Wednesday, September 4, 2024

Teva Pharma (TEVA) PT Raised to $26 at UBS

(9/3, StreetInsider.com) ...UBS analyst Ashwani Verma raised the price target on Teva Pharma to $26.00 (from $24.00) while maintaining a Buy rating. The analyst commented: "We view duvakitug Ph2 data in 4Q as an attractive catalyst for TEVA's stock, with significant upside and limited downside potential...Beyond duvakitug, we see scope for TEVA stock upside from a FY24 beat/raise & potential API sale."... Sub. Req’d

6 Drugs Now in Shortage

(9/3, Paige Twenter, Becker's Hospital Review) ...Here are six new shortages to know about, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists: Amoxapine oral tablet: Teva Pharmaceuticals has four presentations of the antidepressant on back order, and the company expects a release date in late September. Four presentations are available at Chartwell Pharmaceuticals... Full

US Allows More Vyvanse Production to Address ADHD Drug Shortages

(9/3, Ike Swetlitz, Bloomberg Law) ...US drug authorities are allowing 24% more production of Vyvanse, an ADHD drug from Takeda Pharmaceutical Co. and generic rivals, to address treatment shortages that have dragged on for the past two years... Sub. Req’d

US Allows Increased Production of Takeda's ADHD Drug to Address Shortage

(9/4, Mariam Sunny, Reuters) ...The raised production limit follows the Food and Drug Administration's request in July, the DEA said in a notice on Tuesday. Attention deficit hyperactivity disorder (ADHD) drugs have been in short supply for years. The FDA warned of a shortage of Israel-based drugmaker Teva Pharmaceutical Industries' Adderall in October 2022, troubled by manufacturing delays. That led to a spike in demand and subsequent shortage of Takeda's Vyvanse... Full

Sandoz Plans First GLP1 Generic Drug Launch in Canada in 2026

(9/3, Paula Doenecke, Bloomberg) ...Sandoz Group AG plans to launch a semaglutide generic drug in Canada when the patent for the main ingredient of blockbuster diabetic and weight-loss drugs like Ozempic and Wegovy wears off in 2026. "Canada is the second largest market for GLP-1s globally, so it's quite a significant opportunity," Sandoz Chief Executive Officer Richard Saynor said in an interview with Bloomberg Television Tuesday. The company expects to learn important lessons from the launch for the market opening in Europe and the US, expected in 2030, he said... Full

Sunshine Biopharma Expands Its Generics Portfolio In Canada

(9/3, Urte Fultinaviciute, Generics Bulletin) ...Sunshine Biopharma has achieved its goal of expanding its portfolio to 60 generic prescription drugs in Canada by the end of the year by adding nine new generics...The newly launched drugs cover multiple treatment areas, such as oncology, anti-inflammatory, antibacterial, dermatology, endocrinology, cardiovascular, and osteoporosis... Global Sub. Full

Fresenius Offloads Chilean Operation As It Slims Down Manufacturing

(9/3, David Wallace, Generics Bulletin) ...Fresenius Kabi has completed the divestment of its Chilean subsidiary Laboratorio Sanderson to Peru's Medifarma, including the transfer of an IV drug facility in Santiago de Chile, as part of streamlining the German group's manufacturing operations...The transaction includes the transfer of an intravenous drug facility in Santiago de Chile, a move that Fresenius said would contribute towards "streamlining the production network of its operating company Fresenius Kabi in line with its Vision 2026 and #FutureFresenius [strategy]."... Global Sub. Full

Celltrion's Autoimmune Drug ‘Steqeyma' Gains Approval in UK

(9/4, Choi Mun-hee, Business Korea) ...Celltrion announced on September 4 that its biosimilar for the autoimmune disease treatment "Stelara," named "Steqeyma," has received marketing authorization from the Medicines and Healthcare products Regulatory Agency in the United Kingdom. The approval for Steqeyma in the UK covers the same indications as those previously approved by the European Commission (EC), including plaque psoriasis, psoriatic arthritis, and Crohn's disease, which are the main indications of the original drug... Full

Medincell Announces Progress in the Development of its Products Portfolio and R&D Pipeline

(9/3, Medincell) ...The second innovative product developed with Teva is an investigational once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine (mdc-TJK). It has the potential to be the first long-acting olanzapine with a favorable safety profile as other LAIs of olanzapine have been associated with an FDA black box warning for PDSS that limits their use... Full

Roche Trumpets New Fenebrutinib Data in Relapsing MS

(9/4, Phil Taylor, Pharma Phorum) ...Data from a phase 2 trial of Roche's oral BTK inhibitor fenebrutinib have shown "near-complete suppression" of disease activity and disability progression in relapsing multiple sclerosis...The positive readout comes right after Sanofi revealed that its oral BTK drug tolebrutinib failed two phase 3 trials in relapsing MS, although, the company has said it will press ahead with a regulatory filing after a third study in non-relapsing secondary progressive MS was positive... Full

Tolebrutinib Delays Disability Progression in Non-Relapsing Secondary Progressive MS

(9/3, Rose McNulty, AJMC) ...In the phase 3 HERCULES study (NCT04411641), tolebrutinib met its primary end point of delaying time to confirmed disability progression (CDP) in non-relapsing secondary progressive multiple sclerosis (nrSPMS), according to a press release from Sanofi... Full

Dr. Reddy's Banned from China's Drug Procurement Program After Inspectors Turn Up Manufacturing Problems

(9/3, Fraiser Kansteiner, Fierce Pharma) ...Following a remote inspection of a Dr. Reddy's formulations production plant, China's National Medical Products Administration (NMPA) has suspended the import, sale and use of the Indian drugmaker's atomoxetine hydrochloride capsules for attention-deficit/hyperactivity disorder (ADHD). The ban took hold Aug. 30, according to a release (Chinese) from China's National Healthcare Security Administration (NHSA)... Full

FDA Scrutiny of India's Zydus Results in Warning Letter

(9/3, Joseph Keenan, Fierce Pharma) ...Zydus Lifesciences continues to be under intense scrutiny from the FDA, which hit the Indian drugmaker's production facility in Jarod with a warning letter...Although no specific violations were cited in the company's response, Zydus said the most recent FDA reprimand didn't contain any data integrity issues. While the warning won't impact existing supplies from the facility, it does, however, restrict new launches, "which is critical for business growth in the U.S. market," Zydus added in the filing... Full

Pharma Distributors Get Nod in $300 Million Opioid MDL Agreement

(9/3, Ufonobong Umanah, Bloomberg Law) ...Cencora Inc., Cardinal Health Inc., and McKesson Corporation got preliminary approval of a $300 million settlement with third party payors after the payors alleged the healthcare companies harmed them in their pursuit of opioid profits...According to the settlement agreement, McKesson would pay about 38% of the settlement fund, with the other companies paying just over 30%. The parties do not admit wrongdoing, according to the motion... Sub. Req’d

Out-of-Pocket Drug Prices Surge Ahead of Insurers' Costs, Analysis Finds

(9/3, Kyle Munz, AJMC) ...Today, an analysis published in Health Affairs took a deeper look into how out-of-pocket prices and manufacturer rebates factor into the complexities behind pharmaceutical costs. This investigation revealed that the out-of-pocket drug prices faced by consumers have grown quicker over time than those encountered by insurers... Full

New Trend Of Pharma Selling Directly To Consumers Raises Questions

(9/3, Joshua P. Cohen, Forbes) ...Enabling patients to order prescription medications directly from the drug maker is an emerging trend exemplified by the launch this year of two online platforms, LillyDirect and PfizerForAll, by Eli Lilly and Pfizer, respectively. Other pharmaceutical companies may follow suit. While these initiatives facilitate patient access to certain products, they also raise (ethical) questions concerning the possible disruption of established patient-physician relationships and the potential for conflicts of interest... Full

Eli Lilly Sues to Block FDA Interpretation of Biological Product

(9/3, Nyah Phengsitthy, Bloomberg Law) ...Eli Lilly & Co. is seeking to block the FDA's decision to designate its obesity medicine, retatrutide, as a drug instead of a biological product. The Food and Drug Administration's determination that Eli Lilly's product is "neither a protein nor analogous to a protein and is therefore not a biological product" is arbitrary and capricious, the drugmaker wrote in a complaint Tuesday in the US District Court for the Southern District of Indiana... Sub. Req’d

Out-of-Pocket Spending On Prescriptions Grew Even After Accounting for Rebates: Study

(9/3, Paige Minemyer, Fierce Healthcare) ...There's no shortage of attention on rising pharmaceutical costs, but policymakers need to have the full picture of trends in this space to work off of, according to a new study. Researchers at the Bureau of Economic Analysis wanted to account for the role the pharmacy benefit manager-negotiated rebates play in drug pricing trends. They compared claims data with rebate estimates from 2007 to 2020 and found that retail pharmacy prices increased by 9.1% each year... Full

Generics and Biosimilars: The Missing Piece in US Drug Price Negotiations

(9/3, CPI) ...The US government's negotiation of prescription drug prices under the Biden Administration's Inflation Reduction Act has resulted in new maximum prices for Medicare that, according to a Reuters review, remain significantly higher than those in other high-income countries. Despite the newly negotiated rates, the costs are still on average more than double, and in some cases five times, what drug manufacturers have agreed to in countries like Australia, Japan, Canada, and Sweden... Full

Medicare Drug Price Savings Varied, Offset By Part D Redesign

(9/3, Nyah Phengsitthy, Bloomberg Law) ...Negotiated drug prices under Medicare resulted in a variety of price reductions compared with their 2023 net prices, which included five drugs facing cuts in the 30% to 40% range and two drugs subject to no price cuts, health policy analysts say...The true extent of savings have been unclear because the government compared negotiated prices with list prices, which Medicare wasn't originally paying as drugs were subject to rebates... Sub. Req’d

Interpreting The First Round Of Maximum Fair Prices Negotiated By Medicare For Drugs

(9/3, Sean D. Sullivan, Health Affairs) ...Based on our analysis, of the ten drugs selected in the first round of negotiation, Stelara presented the greatest relative price reduction, with an MFP 42% below 2023 Part D net price, followed by Entresto (36%), Enbrel (33%), and Imbruvica (30%)...CMS could further negotiate prices below these ceilings based on how the net prices and clinical benefits of the selected drugs compare to those of their therapeutic alternatives, as well as additional factors specified in guidance... Full

J&J's Drug Discount Plan Prompts Calls for Enforcement Actions

(9/3, Nyah Phengsitthy, Bloomberg Law) ...Johnson & Johnson's proposal to end up-front discounts for drugs purchased by hospitals treating low-income and uninsured patients is likely to fuel potential health agency enforcement actions against the drugmaker, health attorneys say...John Shakow, a partner in the FDA and life sciences practice at King & Spalding LLP, said J&J is being "very modest in its proposal to move to 340B rebates" because it not only applies just to disproportionate share hospitals, but also drugs that were selected under the government's Medicare Drug Price Negotiation Program... Sub. Req’d

Vermont Firing Up Canadian Drug Importation Application

(9/3, Luke Zarzecki, InsideHealthPolicy) ..."I've been asked by both the governor's office and the legislature to take a look at what's been done, and come back with some recommendations about what (a target completion date) could look like," Director of Health Care Reform Brendan Krause in Vermont's Agency of Human Services (VAHS) told Inside Health Policy. The application was stalled due to staffing resources and time, Krause said. Vermont had many "big ticket items" happening in the state, including pursuing a model to replace the all-payer model with CMS that is ending in 2025, hospital financial sustainability and more... Sub. Req’d

Ashley Moody Wants Florida Supreme Court to Decide Opioid Settlement Dispute

(9/3, WUFT) ...Attorney General Ashley Moody wants the Florida Supreme Court to resolve a legal battle about whether hospital districts and school boards should be able to pursue opioid-epidemic lawsuits after she reached settlements with the pharmaceutical industry... Full

Pharma Firms To Benefit From New UK Hub-And-Spoke Clinical Trial Network

(9/3, Eliza Slawther, Pink Sheet) ...Pharmaceutical companies will be able to work with a newly-established network of clinical trial delivery centers and primary care providers in all four UK nations as part of a new public-private investment scheme...£400m from the public-private VPAG investment program will be used to boost clinical trials, manufacturing sustainability and HTA processes across the UK. Three-quarters of the funding (£300m) will be used to establish commercial research delivery centers which industry can use to run clinical studies... Sub. Req’d

EU-US-Japanese-Indian Pharmacopeia Group Says ‘New Members Wanted'

(9/3, Neena Brizmohun, Pink Sheet) ...The deadline is nearing for pharmacopoeias to express their interest in joining the decades-old discussion group that works to harmonize excipient monographs and general chapters and reduce the burden on manufacturers to perform analytical procedures in different ways depending on the jurisdiction...Pharmacopoeias around the world that want to join the PDG have until September 15, to express their interest and December 31, to submit a formal application... Sub. Req’d

DoP Extends Bid Submission Timeline for Selection of Consultancy Firm to Execute PRIP Scheme

(9/4, Pharmabiz.com) ...The Department of Pharmaceuticals (DoP) has extended the bid submission and opening dates for the selection of consulting firm for strategy development and implementation of the Promotion of Research and Innovation in Pharma MedTech (PRIP) sector scheme, due to technical reasons... Full

Making Sustainability Sustainable

(9/3, Viveka Roychowdhury, Express Pharma) ...As Ramesh Swaminathan, Executive Director, Global CFO and Head of Corporate Affairs, Lupin points out, the pharma industry's contribution to the climate crisis comes from its 4.4 per cent share of global CO2 emissions. Although this percentage is lower than that of other industries, without action, emissions are expected to rise. Thus, he points out that the pharma industry has a unique responsibility to take action and promote sustainability. While it needs to reduce its greenhouse gas (GHG) emissions through net-zero strategies, it also needs to address the adverse health effects of the climate crisis by providing affordable medicines... Full

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