Thursday, February 15, 2024

Teva Enlarges Workforce for First Time Since 2016

(2/15, Shiri Habib-Valdhorn, Globes) ...The Israeli pharmaceutical company had 36,472 employees at the end of 2023, up 3.8% from 2022, as Teva returns to growth. For the first time since 2016, Teva Pharmaceutical Industries Ltd. enlarged its workforce during 2023. The Israeli company had 36,472 employees at the end of 2023, up 1,347 or 3.8% from 2022, according to the expanded financial report for last year, which the company filed earlier this week... Full

A Review Of Teva's Prospects

(2/15, Matthew Zeets, Seeking Alpha) ...Teva Pharmaceutical has experienced a significant downturn in the last decade but has recently shown signs of recovery. The company has stabilized its operating income of around $3 billion for the past five years, but its large debt load is holding back shareholder value. Teva's revenue growth in 2023, driven by drugs like Austedo and Ajovy, indicates a potential turnaround, but the company still faces challenges with debt and interest payments... Full

Alvotech Announces Expected Global Market Entry Dates for AVT04 Biosimilar to Stelara® (Ustekinumab)

(2/15, Alvotech) ...Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has reached settlement agreements with Johnson & Johnson in Japan, Canada and in the European Economic Area for AVT04, a biosimilar to Stelara® (ustekinumab). Regulatory approval for AVT04 in these markets has already been granted. Market applications for AVT04 are currently pending in additional global markets, including in the U.S... Full

Alvotech Settles with J&J to Launch Stelara Biosimilar in Europe, Canada

(2/15, Leroy Leo, Reuters) ...The deals allow Alvotech's biosimilar, or near copies of a biological drug, to enter the Canadian market in the first quarter of this year and Japan in May. Entry to the first European markets is expected after late July...In June, Alvotech and its Israeli partner Teva Pharmaceutical reached a settlement and licensing agreement with J&J for the launch of the biosimilar, AVT04, no later than Feb. 21, 2025, if it gets U.S. FDA approval. The regulator's decision is expected by April 16... Full

Lupin Launches Ganirelix Acetate Injection in the US, Shares Down

(2/15, Arushi Mishra, The Hindu) ...Lupin Limited introduced Ganirelix Acetate Injection, 250 mcg/0.5 mL, Single-Dose Prefilled Syringe, in the United States market. This launch marks Lupin's entry into the peptide-based injectable segment...The company said that Ganirelix Acetate Injection is expected to address market opportunity, with estimated annual sales of $87 million in the U.S. as of December 2023 (IQVIA MAT data)... Full

India's Glenmark Pharma Posts Loss for Q3 as Remediation Cost Weighs

(2/14, Rishika Sadam, Reuters) ...India's generic drugmaker Glenmark Pharmaceuticals posted a quarterly loss for the second time straight, hurt by higher expenses and costs related to remediation of its manufacturing sites. The company's consolidated net loss came in at 3.51 billion rupees ($42.28 million) for the third quarter ended Dec. 31, compared with 2.73 billion rupees reported a year earlier. Total expenses during the quarter rose 4.2% to 29.97 billion rupees... Full

Biogen, Grappling With Declining Sales, Slapped With DOJ Subpoena Over Foreign Operations

(2/14, Angus Liu, Fierce Pharma) ...Biogen has received a subpoena from the DOJ seeking information about its "business operations in several foreign countries," the company disclosed in an annual filing. In addition, the company is providing information about its foreign businesses to the U.S. Securities and Exchange Commission, Biogen said. It's not clear which countries the DOJ and the SEC have set their sights on... Full

Pfizer Agrees to Pay $93 Mln to Settle Lipitor Antitrust Lawsuit

(2/15, Mike Scarcella, Reuters) ...Pfizer has agreed to pay $93 million to settle antitrust claims by wholesale drug distributors that accused it of conspiring with India's Ranbaxy Laboratories to delay sales of less expensive, generic versions of the cholesterol drug Lipitor...Pfizer in a statement called the allegations "factually and legally without merit." It said the settlement was "fair, reasonable and the best way to resolve this litigation."... Full

Mark Cuban Drug Company Unveils New Offering for Hospitals

(2/14, Paige Twenter, Becker's Hospital Review) ...Mark Cuban Cost Plus Drug Co. now offers critical drugs in shortage to healthcare providers. Healthcare companies can register for the drug company's new "marketplace," which stocks key medications in short supply, according to a Feb. 14 post on X. The portfolio includes amoxicillin-potassium clavulanate, cefdinir, etoposide, capecitabine, irbesartan and budesonide inhalation... Full

PBMs: When Competition Does Not Benefit Consumers

(2/14, Rose McNulty, AJMC) ...In a session held during the 2023 Patient-Centered Oncology Care meeting, Erin Trish, PhD, codirector of the USC Schaeffer Center and associate professor of pharmaceutical and health economics, University of Southern California in Los Angeles, fielded questions about the PBM landscape from Stephen Schleicher, MD, MBA, chief medical officer at Tennessee Oncology. The discussion, titled "Fireside Chat: Navigating the PBM Landscape: How a Heath Care Economist Sees It," provided a fresh perspective on the topic for an audience of oncology stakeholders... Full

U.S. Agencies Open Inquiry Into Generic Drug Shortages

(2/14, Christina Jewett, The New York Times) ...The Federal Trade Commission and the Department of Health and Human Services said on Wednesday that they would examine the causes of generic drug shortages and the practices of "powerful middlemen" that are involved in the supply chain... Sub. Req'd

FTC, HHS Probe GPO, Wholesaler Roles In Drug Shortages

(2/14, Maaisha Osman, Dorothy Mills-Gregg, InsideHealthPolicy) ...FTC announced Wednesday (Feb. 14) it is exploring whether the wholesalers and GPOs have exploited their market power to push down prices of generic drugs to a point where these drug makers can't make a profit and they must stop manufacturing, thereby causing shortages. In the RFI, FTC and HHS want public input on the market concentration of GPOs and wholesalers and insights into their contracting methods... Sub. Req'd

Drug Shortages Trigger FTC Probe

(2/14, Liz Essley Whyte, The Wall Street Journal) ...The agency is exploring whether the companies that broker drug purchases for hospitals, along with the middlemen that ship the medicines, have misused their market power to push down prices of generic drugs so much that some manufacturers can't profit and have stopped production, causing shortages. The probe is seeking information about a market dominated by a handful of companies. Three groups purchase drugs on behalf of most hospitals in the U.S., while the three leading wholesalers supply about 90% of drugs to hospitals and other buyers across the country... Sub. Req'd

FTC, HHS Probe GPO Contracting Practices As Source Of Generic Drug Shortages

(2/14, Brenda Sandburg, Pink Sheet) ...The agencies said GPOs they were referencing are entities that broker deals for generic pharmaceuticals and other medical supplies between healthcare providers and manufacturers, distributors and other vendors who sell to healthcare providers. They listed 17 topics that they would like the public to address. The first two suggest potential legal challenges. They ask whether and to what extent manufacturers, GPOs, and drug wholesalers are complying with their legal obligations under Section 3 of the Clayton Act and the Robinson-Patman Act and whether and to what extent the available protections for GPOs under the federal Anti-Kickback Statute affect lack of competition, contracting practices by GPOs, and drug shortages... Sub. Req'd

AAM Commends HHS and FTC Call for Information and Solutions On Drug Shortages and Patient Access to Generics and Biosimilars

(2/14, AAM) ..."AAM commends HHS and FTC for seeking input on the impact of group purchasing organizations and wholesale distributors on the sustainability of generic drug competition," said David Gaugh, Interim President & CEO of AAM...AAM has released a white paper highlighting the sustainability challenges facing the industry, worked with IQVIA to establish the facts around drug shortages, and articulated the causes and solutions to drug shortages. We look forward to working with HHS and FTC in this effort... Full

‘D' Is for Dynamic: CMS Proposals Could Shake Up Medicare Drug Benefits

(2/14, Leslie Small, Pink Sheet) ...While many IRA changes are seen as having an adverse effect on stand-alone PDPs, tweaks to the risk adjustment model, TrOOP calculation, and enhanced plan benefit designs rolled out by CMS make predicting how the market will shake out difficult. In two recent proposals, CMS outlines numerous changes to technical aspects of the Medicare Part D program – many of which are related to provisions in the Inflation Reduction Act that restructured the Part D benefit phases. Sources tell AIS Health, a division of MMIT, that the proposals could have both positive and negative effects on Part D plan sponsors and beneficiaries and will likely attract a bevy of industry feedback... Sub. Req'd

Congress Can Fix the Broken PBM Industry

(2/14, Robert Levin and Angus Worthing, Inside Sources) ...As our patients and many healthcare colleagues know, the PBM industry is in dire need of reform. Delinking drug prices from PBM income and requiring PBMs to pass through discounts, rebates and other price concessions are critical steps in the right direction. These reforms would reduce out-of-pocket costs for patients, improve access to affordable medications, and create a more fair and transparent system for all stakeholders... Full

Jackson Bill Seeks to Lower the Price of Insulin, Ease Access for Nonprofit Manufacturers

(2/14, Evan Popp, Maine Morning Star) ...LD 1793, sponsored by Senate President Troy Jackson (D-Aroostook), would require that insurance companies cover the lowest-price insulin available and not pass on any cost-sharing to patients. It would also waive registration fees for non-profit drug manufacturers to incentivize the sale of low-cost insulin in Maine. Jackson said during a hearing on the bill Tuesday before the Health Coverage, Insurance and Financial Services Committee that the measure would help prevent Mainers with diabetes from having to make impossible decisions between affording a critical medication and buying other necessities... Full

Irish Hospital Researchers Discover New AMR Bacteria

(2/14, Brian Maguire, Euractiv) ...Researchers at Ireland's University of Limerick have discovered a new species of bacteria resistant to antibiotics...A spokesperson for Ireland's Department of Health told Euractiv that both the Department of Health and the HSE Antimicrobial Resistance & Infection Control team intend to monitor any future developments, adding that Ireland takes a One Health Approach to tackling AMR, in line with international best practice...In the private sector, pharmaceutical companies have also begun a structured approach to combat AMR linked to drug manufacturing. In November, Sandoz and Teva became the first organisations to qualify for the new global Minimized Risk of Antimicrobial Resistance certification... Full

India Assures of Protection to its Pharma Industry, Generic Drugs in All FTA Talks

(2/15, Abhimanyu Sharma, CNBC TV 18) ...The Commerce Ministry has stated that during the FTA discussions with European Free Trade Association member countries, India rejected Switzerland's demand for data exclusivity for medicines. EFTA comprises Switzerland, Liechtenstein, Norway, and Iceland. Pledging India's full support for its generic drugs industry, the Commerce Ministry has emphasised the importance of ensuring the flourishing of the country's generic drugs industry, contributing to both exports and domestic needs... Full

Leaked Version of EFTA-India Free Trade Deal Sparks Alarm Over Access to Medicines

(2/14, Ed Silverman, STAT Plus) ...A leaked version of a proposed agreement between India and the European Free Trade Association is causing alarm among civil society and patient advocacy groups over concerns the deal would delay access to affordable generic versions of newer, lifesavings medicines for several years. The language in a draft agreement, which is expected to be concluded by April, suggests changes would have to be made to India's patent and regulatory laws. Specifically, drug manufacturers would be given six years of so-called data exclusivity, which refers to the exclusive rights to the results of preclinical tests and clinical trials for a medicine. This information would not have to be shared with generic companies. As a result, a brand-name drugmaker would obtain an extended monopoly... Sub. Req'd

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