Monday, September 23, 2024

Teva Announces New Analysis from European Cohort of RIM-TD Study

(9/23, The Fly) ...Teva announced that a new analysis from the European cohort of the RIM-TD open-label extension, or OLE, study revealed that deutetrabenazine treatment of patients with Tardive Dyskinesia, or TD, was associated with long term improvement of TD symptoms... Full

Teva Presents New Phase 3 Efficacy, Safety Data from SOLARIS Trial

(9/22, The Fly) ...Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, announced new efficacy, safety and tolerability results for Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study, or SOLARIS, trial evaluating TEV-'749 in adult patients diagnosed with schizophrenia... Full

Medincell's Partner Teva Provided Treatment Insights into Switching to UZEDY® from Perseris®

(9/23, Medincell) ...New data presented by Teva at ECNP 2024* demonstrate switching to UZEDY at four weeks after the last dose of once-monthly Perseris® (RBP-7000) provided the most comparable pharmacokinetic (PK) profile based on relevant simulations, with comparable doses identified. Perseris manufacturer announced in July 2024 the discontinuation of its commercialization... Full

Eyes On The Prize: Two More Aflibercept Biosimilars Get EU Nods

(9/20, David Wallace, Generics Bulletin) ...Teva's Pomalidomide Receives Positive Opinion. At the same CHMP meeting, the EMA committee issued a positive opinion for Teva's pomalidomide 1mg, 2mg, 3mg and 4mg hard capsules, a generic rival to the Imnovid treatment of multiple myeloma. "Pomalidomide Teva in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide," the CHMP stated... Global Sub. Full

European Regulators Reaffirm Apellis' Rejection, Add Eight Positive Recommendations

(9/20, Max Bayer, Endpoints News) ...New positive recommendations...Pomalidomide: Regulators recommended Teva's new generic treatment for multiple myeloma when combined with a steroid... Full

Wegovy is Among Drugs Set to Be Targeted in the Next Round of Medicare Price Negotiations, Researchers Say

(9/23, John Wilkerson, STAT Plus) ...Last month, Medicare officials unveiled prices for the first 10 drugs chosen for negotiation. Now, all eyes are on which Part D drugs will be chosen for the next round of 15 drugs. Medicare will announce that list by Feb. 1, and the negotiated prices of those drugs take effect in 2027...The researchers are less certain about many of the other drugs on the list. Potential generic or biosimilar competition, and exceptions made for small biotechs and products that treat rare disease complicate the selection process. In fact, the list stops at 13, and researchers identified seven additional drugs that might fill out the last two spots... Sub. Req’d

Sandoz Among Defeated As US Federal Circuit Breathes New Life Into US Myrbetriq Patent

(9/20, Dean Rudge, Generics Bulletin) ...A US district court "misapprehended its role in adjudicating the issue of patentability," the US Federal Circuit found, as it vacated and remanded the lower court's US patent invalidity decision, raising fresh questions in a market that has already seen generic launches from a pair of manufacturers. Generics manufacturers including Sandoz, Zydus Lifesciences, and Lupin will have to face up to another round of litigation in the US over a key patent shielding Astellas Pharma's Myrbetriq (mirabegron), after the US Court of Appeals for the Federal Circuit vacated and remanded a lower court's earlier finding of invalidity... Global Sub. Full

Samsung Bioepis, Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, Opuviz

(9/23, Pharmabiz.com) ...Samsung Bioepis Co., Ltd., a biopharmaceutical company committed to realizing healthcare that is accessible to everyone, and Biogen Inc., a leading biotechnology company, announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for Opuviz 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea2 (aflibercept), also known as SB15... Full

US FDA Has No Adverse Observations After Scan of Dr Reddy's Hyderabad R&D Unit

(9/20, Jomy Jos Pullokaran, CNBC TV 18) ...Drug makers Dr Reddy's Laboratories Ltd on Friday (September 20) said the United States Food & Drug Administration has completed a routine Good Manufacturing Practice (GMP) inspection at its integrated product development organisation (IPDO) in Bachupally, Hyderabad... Full

Glenmark Pharma Aurangabad Unit Clears FDA Test

(9/20, Jomy Jos Pullokaran, CNBC TV 18) ...Drug firm Glenmark Pharmaceuticals Ltd on Friday (September 20) said its formulation manufacturing facility in Chhatrapati Sambhaji Nagar (Aurangabad), has successfully completed a routine inspection by the US Food and Drug Administration... Full

Bristol Myers Squibb Axes 79 More in New Jersey as $1.5B Cost-Reduction Program Rolls On

(9/20, Kevin Dunleavy, Fierce Pharma) ...The drugmaker is laying off an additional 79 staffers in Lawrenceville, New Jersey, according to a Worker Adjustment and Retraining Notification. The company confirmed the cuts, which will be effective between Dec. 12 and May 30 of next year...The reductions come as the company faces pressure from forthcoming patent expirations for Pfizer-partnered blood thinner Eliquis and PD-1 inhibitor Opdivo. Additionally, Eliquis is subject to a Medicare price adjustment under the Inflation Reduction Act starting in 2026... Full

The Price War in Weight-Loss Drugs Is Here

(9/20, Peter Loftus, The Wall Street Journal) ...Eli Lilly and Novo Nordisk, the pharmaceutical heavyweights selling the popular injections, are each dangling discounts to gain an edge and to induce health plans to pay up. The concessions are slashing as much as half off the price tags of the $1,000-plus-a-month medicines. For people who pay out of pocket, Lilly recently introduced vials of its drug Zepbound that cost as little as $399 a month...The moves could prod more health plans to begin paying for the medicines... Sub. Req’d

Why Did Eli Lilly Ask a Patient On a Compounded GLP-1 Drug for Their Medical Information?

(9/20, Shelby Livingston, Endpoints News) ...A spokesperson for Lilly verified the letter's authenticity, but didn't respond to a question about how many patients received similar letters. "Patient safety is Lilly's top priority, and we actively engage in monitoring, evaluating, and reporting safety information for all our medicines. At times, Lilly may contact individuals who have previously contacted the company so we can gain more information; this represents one of those cases," the company said in its emailed statement... Full

Managing the High Cost of Specialty Medications

(9/20, Karen Blum, Specialty Pharmacy Continuum) ...Employers and health plans are concerned about managing high-ticket items such as cell and gene therapies, and interested in potential savings from biosimilars, according to a large managed care survey presented at Asembia's AXS24 Summit, in Las Vegas..."It's important to remember that there are other biosimilars entering this inflammatory condition category," [Renee Rayburg, RPh, PSG VP of clinical strategy] said. They include IV and subcutaneous tocilizumab (Actemra, Genentech); adalimumab-ryvk (Simlandi, Teva and Alvotech), which was approved in February and became available in May; and ustekinumab-auub (Wezlana, Amgen), which should be available in January 2025... Full

The Role of Risk-Sharing Models in Biosimilar Adoption

(9/22, Cameron Santoro, The Center For Biosimilars) ...Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center, highlights the challenges and opportunities of biosimilar development and utilization in an interview with The Center for Biosimilars®. Abraham suggests innovative risk-sharing models between manufacturers, payers, and providers to incentivize biosimilar development and ensure efficient utilization... Full

France Study Finds High Patient Satisfaction With Adalimumab Biosimilar Treatment for IBD

(9/21, Deana Ferreri, PhD, The Center For Biosimilars) ...An observational study assessing patient satisfaction with adalimumab for inflammatory bowel disease reported overall "a high level of satisfaction with adalimumab treatment." The survey responses showed higher levels of overall patient satisfaction for Hulio, Humira, and Amgevita, and higher levels of satisfaction with the injection device for Yuflyma, Hulio, and Humira, compared to other adalimumab products... Full

FTC Formally Sues PBMs Over Insulin Prices and Warns Manufacturers

(9/20, Noah Tong, Fierce Healthcare) ...The complaint alleges that Optum Rx, Express Scripts and Caremark—all vertically integrated with UnitedHealth Group, Cigna and CVS Health, respectively—caused patients to pay more for life-saving drugs and engaging in "rigging pharmaceutical supply chain competition in their favor."...However, the agency said its internal investigation found potential wrongdoing from insulin manufacturers Eli Lilly, Sanofi and Novo Nordisk, hinting more legal action could be justified... Full

FTC Sues Big 3 PBMs for ‘Artificially Inflated' Insulin Prices Caused by ‘Perverse' Rebating

(9/20, Ed Silverman, STAT Plus) ...The lawsuit accused the pharmacy benefit managers of profiting by receiving rebates from the insulin manufacturers — Lilly, Sanofi, and Novo Nordisk — for advantageous placement on formularies, which are the list of medicines covered by health plans. Drugmakers argue they must raise list prices to compensate for rebates, but pharmacy benefit managers maintain drug companies raise prices to boost profits... Sub. Req’d

ANALYSIS: FTC Joins States to Curb Drug Middlemen Power

(9/23, Laura Travis, Bloomberg Law) ...State-level action to curb PBM power will likely continue to rise even if the federal government takes more action in the near future. It's thus possible that PBMs will have to grapple with both state and federal legal requirements. Compliance with such a framework would necessarily become a top priority and focus for PBMs, particularly those that operate in multiple jurisdictions... Sub. Req’d

PCMA Statement On FTC Enforcement Action

(9/20, PCMA) ..."The FTC's action ignores significant progress PBMs have made lowering costs in the insulin market and is yet another example that the agency is running a biased investigation with predetermined anti-industry outcomes — driven by the self-serving agendas of special interests and designed to misrepresent the role and value of pharmacy benefit managers."... Full

Q&A: PCMA On the Role of PBMs and Drug Pricing Transparency

(9/20, Brian Nowosielski, Drug Topics) ...In part 2 of his interview with Drug Topics, Johnny Garcia, Senior Director of Policy at the PCMA, went into further detail regarding PBMs and how his organization is available to assist them. He also delved into the hot topic of PBM scrutiny, addressing some of the common arguments PBM opposers have gravitated toward in the past few years and why the larger PBMs have been under such attacks... Full

Novo CEO Faces Sanders Over GLP-1 Drug Prices. All of Pharma Should Tune In.

(9/23, Josh Nathan-Kazis, Barron's) ...When Sen. Bernie Sanders, the Vermont independent, brings the CEO of the Danish pharma company Novo Nordisk before a Senate committee on Tuesday, all of big pharma will be under the klieg lights. The hearing, convened by Sanders as part of a long-running investigation into the cost of Novo's weight-loss and diabetes treatments Ozempic and Wegovy, is notionally about the high list prices the company set for those drugs in the U.S. But the questioning and its aftermath will have implications for all drugmakers... Full

Novo Nordisk Faces US Congressional Grilling Over Price of Weight Loss Drugs

(9/23, Oliver Barnes and Ian Johnston, Financial Times) ...Sanders, who chairs the Senate Committee on Health, Education, Labor and Pensions, told the Financial Times that he would tell Lars Fruergaard Jørgensen that the drugmaker must "stop ripping off the American people"...Benedic Ippolito, a senior fellow at the American Enterprise Institute, said that Sanders' ambitions were to "create a cacophony of noise around the price of this drug" so that if it were selected for Medicare price negotiations under a future Harris administration, the government would "have to be especially aggressive when it sets that price"... Full

Challenge to US Drug Price Negotiation Program Revived by Appeals Court

(9/20, Brendan Pierson, Reuters) ...A U.S. appeals court revived a lawsuit on Friday by healthcare and drug industry groups challenging the first-ever U.S. law requiring pharmaceutical companies to negotiate drug prices with the government's Medicare health insurance program that covers 66 million people... Full

The Drug Lobby's Lawsuit Against the IRA Finds a Sign of Life After Appeals Court Ruling

(9/20, Zachary Brennan, Endpoints News) ...Nicole Longo, Pharma's DVP of Public Affairs, told Endpoints News via email, "We are pleased the Fifth Circuit agreed that the merits of our lawsuit challenging the IRA's drug pricing provisions should be heard. The price setting provisions give the administration broad authority to set the price of medicines with virtually no guardrails, block any true transparency and accountability in the process and rely on an unreasonable and excessive enforcement mechanism to force compliance."... Full

Biosimilars Council Urges House to Pass Critical Patent Thicket Legislation

(9/20, Biosimilars Council) ...The Biosimilars Council calls on the House of Representatives to swiftly pass the Affordable Prescriptions for Patients Act (S. 150), a bipartisan measure led by Senator Cornyn (R-TX) and Senator Blumenthal (D-CT). This critical bill aims to reform rampant patent abuse in the pharmaceutical industry by streamlining patent litigation and expediting access to lower-cost biosimilars. S. 150 passed the Senate by unanimous consent in July. This legislation was placed on the House suspension calendar this week for further consideration... Full

Emerging Markets: Experts Talk Best Practices For Regulatory Submissions

(9/23, Urte Fultinaviciute, Generics Bulletin) ..."Emerging markets comprise 85% of the global population and offer vast opportunities for drug development due to rising lifestyle diseases and increased healthcare spending," explained IQVIA's associate director of regulatory affairs Ankit Tyagi during a recent webinar, titled "Expanding Horizons: Regulatory Strategies for Biosimilars and Generics for Global Success." During the event, various experts, both from IQVIA and the industry, shared best practices when it comes to global regulatory submissions, especially in emerging markets... Global Sub. Full

Generic Drugs in the U.S. Face New Economic Pressures 40 Years On

(9/20, Sabri Ben-Achour and Alex Schroeder, Marketplace Morning Report) ...Leslie Walker is a senior producer and senior reporter with the health policy news organization Tradeoffs, which has just released a new podcast series on this called "Race to the Bottom." She spoke with "Marketplace Morning Report" host Sabri Ben-Achour for more on this. The following is an edited transcript of their conversation... Full

40 Doesn't Look Good On Hatch-Waxman

(9/23, Tahir Amin and Timi Iwayemi, STAT) ...One of the main objectives of the Hatch-Waxman Act was to bring more generic drugs into the market. If viewed through that lens only, the act has been an overwhelming success. As PhRMA consistently reminds us, about 92% of all prescriptions in the United States are generics. However, a more complete look at the impact of the act explains why Americans continue to pay more for prescriptions than ever before... Full

Voucher Program Notches Win as Clock Ticks

(9/20, Lauren Gardner and David Lim, Politico) ...Days ahead of the 40th anniversary of landmark legislation that established the modern generic drug industry, former Rep. Henry Waxman (D-Calif.) and a litany of former Hill staffers, government officials and academics gathered Thursday at the Brookings Institute to reflect on the law's impact. "The prices of drugs were quite high, and it just seemed to me that we would be better off if we had some competition of generic drugs," Waxman, now 85, said... Full

OGD Effort to Comply with ICH M13 in High Gear – Drops Fed Study Requirements for Hundreds of Products

(9/20, Bob Pollock, Lachman Consultants) ...Historically, and in most cases, industry knows that it will certainly be required to perform both fasting and fed bioequivalence studies on solid oral immediate-release products or it may have an option to seek a waiver of in-vivo bioequivalence requirements for BCS Class 1 drugs. However, a few days ago, the FDA published a listing of over 825 Product Specific Guidances that it plans to revise to remove the requirement for the conduct of a fed bioequivalence study... Full

In Addressing Inspection Shortfall, FDA Says it's Gaining More Inspectors Than it's Losing

(9/20, Kevin Dunleavy, Fierce Pharma) ......"Post-pandemic, FDA saw a high turnover rate for investigators. Many steps have been taken to decrease attrition and we continue to competitively recruit to fill vacant investigator positions," an FDA spokesperson told Fierce Pharma. "We are currently seeing our hiring rates outpace our attrition in the drug program. Once an investigator is hired, it can take two years or longer until they conduct independent complex inspections."... Full

Stark Reminders Of Why Antibiotic Space Remains Unattractive On Display At FDA Advisory Cmte.

(9/20, Sarah Karlin-Smith, Pink Sheet) ...Antibiotics advisory panel suggests sponsors need to do more to get new treatments to market – taking more responsibility for stewardship and diagnostic development for instance. But few sponsors want to do more work that would almost inevitably result in them narrowing the population for their medicine. FDA meeting offers poignant reminder of challenge of keeping drug developers working in this space... Sub. Req’d

A Mysterious Anti ‘Big Pharma' Bus is Barnstorming Swing States

(9/23, Rachel Cohrs Zhang, STAT Plus) ...A new dark-money group called Americans for Pharma Reform has launched a multi-state bus tour to bring awareness to what they characterize as bad behavior by the pharmaceutical industry. The group is only a few weeks old, and it was officially formed on Aug. 28... Sub. Req’d

New Yorkers Could Be Popping Cheaper Canadian Prescription Drugs if Proposed Bill Succeeds

(9/22, Ann Marie Barron, Silive) ...If the New York Rx Importation Bill S.9838, sponsored by State Sen. James Skoufis of Cornwall, New York, (also known as Assembly Bill A7954) becomes law, it would follow in the footsteps of a similar bill in Florida, which in January became the first state to gain Food and Drug Administration approval for its plan to import... Full

Glenmark's Telma H, Sun Pharma's Ursocol 300 Among 16 Drugs Termed Spurious

(9/22, Priyanka Sharma, Mint) ...The Drugs Controller General of India (DCGI) has declared as many as 16 commonly-used medicines as spurious, after they failed the regulator's quality and safety tests. These include Glenmark Pharmaceuticals' Telma H, prescribed by doctors to manage blood pressure, and Sun Pharmaceutical's Ursocol 300 used for gallstones treatment, a drug alert issued by DCGI, and seen by Mint, said... Full

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