focus of FTC Investigation Over Inhaler Patents

(7/1, Jonathan Block, Seeking Alpha) ...The FTC has begun an investigation of Teva Pharmaceutical over its apparent refusal to withdraw patents related to its asthma and COPD inhalers that the agency argues is delaying generic competition...In June. Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) sent letters to multiple drugmakers, including Teva, asking them to remove "sham patent listings."... Full

US District Court Allows Vanda Pharma's Hetlioz Patent Lawsuit to Proceed Against Teva & Apotex

(7/2, Pharmabiz.com) ...Vanda Pharmaceuticals Inc., a leading global biopharmaceutical company, announced that the US District Court for the District of Delaware (the "Court") denied the motions for judgment on the pleadings that were filed by Teva Pharmaceuticals USA, Inc. and Apotex Inc. and Apotex Corp. and ordered that Vanda's Hetlioz patent lawsuit may proceed... Full

New Ajovy Data Challenges Treatment Breaks in Migraine Prevention

(7/1, The Pharma Letter) ...New data from the 4th interim analysis of the PEARL migraine prevention study with Ajovy (fremanezumab) suggests it may challenge the rationale for treatment pauses with calcitonin gene-related peptide monoclonal antibodies (CGRP MAbs) mandated or recommended by some reimbursement authorities after one year of continuous use, said Israeli drugmaker Teva Pharmaceutical Industries..."This new sub-analysis may challenge the rationale for mandatory treatment pauses and highlights the potential for these breaks to diminish the benefits achieved in reducing migraine for some patients," said Dr Pinar Kokturk, vice president and head of medical affairs Europe at Teva... Sub. Req'd

Celltrion Wins Korean Approval For Xolair Biosimilar

(7/1, Urte Fultinaviciute, Generics Bulletin) ...Celltrion marks another win for its omalizumab biosimilar. The Korean firm won domestic approval from the Ministry of Food and Drug Safety for its biosimilar rival to Novartis' Xolair. Omlyclo, previously known as CT-P39, was approved as a treatment for allergic asthma and chronic idiopathic urticaria. The approval comes one year after the firm filed the biosimilar to the Korean health agency... Global Sub. Full

More Stelara Biosimilars Line Up For Launch In US And EU

(7/1, David Wallace, Generics Bulletin) ...Samsung Bioepis and partner Sandoz have won approval for a third US Stelara biosimilar. Meanwhile, in Europe Celltrion has become the latest firm to qualify for an ustekinumab marketing authorization...Through a settlement with J&J's Janssen, Samsung Bioepis and Sandoz can launch Pyzchiva in late February 2025, around the same time as Teva and Alvotech and around six weeks after Amgen... Global Sub. Full

FDA Approves Samsung Bioepis' Pyzchiva, a Biosimilar to Stelara

(7/1, Skylar Jeremias, The Center For Biosimilars) ...The FDA has approved Samsung Bioepis' Pyzchiva (ustekinumab-ttwe) for the treatment of inflammatory conditions, including plaque psoriasis and ulcerative colitis...Psychiva's approval follows those for Wezlana (ustekinumab-auub) in November 2023 and Selarsdi (ustekinumab-aekn) in April 2024. Wezlana was developed by Amgen and Selarsdi was developed by Alvotech and will be marketed in the US by Teva Pharmaceuticals as part of a commercialization partnership... Full

Amneal Expands Biosimilars Portfolio to Eight Products with Addition of Omalizumab Biosimilar

(7/1, Amneal Pharmaceuticals, Inc.) ...Amneal Pharmaceuticals, Inc. today announced the addition of omalizumab, referencing XOLAIR®, to its biosimilar pipeline...According to IQVIA®, U.S. annual sales for XOLAIR® for the 12 months ended April 2024 were approximately $3.2 billion... Full

Daewoong Pharm Launches Humira Biosimilar Targeting Autoimmune Disease Market

(7/1, Kim Ji-hye, Korea Biomedical Review) ...Daewoong Pharmaceutical said on Monday that it launched Xelenka, LG Chem's biosimilar referencing Humira (active ingredient: adalimumab), in Korea. Approved by the Ministry of Food and Drug Safety in December last year, Xelenka marks the third biosimilar of Humira introduced in Korea...Looking ahead, Daewoong Pharmaceutical plans to expand its biopharmaceutical pipeline, aiming to significantly improve the treatment of various diseases and the quality of life... Full

Quality is About the Patient's Safety, Not About Regulatory Compliance: GV Prasad

(7/2, Naini Thaker, Forbes) ...In a rare public appearance, GV Prasad, co-chairman and managing director of Dr Reddy's Laboratories, was present at the Indian Pharmaceutical Alliance's 9th edition of the Global Pharmaceutical Quality Summit 2024. During a panel discussion at the event, he spoke about the importance of quality, technology disrupting the industry and more... Full

Drugmakers' Appeal to End Zantac Cancer Lawsuits Rebuffed by Judge

(7/1, Brendan Pierson, Reuters) ...The ruling by Judge Vivian Medinilla of the Delaware Superior Court means that the drugmakers, which also include Pfizer, Sanofi and Boehringer Ingelheim, will have to ask the Delaware Supreme Court directly for permission to appeal. GSK said it already submitted its appeal to that court...GSK in a statement said "the scientific consensus remains that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer." Ranitidine is the active ingredient in the now discontinued drug... Full

Bristol Myers to Pay $2.7 Mln to Settle Israel Anti-Competition Charges

(7/1, Steven Scheer, Reuters) ...Bristol Myers Squibb has agreed to pay 10 million shekels ($2.7 million) in Israel to settle a potential case over its blocking of a generic version for anti-cancer drug Imnovid, Israel's Competition Authority said on Monday. The anti-trust agency said that Bristol and Neopharm Scientific, the Israeli distributor of Imnovid - used for the treatment of multiple myeloma and AIDS-related Kaposi sarcoma - declined a request by KS Kim International for drug samples to make a copycat version of Imnovid... Full

Top Migraine Medication Effective for Preventing Migraines, Treating Drug-Induced Headaches is Hard to Access

(7/2, Eric M. Strauss, ABC News) ...Qulipta is one of only two FDA-approved CGRP inhibitors taken as a pill for the prevention of migraine headaches, the other being rimegepant, marketed as Nurtec by Pfizer. All other drugs in this class used for migraine prevention are injectables. The American Headache Society's recently released a position statement says that CGRP inhibitors should be the first treatment a doctor prescribes for migraines. But Insurance companies often require patients to go through a process known as "step therapy" where they have to try less expensive interventions before they can get access to Qulipta or one of the other CGRP inhibitors... Full

ADHD Patients in Pa. Struggle to Find Medication and Maintain Normalcy Amid Ongoing Shortage

(7/2, Sarah Boden, Spotlight PA) ...Increased demand for ADHD drugs plays a big part in the shortage, and is a recent development according to GoodRx. The stress and isolation experienced by many people during the early months of the COVID-19 pandemic exacerbated their ADHD symptoms; this perhaps led more to seek treatment. Also, prior to COVID-19 the federal government did not allow ADHD medications to be prescribed via telehealth because of a potential for misuse... Full

NIPTE Strategy Aims to Mitigate US Pharma Supply Chain Risk

(7/1, Patrick Lavery, PharmTech.com) ...In summary, the authors say that because the United States relies on imports from overseas, primarily China, for the majority of APIs for the manufacture of drug products of crucial importance to US patients, there is a need to find new "synthetic pathways" for APIs as well as excipients, using "chemical building blocks" manufactured in the US or countries which are close allies... Full

Mark Cuban Cost Plus Drugs Expands Partnership with Hospital Operator

(7/1, Alexa Reed, Dalla's Business Journal) ...Through the expansion of the partnership, Community Health Systems-affiliated hospitals will now have be able to purchase 12 drugs from the Cost Plus Drugs Market, including a variety of antibiotics, nausea medications and other pharmaceuticals... Full

Overturn Of Chevron Offers Major Assist To Drug Makers' IRA Battle

(7/1, Gabrielle Wanneh, InsideHealthPolicy) ...The Supreme Court's 6-3 decision Friday (June 28) to overrule its longstanding Chevron precedent creates new opportunities for the drug industry to sue over aspects of the Inflation Reduction Act's drug price negotiation program Congress left up to CMS, such as the definition of what qualifies as a negotiation-eligible drug and implementation of the negotiations themselves... Sub. Req'd

Cassidy To CMS: Strictly Follow No Surprises Act Statute Post Chevron

(7/1, Jalen Brown, InsideHealthPolicy) ...Sen. Bill Cassidy, the ranking Republican on the Senate health panel, is questioning how the Supreme Court's decision to throw out the Chevron precedent affects HHS' implementation of the No Surprises Act, and specifically, the department's reliance and calculation of the qualified payment amount (QPA)...Cassidy gave Becerra 30 days to respond to his questions regarding how the Supreme Court's decision affects HHS' authority over arbitrators' payment determinations under the QPA methodology, potential revisions to pending independent dispute resolution rules, and the implementation timeline for the Advanced Explanation of Benefits provision mandated by the No Surprises Act... Sub. Req'd

Cassidy Targets March-In Rights Again After Supreme Court's Ruling On Chevron Deference

(7/1, Jalen Brown, Gabrielle Wanneh, InsideHealthPolicy) ...In a letter sent to HHS Secretary Xavier Becerra on Sunday (June 30), the ranking Republican on the Senate health committee requested the secretary clarify the legal basis for the National Institutes of Health's proposed framework to use drug pricing as a justification for exercising march-in rights for drug patents. "Exercising march-in rights on the basis of a product's price directly conflicts with congressional intent, as publicly affirmed by the law's bipartisan authors, and how the statute has consistently been interpreted in response to previous march-in petitions during presidential administrations of both parties," Cassidy wrote... Sub. Req'd

FDA Drug Approvals, Rulemaking Are Tested After Chevron Decision

(7/2, Nyah Phengsitthy, Bloomberg Law) ..."For companies that have specific issues with FDA regulations and policies, it will now be easier to bring those challenges and it will be easier to be successful in those challenges," said Maarika Kimbrell, partner at Morgan, Lewis & Bockius LLP in the life science and health-care sector...But while the decision makes it easier to bring lawsuits against the FDA, it also makes "operating in a specifically-regulated industry—such as those regulated by FDA —more difficult," said Sonia Nath, partner and chair of Cooley LLP's global life sciences and health-care regulatory practice group... Sub. Req'd

New SCOTUS Ruling Allows Decades-Old Regs To Be Challenged, Dissenting Justices Predict ‘Chaos'

(7/1, Jessica Karins, InsideHealthPolicy) ...Days after striking down the long-held principle of Chevron deference, the Supreme Court ruled Monday (July 1) that agency actions can be challenged long after regulations are finalized -- a move the dissenting justices warn could spur a "tsunami" of new lawsuits, including against decades-old drug approvals including mifepristone, and they call on Congress to pass legislation avert the "coming chaos."... Sub. Req'd

President Biden: Novo Nordisk, Eli Lilly Must Stop Ripping Off Americans with High Drug Prices

(7/2, President Joe Biden and Sen. Bernie Sanders, USA Today) ...We plan to expand negotiations on drug prices What does that mean? It means that, at a time when many Americans are dealing with the myriads of chronic illnesses, no one in our country should be forced to pay over $2,000 a year for the prescription drugs they need, not just seniors. It also means that the number of prescription drugs up for price negotiation must be expanded to at least 50 a year. We are working together on legislation to do just that. We look forward to every member of Congress supporting this legislation... Full

Senate, FTC Cracking Down On Pharma Patent Shenanigans

(7/2, Dick Durbin and Lina M. Khan, STAT) ...Why do Americans pay so much more for common medications than people in other countries? Why does an inhaler that costs $7 in France cost almost $500 in the United States? These are just a few of the questions the Senate Judiciary Committee looked to answer in a recent hearing. The common answer? Dominant corporations use a variety of patent-related strategies to protect their power, maximize their profits, and squash their competition... Full

Shrinking Drug Coverage Puts Americans in a Medical (and Monetary) Bind

(7/1, Medora Lee, USA Today) ...Health insurers are covering fewer drugs, putting more restrictions on their drug coverage, but still raising costs for consumers, prescription drug comparison site GoodRx found after reviewing more than 3,700 Medicare Part D plans from 2010 to 2024...The Centers for Disease Control and Prevention said 9.2 million adults reported not taking medications as prescribed due to cost, employing such strategies as skipping doses, taking less than the prescribed dose, or delaying filling a prescription. "The high cost of medications can force people to make difficult choices between prioritizing their health and managing other essential expenses," said Tori Marsh, GoodRx research director... Full

U.S. Department of Justice Informs Viatris That It No Longer Considers Mylan a Subject of Generic Drug Industry Antitrust Investigation

(7/2, Viatris Inc.) ...Viatris Inc. today announced that the Antitrust Division of the U.S. Department of Justice has advised that it no longer considers Mylan, and its former President, Rajiv Malik, a subject of its antitrust investigation in the generic drug industry. The Civil Division of the DOJ has also informed the Company that it does not expect to take any further actions in connection with a civil investigative demand related to the pricing and sales of generic drug products... Full

How Drug Shortages Can Make or Break a Patient's Recovery

(7/1, Sara Moniuszko, Skyler Henry, CBS News) ...As more than 300 medicines are in short supply, including treatments for the side-effects of chemotherapy, pharmacists are sounding the alarm and spreading awarness for how these shortages can impact a patient's recovery...Michael Gaino with the American Society of Health-System Pharmacists says drug shortages, a result of both cost and resource issues, are reaching historic highs. "We tend to think of some of the pharmaceutical companies making lots and lots of money, but in reality, some of these generic medications make very, very slim margins," Gaino said... Full

FDA Commissioner Heralds End to US Shortfall of Chemo Drug Cisplatin

(7/1, Joseph Keenan, Fierce Pharma) ...FDA Commissioner Robert Califf, M.D., announced Friday on social media that the cisplatin drug shortage was over. The agency had previously said it would continue to work with drugmakers and other interested parties to address shortages of cancer treatments...In a new survey released by the NCCN last Thursday, the group said only 11% of surveyed centers reported a shortage of carboplatin and 7% for cisplatin. However, new concerns about supplies have emerged, according to the group... Full

FDA Drafts Guidance On Essential Outputs for Drug Delivery Devices

(7/1, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration has issued a draft guidance to assist sponsors of drug-device combination products in developing "essential drug delivery outputs" that deliver consistent performance. Products that are within the scope of this guidance include syringes, injectors, infusion products, nasal sprays, inhalers, nebulizers, and vaginal delivery systems. Information about the delivery devices must be submitted in the corresponding investigational or marketing application for combination products that rely on a delivery device... Full

UK's Pharma Sector Votes for Post-Brexit Clarity Under New Government

(7/1, Akosua Mireku, Pharmaceutical Technology) ...During a recent clinical trials-focused event, industry leaders highlighted problems with regulatory timelines, citing significant backlogs in the MHRA and National Institute for Health and Care Research's review processes as key challenges in the country. Moreover, some attendees at the Outsourcing in Clinical Trials UK and Ireland conference, also stated that there still exist unresolved regulatory issues related to Brexit, which require more clarity. Pharmaceutical professionals said they will be voting for a sleeker system that addresses the pitfalls of Brexit and regulatory uncertainties... Full

Collaboration with Pharma On the Up in Belgium

(7/1, The Pharma Letter) ...pharma.be, the umbrella organization of innovative biopharma companies active in Belgium, has highlighted the publication of the Transparency Register 2023. This annual report provides a summary of the collaborations taking place involving pharma companies, healthcare providers, healthcare institutions and patient associations... Sub. Req'd

India Panel Urges Drug Regulator to Approve Lilly's Obesity Drug Mounjaro

(7/1, Rishika Sadam, Reuters) ...An Indian government-approved expert panel has advised the country's drug regulator to approve the import and sale of U.S. drugmaker Eli Lilly's Mounjaro, a blockbuster diabetes drug and a wildly popular obesity treatment, a document on a government website showed on Monday... Full

Prices of Certain Cheap Medicine to Rise Sharply in Switzerland

(7/2, Swissinfo.ch) ...Consumers in Switzerland face higher prices for certain common medicine following a reform of the pricing system that came into force on July 1. Ibuprofen, for example, is doubling in price. This increase is the result of a change in the way the price of medicine is calculated, which was agreed by the government last year. Under the new system, the manufacturing cost remains the same, but the distribution margin has increased significantly. Value Added Tax has also risen slightly... Full

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