Friday, January 24, 2025

Teva, Astellas Plan to Participate in IRA Drug Price Negotiations

(1/23, Nicole DeFeudis, Endpoints News) ...A spokesperson for Teva told Endpoints that the company is "confident in our ability to navigate the impact of the IRA," despite the selection of its movement disorder treatment Austedo and its extended-release version, Austedo XR. The company said last summer that it had already factored the IRA into its business plan. "While some assumptions and market dynamics have shifted, and are still evolving, we will continue to experience strong growth based on our current analysis," the spokesperson said on Thursday... Full

Teva Lawsuit Labels The IRA A ‘Fiction' As Austedo Opens Up To Price Negotiations

(1/23, Dean Rudge, Generics Bulletin) ...According to Teva's suit, the CMS guidance re-writes two of Congress' critical limitations by making drugs eligible for price controls only after they have been marketed for a set number of years; and through the IRA exempting drugs from price controls when a non-branded competitor – such as a generic or biosimilar – emerges...Stating it will suffer imminent irreparable harm from both the IRA as enacted and from the CMS's "unlawful guidance purporting" to implement the IRA, Teva is seeking injunctive relief, declaratory relief, and relief under the Administrative Procedure Act to "prevent harm to both itself and its patients."... Global Sub. Full

Teva's Multiple Sclerosis Stalwart Copaxone Gets FDA Boxed Warning for Anaphylaxis Risk

(1/23, Zoey Becker, Fierce Pharma) ...After years of legal wrangling surrounding Teva's Copaxone, the latest hit to the lucrative multiple sclerosis drug comes in the form of a safety-related boxed warning. The label update, which also applies to Sandoz's substitutable generic Glatopa, warns of the risk of a rare but serious allergic reaction, anaphylaxis, in patients who take the drug... Full

FDA Adds Boxed Warning to Teva's MS Drug, Sandoz's Generic

(1/23, Elizabeth S. Eaton, FirstWord Pharma) ...After paying close to $1 billion last year to settle litigation in the US and EU over marketing tactics for Copaxone (glatiramer acetate), Teva Pharmaceuticals was hit with another setback for the multiple sclerosis (MS) drug on Wednesday...While Copaxone has been a staple MS treatment for years, a recent FirstWord survey found that newer B-cell depleting agents such as Roche's Ocrevus (ocrelizumab) have slowly pushed down the use of older, established agents... Full

FDA Tacks Boxed Warning On Teva's Copaxone, Other MS Drugs

(1/23, Tristan Manalac, BioSpace) ..The FDA on Wednesday added a new boxed warning to a class of multiple sclerosis therapies—including Teva Pharmaceuticals' Copaxone—about a risk of severe and potentially life-threatening allergic reactions... Full

FDA Adds Boxed Warning to Multiple Sclerosis Drugs After Anaphylaxis Cases

(1/23, Robert Barrie, Pharmaceutical Technology) ...The agency issued the warning about the rare but serious risk of allergic reaction to the medicine, known under the brand names Copaxone and Glatopa, via a drug safety communication on January 22...Teva Pharmaceutical's Copaxone was approved by the FDA in 1996 to treat relapsing forms of MS, an autoimmune disorder that affects the central nervous system. Glatopa, a generic version of Teva's product, was approved by the FDA this year and marketed by Sandoz. The drugs have demonstrated a 34% drop in the number of relapses compared to placebo... Full

India's Torrent Pharma Misses Q3 Profit Estimates, Hurt by Insulin Plant Closure

(1/24, Ashna Teresa Britto, Reuters) ...Indian drugmakers have seen strong growth in domestic formulations, particularly in therapeutic areas, including cardiac, gastrointestinal, and anti-diabetes. However, Torrent Pharma was hurt due to the closure of an insulin manufacturing facility in August and a 17% on-year depreciation in Brazil's currency, the company said. Rival Granules India posted a drop in third-quarter profit hurt by pricing pressure in its key European market, while Mankind Pharma posted a smaller-than-expected profit, hurt by a sharp rise in expenses... Full

India's Mankind Pharma Misses Q3 Profit View as Expenses Jump

(1/23, Nishit Navin, Reuters) ...India's Mankind Pharma reported a smaller-than-expected third-quarter profit on Thursday, hurt by a sharp rise in expenses...Mankind said the $1.6 billion acquisition of Bharat Serums and Vaccines, effective October, also impacted the quarterly results, making them not comparable to the year-ago quarter. It had reported a profit of 4.54 billion rupees in the previous year. Revenue rose 24%, in line with analysts' expectations, driven by an increase in market share of its chronic illness drugs in India to 37.6% from 35.6%... Full

Granules India's Q3 Profit Falls On Weak Drug Pricing in Europe

(1/24, Kashish Tandon, Reuters) ...Granules, which holds a 30% share of the global paracetamol market, supplies the drug as an active pharmaceutical ingredient (API) and as a finished dosage form - ready for consumption - in Europe, Canada, and South Africa. APIs are the active and key components in a drug that produce the intended therapeutic effects. Indian API makers have been grappling with weak pricing in key European and North American markets due to tough competition, even as global drugmakers turn to India to limit their reliance on Chinese contractors... Full

Merck KGaA Says High Asset Prices Call for Prudent M&A Approach

(1/23, Divya Chowdhury, Mehnaz Yasmin, Reuters) ..."We need to stay prudent and patient because our business is returning to growth organically. We are not in a rush," CEO Belen Garijo told the Reuters Global Markets Forum on the sidelines of the World Economic Forum's annual meeting in Davos, Switzerland. Pharma and technology company Merck is particularly focused on strengthening its Life Science unit, which makes lab gear and supplies, but asset prices when measured as a multiple of earnings are high, she added... Full

Purdue Pharma, Sacklers Reach $7.4 Billion National Opioid Settlement

(1/23, Dietrich Knauth, Reuters) ...Under the new settlement, the Sacklers will pay $6.5 billion, with another $900 million coming from Purdue, without fully shutting off lawsuits from states, local governments, or individual victims of the opioid crisis. Those who do not wish to join the settlement are free to pursue lawsuits against the Sacklers, who have said they would vigorously defend themselves in court. The deal was negotiated by 15 states, including New York, California, Connecticut, Oregon, Texas, Florida and West Virginia. The other states will be asked to sign on the settlement, which must be approved by a U.S. bankruptcy judge before it becomes final... Full

FDA Grants Approval to Generic Extended-Release Memantine/Donepezil and Everolimus

(1/23, Gillian McGovern, Pharmacy Times) ...FDA approved generic memantine/donepezil for moderate to severe Alzheimer's dementia, available in 14-mg/10-mg and 28-mg/10-mg extended-release capsules. Everolimus, a generic for Afinitor Disperz, is approved for TSC-associated subependymal giant cell astrocytoma in patients aged one year and older. The availability of these generics provides expanded treatment options for Alzheimer's dementia and tuberous sclerosis complex-associated conditions... Full

J&J Unit Settles With Lannett in Patent Suit Over Uptravi Copies

(1/23, Christopher Yasiejko, Bloomberg Law) ...Actelion Pharmaceuticals US Inc. settled a federal lawsuit that accused Lannet Co.'s proposed copies of Uptravi tablets of infringing two patents the Johnson & Johnson unit licenses from Nippon Shinyaku Co. for the blockbuster pulmonary arterial hypertension drug... Sub. Req’d

Pharmascience Looks Back At First Year Of New CDMO Unit

(1/23, Adam Zamecnik, Generics Bulletin) ...Looking back at his first year at Pharmascience, Foy spoke to Generics Bulletin about the company's expansion into CDMO services and its CDMO+ business model, while also providing an update on its investments and plans in the years to come... Global Sub. Full

Importing Generic Drugs Could Ease U.S. Shortages

(1/17, Chloe Searchinger, Allison Krugman, Thomas J. Bollyky, Think Global Health) ...Life-saving generic injectable drugs, such as chemotherapy for cancer patients or penicillin G to keep mothers' pregnancies safe, should not be making headlines for delayed access in 2025. Patients should not have to and need not wait so long... Full

Why the Distortion in the Pegfilgrastim Market?

(1/23, Stanton Mehr, Biosimilars Review & Report) ...Since the first approval of Fulphila in 2018, the pegfilgrastim market has added competitors and steadily decreased in net price through 2022. The latest Samsung Bioepis Biosimilar Market Report indicates that pegfilgrastim biosimilar marketshare is up to 85% in year 7. And two products account for 73% of that total. The picture has changed considerably since 2022, when IQVIA data reported a 30% biosimilar share. And this figure may eventually grow with Udenyca on-body injector challenging Amgen's Neulasta OnPro marketshare... Full

Mark Cuban's Company Sells 6,000+ Medicines to Healthcare Sites

(1/23, Paige Twenter, Becker's Hospital Review) ...In less than a year, Mark Cuban's Cost Plus Marketplace has expanded its portfolio to more than 6,000 medicines. Mark Cuban Cost Plus Drug Co. launched the Marketplace in February 2024, which at the time had more than 4,000 medicines in short supply to directly sell to healthcare facilities. Since then, customers have realized savings between 40% and 60% compared to traditional wholesalers, according to Chief Commercial Officer Alan Bowe... Full

As Another Trump Term Gets Underway, Pharma Advisors Get Comfortable With Uncertainty

(1/23, Max Bayer, Endpoints News) ..."I don't think that anyone is in any position to predict exactly," Priya Chandran, managing director, senior partner and global sector lead for the Boston Consulting Group's biopharmaceuticals team, said in an interview with Endpoints News on the sidelines of the conference last week...The reality of a Trump administration is that it's a "fluid dynamic," said Stephen Ubl, CEO of the trade group PhRMA..."There can be daily ebbs and flows, but we need to remain focused on our core priorities," Ubl said in an interview with Endpoints. Those priorities include changes to the Inflation Reduction Act and federal 340B program, plus pushing legislation that would overhaul the business of pharmacy benefit managers... Full

E&C Committee Targets PBM Reform, Opioid Epidemic Amid Partisan Clashes Over IRA, ACA, Medicaid

(1/23, Jalen Brown, Inside Health Policy) ...House Energy & Commerce Chair Brett Guthrie (R-KY) said during the committee's organizational meeting last week that advancing pharmaceutical benefit manager (PBM) reforms along with other policies from the bipartisan end-of-year package scuttled in December remain a top priority and that he's seeking a path forward for the legislation... Sub. Req’d

Trump's Early Moves Could Actually Increase Drug Prices for Seniors

(1/23, Paul Brandus, Market Watch) ...On Tuesday, the first full day of his new term, Trump scrapped former President Joe Biden's Executive Order 14087, titled "Lowering Prescription Drug Costs for Americans." That order tasked the Department of Health and Human Services with studying models aimed at further reducing prescription costs for Medicare and Medicaid beneficiaries...Since Biden's order was merely to authorize a study into how prescription costs could be lowered, it's unclear what was illegal or radical about it. It's also hard to see how potentially lowering drug prices could be unpopular or inflationary... Sub. Req’d

Metered Dose Inhaler Propellant Transition: US FDA Eager To Avoid Replay Of CFC-To-HFA ‘Complexity'

(1/23, Michal McCaughan, Pink Sheet) ...The FDA hopes the transition away from HFA propellants in metered dose inhalers is not as complicated as the transition from CFC to HFA propellants. Sponsors are not expected to reformulate their products, but supply chain and cost problems are expected. During a recent workshop, the FDA outlined a development framework that eventually could become a guidance document... Global Sub. Full

Oklahoma Takes CVS Caremark to New PBM Court Over Alleged Underpayments

(1/23, Brendan Pierson, Reuters) ...The complaint, announced Thursday by Oklahoma Attorney General Gentner Drummond, marks the first case against a pharmacy benefit manager brought before an administrative law court within the attorney general's office. The administrative procedure for enforcement actions against pharmacy benefit managers was established in November 2023...The complaint identifies 200 individual prescriptions for which Caremark paid 15 independent Oklahoma pharmacies less than the drugs' acquisition cost, violating Oklahoma law... Full

Birmingham Sues Drug Companies, Says City Hurt by ‘Insulin Pricing Scheme'

(1/23, Savannah Tryens-Fernandes, AL.com) ...The lawsuit, filed last week, says the city paid an estimated $5.5 million for insulin and diabetes medication from 2009-2021 for employee health benefits. The suit says insulin vials cost as little as $2 to produce, were priced at $20 per vial in the 1990s, and "now range in price from $300 to over $700." The city accuses a number of defendants, from insulin manufacturers, like Eli Lilly, Sanofi and Novo Nordisk, to the companies that manage pharmacy benefits, including CVS Health and Express Scripts, of engineering the price of medications to increase their profits - prices that "reflect neither the manufacturers actual cost to produce the drugs nor the fair market value."... Full

Editorial: AG's Suit Highlights Why Insulin Prices Are So High

(1/24, The Boston Globe) ...There is a role for PBMs in health care, and they should be paid through reasonable administrative fees. But they shouldn't be allowed to operate in ways that drive up costs for consumers... Sub. Req’d

India's Biopharma Industry Needs to Become a Little Bit More Ambitious

(1/24, Viveka Roychowdhury, Express Pharma) ...In a free wheeling conversation with Viveka Roychowdhury, Dr Dhananjay Patankar, biopharma consultant, explains why Indian biopharma companies should feel more confident to take the higher investment risks required to tap the US biopharma market, given the successes in Europe, the overall talent base and understanding within the Indian industry. He also emphasises why more engagement between industry and regulators like the CDSCO and US FDA is pivotal to increase the success rate of India's biopharma companies... Full

Panel Asks DoP to Fix Issues Related to Implementation of PRIP

(1/24, Gireesh Babu, Pharmabiz.com) ...Identifying that the Promotion of Research and Innovation in Pharma Med-Tech (PRIP) Scheme to support industry-academia linkage in pharma and med-tech research and development (R&D) has been facing challenges in initiation, a Parliamentary Panel has sought the Department of Pharmaceuticals (DoP) to fix all the issues related to the scheme at the earliest... Full

China Investigates Reports of Bulk-Buy Medicine Quality Problems

(1/24, Andrew Silver, Reuters) ...In a notice, issued early this week, the agency said it would lead a team to Shanghai to gather feedback on the country's drug bulk-buy procurement programmes that focus on off-patent medicines. It said the agency "attached great importance" to reports that some drugs purchased through bulk-procurement might have quality problems...The drugs on the list include off-patent blockbusters made by Western pharmaceutical giants as well as generics produced by local players... Full

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