Tuesday, October 7, 2025

Overcoming Past Mistakes, Generics Powerhouse Teva Embraces An Innovative ‘Mindset Change'

(10/7, Michael Gibney, PharmaVoice) ...In the three years since a leadership change, Teva has evolved its R&D approach beyond a long history making copycat medicines...Now, new drug development is a priority for Teva, said Dr. Eric Hughes, chief medical officer and executive vice president of global R&D — and a portfolio of marketed products as well as a humming pipeline reflect that mindset change...Here, Hughes describes Teva's strategy to turn the ship around during an especially difficult time, change the approach from generics to innovative medicine and overcome the challenges faced by the industry overall... Full

Teva Pharmaceutical: Turnaround Driven By Huge Pipeline Upside

(10/7, Seeking Alpha) ...Teva Pharmaceutical Industries Limited is a pharmaceutical company specializing in generics and biosimilars. The company has been a disappointment for investors due to several issues, including a heavy debt load and legal issues regarding opioids. However, I believe it's time for investors to re-examine this stock, as the company's restructuring plan is leading to improved margins and its pipelines, especially Duvakitug, have huge upside potential... Full

The White House's Drug Plan Has Some Convenient Blind Spots

(10/7, Lisa Jarvis, Bloomberg) ...When weighing the merits of the deal for consumers, it's worth noting the differences in language between Trump's press conferences, the White House fact sheet, and Pfizer's press release, says Stacie Dusetzina, who studies drug policy and prices at Vanderbilt University. A few words in the Pfizer release stand out. "Voluntary," for example, and "confidential." The careful language and lack of real details about the arrangement suggest that, despite the fanfare, "Pfizer got a really good PR deal out of it," Dusetzina says. It's far less clear if American health care consumers got a good deal... Sub. Req’d

There's Much Less Than Meets the Eye in Trump's ‘Historic' Drug Price Deal With Pfizer

(10/7, Michael Hiltzik, Los Angeles Times) ...The truth is that the company won't be suffering any significant reduction in revenue or profits by offering these "discounts." It will, however, be exempted for three years from tariffs of 100% that Trump had threatened to impose on drugmakers. How do we know that Pfizer is the principal beneficiary of the deal? Its stock price has risen nearly 15% in the five trading days since the announcement...Pfizer and the White House both describe the deal terms as "confidential." Pfizer told me that "more details" will be made available as the January implementation date draws nigh. The White House asserts that this deal is secret because it's working out deals with other drug manufacturers... Sub. Req’d

Amgen Launches Direct-To-Patient Program Offering Repatha At 60% Discount

(10/6, Maaisha Osman, Inside Health Policy) ...The program, called AmgenNow, will allow patients -- including those on Medicare, Medicaid or without insurance -- to purchase Repatha for $239 per month, bypassing traditional insurer requirements such as step therapy or prior authorization. Amgen said the new $239 monthly price is the lowest offered in any G-7 country and will soon be available through the White House's TrumpRx website, a platform still under development... Sub. Req’d

Amgen to Sell Cholesterol Drug at 60% Discount to Cash-Paying US Patients

(10/6, Deena Beasley, Reuters) ...Amgen says on its website that 98% of commercially insured U.S. patients have coverage for the drug with monthly co-pays as low as $15...Amgen said its portal will be accessible through TrumpRx. The Thousand Oaks, California-based drugmaker said it intends to eventually add other medicines to AmgenNow. Separately, prescription savings program GoodRx said on Monday it has collaborated with Amgen to offer Repatha at a cash price of $239 through its platform at more than 70,000 pharmacies across the U.S... Full

Oz Hints That Medicare Action On GLP-1s And Weight Loss Coming

(10/6, Sarah Karlin-Smith, Pink Sheet) ...CMS action allowing wider access to GLP-1s for obesity may be near, as Oz declined to publicly discuss the topic due to the Trump Administration's ongoing work in the space. The expectation is that CMS will implement a pilot program to expand coverage through its innovation center. Oz also suggested that commercial health plans should not expect higher drug prices due to the administration's Most Favored Nation agreement with Pfizer... Global Sub. Full

2026 Is First Year Medicare Beneficiaries Will Get Discounts On 10 High-Cost Drugs

(10/6, Tony Pugh, AARP) ...The program is on the cusp of making dozens of innovative medications more affordable and accessible while saving lives and improving the quality of life for millions of Medicare beneficiaries. The savings, which take effect Jan. 1, are expected to lower enrollees' out-of-pocket spending by an estimated $1.5 billion in 2026, according to the Centers for Medicare & Medicaid Services (CMS). First-round discounts start Jan. 1... Full

US Court Rejects Novo Nordisk's Challenge to Medicare Drug Pricing Plan

(10/6, Diana Novak Jones, Reuters) ...A unanimous three-judge panel rejected Novo's constitutional challenges to the program, which was part of Democratic former President Joe Biden's Inflation Reduction Act, and said the law specifically bars courts from reviewing the drugs selected. A Novo Nordisk spokesperson said the company was assessing its options to appeal the ruling... Full

Manufacturing U.S. Jobs and Breakthroughs

(10/6, Drew Voytal, PhRMA) ...PhRMA announced last week that member companies, thanks to President Trump's new tax law and regulatory streamlining, are investing $500 billion in new U.S.-based manufacturing and infrastructure, injecting $1.2 trillion into the U.S. economy and creating over 100,000 new jobs, including at least 25,000 direct biopharmaceutical jobs. Member companies also announced they are providing 10 million patients with financial assistance annually and the creation of AmericasMedicines.com, a search engine to connect patients and businesses with manufacturer direct purchase programs, launching in January 2026...Not only is our industry strengthening America's biomanufacturing capabilities, but companies like Bristol Myers Squibb, Amgen, Astellas, Gilead and AstraZeneca are breaking ground, opening new sites and growing to deliver tomorrow's breakthrough medicines... Full

Second Opinion: Big Pharma's Rhetoric of Deflection Doesn't Address Cause of High Prescription Drug Prices

(10/6, The Campaign for Sustainable Rx Pricing) ...The fact is that brand name drug companies continue to shelter profits overseas to avoid paying U.S. taxes... Full

Better Late Than Never? The FDA Releases New Batch Of PSGs

(10/7, Urte Fultinaviciute, Generics Bulletin) ...The FDA has released a new batch of 81 product-specific guidances for products used for the treatment of chronic obstructive pulmonary disease, opioid overdose, type 2 diabetes mellitus, and other conditions. This batch's publication was delayed, following a pattern of missed deadlines under the current administration. While over 30 PSGs scheduled for October have been postponed without a new date, the next batch is planned to be published in November... Global Sub. Full

US FDA's ANDA Prioritization Pilot Encouraging Production Onshoring

(10/6, Dave Wallace, Pink Sheet) ...The FDA will prioritize the review of ANDA products that are manufactured and tested in the US as part of a new pilot program. The pilot builds on the FDA's PreCheck program, which aims to accelerate the establishment of new US pharma manufacturing facilities. Many generic drug sponsors already have announced billions of dollars in onshoring investments... Global Sub. Full

New US FDA Program Encouraging Domestic Manufacturing May Be ‘Very Selective'

(10/6, Sarah Karlin-Smith, Pink Sheet) ...The US Food and Drug Administration's new PreCheck program to encourage more American-made pharmaceuticals may need to be "very selective early on," due to resource constraints, agency leaders told industry...The FDA told sponsors that they do not want a program with a wide breadth and no impact. The program likely will need to be very selective about the types of facilities and groups that can participate to operate well, officials said. The agency expects to eventually provide more details on PreCheck participation criteria for manufacturers that want to apply... Global Sub. Full

Colorado Just Became the First State to Cap the Price of a Prescription Drug. What Comes Next is Uncertain.

(10/7, John Inglod, The Colorado Sun) ...The board, called the Prescription Drug Affordability Review Board, made Colorado the first state to set, effectively, a price cap on a prescription drug. The cap, known formally as an upper payment limit, puts a ceiling on how much a patient or insurer in Colorado will have to pay for the drug — in this case a drug called Enbrel that treats rheumatoid arthritis and other autoimmune diseases. It will start Jan. 1, 2027...But whether those promises will hold — whether patients will, in fact, save money or whether the relatively small number of Coloradans who take Enbrel will be able to continue to get it — is uncertain... Sub. Req’d

AstraZeneca Drug Baxdrostat Cuts Blood Pressure in Key Late-Stage Trial

(10/7, Maggie Fick, Raechel Thankam Job and Pushkala Aripaka, Reuters) ...AstraZeneca's experimental drug baxdrostat significantly lowered blood pressure over a 24-hour period in a late-stage trial of patients with treatment-resistant hypertension, the company said on Tuesday. The results mark a key step for the Anglo-Swedish drugmaker as it looks to expand in cardiovascular disease and hit a target of $80 billion in annual revenues by 2030, in part through the launch of new medicines... Full

AbbVie's Botox Notches Mid-Stage Win in Essential Tremor

(10/6, Pavan Kamat, FirstWord Pharma) ...AbbVie's Botox (onabotulinumtoxinA) hit the main goal in a mid-stage study of upper limb essential tremor, potentially setting up another indication for the therapeutic neurotoxin. The company announced the top-line findings ahead of presentation at the ongoing International Congress of Parkinson's Disease and Movement Disorders... Full

Sandoz Canada Looks To Savings With First Entresto Rival

(10/7, Dean Rudge, Generics Bulletin) ...Sandoz Canada has launched the first generic version of Entresto (sacubitril/valsartan), a blockbuster heart failure medication, after receiving approval from Health Canada. The company's generic, PrSandoz Sacubitril-Valsartan, is expected to provide significant savings as annual spending on the original drug exceeds CAD$100m. Heart failure, particularly HFrEF, is a significant health issue among Canadians over 65, with hospitalization costs surpassing CAD$2.8bn... Global Sub. Full

Zydus Lifesciences Gets Nod from Health Canada for Liothyronine Tablets

(10/6, Poonam Behura, CNBC TV-18) ...Zydus Lifesciences Ltd said on Monday it has received a Notice of Compliance (NOC) from Health Canada for its generic Liothyronine tablets in 5 mcg and 25 mcg strengths... Full

EMA Accepts Marketing Authorization Application for AVT23, A Proposed Biosimilar to Xolair

(10/7, Pharmabiz.com) ...AVT23 is a proposed biosimilar to Xolair (omalizumab). Omalizumab is a humanized monoclonal antibody that targets free immunoglobulin E (IgE). Xolair, which contains omalizumab, is indicated for severe persistent allergic asthma, chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps (CRSwNP). AVT23 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed... Full

IQVIA Analyst: Biosimilar Uptake Remains Uneven Across Molecules

(10/6, Gina Shaw, Specialty Pharmacy Continuum) ...IQVIA data show that biosimilars launched to date account for 24% of competitive molecule volume overall. But adoption rates by molecule tell a story of stark contrasts... Full

Asthma Inhalers Are Having a Huge Impact On Global Warming

(10/7, Katie Boyden, Metro) ...The findings, published in journal JAMA, found inhaler-related emissions in the US have increased in the last 10 years. Inhalers are the main form of treatment for people with asthma and COPD – but they generated 24.9million metric tonnes of carbon dioxide-equivalent emissions in the US between 2014 and 2024...The study also found that brand-name inhalers produced 72% of total emissions, compared to authorised generics producing 22% and independent generics producing 6%. GlaxoSmithKline products generated the highest overall emissions (10.1million metric tonnes of carbon dioxide-equivalent emissions), followed by AstraZeneca (5.9million metric tonnes), Teva (5.2million metric tonnes), and Boehringer Ingelheim (0.2million metric tonnes)... Full

Merck Completes Acquisition of Verona Pharma

(10/7, Merck) ...Through this acquisition Merck has added Ohtuvayre (ensifentrine), a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), to its growing cardio-pulmonary pipeline and portfolio...Ohtuvayre is the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years and combines bronchodilator and non-steroidal anti-inflammatory effects. Ohtuvayre is also being evaluated in clinical trials for the treatment of non-cystic fibrosis bronchiectasis... Full

US Supreme Court Will Not Hear Purdue Appeal in OxyContin Patent Case

(10/6, Blake Brittain, Reuters) ...The U.S. Supreme Court on Monday declined to take up an appeal by Purdue Pharmaceuticals after the now-bankrupt drugmaker lost a bid to block a generic version of the painkiller OxyContin. The court decided not to reconsider a ruling in a lawsuit involving generic drugmaker Intas Pharmaceuticals' Accord Healthcare that invalidated Purdue's patents for a formulation of the drug designed to deter abuse... Full

EFPIA Presses for Sharper EU Drug Law Overhaul to Secure Global Edge

(10/6, The Pharma Letter) ...Europe's pharmaceutical lobby has welcomed the European Commission's plans to revise the General Pharmaceutical Legislation (GPL), but said draft measures fall short of creating a world-class system...Industry groups warn that some GPL proposals could unintentionally hinder access to medicines, particularly for rare diseases. Changes to orphan drug incentives and environmental provisions are seen as possible barriers if not implemented with flexibility. Misalignment between EU rules and national reimbursement systems also risks slowing patient access... Sub. Req’d

‘We Are Not The Dark Side Of The Force' – EU Regulator Urges ATMP Firms To Use Advice Services

(10/6, Eliza Slawther, Pink Sheet) ...The European Medicines Agency wants to help companies, but is sometimes perceived by developers as the "enemy," according to a member of the agency's scientific advice working party. Companies developing advanced therapies can benefit from a number of EMA schemes, including early advice from the committee for advanced therapies. Developers are also encouraged to take advantage of other offerings, such as orphan designations and the agency's PRIME scheme... Global Sub. Full

Germany: Newly Adopted Contractual Clauses To Reshape Clinical Trial Negotiations

(10/6, Neena Brizmohun, Pink Sheet) ...A set of standard contractual clauses that are expected to streamline and expedite contract negotiations between sponsors and study sites in Germany will start to apply to clinical trial agreements (CTAs) as of Dec. 18. There are 10 template clauses on topics that are routinely addressed in CTAs, including rights to research results, rights to publish clinical trial results, inspections and audits, liability limitations and data protection. The new clauses represent a significant shift in how clinical trial agreements are negotiated in Germany and drug companies should become familiar with them, according to law firm Covington & Burling... Global Sub. Full

Ontario to Offer Early Access to Some New Cancer Drugs in Pilot Project

(10/7, Chris Hannay, Kelly Grant, The Globe and Mail) ...Ontario will give patients access to select new cancer drugs early as part of a pilot project that would make these medicines available whether or not public health plans have finalized price negotiations with the drug manufacturers. At the same time, the pan-Canadian Pharmaceutical Alliance (pCPA), the national body that represents all public insurance plans, says it will try to speed up price negotiations so they are finished earlier, possibly eliminating the need for Ontario's pilot project... Sub. Req’d

Pharma Industry Faces U.S. Tariff Threats and Slow Progress in New Drug Development

(10/7, M. H. Lee, The Korea Bizwire) ...Industry sources said Monday that the most immediate concern is the "U.S. tariff risk" following President Donald Trump's announcement last month that drugs produced by companies without U.S.-based manufacturing plants will face 100 percent tariffs starting this month. Companies such as Celltrion, Lotte Biologics, and SK Biopharm are relatively insulated after securing or building U.S. production facilities...In contrast, Samsung Biologics and its affiliate Samsung Bioepis, which lack U.S. plants, face greater uncertainty. Analysts warn that they could suffer major setbacks if the tariffs are applied broadly... Full

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