Friday, October 25, 2024
Industry News
Alvotech And Fuji File Third Biosimilar Application In Japan
(10/24, Adam Zamecnik, Generics Bulletin) ...Only a month after filing their second biosimilar application with Japanese regulators, Alvotech and Fuji have submitted a further one for an undisclosed biosimilar as part of their local partnership..."Unfortunately, we are unable to give you any more names than Product C in the biosimilar pipeline of our medium-term management plan, which ends in FY2024," stated a Fuji Pharma spokesperson in their written response to enquiries from Generics Bulletin... Global Sub. Full
AbbVie and Richter Partner for Neuropsychiatric Treatments
(10/25, Pharmaceutical Technology) ...The agreement focuses on discovering, co-developing and licensing new targets to address these conditions. The partnership leverages almost two decades of successful collaboration on central nervous system projects. It has already led to the delivery of products such as cariprazine (VRAYLAR/REAGILA) and the development of the investigational drug candidate ABBV-932, aimed at treating bipolar depression and generalised anxiety disorder... Full
Sanofi Reports Beyfortus Sales Jump as RSV Antibody Challenger Merck Nears
(10/25, Ayisha Sharma, Endpoints News) ...As Sanofi declares strong early sales for Beyfortus in its second RSV season, the French pharma is confident that it would still come out on top against potential future competitor Merck because its antibody has set a "high bar to surpass."...While both prophylactic products are monoclonal antibodies targeting RSV, "they are actually quite different," Sanofi CFO François-Xavier Roger said during a company earnings call with the media Friday... Full
Indian Drugmaker Glenmark Life Sciences' Q2 Profit Drops On Temporary Closure of Facility
(10/24, Kashish Tandon, Reuters) ...Indian drugmaker Glenmark Life Sciences posted a fall in second-quarter profit on Thursday, hurt by the temporary closure of a manufacturing facility in the western state of Gujarat. The Mumbai-based company said its profit fell to 953.2 million rupees (about $11 million) in the three months ended Sept. 30, from 1.19 billion rupees a year earlier... Full
Lilly to Launch its Obesity Drug in Denmark, Novo Nordisk's Home Market
(10/24, Stine Jacobsen and Louise Breusch Rasmussen, Reuters) ...Lilly will launch its Mounjaro obesity drug in Denmark next week, the U.S. drugmaker said on Thursday, bringing competition to the home country of its biggest weight-loss rival, Danish pharmaceuticals group Novo Nordisk. The two drugmakers are the first-to-market with highly effective obesity treatments, a booming business that could be worth $150 billion in annual global sales by the early 2030s, according to some analysts... Full
Lundbeck Slashes Value of $250M Abide Buyout After Pain Setback
(10/24, Nick Paul Taylor, Fierce Biotech) ...Lundbeck is slashing the book value of its $250 million Abide Therapeutics buyout in response to phase 1 data that triggered an early end to a pain program...The reappraisal of the value of the acquired assets follows a setback to a pain program. Johan Luthman, executive vice president of R&D at Lundbeck, framed the decision to stop development of Lu AG06474 as part of the company's ethos of "letting the molecule speak."... Full
Baxter International to Restart Highest-Throughput IV Solutions Manufacturing Line Next Week
(10/24, Heather Landi, Fierce Healthcare) ... Baxter International said Thursday it anticipates restarting its highest-throughput IV solutions manufacturing line within the next week...Baxter said Thursday it activated nine plants around the world...HHS Secretary Xavier Becerra said in a statement Thursday that he was "encouraged" by reports that Baxter anticipates restarting the highest throughput manufacturing line at Baxter's North Cove facility next week – sooner than originally expected... Full
Eli Lilly Weight Loss Drug Shortage Underscores Deeper Issues with FDA Oversight
(10/25, Lizzy Lawrence, Elaine Chen, and Ed Silverman, STAT Plus) ...Mariana Socal, a researcher at Johns Hopkins University who studies drug shortages, said the agency is hindered by the fact that it systematically communicates only with drugmakers rather than stakeholders like health systems and pharmacies... Sub. Req’d
AG Nessel Sues Pharmacy Managers for Role in Opioid Crisis
(10/24, Krystle Holleman, WILX) ...Michigan Attorney General Dana Nessel has filed a lawsuit against pharmacy benefit managers OptumRX and ExpressScripts for their role in the Opioid Epidemic in Michigan...The lawsuit alleges claims of Public Nuisance, Negligence, and under the Drug Dealer Liability Act against the pharmacy benefit managers... Full
Pharma's Race for Obesity Drugs is Still Hotting Up
(10/25, Roula Khalaf, Financial Times) ...The latest is a study suggesting such drugs reduce opioid and alcohol addiction by up to half. GLP-1s are being tested on patients with Alzheimer's, on top of conditions that can often go hand-in-hand with obesity. For pharmaceutical companies that are (or want to be) big players in areas from cardiovascular health to renal diseases, developing GLP-1s is becoming an imperative. This race is no longer about catching up with Novo and Lilly in the anti-obesity category, which is forecast to reach $130bn a year in peak sales by 2030... Full
Competition Will Make Weight-Loss Drugs Better, Cheaper and Bigger
(10/24, The Economist) ...The GLP-1 hormone that forms the basis of both drugs has proven highly effective at helping users shed pounds, so much so that their makers have struggled to keep up with demand...At the same time, competition is likely to make weight-loss drugs both better and cheaper. Although Novo Nordisk and Eli Lilly are expected to dominate the market for the time being, challengers are racing to develop alternatives, forcing the duo to continue innovating. Citeline, a research firm, estimates that more than 300 drug candidates are in the works, plenty of which are expected to arrive in the next few years... Full
U.S. Policy & Regulatory News
Latuda, Other Generics Cleared In 2022 Helped Generate Nearly $19Bn In Savings, US FDA Says
(10/24, Derrick Gingery, Pink Sheet) ...The schizophrenia and bipolar disorder treatment's generic versions saved more than $4.4bn, according to a US Food and Drug Administration report estimating the cost savings from new generic drugs approved in calendar year 2022..Savings from Latuda were the second-highest single product savings in the first 12 months of generic competition since 2018. The most savings came from generics of Pfizer's Lyrica (pregabalin), which generated $6.64bn in savings after their 2019 approval... Global Sub. Full
OIG To CMS: Stop Redundant Part D Payments For A Covered Drugs
(10/24, Gabrielle Wanneh, InsideHealthPolicy) ...A new audit report published Tuesday (Oct. 22) by the HHS Office of Inspector General is calling on CMS to employ five recommended strategies to prevent Medicare Part D from making additional payments for drugs that are supposed to be covered under the Part A skilled nursing facility benefit, as improper Part D payments for drugs Part A should cover remain on ongoing issue OIG has asked CMS to address since 2009... Sub. Req’d
Califf Bashes GLP-1 Drug Pricing, Hints At Future FDA Action
(10/24, Jessica Karins, Maaisha Osman, InsideHealthPolicy) ...FDA Commissioner Robert Califf publicly lambasted the producers of GLP-1 weight loss drugs this week, calling the medications' prices "outrageous" and unfair to lower-income Americans and pointing out that the companies producing the drugs for weight loss, Eli Lilly and Novo Nordisk, are not keeping up with demand.... Sub. Req’d
Drug Companies Should Answer the Call to Lower Weight Loss Drug Prices
(10/24, JC Scott, DC Journal) ...To deliver lower prescription drug costs for patients, drug companies need to do their part and lower the list prices of the drugs they make. That has to be the first step. We applaud Sanders for recognizing that. Our industry stands ready to continue our work to negotiate for lower costs and greater access... Full
Bicameral Dems' Bill Would Send Pharma Violators' Profits To NIH, FDA
(10/24, Luke Zarzecki, InsideHealthPolicy) ...A statement on the bill says the money would also only be available in years that appropriations for NIH and FDA are equal to or greater than the prior fiscal year. That provision aims to make sure the money raises the total level of research investment, rather than being used to save federal dollars...The lawmakers point to Teva Pharmaceuticals agreeing to a settlement with the Department of Justice over lawsuits alleging "that the company defrauded Medicare and conspired with other drug-makers to illegally inflate the prices of two generic drugs."... Sub. Req’d
Industry Rejects FDA's Proposal for Biosimilar Product-Specific Guidance
(10/24, Emily Hayes, Regulatory Focus) ...Biosimilars developers have strongly rejected the US Food and Drug Administration's proposal to develop product-specific or class-based guidance and are urging the agency to instead put its efforts toward updating its cornerstone guidance documents for the sector..."Product specific guidances would slow the development of biosimilars and would be an inappropriate use of BsUFA funds," wrote the Biosimilars Forum, whose members include Sandoz, Teva and Pfizer, among other companies... Full
AARP Maryland Calls for Expanded Prescription Drug Affordability Board Oversight
(10/24, AARP) ..."Ensuring prescription drug prices are reasonable and justified results in better access and affordability for consumers," said AARP Maryland State Director Hank Greenberg. "It's only fair. Because drugs don't work if people can't afford them."... Full
Bill To Increase The Authority Of The Maryland Prescription Drug Affordability Board Could Go Before The 2025 General Assembly
(10/25, Kevin McManus, WFMD) ...Tammy Bresnahan, AARP' Maryland's Senior Director of Advocacy, spoke in support of this initiative. "Maryland's landmark Prescription Drug Affordability Board now, as you've heard, has the authority to establish upper payment limits,": she said. "While this promises to help the strained budgets of state and local government, we need it to be expanded to help all Marylanders."... Full
International News
UK's ‘World First' Point Of Care Manufacturing Rules Enter Parliament
(10/24, Eliza Slawther, Pink Sheet) ...The UK government has introduced draft legislation that will regulate the manufacturing of innovative medicines such as cell and gene therapies at the point of care. The country's medicines regulator, the MHRA, says the framework is the "first of its kind in the world."... Global Sub. Full
EU HTA Regulation: Assessors Risk Exclusion for Secrecy Breaches
(10/24, Neena Brizmohun, Pink Sheet) ...The second of six implementing acts for the Health Technology Assessment Regulation has now been adopted. It deals with how the European Medicines Agency is to cooperate with the European Commission and HTA experts in Europe... Global Sub. Full
Gemme Warns French Budget Measures Will Destroy Generics Market
(10/24, Dave Wallace, Generics Bulletin) ...French industry association Gemme has issued a stark warning that recent legislative proposals – including a revision to the country's clawback mechanism and steeper financial penalties for failing to hold sufficient safety stocks – will "bring about the end of the generic economic model in France."... Global Sub. Full
Why Did the Centre Sanction a 50% Hike in Prices of Commonly-Used Drugs?
(10/25, Bindu Shajan Perappadan, The Hindu) ...The Central Government passed the order, citing "extraordinary circumstances" and "public interest." The NPPA comes under the department of pharmaceuticals under the Union Ministry of Chemicals and Fertilizers, and a government release stated that it increased prices in greater public interest... Sub. Req’d
"Quality Control in the Indian Pharma Industry": Who's Responsible?
(10/25, PT Jyothi Datta and Amitha Rajkumar, The Hindu BusinessLine) ...In this episode of the State of the Economy podcast, businessline's Jyothi Datta talks to Rishi Agrawal, CEO and Co-founder of TeamLease RegTech, about the Indian pharmaceutical industry, sparked by a recent report from the National Drug Regulator revealing a concerning number of substandard-quality drugs... Full
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