Thursday, April 4, 2024

UroGen Pharma Files Patent Infringement Lawsuit Against Teva Pharma

(4/3, RTT News) ...Biotech company UroGen Pharma Ltd. announced Wednesday that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 and 9,950,069... Full

Urogen Files Patent Suit Against Teva Over Cancer Therapy

(4/3, Dulan Lokuwithana, Seeking Alpha) ...UroGen Pharma announced Wednesday it filed a lawsuit in a Delaware district court against Teva Pharmaceutical on allegations of patent infringements related to Jelmyto (mitomycin), its FDA-approved drug for bladder cancer... Full

Teva, Viatris Handed Second Bite At Overturning Core US Invega Sustenna Patent

(4/3, Dean Rudge, Generics Bulletin) ...Teva and Viatris hold firm ambitions in the long-acting schizophrenia space, and have just secured a win in their endeavors by convincing the US Court of Appeals for the Federal Circuit that a lower court erred in its analysis of whether a key Invega Sustenna patent was obvious...While targeting an Invega Sustenna ANDA product, Teva is continuing to bet big on the long-acting schizophrenia treatment market with 505(b)(2) products that look to revamp earlier molecules sufficient for long-acting treatment... Global Sub. Full

Why Are Teva Shares Surging and How Does it Plan to Keep it Up

(4/4, Uri Tel Tenne, CTech) ...Investors are focusing on Teva's long-term goals for 2027. These goals are very ambitious. The path to these goals involves a change in direction from focusing on efficiency to focused investment in research and development and sales and marketing to generate sales and profit growth. In recent months, investors have shown confidence in Teva's ability to approach these goals, which is reflected in Teva's surging stock price... Full

FTC's Campaign Against Improper Orange Book Listings Continues With Amicus Brief in Teva's Challenge of Amneal Asthma Inhaler ANDA

(4/3, Bevin M.B. Newman of Sheppard, Mullin, Richter & Hampton LLP, The National Law Review) ...In the case, Teva asserts that Amneal's Abbreviated New Drug Application for an asthma inhaler infringes upon five patents it has listed in the FDA's Orange Book–a challenge that under FDA regulations triggers a 30-month stay of FDA's approval of the generic inhaler. Amneal's counterclaims assert that the Teva patents, which relate to the inhaler device and dose counter, rather than the drug itself, were improperly listed and has asked the court for judgment on the pleadings and an order to delist the patents at issue... Full

Lupin Sharpens Focus With Carve-Out Of Indian Trade Generics Business

(4/3, David Wallace, Generics Bulletin) ...Lupin has announced plans to carve out its trade generics business in India to its Lupin Life Sciences Limited subsidiary, as part of efforts to achieve "agility, better focus and growth" for the unit...A business transfer agreement formally executing the carve-out is "likely to be entered into in Q1 FY25," or the current quarter ending June 30, 2024, Lupin indicated, "subject to customary satisfactory completion of conditions precedent, including securing requisite approvals."... Global Sub. Full

Apotex Adds Branded Division With Searchlight Acquisition

(4/3, David Wallace, Generics Bulletin) ...Apotex has struck a deal to acquire fellow private Canadian company and branded player Searchlight Pharma, in a move that the generics and biosimilars specialist says will "create a Canadian health champion spanning generic, biosimilar and branded pharmaceuticals."...Apotex said the transaction would build on its recent deal with Harrow for exclusive rights to certain branded ophthalmic products, positioning the company to "become the partner of choice for pharmaceutical licensing and acquisition opportunities in the Americas."... Global Sub. Full

Sanofi to Settle 4,000 Zantac Cancer Lawsuits in US State Courts

(4/4, Dietrich Knauth, Reuters) ...Sanofi has reached an agreement in principle to settle 4,000 U.S. lawsuits linking the discontinued heartburn drug Zantac to cancer, the company said on Wednesday...Sanofi did not admit any liability in the settlement, and said it is settling to avoid the expense and ongoing distraction of the litigation. "Sanofi has vigorously defended the Zantac litigation since the outset and will continue to do so," the company said in a statement... Full

Mark Cuban's Startup Sending Drugs to Hospitals Facing Shortage

(4/3, Shelly Hagan, Bloomberg) ...Mark Cuban Cost Plus Drug Co., co-founded by the billionaire entrepreneur and Alex Oshmyansky, a radiologist, is sending epinephrine and norepinephrine to about 10 hospitals in Texas and Pennsylvania beginning Wednesday..."Hopefully it helps the hospitals deliver care in an affordable way because they're constantly struggling to stay above water as well," Oshmyansky said. "But also the products we focus on specifically are drug-shortage products."... Full

Mark Cuban's Startup Is Sending Its First Batch of Essential Meds to Hospitals Facing Shortages

(4/3, Sherin Shibu, Entrepreneur) ...Mark Cuban Cost Plus Drug Co. is shipping out its first batch of allergy medication epinephrine and blood pressure drug norepinephrine starting Wednesday, according to reports...Cost Plus also announced on Tuesday that it would be partnering with Price.com to integrate its drug prices into Price.com'scomparison tool... Full

AI Helps Pharma Find New Drugs But Imperils Lucrative Patents

(4/4, Annelise Gilbert, Christopher Yasiejko and Nyah Phengsitthy, Bloomberg Law) ......"AI can put discovery into hyperspeed and spin out various potential molecules," said Robin Feldman, a professor at the University of California College of the Law, San Francisco. But, she said, it has "the potential to create a huge pool of prior art blocking downstream innovation, long before anyone's figured out what to do with that prior art, or whether it's even useful."... Full

Biden, Senator Bernie Sanders Push Companies to Cut Cost of Asthma Inhalers, Prescription Drugs

(4/3, Steve Holland and Nandita Bose, Reuters) ...President Joe Biden hosted a White House event with U.S. Senator Bernie Sanders on Wednesday to tout their fight against high prescription drug prices and push companies to cut the cost of inhalers for asthma sufferers..."It's time drug companies pay rebates when they increase prices faster than inflation," he said. Sanders and other lawmakers in January criticized four makers of inhalers sold in the U.S. — AstraZeneca, Boehringer, Teva Pharmaceuticals and GSK — over prices that were much higher in the United States than in other countries. In March, three of the four companies decided to cap inhaler costs at $35 each... Full

Biden Touts Success In Pressuring Pharma To Lower Inhaler Prices

(4/3, Gabrielle Wanneh, InsideHealthPolicy) ...President Joe Biden on Wednesday (April 3) touted his administration's and Sen. Bernie Sanders' (I-VT) success in pressuring three of four of the nation's top inhaler manufacturers to cap out-of-pocket costs for patients at no more than $35 a month, saying the administration will look for more ways to get drug makers, who are already backed in a corner due to Medicare drug negotiations, to cut their prices...Seven out of 10 companies FTC warned have since decided to delist their patents from FDA's Orange Book, while Boehringer Ingelheim, AstraZeneca and Teva Pharmaceuticals have not yet done so. FTC is now participating in an ongoing suit against Teva, highlighting the company's refusal to delist its invalid inhaler patents... Sub. Req'd

Biden Touts Lower Drug Prices With Bernie's Help

(4/3, Joseph Choi, The Hill) ...Gathered at the White House with health care advocates and experts, Sanders lamented that despite working to address high health care costs for the past 20 years, "not much has happened" in that time...He noted how three of the top four inhaler manufacturers have recently capped the cost of some of their most popular inhaler products to $35 a month, calling out Teva Pharmaceuticals for being the only remaining company not to follow suit. "But let us be clear, despite all that we have accomplished up to now. It is not enough. Much, much more needs to be done," the Vermont senator said... Full

Biden, Sanders Tout Efforts to Lower 'Outrageous' Prescription Drug Costs

(4/3, Sheri Walsh, UPI) ...During the event, Biden and Sanders touted Medicare's new ability to negotiate the cost of certain prescription drugs with pharmaceutical companies, as well as Inflation Reduction Act caps for Medicare patients that include $35 for insulin and brand-name out-of-pocket expenses below $2,000 a year...Sanders also noted that the cost of inhalers had recently been capped by three of the top four inhaler manufacturers to $35 a month, as he called out Teva Pharmaceuticals for holding out... Full

'We Beat Big Pharma': Biden Applauds IRA, Calls for Expansion of Medicare Negotiations

(4/3, Nicole DeFeudis, Endpoints News) ...President Joe Biden renewed his proposal to expand drug price negotiations under the Inflation Reduction Act on Wednesday, arguing that "we should be more aggressive."...Biden argued in favor of expanding negotiations to include "at least 50 drugs a year," as well as capping out-of-pocket prescription drug costs at $2,000 and insulin at $35 for all Americans. Negotiations are currently ongoing for the first 10 products on CMS' list, though discounts will not take effect until 2026... Full

Ozempic Maker Fires Back at Bernie Sanders Over Claim That The Weight Loss Drug Company 'Ripped Off' Americans

(4/3, Nikolas Lanum, FOX Business) ...During a Tuesday appearance on MSNBC's "Ana Cabrera Reports," Sanders passionately pointed out the stark contrast in drug prices, stating that Novo Nordisk should not be charging people in the U.S. over $1,000 a month for the product while charging those who reside in places like Germany and Canada a fraction of the price...In a statement to MSNBC, Novo Nordisk defended their pricing. "It's easy to oversimplify the science that goes into understanding disease and developing and producing new treatments, as well as the intricacies of U.S. and global healthcare systems. However, the public debate doesn't always take into account this extremely complex reality," the company said... Full

How US Lawmakers Have to Negotiate Drug Prices

(4/4, John Lauerman, Bloomberg) ...When our reporters Robert Langreth and Madison Muller asked Sanders if he planned to hold hearings on the price of the diabetes drug, he said that first he'd like to talk with Novo Chief Executive Officer Lars Fruergaard Jorgensen...The Vermont independent's proposal for a personal conversation with Novo's CEO sounded like an invitation for the company to make some concessions that could potentially circumvent embarrassing public questioning about the enormous markup on the drug's manufacturing cost. That kind of shaming can bring results. President Joe Biden got Novo, Eli Lilly and other companies to lower the prices for insulin by as much as 75% with just such tactics... Full

It's Time for Facts in the PBM Debate

(4/3, David Joyner, Fortune) ...The reality is, the Cost Plus offering is neither novel nor unique—it is a generic sourcing business that is 10 years too late. What's more, it often lacks a consistent supply of products and regularly stocks treatments with short expiration dates, failing to offer the comprehensive and reliable service needed to deliver high-quality pharmacy benefits to a large patient population... Full

Medicare Price Negotiations Carry On As HHS Responds to Big Pharma's IRA Counteroffers

(4/3, Zoey Becker, Fierce Pharma) ...Medicare drug price negotiations under the Inflation Reduction Act are steadily progressing after drugmakers recently submitted their counteroffers to the government's initial pricing proposals. Now, the U.S. Department of Health and Human Services has put forward its own responses to those counteroffers. In addition, the agency invited each company affected by the process to engage in "further discussions," it said in a Tuesday press release...If the drugmakers and the HHS reach an agreement on a maximum fair price by the end of the negotiation period Aug. 1, the new prices will be published Sept. 1 and take effect starting in 2026... Full

HHS Seeks To Avert Shortages With Generic Drug Score Card, Hospital Incentives/Penalties

(4/3, Maaisha Osman, InsideHealthPolicy) ...HHS hopes to work with Congress to stem drug shortages by setting up a program to rate the quality and supply chain resiliency of generic drugs and then incentivize hospitals through Medicare payments and penalties to contract for drugs with high scores and institute programs to protect against shortages... Sub. Req'd

HHS: Medicare Incentives, Penalties for Hospitals Could Help Stem Drug Shortages

(4/3, Dave Muoio, Fierce Healthcare) ...To address the nation's drug shortages, the Department of Health and Human Services is floating a plan that would attach new Medicare payments and penalties to hospitals' supply chain practices...Hospitals, HHS wrote, could potentially be rewarded for managing their inventories with buffer stocks or for securing contracts with group purchasing organizations that have specific minimum purchasing volume requirements to promote supply chain resiliency, HHS wrote... Full

Biden's Plan for Hospitals to Pay More for Drugs in Shortage is ‘Misguided,' Group Says

(4/3, Anna Brown, Endpoints News) ..."It is misguided to punish hospitals if their purchasing practices do not conform to an arbitrary set of principles crafted by a federal agency," Nancy Foster, the American Hospital Association's VP for quality and patient safety policy, told Endpoints News in an email...The onus of drug shortages should be on companies that manufacture and transport drugs, as well as entities such as the FDA, who have a "more direct role" to ensure reliable medicine supply, Foster added. "The focus should be how to support those with the key roles in building a resilient supply chain," she noted... Full

CSRXP Commends President Biden for Holding Big Pharma Accountable for Patent Abuse and Egregious Pricing On Brand Name Inhalers

(4/3, The Campaign for Sustainable Rx Pricing) ..."CSRxP commends President Biden and the Administration for holding Big Pharma accountable for decades of patent abuse and price hikes on brand name inhalers," said CSRxP executive director Lauren Aronson. "The Administration and lawmakers must continue to hold Big Pharma accountable for anti-competitive tactics designed to game the system, block competition from more affordable alternatives and keep prices high."... Full

Drug Cost-Sharing Limits Could Be Strengthened In Self-Insured, Large Group Plans In Upcoming Rule

(4/3, Cathy Kelly, Pink Sheet) ...CMS clarifies that individual and small group plans in the commercial market may not designate covered drugs as non-essential health benefits in the final HHS Notice of Benefit and Payment Parameters for 2025. The "non-EHB" designation has enabled plans to exclude manufacturer assistance from the annual and lifetime cost sharing limits established by the Affordable Care Act. Self-insured and large group plans will be similarly restricted in an upcoming proposal issued by the Health and Human Services, Labor and Treasury Departments... Sub. Req'd

A Critical Year for Drug Discount Management

(4/4, Vishali Amin, Pharma Phorum) ...While the 340B Drug Pricing Program and the Medicaid Drug Rebate Program have grown in recent years, provisions of the Inflation Reduction Act, as well as a recent federal court ruling, are likely to spur significant additional expansion in the coming months and beyond. More opportunities to benefit from 340B discounts and Medicare rebates sounds like great news for eligible consumers. However, for other drug discount system stakeholders – manufacturers, covered entities (CEs), and state Medicaid agencies – an uptick in discount and rebate claims is sure to exacerbate the costly and unresolved challenge of duplicate discounts... Full

WuXi Builds Out Lobbying Bench Amid Legislative Effort to Blacklist Company

(4/3, Lia DeGroot, Endpoints News) ...WuXi AppTec is enlisting more lobbyists to represent its interests before Congress, where China hawks have pushed for limits on how the company works with US biotech and pharma companies...A spokesperson told Endpoints News that the hirings "help us continue to engage policymakers on the important work the company does to support our customers' life-saving treatments for patients and create jobs and strengthen the communities in which we operate."... Full

Virginia Legislators Urge Governor to Sign Prescription Drug Bill

(4/3, Joe Dodson, Courthouse News Service) ...Virginia lawmakers and prescription drug affordability advocates on Wednesday urged the governor to sign legislation lowering the cost of prescription drugs. Republican Governor Glenn Youngkin has until April 8 to sign, veto or offer amendments to all bills passed through the Democrat-controlled General Assembly, including measures to establish a Prescription Drug Affordability Board... Full

WHO Allots Extra Time To Get Pandemic Treaty Talks Over The Line

(4/3, Ian Schofield, Pink Sheet) ...Negotiators from World Health Organization member states have had to schedule an additional set of talks on the proposed pandemic treaty after they failed to finalize an agreement during the 18-March 28, meeting of the Intergovernmental Negotiating Body. The March meeting – the ninth to be held by the INB – saw negotiators discuss all the articles in the draft agreement, including adequate financing for pandemic preparedness and the access to medical countermeasures during health emergencies, according to the WHO... Sub. Req'd

Review Highlights Most Popular European Policies to Boost Biosimilar Uptake

(4/3, Skylar Jeremias, The Center For Biosimilars) ...A systematic review, published in Frontiers in Public Health, examined the policy landscape associated with increased biosimilar uptake in Europe, finding tender systems were very common among member states and automatic substitution was rarely utilized...The authors also emphasized that further research is needed to identify any additional policy measures and instruments that were not included in their analysis... Full

Breaking Barriers: Japan's PMDA To Open First Global Office, In D.C.

(4/3, Lisa Takagi, Pink Sheet) ...To attract more new drugs still at the early stages of development at bioventures to Japan, the country has kick-started an official plan to open the first full-time foreign office of its Pharmaceuticals and Medical Devices Agency, in Washington D.C...Japan's Ministry of Health, Labour and Welfare, under which the PMDA operates, told the Pink Sheet in an exclusive interview that it's planning to open the D.C. office "as early as possible" within the five-year period from 2024 to... Sub. Req'd

China Implements Data Transfer Regulation, With Some Waivers

(4/3, Brian Yang, Pink Sheet) ...On March 22,, the Cybersecurity Administration of China released the final version of a regulation governing the overseas transfer of personal, business and other data, including of health and medical data with implications for the biopharma industry...In a written response, "Angus" Shipo Xie, a lawyer at Hankun Law, told the Pink Sheet that the biggest change, and the one that has drawn most intense discussion, is that pertaining to personal sensitive data and how these can be handled in a compliant way... Sub. Req'd

New Zealand Addresses ‘Significant' & ‘Other' Safety Issues In New PhV Guide

(4/3, Neena Brizmohun, Pink Sheet) ...New definitions for "significant safety issues" and the introduction of an "other safety issues" category are among the changes that New Zealand's Medsafe has made in the latest iteration of its pharmacovigilance guideline. The revised guideline, which is replacing its predecessor that was published in 2020, had been issued for consultation late last year. Most respondents agreed with the proposed updates, the regulator said, adding that there were also requests to add examples or further detail to some sections to improve understanding and interpretation... Sub. Req'd

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