Thursday, January 2, 2025

Teva Looks to Peel Back the Onion On CNS, Mental Health Conditions As it Works On Long-Acting Schizophrenia Candidate

(12/31, Zoey Becker, Fierce Pharma) ...Teva, which launched a Dr. Reddy's-partnered generic to Zyprexa in 2011, spotted a gap in the market for an effective controlled-release version of the popular treatment. Long-acting medicines are especially crucial for schizophrenia treatment adherence, as about 80% of patients end up stopping treatment after two years, Teva's vice president of U.S. innovative medicines, Heather DeMyers, explained in a recent interview with Fierce Pharma...Teva is "not going to stop" exploring available opportunities to advance treatment as it "peels back the onion," in the massively undertreated market, DeMyers said... Full

Duvakitug And Teva's Growth: A Game Changer In Pharma

(12/27, Seeking Alpha) ...Uzedy's sales amounted to $35 million in the third quarter of 2024, increasing more than 16 times year-on-year. Meanwhile, sales of Teva's generics in North America reached $1.09 billion for the three months ended September 30, 2024, up 30.4% from the same period a year earlier. In addition to decreasing its net debt by more than $1 billion in the first three quarters of2024, in this article, you will discover why I continue to cover Teva Pharmaceuticals with a "Buy" rating... Full

Sale of Teva's Active Pharmaceutical Ingredient Division Could Conclude Next Year

(12/31, The Debrecen Sun) ...Teva Pharmaceuticals is undergoing significant transformation as its Israeli-based parent company has decided to sell the company's global active pharmaceutical ingredient (API) division. The transaction, expected to be finalized in the first half of 2025, will impact the manufacturing facilities in Debrecen as well... Full

‘Everyone Thinks Generics And Biosimilars Is Easy' – Sandoz's Saynor Talks Evolution Of Core Businesses

(12/30, Dave Wallace, Generics Bulletin) ...Having already provided an overview of Sandoz's broader trajectory in part one of our exclusive three-part interview, CEO Richard Saynor now delves further into the importance for the company of both its biosimilars and small-molecule generics businesses, discussing portfolio selection for biosimilars and explaining why the firm's ambitions for small-molecule generics are not the same in Europe as they are in the US... Global Sub. Full

Celltrion Receives FDA Approval for Phase 3 Trial of Darzalex Biosimilar 'CT-P44'

(12/27, Jasmine Choi, Business Korea) ...Celltrion has obtained approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application to proceed with the global Phase 3 clinical trial of the Darzalex biosimilar "CT-P44," the company announced on Dec. 27... Full

FDA Approves Injectable Version of Bristol Myers Squibb's Cancer Drug Opdivo

(12/27, Sneha K, Sriparna Roy, Reuters) ...The injection, branded as Opdivo Qvantig, has been approved to treat all previously approved adult, solid tumor indications, either on its own, as maintenance therapy or in combination with chemotherapy. The drug will be available in early January, and will be priced at parity with the list price of the IV version, Adam Lenkowsky, Bristol's chief commercialization officer, told Reuters ahead of the approval... Full

Lupin Acquires Huminsulin in India from Eli Lilly

(12/31, Business Standard) ...Lupin announced the acquisition of Huminsulin in India from Eli Lilly and company (Lilly) to further enhance its diabetes portfolio for an unspecified amount. Lupin has been marketing the Huminsulin range of products comprising of Insulin human, including Huminsulin R, Huminsulin NPH, Huminsulin 50/50, and Huminsulin 30/70, through existing distribution and promotion agreements with Lilly, India... Full

Roche Has No Plans for Job Cuts and Business is Healthy, CEO Says

(12/29, Dave Graham, Reuters) ...Swiss pharmaceutical company Roche is not planning job cuts and its business is healthy, CEO Thomas Schinecker was quoted as saying by a Swiss newspaper on Sunday..."I can say with certainty that we have a very healthy business. And we don't have a growth problem either," he said, while noting that Roche's budget for research and development was stable and not growing. Asked when Roche's planned anti-obesity drug would hit the market, Schinecker said it could be around 2029 or sooner... Full

China's WuXi to Sell Advanced Therapies Unit Amid US Restrictions

(12/24, Rajasik Mukherjee and Shivangi Lahiri, Reuters) ...China's WuXi AppTec said on Tuesday its subsidiaries have signed a deal with U.S.-based private equity firm Altaris LLC for the sale of its cell and gene therapy manufacturing unit, WuXi Advanced Therapies, for an undisclosed sum. The company, along with other Chinese firms, have been at the center of new U.S. laws aimed at restricting their businesses in the United States due to national security concerns... Full

Novartis Must Face Claims it Paid Kickbacks to Promote MS Drug, US Appeals Court Rules

(12/27, Jonathan Stempel, Reuters) ...A U.S. appeals court on Friday revived a whistleblower lawsuit accusing Swiss drugmaker Novartis of paying illegal kickbacks to doctors to induce them to promote its blockbuster multiple sclerosis drug Gilenya. In a 3-0 decision, the 2nd U.S. Circuit Court of Appeals in Manhattan said the whistleblower Steven Camburn can try to prove that Novartis violated the federal False Claims Act by holding "sham" speaker events to boost Gilenya sales... Full

Express Scripts Gets Partial Win in West Virginia Opioid Suit

(12/24, Nyah Phengsitthy, Bloomberg Law) ...Pharmacy benefit managers Express Scripts and OptumRx were able to get Judge John Preston Bailey of the US District Court for the Northern District of West Virginia to dismiss a claim that they violated the Racketeer Influenced and Corrupt Organizations Act by carrying out a fraudulent scheme of dispensing opioids to maximize profits for themselves and drug manufacturers... Sub. Req’d

Cencora Loses Insurance Coverage Dispute Over Opioid Litigation

(12/26, Olivia Alafriz, Bloomberg Law) ...Under Delaware case law, the damages sought in the underlying suits didn't trigger coverage under the policies issued by a number of insurers—including units of American International Group Inc. and Hartford Financial Services Group Inc.—Delaware Superior Court Judge Meghan Adams said in a Dec. 23 ruling granting partial summary judgment to the carriers... Sub. Req’d

2025 Forecast: After Novo, Lilly Expansion Sprees, 'Positive Signals' Emerge Around Future Supply of GLP-1 Drugs

(12/30, Fraiser Kansteiner, Fierce Pharma) ...Following rapid (and pricey) expansion efforts from Novo and Lilly, plus recent shortage updates at the FDA, "positive signals" are emerging when it comes to the consistent supply of GLP-1 medicines for diabetes and weight loss, Bill Coyle, global head of biopharma at ZS, said in a recent interview... Full

Drugmakers to Raise US Prices On Over 250 Medicines Starting Jan. 1

(12/31, Michael Erman, Reuters) ...Drugmakers plan to raise U.S. prices on at least 250 branded medications including Pfizer COVID-19 treatment Paxlovid, Bristol Myers Squibb's cancer cell therapies and vaccines from France's Sanofi at the start of 2025, according to data analyzed by healthcare research firm 3 Axis Advisors. Nearly all of the drug price increases are below 10% - most well below. The median price increase of the drugs being hiked Jan. 1 is 4.5%, which is in line with the median for all price increases last year... Full

Medicare's New Drug Price Cap Kicks in Jan. 1

(12/31, Joseph Choi, The Hill) ...Starting on Jan. 1, 2025, an estimated 19 million Medicare beneficiaries will see their out-of-pocket Medicare Part D spending capped at $2,000 for the year. This annual cap will be indexed to the rate of inflation every year going forward. An interim spending cap of roughly $3,500 was put in place in 2024. According to an administration official, those with Medicare will save an average of $400 a year... Full

Advocates To DOGE: Slash Drug Costs Using 1498 Statute, PBM Reforms

(12/31, Maaisha Osman, Inside Health Policy) ...Public Citizen's recommendations include invoking the rarely used authority under Title 28, Section 1498 of the U.S. Code, which allows the federal government to use patented inventions without permission as long as reasonable compensation is provided, to authorize the production of low-cost generic weight-loss drugs... Sub. Req’d

IRS Moves to Amend Excise Tax Rules on Medicare Drug Price Talks

(12/31, Nyah Phengsitthy, Bloomberg Law) ...The Internal Revenue Service published Tuesday a proposed rule (RIN 1545-BQ92) that would lay out rules governing the imposition and calculation of the excise tax. It also would provide definitions of terms such as "manufacturer," "sale," and "price."...Companies that decline to participate or don't comply with the established price will have to pay taxes that start at 65% of the US sales of a product. The fines would increase by 10% every quarter, with a maximum of 95%... Sub. Req’d

Drug Middlemen Got Spared By Trump and Musk

(12/30, David Wainer, The Wall Street Journal) ...While the PBM provisions in the 1,547-page stopgap bill are now dead, they are far from buried. The bipartisan agreement highlighted a growing consensus that PBM business models are flawed, with both Republicans and Democrats -- and even Trump himself -- signaling intent to take action. In recent weeks, Trump has twice criticized PBMs, declaring in a news conference his intention to "knock out the middleman."... Sub. Req’d

Welch Introduces Bipartisan Skinny Labels, Big Savings Act to Safeguard Generic Drugs, Slash Drug Prices

(12/24, Vermont Biz) ...Vermont Business Magazine U.S. Senator Peter Welch (D-Vt.) joined Senators John Hickenlooper (D-Colo.), Tom Cotton (R-Ark.), and Susan Collins (R-Maine) recently to introduce the bipartisan Skinny Labels, Big Savings Act, legislation designed to lower drug prices by accelerating the roll-out of generic drugs that get FDA approval for certain indications... Full

Saving the Skinny Label Through the Skinny Label, Big Savings Act

(1/2, Sara W. Koblitz, FDA Law Blog) ...Senators John Hickenlooper, Tom Cotton, Peter Welch, and Susan Collins recently introduced the bipartisan Skinny Labels, Big Savings Act, which would amend federal patent infringement law so that generic drug manufacturers can: Submit or seek approval of a skinny label for a generic or biosimilar pharmaceutical product; Include labeling, promotional materials, or commercial marketing, consistent with the Federal Food, Drug, and Cosmetic Act regulations, for a drug with skinny labeling approved by the FDA; Describe, consistent with the Federal Food, Drug, and Cosmetic Act, a drug approved via skinny label as a generic of or therapeutic equivalent to the branded drug... Full

Bill Aims To Expose ‘Hidden' Payments From Pharma To Patient Groups

(12/26, Maaisha Osman, Inside Health Policy) ...Senate Finance Committee senior member Chuck Grassley (R-IA) and Sen. Maggie Hassan (D-NH) are taking aim at pharmaceutical and device manufacturers with a new bill aimed at exposing undisclosed payments to patient advocacy groups. The bill, called the "Open Payments Expansion Act," seeks to force medical product companies to publicly reveal any covered payments made to such organizations -- tightening transparency around the financial ties influencing patient advocates... Sub. Req’d

How Trump's Tariffs Could Impact the Pharmaceutical Market

(12/31, Joseph Choi, The Hill) ...Trump has floated 25 percent tariffs on imports from Mexico and Canada, as well as expanded tariffs on Chinese imports. Economists have warned that such tariffs will drive prices up, and Trump acknowledged earlier this month he "can't guarantee" they won't increase costs for consumers. When it comes to drugs, health care industry insiders say Trump's tariff plan could not only raise prices but also lead to shortages in the U.S... Full

How Tariffs Could Affect Health Care Costs

(12/31, Joseph Choi and Nathaniel Weixel, The Hill) ..."While China accounts for a growing portion of U.S. pharmaceutical imports, particularly [active pharmaceutical ingredients (API)] used in generic drugs, we believe the Trump administration is unlikely to impose hefty tariffs on these imports to avoid increasing U.S. drug costs," said Arthur Wong, health care managing director at S&P Global Ratings. "80 percent of the API is produced overseas. A lot of the components for devices are as well, including packaging, enclosures, delivery systems, etc. There will be an impact, especially for those products," said Mark Hendrickson, director of supply chain policy at the health care improvement company Premier Inc... Full

In a Late Scramble, State Lawmakers Send Health Care Bills On Steward Collapse and Drug Costs to Healey

(12/30, Samantha J. Gross and Anjali Huynh, The Boston Globe) ...Lawmakers sent a pair of health care bills to Governor Maura Healey's desk Monday, delivering their response to some of the biggest problems facing Massachusetts residents this year — the Steward Health Care crisis and increasingly out-of-reach prescription drug costs — less than 48 hours before the two-year legislative session is set to end at midnight Wednesday... Full

Employers Challenge Minnesota's Pharmacy Benefit Manager Law

(12/27, Lauren Clason and Celine Castronuovo, Bloomberg Law) ...A Minnesota law imposing restrictions on pharmacy benefit managers interferes with health-plan design and is preempted by federal statute, the ERISA Industry Committee said in a suit filed in Minnesota federal court. The law also illegally attempts to regulate plans in other states, the employer group argued Friday in the US District Court for the District of Minnesota... Sub. Req’d

More People Switching to Generic Medicine in Switzerland

(12/27, Swissinfo.ch) ...Anyone who wants an original brand medication today in Switzerland, even though a generic version is available, pays 40% more from their own pocket. The aim of this measure is to strengthen personal responsibility in order to curb rising healthcare costs... Full

India's 50% Drug Price Hike Faces Backlash, NPPA Under Fire

(12/30, The Pharma Letter) ...India's Parliamentary panel has come down heavily on the National Pharmaceutical Pricing Authority (NPPA) and directed it to provide a detailed report explaining the recent 50% price increase on 11 essential drug formulations. The directive comes amid concerns over the rising cost of medicines, reports The Pharma Letter's India correspondent... Sub. Req’d

AI To Help Indian Pharma Industry To Pivot On Innovation, Reach 130 Billion In Size By 2030

(12/26, Press Trust Of India) ...As technological advancements like AI, machine learning and precision medicine revolutionise drug discovery, manufacturing and patient care, Indian pharmaceutical industry is set for a 'profound transformation' in 2025 with innovation, wider global access and improvement in quality becoming key themes for the future. The industry, which is expected to grow nearly two-fold to around USD 130 billion in size by 2030, is looking to take advantage of conducive policies, demographic and digital talent, in making India play a pivotal role in advancing global health for all... Full

How is India Transforming the Global Biopharma Landscape?

(12/30, Kiran Mazumdar Shaw, The Economic Times) ...In 2024, India's biopharma sector marked notable achievements, with approvals of key biosimilars and the launch of advanced CAR-T therapy. The sector contributed significantly to the country's bio-economy, valued at over $150 billion, as government policies and initiatives bolstered innovation and sustainable development. India's biopharma sector achieved significant milestones in 2024, reinforcing its position as a global leader in affordable healthcare solutions... Full

Pharma Sector Grappling with New Realities at Home and Overseas

(1/1, PT Jyothi Datta, The Hindu BusinessLine) ...In the new year, the Indian pharmaceutical sector will have to grapple with new realities, at home and overseas...Sujay Shetty, PwC's Global Health Industries Advisory Leader, says the upcoming year will be interesting for two key reasons – changing US dynamics and the opportunity from GLP-1 drugs (diabetes and weightloss drugs). The US is the single most important market for the top 20 Indian drugmakers, says Shetty, pointing to implications following possible policy changes from President-elect Trump involving localisation... Full

How the Pharma Industry is Bringing in Novel Antibiotics and Affordable Car-T Therapy

(1/2, PT Jyothi Datta and Prethicshaa Gurumoorthy, The Hindu BusinessLine) ...In this episode of the State of Economy Podcast, businessline's Jyothi Datta speaks with Sudharshan Jain, the Secretary General of the Indian Pharmaceutical Alliance (IPA), as they reflect on the achievements and challenges of India's pharmaceutical industry in 2024... Full

India to Become a Global Leader in Development of Complex Biotherapeutic Products: Kiran Mazumdar Shaw

(12/31, Nandita Vijayasimha, Pharmabiz.com) ...Kiran Mazumdar Shaw, chairperson, Biocon and Biocon Biologics said that the sector's impressive growth trajectory, with pharmaceutical exports crossing $2.3 billion in July 2024, highlights its critical role in addressing global healthcare challenges. As India focuses on building its capacity for innovation and scaling up production, the industry is expected to become an even more significant contributor to global healthcare solutions by 2025... Full

2024: A Year of Building On a Foundation for Sustainable Growth in India's Pharma Sector

(12/30, Sudarshan Jain, CNBC TV-18) ...The Production Linked Incentive (PLI) schemes aimed at self-reliance and making global champions from India have started seeing dividends with the launch of green-field projects for the production of Penicillin G and Clavulanic acid among others. This is important for healthcare security and facilitating diversified supply chain. Quality is a fundamental license to operate in the pharma sector. The implementation of revised Schedule M, the key quality manufacturing standards in India, will strengthen the quality landscape... Full

Access to Medication is Increasingly Being Dictated by Preferred Pharmacy Networks

(12/31, Chris Hannay, Susan Krashinsky Robertson, Clare O'Hara, The Globe and Mail) ...Other players in the medication ecosystem say the lack of transparency may be driving up costs and unfairly steering employees to health care providers that are not convenient for them, but are more lucrative than others for the insurers. As drug costs and premiums continue to rise, major insurers say the deals are the best way of controlling costs. But critics point to other cost-saving measures used by public insurance plans that are more patient-friendly ways to make private plan costs sustainable... Sub. Req’d

Bio-Thera Solutions Partners with Tabuk Pharma to Commercialize BAT2206, A Stelara Biosimilar in Saudi Arabia

(12/27, Pharmabiz.com) ...Bio-Thera Solutions Inc., a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, announced the company has partnered with Tabuk Pharmaceutical Manufacturing Company (a fully-owned subsidiary of Astra Industrial Group), a leading pharmaceutical company in the Middle East and North Africa (MENA) region, for BAT2206, its ustekinumab biosimilar, under which Tabuk will have exclusive rights to manufacture, distribute and market the drug in Saudi Arabia... Full

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