Wednesday, May 22, 2024

Teva And Alvotech Launch Humira Rival In US

(5/21, David Wallace, Generics Bulletin) ...Teva and Alvotech have finally launched their adalimumab biosimilar, Simlandi, in the US. While arriving many months behind their rivals, the partners are hoping that the product's unique combination of a citrate-free, 100mg/ml high concentration and an interchangeability designation will position it for success...The next opportunity on the horizon for Teva and Alvotech will be the pair's partnered Selarsdi (ustekinumab-aekn) US rival to Stelara... Global Sub. Full

Simlandi, An Interchangeable Biosimilar to Humira, Now Available

(5/21, Brian Park, PharmD, MPR) ...Simlandi® (adalimumab-ryvk) injection, a citrate-free, high-concentration, interchangeable biosimilar to Humira® (adalimumab), has been made available by Teva and Alvotech..."We are proud to make Simlandi available in the US to patients and providers," said Thomas Rainey, Senior Vice President, US Market Access at Teva... Full

Teva and Alvotech Introduce Simlandi Injection in US Markets

(5/22, Pharmabiz.com) ...Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. and Alvotech announced the availability of Simlandi (adalimumab-ryvk) injection in the US, as an interchangeable biosimilar to Humira for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn's disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis... Full

Teva and Alvotech Launch SIMLANDI in US for Arthritis

(5/21, Pharmaceutical Business Review) ...Teva US Market Access senior vice-president Thomas Rainey said..."Biosimilars create opportunities for cost savings across the healthcare system, and SIMLANDI's launch now offers the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the US market. We will be working with payors to ensure access to SIMLANDI, as well as the six other biosimilars we are committed to bringing to market by 2027."... Full

Biopharma Leaders Shape the Future of Drug Development at Veeva R&D and Quality Summit Europe

(5/21, Veeva Systems) ...Veeva Systems today announced that leaders from Ascendis Pharma A/S, Bayer, Boehringer Ingelheim, Jazz Pharmaceuticals, Novo Nordisk, Sanofi, and Teva will be keynote speakers at Veeva R&D and Quality Summit, Europe, June 4-5 in Madrid, Spain. Life sciences professionals across the industry will come together to share how connected technologies across clinical, regulatory, safety, and quality are advancing innovations for patients... Full

Amphastar Receives FDA Approval for Albuterol Sulfate Inhalation Aerosol

(5/22, Amphastar Pharmaceuticals, Inc) ...Amphastar Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application for Albuterol Sulfate Inhalation Aerosol, previously known as AMP-008. This product is for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients four years of age and older. The FDA determined that Amphastar's albuterol is bioequivalent and therapeutically equivalent to Teva Respiratory LLC's ProAir® HFA(albuterol sulfate) Inhalation Aerosol... Full

Dr. Reddy's Secures Rights For Denosumab In US, Europe And UK

(5/21, Press Trust Of India) ...Alvotech, a global biotech company and a subsidiary of Dr. Reddy's Laboratories on Tuesday have entered into a licence and supply agreement for the commercialisation of AVT03, the latter's biosimilar candidate to Prolia and Xgeva (denosumab). A press release from Dr Reddy's said the collaboration combines the city-based drug maker's global commercial presence with Alvotech's proven capabilities in developing biosimilars for markets worldwide... Full

European Commission Grants Approval to Sandoz's Denosumab Biosimilars in Europe

(5/22, Financial Express) ...Sandoz, a key player in generic and biosimilar medicines, on Wednesday announced that the European Commission (EC) has granted marketing authorization for Wyost (denosumab) and Jubbonti (denosumab), the first and only biosimilar versions of reference medicines Xgeva and Prolia in Europe... Full

Gedeon Richter Teases Denosumab Partnering Opportunity In Japan

(5/21, Urte Fultinaviciute, Generics Bulletin) ...Hungary's Gedeon Richter is on a lookout for a potential partner to bring its denosumab biosimilar to the Japanese market, teased CEO Gábor Orbán during the firm's Q1 2024 earnings call...Richter's biosimilar rival to Amgen's Prolia and Xgeva brands, which are indicated for osteoporosis and fractures due to bone metastasis, respectively, has completed its clinical trial and the data is currently being processed. Orbán said that the firm plans to submit a regulatory application with the European Medicines Agency in the second half of this year, with the US Food and Drug Administration filing coming after that... Global Sub. Full

India's Sun Pharma Beats Q4 Profit Estimates

(5/22, Rishika Sadam, Reuters) ...Indian drugmaker Sun Pharmaceutical Industries posted fourth-quarter profit above estimates on Wednesday, helped by strong performance in its key U.S. and domestic markets...Sun Pharma's U.S. sales rose nearly 11.9% to 39.54 billion rupees, boosted by speciality complex drugs such as Ilumya used to treat chronic skin condition such as plaque psoriasis. India sales rose more than 10.2% to 37.1 billion rupees... Full

Alvotech Reports Financial Results for First Quarter of 2024 and Provides a Business Update

(5/21, Alvotech) ...Total revenues in Q1 2024 increased to $37 million compared to $16 million in the same period last year. Gross margin in Q1 2024 increased to $17 million, by $40 million compared to the same period last year...Joel Morales, Chief Financial Officer of Alvotech, added: "Based on rapid progress in commercialization and development, we raise our revenue guidance for 2024, to $400 - $500 million and tighten our guidance for EBIDTA to $100 - $150 million for the full year." Alvotech and its commercialization partner in the U.S., Teva Pharmaceuticals, announced that the FDA approved AVT04 (ustekinumab-aekn) for marketing in the U.S. as a biosimilar to Stelara, under the tradename Selarsdi... Full

Is Towa's Guidance For 2024 ‘Somewhat Mediocre?'

(5/22, Dean Rudge, Generics Bulletin) ...Japanese generics giant Towa Pharmaceutical has delivered its annual financial results for the company's year ended March 2024, achieving 17.4% revenue growth and a trebling of its operating profit for the 12 months, against a comparatively weak prior financial year...The Swiss financial services giant laid out an expectation for "sustainable growth in sales, as at competitor Sawai, reflecting Towa's bolstering of its production of domestic generics."...With the Japanese market firmly in the control of domestic manufacturers, Teva earlier this month announced that it would put its Japanese generics business up for sale in a process that the Israeli generics giant expects to close within the next 12 months... Global Sub. Full

Sawai Narrowly Misses Annual Sales Forecast For 2023

(5/21, Adam Zamecnik, Generics Bulletin) ...Sawai Pharmaceutical has reported an 8% growth in net sales for its 2023 fiscal year ending March 31, 2024, narrowly missing past forecasts of its annual results for the year...The firm said it had benefited from increased sales of recently-launched products introduced in FY2022 and FY2023, as well as a reflection of "the impact of rising costs on prices, mainly on low-priced generics."... Global Sub. Full

Expect Formulations Biz to Outpace API Biz: Biocon Group CEO Peter Bains

(5/21, Aneeka Chatterjee, Business Standard) ...Biocon delves into the evolving dynamics of the biosimilars market, with a focus on its strategies and outlook for 2024-25 (FY25). Peter Bains, group chief executive officer of Biocon, in a video interview with Aneeka Chatterjee, discusses their efforts to gain market share in key regions, the impact of lower active pharmaceutical ingredient prices, and growth plans for biosimilars and generics. He also highlights Biocon's strategic partnerships, debt reduction plans, and the expected recovery in their contract research business... Sub. Req'd

Novo Nordisk Looks Beyond Weight Loss and Diabetes to Expand in New Illnesses

(5/21, Nicole DeFeudis, Endpoints News) ...During a press call Tuesday, Novo executives laid out ambitions in a handful of conditions, including liver disease, chronic kidney disease and Alzheimer's. And it has the assets to grow — last year, it reported net profits of 83.7 billion Danish kroner ($12.2 billion). "It's really about sustaining our leadership within diabetes, obesity, and then establishing a presence within cardiovascular and a few emerging therapy areas, and then solidifying also our leadership in rare diseases," CEO Lars Fruergaard Jørgensen told reporters Tuesday... Full

AstraZeneca Counts On ‘Difficult-to-Copy' Therapies for Big 2030 Goal and Beyond

(5/21, Ayisha Sharma and Amber Tong, Endpoints News) ...Pascal Soriot has set an ambitious $80 billion revenue target for AstraZeneca by 2030. But he's not stopping there...Speaking separately to media at a packed makeshift conference area, Soriot said that AstraZeneca is advancing cell therapies, gene therapies, antibody-drug conjugates and radioconjugates — areas where the British pharma has announced significant partnerships or investments over the past 18 months... Full

Strides Pharma Gains On Receiving USFDA Approval for Stomach Ulcer Treatment Drug

(5/22, CNBC TV 18) ...Strides Pharma Science Ltd shares gained on Wednesday, May 22, after the company said it has received the approval from the United States Food and Drug Administration for a drug used in treatment of stomach ulcer...The USFDA nod for this product marks the first Indian approval from the regulator for this complex formulation. This approval strengthens Strides Pharma's portfolio in the US by adding another differentiated and niche product with limited competition, the company said... Full

GSK's Long-Acting Asthma Drug Hits Primary Endpoint in Phase III Trials

(5/21, Nick Paul Taylor, BioSpace) ...Management's confidence in depemokimab is underpinned by surveys of physicians and patients. The surveys found physicians have positive views of depemokimab, GSK said at its respiratory diseases event in November 2023. Physicians told GSK they are interested in switching patients to depemokimab and prescribing the antibody to people with asthma who are yet to try a biologic therapy. AstraZeneca and Teva Pharmaceuticals sell IL-5 asthma drugs but both are given far more frequently than depemokimab... Full

Viatris Publishes 2023 Sustainability Report: Building Sustainable Access at Scale

(5/21, Viatris Inc.) ...Viatris Inc., a global healthcare company, today published its 2023 Sustainability Report: Building Sustainable Access at Scale. The report highlights its actions and initiatives across multiple areas of focus in support of the Company's efforts to continue to be a model for sustainable access to medicine and to make a difference in the communities it serves. "This year's report delivers many examples of the important efforts occurring across Viatris and the collaboration required to supply high-quality medicines to approximately 1 billion patients annually," said Lara Ramsburg, Chief Corporate Affairs Officer, Viatris... Full

Prescription Prices Continue to Rise, Forcing Some Independent Pharmacies to Close Across the Triangle

(5/21, Deana Harley, CBS 17) ...Some independent pharmacies are closing up shop as prescription drug prices continue to rise. Melissa Illig, the owner of White Oak Pharmacy in Garner, says insurance companies are switching patients to brand name drugs as some generic ones become harder to find...She says the average cost of a generic drug is around $6. The average cost of a name brand drug is around $56. It means some patients just can't afford the care they need and some pharmacies can't operate... Full

Cyberattacks Are Soaring—And More Lucrative for Criminals Than Drugs. It's Time to Treat Them As An ‘Act of War,' Health Care Exec Warns

(5/21, Beth Greenfield, Fortune) ...The Change Healthcare cyberattack that disrupted nationwide health care systems earlier this year—affecting a third of Americans at a total loss of $100 million—was a major wake-up call: Such attacks in the health care industry are on the rise. And they should be treated with utmost seriousness, agreed a panel at Fortune's Brainstorm Health conference in Dana Point, Calif., on Tuesday... Full

Senators Blame Sky-High Drug Prices On Abuse of the Patent System

(5/21, Berkeley Lovelace Jr., NBC News) ...The drug industry's top lobbying group on Tuesday faced fierce questioning at a Senate Judiciary Committee hearing that explored whether abuse of the patent system is responsible for keeping prescription drug prices sky-high in the United States... Full

Judiciary Members Seek Floor Vote On Patent Reforms, Schumer Receptive

(5/21, Luke Zarzecki, InsideHealthPolicy) ...Members of the Senate Judiciary Committee called on Senate Majority Leader Chuck Schumer (D-NY) to schedule floor votes on bipartisan drug patent reform bills previously passed out of the committee during a Tuesday (May 21) hearing on the prescription drug market, and Schumer's office told Inside Health Policy he hopes to move them soon...Sources closely following the issue told Inside Health Policy the bills have not come to floor because of opposition from the pharmaceutical industry, particularly its concerns that the product hopping provisions would impede innovation... Sub. Req'd

Senators Strike Bipartisan Tone On More Pharma Patent Reforms

(5/21, Zachary Brennan, Endpoints News) ...The issue of drug patent reform appears to have brought members from both sides of the aisle together. Senators said at Tuesday's hearing that they were inundated with stories from their home states on unaffordable medicines. There was a frequent mention of AbbVie's Humira, the blockbuster drug that has become a poster child for patent thickets — webs of legal protection that can delay the entry of competitor drugs. While no Republicans voted for the Inflation Reduction Act's drug price negotiations when they passed in 2022, Sen. Lindsay Graham (R-SC) and others made clear that they think the patent system is being abused... Full

Senators Mull Ways to Stop Patent 'Abuse' by Pharma Companies

(5/21, Shannon Firth, MedPage Today) ...Senators and experts on Tuesday examined the range of tools that brand-name drug manufacturers have used to keep generic and biosimilar competition at bay -- from patent thickets and product hopping to "pay-for-delay" settlements -- and wrestled with how to prevent such abuses... Full

Weight Loss, Diabetes Treatments Focus Of FTC's Second Round Of Patent Listing Challenges

(5/21, Sue Sutter, Pink Sheet) ...The FTC's second round of patent listing challenges encompasses 130 patents for 20 branded products. The commission is moving beyond asthma and COPD inhalers to also challenge listed patents for self-injection pens to treat diabetes and obesity. 89 of 110 patents challenged by the FTC in its first wave of warning letters remain listed, although sponsors of some asthma/COPD inhalers have capped patient copays... Sub. Req'd

Patent Reform Could Be The Next Big Move On Drug Pricing

(5/22, Victoria Knight, Axios) ...After pitched battles over Medicare drug price negotiations, Congress may be pivoting to more bipartisan ground: overhaul of the patent system that allows brand-name drugs to delay competition for years...However, a legislative package of patent reforms has been stuck in the Senate for 15 months, raising questions about whether leadership will try to pass anything before the elections. Drugmakers are pushing back against these bills, arguing that 90% of prescriptions at pharmacy counters already are filled with generics and biosimilars — and that pharmacy benefit managers and pharmacies they work with are the real culprits behind price increases... Full

AAM Applauds Senate Judiciary Committee Efforts to Protect Patients and Skinny Labeling

(5/21, AAM) ...The Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, and the Biosimilars Council, a division of AAM, submitted a formal statement for the record for the Senate Committee on the Judiciary hearing on drug pricing held today. AAM applauds and thanks the Committee for its efforts to provide a safe harbor for skinny labeling and supports legislation being considered by the Senate Judiciary Committee that will protect patients and the health care system... Full

PCMA Statement On Senate Judiciary Committee Hearing On Competition in The Prescription Drug Market

(5/21, PCMA) ..."Ensuring Affordable & Accessible Medications: Examining Competition in the Prescription Drug Market. We applaud Chairman Durbin, Ranking Member Graham, and members of the Senate Judiciary Committee for holding this important hearing to explore increasing competition in the prescription drug market. Pharmacy benefit companies believe increasing competition in the prescription drug market is the key to further lowering costs for patients. Increasing competition in the market requires policies that address anti-competitive practices and patent abuses by drug companies that are the root cause of high drug costs."... Full

20-Year Health Insurance Exec Says Don't Look to His Industry to Solve the Medical System: ‘You Cannot Fight Financial Self-Interest'

(5/21, Marco Quiroz-Gutierrez, Fortune) ...The nonprofit insurer, which brings in $20 billion in annual revenue, replaced its existing pharmacy benefit manager with healthcare upstarts including Amazon Pharmacy for drug delivery and Mark Cuban Cost Plus Drug Company to provide affordable drugs. CEO Paul Markovich says the effort will save the insurer $500 million per year once it's fully implemented—while keeping patients' own costs down. Speaking at Fortune's Brainstorm Health conference in Dana Point, Calif., on Tuesday, Markovich said the insurer was still on track to meet the ambitious goal it announced last year when it rolled out the program... Full

The Looming US Election Weighs On The Minds Of Pharma

(5/21, Jessica Merrill, Pink Sheet) ...Whether Democrats retain the White House or Republicans return, drug pricing is expected to remain a political pressure point. Many pharma executives and experts at the FT Pharma Summit said both Biden and Trump pose risks to pharma. While Biden could try to expand initiatives under the IRA, Trump was an advocate of international reference pricing... Sub. Req'd

NIH Issues First Policy For Equitable Medicine Access, Price-Control Groups Call It ‘Narrow'

(5/21, Maaisha Osman, InsideHealthPolicy) ...The National Institutes of Health has issued a first-ever policy proposal to use its licensing process to achieve equitable and affordable access to drugs, vaccines, devices and treatments developed from NIH-owned inventions. The move comes as Senate health committee Chair Bernie Sanders (I-VT) and drug price control groups push to expand HHS' best-price provisions in Project NextGen pharmaceutical contracts to NIH-developed drugs... Sub. Req'd

NIH Drafts Policy On Ensuring Access to New Drugs Funded by Taxpayers

(5/21, Zachary Brennan, Endpoints News) ...The NIH has proposed requiring biopharma companies or licensees to submit plans for how patients will access drugs or devices that are developed with the help of taxpayer funding. Tuesday's proposal is part of a wider push from the Biden administration to lower prescription drug prices, built off the passage of the drug price negotiations in the Inflation Reduction Act, which Biden has been campaigning on. Biden previously drew bipartisan pushback for a plan to exercise the government's so-called march-in rights when drug prices rise too high... Full

Sen. Wyden Questions Pfizer Over Tax Rate as Part of Ongoing Investigation

(5/21, Lia DeGroot, Endpoints News) ...Senate Finance Chair Ron Wyden (D-OR) is pressing Pfizer over its tax practices as part of his investigation into how large pharma companies use subsidiaries in other countries to skirt US corporate taxes...A Pfizer spokesperson told Endpoints News that it had received Wyden's letter but wouldn't comment before responding directly to the senator... Full

In Pharma Tax Probe, Wyden Puts Pfizer in Hot Seat with CEO Letter

(5/21, Zoey Becker, Fierce Pharma) ...By sending a letter to Pfizer CEO Albert Bourla, Ph.D., Wyden hopes to learn more about the tax payments made by the pharma giant in recent years. The senator noted that the company's 9.6% tax rate in 2022—and its negative tax rate last year—were "substantially lower" than the U.S. corporate tax rate of 21%. "Despite generating over $364 billion in sales over the last six years, Pfizer incomprehensibly pays a lower tax rate than millions of working American families," Wyden wrote in the letter... Full

Novartis, United Therapeutics Defeat US On Discount Drug Limits

(5/21, Mary Anne Pazanowski, Bloomberg Law) ...Drugmakers like Novartis Pharmaceuticals Corp. and United Therapeutics Corp. are obligated to participate in the Public Health Act's Section 340B program as a condition of their participation in Medicare Part B and Medicaid. The statute's silence on whether they can limit the number and kinds of contract pharmacies where they ship orders, however, can't plausibly be interpreted to subject them "to whatever delivery conditions any covered entity might find most convenient," the US Court of Appeals for the D.C. Circuit said... Sub. Req'd

Graham: Lower Drug Prices In Other Countries Is An Unfair Trade Practice

(5/21, Luke Zarzecki, InsideHealthPolicy) ...Senate Judiciary Committee ranking Republican Lindsey Graham (SC) said drugs costing more in the United States compared to in other countries is an unfair trade practice and said that is one road to address high U.S. drug prices. "What I like to do is let countries know that most of these drugs are developed in the United States and the drug company has the right to get its money back. If a foreign country is basically subsidizing a drug, putting a burden on the American consumer to have to pay a higher price, I think that's an unfair trade practice," he said... Sub. Req'd

Cutting Foreign Ties Could Lead To Drug Supply Chain Disruptions, Industry Warns

(5/21, Maaisha Osman, InsideHealthPolicy) ...As House committees advance bills that would bar American companies from working with some foreign-owned biotechnology companies in the future, industry experts warn ending pharmaceutical relationships with China could lead to drug shortages and supply chain disruptions... Sub. Req'd

US Pharma and Biotech Summit 2024: Artificial Intelligence and Machine Learning Through the Eyes of the FDA Part II

(5/21, Don Tracy, PharmExec.com) ...In an interview with Pharm Exec Associate Editor Don Tracy, Tala Fakhouri, at Financial Times' US Pharma and Biotech Summit, Tala Fakhouri, Associate Director for Policy Analysis, FDA, discusses whether the FDA plans on restricting the use of AI and what the future could look like when it comes to machine learning... Full

California Senate Passes Drug Pricing Transparency, Could Slash Health Costs

(5/21, Kenneth Schrupp, The Center Square) ...The California Senate passed a bill that could significantly reduce drug prices and potentially even health insurance for insured Californians by requiring greater drug pricing transparency from insurers, drug manufacturers, and pharmacy benefit managers. Market-focused economists argue these groups engage in monopolistic practices that limit consumer information and choice while increasing prices for health insurance and drugs... Full

Pharma Industry Fears Bulgarian Political Crisis Could Hurt Negotiations

(5/21, Krassen Nikolov, Euractiv) ..."During the trialogue, a final EU position is being sought, and Bulgaria's participation is extremely important. With a new government, the new negotiating teams will need time to explore the previous positions. It will be a big challenge for Bulgaria to participate actively," Deyan Denev, the executive director of the Association of research-based pharmaceutical manufacturers in Bulgaria (ARPharM-Bulgaria), told Euractiv... Full

European Pharmacopoeia Gets To Grips With Quality Standards for mRNA Vaccines

(5/21, Neena Brizmohun, Pink Sheet) ...Stakeholders have until June 30, to comment on a set of common quality standards for mRNA vaccines that are said to be needed in light of rapid developments in this field and the emergence of novel vaccines coding for a range of specific antigens...There is a "need for common quality standards for mRNA vaccines across Europe and beyond," according to the European Directorate for the Quality of Medicines & HealthCare, which announced the launch of the consultation this month... Sub. Req'd

China, EU Regulators Highlight Innovation, Access And Collaboration As Key Policy Aims

(5/22, Dexter Yan, Pink Sheet) ...As the global pharma industry experiences turbulence from the heightened geopolitical tensions between the US and China, former and incumbent regulatory officials from China and the European Union tried to inject the sector with reassurances of collaboration on innovation and access at the recent DIA China Annual Meeting... Sub. Req'd

France Reveals The Drugs That Are Most Likely To Require Post-Market RWE Studies

(5/21, Eliza Slawther, Pink Sheet) ...A study from the health technology assessment department of France's national health agency, HAS, has identified which pharmaceutical products are most likely to receive a request for post-market studies. The agency hopes this information will aid in companies' forward planning... Sub. Req'd

Experts Advocate Multi-Faceted Collaboration in Indian Biopharma

(5/21, Prabhat Prakash and Prarthana Sharma, ET HealthWorld) ...The panellists supported tripartite collaboration, highlighting the necessity of coordinated efforts among industry, academia, and regulatory organisations. Additionally, there's a rising focus on improving injectable drug formulation methods and comprehending immunogenicity in oral formulations, which reflects a deliberate attempt to improve drug delivery systems in the Indian pharmaceutical industry... Full

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