Tuesday, February 4, 2025

Gland Pharma Shares Slip 5% On Disappointing Revenue Growth in Q3

(1/4, Deepak Korgaonkar, Business Standard) ...Shares of Gland Pharma slipped 5 per cent to Rs 1,437.70 on the BSE in Tuesday's intra-day trade after the company's revenues de-grew 10 per cent year-on-year (YoY) to Rs 1,384 crore in the December quarter (Q3FY25). The company's topline was impacted by the low base business arising due to a dip in volumes in the US as well as some shipment delays to Saudi Arabia... Full

Pfizer Beats Fourth-Quarter Profit Estimates On Cost-Cutting Efforts

(1/4, Manas Mishra, Bhanvi Satija and Michael Erman, Reuters) ...U.S. drugmaker Pfizer beat Wall Street estimates for fourth-quarter profit on Thursday, boosted by cost-cutting, a smaller-than-feared drop in sales of its COVID-19 vaccine and strong demand for its heart drug Vyndaqel...The company is also under pressure from investors over its recent acquisitions, which include the $43 billion purchase of cancer drugmaker Seagen. The company has turned to cost-cutting measures as well that are expected to help it save more than $5 billion by 2027... Full

Merck Pauses Gardasil Shipments to China, Hitting Its 2025 Outlook

(1/4, Michael Erman and Mariam Sunny, Reuters) ...Merck said it will pause shipments of Gardasil to China through at least mid-year, as continued weak demand for the HPV vaccine there is expected to hurt 2025 revenue, but it still posted a strong fourth-quarter profit on sales of cancer drug Keytruda...The company said it expects 2025 revenue in the range of $64.1 billion to $65.6 billion. Analysts, on average, had forecast revenue of $67.3 billion for the year, according to LSEG data... Full

Biogen's Revised Research Strategy is to Avoid Becoming Obsolete, Top Exec Says

(1/3, Max Bayer, Endpoints News) ...Fresh off a reorganization, Biogen's research leader Jane Grogan says the biotech has to "look outside the walls of the company" to avoid being left behind. In her first interview since then, she told Endpoints News what exactly the company is looking for. That includes prioritizing "external opportunities," according to a letter to employees last month, in which the company also announced job cuts... Full

Novo Nordisk's Next-Gen Obesity Drug Cagrisema: Investors Seek Answers

(1/4, Maggie Fick, Robin Respaut, Reuters) ...Novo believes CagriSema could be more powerful than its blockbuster weight-loss injection Wegovy, but investors are worried whether it will be good enough to retake the lead from rival Eli Lilly in the competitive obesity drug market. In interviews with Reuters, five patients who participated in the trial that reported in December - or are part of a separate late-stage study - said the weekly injection helped them shed pounds quickly, but that they encountered what they characterised as significant side-effects including nausea, constipation and fatigue... Full

Lupin Receives USFDA Approval for Generic HIV Medication

(1/3, Press Trust Of India) ...Drug maker Lupin on Monday said it has received approval from the US health regulator to market a generic medication for Human Immunodeficiency Virus. The company has received tentative approval from the US Food and Drug Administration for Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide tablets... Full

Prestige Biopharma and Dr. Reddy's Push Herceptin Biosimilar into Brazil

(1/4, Kim Ji-hye, Korea Biomedical Review) ...The Korean biosimilar developer said Tuesday that its partner, Dr. Reddy's Laboratories, has submitted a marketing authorization application for Tuznue, its trastuzumab biosimilar, to Brazil's National Health Surveillance Agency (Anvisa)...Dr. Reddy's, a multinational pharmaceutical company headquartered in India, will oversee the commercialization of Tuznue across eight key Latin American countries, including Brazil, Mexico, Argentina, Chile, and Venezuela, as well as the entire Asian region, including India... Full

Novartis Keeps Faith That Six-Month Entresto Extension Will ‘Be Respected'

(1/3, Dean Rudge, Generics Bulletin) ...As MSN Laboratories continues to battle hard in court to accelerate the launch of its US generic version of Novartis' Entresto (sacubitril/valsartan), the Swiss originator has told investors that "we currently believe we will be able to secure" a six-month pediatric extension for one of its key Entresto patents, maintaining expected loss-of-exclusivity for the heart failure mega-blockbuster in the middle of 2025... Global Sub. Full

New ACP Guideline On Migraine Prevention, Shows No Clinically Important Advantages for Newer, Expensive Medications

(1/4, American College of Physicians) ..."This guideline assessed the comparative effectiveness of medications to help clinicians select which medications to use for prevention of episodic migraine and will be of great value to internal medicine physicians who are on the frontline of treating patients suffering from these types of migraines," said Isaac O. Opole, president, ACP. "Based on the evidence of the clinical recommendation, we can then take into consideration cost and personal preference in prevention treatment choices. These recommendations will be critical in helping physicians and other clinical staff to treat their patients with episodic migraine, ultimately supporting them in the prescribing process and contributing to patients' improved wellbeing."... Full

Trump Tariffs Will Escalate Costs and Disrupt the Medical Supply Chain, Industry Execs Warn

(1/3, Heather Landi, Fierce Healthcare) ...Out of 200 survey respondents, 164 predict that costs for hospitals and health systems will surge by at least 15% in the next six months due to increased import expenses. And, 69% estimate pharmaceutical costs will rise by at least 10% as a result of the China tariff on active pharmaceutical ingredients, the Black Book Research survey found. The U.S. relies heavily on China for supplies of active pharmaceutical ingredients, Fierce Pharma reported... Full

Trump's China Tariffs Are Likely to Drive Up Drug Prices and Spur Shortages

(1/3, Berkeley Lovelace Jr., NBC News) ...About half of generic drugs people take in the U.S. — including cancer drugs, antibiotics and blood thinners — are made entirely overseas, where manufacturing is cheaper, said Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School whose research focuses on prescription drugs. An even greater share of the active pharmaceutical ingredients, or APIs, used in drugs comes from abroad: around 80%, he said...Unlike brand-name drugs, generics are sold at low prices, often close to the cost they were made, meaning any disruptions, like tariffs, can lead to shortages and force companies to pass on the cost to consumers, Kesselheim said... Full

Trump Tariffs Threaten US Drug Supplies and Risk Higher Prices, Trade Groups Warn

(1/3, Fraiser Kansteiner, Fierce Pharma) ...On Sunday, the HDA requested that Trump work out tariff exemptions for pharmaceutical products and allow for "long implementation timelines" for the fees...Meanwhile, the president and CEO of the National Association of Manufacturers, Jay Timmons, adopted a more evenhanded approach, conceding in a press release that "manufacturers understand the need to deal with any sort of crisis that involves illicit drugs crossing our border." That said, protecting manufacturing gains that have come with the U.S.' North American partnerships is critical to those wins, Timmons said, noting that one-third of critical U.S. production inputs come from Canada or Mexico... Full

Trump Agrees to Pause Tariffs On Canada and Mexico But Not On China

(1/4, Madeline Halpert and Jessica Murphy, BBC) ...After last-minute calls with Trump, Canadian Prime Minister Justin Trudeau agreed to reinforce his country's border with the US to clamp down on migration and the flow of the deadly drug fentanyl. Earlier, Trump made a deal with Mexican President Claudia Sheinbaum. She agreed to reinforce the northern border with troops. In return the US would limit the flow of guns into Mexico. But a US tariff of 10% on Chinese imports has come into effect, after a deadline of 00:01 EST (05:00 GMT) on Tuesday passed. Shortly after, Beijing announced it was imposing retaliatory tariffs on a raft of American products, including 15% on coal and liquefied natural gas and 10% on crude oil and agricultural machinery... Full

RFK Jr. Skirts Around Senate Dems' Questions On Drug Pricing Reform

(1/3, Gabrielle Wanneh, Inside Health Policy) ...HHS secretary nominee Robert F. Kennedy Jr. answered nearly all of the Senate Finance Committee Democrats' detailed drug pricing questions with a simple response that he will "follow the law," declining to show his hand on whether he might seek changes to the Inflation Reduction Act's Medicare drug price negotiation language or to CMS' implementation policies, modify ongoing CMS Innovation Center demonstrations or revamp FDA's treatment of the Orange book, according to his written responses posted Friday (Jan. 31) following his Jan. 29 and Jan. 30 confirmation hearings... Sub. Req’d

NCPA: 30% Of Community Pharmacies Will Not Carry IRA-Selected Drugs

(1/3, Gabrielle Wanneh, Inside Health Policy) ...The National Community Pharmacists Association (NCPA) says about 30% of its members have decided not to stock drugs selected for Medicare drug price negotiation. NCPA is demanding CMS scrap the requirement that pharmacies participate in the drug price negotiation program, and incorporate a series of Part D reimbursement and contracting reforms for pharmacies... Sub. Req’d

The Biosimilar Void: A Crisis in Patient Access and a Call to Action

(1/3, Biosimilars Council) ...If nothing changes, patients and the healthcare system will pay the price. A fully competitive biosimilar market could save the U.S. an additional $189 billion over the next decade—but those savings will vanish if biosimilars remain trapped in the void. This isn't just a theoretical discussion—it's a crisis that will impact real people: the diabetic patient struggling to afford their insulin, the cancer survivor burdened by high treatment costs, the retiree on a fixed income choosing between medicine and rent. We have the tools to fix this. Now, policymakers need to use them. The future of biosimilar competition—and the health of millions of Americans—depends on it... Full

Biosimilar Void is a Crisis in Patient Access According to IQVIA Report

(1/3, Biosimilars Council) ..."Biosimilars are making more therapies more available for America's patients, but too many government policies are slowing biosimilar development and adoption," said Craig Burton, Executive Director of the Biosimilars Council. "Today's report highlights the harm – 90 percent of the brand biologics scheduled to lose exclusivity in the next ten years do not have biosimilars in development. The ‘biosimilar void' in the U.S. threatens patient access to lower cost treatments. Policymakers must take concerted action to encourage biosimilar development through streamlining FDA processes, ending patent thickets, ensuring rapid PBM adoption, stabilizing provider reimbursement, and ending the misguided IRA price controls that undermine biosimilar investment."... Full

US Biosimilar 'Void' Spells Trouble as Biologic Patent Expirations Loom, IQVIA Report Says

(1/3, Zachary Brennan, Endpoints News) ...Only 10% of those 118 biologics have a biosimilar in the pipeline and currently, only 14 out of 62 biologics that will lose patent protection at the end of 2024 have biosimilars, the report says...So why such a gap in biosimilar development considering how many biologics are coming off-patent? The IQVIA report, entitled "Assessing the Biosimilar Void in the U.S.," points to challenges in "regulatory requirements, market acceptance, high investment costs, obscurity around interchangeability, and reimbursement."... Full

FDA Communications In Flux As HHS Assesses Mission-Critical Activities

(1/3, Sue Sutter and Derrick Gingery, Pink Sheet) ...The communications freeze at the FDA is thawing, but the agency still is determining what information it can share with the public. New drug approvals and drug development meetings have continued during the freeze, although some industry interactions with the device center reportedly have been impacted. HHS decisions on the activities considered not mission-critical could affect agency involvement in educational activities, scientific meetings and workshops going forward... Global Sub. Full

Insulin Prices Are Falling Due to Market Forces — No Price Caps Required

(1/3, Sally C. Pipes, The Orange County Register) ...California State Sen. Scott Wiener, D-San Francisco, recently introduced legislation that would cap cost-sharing for insulin at $35 a month, regardless of whether a patient has public or private insurance. It's a popular idea. But it may not be necessary. The cost of insulin has been falling due to market forces...In other words, insulin manufacturers have been dropping their prices because of old-fashioned competition. And that's largely solved the problem the proposed out-of-pocket cap is meant to fix... Full

Pharmacy Middlemen Face NY Crackdown Under Gov. Hochul Plan

(1/4, Zach Williams, Bloomberg Law) ...New York would become the first state to force pharmacy benefit managers to publicly reveal how much they profit from rebates issued by drug manufacturers under a measure backed by Gov. Kathy Hochul. Lawmakers and pharmacists said Hochul's proposal for the state budget due on April 1 would push boundaries for transparency requirements on PBMs, the companies that manage drug benefits for employers and negotiate those prices with drugmakers... Sub. Req’d

BioRationality: No More Biosimilars—Just Biogenerics

(1/3, Sarfaraz K. Niazi, PhD, The Center For Biosimilars) ...Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy... Full

Sweden's Annual Life Science Conference Highlights Need for Action

(1/3, The Pharma Letter) ...At Sweden's annual life science conference, stakeholders from healthcare, academia, and industry discussed implementing the country's new life science strategy. Key topics included patient involvement and clinical trials, with an emphasis on moving from strategy to action, particularly in terms of promoting uptake of advanced precision medicines. While these have improved personalized care, implementing these innovations across the healthcare system remains a challenge... Sub. Req’d

Trade Group Issues Message at Key Time for Belgian Pharma

(1/3, The Pharma Letter) ...Political parties in Belgium agreed Friday to form a new government, ending almost eight months of negotiations...From a pharma perspective, this change is happening at an already key moment for the industry, as the European Commission has just published the ‘competitiveness compass', which aims to respond to the decline in European competitiveness in a geopolitically tense environment. The innovative biopharmaceutical industry has called on Belgian government negotiators to pay more attention than ever to supporting innovation and strengthening competitiveness in Belgium... Sub. Req’d

Novartis Chided After LinkedIn Likes Break Drug Promotion Rules

(1/3, Nick Paul Taylor, Fierce Pharma) ...Novartis has become the latest drugmaker to get in trouble over an employee's LinkedIn likes. The U.K. drug marketing watchdog ruled the employee's act broke the rules on advertising prescription medicines to the public but placed the blame on the worker, not the company...The company accepted the breach of the rule on drug promotion, adding that "it is disappointed that the employee has failed to comply with Novartis' policies and instructions on this specific occasion."... Full

Russia to Significantly Expand Geography of its Drug Export

(1/3, The Pharma Letter) ...Russia plans to significantly expand the geography of the export of its drugs this year, paying attention both to emerging nations and developed countries, reports The Pharma Letter's local correspondent. At present, Russia supplies about 45,000 tons of drugs annually to more than 160 countries. According to the Russian Ministry of Industry and Trade, in 2024 exports amounted to 180 billion roubles ($18 billion) and, as part of state plans, this figure should grow significantly this year... Sub. Req’d

Russia Experiences Sharp Growth in Demand for Diabetes Drugs

(1/4, The Pharma Letter) ...In January of the current year sales of these drugs in most of Russian pharmacies increased by 50%-70% year-on-year basis, with the growth currently ongoing. At the same time, according to representatives of Russian pharmacies, the growth was even higher in value terms, exceeding 140%. With expected drug sales for GLP-1Rs in obesity estimated to surpass $126 billion by 2030, this drug category presents a lucrative market for drug developers. Now Russian drugmakers are making inroads into the sector with analogs of western blockbusters... Sub. Req’d

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