Wednesday, October 16, 2024

Teva Adopts Biotech Ethos as it Leans into Innovative Drug Development, Exec Says

(10/15, Fraiser Kansteiner, Fierce Biotech) ...Amid a reorganization campaign that's breathed new life into hybrid generic and innovative medicines player Teva, the company is leaning into novel medicines and formulations more than ever and adopting a biotech mindset as it pushes a range of assets through the clinic. That's according to Eric Hughes, M.D., Ph.D., Teva's executive vice president of global R&D and chief medical officer, who arrived in August 2022 to help reinvigorate the company's generic and innovative drug pipelines, hire on new R&D leadership and spearhead a restructuring of Teva's research arm... Full

Baxter Bolsters IV Supplies with Imports to Address US Shortages in Wake of Hurricane Helene

(10/15, Joseph Keenan, Fierce Pharma) ...Baxter International, which was forced by flooding from Hurricane Helene to temporarily halt production at its North Carolina facility, has started importing intravenous fluids from foreign facilities to help alleviate a U.S. shortage of essential medical supplies... Full

Why Hospitals Are Likely to See IV Fluid Shortage for Some Time

(10/16, Ron Southwick, Chief Healthcare Executive) ...Tom Cotter, the executive director of Healthcare Ready, a nonprofit group that works to ensure the availability of medical supplies in emergencies, says hospitals will likely need to continue to manage stores of IV fluids carefully for some time. Federal officials are working to help obtain more IV fluids, but Cotter tells Chief Healthcare Executive® that it's going to take a while before health systems see some relief. Even if more supplies come from abroad, they won't arrive overnight... Full

Alvotech's Denosumab Biosimilar Takes Steps Forward With EMA Filing Acceptance

(10/15, Urte Fultinaviciute, Generics Bulletin) ...Alvotech is the latest to join several other competitors who have already submitted their denosumab biosimilar marketing authorization applications to the EMA...Several other competitors have already progressed with their European applications for denosumab biosimilars. The latest is Teva, which submitted its TVB-009P both in the EU and the US at the beginning of October. However, the firm only filed the biosimilar for indications that are approved for Prolia, but not Xgeva... Global Sub. Full

Formycon Published Results of Analytical Similarity Study of Biosimilar Candidate FYB206 and Keytruda® in Peer-Reviewed Journal Drugs in R&D

(10/16, Formycon AG) ...The comparative analytical evaluation results indicate that the proposed Keytruda®-biosimilar FYB206 is structurally and functionally highly similar to the reference product. Strong analytical results provide a solid foundation for the ongoing clinical trials with FYB206 and underline Formycon's excellent position in the leading group of pembrolizumab biosimilar developers... Full

Celltrion's Zympentra Shows Promising Results in Phase 3 Trial

(10/16, Choi Mun-hee, Business Korea) ...Celltrion has unveiled promising results from a post-hoc analysis of its global Phase 3 clinical trial for CT-P13 SC (Zympentra) at UEGW 2024 in Vienna, Austria. The United European Gastroenterology Week event, held from Oct. 12 to 15 (local time), served as the platform for this significant announcement, which was made public on Oct. 16... Full

Video: Amneal Pharmaceuticals' 1,600 Crore Investment in India: Insights from Co-CEO Chirag Patel | N18V

(10/15, CNBC-TV18) ...Ekta Batra speaks with co-founder and co-CEO Chirag Patel as the company invests 1,600 crore in two new Ahmedabad manufacturing facilities for GLP-1 drugs... Full

Investments Are A Part Of Our Innovation Plan: Amneal | CNBC TV18

(10/15, CNBC-TV18) ...Investments are integral to the company's innovation strategy, says Chirag Patel, Co-founder & Co-CEO of Amneal, as the company announces a 1,600 crore investment plan for new manufacturing facilities in Ahmedabad. tells CNBC-TV18 that they will produce weight loss drugs in India for global markets... Full

J&J Quarterly Earnings Beat Expectations, Shows Progress on Talc Liabilities

(10/15, Robert Langreth, Bloomberg) ...J&J is working to maintain growth as it faces the loss of exclusivity for the psoriasis treatment Stelara. Biosimilar copies of the drug entered the European market this summer, and US launches are expected early next year...Demand for the medicine is growing because it's increasingly being used to treat newly diagnosed patients, Joe Wolk, J&J's chief financial officer, said in an interview with Bloomberg Television...The drug "is part of the equation in terms of how we are going to overcome Stelara loss of exclusivity next year," he said... Sub. Req’d

J&J Trims Pipeline, Including Two Mid-Stage Neuroscience Studies

(10/15, Max Bayer, Endpoints News) ...Missing in the company's updated pipeline list is a trial testing seltorexant in patients with probable Alzheimer's disease who have clinically significant agitation or aggression...Additional cuts to the neuroscience pipeline include a Phase 2 bipolar treatment targeting the P2X7 receptor, and a Phase 1 treatment for Parkinson's disease, JNJ-0376. An early-stage psoriasis candidate was also culled. In the oncology unit, J&J ended a Phase 3 study of Imbruvica as a treatment for relapsed or refractory patients with mantle cell lymphoma in combination with venetoclax... Full

Takeda Parts Ways with Wave Life Sciences Even with Huntington's Trial Win

(10/16, Ayisha Sharma, Endpoints News) ...In an SEC filing Tuesday, Wave said Takeda "elected to terminate its option" for the huntingtin target, which is the only active portion left under the terms of the original deal. The biotech is now fully responsible for advancing the drug candidate, WVE-003, through clinical development for Huntington's disease, as well as any other programs targeting the huntingtin protein... Full

Eli Lilly Expands Innovation Reach with Another Global Gateway Lab, This Time in China

(10/15, Zoey Becker, Fierce Biotech) ...Eli Lilly is expanding its innovation digs to Beijing, China, opening two research centers called the Eli Lilly China Medical Innovation Center and Lilly Gateway Labs...The new set-ups in Beijing will "further deepen Eli Lilly's century-old business layout in China," Chief Scientific Officer and president of Lilly research laboratories Daniel Skovronsky, M.D., Ph.D. said in an Oct. 15 release. "The new center will enable us to explore new clinical research designs to accelerate patient access to breakthrough therapies," Skovronsky added... Full

Mark Cuban Has No Doubt He Can Disrupt Health Care

(10/16, Torie Bosch, STAT) ...Cuban and I were joined by Matthew Herper, STAT senior writer for medicine and editorial director of events, to discuss pharmacy benefit managers, the 2024 presidential campaign, and how the health care industry should work...Throughout the conversation, as Herper pointed out, Cuban seemed incredibly frustrated with the health care system — not just the PBMs, but also the broader ways that it's inefficient... Full

There's a Big Ozempic Controversy Brewing Online. Doctors Say it's the 'Wild West.'

(10/15, Charles Trepany, USA Today) ...The distribution of compounded weight-loss medication - particularly through telehealth and online platforms - remains controversial, and it's a growing gray area as the world embraces weight-loss medication. For some, especially the uninsured or those who can't afford traditional brands like Ozempic, Wegovy and Mounjaro, these cheaper, non-FDA-approved versions are a lifeline... Full

Why Your Drug Store is Closing

(10/16, Nathaniel Meyersohn, CNN) ...CVS is closing 900 stores. Rite-Aid is closing 500. Walgreens announced Tuesday it plans to close 1,200 stores, meaning 1 in 7 will disappear...Drug store chains are struggling because of lower reimbursement rates for prescription drugs, according to analysts who cover the industry... Full

NCPA Study: Over 90% Of Pharmacies May Drop IRA-Negotiated Drugs

(10/15, Gabrielle Wanneh, InsideHealthPolicy) ...More than 90% of independent pharmacies may not sell Medicare Part D prescription drugs selected to undergo price negotiation due to CMS' lack of protocol to ensure pharmacies will be fairly reimbursed by pharmacy benefit managers and insurers once negotiated prices for the drugs go into effect, according to survey results released by the National Community Pharmacists Association Tuesday (Oct. 15)... Sub. Req’d

Independent Pharmacies May Skip Low-Cost Medicare Drugs

(10/16, Maya Goldman, Axios) ...More than half of independent pharmacies are considering not stocking the first 10 drugs that were subject to Medicare price negotiations over concerns they'll have to absorb upfront costs...If the drug stores decide it's not worth it to carry these drugs, seniors could have a harder time benefiting from the first round of reduced drug prices that take effect in 2026 — especially as more chain pharmacies close. "Lower prices won't mean much to people who can't find the drugs," B. Douglas Hoey, CEO of the National Community Pharmacists Association, said in a news release... Full

CBO: Most Drug Cost Plans Wouldn't Save Big

(10/15, Peter Sullivan and Victoria Knight, Axios Pro) ...The next Congress and president have few policy options for lowering prescription drug prices that would deliver significant results, CBO says in a new review of seven approaches...Growth in U.S. brand-name drug prices has outpaced inflation in recent years, with federal projections showing the retail prescription drug market will total $690 billion in 2031. By CBO's measuring stick for a "large effect," a policy would have to reduce average prices for the market by more than 5% in 2031... Sub. Req’d

FDA Announces Enforcement Discretion For IV Drugs In Shortage

(10/15, Jessica Karins, InsideHealthPolicy) ...FDA released a guidance document last week allowing increased compounding of IV solution drugs that are in shortage following a hurricane that struck a major producer of those products, clearing the way for hospital systems' pharmacies to compound the drugs in-home. The agency also added three new parenteral drug products to its shortages database: dextrose 70% IV solution, lactated ringers IV solution and peritoneal dialysis solution. FDA is allowing for temporary imports to fill IV solution production gaps... Sub. Req’d

APC Advises Compounders To Halt Tirzepatide Production Until FDA Clarifies Stance

(10/15, Maaisha Osman, InsideHealthPolicy) ...The Alliance for Pharmacy Compounding (APC) is urging FDA to formally clarify its position after the agency told a Texas court it would reconsider removing Eli Lilly's GLP-1 drug tirzepatide from the shortage list and won't take enforcement action against some compounders in the meantime. FDA's court filing doesn't mention whether this applies to 503a compounding facilities, prompting APC to advise its 503a members to halt production until receiving formal confirmation from the agency... Sub. Req’d

If Plan Sponsors Are So Unhappy with Their PBMs' Transparency, Why Won't They Change the Model?

(10/15, Adam J. Fein, Ph.D., Drug Channels) ...Smaller PBMs win big on transparency to rebates. The largest gap between large and small PBMs comes from transparency to rebates. About two-thirds of plan sponsors are satisfied with transparency to rebates from smaller PBMs, compared with only 38% of the larger PBMs' clients... Full

Q&A: FDA Chief On Why Our Hearts Are Less Healthy, How Obesity Drugs Impress Him, and What Worries Him

(10/16, Elizabeth Cooney, STAT Plus) ...Robert Califf, a cardiologist and commissioner of the U.S. Food and Drug Administration, has been deeply involved in cardiovascular research: investigating health outcomes, health care quality, and clinical research in large, complex studies. In a recent conversation with STAT, though, he invoked his role as a grandfather, challenged in a grocery store checkout line to resist the ultra-processed foods marketed to American children and adults... Sub. Req’d

FDA Examines AI Potential in Health Care, Product Supply Chain

(10/15, Nyah Phengsitthy, Bloomberg Law) ...The FDA will continue to play a central role in evaluating AI tools to improve health-care and biomedicine, but all involved entities will need to be equipped with the rigor that the transformative technology merits, high-ranking officials for the Food and Drug Administration wrote Tuesday in a JAMA Network Special Communication... Sub. Req’d

Key Committee to Vote On Maryland Drug Affordability Board Plan

(10/15, Scott Maucione, WYPR) ...Next week, the Maryland General Assembly's Legislative Policy Committee will vote on the Maryland Prescription Drug Affordability's plan for setting upper payment limits with drug companies..."We are hopeful that the legislative policy committee will approve it, and once that happens, we are hopeful that the board will use that authority to make high-cost drugs more affordable for state and local governments," said Vincent DeMarco, president of Maryland Healthcare for All!, a drug affordability group... Full

Senators Demand Another Antitrust Investigation into Pharmacy Middlemen

(10/15, Marty Schladen, Oregon Capital Chronicle) ...In their letter, Brown and Wyden, both members of the Senate Finance Committee, are asking the FTC to open a separate 6(b) investigation into the co-manufacturing arrangements of CVS Caremark and Express Scripts...CVS spokesman David Whitrap said the senators are missing a basic point — that CVS has brought down the cost of adalimumab by preferring lower-cost "biosimilars" to Humira... Full

BGMA Urges UK Policy Reforms To Help Counter Shortages

(10/15, David Wallace, Generics Bulletin) ...Citing a "rising number of medicines facing supply issues," the BGMA said that "as a result, many more patients are finding it difficult to access the treatments they need."...The resulting proposals fall into three categories: policies to reduce the overall number of shortages; policies that reduce the impact of shortages when they do occur; and future areas of focus... Global Sub. Full

Surging Drug Costs Straining European National Budgets, Health Insurers Warn

(10/16, Gerardo Fortuna, Euronews) ...Rising pharmaceutical prices, particularly for novel therapies and cancer treatments, are driving increased health spending across Europe, placing significant strain on national budgets, according to a new study published this week...The study highlights a steady rise in pharmaceutical expenditure, both in hospitals and retail pharmacies—referred to as in-patient and out-patient expenditure, respectively. The main factor driving these hikes is the rising cost of medicines, rather than an increase in the volume of prescriptions... Full

Tuberculosis, Asthma, Glaucoma and Bipolar Disorder Medicines to Get Costlier by 50 Percent as NPPA Announces Price Hike

(10/16, Sushmita Panda, Financial Express) ...The common medicines are prescribed for various medical issues like Asthma, Glaucoma, Thalassemia, Tuberculosis, mental health disorders like Bipolar Disorder. In a statement issued by the Health Ministry, the drug pricing authority said that the decision has been taken after it received applications from manufacturers for upward revision of prices citing various reasons... Full

Prices of TB, Asthma, Thalassemia Medicines Go Up: Why Drug Regulator Okayed 50% Hike

(10/15, Anonna Dutt, The Indian Express) ...The medicines for which the prices have been increased are not very expensive to begin with. So the 50 per cent increase in ceiling prices is unlikely to hit people very hard. The cost of these medicines will range Rs 1.02 per ml solution to Rs 16.25 per ml drop, with the exception of a more expensive Desferroxamine that will cost a little over Rs 280 per vial...They argued that manufacturing such medicines was becoming unviable because of an increase in the prices of active pharmaceutical ingredients, production costs or change in exchange rates... Full

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