Monday, June 9, 2025

Goldman Sachs Starts Teva Pharma (TEVA) at Buy

(6/6, StreetInsider.com) ...Goldman Sachs analyst Matt Dellatorre initiates coverage on Teva Pharma with a Buy rating and a price target of $24.00... Full

Teva, Amneal Rated Buy, Viatris Neutral as Goldman Sachs Reviews Generics Space

(6/6, Dulan Lokuwithana, Seeking Alpha) ...The analyst Matt Dellatorre issued mostly positive remarks on the industry, citing opportunities to benefit from the sector's "undemanding" valuations driven by recent micro volatility and macro concerns...With a 12-month per-share target of $24 on Teva, the analyst pointed to an improvement in the Israeli drugmaker's core business, which he said could generate upside to near-mid-term EBITDA consensus driven by strong growth in its branded portfolio... Full

Teva Appoints New Chief Commercial Director

(6/6, The Debrecen Sun) ...Diderick Turpijn, with over two decades of experience in the pharmaceutical industry, will replace Jelena Livšic as the Chief Commercial Officer at Teva Pharmaceuticals Ltd. Livšic, who achieved great success in Hungary, will now apply her expertise in a similar role in Teva's Czech and Slovakian markets...Diderick's goal as the head of Teva's commercial organization in Hungary is: "To help people regain control of their lives so they can focus on what they truly love. Is there anything more beautiful than that?"... Full

Teva Birth Control Pills Recalled Across Canada Over Extra Placebos

(6/6, Elissa Mendes, The Toronto Star) ...Birth control medication is being pulled from Canadian shelves over extra placebo tablets, Health Canada says. The recall concerns Teva Canada's Seasonale tablet with lot numbers 100059661 and 100069150, according to the agency's recall notice... Full

Seasonique Birth Control Pills from Teva Canada Recalled Due to Extra Yellow Tablets

(6/7, CBC) ...Health Canada issued a recall notice on Friday for some Seasonique birth control products due to some packages containing the correct blue-green pills coming with extraneous yellow tablets. The agency says the recall is for the 0.01-milligram ethinyl estradiol, 0.03-milligram ethiny lestradiol and 0.15-milligram levonorgestrel Seasonique pills made by Teva Canada... Full

Trump's FTC Continues The Mission Of Eliminating Orange Book's Improper Patent Listings

(6/6, Urte Fultinaviciute, Generics Bulletin) ...In a somewhat surprising move, president Donald Trump's Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA's Orange Book. Law firm Polsinelli's chair Chad Landmon told Generics Bulletin what it means for the generic drug industry...The third round of FTC's warning letters addressed brand-name asthma, diabetes, epinephrine autoinjector, and COPD drugs that have been included in previous campaigns. The recent ruling from the Teva-Amneal inhaler case, which has been quoted in the letters, provides the FTC with legal backing and support... Global Sub. Full

Here FTC Goes Again On Its Own

(6/9, Sara W. Koblitz, FDA Law Blog) ...Well, the FTC is back at it—again without the help of FDA. Armed with the Federal Circuit opinion in Teva v. Amneal, the FTC sent another spate of "warning letters" on May 21, 2025 to Novartis, Amphastar Pharmaceuticals, Mylan Specialty, Covis Pharma, and three Teva entities. It also notified FDA that it disputes the appropriateness of more than 200 patent listings, most of which FTC "previously disputed" but remain in the Orange Book. The FTC is again taking the position that "[t]hese patents do not meet the statutory criteria for listing in the Orange Book, as confirmed by a recent ruling in the U.S. Court of Appeals for the Federal Circuit."... Full

Trump Drug Price Plan Risks Fallout for Medicaid, Beneficiaries

(6/9, Ganny Belloni, Bloomberg Law) ...The executive order's ambiguity raised eyebrows from drug pricing researcher Antonio Ciaccia, who said he fears extending an international best price unilaterally across the US health-care ecosystem would "arguably be the most disruptive thing that could ever occur."..."The Medicaid drug rebate program and, by extension, the 340B program are built on the premise that those programs will receive best-in-class discounts in the marketplace," said Ciaccia, CEO of the drug pricing research group 46brooklyn. Any move to equalize the price would lead to a systemic collapse of those programs, he said... Sub. Req’d

Sen. Mike Lee Proposes New Legislation to Cut Drug Prices and Bureaucratic Red Tape

(6/6, Charlie Schill, Cache Valley Daily) ...Sen. Mike Lee (R-UT) has proposed bipartisan legislation to cut drug prices and bureaucratic red tape for American consumers..."Many consumers would choose a cheaper generic-brand version of their medications," Lee explained, "but technicalities from Congress have kept these out of reach. "This legislation will cut red tape to bring drug prices down, break up the big pharma monopolies and let Americans make their own medication choices."... Full

US ‘Red Tape' Bill Again Targets Biosimilar Interchangeability – Will It Succeed This Time?

(6/9, Dave Wallace, Generics Bulletin) ...Responding to the latest version of the bill, the US Association for Accessible Medicines and its Biosimilars Council said the proposal would "reduce brand misinformation and remove unnecessary requirements that block patient access to biosimilar medicines," eliminating what it called an "arbitrary and unscientific distinction between biosimilars and interchangeable biologics." "As the FDA has made clear, there is no clinically meaningful difference between biosimilars and interchangeable biosimilars," said AAM president and CEO John Murphy... Global Sub. Full

CSRXP Applauds U.S. Senate Reintroduction of Bipartisan Solution to Promote Greater Biosimilar Competition in the Prescription Drug Market

(6/6, The Campaign for Sustainable Rx Pricing) ..."CSRxP commends Senators Lee (R-UT), Paul (R-KY), Hassan (D-NH) and Luján (D-NM) for supporting greater competition in the prescription drug marketplace with the reintroduction of the bipartisan Biosimilar Red Tape Elimination Act," said CSRxP executive director Lauren Aronson. "By eliminating outdated FDA requirements, this bipartisan, market-based solution will help bring more biosimilars to market more quickly, fostering greater competition from more affordable alternatives to high-priced brand name drugs to help lower prices for patients, taxpayers and the U.S. health system."... Full

Patent Settlements Are ‘Critically Necessary' As AAM Calculates $423Bn Savings Since 2013

(6/9, Urte Fultinaviciute, Generics Bulletin) ...Patent settlements in the US have generated $423bn in healthcare savings since 2013 by allowing early market entry for generics and biosimilars. The AAM warned that patent thickets and serial patent litigations are complicating the process for off-patent companies to reach settlements. The reintroduced Preserving Access to Affordable Generics and Biosimilars Act (S. 1096) poses additional risks by potentially limiting pro-competitive settlements... Global Sub. Full

CMS In Contact With Stakeholders On AOM Coverage Models

(6/6, Luke Zarzecki, Inside Health Policy) ...CMS is still considering ways to cover anti-obesity medications after the Trump administration scrapped a Biden administration proposal for CMS to cover anti-obesity medications (AOMs) earlier this year, with a source close to the issue telling Inside Health Policy CMS is reaching out to stakeholders on possible coverage models... Sub. Req’d

Transparency for PBMs. Can It Become Something More than Just a Buzzword?

(6/6, Denise Myshko, Managed Healthcare Executive) ...In this story, we are turning our attention to transparency. "Transparency is not just a buzzword in the PBM space," said Justin Jasniewski, CEO of Serve You Rx, one upstart PBMs that is positioning itself as an alternative to the large PBMs that dominate the industry. "If I could change one thing, it would be making the entire ecosystem, both PBM and medical, more transparent, so that providers can compete on price versus consumers just bearing the cost of whatever it is," he said in an interview with MHE. Jasniewski has been selected as one of this year's Managed Healthcare Executive Emerging Leaders in Healthcare... Full

Inside the FDA: The Cost of Supply Chain Silence

(6/6, Libby Hargreaves, SupplyChain Digital) ...The US Food and Drug Administration (FDA) says it is increasingly concerned about the impact of these shortages. Its data shows that, while disruptions to adult device supply chains can usually be absorbed, shortages in paediatrics can cause far more disruption. That's partly because fewer manufacturers make these specialised devices and production is often not prioritised due to low profit margins. However, there exists a wider issue: the system for identifying and responding to supply chain problems is fragmented... Full

AstraZeneca Sues Utah Attorney General Over New Utah Drug Price Law

(6/6, Cassidy Wixom, KSL) ...Pharmaceutical company AstraZeneca sues Utah over SB69, claiming it contradicts federal drug pricing laws. The company argues SB69 unlawfully expands the Section 340B drug discount program, violating the supremacy clause. AstraZeneca seeks a halt on the law's enforcement, citing financial harm and reputational damage... Full

Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says

(6/6, Cathy Kelly, Pink Sheet) ...Maryland's Prescription Drug Affordability Board does not assume that establishing upper payment limits is the automatic solution for drugs with cost concerns, Executive Director Andrew York said. The board identified Ozempic/Wegovy/Rybelsus, Dupizent, Trulicity and Farxiga as products with potential affordability problems that will be subject to further review. The drug affordability criteria across state PDABs is inconsistent, but Maryland is interested in a consensus-based approach, York said... Global Sub. Full

Florida Receives Second Extension By FDA To Import Rx Drugs

(6/6, Gabrielle Wanneh, Inside Health Policy) ...FDA on Monday (June 2) granted Florida a four-month extension until November of its existing Section 804 Importation Program (SIP) authorization to import affordable prescription drugs from Canada to lessen costs for state residents so long as public health and safety isn't compromised. This is the second extension FDA has granted for Florida's drug importation program, with the first extension set to expire in July, and follows President Donald Trump's executive order demanding FDA make it easier for states to obtain drug importation approval... Sub. Req’d

Samsung Bioepis Partners with NIPRO to Enter Japanese Biosimilar Market

(6/9, Kim Ji-hye, Korea Biomedical Review) ...This agreement marks Samsung Bioepis's first collaboration with a local company for its entry into Japan. Under the terms of the deal, Samsung Bioepis will manage product development, production, and supply, while NIPRO will be responsible for sales and commercialization in Japan... Full

Celltrion Secures EU Approval for Second Stelara Biosimilar Qoyvolma

(6/9, Lee Han-soo, Korea Biomedical Review) ...With this approval, Celltrion now holds two distinct biosimilars targeting ustekinumab, strengthening its competitive position in the global biologics market. Unlike Steqeyma, its previously approved Stelara biosimilar, Qoyvolma includes an additional indication for ulcerative colitis (UC), expanding its therapeutic coverage alongside existing indications such as plaque psoriasis, psoriatic arthritis, and Crohn's disease (CD). By deploying two biosimilars with overlapping but distinct label indications, Celltrion plans to strategically navigate Europe's complex patent landscape... Full

Glenmark Pharma Rises After Zanubrutinib Launch in India

(6/9, Business Standard) ...Co-developed with global oncology leader BeOne Medicines, zanubrutinib will be marketed under the brand name Brukinsa. It is the first and only Brutons tyrosine kinase (BTK) inhibitor approved in India for five types of B-cell malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenstr macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and follicular lymphoma (FL)... Full

Lupin Receives Tentative US FDA Approval for Oxcarbazepine ER Tablets

(6/9, Express Pharma) ...The tablets are bioequivalent to Oxtellar XR ER Tablets of the same strengths, developed by Supernus Pharmaceuticals, Inc. The approved product is indicated for the treatment of partial-onset seizures in patients aged six years and older. Lupin stated that the approved product will be manufactured at its facility in Nagpur, India... Full

AstraZeneca's Fixed-Duration Calquence-Based Regimens Approved in EU for Patients with Chronic Lymphocytic Leukaemia

(6/7, Indian Pharma Post) ...A fixed-duration regimen of AstraZeneca's Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, has been approved in the European Union (EU) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)... Full

Biocon, Wockhardt, Eris to Double Insulin Output, As Global Drugmakers Scale Back to Focus On GLP-1, New Generation Insulins

(6/7, Viswanath Pilla, Money Control) ...Biocon, a pioneer in biosimilars, has doubled its insulin manufacturing capacity in Malaysia, positioning itself as the only global player with the scale to fill the void left by multinationals. Chairperson Kiran Mazumdar-Shaw called FY26 an "acceleration year," citing a "significant windfall" expected from the insulin business...Meanwhile, Eris Lifesciences, which acquired Biocon's domestic insulin portfolio in 2024, is also doubling its capacity over the next 24 months...Eris reported 22 percent growth in its insulin franchise despite supply shortages, and expects further margin expansion as it insources production... Full

Biotech Behind Eli Lilly Obesity Pill Aims for New Standard of Care

(6/8, Harry Dempsey and Hannah Kuchler, Financial Times) ...The Japanese biotech behind Eli Lilly's new blockbuster obesity pill believes it could be used with an anti-muscle wasting drug it has developed to create a new standard of patient care for weight loss. Hitoshi Iikura, a senior executive at Chugai Pharmaceutical, told the Financial Times that the business had "high expectations" that its drug to treat spinal muscular atrophy could be combined with orforglipron, the once-daily weight-loss pill it has licensed to Lilly, or other similar treatments. Muscle loss is a common side effect of weight-loss drugs... Sub. Req’d

Sanofi Moves Early On Beyfortus Shipments to Get Ahead of Demand

(6/9, The Pharma Letter) ...To meet global needs, Sanofi and AstraZeneca have tripled production capacity and doubled the number of manufacturing sites. According to Sanofi, current supply levels already match last year's full-season output, with further production underway. Thomas Triomphe, who leads vaccines at Sanofi, said the company has carefully prepared its global logistics to meet growing demand. He highlighted that Beyfortus continues to deliver "high, sustained efficacy for infants regardless of underlying health conditions or the timing of when they are born."... Sub. Req’d

AstraZeneca Agrees Last-Minute $50M Settlement In Seroquel XR Delay Case

(6/9, Dean Rudge, Generics Bulletin) ...AstraZeneca has agreed to a settlement of approximately $50.9m to resolve allegations from a class of direct purchasers of a ‘pay-for-delay' scheme concerning its drug Seroquel XR (quetiapine). Meanwhile, ANDA filer Handa Pharmaceuticals has agreed to pay $494,000 as part of its involvement in the alleged conspiracy, having asserted limited financial capacity to contribute more... Global Sub. Full

Sandoz Slams Big Pharma Call for Higher Drug Prices in Europe

(6/7, Shiyin Chen, Bloomberg Law) ...Swiss generic-drug maker Sandoz Group AG sharply criticized a recent appeal by Europe's pharmaceutical industry urging the European Union to increase drug prices as a way to counter the threat of US tariffs. "When we talk about the need for US prices to fall, it's certainly not European patients who should be paying more as a result," said Sandoz Chief Executive Officer Richard Saynor in an interview with Swiss newspaper Aargauer Zeitung published on Saturday. "That is a highly questionable proposal," Saynor said. "How could European governments ever consider it? It defies all logic."... Sub. Req’d

EU Council Agrees On the Revision of the General Pharma Legislation

(6/9, The Pharma Letter) ...The European Council of Minister last week said it is ready to begin negotiations with the European Parliament, having agreed its position on new rules that aim to make the European Union's (EU) pharmaceutical sector fairer and more competitive...The announcement from the EU Council represents a missed opportunity to position Europe's life sciences sector at the forefront of global competition, according to trade group the European Federation of Pharmaceutical Industries and Associations (EFPIA)... Sub. Req’d

Ireland Welcomes a ‘Balanced, Predictable, Globally Competitive' Pharma Package

(6/6, Brian Maguire, Euractiv) ...A spokesperson for Ireland's Department of Health welcomed the Council's mandate, telling Euractiv it is a "significant milestone" in modernising the EU's pharmaceutical landscape. "The outcome of these negotiations will be of vital importance to patients, national health systems and to the pharmaceutical industry for many years to come," they said... Full

Big Pharma Warns Starmer Over NHS Drugs Pricing

(6/9, Alex Ralph, The Times) ...A government offer to cut the cost of a contentious NHS drugs pricing scheme has been rejected by the pharmaceutical industry as "falling significantly short". In a stark letter to Sir Keir Starmer, the Association of the British Pharmaceutical Industry suggested that £2 billion of potential investment discussed with Treasury officials was now at risk. The industry said it was "extremely concerned" that the government's commitment to the Trump administration "to improve the overall environment for pharmaceutical companies in the United Kingdom" would not be met... Full

Indian Pharma Grapples Headwinds of US Pricing Reform & Europe's HTA-Driven Cost-Effectiveness: Akash Kedia

(6/9, Nandita Vijayasimha, Pharmabiz.com) ...Indian pharma is currently navigating a challenging landscape shaped by US pricing reforms and Europe's increasing reliance on HTA (Health Technology Assessment) frameworks. India remains a global powerhouse in generics and vaccines but is grappling with headwinds like 8–10% YoY US price erosion, increased US FDA scrutiny, and margin compression due to input cost inflation, said Akash Kedia, managing director, Alvarez & Marsal... Full

China Is Putting Aside Its Self-Sufficiency Push for American Medicine

(6/7, Stu Woo, The Wall Street Journal) ...China is racing toward economic self-sufficiency by weaning itself off American technology. But it has made a critical exception for another national priority: public health. To achieve its goal of elevating healthcare to the level of wealthy nations by the end of the decade, Beijing has continued to welcome American-made medical supplies. It has opened its market to advanced U.S. drugs over the past decade and, more recently, exempted medical goods from retaliatory tariffs... Sub. Req’d

India is ‘No Replacement' for China in Pharmaceutical Supply Chain: Consultant

(6/9, CNBC) ...Sam Radwan from Enhance International says China's sheer dominance in APIs (active pharmaceutical ingredients) makes it crucial in producing even the most basic meds. He says China is irreplaceable in the global pharmaceutical and biotech market, and that tariffs will lead to inevitably higher healthcare costs... Full

Select Chinese Drug Inputs May Face Price Floor In India

(6/9, Aruna Sharma, Khabar India) ...India plans to introduce a minimum import price (MIP) for select pharmaceutical raw materials in a move to shield its domestic industry from a flood of cheap Chinese imports, two people directly involved in the process said, a step that will also shore up India's status as the world's largest supplier of generic drugs...The move also aims to bolster India's goal of self-reliance in the pharmaceutical sector. The heavy reliance on China, the world's largest producer and exporter of APIs, creates significant risks for India's medicine supply chain... Full

India Seizes $41 Billion Russian Pharma Opportunity

(6/9, The Pharma Letter) ...While geopolitical shifts and Western sanctions have created a significant vacuum, the doors have been thrown open for Indian players, and the veritable red carpet rolled out, as Russia turns to India to establish production facilities and enhance pharmaceutical exports, reports The Pharma Letter's India correspondent. The Russian Direct Investment Fund (RDIF) is eager to provide financial support and is actively supporting joint ventures in India. RDIF has partnered with several Indian companies to facilitate investment and production expansion, said an official... Sub. Req’d

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