Wednesday, May 8, 2024

Teva Pharmaceutical Industries 1Q Revenue Tops Estimates On Generic Products Sales Boost

(5/8, Denny Jacob, Dow Jones) ...Teva Pharmaceutical Industries posted better-than-expected revenue in its latest quarter as it benefited from sales from its generics products in major markets... Sub. Req'd

Teva Pharm Q1 Profit Misses Estimates, Revenue Rises

(5/8, Steven Scheer, Reuters) ...Teva reiterated its outlook of 2024 revenue of $15.7-$16.3 billion and adjusted EPS of $2.20-$2.50. In 2023, it posted revenue of $15.8 billion and adjusted EPS of $2.56. The company is betting a trio of branded drugs - its Huntington's treatment Austedo, migraine product Ajovy and the recently launched schizophrenia drug Uzedy - will help Teva bounce back from a rough few years... Full

Teva Loss Narrows As Revenue Grows

(5/8, Shiri Habib-Valdhorn, Globes) ...As the US generics market recovers Teva Pharmaceutical Industries Ltd. ended the first quarter of 2024 with revenue of $3.81 billion, up 4.3% from the first quarter of 2023, and above the analysts' expectations of $3.73 billion...Teva president and CEO Richard Francis said, "In 2024 Teva is off to a good start, with global revenues of $3.8 billion showing growth of 5% in local currency terms compared to Q1 2023, fueled by robust growth in our generics business across all regions, and continued growth of our innovative brands AUSTEDO and AJOVY."... Full

Teva Pharmaceutical Industries Posts Narrower Loss In Q1 - Update

(5/8, RTT News) ...Teva Pharmaceutical Industries Ltd. posted a first quarter net loss attributable to Teva of $139 million or $0.12 per share, compared to a net loss of $220 million and $0.20, per share, in the first quarter of 2023. The company said the lower net loss in the first quarter of 2024 was mainly due to higher net loss attributable to non-controlling interests, higher gross profit and lower legal settlements and loss contingencies, partially offset by higher other asset impairments, restructuring and other items... Full

Teva Reports Q1 EPS 48c, Consensus 51c

(5/8, The Fly) ...Reports Q1 revenue $3.8B, consensus $3.73B. Richard Francis, Teva's President and CEO, said, "In 2024 Teva is off to a good start, with global revenues of $3.8 billion showing growth of 5% in local currency terms compared to Q1 2023, fueled by robust growth in our generics business across all regions, and continued growth of our innovative brands AUSTEDO and AJOVY."... Full

Teva Backs FY24 EPS View $2.20-$2.50, Consensus $2.41

(5/8, The Fly) ...Backs FY24 revenue view $15.7B-$16.3B, consensus $15.86B. Backs FY24 adjusted EBITDA view $4.5B-$5B. Francis continued, "As we mark the first anniversary of our Pivot to Growth Strategy, I am proud of the significant strides we have been making in realizing the goals and milestones we set out to achieve on our journey to growth, including the progression of our innovative pipeline and growth drivers, as well as the recent FDA approvals of SIMLANDI and SELARSDI, the biosimilars to Humira(R) and Stelara(R), respectively, and the positive Phase 3 efficacy results for olanzapine Once-Monthly LAI announced this morning.”... Full

Teva and Medincell's Schizophrenia Drug Meets Main Goal of Late-Stage Study

(5/8, Puyaan Singh, Reuters) ...Teva Pharmaceuticals and partner Medincell said on Wednesday their experimental schizophrenia drug had met its main goal in a late-stage study... Full

Teva's Antipsychotic Asset Passes Phase 3 Test in Schizophrenia

(5/8, Ayisha Sharma, Endpoints News) ...Teva said Wednesday morning that its schizophrenia drug succeeded in a Phase 3 trial with signs of a differentiated safety profile versus standard of care. The Phase 3 SOLARIS trial set TEV-‘749 — a once-monthly subcutaneous version of atypical antipsychotic olanzapine — against placebo in adults with schizophrenia. The drug, which is being developed by Teva, is delivered using Medincell's extended release technology... Full

Teva, Medincell Succeed in Late-Stage Trial for Injectable Schizophrenia Therapy

(5/8, Dulan Lokuwithana, Seeking Alpha) ...Teva Pharmaceuticals, a U.S.-based unit of the generic drugmaker Teva and French drug developer MedinCell, announced Wednesday that TEV-‘749, a subcutaneously delivered schizophrenia therapy, reached its main goal in a Phase 3 trial... Full

Teva, Medincell Report 'Positive' Results from Phase 3 Trial of TEV-'749

(5/8, The Fly) ...Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Medincell announced results from the efficacy portion of the Phase 3 Subcutaneous OLAnzapine extended-Release Injection Study trial evaluating TEV-'749 in adult patients with schizophrenia compared to placebo. Results demonstrated that TEV-'749 met its primary endpoint as measured by a change in the PANSS total score from baseline after 8 weeks compared to placebo... Full

Teva Commits to Net Zero Across Value Chain, 100% Renewable Energy

(5/7, Susan Lahey, ESG Today) ...Multinational pharmaceutical company Teva Pharmaceutical announced a series of new sustainability goals, including targets to achieve net zero emissions across the company's operations and value chain by 2045 and to reach 100% renewable electricity across all Teva sites by 2035...Richard Francis, Teva's President and CEO said: "Operating in a sustainable way is the right thing to do. Our renewed sustainability strategy is our purpose in practice—we are all in for better health—and our 2023 Healthy Future Report shows how we are taking action and tracking progress in areas where Teva can uniquely make an impact."... Full

Boehringer Secures FDA Approval For High-Concentration Cyltezo – But Without Interchangeability

(5/7, Adam Zamecnik, Generics Bulletin) ...Despite meeting the FDA's requirements, Boehringer's higher-concentration formulation of its Cyltezo rival to Humira has yet to receive the status, putting it at odds in a landscape that now has further options with the designation – including Alvotech that still enjoys exclusivity for its own interchangeable 100mg/ml adalimumab...Alvotech only recently secured FDA approval for its Teva-partnered Simlandi (adalimumab-ryvk) version in February, as the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira... Global Sub. Full

Sandoz Delivers 6% Sales Growth with Humira Biosimilar Leading the Charge

(5/7, Kevin Dunleavy, Fierce Pharma) ...With Hyrimoz leading the way, sales of the company's biosimilars reached $623 million in the first three months of this year, good for a 21% increase from the first quarter of last year. Meanwhile, Sandoz's generics sales reached $1.87 billion in the first quarter, a 1% gain from the same period in 2023. That adds up to 6% growth rate for the company overall. During the period, biosimilar sales represented 25% of the company's total sales, up from 22% a year ago... Full

Dr Reddy's Healthy Q4 Results Fail to Impress Brokerages Amid Lack of Growth Triggers

(5/8, Vaibhavi Ranjan, Money Control) ...While Revlimid push helped Dr Reddy's report healthy Q4 earnings, a lack of strong US launch pipeline, high R&D costs and weakness in base business are expected to put near-term pressure on the drugmaker. Dr Reddy's Labs' healthy Q4 numbers could not impress brokerages as analysts warned of a lack of near-term growth triggers for the drugmaker. While Dr Reddy's remains focused on biosimilars and initiatives to strengthen its business in key markets, brokerages forecasted its benefits to play out only after FY25... Full

Dr Reddy's to Launch Over 20 Products in US in FY25

(5/8, Neethi Rojan, Money Control) ...Dr Reddy's plans to launch more than 20 products in the US in the financial year 2024-25, the Indian generic drug manufacturer said in a post- earnings call after reporting better-than-expected profit for the March quarter. The company introduced 21 new molecules in the US in FY24, which drove a 28.8 percent on-year growth in sales in that country to Rs 32.6 billion (approximately $393 million), accounting for 46 percent of its total sales, the Hyderabad-based firm said on May 7... Full

Lupin Set for Strong Growth, But Expensive Stock Valuations May Cap Upside

(5/8, Vaibhavi Ranjan, Money Control) ...With a strong US launch pipeline, benign price erosion and focus on complex generics, Lupin sits on tracks for a robust growth trajectory. However, the stretched valuations of the stock will hinder the scope for further upside...Company executives have predicted revenue growth of over 10 percent and 20 percent margins despite loss-funding of adjacent business such as diagnostics, neuro rehab, and digital health, and continuing and increased R&D expenses, which paint a picture of a solid FY25... Full

Fresenius Raises Outlook On Strong Quarterly Results, Exits Vamed

(5/8, Tristan Veyet, Reuters) ...German healthcare group Fresenius first-quarter results beat expectations, the company said on Wednesday, citing strong performance at its Kabi and Helios businesses, prompting it to raise its full-year outlook...In a bid to get leaner, Fresenius also said that it would sell its investment unit, Fresenius Vamed, completing its portfolio restructuring. The business accounted for 10% of its revenue last year...The Hessian-based firm raised its full-year outlook after the strong first quarter and due to improved business prospects for its maker of generic hospital drugs, Fresenius Kabi. It now expects its organic group revenue to grow by 4%-7% this year, up from the 3%-6% it had expected earlier... Full

Formycon Reports On Successful Operating Business and Financial Figures for the First Quarter of 2024

(5/8, Formycon AG) ...Enno Spillner, CFO of Formycon AG, comments: "We have made a very good start to the new financial year in line with our plans and are positive about the first three months. In March, Sandoz announced the acquisition of the CIMERLI® business including the Coherus ophthalmology sales team in the USA, which we very much welcome and are looking forward to working together in the future. We can also report approvals and market launches in Saudi Arabia, Canada and Switzerland and are pleased that our partners MS Pharma and Teva are providing many patients access to this treatment for serious eye diseases.”... Full

Henlius Reports Revenue Rise For First Quarter Of 2024

(5/7, Adam Zamecnik, Generics Bulletin) ...Shanghai Henlius Biotech has reported a revenue of about RMB1.349bn ($187m) in the first quarter of 2024 as the Chinese company continues expanding the sales of its flagship biologics at home and abroad. The biotech's freshly reported revenue showcased continued growth, doubling down on the firm's recent announcement of its results for 2023, which was Henlius' first fully profitable year... Global Sub. Full

McKesson Misses Quarterly Estimates As US Pharmaceuticals Segment Weighs

(5/7, Pratik Jain, Reuters) ...McKesson Corp reported weaker-than-expected quarterly revenue and profit on Tuesday due to slump in demand for the company's branded and specialty drugs that dragged sales in its U.S. pharmaceutical segment. The drug distributor's pharmaceutical segment in the U.S., its largest unit by revenue that sells drugs used to treat complex conditions such as cancer, saw weaker-than-expected sales...Sales in the segment rose 11.5% in the fourth quarter to $68.79 billion, but missed analysts' estimate of $71.65 billion, according to LSEG data. The rise in sales in the reported quarter was helped by higher volumes from specialty products and partly by the demand for GLP-1 medications... Full

Stada Could See IPO as Soon as Opioid Litigation Monitorings End Q3, Sources Say

(5/7, Emma-Victoria Farr and Andres Gonzalez, Reuters) ...German drug manufacturer Stada could return to the stock market as soon as after the summer if bids are not high enough in a possible sale sought by its owners, three people familiar with the matter told Reuters...In the event of a sale, private equity firms CVC Capital Partners, KKR, and Clayton Dubilier & Rice are expected to be among the most likely parties to submit offers for the business, the people said... Full

US FDA Panel to Discuss Eli Lilly Alzheimer's Drug On June 10

(5/7, Christy Santhosh, Reuters) ...In clinical trials, the treatment slowed the progression of memory and thinking problems by 22% to 29% overall, roughly comparable to the 27% slowing seen with Leqembi...Experts have, however, said the drug's association with side effects such as brain swelling and bleeding could pose a challenge to its approval. Three people who were on the treatment in the company's trial died. Analysts on average expect donanemab to clock $65.6 million in sales in 2024, rising to $630.75 million next year, according to LSEG data... Full

AstraZeneca Fails to Block Biosimilar of Blockbuster Soliris

(5/7, Christopher Yasiejko, Bloomberg) ...AstraZeneca Plc unit Alexion Pharmaceuticals Inc. can't block a biosimilar version of Soliris for the duration of its patent-infringement lawsuit against a Samsung Biologics Co. subsidiary over the $500,000-per-patient treatment, a federal judge ruled... Full

Endo Health Ordered to Pay More Than $1.5 Billion in Opioid Criminal Case

(5/7, Ed Silverman, STAT Plus) ...In the second-largest fine ever levied on a pharmaceutical company, Endo Health Solutions was ordered to pay nearly $1.1 billion in criminal penalties and another $450 million in criminal forfeiture for illegally marketing its Opana ER prescription opioid...As a result of the litigation, Endo filed for bankruptcy and will cease to operate, although some affiliates emerged last month... Sub. Req'd

IQVIA: Medicine Spending Expected to Grow 4% to 7%

(5/7, Denise Myshko, Managed Healthcare Executive) ...Spending on prescription drugs at list prices increased on average 7.6% per year over the last five years, while payer net spending increased from $504 billion to $650 billion, or 5.5%, according to the newest Use of Medicines report by IQVIA Institute for Human Data Science... Full

Injectable Drug Delivery Market to Value $1139.4B by 2029

(5/7, Catherine Eckford, European Pharmaceutical Review) ...A new report by MarketsandMarkets™ has predicted that the injectable drug delivery market will reach an 8.6 percent compound annual growth rate (CAGR) between 2024 to 2029. The market is anticipated to value $1139.4 billion by 2029...The report stated that key players in the injectable drug delivery market include Pfizer Inc., Teva Pharmaceuticals Industries Ltd., Eli Lilly and Company and Sandoz... Full

Merck and Other Pharma Giants Are Bracing for Competition to Their Blockbuster Drugs. Here's How.

(5/8, Bruce Gil, Quartz) ...Pharmaceutical giants including Merck, Bristol Myers Squibb, and AbbVie are set to lose key patents on some of their most lucrative drugs this decade. As the clock counts down to the end of that exclusivity, more affordable generic and biosimilar alternatives are waiting to enter the market — taking a portion of the giants' blockbuster business, driving prescription prices down, and giving consumers potentially better options. With competition closing in, these pharmaceutical companies are bracing for impact. But they're also prepping their own playbooks, healthcare analysts and industry academics say — and looking ahead to both survive business shake-ups and stymy their competitors... Full

Asembia: Pharmacists Have a Role in Health Care System Sustainability

(5/7, Lauren Biscaldi, MS, Drug Topics) ...Fran Gregory, Vice President of Emerging Therapies at Cardinal Health, sat down with Drug Topics at AXS24, the Asembia Specialty Pharmacy Summit, to discuss the role of pharmacists in improving biosimilar uptake and advocating for health system sustainability... Full

Part 1: Unlocking the Potential of Biosimilars to Improve Health Equity

(5/7, Cameron Santoro, The Center For Biosimilars) ...This marks the first installment of a 2-part series, brought to you by The Center for Biosimilars®. We will delve into the potential of biosimilars to empower underserved communities while dissecting the obstacles that currently prevent them from accessing these affordable treatments...In an interview with The Center for Biosimilars, Robert Popovian, PhD, MS, a health economist, and founder of Conquest Advisors, stated, "We need to address benefit design. Over the last 10 years there's been coinsurances and deductibles introduced in the benefit design for biopharmaceuticals. Because of that, [drug prices] are a little bit of an unknown."... Full

Mark Cuban Cost Plus Drug Company Teams Up with RxLink to Bring Pharmacy Cost Transparency to Patients of Leading Health Systems

(5/7, RxLink Inc) ...Today, RxLink, a firm founded with the same commitment to price transparency in prescription medicine as Mark Cuban Cost Plus Drug Company, PBC announced a new collaboration to connect patients of leading health systems with Cost Plus Drugs' offering of safe medicines at the lowest possible price... Full

Novo Asks for More Time to Answer Sanders On Ozempic's Price

(5/7, Naomi Kresge and Madison Muller, Bloomberg) ...Novo Nordisk A/S is asking for more time to answer questions from US Senator Bernie Sanders on the prices of Ozempic and Wegovy, the company's blockbuster drugs for diabetes and weight loss. "We plan to respond to the latest inquiry in a timely manner; however given the tight turnaround requested, we will need additional time to develop our response," a spokesperson for the Danish drugmaker said Tuesday in an emailed response to questions... Sub. Req'd

Welch Holds Virtual Press Conference to Discuss Healthcare Costs

(5/7, Ike Bendavid, WCAX) ...In a virtual press conference today, Senator Welch joined representative Debbie Dingell from Michigan and the nonprofit Protect Our Care. In a new report from Protect Our Care, they say that in the first three months of 2024, big drug companies raked in nearly $29 billion in profits and rewarded shareholders over $28 billion. In the call, they also discussed how big pharma companies are working to shoot down the the Inflation Reduction Act... Full

House Ways and Means Committee Unveils 2-Year Telehealth Extension Bill and Tacks On PBM Reforms

(5/7, Emma Beavins, Fierce Healthcare) ...Telehealth lobbyists told Fierce Healthcare on the sidelines of the American Telemedicine Association annual conference in Phoenix this week that they are happy with the extension, though they prefer telehealth permanency...The offsets for the bill include pharmacy benefit manager reforms one source said were included in Senate Finance Committee PBM transparency legislation, the Modernizing and Ensuring PBM Accountability Act introduced in 2023. Two sources told Fierce Healthcare it's likely the House will move on telehealth before the lame-duck session, possibly by August. It's unclear where telehealth falls on the Senate's list of priorities... Full

"Delinking" Proposal Increases Drug Costs For Medicare Beneficiaries And Taxpayers, Hands $10 Billion Giveaway To Big Pharma

(5/7, PCMA) ...The House Ways and Means Committee will vote tomorrow, May 8, on legislation that will include a so-called "delinking" policy in Medicare. To be clear, the "delinking" policy proposal is backed by Big Pharma because it will significantly boost profits. At the same time as creating a financial windfall for drug companies, if enacted, "delinking" would increase Medicare Part D premiums and cost taxpayers billions. In addition, "delinking" upends the current Part D regulatory set up to mandate how pharmacy benefit managers are paid for services. Under a new regulatory landscape created by the "delinking" policy, value-based arrangements would be nearly impossible to achieve... Full

Mapping the Vertical Integration of Insurers, PBMs, Specialty Pharmacies, and Providers: A May 2024 Update

(5/7, Adam J. Fein, Ph.D., Drug Channels) ...It's time for Drug Channels' annual update of vertical integration among insurers, PBMs, specialty pharmacies, and providers within U.S. drug channels. Below you'll find our latest illustration of the major vertical business relationships among the largest companies along with some of the notable activity since our previous update. These organizations continue to exert greater control over patient access, sites of care/dispensing, and pricing, although some have started to unwind their vertical efforts. The companies face renewed scrutiny from the Federal Trade Commission, the Office of Inspector General, and members of Congress... Full

BMS, J&J Losses Not the End of IRA Legal Battle

(5/8, Roxanne Nelson, BioSpace) ...Although a New Jersey federal judge last week dismissed the cases brought by Johnson & Johnson and Bristol Myers Squibb against the IRA, both companies have said they will appeal the ruling. In addition, there are several remaining lawsuits challenging the Inflation Reduction Act's (IRA) Drug Price Negotiation Program... Full

Filling in the Blanks On the IRA: The First 10 Drugs Inform the Next Round

(5/7, Mary Caffrey, AJMC) ...The panel was moderated by Sean Sullivan, BScPharm, PhD, professor, The CHOICE Institute School of Pharmacy at the University of Washington; Inmaculada Hernandez, PharmD, PhD, professor at the University of California San Diego, presented highlights from unpublished findings of a project that simulated CMS' price negotiation process. Sullivan started the session with questions that have bedeviled both drug companies and experts who analyze the relative value of therapies, as they have wondered from afar how CMS will interpret a brand-new law... Full

Pharma Needs Help Preparing for IRA, New Tool Suggests

(5/7, The Pharma Letter) ...Half of pharma execs are bracing for significant revenue impact from Medicare price negotiations this year, compared to just 22% in 2023, according to research from revenue and compliance experts at Model N. Model N's 2024 State of Revenue Report finds that pharmaceutical executives are preparing for a significant revenue impact from the Biden administration's Inflation Reduction Act (IRA) in the USA... Sub. Req'd

Another Administration Win In Medicare Drug Price Negotiation Lawsuits

(5/7, Sheela Ranganathan Zachary Baron, Health Affairs) ...With Medicare negotiations between drug manufacturers and the Biden Administration continuing to proceed behind the scenes, litigation to stop the results of those negotiations from going into effect is also advancing through the courts. As we have previously written about, even before the U.S. Department of Health and Human Services (HHS) selected the initial drugs that would be negotiated under the Inflation Reduction Act, drug companies and industry allies have engaged in an aggressive legal strategy to block the implementation of the program... Full

Critics Repeat Same, Misleading Narrative On Potential "Costs" of New Medicines

(5/7, Alex Schriver, PhRMA) ...Every time new groundbreaking medicines are approved insurance companies claim these life-changing innovations will bankrupt the health care system. Here's what it looks like: overestimate the potential costs of providing access to new transformational medicines, ignore that payers leverage competition to extract significant discounts that lower the costs of brand medicines, undervalue the savings from treatment and prevention, and overlook that medicines are the only part of the health care system where prices go down over time. Insurers use these scare tactics as an excuse to put in place unnecessary and burdensome restrictions or to deny coverage altogether... Full

How Sham Patents Are Hurting the Pharma Industry

(5/7, Sally Turner, Pharmaceutical Technology) ...The world of patents is complex, particularly in the pharmaceutical industry as innovation is crucial for the development of life-saving drugs. In this backdrop, concern is now growing over the emergence of sham patents, the integrity of the patent system, and the potential for abuse. Sham patents, also known as "fraudulent" or "bad faith" patents, are obtained with deceptive practices or with the intent to hinder competition rather than to protect genuine innovations... Full

Should FDA Have More Say Over Patent Listings in the Orange Book?

(5/7, Bob Pollock, Lachman Consultants) ...This morning, I was reading an article written by Sally Turner in Pharmaceutical Technology, suggesting that the FDA take a greater role in the review and validation of the patents that brand-name companies list in the Orange Book. She addresses the Hatch-Waxman Act's patent listing provisions and discusses other views held on the benefit of patent listings, which give applicants a chance to litigate challenged patents both during the application review process and prior to approval (which can sometimes take longer than the thirty-month stay afforded innovators if they sue generic applicants within forty-five days after proper paragraph IV challenge notices are given)... Full

FDA Approved Second Highest Amount Of Drugs In 2023 Since 2013

(5/7, Luke Zarzecki, InsideHealthPolicy) ...FDA's Office of New Drugs approved 55 new drugs in 2023, with a little over half of those drugs for rare diseases. It's the second highest amount since 2013 -- with 59 approvals in 2018 as the peak-- and is up from 37 new drugs in 2022... Sub. Req'd

House Oversight Chair Presses FDA On China Amid Growing Tensions

(5/7, Lia DeGroot, Endpoints News) ...House Oversight Committee Chair James Comer (R-KY) is pressing the FDA to share more information on its presence in China amid growing concerns on Capitol Hill about Chinese involvement in biotech and other industries. The FDA's monitoring activities in China haven't been compliant since before the Covid-19 pandemic, Comer wrote in a 14-page letter sent to FDA Commissioner Robert Califf. The letter underscores that China is a dominant manufacturer of active pharmaceutical ingredients and that quality control issues at Chinese facilities have led to shortages of drugs and devices... Full

US FDA Transparency Win: Sponsors Know More Product-Specific Guidances Coming, Requests Fall

(5/7, Derrick Gingery, Pink Sheet) ...After creating a list of anticipated product-specific guidances to be published for generic sponsors and increasing PSG production, public requests for the agency to write a PSG declined...Sponsors have complained that they never knew when new PSGs or updates to existing PSGs would be released, which can hinder or delay generic development... Sub. Req'd

Cavazzoni: FDA Wants to Prevent Manufacturing Stoppages During Inspections

(5/7, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration is piloting a program to enhance communication between drugmakers, investigators, and its drug shortage team during inspections to prevent facilities from unnecessarily shutting down and potentially contributing to shortages of essential drugs, said Patrizia Cavazzoni, MD, director of the agency's Center for Drug Evaluation and Research... Full

European Progress On Biosimilars Is Just The Beginning

(5/7, David Wallace, Generics Bulletin) ...Speaking at Medicines for Europe's 20th annual biosimilar medicines conference, Isabell Remus, chair of Medicines for Europe's biosimilar medicines sector group, looks to the future for European biosimilars over the next decade and outlines the potential that can be realized – but only if a comprehensive strategy for biosimilars is put in place... Global Sub. Full

Euro Convergence: Experts Seek ‘Future Proof' Pharma Legislation As EU Elections Nears

(5/7, Ferdous Al-Faruque, Regulatory Focus) ...Experts and stakeholders involved in the discussions over the EU's pharmaceutical legislation say they are in talks with key players to ensure the upcoming June parliamentary elections don't disrupt its chances of being implemented... Full

Irish Pharma Sector Quizzes European Election Candidates On Innovation, Sustainability, and Regulation

(5/7, Brian Maguire, Euractiv) ...Irish candidates for the upcoming European parliament elections are attending a series of healthcare manifesto events hosted by the Irish Pharmaceutical Healthcare Association, where industry experts, the press and the public have an opportunity to quiz candidates' support for innovation, sustainability and their regulatory approach... Full

Pandemic Treaty Talks Go Up To The Wire

(5/7, Ian Schofield, Pink Sheet) ...The talks are still tough, with the Pathogen Access and Benefit Sharing proposal proving the most difficult aspect of the treaty, but there is cautious optimism that some form of agreement may be reached this week... Sub. Req'd

India Reverses Old Trend in Medical Consumables Business, is Now a Net Exporter

(5/8, The Economic Times) ...India, widely regarded as the pharmacy of the world owing to its generic medicines and low-cost vaccines, has achieved another big feat in the area of medical goods business, Times of India reported on May 8. According to the report (by Durgesh Nandan Jha), India has now reversed an old trend to become a net exporter of medical consumables and disposables, a first for the country. Till now, foreign products dominated the country's market for medical consumables, which include needles and catheters, among other things... Full

Report Calls for Changes to Government's Interaction with Drug-Pricing Board, Pharmaceutical Industry

(5/7, Carly Weeks, The Globe and Mail) ...A long-awaited report into several high-profile resignations at Canada's drug price regulator is calling for changes to how members of the government interact with the quasi-judicial body as well as the pharmaceutical industry. The House of Commons health committee report, made public this week, has 10 recommendations stemming from a string of events that seem to have indefinitely sidelined Ottawa's attempts at drug price reform... Sub. Req'd

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