Monday, February 3, 2025

Analysts Remain Positive On Teva

(2/2, Shiri Habib-Valdhorn, Globes) ...Piper Sandler says that Teva should not have been "punished" for its guidance. It says that there was perhaps room to complain at the fact that operating profit is not expected to grow this year despite the growth in revenue, but that the context is large investment in R&D and in promoting the original drugs Austedo and Ajovy. Piper Sandler's recommendation remains unchanged at "Outperform", with a price target of $30, 69.2% above the current market price... Full

Sun Pharma Targets Faster Growth Than The Market, Led by New Products

(2/3, Vinnii Motiwala, CNBC TV-18) ...Sun Pharmaceutical Industries is well positioned to grow in line with or above the market, led by healthy contribution from volumes and new products, said Group CFO CS Muralidharan in an interview with CNBC-TV18. All products in the specialty portfolio of the Mumbai-based Sun Pharma, performed well during the quarter... Full

Alembic Pharma Q3 Results | Net Profit Declines 23% to 138 Crore, Net Sales Up 4%

(2/3, Jomy Jos Pullokaran, CNBC TV-18) ...Alembic Pharmaceuticals reported a 4% year-on-year increase in net sales for Q3 FY24, reaching 1,693 crore. The growth was driven by steady performance across key segments, including India Branded Business, US Generics, and API...Shaunak Amin, MD, Alembic Pharmaceuticals, said. "In the current quarter, we faced market headwinds in the acute segment. However, other key therapies in our speciality business continued to outpace the market growth."... Full

Biocon Biologics Sees Diversified Global Expansion Offsetting US Localisation Risks

(2/1, Aishwarya Kumar, The Hindu BusinessLine) ...The pro-localisation policy in the US will not impact Biocon Biologics' revenue, noted Shreehas Tambe, CEO of Biocon Biologics. The US, which contributes 40 per cent of the company's revenue has a limited risk due to Biocon's Biologics's market diversification, coupled with the company's strategy of hiring internationally, Tambe said. "In the US, we have a large workforce of Americans, and we operate as a local company," he added... Full

Novartis' Kisqali Off to 'Very Rapid' Launch in Early Breast Cancer, CEO Says. Can it Keep Up the Momentum?

(1/31, Angus Liu, Fierce Pharma) ...Following a broad FDA approval for the adjuvant treatment of HR-positive, HER2-negative early breast cancer in September, Novartis' Kisqali grew U.S. sales by 65% year over year—or nearly 25% sequentially—to $549 million in the fourth quarter of 2024...Kisqali is undergoing "a very rapid launch" in early breast cancer, Novartis CEO Vas Narasimhan said during a media call Friday. As Narasimhan shared during the J.P. Morgan Healthcare Conference on Jan. 14, Kisqali reached 52% in new-to-brand market share in early breast cancer within three months of the launch... Full

AbbVie Executives Bask in Skyrizi, Rinvoq Successes as the Drugs Take Up Humira's Mantle

(1/31, Max Gelman, Endpoints News) ...On Friday, AbbVie raised its 2027 sales guidance by $4 billion for the two newer drugs and triggered a 5% stock jump, partially erasing the losses from November's schizophrenia failure and $3.5 billion write-off...The biggest reason for the upward revision is due to what chief commercial officer Jeff Stewart called "share capture."... Full

Three's A Crowd: Celltrion Picks Up Latest US Tocilizumab Nod

(1/31, Dave Wallace, Generics Bulletin) ...Celltrion has celebrated becoming the third firm to gain US Food and Drug Administration approval for a biosimilar rival to Actemra (tocilizumab), registering its Avtozma (tocilizumab-anoh) version in both intravenous and subcutaneous formulations...The IV infusion will be available as a 20mg/ml concentration in 80mg/4ml, 200mg/10ml and 400mg/20ml versions, while the SC injection comes as a 162mg/0.9ml single-dose pre-filled syringe or single-dose autoinjector... Global Sub. Full

Lupin Receives Tentative FDA Approval for Generic Darunavir Combination Tablets

(2/3, Express Pharma) ...Lupin has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Tablets, 800 mg/150 mg/200 mg/10 mg. The product has been found to be bioequivalent and therapeutically equivalent to Janssen Products, LP's reference listed drug (RLD), Symtuza Tablets, 800 mg/150 mg/200 mg/10 mg... Full

CuraTeQ Biologics Receives Positive Opinion for Biosimilar Dyrupeg from EMA

(2/2, Indian Pharma Post) ...CuraTeQ Biologics, a step-down subsidiary of Aurobindo Pharma Limited, has announced that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency has adopted a positive opinion for Dyrupeg (BP14, a pegylated filgrastim biosimilar) recommending the granting of a marketing authorisation. The CHMP positive opinion is expected to translate into a formal decision of approval by the European Commission in April 2025... Full

Amgen's Aflibercept And Aurobindo's Pegfilgrastim Win EU Nods

(2/3, Dave Wallace, Generics Bulletin) ...Amgen's biosimilar version of Eylea (aflibercept) and Aurobindo's Neulasta (pegfilgrastim) rival have been lined up for pan-European marketing authorizations, after the European Medicines Agency's Committee for Medicinal Products for Human Use issued positive opinions for the products at its January meeting. While positive opinions do not represent formal European approvals, the European Commission typically converts them into marketing authorizations within 67 days... Global Sub. Full

Regeneron Shuts Out Samsung Bioepis, Keeping Eylea Biosimilars at Bay—for Now

(2/1, Kim Ji-hye, Korea Biomedical Review) ...U.S. federal ruling locks Samsung Bioepis out of the multi-billion-dollar market, as Regeneron fights to preserve its blockbuster drug's dominance. In a decision that sends a clear message to biosimilar manufacturers, the U.S. Court of Appeals for the Federal Circuit has upheld a preliminary injunction barring Samsung Bioepis from launching its Eylea biosimilar (ingredient: aflibercept) in the U.S... Full

Vertex's Pain Drug Journavx Breaks Through US FDA Communications Freeze

(1/31, Sue Sutter, Pink Sheet) ...The FDA issued its first press release under a Trump Administration communications freeze announcing the approval of Vertex's non-opioid pain drug Journavx. Recent agency website updates and Federal Register notices suggest the communications freeze is slowly starting to thaw. Public meetings continue falling by the wayside, the latest a joint FDA/Health Canada meeting on ICH that was postponed... Global Sub. Full

AstraZeneca Ditches Plan to Build £450Mn UK Vaccine Plant

(1/31, Anna Gross, Hannah Kuchler and George Parker, Financial Times) ...AstraZeneca has cancelled plans for a £450mn UK vaccine manufacturing plant after months of wrangling with British officials about state support for the project, in a major blow to Prime Minister Sir Keir Starmer's government..."Following protracted discussions with the government, we are no longer pursuing our planned investment at Speke," AstraZeneca said in a statement on Friday. "Several factors have influenced this decision including the timing and reduction of the final offer compared to the previous government's proposal."... Sub. Req’d

Novartis Sues MSN Pharmaceuticals Over ‘Novadoz' Trademark

(1/31, Kyle Jahner, Bloomberg Law) ...Novartis Pharmaceuticals Corp. accused generics-maker MSN Pharmaceuticals Inc. of planning a "scheme designed to confuse consumers" over the source of its "Novadoz" version of the blockbuster heart medication Entresto. Novartis—already fighting a patent battle over the generic—alleged MSN plans to distribute its generic under its Novadoz brand, according to a US District Court for the District of New Jersey complaint. It said that name blends "Novartis" and "Sandoz," the name of Novartis' own generics-making subsidiary... Sub. Req’d

CVS, Walgreens, Walmart Evade $650 Million Ohio Opioid Judgment

(1/31, Eric Heisig, Bloomberg Law) ...The Sixth Circuit on Friday wiped out a $650 million judgment and corresponding injunction against CVS Pharmacy Inc., Walgreens Boots Alliance Inc., and Walmart Inc. after the Ohio Supreme Court ruled that state law prohibits the specific claims the pharmacy megachains faced for the opioid epidemic... Sub. Req’d

Breckenridge To Strengthen Generic Everolimus Launch With Copay Program

(2/3, Generics Bulletin) ...Breckenridge Pharmaceutical and its Indian partner Natco Pharma have celebrated US Food and Drug Administration approval for their generic everolimus tablets for oral suspension, referencing Novartis' Afinitor Disperz. The kinase inhibitor was approved in 2mg, 3mg, and 5mg doses for the treatment of subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected in adult and pediatric patients aged one year and older with tuberous sclerosis complex... Global Sub. Full

Welcome Wezlana: The First Stelara Biosimilar to Launch in the US

(1/31, Skylar Jeremias, The Center For Biosimilars) ...Earlier this month, the US market welcomed its first ustekinumab biosimilar, Amgen's Wezlana (ustekinumab-auub), ushering in a new class of lower-cost biologics for Americans with a number of rheumatic and gastrointestinal conditions. However, the biosimilar is only available through Nuvaila.2 Nuvalia is a biosimilar procurement business, comparable to CVS Health's Cordavis and Cigna/Express Scripts' Quallent. Earlier this month, AIS Health reported on its exclusive arrangement with Nuvaila... Full

Assessing the Biosimilar Void in the U.S.

(2/3, IQVIA) ...In this report, patent expiries were assessed for all biologic medicines on the U.S. market. The current status of biosimilar development was collated and overlayed with patent expiries occurring over the next decade from 2025 to 2034. We looked at a range of characteristics of biologic medicines that could limit biosimilar development and contribute to a ‘biosimilar void'—or areas where biosimilar competition may not transpire...Understanding and addressing the biosimilar void is critical to realize the benefits these medicines bring... Full

Trump's Move to Put Tariff Hikes Ahead of Tax Cuts Has Spooked Almost Everyone

(2/2, Lindsay Wise, The Wall Street Journal) ...Larry Summers, the former U.S. Treasury secretary under President Bill Clinton, said that Trump's move amounted to "a self-inflicted supply shock." Kentucky Republican Sen. Rand Paul said: "Taxing trade will mean less trade and higher prices." The head of the National Association of Manufacturers, Jay Timmons, said it put American jobs at risk. "The ripple effects will be severe," he said. For many of those reasons, tariffs were the part of Trump's economic plan investors disliked the most... Full

Drug Prices Likely to Soar Due to Trump Tariffs, Pharma Bodies Warn

(2/3, Anna Brown, Endpoints News) ...The Trump administration imposed a 25% tariff on imports from Mexico and Canada and a 10% tariff on China on Saturday. The US relies on importing pharmaceutical products globally, in particular from China, which is a large supplier of APIs. Tariffs will put a strain on "already problematic drug shortages" by forcing generic manufacturers out of the market due to low profit margins, warned Association for Accessible Medicines CEO John Murphy... Full

How Trump's Tariffs May Raise Health care Costs, From Medical Devices to Prescription Drugs

(2/2, John Wilkerson, STAT+) ...Marta Wosinska, a senior fellow in economic studies at The Brookings Institution, said tariffs could cause more shortages of generic drugs with thin profit margins if the makers of those drugs can't raise prices. That would reverse progress toward curbing drug shortages...Generic drug companies may not be able to raise their prices in response to tariffs because of penalties for raising prices too quickly in some government programs, and because they may have long-term contracts with group purchasing organizations, which buy drugs and medical equipment for hospitals... Sub. Req’d

RFK Jr. Fields Pharma Questions On Day Two

(1/31, Lauren Gardner and David Lim, Politico) ...Kennedy struggled to answer questions about the differences between Medicare Parts A, B and C when questioned by Sen. Maggie Hassan (D-N.H.) — a day after appearing to confuse aspects of Medicare and Medicaid. The nominee also touched on FDA policy, indicating he would implement President Donald Trump's chosen position on the abortion pill mifepristone — noting Trump has not yet taken one — and agreeing more should be done to reduce the drug supply chain's reliance on China... Full

Kennedy Rejects Use Of March-In Rights To Lower Drug Prices

(1/31, Jessica Karins, Gabrielle Wanneh, Inside Health Policy) ...President Donald Trump's nominee to lead HHS, Robert F. Kennedy Jr., does not support using march-in rights under the Bayh-Dole Act to lower drug prices, he confirmed in a written response to additional questions from senators published Friday (Jan. 31). Kennedy rejected the draft framework for use of march-in rights to lower drug prices that the Biden administration had published but never finalized... Sub. Req’d

RFK Jr. Says U.S. Won't Threaten Pharmaceutical Patents to Push for Lower Drug Prices

(1/31, Rachel Cohrs Zhang, STAT+) ...In response to a question from Sen. Elizabeth Warren (D-Mass.) about whether he supported using march-in rights to lower drug prices, RFK Jr. said that, "would not be an appropriate use of march-in rights," according to responses obtained by STAT. RFK Jr. has said plenty over the past few days that may displease the pharmaceutical industry, from refusing to say that vaccines don't cause autism, to committing to continue Medicare drug price negotiations, to agreeing with Sen. Bernie Sanders (I-Vt.) that the United States should bring what it pays for drugs in line with prices in Europe... Sub. Req’d

Democrats Want Answers On Cost-Cutting Prescription Payment Models Abandoned by Trump

(1/31, Joseph Choi, The Hill) ...A group of 51 House Democrats led by Rep. Shontel Brown (Ohio) wrote to Dorothy Fink, acting Health and Human Services secretary, and Jeff Wu, acting Centers for Medicare and Medicaid Services administrator, asking for answers on how Trump's rescinding of Executive Order 14087 could affect the future of the prospective payment models developed by the Biden administration... Full

Drug Coverage Harder to Find for Traditional Medicare Enrollees

(2/3, Tony Pugh, Bloomberg Law) ...Known simply as "PDPs," the plans provide drug coverage for beneficiaries in traditional, fee-for-service Medicare. They also provide premium-free "benchmark plans" for fee-for-service beneficiaries who receive the Medicare prescription drug Low Income Subsidy. Medicare Advantage drug plans provide both medical and drug coverage for enrollees, who account for more than half of all Medicare beneficiaries... Full

Association for Accessible Medicines Comments On New Tariffs

(2/2, AAM) ..."Americans pay less for generics than almost anywhere in the world but are facing growing challenges of drug shortages. The previous Trump Administration opted not to impose tariffs on generic and biosimilar manufactures. AAM and its members urge the Administration to follow their past practice and work with our industry on constructive policies and regulatory reforms that will bolster the resiliency and vibrancy of this critical healthcare market to the benefit of the American economy, lower overall healthcare costs, and keeping America's patients healthy."... Full

The U.S. Biosimilars Market Continues to Increase Competition and Savings but Reforms are Needed to Realize Its Full Potential

(2/3, PhRMA) ...Since Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2010, biosimilars have bolstered competition and increased options for patients. As more biosimilars and interchangeable biosimilars are anticipated to enter the market in the years ahead, competition and savings are expected to grow substantially. But more can be done to realize the full potential of the biosimilar marketplace by addressing market distortions that impede more robust competition and savings from biosimilars, particularly when they could offer lower out-of-pocket costs for patients... Full

Durbin, Grassley Urge PhRMA To Embrace Their Bill To End Price Secrecy In Prescription Drug Advertisements

(1/31, U.S. Senator For Illinois Dick Durbin) ...U.S. Senate Democratic Whip Dick Durbin (D-IL) and U.S. Senator Chuck Grassley (R-IA), a senior member and former chairman of the Senate Finance Committee, today sent a letter to the President and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) urging them to embrace their bipartisan legislation, the Drug-price Transparency for Consumers (DTC) Act, to empower patients and providers and commit to voluntarily disclosing list prices in DTC advertisements... Full

More Heart, Less Skin: US FDA's 2025 Novel Approvals Should Reflect Pipeline Shifts

(1/31, Bridget Silverman, Pink Sheet) ...Cardiovascular drug development is returning to the spotlight by building on the explosive growth across cardiometabolic conditions with potential therapies that have mechanisms familiar (PCSK9 inhibition, calcium channel blockade, cardiac myosin inhibition) and pioneering (cell therapy). Only one immunodermatology agent is under review after being one of the most active spaces of recent years. The class of novel agents vying for approval in 2025 are less concentrated in oncology, hematology and neuroscience than recent years, driven by a drop-off in blood disorder candidates... Global Sub. Full

Pediatric RSV Vaccine Safety Casts A ‘Long Shadow' For US FDA

(1/31, Michael McCaughan, Pink Sheet) ...With vaccine skepticism rampant, the FDA continues to have communication challenges. A December 2024 VRBPAC meeting may have been a trial of its strategy to demonstrate the importance of vaccine safety during development, while also reassuring the public about the safety of licensed products. In briefing documents for the VRBPAC meeting, the FDA may have erred by suggesting all pediatric trials for RSV vaccine were on hold in children younger than two, when live-attenuated vaccine trials were still active... Global Sub. Full

Independent Pharmacies Fight Back As PBM Reform Gains Steam

(1/31, Charlotte Rene Woods, Virginia Mercury) ...A bill to reign in pharmacy benefit managers faced early resistance in the General Assembly but is now picking up steam. After a House Finance subcommittee skipped a vote earlier this week, Del. Mark Sickles, D-Fairfax, called the bill "controversial." By Friday, however, it had cleared the full Finance committee and is now headed to the full House of Delegates for consideration... Full

WHO Issues Environmental Sustainability Call To Regulators And Pharmaceutical Industry

(1/31, Anabel Costa-Ferreira, Pink Sheet) ...Proposals set out in a call to action issued by the World Health Organization to improve sustainability in the pharmaceutical address all stages of the regulatory cycle from manufacturing to distribution. The call to action will lead to a comprehensive white paper that will inform discussions at the COP30 in November 2025. The pharmaceutical industry recognizes the need to improve environmental sustainability and is calling for convergence and collaboration among regulators and companies to tackle the issue... Global Sub. Full

Budget 2025: Experts Welcome Budget Push for Accessibility, Call for Stronger R&D

(2/3, The Economic Times) ...The Union Budget 2025-26 has received a mixed response from healthcare experts, with some welcoming its focus on accessibility and affordability while others feel it lacks long-term vision in key areas like research and innovation. The government's push for preventive healthcare, medical education, and public-private partnerships has been appreciated, but concerns remain over insufficient funding for research and development... Full

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