Monday, October 28, 2024

Teva And Alvotech Add Indications For US Stelara Rival

(10/25, Dave Wallace, Generics Bulletin) ...Rainey said Teva was "thrilled with the expansion of Selarsdi's indications, marking another significant milestone in Teva's commitment to increasing access to biosimilars in the US." The latest approval "allows us to serve patients battling gastrointestinal diseases as the US launch of Selarsdi approaches in early 2025," he observed, insisting that "Teva's dedication to increasing uptake of biosimilars remains steadfast, and we are proud to continue this partnership with Alvotech across a portfolio of nine partnered products."... Global Sub. Full

Celltrion's Phase 3 Trial Confirms Yuflyma's Interchangeability with Humira

(10/28. Kim Ji-hye, Korea Biomedical Review) ...Celltrion said Monday that its global phase 3 trial results confirmed the interchangeability of its biosimilar Yuflyma (adalimumab, development code: CT-P17) with Humira for autoimmune disease treatment, showing comparable efficacy, safety, and pharmacokinetics in 367 patients with moderate to severe plaque psoriasis... Full

India's Sun Pharma Beats Q2 Profit Estimates On Strong Sales

(10/28, Rishika Sadam and Kashish Tandon, Reuters) ...Sun Pharmaceuticals, India's largest drugmaker by revenue, reported second-quarter profit above analysts' estimates on Monday, aided by strong sales of its specialty drugs that are used to treat uncommon medical conditions... Full

Torrent Pharma Q2 Results | Net Profit Up 17%, Revenue Grows 9%

(10/25, Jomy Jos Pullokaran, CNBC TV 18) ...Drug firm Torrent Pharmaceuticals Ltd on Friday (October 25) reported a 17.4% year-on-year (YoY) increase in net profit at 453 crore for the second quarter that ended September 30, 2024. In the corresponding quarter of the previous fiscal, Torrent Pharmaceuticals posted a net profit of ?386 crore, the company said in a regulatory filing... Full

Pfizer Management Looks to Show Turnaround as Starboard Looms

(10/28, Michael Erman, Reuters) ...Investors and analysts said they want to see improved profitability following the company's billions in cost cuts over the past year, as well as revenue growth, particularly from the cancer drugs picked up in the company's 2021 to 2023 acquisition spree...Gabelli's Jonas said he would like Pfizer to tighten its focus on three or four key therapeutic areas, noting that the company has had recent successes in oncology and vaccines. "They've kind of done a little bit of everything, and not really focused," he said. "So I think there's room for improvement."... Full

Eli Lilly Gets Nod to Launch Blockbuster Weight-Loss Drug in HK

(10/27, Shirley Zhao, Bloomberg) ...Eli Lilly & Co. expects to start selling its highly popular weight-loss drug in Hong Kong as early as the end of this year, potentially making it the first of its kind to become available in the China region...The launch in Hong Kong could fuel an instant spike in demand and even encourage customers from mainland China — where illegal copies of these shots are rampant — to visit the city for the shots. Amid the global shortage, Novo has said it will limit initial sales of Wegovy in China, which approved the drug in June, to avoid disruption in supply to other markets... Sub. Req’d

IV Shortage After Hurricane Helene Reveals a Bigger Problem

(10/26, Lisa Jarvis, Bloomberg) ...After the shortage is confirmed, hospitals try to conserve supplies — considering which patients can get by on alternatives and cutting back on care. According to a recent survey from Premier Inc., a health analytics consulting firm, around 12% of hospitals are cutting back on elective surgeries and 58% are considering that option in the coming weeks. So what can we do to improve the resilience of the supply chain? Several simple efforts could help. One would be increasing visibility into supply chain... Full

Why Do Hospitals Keep Running Out of Generic Drugs?

(10/25, Sally Helm, Alexi Horowitz-Ghazl, Martina Castro and Willa Rubin, NPR) ...There's something strange going on in hospitals. Cheap, common drugs that nurses use every day seem to be constantly hit by shortages. These are often generic drugs that don't seem super complicated to make, things like dextrose and saline (aka sugar water and salt water). So what's going on? The answer, as with anything in healthcare, is complicated... Full

Strengthening Regulatory Framework for Compounded Medications

(10/28, Miranda Schmalfuhs, PharmExec.com) ...Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, of the Alliance for Pharmacy Compounding discuss the challenges faced by patients and healthcare providers due to drug shortages, particularly for semaglutide and other medications. It highlighted the role of compounding pharmacies in addressing these shortages and the importance of distinguishing legitimate compounding pharmacies from illicit actors. The conversation also emphasized the need for collaboration between pharmaceutical manufacturers, healthcare providers, and regulatory agencies to improve the drug supply chain and ensure patient access to essential medications... Full

The FDA Commissioner Takes a Seat with AAM On the Final Day of GRx+Biosims Conference

(10/25, Bob Pollock, Lachman Consultants) ...On the last day of GRx+Biosims, David Gaugh, Executive Vice President of AAM, had a fireside chat with Robert Califf M.D., commissioner of the Food and Drug Administration...He left the audience with two thoughts: Be honest...Keep doing what you are doing with generics and biosimilars because it is the one thing that really holds down drug costs effectively... Full

Califf: AI Can Boost Post-Market Surveillance, Mitigate Drug Shortages

(10/25, Maaisha Osman, InsideHealthPolicy) ...Artificial intelligence (AI) can help boost FDA's post market surveillance by analyzing vast amount of real-world data to identify safety issues, benefits and performance patterns, as well as alleviate drug shortages, FDA Commissioner Robert Califf wrote in a JAMA commentary published Oct. 15... Sub. Req’d

Strengthening the Supply Chain: Key Insights From FDA Commissioner Robert Califf

(10/25, Skylar Jeremias, The Center for Biosimilars) ...During a fireside chat at GRx+Biosims, FDA Commissioner Robert Califf, MD, shared his perspective on key challenges and sustainability concerns in the generic drug industry, touching on pressing issues within the US health care system and broader global supply chain vulnerabilities... Full

Biden's Cancer Moonshot's Last Acts: Easing Pediatric Drug Shortages

(10/28, Brianna Abbott, The Wall Street Journal) ...The federal government is testing a new way to prevent treatment disruptions for seven pediatric cancer drugs by improving communication between hospitals, nonprofits and wholesalers. Shortages of cancer medicines regularly plague hospitals and patients, sometimes forcing them to delay or change care. "No one in this country should struggle for access to the treatment they need, but kids and families facing cancer in particular ," said Danielle Carnival, an adviser to Biden who leads his "Cancer Moonshot" effort... Sub. Req’d

Insured Americans Can't Predict Drug Costs: Survey

(10/28, Maya Goldman, Axios) ...51% of Americans with insurance say they can't predict how much their covered prescription medications will cost...Many Americans "don't believe that the system is working for them. Their costs are going up, they're getting less affordable coverage, and some complain about more bureaucracy," said Mark Keida, public affairs vice president at PhRMA... Full

Medicare Plans Should Halt Off-Label Avastin Step Therapy Amid Supply Disruption, CMS Told

(10/25, Cathy Kelly, Pink Sheet) ...A major supplier of off-label compounded Avastin for ophthalmic use is discontinuing the product, prompting physician groups to urge that Medicare Advantage plans suspend step therapy requirements favoring the off-label product. An alternative supplier could emerge, but repackagers may be discouraged by the prospect of an FDA-approved version launching in the latter half of 2025, which would limit access to the compounded product. The development could lead to higher Medicare costs, the leading payer for treatments of age-released eye disease, because the approved product will cost more than off-label Avastin... Global Sub. Full

The Costly Failures Of Medicine's Middlemen

(10/28, Robert Pearl, M.D., Forbes) ...Today, half of all Americans can't afford their out-of-pocket medical expenses and 70% are unsure what healthcare services will cost before undergoing treatment. Meanwhile, employers now pay an average of over $25,000 a year to insure a family of four. To understand the failure of healthcare's middlemen, let's examine two of the most influential types... Sub. Req’d

Pharmacy Benefit Managers Are Under Fire. What Do Their Lobbyists Say?

(10/25, McKenzie Beard, The Washington Post) ...The industry has faced accusations of using pricing tactics that drive up costs for patients, but the main PBM trade group contends that much of the criticism from state and federal agencies, lawmakers, and others is misplaced. Last week, I spoke with JC Scott, president and CEO of the Pharmaceutical Care Management Association, to learn more. Our conversation has been edited for length and clarity... Full

Finish The Fight: Patients Can Push PBM Reform Legislation Over the Finish Line | NCPA 2024

(10/27, Lauren Biscaldi, Drug Topics) ...At the 2024 National Community Pharmacists Association Annual Convention and Expo, Cole's father Bil Schmidtknect shared his son's story with a room full of independent pharmacists and pharmacy owners, all of whom have struggled at the hands of pharmacy benefit managers... Full

PhRMA: HRSA's Pushback Against Drug Maker Policies Permits Program Exploitation

(10/25, Gabrielle Wanneh, InsideHealthPolicy) ...The brand drug lobby is calling on Congress to pass legislation that would demand more transparency from hospitals and community health centers participating in the 340B drug discount program and curb statutory violations following the government's success in getting Johnson & Johnson to cease implementation of a policy that would have paid a rebate to certain covered entities for select 340B drugs instead of the traditional upfront discount... Sub. Req’d

Everyone's Tough On Drugs Again

(10/27, Carmen Paun, Politico) ...The Harris and Trump campaigns said the presidential candidates are talking about drug treatment, albeit more quietly than they are border security. Vice President Harris' campaign pointed to her web site, where she touts her prosecution of drug traffickers and the Biden-Harris administration's investment in "lifesaving programs."... Full

NYC Drops GLP-1 From City Health Benefits Over High Costs

(10/25, Luke Zarzecki, InsideHealthPolicy) ...The city said GLP-1 drugs for weight loss were incorrectly added to city employees' benefits through EmblemHealth and the city never planned to cover them, saying they could dramatically increase premiums, according to the outlet's article. The Alliance for Women's Health and Prevention criticized the decision in a statement Thursday, saying a quarter of adults in NYC live with obesity. The group, which has ties to GLP-1 manufacturers, advocates for full coverage of anti-obesity medications... Sub. Req’d

Future EU Health Commissioner Pledges Action On Pharma Reform, Shortages & Biotech

(10/25, Ian Schofield, Pink Sheet) ...Olivér Várhelyi has outlined his roles and responsibilities over the next five years if he is confirmed as European Commissioner-designate for health and animal welfare before he undergoes what is expected to be a tough grilling by members of the European Parliament. Pursuing the completion of the EU pharmaceutical reform is among his plans... Global Sub. Full

Hungary's Olivér Várhelyi Readies to Be EU Health Commissioner, Pledging Major Pharma Support

(10/25, Zachary Brennan, Endpoints News) ..."We need a regulatory framework suited to the rapid pace of technological change in the healthcare sector," Várhelyi wrote. "That is the goal of the overhaul of the EU pharmaceutical legislation proposed in April 2023. This would put in place a modern, simplified and supportive regulatory framework that makes it more attractive for companies to invest in research and development for innovative medicines in the EU, including specific incentives for medicines for rare diseases."... Full

Generics Industry Sounds Alarm Over Northern Ireland Requirements As Deadline Looms

(10/25, Dave Wallace, Pink Sheet) ...With a looming deadline of January 1, 2025 for firms supplying Northern Ireland to comply with the Windsor Framework, UK generics and biosimilars association the BGMA has warned of potential supply interruptions due to requirements that include a "UK only" label for all packs as well as UK-based batch testing for biologicals... Global Sub. Full

ePharma Sector Launches Campaign to Push the EU Towards a Digital Shift

(10/27, Tohomas Mangin, Euractiv) ...In a bid to make their voices heard, around fifteen sectoral organisations, including the Alliance for Safe Online Pharmacies, the European Association of e-Pharmacies, and the European Health Management Association, will launch their "Coalition for Online Ordering and Home Delivery of Medications" on Tuesday, October 29... Full

UK Health Secretary Warns GLP-1s Not for 'Body Beautiful Picture for Instagram' Amid Misuse Concerns

(10/25, Ben Adams, Fierce Pharma) ...The Medicines and Healthcare products Regulatory Agency (MHRA), concerned about a rise in misuse of the drugs, has issued a joint statement with the British government warning that people risk potential side effects from using the drugs when not needed, with GI issues, plus more serious problems like pancreatitis and hypoglycaemia, representing some of the risks. There are also warnings about private prescriptions of the drug... Full

Tweaks in Drug Formulations to Extend Copyrights is a Public Health Challenge

(10/28, Dhanendra Kumar, The Indian Express) ...Under the Make in India Initiative, the Centre has launched the National Biopharma Mission (NBM) — an industry-academia collaborative mission managed by the Biotechnology Industry Research Assistance Council. This $250 million mission, co-funded by the World Bank, aims to accelerate biopharmaceutical development. It supports nearly 150 organisations and 300 MSMEs, with 21 shared infrastructure facilities established for research and biomanufacturing... Full

Jan Aushadhi Kendras Catch Up as Quality Medicines Made Available at Cheaper Rates

(10/26, International Business Times) ...The demand for opening more Pradhan Mantri Jan Aushadhi Kendras across the country is increasing as more and more people avail of the cheap generic drugs available at the centres which are as effective as the expensive, branded drugs in the market... Full

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