Wednesday, March 13, 2024

Drugs Companies Clap Back at Congress…Then Get Sued

(3/13, Sara W. Koblitz, FDA Law Blog) ...FTC's and Congress's activities seem to have triggered litigation. On March 6, 2024, the first antitrust suit arising from these letters was filed by the Massachusetts Laborers' Health and Welfare Fund in the District Court of Massachusetts against Boehringer Ingelheim. That Complaint alleges that "Boehringer improperly submitted 23 device patents to the Orange Book as claiming Combivent Respimat" and another 16 "as claiming Spiriva Respimat" citing specifically to FTC's and Congress's inquiries. We expect that this is just the first of many antitrust cases to come—with AstraZeneca, Abbvie, Mylan/Viatris, and Teva all likely to be on the front lines... Full

Increased Prices, On Top of Scarcity, Present a Burden for Patients With ADHD

(3/12, Myles Starr, Specialty Pharmacy Continuum) ...Patients who need amphetamine and dextroamphetamine (Adderall, Teva Pharmaceuticals), a medication used to treat attention-deficit/hyperactivity disorder, binge eating disorder and narcolepsy, have faced a shortage of the drug for more than a year..."The simplest explanation for the shortage of ADHD medications is an increase in demand for this class of drugs," explained Michael Ganio, PharmD, the senior director for pharmacy and quality at ASHP, in Bethesda, Md...The increased demand led to a shortage, which the FDA announced in October 2022. This announcement was largely the result of Teva, one of the top suppliers of generic formulations of the drug, struggling to keep up with the demand... Full

Alvotech Sees Opportunities Open Up With US Approvals

(3/12, David Wallace, Generics Bulletin) ...With long-awaited US approvals now rolling in and a growing pipeline of future biosimilars, further opportunities are opening up for Alvotech – including potentially launching a second interchangeable Stelara biosimilar in the US just a few months after market formation – chief commercial officer Anil Okay and chief strategy officer Ming Li tell Generics Bulletin...[Anil Okay] "Our partnership in biosimilars with Teva is a strong one. We have multiple launches coming up and a shared interest and desire to promote biosimilars."... Global Sub. Full

Sandoz Growth Driven by Biosimilars in First Year Since Spinoff

(3/13, Paula Doenecke, Bloomberg Law) ...The company, which was spun off from Novartis AG last year, expects to generate a core earnings before interest, taxes, depreciation and amortization margin of 20% in 2024, which is up slightly on the 18.1% it achieved last year...[Sandoz Chief Executive Officer Richard Saynor] said that the company has three strong candidates in its biosimilars pipeline this year. Sandoz's generics business grew 15% in 2023, lagging behind the smaller biosimilars business but still topping competitors like Teva and Viatris. "We believe investors will be reassured by the 2024 guidance which is in line with expectations," said Thibault Boutherin, an analyst at Morgan Stanley... Sub. Req'd

Richter On Formycon Investment: ‘Indispensable' To Partner On Everything We Do

(3/12, Dean Rudge, Generics Bulletin) ..."Given the size of our company and given the complexity and fast-paced nature of the biotechnology scene, it's very important, almost indispensable, that we partner in everything we do in biotechnology," Gedeon Richter says, in the firm's first detailed comments since agreeing to take a 9.08% stake in German biosimilars developer Formycon. Meanwhile, Richter has underlined that following its recent investments in biosimilars, "we are committed to Biotechnology breaking even in 2027. And from then on, we have good reason to hope that this can be a profit-generating business unit which can stand on its own two feet and will be financially viable on its own."... Global Sub. Full

Roche is Trying Again and Again in Alzheimer's. This Time, Early Data Are ‘Worth Watching'

(3/12, Max Gelman, Endpoints News) ...At a medical conference Saturday, Roche presented new Phase Ib/IIa data for high-dose trontinemab, an amyloid-targeting antibody. The results are very early: Roche had efficacy data from eight patients at an interim 12-week follow-up...The FDA on Monday also released revised draft guidance for early-stage Alzheimer's development, putting an added emphasis on surrogate biomarkers and boosting amyloid's overall case as reasonably likely to predict clinical benefit. Although Roche's data coming a couple days earlier was happenstance, it offered the first peek at an experimental drug that may be the first to take advantage of the revisions... Full

Eli Lilly Taps Amazon Pharmacy to Dispense its Prescription Medicines

(3/13, Beth Snyder Bulik, Endpoints News) ...Eli Lilly has struck a deal with Amazon Pharmacy to deliver its obesity, diabetes and migraine medicines directly to patients. Amazon will work through Lilly's recently launched LillyDirect telehealth platform. It's the first time Amazon's pharmacy business has worked directly with a drugmaker, establishing a new kind of direct relationship between the maker of a medication and the tech and retail giant...The Amazon deal is not an exclusive agreement, said Frank Cunningham, Lilly group VP of global value and access, and Lilly is continuing to evaluate other telehealth, pharmacy and service provider partners for LillyDirect... Full

Endo Intl's Par Pharma Recalls Treprostinil Injection For Silicone Particulates

(3/13, RTT News) ...Endo International plc announced that its operating company Par Pharmaceutical, Inc. is recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The recall, being conducted along with the U.S. Food and Drug Administration, is due to the potential for the presence of silicone particulates in the product solution... Full

Treating ADHD Patients With Medication Linked to Lower Risk of Death Overall, Study Finds

(3/12, Deidre McPhillips, CNN) ...People with attention-deficit/hyperactivity disorder are at increased risk for premature death and other adverse health outcomes, but a large study out of Sweden suggests that treating the disorder with medication can help reduce the overall mortality risk for patients...Experts say that the new report emphasizes the importance of timely ADHD diagnoses and adds important considerations for clinicians to discuss with patients who are deciding how to manage their ADHD. In the United States, it also adds urgency to address the shortage of Adderall and other stimulant drugs used that has been ongoing since October 2022... Full

AION Labs Launches CombinAble.AI to Reduce Time and Cost of Targeted Antibody Design, Advancing Optimization of Drug Development

(3/12, AION Labs) ...AION Labs, the first-of-its-kind venture studio spearheading the adoption of AI technologies and computational science to solve therapeutic challenges, announced today the launch of CombinAble.AI. The new startup has been created to address the challenges associated with antibody design in order to enhance and accelerate the development of more effective therapeutics... Full

Provell Pharmaceuticals and Mark Cuban Cost Plus Drug Company Bring Leading Hypothyroid Drug, Euthyrox®, to U.S. Patients at Low-Cost Prices through Direct-to-Consumer Model

(3/12, Provell Pharmaceuticals) ..."Our mission is to remove the cost barrier for millions of Americans, regardless of insurance coverage, who need quality medications but who often cannot afford them due to markups imposed by a variety of players in the U.S. healthcare landscape," said Steve Hodge, CEO at Provell Pharmaceuticals. "By working directly with online platforms such as Cost Plus Drugs, which shares our vision to make drugs affordable and accessible to all, we are disrupting the traditional model and conferring significant savings to patients."... Full

Biden's Silence On PBMs In SOTU, Budget Spurs Lobbying

(3/12, Luke Zarzecki, InsideHealthPolicy) ...A March 12 newsletter from the Biotechnology Innovation Organization says "it appears the administration is unwilling to take meaningful action" on PBMs driving up drug costs. And chain drug store representatives from 50 states plan will blanket Capitol Hill this week to urge action on bipartisan PBM reforms that were left out of the mini-bus spending package enacted this weekend...The push for action comes as the National Community Pharmacists Association warned that one-third of independent pharmacies could close this year if PBM billing practices aren't reined in... Sub. Req'd

Biden Plan Would Axe Interchangeable Status for Biosimilars

(3/12, Phil Taylor, Pharma Phorum) ...The White House goes on to say that the making all biosimilars interchangeable would make the regulation of these products "more consistent with current scientific understanding as well as with the approach adopted by other major regulatory jurisdictions such as the [EU] where biosimilars are interchangeable with their respective reference products upon approval." The aim is to encourage greater use of biosimilars, which tend to be lower-priced than the original brand, in the US market... Full

Biden Calls On ‘All Sectors' To Help Address Opioid Abuse Crisis

(3/13, Dorothy Mills-Gregg, InsideHealthPolicy) ...The White House is issuing a challenge for other sectors to join the fight against opioids, building on several years of efforts by health care agencies to stem the crisis through myriad actions, including switching the naloxone overdose prevention drug to over the counter and making it more widely available... Sub. Req'd

Biden Administration Announces Focus On ‘Flooding the Zone' With Life-Saving Overdose Reversal Medicine

(3/13, Jen Christensen, CNN) ...The Biden administration launched an initiative Wednesday that it describes as a nationwide call to increase training on and access to life-saving opioid overdose reversal medications, dubbed the Challenge to Save Lives from Overdose...White House Domestic Policy Adviser Neera Tanden said in a briefing Tuesday that the overdose crisis is a "top priority" for the Biden administration, which has invested more than $100 billion to disrupt the flow of illicit drugs and expand access to drug treatment... Full

NJ Judge Shows Skepticism Of Claims Against IRA Implementation

(3/12, Gabrielle Wanneh, InsideHealthPolicy) ...A New Jersey district court judge showed signs that he, like other judges before him, may also be skeptical of drug industry allegations that the new Medicare drug price negotiation program is unconstitutional -- whether it be allegations that it compels drug makers to agree to negotiate lower prices for their products or permits the government to take manufacturers' private, patented drugs without providing just compensation -- as four drug makers presented oral arguments before the district court on March 7... Sub. Req'd

Becerra to Stakeholders: It's Time to Take Accountability for Cybersecurity

(3/12, Noah Tong, Fierce Healthcare) ...Cybersecurity concerns sucked up much of the air in the room during President Joe Biden's proposed 2025 fiscal year budget briefing amid the ongoing Change Healthcare cyberattack drama. Department of Health and Human Services officials said Monday the new budget invests $141 million for cybersecurity initiatives, including $12 million to the department's internal agency, the Administration for Strategic Preparedness and Response... Full

McKesson Whistleblower's Kickback Lawsuit is Revived

(3/12, Jonathan Stempel, Reuters) ...A federal appeals court on Tuesday revived a lawsuit by a whistleblower who accused McKesson of providing drug pricing tools to doctors for free, to induce them to buy drugs from the company. The 3-0 decision by the 2nd U.S. Circuit Court of Appeals in Manhattan restored state law claims by Adam Hart, a former McKesson business development executive, over tools to help oncologists increase profit margins for prescribed cancer drugs... Full

FDA Wants $7.2B for Product Safety, Public Health in Biden's FY 2025 Budget

(3/12, Jeff Craven, Regulatory Focus) ...FDA's request includes $3.5 billion in user fees as well as $157 million for a host of initiatives and programs, including medical product safety, public health and mission support, infrastructure modernization, and other modernization efforts. It also contains a list of legislative proposals the agency says will help facilitate competition, support innovation, enhance safety, address product shortages, and provide other services... Full

US FDA Looks To Re-Establish African Foreign Office, Add Brazil Post

(3/12, Derrick Gingery, Pink Sheet) ...As Congress pressures the US Food and Drug Administration to increase foreign inspections, the agency is offering plans to reestablish its presence in Africa, as well as add another South American post. A new foreign office is planned for Kigali, Rwanda, Kimberlee Trzeciak, FDA deputy commissioner for policy, legislation and international affairs, said. The city is the home for the new African Medicines Agency. Another new office is slated for Brasília, the capital of Brazil. And the FDA is hoping to add more personnel to its existing office in New Delhi, India... Sub. Req'd

Drug Lobby Dealt Setback Over Arkansas Contract Pharmacy Law

(3/12, Nyah Phengsitthy, Bloomberg Law) ...An Arkansas law prohibiting drugmakers from refusing to supply discounted drugs to certain pharmacies is constitutional, a federal appeals court ruled Tuesday...PhRMA still believes Arkansas's 340B provision is preempted and disagreed with the appeals court's decision... Full

Pharma Dealt a Loss Over Drug Discount Program

(3/13, Adriel Bettelheim, Axios) ...The decision from the 8th U.S. Circuit Court of Appeals could encourage look-alike state laws that take aim at restrictions on when providers can use discounts from the 340B program...The dispute centered on contract pharmacies that dispense discounted drugs to hospitals, community health centers and other safety net providers covered by the program... Full

Ozempic, Other Drugs Selected for Maryland Pricing Review

(3/12, Celine Castronuovo, Bloomberg Law) ...Maryland's prescription drug affordability review board is looking at whether to set health plan payment limits for the blockbuster diabetes drug Ozempic, along with other products from companies that have sued the Biden administration over Medicare price negotiations...The other drugs on the list are Gilead Sciences, Inc.‘s HIV treatment Biktarvy, the injectible asthma drug Dupixent from Regeneron Pharmaceuticals, Inc., AbbVie Inc.‘s Skyrizi for Crohn's disease and other conditions, Eli Lilly & Co.‘s type 2 diabetes drug Trulicity, and the ADHD drug Vyvanse from Takeda Pharmaceuticals... Sub. Req'd

Senate Democrats Support Bill They Say Will Make Prescription Drugs More Affordable

(3/12, Hudson Kamphausen, CT News Junkie) ...In the face of rising prescription drug prices in the state, Senate Democratic leaders again laid out their plan to help mitigate those costs Tuesday during a news conference at the Legislative Office Building. Senate Bill 8, which is currently before the Human Services Committee, includes several provisions that would presumably improve access to more affordable prescription drugs for Connecticut residents. Pharmacists, however, are opposed to the legislation... Full

Utah at the Forefront of America's Alarming Prescription Drug Shortages

(3/11, Emma Pitts, Deseret News) ...As many as 70% of American adults are taking at least one prescription drug a day, a 14% increase from 2019, according to a new report from Help Advisor. Medication to treat anxiety and depression has skyrocketed following the pandemic. The report found that more than 30 million Americans — 1 in 8 individuals — are facing a prescription shortage, and the severity of shortages varies by state... Full

UK, US & Canada Regulators Explain Why Decentralized Trials May Get A Closer Look

(3/12, Vibha Sharma, Pink Sheet) ...While the use of decentralized elements in clinical trials is gaining momentum, a common refrain by sponsors wanting to experiment with new approaches on this front is that regulators tend to review such studies more aggressively than traditional trials conducted at investigative sites..."We don't really treat them any differently," but DCTs are of special interest to regulators because they are "new" and "exciting" and represent "a different way of working," said Jason Wakelin-Smith, expert GCP inspector and head of the Compliance Expert Circle at the UK Medicines and Healthcare products Regulatory Agency... Sub. Req'd

EU's DARWIN Project To Expand Geographical Reach With 10 New Data Partners

(3/12, Eliza Slawther, Pink Sheet) ...The EU DARWIN initiative is expected to deliver more than 70 real-world data studies this year and twice this figure from 2025 onwards to enhance European decisions on medicines. The European Medicines Agency is selecting 10 new data partners to join the DARWIN EU initiative in the coming months to increase the "geographical coverage" of the project, an agency spokesperson told the Pink Sheet... Sub. Req'd

Super Generics: Market Trends In Europe

(3/12, Sabyasachi Ghosh and Arun Kumar Gautam, Future Market Insights, Pharmaceutical Online) ...According to new market research from Future Market Insights, the super generics industry in Europe is predicted to surpass $14.2 billion by 2033, expanding at a 2.0% CAGR. Super generics outperform traditional generic models and are an influential force in the European pharmaceutical industry. The rising consumer awareness of super generic drugs, the prevalence of chronic diseases, and expanding geriatric populations contribute to this industry's expansion. The European Medicines Agency and other regulatory organizations play a critical role in driving the expansion of the super generics industry... Full

UK Competition Watchdog Attacks Tribunal As Hydrocortisone Fines Overturned

(3/12, David Wallace, Pink Sheet) ...UK competition watchdog the CMA says it will be appealing against a tribunal decision that has overturned nearly £100m of fines imposed over anti-competitive deals around hydrocortisone, based on what the CMA criticized as a "fundamentally misconceived procedural point" linked to the cross-examination of witnesses... Sub. Req'd

Panel to Review Prices of Drugs, Medical Devices

(3/13, Teena Thacker, The Economic Times) ...The government has constituted a panel to reform the pricing framework for drugs and medical devices. The committee will evaluate the availability and pricing of essential medicines, balance price and availability, and consider institutional reforms within the NPPA. It will also design a price moderation framework for medical devices and minimize imports... Full

Govt Move to Review Drug Pricing Mechanism Triggers Concern as Pharma Industry Invited to Join Panel

(3/12, Sumi Sukanya Dutta, ThePrint) ..."The idea behind introducing a pricing mechanism for drugs has been to raise affordability and access to medicines, but the way this committee has been constituted is a testament to the growing influence of the industry on policymaking and on crucial issues such as drug pricing," Malini Aisola, co-convenor of All India Drug Action Network, told ThePrint...Pharma industry representatives ThePrint spoke to hope that the review will allow the government to look at issues around drug pricing in a "holistic manner". "There are several issues that the industry has been raising over the past several years. I am glad the government has taken a step in the right direction," IPA secretary general Sudarshan Jain... Full

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