Friday, August 30, 2024

Please note: Teva Daily News will not publish Monday, September 2 in observance of the U.S. Labor Day holiday. Publication will resume on Tuesday, September 3.

MedImpact Selects Simlandi and an Unbranded Humira Biosimilar

(8/29, Denise Myshko, Formulary Watch) ...MedImpact Healthcare Systems is providing access to two Humira biosimilars: Alvotech/Teva's Simlandi (adalimumab-ryvk) and Sandoz's unbranded adalimumab-adaz...MedImpact, however, is not requiring patients currently taking Humira to switch, and all three products are on a preferred tier. Member copay, deductible, and other factors will be the same for the biosimilars and Humira. Teva offers a $0 copay for Simlandi for those with commercial insurance... Full

‘No Disagreements' With Former CEO As Endo Looks To Rebuild And Grow

(8/30, Dean Rudge, Generics Bulletin) ...After emerging from bankruptcy and announcing the departure of its CEO, Endo has spoken in optimistic terms of its future prospects, especially its Sterile Injectable operations...Going into 2025, Endo expects the growth rate for its Sterile Injectables revenues to be in the low- to mid-single digits compared to the mid-point of the firm's 2024 guidance... Global Sub. Full

Days After US Aflibercept Approval, Sandoz Is Hit By Regeneron Lawsuit

(8/30, David Wallace, Generics Bulletin) ...Days after Sandoz received US FDA approval for its Enzeevu aflibercept biosimilar rival to Regeneron's Eylea, the originator has hit the firm with a lawsuit alleging that it failed to follow the "patent dance" set out in the BPCIA biosimilars framework and claiming infringement of multiple patents... Global Sub. Full

Lupin Launches Generic Formulation to Treat Ovarian Cancer in United States

(8/30, Financial Express) ...Pharma major Lupin Limited on Friday announced the launch of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials in the United States. This comes following Lupin's alliance partner, ForDoz Pharma Corporation, USA received an approval for its ANDA from the United States Food and Drug Administration... Full

Natco Pharma Submits Abbreviated New Drug Application with USFDA for Generic Cancer Drug

(8/29, Press Trust Of India) ...The drug firm believes it is the first company to have filed a substantially-complete ANDA containing a Paragraph IV Certification for this product and expects to be eligible for 180 days of sole marketing exclusivity at the time of potential launch of the product under certain circumstances, it added...The company has submitted an abbreviated new drug application containing a paragraph IV certification with the US Food and Drug Administration for the generic version of Novartis' Tabrecta (Capmatinib hydrochloride), it said in a regulatory filing... Full

AbbVie's Ubrelvy Wards Off Migraines When Used in Reaction to Early Warning Signs: Study

(8/29, Kevin Dunleavy, Fierce Pharma) ...Despite competing against several drugs that have been approved to fend off migraine headaches, AbbVie's Ubrelvy (ubrogepant) —which is approved only to treat them—has carved out a significant niche in the crowded migraine market...In a study published this week in the journal Neurology, Ubrelvy was 73% more effective in preventing a migraine attack than a placebo...Three other CGRPs—all approved in 2018 for the prevention of migraines—remain formidable. Eli Lilly's Emgality generated $678 million in sales last year, while Teva's Ajovy pulled in $435 million and Amgen's Aimovig collected $303 million... Full

Torrent Pharma Rallies 4% as USFDA Issues EIR for Gujarat Facility

(8/30, Business Standard) ...In its exchange filing, Torrent Pharma said that the USFDA issued its Establishment Inspection Report (EIR) with Voluntary Action Indicated classification for the said manufacturing facility and the inspection has now been successfully closed by the USFDA. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action... Full

API Maker Global Calcium Stung with Form 483 Filing After FDA Inspection of Indian Plant

(8/29, Fraiser Kansteiner, Fierce Pharma) ...Following an inspection that ran from July 29 to Aug. 2, the FDA handed Global Calcium a six-observation Form 483. The heavily redacted document was posted online by the U.S. regulator on Wednesday. The FDA's writeup covers an array of production infractions, ranging from incomplete batch records and poorly followed manufacturing procedures to subpar testing and poor facility upkeep... Full

Switching Asthma Inhalers Could Reduce Carbon Emissions, Says Study

(8/29, Brittany Trang, STAT) ...Concerns over health care's carbon footprint typically revolve around issues like overly-air-conditioned hospitals and single-use medical supply waste. But researchers like Stanford University's Jyothi Tirumalasetty think that asthma inhalers are also a good place to start when it comes to reducing emissions... Full

IRA Biosimilar Measure Intended to Boost Uptake So Far Has 'Limited' Impact: Report

(8/29, Zoey Becker, Fierce Pharma) ...Drug development consultancy Certara sought to find out. In its "Boost or Bust?" report, the company surveyed oncology account staff at 79 healthcare facilities—including a mix of hospitals and community infusion sites—on their use of 17 biosimilar products targeting five reference medicines (Roche's Avastin, Herceptin and Rituxan as well as Amgen's Neupogen and Procrit). On top of investigating the effectiveness of the IRA biosimilar reimbursement measure, the findings also offer a glimpse into the role biosimilars play in cancer treatment today... Full

AARP Touts IRA Savings, Defends CMS' Part D Demonstration

(8/29, Dorothy Mills-Gregg, InsideHealthPolicy) ...CMS' new demo is meant to fill in the gap created by the IRA, which is putting pressure on premiums by setting a $2,000 out-of-pocket cap for Medicare enrollees and letting Medicare negotiate drug prices. Leigh Purvis, AARP's Public Policy Institute prescription drug policy principal, told reporters Wednesday (Aug. 28), stakeholders expect once the IRA is fully implemented, those premiums will decrease along with beneficiaries' out-of-pocket costs... Sub. Req'd

Rep. Comer Threatens PBM Execs with Fines, Jail Time Over 'Fraudulent' Hearing Testimony

(8/29, Paige Minemyer, Fierce Healthcare) ...Rep. James Comer, chair of the House Committee on Oversight and Accountability, sent letters to the three PBMs calling for the CEOs to "correct" statements made to the panel that he says contradict findings from both the committee and the Federal Trade Commission...In the letters, Comer said that the alleged perjury would come with a punishment including fines and up to five years in jail. The letter gives the executives until Sept. 11 to correct the record... Full

House Oversight Chair Alleges PBM Execs Gave False Testimony, Demands They Correct Record

(8/29, Gabrielle Wanneh, InsideHealthPolicy) ...In separate letters sent Wednesday (Aug. 28) to CVS Caremark President David Joyner, Optum Rx CEO Patrick Conway and Express Scripts President Adam Kautzner, Comer highlights specific instances from the July 23 hearing in which the company executives told lawmakers their companies did not steer patients to pick up their prescriptions at affiliated pharmacies over independent pharmacies, reimburse their affiliated pharmacies at a higher rate than the independent pharmacies in their network or reimburse independent pharmacies below the acquisition cost for a drug... Sub. Req'd

Reminder: Pharmacy Network Design Saves Money

(8/29, PCMA) ...Pharmacy benefit managers continue to work every day to lower prescription drug costs, leading to savings of an average of $1,040 per person per year. While PBMs work to leverage competition to lower costs, there have been many common misconceptions surrounding pharmacy networks and how they somehow lead to increased health care costs... Full

PBM Rebating Practices: How Much Do Employer Plan Sponsors Really Know?

(8/29, Cathy Kelly, Pink Sheet) ...Almost 63% of employers offering self-insured pharmacy benefits choose guaranteed rebates in their vendor contracts with PBMs, according to a survey by the National Pharmaceutical Council. Guaranteed rebate arrangements focus on a total rebate amount and generally do not specify how a PBM will approach rebate negotiations on specific drugs, which could leave employers unsure of how access to individual drugs might be impacted... Sub. Req'd

Decades Later, Congress Continues Debating the Preserve Access to Affordable Generics (and Biosimilars) Act; But will the Recent Jarkesy SCOTUS Decision Finally Put an End to the Insanity?

(8/30, Kurt R. Karst & Michael D. Shumsky, FDA Law Blog) ...Well, Congress can move forward and pass the bill, but it would likely be immediately challenged in court as unconstitutional. And with the Jarkesy decision, it seems almost certain that an enacted version of the Preserve Access to Affordable Generics and Biosimilars Act would be invalidated by a court because its entire remedial structure is contrary to the Seventh Amendment. That means legislators will either have to go back to the drawing board or drop the issue all together... Full

House Plans Votes On Biosecure Act, Other Measures Hitting China

(8/29, Steven T. Dennis, Billy House and Jamie Tarabay, Bloomberg) ...The party leadership notified Republican congressional offices in an email Thursday to expect House votes on the Biosecure Act and other legislation aimed at Chinese companies when lawmakers return to work from their summer break on Sept. 9, according to several people who have seen the email... Sub. Req'd

FDA Hints at What Chevron's Elimination Means in New SCOTUS Filing

(8/29, Zachary Brennan, Endpoints News) ...David Simon, associate professor of law at Northeastern University, told Endpoints via email, "FDA's motive is plain: without deference, such broad delegations will always be subject to judicial review in some form, creating a system where courts second guess agency determinations on any number of issues. The net effect will be to reduce the efficiency of agency-decision making and potentially gum up the machinery the administrative state."... Full

Latest FDA Product-Specific Guidances Cover Inhalers, Ear Drops And Paxlovid

(8/30, David Wallace, Generics Bulletin) ...Among the newly-added guidances are 41 PSGs for products with no approved ANDAs, including 26 complex products; and 33 PSGs for complex products, including eight new and 25 revised PSGs...Finally, the agency pointed to revised PSGs for metered-dose inhalers for albuterol products referencing ProAir, Proventil and Ventolin, as well as for Flovent (fluticasone) generics and levalbuterol products based on Xopenex. "These PSGs were revised to recommend two options for in vitro and in vivo BE studies," the agency noted... Global Sub. Full

Industry Seeks Clarity On FDA's Platform Technology Designation Program

(8/29, Joanne S. Eglovitch, Regulatory Focus) ...The Biotechnology Industry Organization (BIO) said it "welcomes" the guidance, which is a "first step toward implementation of this promising program." The group added, "We strongly believe the program could provide opportunities for early and continuous engagement with the Agency that will ultimately streamline drug development." Yet BIO took issue with several elements of the guidance and called for greater flexibility for leveraging platform knowledge and submitting requests for designation... Full

FDA's Drug Evaluation Wing Launches New AI Oversight Panel

(8/29, Max Bayer, Endpoints News) ...The agency's Center for Drug Evaluation and Research (CDER) has launched its own AI Council, according to an email from center director Patrizia Cavazzoni made publicly available. The council will be co-led by Sri Mantha, head of CDER's Office of Strategic Programs, Tala Fakhouri, associate director of data science and AI policy, and Qi Liu, who helps lead innovation and partnerships... Full

California Senate Passes New Restrictions On Drug Middlemen

(8/29, Andrew Oxford, Bloomberg Law) ...California legislation that would curb some of the most contentious business practices of pharmacy benefit managers passed the state Senate by a vote of 37-1 on Thursday. The bill heads next to Gov. Gavin Newsom (D) after it passed the Assembly on a vote of 70-0 on Wednesday. The votes raise the prospect that California will become the latest and largest state to tighten rules on the industry. Idaho, Oregon, Vermont, and Washington have recently passed similar measures... Sub. Req'd

Pennsylvania Judge Sides with Drugmakers On First Steps for Growing GLP-1 Lawsuits

(8/29, Nicole DeFeudis, Endpoints News) ...A Pennsylvania federal judge has agreed to prioritize two main arguments at issue in a growing number of lawsuits over the alleged side effects of GLP-1s, a legal decision that developers of the drugs say could significantly limit the number and nature of claims. Hundreds of plaintiffs have alleged a variety of gastrointestinal symptoms after taking Novo Nordisk and Eli Lilly's blockbuster GLP-1 products, with the vast majority — perhaps more than 95%, according to plaintiffs' attorneys — involving gastroparesis, or paralysis of the stomach... Full

Mississippi AG Files Lawsuit Against PBMs for Role in Opioid Epidemic

(8/29, Kaitlin Howell, WJTV) ...Attorney General Lynn Fitch (R-Miss.) filed a lawsuit in the Hinds County Chancery Court against drug manufacturers and pharmacy benefit managers accused of contributing to the opioid epidemic...According to the court documents, PBMs had "a central role in facilitating the oversupply of opioids through conduct that has the intended purpose of ignoring the necessary safeguards for purposes of increasing the prescribing, dispensing and sales of prescription opioids."... Full

Ireland Steps Up Efforts To Boost Clinical Trial Performance By Standardizing CTAs

(8/29, Ian Schofield, Pink Sheet) ...Ireland's Health Service Executive says that a new four-way model template for clinical trial agreements is being prepared as part of a drive to improve the country's performance in the clinical trials arena...The new template, which is being developed in collaboration with the pharma industry body, the Irish Pharmaceutical Healthcare Association, will add to the existing bipartite and tripartite templates... Sub. Req'd

Pharma Warming Up To Benefits Of Australia's Teletrials Initiative

(8/29, Vibha Sharma, Pink Sheet) ...The Australian Teletrials Program is making good progress in setting up infrastructure needed to enable studies that make use of digital telecommunications to connect regional and rural clinical trial site clusters...As teletrials can enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas, the program has drawn the interest of several companies, including Eli Lilly, Novo Nordisk and Sanofi... Sub. Req'd

Why the Centre Banned 156 Irrational Fixed Dose Combinations

(8/30, Bindu Shajan Perappadan, The Hindu) ...Speaking about the need bring in such measures, a senior Health Ministry official explained that most of the drugs that made it to the banned list were approved by various State authorities but had no research or trials to back-up its safe use in humans. "The new drugs and clinical trial rules of 2019 make it clear that fixed dose combinations are to be considered as new drugs and as such must be approved by the central drug regulator,'' he said... Sub. Req'd

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