Monday, May 13, 2024
Top News
Teva Price Target Raised to $20 from $19 at Piper Sandler
(5/13, The Fly) ...Piper Sandler raised the firm's price target on Teva to $20 from $19 and keeps an Overweight rating on the shares after hosting a dinner with senior management and investors. Brand opportunities certainly were a key area of focus, and with that in mind... Full
Industry News
Kabi Awaits Biosimilar Tocilizumab Boost, Upgrades 2024 Guidance
(5/13, Dean Rudge, Generics Bulletin) ...Fresenius Kabi enjoyed a good start to 2024, boosted by the recent US launch of its biosimilar tocilizumab product and a key licensing agreement signed with Teva – factors that have allowed the German generics and biosimilars giant to boost its financial guidance for 2024... Global Sub. Full
Lupin's Confidence Over Mirabegron Relaunch Doesn't Convince Analyst
(5/10, Urte Fultinaviciute, Generics Bulletin) ...As the legal saga between Astellas and two generics firms Lupin and Zydus reached its culmination just a few weeks ago, Lupin's CEO Vinita Gupta said the company feels certain about the opportunity to relaunch the generic version of Myrbetriq (mirabegron) shortly. "We feel pretty good about our position, and we'll have a read on it over the next few days," Gupta said during the firm's Q4 and end-of-fiscal year 2024 earnings call... Global Sub. Full
Roche's Soaring Vabysmo Sales Raise the Stakes in Ophthalmology Face-Off with Regeneron's Eylea: Analyst
(5/10, Andrea Park, Fierce Pharma) ...The companies' latest earnings reports show Roche's Vabysmo sales skyrocketing while heavyweight Eylea plateaus. For the first quarter of 2024, Roche reported total global sales of 847 million Swiss francs ($933 million) for Vabysmo, for an analyst-estimate-smashing year-over-year increase of 108%, while noting that the eye medicine was its biggest growth driver for the quarter. Regeneron, meanwhile, tallied first-quarter sales of $2.25 billion for both Eylea and its recently launched higher-dose sibling, Eylea HD... Full
Alembic Pharmaceuticals Gets 5 USFDA Product Approvals in Q1FY25
(5/13, Sushmita Panda, Financial Express) ...According to a press statement, the company has received five product approvals – three final and two tentative – from 1st April 2024 till 8th May 2024. This includes Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringe, Selexipag Tablets 1,000 mcg and 1,200 mcg, Binimetinib, Tretinoin Cream USP, 0.1%, and Clindamycin Phosphate Topical Gel USP 1%... Full
‘Pfizer for All' Consumer Platform Aims to Provide Post-Covid Boost
(5/12, Oliver Barnes, Financial Times) ...The New York-based drugmaker filed a trademark application in mid-April for a website and app providing medical information as well as mail-order pharmacy and telehealth services to US patients under the brand "Pfizer for All", according to a US Patent and Trademark Office filing. The early-stage plans are the latest effort by a pharmaceutical company to circumvent industry middlemen and sell drugs directly to US patients. Earlier this year, weight loss drugmaker Eli Lilly launched its LillyDirect platform in an industry first... Sub. Req'd
Takeda Pays AC Immune $100M Upfront for Alzheimer's Drug as Phase 2 Readout Nears
(5/13, James Waldron, Fierce Biotech) ...Takeda may be paring back its R&D pipeline in the name of efficiency, but the Japanese pharma has still found $100 million to ensure its clinical pipeline once again features an Alzheimer's disease drug. The asset in question, ACI-24.060, is an anti-Abeta active immunotherapy from AC Immune "designed to induce a robust antibody response against the toxic forms of Abeta believed to drive plaque formation and Alzheimer's disease progression," Takeda explained in a May 13 release... Full
France Draws €2B+ Research, Manufacturing Investment from Sanofi, Pfizer, AstraZeneca, GSK
(5/13, Amber Tong, Reynald Castañeda and Anna Brown, Endpoints News) ...Sanofi, Pfizer and AstraZeneca separately pledged to increase their footprint in France, with investments adding up to almost €2 billion. The big pharma announcements are a part of a much larger €15 billion investment from various companies in different industries, according to Reuters, as the foreign direct investment summit dubbed Choose France kicks off on Monday. GSK is also set to unveil new investments in the country on Monday... Full
Jeffrey Casberg Predicts Generic, Biosimilar Competition in the Pharmaceutical Market
(5/12, Cameron Santoro, The Center For Biosimilars) ...Jeffrey Casberg, RPh, MS, senior vice president of pharmacy at IDP Analytics, LLC mentions several drugs due to lose patent exclusivity soon, which would allow generic versions to be produced. Casberg discusses biosimilar competition, a relatively new phenomenon in the pharmaceutical industry that could lead to significant price reductions... Full
U.S. Policy & Regulatory News
Sanders Urges Denmark to Pressure Novo Nordisk On Lowering Drug Prices
(5/13, Christian Wienberg, Bloomberg) ...Sanders, who chairs the Senate's Health, Education, Labor and Pensions Committee, called on Danes to pressure Novo to "significantly reduce the outrageously high prices for Ozempic and Wegovy in the US and other parts of the world," according to the letter, published by the Politiken newspaper on Monday. Sanders has also called on Novo directly to lower its prices and has asked the drugmaker to reply to a series of questions on costs and manufacturing... Full
Despite Lower Out-Of-Pocket Costs, Insulin Affordability Is Still A Critical Issue
(5/12, Joshua Cohen, Forbes) ...The out-of-pocket costs for insulin have declined for most people in recent years, including patients with private health insurance. Nonetheless, about one-fifth of commercially insured patients pay more than $35 a month for insulin, a New York Times article reported this week. For these individuals, insulin affordability—and even availability in the case of pregnant women who will need Levemir in 2025 and beyond—continue to be urgent issues... Full
Durbin Writes Amgen CEO About Marketing of Firm's Oncology Drug
(5/10, Lauren Dezenski, Bloomberg Law) ...Democratic Senator Dick Durbin writes Amgen CEO Robert Bradway over the company's decision to continue marketing oncology drug Lumakras at an elevated dosage despite an FDA study showing the medication has comparable efficacy and fewer side effects when taken at a much lower dose. Durbin seeks an explanation of Amgen's dosing, research and marketing strategy for Lumakras by June 10... Full
Senators Question Chamber of Commerce's Motives Around March-In Rights
(5/10, Nicole DeFeudis, Endpoints News) ...Sens. Elizabeth Warren (D-MA), Bernie Sanders (I-VT) and Jeff Merkley (D-OR) accused a new US Chamber of Commerce coalition of attempting to "stymie the White House's drug pricing initiatives."...Paul Michel, a former federal Fifth Circuit judge and honorary co-chair of the BASIC Coalition, told Endpoints News on Friday that the proposed march-in framework is the coalition's primary focus at the moment. "I think it's in the national interest to maintain a functioning system for innovation in America," he said... Full
GOP E&C Leaders Call Out ASPR Over Issues With National Stockpile
(5/10, Jessica Karins, InsideHealthPolicy) ...Republican leaders on the House Energy & Commerce Committee are criticizing the Administration for Strategic Preparedness and Response (ASPR) over the financial and procurement practices of the Strategic National Stockpile (SNS), asking for answers from ASPR on issues they say could impact a public health response. Among their concerns are that a significant number of stockpiled products are several decades beyond their original FDA-approved expiration date and no longer are manufactured... Sub. Req'd
Axios Event: Drug Shortages Problem Will Require Policy Solutions to Fix Low Prices, Shift Market Dynamics
(5/10, Emily Hamilton, Axios) ...Experts agreed that this is a systemic economic problem that will require action from policymakers to fix, and that low prices driven by concentrated power among a few market actors are further exacerbating the issue..."We have been pointing to this for a number of years … some of this gets to buyer issues, to incentives and what people are paying, but we also can't ignore the role of government policies in this," said Craig Burton, SVP of policy and strategic alliances for the Association for Accessible Medicines... Full
DOJ To Combat PBM Consolidation With New Health Care Task Force
(5/10, Gabrielle Wanneh, InsideHealthPolicy) ...A new task force launched by the Justice Department Thursday (May 9) aims to take a whole-of-division approach to tackling consolidation and collusion in the health care sector that is preventing Americans from affording and accessing the services they need, and DOJ officials said the group will tackle consolidation practices by pharmacy benefit managers in addition to payers and providers. The group will also target misuse of patient data... Sub. Req'd
Biotechs Want Time to Wean From China as Congress Weighs Limit
(5/13, Alex Ruoff, Bloomberg Law) ...The US biotechnology industry is deeply reliant on China-based companies, the industry is warning lawmakers as they consider legislation cutting taxpayer dollars from pharmaceutical companies over concerns with China ties. The House Oversight Committee plans to mark up a bill (H.R.7085) Wednesday that would prohibit federal contracting with certain biotechnology providers controlled by "foreign adversaries." The measure specifically names four Chinese companies—BGI Group, MGI, Complete Genomics, and WuXi Apptec—as banned from receiving federal contracts... Sub. Req'd
Senate Work On Biosecurity Issues Continues Even As House Is Current Focus Of Legislative Activity
(5/10, Derrick Gingery, Pink Sheet) ...US FDA Principal Deputy Commissioner Namandjé Bumpus recently attended a biotech-themed roundtable with the Senate Select Committee on Intelligence and national security officials as Congress' pulls the FDA into its worries about Chinese influence of the pharma industry...The impact of the legislation could be substantial for US and foreign firms, who could be barred from government contracts if they use equipment or services from the companies of concern... Sub. Req'd
FDA is Criticized for Taking a ‘Ministerial' Role in Sorting Out Some Pharma Patents
(5/13, Ed Silverman, STAT Plus) ..."The FDA needs to show some leadership and say which stuff won't go in the Orange Book, but instead, they have been flip-flopping for years," said Tahir Amin, the executive director at the Initiative for Medicines, Access & Knowledge, a nonprofit that focuses on pharmaceutical patent issues...As a result, the FDA will not change patent information in the Orange Book unless the patent holder agrees to amend or correct information in response to a dispute. It remains unclear when the FDA will address the issue... Sub. Req'd
Are You Getting the Most Out of the PSG Program Under GDUFA III?
(5/10, Jennifer Leaming, Lachman Consultants) ...The FDA recently hosted a webinar focused on the facilitation of generic drug product development through Product Specific Guidances, also known as PSGs...The webinar provided an overview of the PSG program, provided some details on tailored recommendations for IR oral products, discussed suitability petitions and their impact on PSGs, provided more information on device information being listed in PSGs, discussed considerations for study population selection in BE studies with PK endpoints, and provided some instructions on navigating the FDA dissolutions method database as well as how the database is used with and relates to PSGs... Full
Oklahoma Asks Supreme Court to Review Pharmacy Middlemen Law
(5/10, Sara Hansard, Bloomberg Law) ...Oklahoma asked the US Supreme Court to review an appeals court's decision invalidating parts of a state law regulating pharmacy benefit managers. The state filed a petition for review Friday, arguing that a previous high court ruling "should have signaled to lower courts that state efforts to regulate PBMs are unlikely to be preempted by federal law."... Sub. Req'd
Drugmaker Millions Go Untapped as States Fail to Collect Rebates
(5/10, Ganny Belloni, Bloomberg Law) ...A report released this week by the Department of Health and Human Services Office of Inspector General found state Medicaid agencies could have invoiced manufacturers for an additional $225.7 million in rebates for drugs reimbursed on a fee-for-service basis. States also should have collected an extra $236.2 million tied to medicines given to Medicaid patients enrolled in managed care plans, the report concluded... Sub. Req'd
Local Governments Struggle to Distribute Their Share of Billions from Opioid Settlements
(5/12, Geoff Mulvihill, Associated Press) ...Settlement money to help stem the decades-long opioid addiction and overdose epidemic is rolling out to small towns and big cities across the U.S., but advocates worry that chunks of it may be used in ways that don't make a dent in the crisis. As state and local governments navigate how to use the money, advocates say local governments may not have the bandwidth to take the right steps to identify their communities' needs and direct their funding shares to projects that use proven methods to prevent deaths... Full
International News
EU Parliament Waters Down Planned Antimicrobial Voucher Scheme
(5/10, Ian Schofield, Pink Sheet) ...In the second in a series of articles on amendments to the EU pharmaceutical reform proposals, the Pink Sheet looks at changes made by the European Parliament to the "transferable exclusivity voucher" and its ideas for a milestone payment and subscription-model scheme. Among the numerous amendments introduced by the European Parliament to the European Commission's pharmaceutical legislative reform is a dilution of the additional regulatory data protection available when a company is awarded a "transferable exclusivity voucher" (TEV) for the development of a "priority" antimicrobial drug... Sub. Req'd
Pharma Should Include ‘Heterogeneous Health Data' In EU Regulatory & HTA Dossiers
(5/10, Eliza Slawther, Pink Sheet) ...The European Commission has indicated a "strong intent" to take real-world evidence and "broader health care data" into greater consideration during regulatory and HTA decision-making in the future, according to Rebecca Lumsden, Sanofi's head of regulatory science & policy, EU/AMEE regions. During a presentation at the RAPS Euro Convergence meeting on May 7, Lumsden outlined the potential for companies to use "heterogenous health data" in their dossiers, "whether it's [for] regulatory or HTA decision-making."... Sub. Req'd
Reuters Pharma Europe 2024 – Peter Stenico
(5/10, Eloise McLennan, Pharma Phorum) ...Pioneering access to biosimilars is crucial for strengthening health equity by providing affordable, life-changing therapies to patients worldwide. However, despite 85% of the world's population living in low- and middle-income countries, 80% of biologics are used in high-income nations. At last month's Reuters Pharma Europe conference in Barcelona, pharmaphorum's Eloise McLennan sat down with Peter Stenico, global head of biosimilars and country president for Sandoz Austria, to talk about the crucial role of biosimilars in promoting health equity and expanding access to life-changing biologics... Full
Explainer: Swiss to Vote On Healthcare ‘Cost Brake'
(5/12, Katy Romy, Swissinfo.ch) ...The Swiss healthcare system is one of the most expensive in the world. Spending in the sector has risen steadily since the 1990s; it now accounts for 11.8% of GDP. The spiraling costs have invariably led to significant annual hikes in the cost of health insurance premiums, putting a heavy strain on lower-income households. Surveys have shown that health costs are the biggest issue of concern for the Swiss population. To address the problem, the Centre's initiative, which comes to vote along with three other issues on June 9, wants to introduce a mechanism to curb the rise in compulsory health insurance costs... Full
Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].
Teva global subscription access: Registration is required to access FirstWord and Generics Bulletin. Click on the links below to register. If you have any questions or issues with access, contact InfoNOW or visit InfoNOW's Industry News page for more details regarding these subscriptions.
FirstWord Pharma Plus: Enter your work email address on the Registration page along with your contact information in order to receive access.
• Registration: Click on "Sign In" (link on the upper right side of the page). Enter your work email address in the "username" box and press the "Tab" button on your keyboard or click out of the box. You will then be automatically logged into the Informa news resource (no password required). You may be redirected to the Account Settings page to update your contact information.
• Subsequent Access: If you're not automatically logged in, click on "Sign In" (link on the upper right side of the page). Enter your work email address. You will be automatically logged in (no password is required).
• Note: You must be on the Teva Network (in a Teva location or connected via VPN) in order to access the Informa news resources. You can toggle between the Informa news resources by clicking the news resource on the top.