Friday, December 20, 2024

Sandoz Boss Warns There's a Climate Cost of Obesity Wonder Drugs

(12/20, Paula Doenecke and Anna Edwards, Bloomberg) ...Richard Saynor wants to transform Sandoz Group AG into a world champion in copying leading-edge drugs, including anti-obesity and biological treatments, with the goal of bringing them to the masses...Saynor spoke with Bloomberg about why he enjoys tangling with big pharma companies, the merits of being boring, the environmental downside of obesity medications and why many governments will be disappointed in their quest to onshore medicine production... Sub. Req’d

In Weight Loss Battle, Novo and Lilly Face Growing Offensive from Licensed Copies

(12/20, Andrew Silver, Reuters) ...Regulators have approved copies in Laos, Bangladesh, Russia and Paraguay. Proliferation of copies could lower prices in key markets, erode market share. At least seven new products containing Novo's semaglutide approved this year... Full

In Blow to Compounders, FDA Reaffirms Tirzepatide Shortage is Over

(12/19, Shelby Livingston, Endpoints News) ...In a statement Thursday, the OFA said it "fundamentally disagrees" with the FDA that the shortage is over. "The agency's decision to declare the shortage over based on the manufacturer's say-so ignores the facts, violates the law, and puts patient access at risk," the group said...In a statement Thursday, a Lilly spokesperson said the FDA decision reflects the drugmaker's work to expand manufacturing capacity and "is a critical step towards protecting patients from the dangers of counterfeit and compounded knockoffs."... Full

Alembic Pharma Gets USFDA Nod for Seizure Treatment Drug

(12/20, Business Standard) ...Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration for its abbreviated new drug application Divalproex Sodium Delayed-Release Capsules. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Depakote Sprinkle Capsules... Full

Fresenius to Expand Biopharma Portfolio with a New Licensing Agreement to Commercialize a Proposed Aflibercept Biosimilar

(12/20, Fresenius Kabi) ...Fresenius, through its operating company Fresenius Kabi, is broadening its growing biopharma portfolio through a new licensing agreement with South Korea's SamChunDang Pharm (SCD). Under the agreement, Fresenius Kabi will exclusively commercialize SCD's aflibercept biosimilar candidate in the U.S. and several countries in Latin America. Aflibercept is used to treat a range of ophthalmic disorders, including wet age-related macular degeneration... Full

Analysts Tip BMS' Cobenfy to Be Top Dog in Growing Schizophrenia Market

(12/19, Nick Paul Taylor, Fierce Pharma) ...Launches from companies including Boehringer Ingelheim and Bristol Myers Squibb could drive sales of schizophrenia drugs up to $17 billion by 2031 despite generic erosion of incumbent products, according to GlobalData...The period is expected to feature launches of new branded drugs, along with tough years for the long-acting injectables (LAI) Abilify Maintena, Aristada and Invega Sustenna, all of which are set to lose patent protection... Full

GoodRx Sued by Independent Pharmacy Over Rebate Pricing Scheme

(12/19, Bernie Pazanowski, Bloomberg Law) ...GoodRx Inc. orchestrated a pricing scheme that benefited it and other big pharmacy benefit managers at the expense of independent pharmacies, a proposed class action filed in federal court says. The PBMs named in the suit as co-conspirators with GoodRx are CVS Caremark Corp., Express Scripts Holding Co., Medimpact Healthcare Systems Inc., and Navitus Health Solutions LLC. Together with GoodRx, they control 95% of the market... Sub. Req’d

Why Supply Chain Resilience Remains Elusive — and What Leaders Can Do About It

(12/19, Alexandra Murphy, Becker's Hospital Review) ...The American Hospital Association's 2025 Environmental Scan report found 80% of healthcare providers expect supply chain disruptions to worsen or remain the same over the next year. Additionally, 39% of providers said product shortages have forced them to cancel or reschedule procedures at least quarterly. Here are some of the barriers standing in the way of a more resilient supply chain, and what health systems are prioritizing to improve their ability to predict and respond to disruptions... Full

Health Plan Formularies Lowered Barriers to Fair Access to Some Drugs, Analysis Finds

(12/19, Ed Silverman, STAT+) ...Most of the formularies run by some of the largest health plans in the U.S. generally provide "fair access" to 11 treatments for several serious diseases, although transparent coverage information is often lacking for some medicines, a new analysis has found...The mixed findings suggest that patients still face significant barriers to access because of policy choices made by payers, according to Sarah Emond, chief executive officer and president at the Institute for Clinical and Economic Review, a nonprofit that ran the analysis... Sub. Req’d

PBM, Patent Reforms Snuffed Out Of House GOP's Latest CR Plan

(12/19, Gabrielle Wanneh, Inside Health Policy) ...Long-sought pharmacy benefit manager reforms and other drug-pricing measures are absent from House Republicans' new slimmed-down continuing resolution proposal, just two days after appearing in a massive bipartisan health care deal that was torpedoed by President-elect Donald Trump on Wednesday... Sub. Req’d

Chaos In Washington Raises Shutdown Fears, PBM And Rare Disease Priorities Cut From CR

(12/20, Sarah Karlin-Smith and Derrick Gingery, Pink Sheet) ...House Republicans released a much smaller, but Trump-backed, proposal late December 19, that would extend government funding for three months, suspend the debt ceiling until early 2027, and provide disaster aid. All of the drug's industry's priorities, including PBM reform and a five-year reauthorization of the pediatric priority review voucher program, were left out. The new bill was only 117 pages compared to previous version's 1,547 pages... Global Sub. Full

Medicare Negotiated Prices Higher Elsewhere

(12/19, Nathaniel Weixel, Joseph Choi and Alejandra O'Connell-Domenech, The Hill) ...A new analysis from KFF found that while the Medicare drug price negotiation program set up by the Inflation Reduction Act achieved significant savings, the prices for the drugs still end up higher than what peer nations pay for the same products... Full

A Drug Price Dynamic to Watch

(12/19, Caitlin Owens, Axios) ...Even the Medicare-negotiated rates that the U.S. pays for some drugs is generally much higher than what other comparable countries pay for the same products, a new KFF analysis found. Why it matters: Trump seemingly dropped his proposal to drive better bargains for what the U.S. pays for drugs when he removed his "most favored nation" policy proposal from his campaign website. But that certainly doesn't mean that the concept has gone away forever...Getting other countries to pay more, even if the U.S. pays less, has an obvious appeal to pharma — and a pretty obvious appeal to Trump, who hates any suggestion that the U.S. is getting ripped off... Full

Hickenlooper, Cotton, Welch, Collins Introduce Skinny Labels, Big Savings Act to Safeguard Generic Drugs, Slash Drug Prices

(12/19, U.S. Senator John Hickenlooper for Colorodo) ..."Big pharma uses endless patent litigation to squeeze patients and stop competitors from coming into the market," said Hickenlooper. "Our bill levels the playing field so generic drug manufacturers can help working people afford life-saving medication." "Generic drugs lower costs and provide options for patients. Our legislation will ensure more of them come to market by clarifying generic companies that comply with FDA requirements are not subject to unnecessary lawsuits," said Cotton... Full

FTC Pushes to Dismiss Lawsuit Challenging Insulin Price Case Proceedings

(12/19, CPI) ...The Federal Trade Commission (FTC) has taken action to dismiss a lawsuit filed by major U.S. pharmacy benefit managers (PBMs) that challenges the agency's authority to pursue its case in an administrative court. The lawsuit, which targets CVS Health Corp., Cigna Group, and UnitedHealth Group Inc., claims that the FTC's in-house proceedings violate constitutional protections... Full

Why the Drug Industry and its Friends Are Holding Their Fire On RFK Jr.

(12/20, Caitlin Owens, Axios) ...The pharmaceutical industry sees little upside to launching public attacks against Kennedy, multiple sources said. That's partially because there's a good chance he gets confirmed regardless, which would mean the industry will have to try to work with him. And while he's said a lot of things about vaccines and other drugs that the industry vehemently disagrees with, there's a genuine sense that his agenda remains unknown, and could be largely driven by lower-level appointees to head various subagencies... Full

Class Dismissed: US FDA's ‘Dean' Bob Temple Retiring After 52 Years

(12/19, Michael McCaughan, Pink Sheet) ...Robert Temple, a leader in drug regulation at the FDA for decades, will retire at the end of 2024. Former Acting Commissioner Janet Woodcock said Temple and others "basically invented the regulatory standards for clinical evidence generation." Temple's departure comes at a potential inflection point for the FDA as the Trump Administration prepares to take over... Global Sub. Full

Colorado to Consider State Rules On Massive Federal 340B Drug-Pricing Program

(12/19, Ed Sealover, The Sum & Substance) ...The Colorado Hospital Association is working with a group of lawmakers to introduce a bill early in the session that would prohibit drug manufacturers from limiting the use of the discount program to certain pharmacies. Eight states have passed similar laws and about a dozen others are expected to consider them next year, making it arguably the most divisive health-care debate in America today... Full

Lucas Sigman and Allan Oberman appointed 2025 Chair and Vice-Chair of the IGBA CEO Advisory Committee

(12/19, IGBA) ...The International Generic and Biosimilar medicines Association (IGBA) announced today the annual leadership change of its CEO Advisory Committee (AC). Lucas Sigman, CEO of Insud Pharma, has been appointed Chair and Allan Oberman, President and CEO of Apotex, Vice-Chair... Full

Move Towards ‘Default Disclosure' In Revamped EU Transparency Guidance Concerns Industry

(12/19, Francesca Bruce, Pink Sheet) ...New guidance on data transparency from European medicines regulators will mean more administrative burden for small and medium sized companies. The "overwhelming majority of data" laid out in European marketing authorization applications (MAAs) is not considered commercially confidential information (CCI), according to newly overhauled guidance on identifying CCI and personal data in MAAs, which was published by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA)... Global Sub. Full

EU Pharma Package Incentivises Innovation in Gap Zones, Says Czech Expert

(12/20, Aneta Zachová, Euractiv) ...Jakub Hlávka, a Czech healthcare economic expert, has praised the European Commission's pharmaceutical reform for proposals to reduce standard patent protection while extending it for medicines that address unmet medical needs. Supporting the plan, he said it's a fair way to encourage innovation and improve access to life-saving treatments across Europe... Full

Pharma Lobbying Fears Shadow Parliament's New, Full-Standing Health Committee

(12/20, Thomas Mangin, Euractiv) ...The European Parliament approved on Wednesday (December 18) the creation of a permanent Public Health Committee (SANT), but some MEPs are concerned that the committee will become a playground for pharmaceutical sector lobbyists..."It remains to be seen whether the EPP group will use this committee solely to advance the interests of pharmaceutical or tobacco lobbyists, or if they will work with the democratic centre to advocate for the well-being of patients," said MEP Tiemo Wölken (S&D, Germany) to Euractiv... Full

Poland Develops its First National Critical Medicines List, Boosting Pharma Resilience

(12/20, Paulina Mozolewska, Euractiv) ...The Polish Ministry of Health has taken a significant step to enhance the country's pharmaceutical security by drafting the first-ever National Critical Medicines List. This initiative addresses the pressing need to strengthen Poland's medical supply chain while also meeting the expectations of the domestic pharmaceutical market... Full

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