Wednesday, August 28, 2024

Lilly Launches Vials of Weight-Loss Drug Zepbound for as Low as $399 a Month

(8/27, Patrick Wingrove, Reuters) ...Eli Lilly said on Tuesday it has begun selling vials of the lowest starter dose of its popular weight-loss drug Zepbound in the United States for $399 for a month supply through its direct-to-consumer website to help increase its availability in the marketplace... Full

Lilly Sells Zepbound Vials at 50% Discount to Meet Weight Loss Drug Demand

(8/27, Madison Muller, Bloomberg) ...Patients with a prescription for Zepbound can purchase a month's supply of single-use vials through Lilly's direct-to-consumer site starting Tuesday, the company said in a statement. The vials are priced at about half of what shots cost, with a higher dose going for $549 a month...President Joe Biden, who has taken steps to lower drug prices, hailed Lilly's price cut as a "a welcome first step," according to a statement Tuesday... Full

Lilly Slashes Prices On Two Lowest Doses of Zepbound — If You're Willing to Give Up Injector Pen

(8/27, Berkeley Lovelace Jr., NBC News) ...The lower-cost doses will be offered only through Lilly's telehealth platform, LillyDirect, however, and they won't be covered by insurance, meaning patients will need to pay for them in cash. Patients who opt for the lower-cost doses also won't qualify for Lilly's discount savings program..."These new vials not only help us meet the high demand for our obesity medicine, but also broaden access for patients seeking a safe and effective treatment option," Patrik Jonsson, president of Lilly USA, said in a press release... Full

CSRxP: Eli Lilly's Zepbound Announcement Leaves Prices High for Most Patients, Serves as Powerful Reminder Big Pharma Alone Sets Prices

(8/27, The Campaign for Sustainable Rx Pricing) ...The Campaign for Sustainable Rx Pricing (CSRxP) issued a statement Tuesday reacting to an announcement from Eli Lilly on price changes for its GLP-1 weight loss drug Zepbound. The Big Pharma giant reduced prices only at certain dosages and only for patients purchasing the product directly, not those relying on their insurance... Full

MedImpact Expands Access to Two Humira Biosimilars for New Patients

(8/27, MedImpact) ...MedImpact Healthcare Systems, Inc., the nation's largest independent provider of health solutions, technology, and pharmacy benefit services, today announced that it is expanding access to Humira biosimilars, Simlandi and adalimumab-adaz, for new patients requiring medication for inflammatory conditions such as Crohn's disease or rheumatoid arthritis. Patients already taking Humira through their pharmacy benefit can continue to do so, and new patients who have taken one of the two biosimilars but did not see the desired results may switch to Humira... Full

Sandoz Reports 29% Growth in Biosimilar Revenues for First Half of 2024

(8/27, Skylar Jeremias, The Center For Biosimilars) ...Sandoz reported strong financial results for the second quarter and first half of 2024, with notable sales growth fueled by the strong performance of its biosimilars and generics segments, while also making strategic investments in future growth opportunities... Full

USFDA Grants Tentative Approval to Zydus' Drug to Treat Parkinson's Disease

(8/28, Financial Express) ...Zydus Lifesciences Limited on Wednesday announced that it has received final approval from the United States Food and Drug Administration to market Amantadine extended-release capsules, 68.5 mg, and tentative approval for 137 mg (USRLD: Gocovri (amantadine) extended-release capsules, 68.5 mg and 137 mg)... Full

USFDA Gives Nod to Lupin's Generic Formulation for Eye Disorder Treatment

(8/28, Financial Express) ...Pharma major Lupin Limited on Wednesday announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Brimonidine Tartrate Ophthalmic Solution, 0.1%... Full

Advanz Adds Biosimilars Alliance With Alkem's Enzene

(8/28, David Wallace, Generics Bulletin) ...Advanz Pharma has ventured further into biosimilars by agreeing an exclusive partnership with Alkem subsidiary Enzene Biosciences to develop and commercialize a proposed biosimilar for a rare disease indication. The specific molecule covered by the alliance was not disclosed... Global Sub. Full

Zydus Buys Stake In Sterling Biotech – Will API Segment Restructuring Accelerate?

(8/28, Vibha Ravi, Generics Bulletin) ...The latest to join the bandwagon is Zydus Lifesciences Limited, which via subsidiary Zydus Animal Health and Investments Ltd, has acquired a 50% stake in gelatin, dicalcium phosphate and API maker Sterling Biotech from Perfect Day Inc, turning Sterling into a joint venture...If Zydus builds out API capability at the two sites owned by Sterling in Gujarat state, it would add to its six API manufacturing sites mentioned in a post stake acquisition presentation... Global Sub. Full

Regeneron Sues Sandoz to Block Just-Approved Biosimilar of Eylea

(8/27, Christopher Yasiejko, Bloomberg Law) ...Regeneron Pharmaceuticals Inc. sued Sandoz Group AG seeking damages and an order blocking Enzeevu, a recently approved biosimilar version of its blockbuster eye drug Eylea that it said infringes 46 patents. Sandoz Inc., a subsidiary based in Princeton, N.J., failed to provide information about its biosimilar as required by the Biologics Price Competition and Innovation Act, according to a complaint filed Monday in the US District Court for the District of New Jersey... Sub. Req'd

MSN Generic Entresto Launch In Doubt After US Appeals Court Stops Approval

(8/27, Dean Rudge, Pink Sheet) ...MSN Laboratories will be unable to move forward with any potential ‘at-risk' launch for its generic version of Novartis' Entresto blockbuster in the US for now after the originator won a stay of the firm's ANDA approval pending appeal from the US Court of Appeals for the District of Columbia Circuit... Sub. Req'd

Bio-Thera And Pharmapark Add Cosentyx Rival To Russia-CIS Collaboration

(8/27, David Wallace, Generics Bulletin) ...China's Bio-Thera Solutions and Russia's Pharmapark have struck a deal to expand their existing biosimilars collaboration for Russia and the Commonwealth of Independent States with a further candidate: the Chinese firm's BAT2306 proposed secukinumab biosimilar to Cosentyx... Global Sub. Full

Jazz, Hikma Must Face 'Reverse Payment' Claims Over Narcolepsy Drug

(8/27, Mike Scarcella, Reuters) ...Drug companies Jazz and Hikma must face claims that they schemed to delay a generic version of Jazz's blockbuster narcolepsy drug Xyrem, causing health plans to pay higher prices, a U.S. judge in California has ruled...Jazz in a statement on Tuesday said the judge's order "meaningfully" trimmed the plaintiffs' claims, and the company remained "confident about the strength of its defenses."... Full

Delaware Top Court Will Hear Drugmakers' Appeal to End Zantac Lawsuits

(8/27, Brendan Pierson, Reuters) ...Delaware's highest court said on Tuesday it will hear an appeal by GSK and other drugmakers seeking to end more than 70,000 lawsuits claiming discontinued heartburn drug Zantac caused cancer...GSK said in a statement that it was "pleased that the Supreme Court is of the view that such circumstances are present here." Jennifer Moore and Brent Wisner, lawyers for the plaintiffs, said in a joint statement that they were "confident that the (Supreme) Court will reach the same conclusion that the trial court did."... Full

Endo CEO Coleman Is Out, Four Months After Steering Through Bankruptcy

(8/28, Dean Rudge, Generics Bulletin) ...After emerging from a painful bankruptcy, and with plans to list its common stock on the New York Stock Exchange, the now-restructured Endo must find a new CEO...Scott Hirsch, the former CEO of Solta Medical, has stepped into the CEO's seat on a temporary basis..."Our priority in the near term will be continued focus on execution across our branded, sterile injectables and generics portfolios as we position the company for long-term growth. I look forward to working closely with Endo's dedicated team as we transition to new leadership," commented Hirsch... Global Sub. Full

Pfizer Launches New Website for Migraine, Respiratory Offerings

(8/27, Michael Erman, Reuters) ...The drugmaker said on Tuesday that it launched the site called PfizerForAll to help patients get access to treatments like its COVID-19 drug Paxlovid and its migraine pill Nurtec by offering services like telehealth appointments and diagnostic tests. It can also help them find vaccines for respiratory illnesses like COVID, flu, respiratory syncytial virus (RSV) and pneumonia... Full

To Help Migraine Patients — and Sell More Medicines — Major Drugmakers Turn to Telehealth

(8/27, Katie Palmer, STAT Plus) ...The portal includes resources for migraine sufferers — and in a new twist, it gives patients the ability to "talk to a doctor now" via telehealth and fill their scripts through an online pharmacy. For migraine patients, telehealth platforms can be a lifeline to get the care and medications they want, when they need them. And for drugmakers, telehealth could be a lucrative distribution channel for their newest, most expensive migraine medications — the anti-CGRPs, which came to market in the midst of a pandemic-driven boom in virtual care... Sub. Req'd

SaveRxCanada.to Empowers American Seniors to Access Affordable Prescription Drugs, Bridging the Healthcare Gap

(8/27, SaveRxCanada.to) ...SaveRxCanada.to, a trusted online prescription service, is stepping up to address the growing crisis of unaffordable medication costs for American seniors. With prescription prices continuing to rise in the U.S., many elderly individuals are finding it increasingly difficult to manage their healthcare expenses. SaveRxCanada.to provides a vital solution by connecting seniors with licensed Canadian pharmacies, offering significant savings on essential medications without compromising safety or quality... Full

Why More PBMs Are Embracing Biosimilar Medications

(8/28, Lauren Berryman, Modern Healthcare) ...As the healthcare industry and consumers contend with rising prescription drug spending, AbbVie's popular rheumatoid arthritis biologic Humira, which brandishes a $7,000 monthly list price, has captured the attention of PBMs looking to rein in costs...Contracts with pharmaceutical companies featuring lucrative rebates for brand name drugs are expiring, leading PBMs to reconsider biosimilars... Sub. Req'd

J&J Casts Aside HRSA Warnings, Will Press Forward With 340B Rebate Model

(8/27, Gabrielle Wanneh, InsideHealthPolicy) ...Johnson & Johnson is standing firm on its transition to a new 340B drug rebate model even though the Health Resources and Services Administration warned the company last week the model is inconsistent with 340B statute and has not been approved by the HHS secretary, the drug maker told Inside Health Policy Tuesday (Aug. 27). J&J says its new discount approach is "fully consistent" with the statute and will also better ensure hospitals meet the goals of the discount program... Sub. Req'd

HRSA-J&J Dispute Over 340B Rebate Plan Again Underscores Need For Program Reform

(8/27, Cathy Kelly, Pink Sheet) ...Johnson and Johnson is blazing a new trail in the 340B program by shifting up-front 340B discounts on Stelara and Xarelto to back-end rebates, which will increase company oversight of the price concessions...The move also may have been prompted by concerns that Xarelto and Stelara could be subject to both 340B discounts and Medicare negotiated prices beginning in 2026 due to a lack of government oversight... Sub. Req'd

Centene Eliminates Brokers' Commissions for Medicare Drug Plans

(8/27, Bob Herman, STAT Plus) ..."We have made a difficult decision — effective Jan. 1, 2025 — to cease new and renewal commissions for [Medicare Part D plans] beginning with the 2025 plan year," Centene's WellCare subsidiary said last Friday in an email sent to brokers, which was obtained by STAT... Sub. Req'd

SCOTUS Overturn of Chevron Doctrine Opens a Pandora's Box for Biopharma Industry, Expert Says

(8/27, Kevin Dunleavy, Fierce Pharma) ...In a LinkedIn post, former FDA chief Scott Gottlieb, M.D., said that he expects courts to continue to defer to the agency on fact-based decisions, such as those on drug approvals and product reviews. But he does expect that there will be "considerable churn over the next few years as litigants come forward and courts sort out when and how to respect the FDA's prior decisions."... Full

Stakeholders Ask for Transparency, Agency Rationale in FDA Meeting Decisions

(8/27, Ferdous Al-Faruque, Regulatory Focus) ...Several industry groups, including PhRMA and the Biotechnology Innovation Organization, wrote to FDA in response to a July public meeting on best practices for conducting meetings between regulators and sponsors regarding its meeting obligations under the Prescription Drug User Fee Act (PDUFA VII). They noted that the agency has consistently missed negotiated PDUFA performance goals for key meeting management metrics, which the groups said is burdensome for companies... Full

Drugmakers Sue to Block Missouri Law On Federal Prescription Discounts

(8/27, Rudi Keller, Missouri Independent) ...In four federal lawsuits filed over the past month, Novartis, AstraZeneca, Abbvie and PhRMA, the lobbying arm of the pharmaceutical industry, argue that Missouri lawmakers unconstitutionally intruded into interstate commerce with the bill passed this year...The law takes effect on Wednesday. The plaintiffs in each case have asked for a preliminary injunction to block enforcement, but no hearings on the requests have been scheduled and only one case, filed Aug. 2 by Novartis, has had enough activity for the judge to schedule any proceedings... Full

States Force Drugmakers to Keep Selling Cheaper Meds Under Federal Program

(8/28, Shalina Chatlani, Stateline) ..."It's very hard to maintain services and keep a hospital open. So, when 340B came into play, it was very helpful," West Virginia Republican state Sen. Tom Takubo, the sponsor of the legislation in his state, told Stateline. "They just unilaterally stopped delivering medications to those peripheral pharmacies," Takubo said. "And so, we passed a bill that said you can't do that. You gotta deliver out there. And if you don't do it, we're gonna fine you."... Full

Illinois Bill Would Create Board to Tackle High Prescription Drug Prices; Doctors, Patients Weigh In

(8/27, Leah Hope, ABC 7) ...Monday's discussion in Chicago at the office of Service Employees International Union centered around proposed state legislation that would cap costs of prescription drugs with a Prescription Drug Affordability Board. Jessica Schlotfeldt is a pharmacist, and she says despite efforts to negotiate with insurance companies and manufacturers, sometimes, it is too much... Full

Responsible Antimicrobial Manufacturing A Must For UK's Subscription Model Applicants

(8/27, Eliza Slawther, Pink Sheet) ...The UK will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance... Sub. Req'd

Netherlands Should Raise Generics Prices to Combat Drug Shortages, Says Dutch Bank

(8/27, Christoph Schwaiger, Euractiv) ...The Netherlands should increase the maximum price of generic medicines sold to Dutch patients to help combat drug shortages, Dutch bank ABN AMRO said in a recent report...The country's Medicine Evaluation Board (CGB) attributes 68% of the shortages to generics, and cheaper versions of brand-name medicines while sharing the same active ingredient... Full

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