Friday, January 31, 2025

Teva Plots 16 Complex Launches To Weather US Revlimid Storm In 2026

(1/30, Dean Rudge, Generics Bulletin) ...Teva has revealed plans to launch up to 16 complex generics in the US in 2025 and 2026 to counteract the erosion of its core US generic Revlimid (lenalidomide) beginning in March 2026, alongside a slate of up to seven US biosimilars, including the impending launch of its Alvotech-partnered Selarsdi (ustekinumab-aekn)... Global Sub. Full

FDA Reviews Golimumab Biosimilar, Samsung Biologics Hits Record Sales, Japan Approves Stelara Biosimilar

(1/30, Cameron Santoro, The Center For Biosimilars) ...The FDA accepted the biologics license applications (BLA) for AVT05, Alvotech's and Teva Pharmaceuticals' proposed biosimilar to golimumab (Simponi and Simponi Aria), which treats inflammatory conditions like rheumatoid arthritis. This is the first BLA for golimumab biosimilar to be accepted by the FDA. The FDA expects to complete the review by the fourth quarter of 2025... Full

Sanofi's RSV Antibody Beyfortus, After Smashing Blockbuster Sales Threshold, Still Has Room to Grow in US: Execs

(1/30, Fraiser Kansteiner, Fierce Pharma) ...While Sanofi's immunology megablockbuster Dupixent predictably dominated the company's sales charts in 2024, a new golden child could be emerging in the form of Beyfortus. During its first full year on the market, the respiratory syncytial virus (RSV) antibody easily broke the $1 billion sales threshold. Plus, the drug still has plenty of room left to grow in places like the U.S., Sanofi executives said on an analyst call Thursday... Full

Novartis Beats Q4 Earnings Consensus As Drug Sales Surge

(1/31, Ludwig Burger, Reuters) ...Novartis on Friday posted adjusted net income well above analyst estimates as sales of established heart failure drug Entresto and newer multiple sclerosis drug Kesimpta exceeded forecasts...Harry Kirsch, Novartis' finance chief, told Reuters that seeing the newer drugs beat expectations "really lifts these brands to a new level". The company predicted that 2025 operating income, adjusted for special items, would grow by a "high single to low double-digit" percentage, excluding the effect of currency swings... Full

Top Indian Drugmaker Sun Pharma's Q3 Profit Beats Estimates On Strong Local Sales

(1/31, Kashish Tandon, Rishika Sadam, Reuters) ...The Mumbai-based firm's consolidated net profit rose 15% to 29.03 billion rupees ($335.3 million) in the third quarter, beating analysts' average estimate of 28.81 billion rupees, according to data compiled by LSEG. Sales in India, Sun Pharma's largest revenue-generating region, rose 14% to 43 billion rupees, or about 31% of total sales. That was bigger than the 11% increase in the previous quarter... Full

Biocon's Q3 Revenue Dips; Banks On Obesity Drugs for Future Growth

(1/30, Rishika Sadam, Reuters) ...Indian biopharma company Biocon reported third-quarter revenue on Thursday that fell about 3% when compared with the year-earlier period, which included revenue from its domestic branded formulation business that has since been divested...Revenue from the generics unit fell 2.4%, while revenue from its research services business rose 11%. Biocon, which expects a recovery in its generics business in the next few quarters, is banking on its portfolio of obesity drugs, which have seen skyrocketing demand in global markets... Full

Roche Expects Sales, Earnings Growth After Better-Than-Expected Results

(1/31, Helena Smolak, The Wall Street Journal) ...The Swiss pharmaceutical giant is forecasting sales growth in the mid-single-digit range at constant exchange rates in 2025, and core earnings-per-share growth in the high-single-digit range. Chief Executive Thomas Schinecker said in a call with reporters that Roche remained committed to keeping its research-and-development spending broadly flat in 2025. However, he said the company expects the new U.S. administration under President Trump to encourage more investments in the country, a development he anticipates will benefit Roche... Sub. Req’d

Takeda Axes Failed Epilepsy Asset After FDA Weighs in On Data Package

(1/30, Nick Paul Taylor, Fierce Biotech) ...Takeda has axed plans to seek approval for its failed epilepsy drug candidate soticlestat. The Japanese drugmaker pulled the plug on the program after the FDA pointed out the shortcomings of its clinical data package... Full

FDA Approves Axsome's Acute Migraine Treatment After 2022 Rejection

(1/30, Max Gelman, Endpoints News) ...More than two and a half years after the FDA rejected its migraine treatment, Axsome Therapeutics received an approval for the drug on Thursday to treat acute migraines with or without aura. The drug, previously called AXS-07, will be branded as Symbravo. A company spokesperson said Axsome will detail pricing plans closer to launch. Symbravo was first rejected in May 2022 after regulators raised issues with its manufacturing process, Axsome said at the time. Axsome's COO Mark Jacobson told Endpoints News ahead of the decision that the company took its time resubmitting because of the complexity of making the drug... Full

Celltrion Secures FDA Nod for Actemra Biosimilar Avtozma

(1/31, Kim Hae-yeon, The Korea Herald) ...Celltrion announced on Friday that its biosimilar Avtozma, a version of the autoimmune disease treatment Actemra (active ingredient tocilizumab), has received product approval from the US Food and Drug Administration...The original drug, Actemra, is available in two formulations: subcutaneous injection and intravenous injection. Celltrion has secured FDA approval for Avtozma in both formulations, allowing healthcare providers to prescribe the most suitable option based on patient needs... Full

Vertex's Non-Opioid Pain Drug is Approved by FDA, Bringing First of New Class to Market

(1/30, Max Gelman, Endpoints News) ...The FDA approved Vertex's non-opioid drug for moderate to severe acute pain, bringing to market the first in a new class of alternatives to painkillers. The drug, known as suzetrigine, will have the brand name of Journavx. Vertex said in a press release that it will cost $15.50 per pill, or about $31 a day. That's roughly three times the price of commonly used opioids, and is a far smaller margin than what companies with new brand-name drugs often charge compared with products that have wide generic competition... Full

Regeneron Wins Appeals Court Orders Backing Halt On Eylea Biosimilars

(1/30, Max Bayer and Alexis Kramer, Endpoints News) ...Two biotech companies failed to reverse orders barring them from selling biosimilars of Regeneron's eye disease drug Eylea in rulings from a federal appeals court. The US Court of Appeals for the Federal Circuit affirmed a lower court's preliminary injunctions against Samsung Bioepis and Formycon... Full

Ex-CBO Chief: Trump's Pharma Tariffs Unrealistic, Could Boost China's Drug Market

(1/30, Maaisha Osman, Inside Health Policy) ...A former director of the Congressional Budget Office (CBO) told Inside Health Policy that President Donald Trump's proposal to impose tariffs on pharmaceutical products to boost U.S. manufacturing is unrealistic, arguing that ramping up domestic production would take years and tariffs could ultimately strengthen China's drug market as U.S. companies shift sales overseas...Association for Accessible Medicines also warned President Donald Trump's planned tariffs on Mexico, Canada and China could worsen drug shortages as manufacturers of generics would struggle to absorb rising costs... Sub. Req’d

Cardinal Health May Raise Prices to Offset Potential Tariffs

(1/30, Christy Santhosh, Kamal Choudhury, Reuters) ...Drug distributor Cardinal Health said on Thursday it may need to increase prices of some of its products if the proposed tariffs on Mexico go into effect, to counter increasing costs of manufacturing in the region. Redirecting production from Mexico is difficult as the cost of production is "pretty low cost" CEO Jason Hollar told Reuters in an interview...Cardinal said it might move production away from China, where it has limited supply chain exposure but is also expected to be affected by tariffs, to Southeast Asia... Full

Novartis CEO Says U.S. Exit from Global Health Programmes to Affect Millions

(1/31, Ludwig Burger, Reuters) ..."I don't think there's a lot of logic in stopping these programmes, (some of which were) actually started by Republican administrations, ... given the millions of people who rely on these programmes to get the medicines that they need," CEO Vas Narasimhan said at a news conference after the release of quarterly financial results. There is a lot of pressure on initiatives that have lost funding, including a U.S. push to fight HIV/AIDS and malaria abroad, he said... Full

AAM Urges CMS To Enforce Its Rightful Power Over Medicare Part D Formularies

(1/31, Urte Fultinaviciute, Generics Bulletin) ...While the AAM encouraged CMS to impose its "clear authority" to regulate Medicare Part D formularies, the agency announced that the Trump administration will continue the second cycle of Medicare price negotiations, which has been criticized by the US off-patent trade group...The off-patent medication trade group said that the Centers for Medicare and Medicaid Services "can, and should, do more to ensure that [Medicare] Part D enrollees benefit from rapid access to lower cost generic drugs and biosimilar products as soon as those products are available."... Global Sub. Full

Trump's CMS Signals Flexibility On Medicare Drug Price Negotiation, Sparking New Questions for RFK Jr.

(1/30, Dave Muoio, Fierce Healthcare) ...The Trump administration's Centers for Medicare & Medicaid Services (CMS) has signaled that it will be revamping the process of negotiating prices for certain Medicare Part D drugs with input from external stakeholders, sparking some alarms from Democrats who support the program... Full

Lawmakers Probe RFK Jr. On Rx Price Negotiation As New Cycle Starts

(1/30, Gabrielle Wanneh, Inside Health Policy) ...Key Senate Democrats are seeking a firm commitment from HHS secretary nominee Robert F. Kennedy Jr. to oppose pharmaceutical and GOP efforts to water down Medicare drug price negotiations. They note that an HHS statement put out Wednesday (Jan. 29) opens the door to changing the negotiation process and, while backing negotiations, doesn't say the Trump administration will defend the underlying statute -- a point Kennedy also danced around at his Senate health committee confirmation hearing Thursday (Jan. 30)... Sub. Req’d

Beyond Vaccines: Kennedy's Anti-Pharma Side On Display At Senate Hearings

(1/31, Pink Sheet) ...HHS Secretary nominee Robert F. Kennedy Jr. is well known for his anti-vaccine beliefs, but his Senate confirmation hearings demonstrated a broader animosity toward the pharmaceutical industry. Kennedy raised concerns about overprescribing and injuries from several drugs, including anti-depressants and ADHD medicines. He also argued the drug industry has too close a relationship with US health agencies. Kennedy indicated he and Trump may interfere with the regulation of the abortion pill mifepristone... Global Sub. Full

Sen. Sanders Grills RFK Jr. On Drug Prices

(1/31, WCAX) ...Vermont Senator Bernie Sanders is the minority ranking member in the committee. He praised Kennedy's phrase "Make America Healthy Again." While he did touch on vaccines, making health care affordable was a main focus for the Independent Senator. "Lowering the cost of prescription drugs. How do you make America healthy again if one out of four people in this country cannot afford the price of prescription drugs, which is far higher in America than any other country on earth?"... Full

US FDA In ‘First Stages' Of Reconsidering Black Box For Antipsychotics

(1/31, Ramsey Baghdadi, Pink Sheet) ...FDA officials are reconsidering the current class-wide warning for antipsychotic drugs, but any changes may not include newer agents. Sponsors and other stakeholders want the black box warning applied on a drug-by-drug basis rather than class-wide. An FDA meta-analysis found the risk of death remains similar to the 2005 meta-analysis that lead to the original warning... Global Sub. Full

Fox Carolina Investigates: Why Prescription Drugs Prices Are So High

(1/30, Kari Beal, FOX Carolina) ..."PBMs should get the Nobel prize for greed," South Carolina Pharmacy Association CEO, Brian Clark said. "PBMs are nothing but pharmacy benefit manipulators."...According to the FTC, middlemen in the system, known as pharmacy benefit managers, are forcing patients to buy the brand name instead of the generic. Fox Carolina received a document from a pharmacist showing this in action. It says the "generic will not be covered" and generic claims should receive a "reject." "They're not controlling the cost, they're forcing the patient to pay more when a generic is available," Brian Clark said. Clark says rebate incentives are to blame... Full

Biosimilar Medicines: The Intersection of Access, Affordability, and Innovation

(1/31, Julie Maréchal-Jamil, European Pharmaceutical Review) ...In this article, Julie Maréchal-Jamil, Director, Biosimilar Policy & Science, Medicines for Europe, explores the strategies needed at European and national levels to secure the benefits of biosimilar medicines in an evolving landscape to deliver a pipeline for these drugs by 2030... Full

Five Ways Health Authorities Hope to End Medicine Shortages

(1/31, Jessica Davis Plüss and Pauline Turuban, Swissinfo.ch) ...Countries on all continents are reporting shortages of a range of medicine and their troubling effects on patients...In Europe, pharmacists set aside 10 hours a week just looking for solutions to medicine shortages. Health authorities globally are now debating possible solutions, including some that address the root causes of shortages such as the globalised medicine supply chain. Switzerland too is witnessing a growing push to address the issue. How much hope do the proposed solutions offer? We looked at five options... Full

Competitiveness Compass: A Boon to Pharma, A Blow to Public Health?

(1/31, Emma Pirnay, Euractiv) ...While the newly unveiled EU Competitiveness Compass might spell good news for the pharma industry, health experts and unions warned it is pointing in the wrong direction for public health. The 27-page strategy unveiled by Commission President Ursula von der Leyen on Wednesday, aimed at reviving the bloc's economy, includes plans to reshore the production of critical drugs to Europe and reduce dependency on everyday medicines manufactured in India and China... Full

Uncertainty For Pharma At All-Time High As Controversial Finance Bill Returns To French Parliament

(1/30, Francesca Bruce, Pink Sheet) ...The social security financing bill that brought down the last government in France has returned to the lower house of the parliament for debate. The final version of the bill that included €1bn of price cuts aimed at medicines could emerge from the parliamentary process with more punitive measures due to France's worsening economic outlook. The government and the French industry association, Leem, are at odds over whether overspending on medicines totaled €1,2bn in 2024... Global Sub. Full

The Bad Side-Effects of China's Campaign to Cut Drug Costs

(1/30, The Economist) ...Anaesthetics that don't put patients to sleep. Laxatives that fail to clear bowels. Blood-pressure medication with little effect. These are some of the problems that doctors have encountered in China's public hospitals. They have been speaking out in recent weeks, questioning the quality of the country's drugs and urging reform of the government's procurement programme. The public has chimed in, too. "Medicine that doesn't work, no matter how cheap, is useless," wrote one user of Weibo, a social-media platform... Full

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