Thursday, February 22, 2024

Teva CEO: "The Company Played Not to Lose, Now We'll Play to Win"

(2/21, Sophie Shulman, CTech) ..."In recent years, Teva has played not to lose, but now we are shifting to play to win. Sometimes we will lose, but we will not play defense anymore," this statement is a distilled summary of the plan Richard Francis, who assumed the position of CEO of the Israeli pharmaceutical giant a year ago, has got for the company... Full

House Dems Press Drug Companies On Nationwide Shortages

(2/21, Lauren Sforza, The Hill) ...House Oversight Democrats are pressing pharmaceutical companies on the nationwide shortages of a number of drugs in a new investigation announced Wednesday...The lawmakers noted that Teva Pharmaceuticals is one of the leading manufacturers of Adderall, which has faced shortages since October 2022, according to the Food and Drug Administration. Students in particular have faced long-term problems as they struggle to fill their Adderall prescriptions... Full

House Dems Press Drugmakers On Shortages

(2/21, Peter Sullivan, Axios) ...The letters, led by Ranking Member Jamie Raskin, put additional pressure on Pfizer, Teva and Sandoz and highlight the harms stemming from the shortages of important drugs. What they're saying: "Our constituents share story after story detailing how hard it is to fill prescriptions for Adderall and that the shortage affects every element of their lives," the lawmakers wrote to Teva... Sub. Req'd

Democrats Pressure Pharmaceutical Companies On Answers to Drug Shortages

(2/21, Gabrielle M. Etzel, Washington Examiner) ...Raskin and committee Democrats also requested information from Teva Pharmaceuticals CEO Richard Francis regarding recent shortages of Adderall and its generic equivalents, used to treat neurodivergence disorders such as ADHD. An estimated 41 million patients in the United States depend on Adderall or similar generic medication to treat ADD/ADHD symptoms. Committee Democrats requested written responses and staff briefings by March 6 from each of the three entities to address how they are responding to consumer shortages... Full

Teva Reports Positive Data from Anti-TL1A Antibody for Inflammatory Bowel Diseases

(2/21, Don Tracy, PharmExec.com) ...Yesterday, Teva Pharmaceuticals announced positive data for its inflammatory bowel diseases therapy TEV-'574, an anti-TL1A antibody, at the 2024 European Crohn's and Colitis Organization Annual Meeting. According to a company press release, the treatment demonstrated promise in providing anti-inflammatory and anti-fibrotic effects, which are essential for treating inflammatory bowel diseases such as ulcerative colitis and Crohn disease. These findings come amid Teva's recent agreement with Sanofi to co-develop and co-commercialize TEV-'574 for UC and CD... Full

Unipharm Plavix Ruling May Change Game On Recouping Lost Generics Profits In Israel

(2/21, Dean Rudge, Generics Bulletin) ...In a much watched and controversial case that may have significant ramifications on the "chilling effects" of generics manufacturers in Israel being deterred from chasing after approvals in which an originator has deceitfully sought to ‘evergreen' its branded intellectual property, the Israeli Supreme Court has once again come down on the side of the generics industry...Israel-based Unipharm and French giant Sanofi had brought the issue before the court, in a years-old legal wrangle which sought to decide whether Unipharm and Teva were discouraged unlawfully from pursuing and receiving generic approvals of a generic version of Sanofi's powerhouse Plavix (clopidogrel) brand... Global Sub. Full

Parents Search for Flovent Alternatives As Childhood Asthma Inhaler Production Stops in US

(2/21, Ahjane´ Forbes, USA Today) ...Although Fluticasone is the preferred medical treatment, some factors like insurance coverage, medical history and severity of asthma symptoms can play a role in the type of medication children will receive. Some parents say their children are given other alternative medicines to help with their asthma that don't work as effectively...By the end of 2023, doctors began to switch their patients from Flovent to other medications. However, some parents expressed their concerns with the newly prescribed alternatives... Full

Biocon Eyes 'Foothold To Stronghold' For (b)Humira In US, Pauses RH-Insulin Program

(2/21, Anju Ghandurde, Generics Bulletin) ...Biocon sees some wins for biosimilar adalimumab in the US and signals more opportunities amid the slower than anticipated build-out for Humira rivals. Chinese competition looms for glargine, but the Indian company declares it "will be competitive if these folks launch." "The market for [biosimilar] adalimumab is not going to open up in a big way in calendar 2024, and the expectation is that it will happen in a more structured fashion in 2025," said Biocon's group CEO Peter Bains, reflecting on the slower than anticipated build-out in the US for rivals to AbbVie's Humira... Global Sub. Full

Samsung Bioepis to Supply Hadlima to US Government

(2/21, Dae-Kyu Ahn, The Korea Economic Daily) ...South Korea's Samsung Bioepis and the US-based Organon, the local partner company of Samsung group's biopharmaceutical research and development unit, have secured a bid to supply its biosimilar Hadlima (adalimumab-bwwd), a treatment for autoimmune diseases, to the US Department of Veterans Affairs (VA)... Full

Samsung Bioepis Confirms SB17's Efficacy in All Indications of Stelara

(2/22, Lee Han-soo, Korea Biomedical Review) ...Samsung Bioepis said it has made significant progress with its autoimmune disease treatment biosimilar, SB17, suggesting its potential use across all indications treatable by the original drug, Stelara...The announcement was made in conjunction with the presentation of two new study results at the 19th Congress of the European Crohn's and Colitis Organisation, which is currently ongoing from Wednesday to Saturday in Stockholm, Sweden... Full

A $31Bn Opportunity? Future Of Biosimilars Inches Closer With Samsung Keytruda Study

(2/21, Dean Rudge, Generics Bulletin) ...Samsung Bioepis has kicked off a Phase I clinical study for its SB27 biosimilar Keytruda (pembrolizumab) candidate, putting another player in the race to develop competition to the definitive immuno-oncology powerhouse that has been tipped to generate sales of $31bn by the time biosimilars roll around at the end of the current decade. The Korean firm's study will compare the pharmacokinetics, efficacy, safety, and immunogenicity of SB27 versus EU-sourced and US-sourced Keytruda, in patients with stage II-IIIA non-small cell lung cancer following complete resection and adjuvant platinum-based chemotherapy... Global Sub. Full

India Pharma Companies Develop Versions of Wegovy to Get In On Weight-Loss Windfall

(2/22, Rishika Sadam, Reuters) ...Indian drugmakers aiming to grab a slice of the burgeoning weight-loss treatment sales pie, both at home and abroad, have begun developing their own versions of Novo Nordisk's wildly-in-demand Wegovy. With some analysts predicting a weight-loss market reaching $100bn a year or more by the end of the decade, executives at Sun Pharma, Cipla, Dr Reddy's and Lupin — some of the world's largest maker of generic drugs — all said they had started work on Wegovy versions... Full

Drugmaker Hikma Expects Profit to Be Slightly Lower in 2024

(2/22, Radhika Anilkumar, Reuters) ...British drugmaker Hikma Pharmaceuticals reported a bigger-than-expected profit for 2023 on Thursday, helped by a strong performance of its generics businesses, but expects profit to be slightly lower this year. The company said its core operating profit jumped 19% to $707 million in the year ended on Dec. 31, higher than analysts' expectation of about $689 million, according to a company-compiled consensus... Full

Moderna Reports Surprise Profit, Sets Out Road Map for RSV Vaccine

(2/22, Patrick Wingrove and Leroy Leo, Reuters) ...Moderna on Thursday reported a surprise fourth-quarter profit helped by cost cutting and some deferred payments, and the vaccine maker set out a commercial roadmap for its experimental respiratory syncytial virus shot. Moderna posted a profit of $217 million, or 55 cents a share, for the quarter. Analysts had expected a loss of 97 cents a share, according to LSEG data... Full

On-Body Injector Now Available for Use With Pegfilgrastim Biosimilar Udenyca

(2/21, Diana Ernst, Rph, MPR) ...Udenyca Onbody™, an on-body injector presentation of Udenyca® (pegfilgrastim-cbqv), has been made available by Coherus Biosciences...The approval of the on-body injector was supported by a comprehensive analytical and clinical data package as well as pharmacokinetic and pharmacodynamic bioequivalence data, which included an open-label, crossover study comparing the on-body injector to a prefilled syringe... Full

First Keytruda Biosimilars Move into Clinical Trials As Merck Pushes Ahead With New Formulation

(2/21, Katherine Lewin, Endpoints News) ...At least three companies have started or are about to start trials of Keytruda biosimilars in what's expected to create a wave of less expensive competitors for Merck's blockbuster immuno-oncology drug. The biosimilars are being tested by Samsung Bioepis, Sandoz and mAbxience Research, all with estimated primary completion dates in mid-2025, according to ClinicalTrials.gov, the US government database. Samsung Bioepis and mAbxience's trials have already begun, while Sandoz's study is scheduled to begin at the end of this month... Full

This RSV Shot Keeps Babies Out of the Hospital. But Parents Can't Find It.

(2/21, Liz Essley Whyte, The Wall Street Journal) ...Across the U.S., parents are spending weeks and even months searching -- at times without success -- for Beyfortus, a new monoclonal antibody that promises to reduce drastically infants' chances of serious illness from RSV. A bumpy rollout of the shot is tarnishing what otherwise promised to be a radically different RSV season, with the hunt for doses especially difficult for parents with commercial insurance. Meanwhile, the government has hundreds of thousands of doses that remain unused through a program reserved for at-risk children... Sub. Req'd

Pharmaceutical Giants Unite Against Government in Landmark IRA Price-Setting Challenge

(2/21, BNN) ...Amid the legal jargon and corporate statements, the voices of everyday Americans loom large. Many see the IRA's price negotiation provisions as a lifeline, a means to access life-saving medications without the burden of exorbitant costs. "This isn't just about dollars and cents; it's about life and death," one Medicare beneficiary remarked, highlighting the personal stakes involved. Pharmaceutical executives, however, warn that stringent price controls could hamper innovation, potentially slowing the development of new drugs... Full

Advocates Tout Drug Patent Bills As Pay-For Amid Health Reform, Approps Uncertainty

(2/21, Gabrielle Wanneh, InsideHealthPolicy) ...Health care advocates say bipartisan prescription drug patent reforms could emerge as a pay-for for other pressing health care priorities if Congress is able to cobble together a health extender package by this spring, particularly since hospital site-neutral offsets appear to be falling by the wayside, or could be sidelined for consideration later in the year along with pharmacy benefit manager and other health reforms... Sub. Req'd

Biden's Coming For Your Cures

(2/21, Rep. Brett Guthrie, R-KY., The Hill) ...Recent data shows net prices for branded drugs, the most expensive therapies, have steadily declined since 2017. This data shows that more targeted solutions are needed to truly lower the costs of everyday medications and continue to promote access to innovative products. Unfortunately, President Biden has resorted to price controls and removing incentives for innovation by taking the intellectual property of innovators... Full

Medicare Drug Price Negotiation Will Lower Prices by Thousands of Dollars Per Month

(2/21, Nicole Rapfogel, Center for American Progress) ...This new Center for American Progress analysis builds on net per-unit Medicare Part D drug price estimates from the Commonwealth Fund, inclusive of discounts, rebates, and price concessions, to estimate net Medicare prices for a typical 30-day supply of the first 10 drugs up for price negotiation. From there, the center calculated the likely monthly savings that will result from Medicare's price negotiation. CAP estimates that 30-day net price reductions for negotiation-eligible drugs could range from a low of $30 for insulin product NovoLog FlexPen to a high of $6,548 for cancer drug Imbruvica... Full

For Cheap Generic Drug Prices, You Can Thank 40 Years of Hatch-Waxman

(2/21, Matt Sandgren, Washington Examiner) ...However, generics weren't always so common. In the early 1980s, they constituted a meager 13% of prescriptions. Development was difficult, and regulatory barriers were high. So, what changed? Congress recognized there was a problem and acted to solve it... Full

340B Audit ‘Protections' Needed Prior To Dispute Resolution Final Rule, Lilly Tells OMB

(2/21, Cathy Kelly, Pink Sheet) ...A final rule revising the 340B administrative dispute resolution process should not be released until federal regulators issue guidance or regulations affirming manufacturer protections against providing duplicate 340B and Medicaid discounts on the same drug and providing discounts on drugs diverted to ineligible patients, Eli Lilly and Company urged the White House Office of Management and Budget during a January 22, meeting... Sub. Req'd

FDA Commissioner: ‘I Wish The Taxpayer Would Pay For The FDA'

(2/21, Maaisha Osman, InsideHealthPolicy) ...FDA Commissioner Robert Califf would prefer a fully taxpayer-funded FDA over direct appropriations supplemented with funding from pharmaceutical and device industry user fees, noting at a recent National Press Club event that the agency needs to "justify" how it spends money to those "paying the bills."... Sub. Req'd

Colorado PDAB Takes Precedent-Setting Steps That Could Spur Suits

(2/21, Luke Zarzecki, InsideHealthPolicy) ...Colorado's Prescription Drug Affordability Board voted Friday (Feb. 16) that Amgen's Enbrel, used to treat various forms of arthritis and psoriasis, is "unaffordable," and that Gilead Sciences' Genvoya, a medication for HIV, was "not unaffordable." The board is set to determine whether it will impose an upper payment limit on Enbrel on Friday (Feb. 23) -- a potentially precedent-setting move that is being closely watched by drug-price control advocates and the drug industry as other states consider setting up similar price affordability boards... Sub. Req'd

Colorado PDAB Decisions Highlight Differing State Drug Board Structures

(2/21, Luke Zarzecki, InsideHealthPolicy) ...How state bills creating prescription drug affordability boards (PDABs) define affordability result in varied scenarios for what could happen as the boards move forward. In Colorado, where the board focuses on affordability for consumers, manufacturers' assistance programs have played a large role, specifically in determining whether Vertex's Trikafta and Gilead Sciences' Genvoya are affordable..."Some states and some legislation talk about affordability, but it is really not clear whether it means affordability to the payer or to the state or to the patient," Manatt Health Partner Michael Kolber told Inside Health Policy... Sub. Req'd

Legislation to Control Prescription Drug Costs Marches On, As Critics Warn of Unintended Consequences

(2/22, Emily Schabacker, Cardinal News) ...Virginia is the latest state to prioritize legislation that puts prescription drug affordability front and center, with a bill moving through the General Assembly that would create a body to review and regulate pharmaceutical prices...Critics who say PDABs don't return on their promises point to the Trikafta outcome and echo concerns that with a price cap on Enbrel, the drug might not be offered in the state anymore... Full

Multi-Agency Report Highlights Importance of Reducing Antibiotic Use

(2/21, European Medicines Agency) ...Countries that have decreased their consumption of antibiotics in both animals and humans have seen a reduction in antibiotic-resistant bacteria. This is according to the fourth joint report on the integrated analysis of the consumption of antimicrobial agents and occurrence of antimicrobial resistance in bacteria from humans and food-producing animals (JIACRA IV), published by the European Centre for Disease Prevention and Control, the European Food Safety Authority, and the European Medicines Agency. Taking a One Health approach, which recognises the connection between the health of people and animals, the report presents data primarily collected between 2019 and 2021 on antibiotic consumption and AMR in Europe... Full

What Does The UK's ‘Flexible' Approach To AI Regulation Mean For Pharma?

(2/21, Eliza Slawther, Pink Sheet) ...The UK government says that its non-legislative approach to AI regulation will promote innovation and allow it to react quickly to changes in the ecosystem. But a life sciences lawyer warns that creating an uncertain regulatory environment could be problematic..."The government's intention is that the regulator will be better placed to develop guidance that is right for its sector," Jacqueline Mulryne, partner at multinational law firm Arnold & Porter, told the Pink Sheet... Sub. Req'd

Disputes Over Access & Benefit Sharing Dog Pandemic Treaty Talks

(2/21, Ian Schofield, Pink Sheet) ...With the deadline for agreeing the text of World Health Organization's pandemic treaty just weeks away, the latest talks on the proposed text are focusing on a highly disputed issue: how best to ensure the timely sharing of biological materials with pandemic potential and guarantee equitable global access to any pandemic-related products. The treaty is being discussed by the WHO's Intergovernmental Negotiating Body, which is drafting the proposed pandemic treaty and is holding its eighth meeting from February 19, to March 1... Sub. Req'd

Ray Shelley of Apotex Elected Chair of Canadian Generic Pharmaceutical Association

(2/21, Canadian Generic Pharmaceutical Association) ...The Canadian Generic Pharmaceutical Association (CGPA) is pleased to announce the unanimous election of Ray Shelley, President of Apotex Canada, as Chair of CGPA. Michel Robidoux, President and General Manager at Sandoz Canada, has been unanimously elected as Vice Chair of CGPA. "Our industry's focus remains ensuring a stable, predictable market for our sector, and the continued supply and introduction of cost-saving generic prescription medicines for Canadians," said Mr. Shelley... Full

Orphan Drug, Domestic Developers Shine In China Annual Approvals Tally

(2/21, Brian Yang, Pink Sheet) ...10 orphan drugs imported from overseas, and 40 new drug approvals, including many from domestic developers, capped 2023 as one of the busiest years for China's drug regulatory agency, as Beijing pivoted to emphasizing affordable innovation and expanding access to newer therapies for rare conditions. According to the latest National New Drug Approval Report for 2023 from China's National Medical Products Administration, 15 orphan drugs were approved through the regulator's designated priority review pathway... Sub. Req'd

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