Wednesday, July 10, 2024

Teva Price Target Raised to $24 from $22 at UBS

(7/10, The Fly) ...UBS analyst Ashwani Verma raised the firm's price target on Teva to $24 from $22 and keeps a Buy rating on the shares. The firm continues to be bullish on its Teva thesis going into the second half of 2024, and believes proceeds from the active pharmaceutical ingredients sale could be in the $4.8B-$6.8B range, with faster timing potentially resulting in quicker deleveraging, the analyst tells investors in a research note... Full

Teva Pharma (TEVA) PT Raised to $24 at UBS

(7/10, StreetInsider.com) ...The analyst commented: "TEVA stock is down ~10% in the last three weeks on short-term noise (ITA, FTC, Indivior), but we continue to be bullish on our Teva buy thesis going into 2H24 "... Sub. Req'd

Argus Upgraded Teva Pharma (TEVA) to Buy

(7/10, StreetInsider.com) ...Argus analyst Jasper Hellweg upgraded Teva Pharma from Hold to Buy... Sub. Req'd

Argus Upgrades Teva to Buy, Sees Stock 'Attractively Priced'

(7/10, The Fly) ...The company appears to have "steadied its ship" following several years of challenges, launching a range of new drugs and achieving margin growth across all of its three primary business segments, the analyst tells investors in a research note. Argus adds that Teva has recently launched a range of new drugs, including an extended release version of its treatment for tardive dyskinesia, TD, and Huntington's disease chorea, as well as generic versions of the blockbuster drug Humira, plaque psoriasis and psoriatic arthritis drug Stelara, and GLP-1 treatment for type 2 diabetes, Victoza... Full

Pharmacist Support and Teva UK Renew Partnership to Expand Charitable Support

(7/10, Longjam Dineshwori, Pharmacy Business) ...Pharmacist Support and Teva UK have renewed their partnership, committing to expand charitable support across the pharmacy profession...Kim Innes, General Manager UK at Teva UK, added: "Teva UK is proud to continue our partnership with Pharmacist Support and the important work they do in championing wellbeing within the pharmacy profession. "As a front-line health service, pharmacy serves as a linchpin in healthcare, providing a valuable service in often challenging and pressurised circumstances."... Full

Xbrane Working Towards Q2 2025 US Ranibizumab Approval

(7/9, Dean Rudge, Generics Bulletin) ...Xbrane Biopharma aims to resubmit its proposed US Xlucane (ranibizumab) biosimilar to Lucentis in the final three months of this year, potentially teeing up a BsUFA date and approval during the second quarter of 2025...In response to the news, Xbrane assembled a task force of "very experienced team members," both from the firm and also with "external expertise," while promising to "work closely with the agency to submit as quickly as possible responses to the issues raised."... Global Sub. Full

Olainfarm Becomes Olpha And Sets Out European Strategy

(7/9, David Wallace, Generics Bulletin) ...Latvia's Olainfarm has unveiled details of its long-term strategy shortly after rebranding as Olpha, as it seeks to grow "from a regional player to an international company" in Europe and ultimately become one of the region's top ten pharmaceutical companies, with sales of "at least €1bn ($1.08bn) over the next ten years."... Global Sub. Full

Amneal Launches FOCINVEZ™, The First Ready-to-Use Version of Fosaprepitant

(7/9, Amneal Pharmaceuticals, Inc.) ...Amneal Pharmaceuticals, Inc. today announced the launch of FOCINVEZ™, a ready-to-use injectable. Unlike other versions of fosaprepitant, this single-dose vial product is free of Polysorbate 80 and does not require reconstitution or dilution and can be administered directly from the vial using the included vial hanger... Full

Novo Nordisk, Indonesia's Bio Farma Sign Deal to Produce Insulin

(7/10, Stanley Widianto, Reuters) ...Danish drugmaker Novo Nordisk has signed a deal with Indonesia's state-owned pharmaceutical company Bio Farma to produce insulin to combat diabetes in the Southeast Asian country, a senior Bio Farma official said on Wednesday. The deal comes as Novo, a dominant player in the global insulin market, shifts its century-old focus on insulin to a newer class of medicines called GLP-1 agonists... Full

Exclusive: Most Patients Stop Using Wegovy, Ozempic for Weight Loss Within Two Years, Analysis Finds

(7/10, Chad Terhune, Reuters) ...Only one in four U.S. patients prescribed Novo Nordisk's Wegovy or Ozempic for weight loss were still taking the popular medications two years later, according to an analysis of U.S. pharmacy claims provided to Reuters that also showed a steady decline in use over time...Evidence that many people may stop using the weight-loss therapies not long after starting is influencing a debate over their cost to patients, employers and government health plans... Full

Ozempic's Popularity Leads to Shortages for People with Type 2 Diabetes

(7/10, Sydney Lupkin, NPR) ...Telehealth company Ro built a free online tool to help patients report shortages of these drugs. Every few seconds, the map lights up with a little lightning bolt, indicating someone at that location went to their pharmacy to get their weight loss or diabetes drug and couldn't fill the prescription. The tracker received 35,000 reports of shortages by mid-June, within the first two weeks of its launch, says Ro's CEO Zach Reitano...These medications have been so wildly successful that the drugmakers can't keep up with demand, says Boston University health economist Rena Conti. "They should have been prepared to meet demand given their very aggressive advertising campaigns," Conti says... Full

Drug Shortages in America

(7/9, Molly Huth, MM+M) ...Though the chemotherapy drug cisplatin is now back in available supply, six other drugs have gone into shortage, according to multiple drug databases. Check out six of the latest drugs to face scarcity issues, what is causing these issues and when they can return to supply... Full

Purdue Pharma Secures Litigation Ceasefire After US Supreme Court Ruling

(7/9, Dietrich Knauth, Reuters) ...Purdue Pharma on Tuesday received U.S. court approval for a 60-day freeze on lawsuits against its owners, members of the wealthy Sackler family, in its first court appearance since a landmark Supreme Court ruling upended its bankruptcy settlement... Full

Mashantucket Pequots Planning To Add Generic Drug Manufacturing To Portfolio

(7/10, Jamil Ragland, CT News Junkie) ...With an ongoing shortage of hundreds of different drugs and rising pharmaceutical prices driving health care costs higher, one of the state's two tribal nations has started the process of establishing a manufacturing hub for generic drugs. The Mashantucket Pequot Tribal Nation announced Tuesday that it had been awarded a $2.45 million grant comes from the U.S. Economic Development Administration to start developing a comprehensive business plan on their way to the construction of a facility... Full

Middlemen Have Outsized Influence On US Drug Prices Due to Market Consolidation, FTC Says

(7/9, Ahmed Aboulenein and Jody Godoy, Reuters) ...The consolidation of pharmacies and health insurance companies through years of deal making has led to a handful of pharmacy benefit managers exercising outsized influence over prescription drug prices, the U.S. Federal Trade Commission said on Tuesday...The FTC argues the three biggest PBMs - managing 79% of U.S. prescription drug claims - have greatly enriched themselves at the expense of smaller pharmacies and consumers, according to an interim staff report calling for possible greater regulation... Full

FTC Report Finds PBMs Profit at the Expense of Patients and Independent Pharmacies

(7/9, Ed Silverman, STAT Plus) ...he agency noted that the three largest PBMs processed nearly 80% of the roughly 6.6 billion prescriptions dispensed by U.S. pharmacies in 2023. And the six largest PBMs — Caremark Rx, Express Scripts, OptumRx, Humana Pharmacy Solutions, Prime Therapeutics, and MedImpact Healthcare Systems — processed more than 90% of the prescriptions. Moreover, the FTC found the prescription drug market is "highly concentrated" because the largest PBMs are owned by insurers and, in turn, own specialty, mail order, or retail pharmacies... Sub. Req'd

Big Pharmacy-Benefit Managers Increase Drug Costs, FTC Says

(7/9, Liz Essley Whyte, The Wall Street Journal) ..."Any suggestions from the FTC about policies that limit the use of PBM negotiating tools would instead reward the pharmaceutical industry, leaving American businesses and patients at the mercy of the prices drugmakers set," a CVS spokesman said. An Express Scripts spokeswoman said the report was inaccurate and said its findings "will do nothing to address the rising prices of prescription medications driven by the pharmaceutical industry."... Sub. Req'd

Wyden Vows To Get PBM Reforms To WH After FTC Probe Finds Middlemen Abuse Power

(7/9, Gabrielle Wanneh, InsideHealthPolicy) ...Senate Finance Committee Chair Ron Wyden (D-OR) vowed to "go to the mat" to get pharmacy benefit manager reform legislation to the president's desk by December after the Federal Trade Commission reported Tuesday (July 9) its two-year staff investigation found PBMs use their market power to drive up costs to consumers... Sub. Req'd

PCMA Statement On FTC Interim PBM Report

(7/9, PCMA) ...[PCMA President and CEO JC Scott] "Today's interim FTC report falls far short of being a definitive, fact-based assessment of PBMs or the prescription drug market. Members of the commission themselves disagree with the content of the report and the decision to release it..The report completely overlooks the volumes of data that demonstrate the value that PBMs provide to America's health care system by reducing prescription drug costs and increasing access to medications."... Full

FTC Report Critical of PBMs Highlights Middlemen Profits Over Patient Savings

(7/9, AAM) ..."PBM practices too often block patient access to lower-priced generic and biosimilar medicines," said David Gaugh, Interim President and CEO of AAM. "Today's FTC report is merely further evidence that policymakers must act to ensure that safe and effective generic and biosimilar medicines are more available for patients." The FTC report points out that, "the dominant PBMs often exercise significant control over which drugs are available, at what price, and which pharmacies patients can use to access their prescribed medications."... Full

Biosimilars Forum Calls for Reform of the PBM Monopoly

(7/9, PhRMA) ...[Executive Director Biosimilars Forum Juliana M. Reed] "The FTC interim report importantly notes that PBMs exclude generic drugs and biosimilars from formularies in exchange for higher rebates paid to PBMs. These exclusionary schemes cut off patient access to lower-cost medicines. These unethical businesses practices should be investigated and reformed by the FTC, policymakers, and industry stakeholders."... Full

New 50-State Poll: Americans Want to Hold Health Insurers and PBMs Accountable for High Out-Of-Pocket Costs and Other Harmful Practices

(7/9, Cynthia Hicks, PhRMA) ...According to a new Morning Consult/PhRMA poll of more than 20,000 Americans, with insights reflective of all 50 states and 435 congressional districts, Americans want policymakers to address harmful insurer and pharmacy benefit manager practices that limit their access to new medicines and treatments... Full

Scoop: PBM Execs to Testify On July 23

(7/9, Peter Sullivan, Axios) ...Executives from the three biggest PBMs will testify at the House Oversight Committee on July 23, the panel confirmed to Axios...House Oversight spokesperson Jessica Collins told Axios executives from CVS Caremark, Express Scripts and OptumRx have agreed to testify at the hearing... Sub. Req'd

How Drug Middlemen Keep Beating the System

(7/10, David Wainer, The Wall Street Journal) ...Drug middlemen, known as pharmacy-benefit managers, have accomplished something rare in Washington: Their business practices have led to a bipartisan consensus of sorts around the need for more regulation. Yet successfully cracking down on the tactics that drive health costs higher won't be easy. That is because PBMs operate in a highly complex and opaque world where key information is kept from the public... Sub. Req'd

Lawmakers: Chevron Hinders FTC Privacy Regs, APRA

(7/9, Cara Smith, InsideHealthPolicy) ...At a House Energy & Commerce innovation subcommittee hearing on Tuesday (July 9) lawmakers questioned FTC commissioners on their budget request and asked for additional information on their recent consumer protection initiatives, including efforts to protect consumers' sensitive health data and geolocation data. Lawmakers also focused on a new FTC report on Pharmacy Benefit Managers and vertical integration... Sub. Req'd

Who Will Pay for Prescription Drugs in 2032: Four Takeaways from the New Government Forecasts

(7/9, Adam J. Fein, Ph.D., Drug Channels) ...The econowonks at the Centers for Medicare & Medicaid Services recently released the latest projections for U.S. spending on healthcare. These data provide the latest official look at how the Inflation Reduction Act will affect U.S. healthcare spending. As you will see below, CMS projects that outpatient prescription drugs dispensed by retail and mail pharmacies will remain a small share of total U.S. healthcare spending. The Inflation Reduction Act's changes to the Medicare Part D program, along with coming demographic shifts, will have a significant impact on future spending by government programs and consumers... Full

Contract Breach Suit Against Bausch Persists Under Judge's Order

(7/9, Celine Castronuovo, Bloomberg Law) ...A generic drug developer sufficiently alleged that the multinational pharmaceutical company Bausch Health breached its duty of good faith and fair dealing in agreements to help develop two generic ophthalmic drugs, a federal judge ruled... Sub. Req'd

House Speaker Mike Johnson Pledges Vote for BIOSECURE as China-Targeting Bill Hangs in Limbo

(7/9, Fraiser Kansteiner, Fierce Pharma) ...Ahead of an election in November—and amid a period of legislative uncertainty for the China-targeting BIOSECURE Act—U.S. House Speaker Mike Johnson (R - LA) has pledged to hold a vote for the controversial bill before the year is out. Speaking at an event held by conservative think tank the Hudson Institute, Johnson guaranteed that BIOSECURE would get his support and promised to push through more legislation around China-U.S. competition in 2024... Full

Closing Thoughts On US FDA Advisory Committee Reforms

(7/9, Michael McCaughan, Pink Sheet) ...The US Food and Drug Administration's day-long "listening session" on ideas to reform the advisory committee process bore an uncanny resemblance to the regular open public hearing in those meetings. Nearly 50 speakers offered five-minute perspectives to the agency, with most representing consumer or patient advocacy organizations. AbbVie Inc. was the only biopharma company to offer an industry view, although two trade associations, the Biotechnology Innovation Organization (BIO) and Consumer Healthcare Products Association, also presented... Sub. Req'd

FDA Releases Draft Guidance On Use-Related Risk Analysis for Combo Products

(7/9, Jeff Craven, Regulatory Focus) ...The US Food and Drug Administration has released a draft guidance outlining the purpose and content of a use-related risk analysis for drug- and biologic-led combination products..."A URRA is important to help identify use-related hazards associated with the user interface design of the combination product, as well as to characterize risks so they can be mitigated (such as through risk controls) or eliminated through improved product user interface design," FDA said... Full

Nordic HTA Initiative Offers ‘Practice Ground' For Worrisome EU-Level Joint Clinical Assessment

(7/9, Francesca Bruce, Pink Sheet) ...Concern continues to grow among industry and health technology assessment (HTA) bodies about the imminent EU-wide joint clinical assessments. However, if companies want to increase their chances of readiness for the challenges ahead, they should consider submitting a dossier through the Joint Nordic HTA-Bodies (JNHB) initiative to get a taste of how the collaborative assessment process might work. This was the message from Anja Schiel and Karen Kleberg Hansen, from the Norwegian Medical Products Agency and the Danish Medicines Council respectively... Sub. Req'd

Poland Leans Towards Shorter Data Exclusivity Period, One Year Market Protection

(7/9, Paulina Mozolewska, Euractiv) ...Warsaw has sided with the European Commission on the length of the Regulatory Data Protection period in the EU Pharma Package. Poland advocates that the incentives scheme should focus on market protection and not last more than a year..."In the ongoing discussion about reforming EU pharmaceutical law, it is crucial to consider drug safety and sector development not only at a national level but across Europe," Michal Byliniak, General Director of INFARMA, told Euractiv. "This is essential for advancing innovative therapies and maintaining Europe's global competitiveness."... Full

Swissmedic Cracks Down On Vague Drug Indications & Tightens Assessments of CCI Claims

(7/9, Neena Brizmohun, Pink Sheet) ...The Swiss drug regulator makes public the indications in drug marketing applications within 60 days of receiving them, but says the level of detail that companies provide on this front is inconsistent. It also promises to be more stringent when it comes to assessing claims by companies who are worried that their commercially confidential information will be disclosed... Sub. Req'd

Chinese Drugmakers Still Lag in R&D Depth Despite Outpacing Europeans in New Launches

(7/9, Ayisha Sharma, Endpoints News) ...China may have outranked Europe for the first time in the number of new medicines it developed through to launch last year. But analysts told Endpoints News that Europe still has the edge when it comes to the quality of drug innovation. An annual report by the European Federation of Pharmaceutical Industries and Associations (EFPIA) published last month showed that China displaced Europe to take second spot as an originator of new active substances to reach the market... Full

J&J Agrees to Slash Sirturo Price in South Africa, Prompting Authorities to End Antitrust Probe

(7/9, Zoey Becker, Fierce Pharma) ...The country's Competition Commission decided not to move forward with a complaint after "extensive engagements" with the Sirturo maker, the commission said in a press release. Along with J&J's prior commitment to not enforce its Sirturo patent in 134 low-and middle-income countries (including South Africa), the company agreed to slash the South African government's procurement price by 40%. The new price matches the figure that J&J offers to the Stop TB Partnership's Global Drug Facility, according to the commission. GDF supplies the med to "the majority of low-and middle-income countries," J&J has said... Full

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