Thursday, January 30, 2025

Teva Pharma CEO: Guidance Based On The New Teva That Grows Every Year

(1/29, CNBC) ...Richard Francis, Teva Pharmaceuticals CEO, joins ‘Money Movers' to discuss the company's quarterly earnings results, drug price negotiations, and much more... Full

Teva Pharm CEO Says Not Worried About US Tariffs On Drugs Sector

(1/29, Steven Scheer, Reuters) ...Teva Pharmaceutical Industries is not overly concerned about U.S. President Donald Trump potentially imposing tariffs on drugs since many medicines are already made in the United States, its chief executive said on Wednesday. Tariffs "may take time to come to this sector because if you stop pharmaceuticals from abroad, you have to have them made in the U.S. to make a substitution," Teva CEO Richard Francis told Reuters after the Israeli drugmaker issued fourth-quarter results... Full

Teva CEO Says Austedo Can Grow 'Way Beyond' Impact of IRA

(1/29, Nicole DeFeudis, Endpoints News) ...The chief executive told Endpoints News in an interview on Wednesday that the company has planned for negotiations, and still sees a "huge opportunity" within Austedo...While the chief executive declined to comment on Teva's strategy heading into negotiations with the government, he said "we think we have a very good dossier to help them understand the value we bring."... Full

Teva, Despite Delivering in 2024, Startles Investors with Subdued 2025 Guidance

(1/29, Fraiser Kansteiner, Fierce Pharma) ..."As a percentage of revenue, we are actually improving our investment in our [operating expenses], and therefore we don't see much flow through to the [earnings]," Eli Kalif, Teva's chief financial officer, added. Overall, 2024 marked Teva's second consecutive year of growth since Francis took the reins at the once-ailing generic and innovative medicines hybrid. Much of Teva's recent success can be attributed to the company's Pivot to Growth Strategy, which is now preparing to enter its second phase in 2025... Full

Teva Stock Dives 14%. Why Its CEO Says It's A Victim.

(1/29, Allison Gatlin, Investor's Business Daily) ...Teva Pharmaceutical is a victim of its own success, Chief Executive Richard Francis said Wednesday as Teva stock plummeted on its light earnings outlook."We're still growing and, by the way, we're growing off a higher base," Francis told Investor's Business Daily. "Sometimes I think we're the victims of our own success. When we started talking years ago, there were no expectations. Now, we've got to knock it out of the park all the time."... Full

"Teva Ramps Up R&D Spending to Fuel Growth—Analysts Get It"

(1/30, Bizportal) ...Adding to market uncertainty, the appointment of Robert F. Kennedy Jr. as U.S. Health Secretary has raised concerns given his vocal opposition to vaccines and skepticism toward excessive drug prescribing. However, Teva CFO Eli Kalif remains unfazed, stating that the company's regulatory relationships remain strong and that demand for pharmaceuticals and vaccines will remain high. "The U.S. Department of Health and Human Services is run by professionals, and we've successfully worked with various administrations over the years. Nothing has changed at this stage," Kalif reassured. "There's no specific regulatory risk I can point to right now."... Full

Teva Price Target Lowered to $27 at UBS, Says Pullback 'Somewhat Unfair'

(1/30, The Fly) ...UBS says the pullback on the stock Wednesday was "somewhat unfair" given 2025 is a "unique" year in terms of margin evolution, and that the firm sees a path to operating margin expansion in 2026-2026, but is lowering its expectations as the starting point is now lower. The firm says the valuation is attractive, and sees potential beat and raises during 2025, which can drive stock recovery from here, the analyst tells investors in a research note... Full

Teva Price Target Lowered to $23 from $26 at BofA

(1/29, The Fly) ...BofA believes that Teva can grow EBITDA, and that it still sees fundamentals of long-duration brands as unchanged. The firm reiterated its Buy rating on undemanding valuation multiple and pipeline-driven revenue upside... Full

Teva Price Target Lowered to $26 from $28 at Barclays

(1/30, The Fly) ...The firm says limited near-term catalysts acted as a pivot to reverse Teva's stock momentum. However, it stays confident in the company's ability to sustain growth across all its segments... Full

Medincell: UZEDY® Surges to $117M in Sales in 2024, First Full Year of Commercialization

(1/29, Medincell) ...2024 sales: $117 million with $43 million in Q4 + 17% compared to $100 million updated Teva outlook in November 2025. Initial 2025 Teva outlook: $160 million vs. initial 2024 Teva outlook: $80 million Medincell receives mid- to high-single digit royalties on all sales and is eligible for $105 million of commercial milestones... Full

Sanofi is in the Market for M&A, Thanks to ‘Strong' Balance Sheet

(1/30, Reynald Castañeda, Endpoints News) ...Sanofi is likely to increase its M&A this year since it has more cash in its pockets, as the French pharma also monitors China as a possible source of new drug innovation, CFO François Roger said during a media call Thursday morning...In a separate media call, CEO Paul Hudson said Sanofi would likely target preclinical and Phase 1 assets because it already has a robust late-stage pipeline. Roger added Sanofi would prefer to focus on assets worth between €2 billion and €5 billion... Full

Japan's Takeda Says CEO Weber to Step Down, Raises Profit Forecast

(1/30, Rocky Swift, Reuters) ...Takeda says Christophe Weber to step down as CEO, names Julie Kim as successor. Takeda raises full-year profit forecast despite quarterly results lagging estimates. Takeda shares down 10% since Shire deal, Nikkei up over 170%... Full

Roche Sees High Single-Digit Core Profit Growth in 2025

(1/30, Ludwig Burger, Reuters) ...Roche said on Thursday it is targeting a continued increase in adjusted earnings per share (EPS) at a high single-digit percentage this year, helped by lower costs and growth from drugs such as eye treatment Vabysmo and cancer drug Phesgo... Full

Stelara: The Beginning Of The End

(1/30, Dave Wallace, Generics Bulletin) ...J&J's fourth-quarter and full-year results have confirmed the decline for Stelara that had already begun to be seen late last year. And with US biosimilars now set to take a slice of the ustekinumab market following the launch of multiple European rivals last year, for the originator the only way is down... Global Sub. Full

Piramal Pharma to Expand Injectables Portfolio in Complex Hospital Generics Business

(1/30, Jessica Jani, Mint) ...Piramal Pharma Ltd, which has a strong presence in the inhaled anaesthetic generics segment in the US and emerging markets, plans to expand its pipeline of injectables to drive growth, chairperson Nandini Piramal told Mint in an interview. The company launched Chlorpromazine Hydrochloride, an injectable used to treat psychiatric disorders, in the US on January 22,. This is the latest injectable from Piramal Critical Care, the company's complex hospital generics arm... Sub. Req’d

Torrent Weathers Currency Storms In Brazil

(1/29, Dave Wallace, Generics Bulletin) ...India's Torrent managed to register growth in its financial third quarter – despite being hit by severe currency headwinds in Brazil and suffering a decline in the US – as growth in Germany and its domestic market more than offset the damage. In a financial third quarter of ups and downs, India's Torrent Pharmaceuticals managed to offset currency headwinds in Brazil and a downturn in its US business thanks to double-digit growth in India and continued momentum in the German market... Global Sub. Full

Lannett's US Selexipag Chance Moved Back To 2030, Alembic Leads The Charge

(1/29, Dean Rudge, Generics Bulletin) ...Lannett will recognize the validity and enforceability of pair of US patents shielding the tablet formulation of J&J's Uptravi (selexipag) blockbuster until 2030, under a consent judgment and order of permanent injunction signed by a judge in a federal district court in Delaware... Global Sub. Full

Federal Circuit Affirms Injunctions On Eylea Biosimilar Sales

(1/29, Michael Shapiro, Bloomberg Law) ...Specifically, the Federal Circuit rejected Samsung Bioepis' argument there was a lack of necessary evidence it planned to commercialize its SB15 "in West Virginia in particular." The company would be working with Biogen MA Inc., which would have "exclusive rights to determine where to market" the drug, according to a precedential opinion issued by the US Court of Appeals for the Federal Circuit... Sub. Req’d

Granules India Gets USFDA Nod for ADHD Treatment

(1/30, Press Trust Of India) ...The approval granted by the US Food & Drug Administration to Granules Pharmaceuticals, Inc is for the Abbreviated New Drug Application for Lisdexamfetamine Dimesylate capsules in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg, Granules India said in a regulatory filing. This generic drug product is bioequivalent and therapeutically equivalent to the reference listed drug, Vyvanse capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of Takeda Pharmaceuticals USA, Inc, it added... Full

NATCO Pharma Gets Approval for its ANDA for Everolimus Tablets

(1/30, Business Standard) ...NATCO Pharma said that it has received approval of its ANDA for Everolimus tablets for oral suspension, a generic version of AFINITOR DISPERZ by Novartis Pharmaceutical Corporation. The companys marketing partner for the ANDA, Breckenridge Pharmaceutical, Inc plans to launch the product immediately in the US market... Full

GLP-1 Compounding: Lilly Takes Advertising Complaints To NAD

(1/30, Sue Sutter, Pink Sheet) ...A National Advertising Division challenge by Lilly led an Oregon clinic to discontinue numerous advertising claims about the safety and efficacy of its compounded tirzepatide product. Lilly is bringing false advertising and deceptive trade practice lawsuits against GLP-1 compounders and has intervened in a case against the FDA from outsourcing facilities. The pharma company says it will continue to consider all avenues to address the patient safety risks of compounding... Global Sub. Full

Unsustainable Biosimilar Market Leaves Practices, Patients at a Loss

(1/30, Lucy Hicks, Medscape News) ...Biosimilars are often promoted as cost-saving alternatives to their reference medications. Designed to provide comparable therapeutic efficacy at a reduced price, they have the potential to lower healthcare costs for both patients and healthcare systems. However, practices nationwide are facing the opposite issue with certain infused biosimilars. Rather than saving money, the acquisition costs of these drugs exceed reimbursement rates. As a result, many practices can no longer afford to offer these "underwater" medications... Full

Medicare 2027 Negotiating Class: Austedo, Linzess, Xifaxan May Face Generic, OTC Price Comparators

(1/30, Cathy Kelly, Pink Sheet) ...Teva may grapple with questions about how its Austedo (deutetrabenzene) is worth the price premium over generic tetrabenzene while negotiating a "maximum fair price" with the US Centers for Medicare and Medicaid Services...Austedo's revenues are heavily dependent on the US market. The drug is not approved in Europe outside of an ethical unlicensed medicines program because the generic is available, [ATI Advisory prescription drug reimbursement practice lead Anna Kaltenboeck] said."That speaks to the [product development] incentives in the US system," she added... Global Sub. Full

Medicare Price Negotiation Will Continue Under Trump With Possible ‘Improvements'

(1/29, Cathy Kelly, Pink Sheet) ...The Trump Administration will continue the second cycle of the Medicare price negotiation program, but wants to increase transparency and make other potential "improvements" to the process. HHS Secretary nominee Robert F. Kennedy Jr. indicated the administration supported the program during his confirmation hearing in the Senate Finance Committee. Kennedy also wants to reduce the disparity in drug prices between the US and abroad... Global Sub. Full

Trump Administration Makes First Comments On How it Will Run IRA Drug Negotiations

(1/29, Nicole DeFeudis, Endpoints News) ...The Trump administration said on Wednesday it will consider "opportunities to bring greater transparency" to the Medicare drug price negotiation process under the Inflation Reduction Act. With the second cycle of negotiations set to begin in a month, CMS said in a statement that it is "committed to incorporating lessons learned to date from the program." The administration said lowering drug prices will be a "top priority," and that it intends to give stakeholders the opportunity to "provide specific ideas to improve the negotiation program."... Full

Trump's Administration Aims for 'Greater Transparency' in Drug Price Negotiations

(1/29, Bhanvi Satija, Reuters) ...The Centers for Medicare and Medicaid Services will give opportunities for "stakeholders to provide specific ideas" that can improve the negotiations, the agency, which oversees the Medicare health program, said on Wednesday... Full

CMS Statement Supports Drug Negotiation, RFK Jr. Says Exec Order Planned

(1/29, Jessica Karins, Inside Health Policy) ...Asking about CMS' drug price negotiation program during the Senate Finance Committee hearing, Kennedy said, "The White House issued an executive order, I believe today, supporting the drug negotiations under the IRA."..."President Trump was very aggressive during his first term about negotiating drug prices," Kennedy said, adding that he has met with the president about the priority of lowering drug prices for seniors... Sub. Req’d

RFK Jr. Backs PBM Reforms, Says Trump Wants To Strip Excess Profits

(1/29, Gabrielle Wanneh, Inside Health Policy) ...HHS Secretary nominee Robert F. Kennedy Jr. told Senate Finance members Wednesday (Jan. 29) that pharmacy benefit manager reform is a must for him and President Donald Trump, and that he will support Congress as it seeks to crackdown on PBMs and to require pricing information on direct-to-consumer prescription drug advertisements... Sub. Req’d

Articulating Policy Options Regarding Implementation of the Medicare Drug Price Negotiation Program's Renegotiation Provision

(1/29, Rachel Sachs and Richard G. Frank, Brookings) ...CMS has yet to promulgate guidance for the 2028 cycle of the program and make its views public regarding the structure of the renegotiation process. In this piece, we identify three key questions CMS will face in implementing and operationalizing the renegotiation process for the program and offer policy options for the agency to consider... Full

Celltrion Considers US Manufacturing In Response To Trump Tariffs

(1/30, Dave Wallace, Generics Bulletin) ...Celltrion may consider establishing or acquiring US manufacturing facilities as well as securing more US inventory and shifting its focus onto drug substance rather than drug product imports, the Korean biosimilars giant has suggested, as it sought to assuage investor concerns over pharmaceutical tariffs announced by US president Donald Trump... Global Sub. Full

Congressman Pat Ryan Introduces Affordability Agenda to Lower Costs

(1/29, Congressman Pat Ryan) ...Today Congressman Pat Ryan introduced his first legislation of the 119th Congress, his Affordability Agenda. The package includes landmark legislation to lower costs across the board for Hudson Valley families, with specific focuses on groceries, prescription drugs, housing, and Social Security...Congressman Ryan's Stopping Pharma's Ripoffs and Drug Savings For All Act would rein in Big Pharma's current abuse of U.S. patent law, and make it easier to produce less-costly generic drug alternatives... Full

Express Scripts Takes New Steps to Improve Transparency, Address Affordability

(1/30, Paige Minemyer, Fierce Healthcare) ...The PBM said in an announcement that about 80% of its members pay less than $100 per year on their medications, but the remaining 20% are at times exposed to higher costs, a trend that's particularly true for people who may be in high-deductible plans...Adam Kautzner, president of Evernorth Care Management and Express Scripts, told Fierce Healthcare that the initiatives announced Wednesday follow a series of changes made by the Express Scripts team with the goal of tackling affordability and transparency... Full

Cigna Plans to Limit Out-Of-Pocket Drug Costs for US Patients

(1/29, John Tozzi, Bloomberg) ...Cigna Group plans to limit patients' out-of-pocket expenses for medications as the insurer faces pressure from Washington over its role in prescription costs. The changes aim to ensure that patients don't pay the drug company's list price for medications and don't pay more out-of-pocket for their medications than the amount that their employer contributes, a top executive said in an interview with Bloomberg News... Full

Legislators Try Again to Create State Board to Review Drug Prices

(1/29, George Wiebe, Chicago Sun-Times) ..."If we have the ability to review some of these drugs that pose the biggest affordability challenge, then we will hopefully see all health insurance premiums decrease across the board," state Rep. Nabeela Syed, D-Palatine, told the Sun-Times Wednesday... Sub. Req’d

Maine Health Groups Push for Law to Protect Access to Discount Drug Program

(1/30, Joe Lawlor, Portland Press Herald) ...Groups including the Maine Pharmacy Association, the Maine Primary Care Association — which represents the clinics — and the Maine Hospital Association said on Wednesday that the bill would prevent pharmaceutical companies from restricting access to discounted drugs through what's known as the 340B program. But a representative from the pharmaceutical industry criticized the bill, arguing it would open the door to more abuse by hospitals that are exploiting the program... Full

Pharma Industry Calls For Policy Changes At EU Level To Address Shortages

(1/29, Eliza Slawther, Pink Sheet) ...Industry federation EFPIA has set out recommendations for regulators and policymakers in the EU to tackle medicines supply shortages. The federation backs initiatives such as the new European Shortages Monitoring Platform and says that it should be harmonized with other shortage tools. EFPIA warns against ‘disproportionate and uncoordinated' national stockpiling requirements, and says any stockpiling efforts should take place at the European level... Global Sub. Full

European Shortages Monitoring Platform Fully Operational for Monitoring of Shortages in the EU

(1/29, European Medicines Agency) ...The European Shortages Monitoring Platform (ESMP) is now live with the full scope of functionalities. This will enable marketing authorisation holders (MAHs) and national competent authorities (NCAs) to directly report information on supply, demand and availability of nationally and centrally authorised medicines during crises and preparedness actions led by EMA's Executive Steering Group on Shortages and Safety of Medicinal Products... Full

Renewed Push to Turbo-Charge UK-EU Science and Technology Links

(1/30, The Pharma Letter) ...Today (January 30) the government is announcing the launch of a new nationwide advertising campaign to further boost UK participation in Horizon Europe, the world's largest program of research collaboration. The UK is also joining four European Research Infrastructure Consortia (ERICs) to further boost collaborative ties between researchers, across the Channel... Sub. Req’d

Belgian Agency To Lead EU Joint Clinical Assessments Under HTA Regulation

(1/29, Francesca Bruce, Pink Sheet) ...The Belgian health technology assessment (HTA) body, INAMI-RIZIV, will lead the consortium of EU member state HTA bodies that will carry out joint clinical assessments (JCA) under the HTA Regulation. In this role, the Belgian body will draw on its experience gained through the BeNeLuxA cross-country coalition, which among other things conducts joint HTAs for new medicines... Global Sub. Full

Budget 2025: Will Nirmala Sitharaman Cut the Cost of Medicines and Hospitalisation?

(1/29, Sushmita Panda, Financial Express) ...Finance Minister Nirmala Sitharaman will table Budget 2025 on February 1 2025. Ahead of Budget 2025, leaders are anticipating that the Finance Minister will prioritise making medicines and other healthcare facilities more accessible and affordable... Full

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