Wednesday, October 2, 2024

Teva: ‘We Have To Overachieve To Get Back Our Credibility'

(10/1, Dean Rudge, Generics Bulletin) ...Teva's CEO Richard Francis has spoken candidly about the steps he has taken in order for Teva to reclaim its credibility, underpinned by the company's ‘Pivot to Growth' strategy. Teva feels its present and its recent past will be "valued far more than the distant past," as its leader admitted the company was continuing to battle to regain "credibility" following years of stagnation and decline... Global Sub. Full

BofA Securities Reiterates Buy Rating On Teva Pharma (TEVA)

(10/1, StreetInsider.com) ...BofA Securities analyst Jason Gerberry reiterated a Buy rating and $22.00 price target on Teva Pharma. The analyst comments..."Given positive surprises in other areas of TEVA portfolio (Austedo, g-Revlimid and b-Humira) we view the Sandostatin LAR as a positive providing upside optionality for 2024-25 numbers. We estimate that if exclusivity remains, the TEVA generic could be a $200m contributor on an annual basis. Key to Teva's exclusivity are barriers to approval for this injectable both on regulatory and manufacturing side (bigger issue per Novartis). We maintain our Buy on Teva re-rating to growth multiple."... Sub. Req’d

First Generic Version of Sandostatin LAR Depot Now Available

(10/1, Diana Ernst, Rph, MPR) ...Octreotide Acetate for Injectable Suspension is supplied in 3 dosage strengths. The first generic version of Sandostatin® LAR Depot is now available from Teva Pharmaceuticals...After reconstitution and preparation of the injection, the product should be administered intramuscularly in the gluteal region at 4-week intervals... Full

Generic Version of Injectable Acromegaly Treatment Launches in US

(10/1, Healio) ...Teva Pharmaceuticals announced the launch of a generic form of Sandostatin LAR Depot. The medication is indicated for adults with acromegaly who had inadequate response to surgery or radiotherapy...[Ernie Richardsen Senior VP U.S. Commercial Generics for Teva] "This first-to-market launch showcases Teva's expertise in bringing complex generic formulations to market and demonstrates once again our ability to not only sustain a generics powerhouse, but also to bring value to patients and health care systems."... Full

A Free Drug Experiment Bypasses the US Health System's Secret Fees

(10/1, John Tozzi, Bloomberg) ...Blue Shield of California struck an unusual deal to buy a lower-cost version of Humira directly from a manufacturer, bypassing the giant pharmacy benefit managers that normally determine which maker's drug will go to tens of millions Americans. Beginning next year, Blue Shield will pay for $525 a month for the drug. That's about a quarter of what the company currently pays for Humira after rebates, according to a person familiar with the pricing who asked not to be named discussing private information... Sub. Req’d

Aurobindo Pharma Receives US FDA Approval For An Antibiotics Tablet

(10/1, Sreshti Srinivasan, NDTV Profit) ...Aurobindo Pharma Ltd. has received final approval from the US Food and Drug Administration to manufacture and market Cephalexin Tablets USP, an antibiotic, in 250 mg and 500 mg dosages...The tablet is expected to be launched in the third quarter of the financial year 2025... Full

$400 Million for An Obesity Drug Startup? A New Venture is a Sign of the Times

(10/1, Allison DeAngelis, STAT Plus) ...Atlas, Bain, and RTW Investments announced Tuesday that they have co-led a $400 million Series A financing for a new Boston-area startup company called Kailera Therapeutics...In an interview, [Ron Renaud] acknowledged that, in many ways, the company's pitch has a similar ring to some of the other efforts in the weight loss field: Kailera is focused on incretin mimetics that emulate the effects of hormones that help people feel full, including glucagon-like peptide 1, or GLP-1, or glucose-dependent insulinotropic polypeptide, or GIP... Sub. Req’d

Johnson & Johnson to Pour $2B into North Carolina Biologics Plant, Add 420 Jobs

(10/1, Zoey Becker, Fierce Pharma) ...J&J is planning to build a state-of-the-art biologics plant to provide supplies for treatments across the oncology, immunology and neuroscience treatment areas, J&J said in a Tuesday press release. Construction is slated to begin in the first half of 2025, and the site will have a workforce of 420 once fully operational..."We are investing in capacity and new technologies to enhance our industry leading capabilities and ensure a resilient supply chain for the future," Dapo Ajayi, J&J's vice president of innovative medicine supply chain... Full

Amid Large Cost-Cutting Drive, Pfizer Plans Manufacturing Layoffs in Ireland

(10/1, Eric Sagonowsky, Fierce Pharma) ...Pfizer is planning to cut up to 210 jobs in Ireland, several local news sources reported Tuesday. A company spokesperson told Fierce Pharma the drugmaker "recently launched a multi-year, multi-phased programme designed to assess the efficiency of our manufacturing, with the initial phase focused on finding operational efficiencies to increase productivity within the network." This has resulted in the company targeting a "reduction in the number of people supporting our overall manufacturing operations in Ireland."... Full

CVS to Lay Off Nearly 3000 Employees as Part of Cost-Saving Initiative

(10/1, Pearl Steinzor, AJMC) ...Mike DeAngelis, executive director, Corporate Communications at CVS Health, cited continued disruption, regulatory pressures, and evolving consumer needs as reasons for the layoffs, which represent 1% of the company's workforce. Front-line workers in stores, pharmacies, and distribution centers will not be affected...Additionally, CVS Health is exploring the possibility of splitting its retail and insurance units in response to pressure from investors, according to Reuters' sources... Full

Port Strike Fallout: Blockbuster Weight-Loss Drug Supply from Wegovy to Ozempic, Mounjaro, Zepbound, Caught Up in East Coast Trade Shutdown

(10/1, Lori Ann LaRocco, CNBC) ...As a port strike stretching from New England to Texas halted nearly half of all trade coming into the U.S., customs data shows that critical medical devices and drug components for the booming, expensive weight-loss and diabetes drugs from Novo Nordisk and Eli Lilly — Ozempic, Wegovy, Mounjaro and Zepbound — are among the trade casualties in the ILA union port work stoppage... Full

US Dockworkers Strike, Halting Half the Nation's Ocean Shipping

(10/2, Doyinsola Oladipo and David Shepardson, Reuters) ...The strike blocks everything from food to automobile shipments across dozens of ports from Maine to Texas, a disruption analysts warned will cost the economy billions of dollars a day, threaten jobs and potentially stoke inflation...Danish drugmaker Novo Nordisk, meanwhile, said it has workaround plans in place to minimize or prevent any disruption to its production, including by using air freight, CNBC reported on Tuesday, citing a company spokesperson... Full

Wyden, Brown Urge FTC to Investigate PBM 'Co-Manufacturing' Arrangements

(10/1, Paige Minemyer, Fierce Healthcare) ...Sen. Ron Wyden, D-Ore., chair of the Senate Finance Committee, as well as committee member Sherrod Brown, D-Ohio, wrote in a letter (PDF) to the FTC on Tuesday expressing concern about units formed recently at two major PBMs that seek to manufacture biosimilars that challenge high-cost branded drugs... Full

Senate Finance To FTC: Address New PBM ‘Co-Manufacturing' Practice

(10/1, Gabrielle Wanneh, InsideHealthPolicy) ...At issue are the separate decisions made by CVS Caremark and Cigna's Express Scripts to launch PBM-affiliated drug manufacturers this summer that purport to co-manufacture certain biosimilar alternatives for the blockbuster drug Humira. The CVS subsidiary Cordavis claims to co-manufacture Sandoz's Hyrimoz and the Express Scripts subsidiary Quallent Pharmaceuticals claims to co-manufacture Boehringer Ingelheim's Cyltezo. In the letter sent Monday (Sept. 30) to FTC Chair Lina Khan, the senators specifically ask the commission to launch a new Section 6(b) investigation of the emerging business practice... Sub. Req’d

Cassidy To FDA: It's Your Job, Not FTC's, To Clarify Orange Book Listings For Combo Products

(10/1, Maaisha Osman, Jessica Karins, InsideHealthPolicy) ...The Senate health committee's top Republican says the Federal Trade Commission (FTC) has exceeded its authority by trying to eliminate "junk" patent listings in FDA's Orange Book, and he demands FDA clarify patent listings for drug-device combination products rather than leaving the responsibility to FTC... Sub. Req’d

Ranking Member Cassidy Requests Answers on FDA's Failure to Provide Clarity on Drug Patent Listings

(10/1, U.S. Senate Committee On Health, Education, Labor & Pensions) ..."Despite Congress' clear charge to FDA to set the rules for listing patents in the Orange Book, FDA has been absent...Letting FTC enforce terms of the FDCA is an extraordinary abdication of authority by FDA," wrote Dr. Cassidy. "It is well within FDA's authority to identify the types of patents that manufacturers should, or should not, list in the Orange Book."... Full

Senators Question FDA and FTC Over Patent and PBM Reforms

(10/1, Zachary Brennan, Endpoints News) ...In a letter sent Monday to FTC Chair Lina Khan, Senate Finance Chair Ron Wyden (D-OR) and Sen. Sherrod Brown (D-OH) commended the regulator's recent PBM lawsuit and urged the commission to examine "new PBM tactics that appear to create further barriers to competition and harm the ability of consumers to access lower cost prescription drugs."...Separately, Sen. Bill Cassidy (R-LA), the top Republican on the Senate Health, Education, Labor and Pensions Committee, sent a letter Monday to FDA Commissioner Robert Califf telling him to not let the FTC enforce the terms of when patents should be listed in the FDA's directory of relevant patents, known as the Orange Book... Full

Why the FTC Suit Against Drug Benefit Managers Is an Unusual Step

(10/2, David Schwartz, Rebecca Nelson and Steve Scannell, Bloomberg Law) ...The FTC's administrative complaint alleges the PBMs chose to exclude insulins with lower list prices in favor of insulins with higher rebates and higher list prices. In turn, this allegedly led to certain patients having to pay higher out-of-pocket costs for insulin medication. The FTC's administrative complaint raises more questions than it answers. Initially, it claims the PBMs engaged in both "unfair methods of competition" and "unfair acts and practices" under Section 5 of the FTC Act. Normally these claims are brought separately, with different standards, procedures, and staff... Sub. Req’d

Evio Announces Groundbreaking Direct Purchase Agreement for Adalimumab Biosimilar

(10/1, Evio Pharmacy Solutions) ...Evio Pharmacy Solutions, a Blues-founded company focused on transformational solutions in the high-cost medication space, today announced the successful negotiation and implementation of an innovative direct purchase agreement with Fresenius Kabi, an operating company of Fresenius, for Adalimumab-aacf — a lower priced biosimilar version of Humira... Full

With Humira Biosimilar Deal, Some Blues Plans Are Cutting the Middleman — And AbbVie

(10/1, Jon Asplund, Crain's Chicago Business) ...With the deal, Blue Shield of California, one of Evio's owners, announced it will provide the biosimilar to health plan members for free in a bid to show the medicine can reach Americans affordably without going through the middlemen that typically control its flow. Blue Shield of California says it is challenging the practice of PBMs negotiating rebates, which the U.S. Federal Trade Commission recently ruled illegally drives up drug prices... Sub. Req’d

HHS Touts Fourth Quarter Part B Drug Cost Savings Due To Inflation Rebates

(10/1, Gabrielle Wanneh, InsideHealthPolicy) ...HHS announced Monday (Sept. 30) that 54 prescription drugs covered under Medicare Part B are expected to have their coinsurance rates lowered between Oct. 1 and Dec. 31 following price hikes from drug makers that were implemented faster than the rate of inflation. Seniors taking these drugs during the last quarter of the year may save anywhere between $1 and $3,854 a day... Sub. Req’d

CMS Should 'Clarify' Part B Inflation Rebates Don't Apply In Medicare Advantage, Pharma Says

(10/1, Cathy Kelly, Pink Sheet) ...Manufacturers ‘strongly object' to the possibility floated by the Centers for Medicare and Medicaid Services that it could extend price inflation rebates to Part B drugs furnished to enrollees in Medicare Advantage plans in addition to those covered by fee-for-service Medicare...PhRMA also urged CMS to require 340B claims modifiers for Part B drugs subject to price inflation rebates and establish a Part D claims repository to ensure drugs subject to 340B discounts are not included in the inflation rebates calculation... Global Sub. Full

ASPR Makes Second Defense Production Act Award For API Production

(10/1, Jessica Karins, InsideHealthPolicy) ...The Administration for Strategic Preparedness and Response (ASPR) will spend another $17.5 million to boost innovative manufacturing of active pharmaceutical ingredients (API) in the United States, HHS announced Tuesday (Oct. 1), the second award funded by ASPR's Defense Production Act program... Sub. Req’d

Q&A with John Murphy of AAM

(10/1, Peter Sullivan, Axios Pro) ...We spoke with the incoming CEO of the Association for Accessible Medicines, John Murphy, to get a sense of his priorities as the generic drug industry's point person in DC...[John Murphy:] At a big, high level, I think part of my vision, and I've talked extensively with the AAM board about this, is really to be extraordinarily vocal and utilize a lot of more diverse allies in the supply chain for pharmaceuticals, from patients to providers to health system pharmacists... Sub. Req’d

Vanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals, Inc.'s Big Bets On Petitioning and Litigation Against FDA and the Federal Government

(10/2, Kurt R. Karst, FDA Law Blog) ...The ramifications of the Federal Claims case and some of the other lawsuits brought by Vanda could be significant to regulated industry and to the food and drug bar... Full

Louisiana Board Report Sheds Light On DSCSA Adoption

(10/1, Joanne S. Eglovitch, Regulatory Focus) ...A majority of facilities have the necessary electronic systems to exchange data with their trading partners under the Drug Supply Chain Security Act (DSCSA), which goes into effect this November, according to a recent survey by the Louisiana Board of Drug and Device Distributors. The report notes, however, that a minority of companies have processes in place to identify authorized trading partners (ATPs) or to manage waivers, exceptions and exemptions (WEEs)... Full

FDA's FY23 GDUFA for Generic Drugs Development

(10/2, The Pharma Letter) ...The US Food and Drug Administration (FDA) yesterday released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report... Sub. Req’d

FDA Pulls the Trigger On Major Agency Reorganization

(10/1, Ferdous Al-Faruque, Regulatory Focus) ...The long-anticipated reorganization of two of the US Food and Drug Administration's (FDA) core programs is finally here. FDA Commissioner Robert Califf on Tuesday announced that agency has implemented its plan to create a unified Human Foods Program and a new field operations office in place of the former Office of Regulatory Affairs... Full

New York Targets Pharma Middlemen's Grasp On Drug Pricing Discussions

(10/2, Amanda D'Ambrosio, Crain's New York Business) ...Gov. Kathy Hochul signed a new bill last week that will crack down on the middlemen companies, who were previously permitted to control what pharmacists could tell patients about how much they get reimbursed for prescription drugs. It builds on previous legislation introduced in 2018 that banned PBMs from prohibiting all conversations between pharmacists and patients about their out-of-pocket costs for certain drugs... Sub. Req’d

EU HTA Regulation: Views Wanted On Draft Rules On Joint Scientific Consultations

(10/1, Francesca Bruce, Pink Sheet) ...A newly published draft implementing act sets out the procedural rules for the joint scientific consultations that are foreseen by the EU's Health Technology Assessment Regulation. Health technology developers will for the next four weeks have a chance to influence the rules governing the joint scientific consultations (JSCs) that will help them prepare for EU-level joint clinical assessments, which go live from January... Global Sub. Full

EMA And FDA Eliminating ‘Needless Differences' – Particularly For Rare Diseases

(10/1, Eliza Slawther, Pink Sheet) ...The European Medicines Agency and the US Food and Drug Administration are actively "working towards convergence," and usually "agree on common endpoints," for drugs in most therapeutic areas, according to Steffen Thirstrup, chief medical officer at the EMA... Global Sub. Full

French Industry Calls For Reduction In Rebates, Proposes Savings Plan

(10/1, Ian Schofield, Pink Sheet) ...As the government prepares to reveal its social security financing bill (PLFSS) for 2025, France's pharmaceutical industry association, Leem, has called for a progressive reduction in the sales rebate the industry has to pay each year through the so-called "safeguard clause."... Global Sub. Full

Russia Faces New Wave of Drop in Clinical Trials for New Drugs

(9/30, The Pharma Letter) ...The number of clinical trials of new drugs in Russia is steadily declining, which could be mainly related with the overall reduction of investment activities in the local pharmaceutical market, reports The Pharma Letter's local correspondent. In accordance with the recent report of the Russian Association of Clinical Research Organizations (AOKI), the number of permits issued by the Russian Ministry of Health to conduct trials of new drugs in Russia for the January-June 2024 period decreased by 26.4% year-on-year... Sub. Req’d

Leverage India's Unmatched Scale: Piyush Goyal Tells US Companies

(10/1, ANI) ...Union Minister of Commerce and Industry, Piyush Goyal, met with young Indian-origin CEOs and entrepreneurs in New York, emphasising the reforms introduced under PM Narendra Modi's leadership that have driven India's growth over the past decade...The Union Minister also met with Chirag Patel and Chintu Patel, Co-CEOs of Amneal Pharmaceuticals, to explore ways to leverage India's existing pharmaceutical ecosystem... Full

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