Monday, July 22, 2024

Fremanezumab Effective in Preventing Pediatric Episodic Migraine

(7/19, Diana Ernst, Rph, MPR) ..."The study outcome is excellent news in light of the unmet need for effective preventive therapies for children and adolescents living with migraine who are greatly impacted by this debilitating disease," said Eric A. Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, at Teva Pharmaceuticals. "The SPACE data supports our ambitions to bring the proven benefits of Ajovy to children and adolescent patients who have fewer treatment options available to them."... Full

STADA and Alvotech Launch Uzpruvo, The First Approved Ustekinumab Biosimilar to Stelara, Across Europe

(7/2, STADA and Alvotech) ...STADA and Alvotech have launched Uzpruvo®, the first approved biosimilar to Stelara® in Europe, across a majority of European countries. This includes the largest markets in the region, where pricing and reimbursement approvals have been secured for market entry. The pioneering launch comes immediately upon expiry of exclusivity rights linked to the European reference molecule patent, offering patients, physicians and payers expanded access at the earliest possible opportunity to a life-altering medicine used in certain indications within gastroenterology1, dermatology and rheumatology. Launches in further European countries are scheduled over the coming months, following national price approvals, via a fully European supply chain... Full

Amneal Launches Polysorbate-Free Fosaprepitant In The US

(7/19, Adam Zamecnik, Generics Bulletin) ...According to Amneal's vice president of biosimilars and branded oncology Sean McGowan, Focinvez's launch marks a further step in the company's complex product strategy. "This is the second ready-to-use injectable we have launched this year that offers hospitals and oncology clinics a new presentation format that can improve pharmacy efficiency," McGowan said. "These new 505(b)(2) injectables represent a new vector of growth for our expanding injectables portfolio."... Global Sub. Full

EMA Accepts Richter's MAAs for Biosimilar Denosumab

(7/19, The Pharma Letter) ...Hungary's largest drugmaker Gedeon Richter today announced that the European Medicines Agency has accepted the company's two marketing authorization applications for its proposed biosimilar to denosumab... Sub. Req’d

Eli Lilly's Weight Loss Drug Tirzepatide Gets Approval in China

(7/19, Andrew Silver, Reuters) ...Eli Lilly said in a social media post Friday its weight loss drug tirzepatide had received approval from Chinese regulators, further intensifying competition with its Danish rival Novo Nordisk in the key Asian market... Full

Zydus Gets Final Approval from US FDA for Type 2 Diabetes Pills

(7/20, IANS) ...Indian pharma company Zydus Lifesciences on Friday said that it has received final approval from the US Food and Drug Administration to market tablets for Type 2 diabetes. The drugmaker said it got "approval for its New Drug Application to market Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets"... Full

Alembic Receives Tentative OK from FDA for Generic Uptravi

(7/19, Sandra Levy, Drug Store News) ...Alembic has received tentative approval from the Food and Drug Administration for selexipag for injection, 1,800 mcg per vial, which is the generic of Actelion's Uptravi...Alembic may be eligible for 180 days of generic marketing exclusivity in the United States, upon approval... Full

Sanofi Initiates Voluntary Recall of Allegra, Combiflam Suspensions Due to Contamination in Some Batches

(7/22, ANI) ...French multinational pharma company Sanofi has issued a circular to all pharma distributors, hospitals and retailers in the Indian market regarding a "temporary halt" of sales of its Allegra Suspension syrup (Fexofenadine Hydrochloride Suspension) and Combiflam Suspension (Ibuprofen and Paracetamol Suspension)... Full

Impax Sues to Stop Reddy's From Selling Generic Parkinson's Drug

(7/19, Lauren Castle, Bloomberg Law) ...Impax Laboratories LLC filed a lawsuit against Dr. Reddy's Laboratories Ltd. and its American unit to stop the sale of a generic medication for Parkinson's disease. Dr. Reddy's, an Indian drugmaker, submitted an abbreviated new drug application to the US Food and Drug Administration to sell a similar drug as Rytary , according to a complaint filed Thursday in the US District Court for the District of New Jersey. California-based Impaxsaid manufacturing and importing the generic would infringe US Patent Nos. 8,557,283; 9,089,608; 9,463,246; 9,533,046 and 9,901,640... Sub. Req’d

Pharma Companies Report Different Impacts from IT Outrage Caused by CrowdStrike, Microsoft

(7/19, Angus Liu, Fierce Pharma) ...While the national IT outrage caused by cybersecurity specialist CrowdStrike—and subsequently Microsoft—has grounded airlines and forced cancelations at hospitals, the experience from the meltdown appeared different among large pharma companies. About 5% to 10% of individual computers at Biogen have been impacted by the CrowdStrike issue, but the Big Biotech has "not identified any business continuity concerns," a company spokesperson told Fierce Pharma... Full

A Discontinued Asthma Medication Has Patients Scrambling, Some to the ER

(7/22, Alan Yu, NPR) ...The reasons GSK stopped making Flovent and why alternatives weren't covered are complex. Pharmacy benefit managers, middlemen that decide what medications insurance plans will pay for, decided not to cover generic asthma medications that could have worked as alternatives... Full

Biosimilars in America: Overcoming Barriers and Maximizing Impact

(7/21, Skylar Jeremias, The Center For Biosimilars) ...On today's episode, we'll dive deep into the US biosimilars market landscape, a topic of growing importance as biosimilars offer significant potential for reducing health care costs and increasing access to life-saving therapies...Today, we're joined by Kyle Noonan, PharmD, MS, is a highly qualified expert who supports scientific and commercial consulting engagements at Cencora, helping manufacturers demonstrate the clinical and economic value of their products... Full

Real-World Study: No Increase in Health Resource Costs After Infliximab Biosimilar Introduction

(7/20, Deana Ferreri, PhD, The Center For Biosimilars) ...Although biosimilars reduce drug purchasing costs for hospitals, it's unclear whether those savings might be offset by increased health resource utilization following a non-medical switching initiative, according to the authors of a study of the introduction of the infliximab biosimilar CT-P13 in a single hospital in Switzerland. They found no differences in outpatient costs, inpatient costs, and length of hospital stays associated with introduction of the biosimilar... Full

Harris Enters Presidential Race With Health Record That Includes ‘MA For All' Option, Pharma Lawsuits, Abortion Advocacy

(7/21, Jessica Karins, InsideHealthPolicy) ...Vice President Kamala Harris, endorsed by President Joe Biden Sunday (July 21) to take his place at the top of the Democratic ticket, has spotlighted health care policies like abortion access, health equity and telemedicine while in the White House. But in her 2019 run for president, she clashed with Biden on health care reform, pushing a plan that would have introduced a public option for health insurance and a tightly regulated insurance market similar to Medicare Advantage... Sub. Req’d

Where 3 Democrats Who Could Replace Biden Atop the Ticket Stand On Health Care

(7/21, John Wilkerson and Rachel Cohrs Zhang, STAT) ...Delegates are set to vote in just a few weeks at the convention, and could even vote earlier. There are a few names that have reliably surfaced as potential replacements in addition to Harris, including California Gov. Gavin Newsom, and Michigan Gov. Gretchen Whitmer. But Newsom on Sunday evening endorsed Harris as the party's nominee. STAT reviewed each of these potential candidates' records on health care. With experience in the Senate and White House for Harris, and as governors of states grappling with health care challenges for Newsom and Whitmer, there is no shortage of history to examine... Full

Issa, Johnson Introduce Landmark Reform to Advance Innovation, Enhance Patient Access, Increase Prescription Affordability

(7/19, Congressman Darrell Issa) ...Congressman Darrell Issa (CA-48), Chairman of the House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet, and Subcommittee Ranking Member Hank Johnson (GA-04) have introduced the Affordable Prescriptions for Patients Act – new legislation to address prescription drug costs borne by patients through amending the patent code and increasing competition in the market... Full

House Oversight PBM Hearing Comes As Comer Probes FTC, HHS On Post-Chevron Authority

(7/19, Gabrielle Wanneh, InsideHealthPolicy) ...The House Oversight & Accountability Committee on Tuesday (July 23) will hold a third hearing spotlighting pharmacy benefit managers' role in unaffordable prescription drug costs, coming as committee Chair James Comer (R-KY) separately presses the Federal Trade Commission and HHS to pinpoint areas where they may have a hard time regulating now that the Supreme Court has axed its Chevron principle of letting agencies interpret vague laws. Both agencies have struggled to rein in PBM practices and may face new hurdles post-Chevron, which could hike pressure on Congress to move on prescriptive PBM reforms... Sub. Req’d

How FTC's Battle With PBMs Could Reshape The Pharmaceutical Industry

(7/20, Rita Numerof, Forbes) ...The investigation, its outcomes and implications are yet to come. It could lead to stricter regulations that better prevent anticompetitive practices and ensure greater transparency in PBM operations. It may also lead to a reexamination of the vertical integration of PBMs, health insurers, distribution, and increasingly providers. Policymakers may consider ways to separate these entities or impose safeguards specifically designed to prevent such behemoths from engaging in anticompetitive behavior. Whatever the approach, this investigation is a needed reminder that competition must be restored across the healthcare ecosystem at large, not just the PBM market... Full

The FTC's Incomplete PBM Report Falls Short

(7/19, John M. Yun, RealClearPolicy) ...The bottom-line is that there is strong evidence that the leadership of the FTC put the cart before the horse. They ignored the agency's prior report on PBMs (which reached very different conclusions); published a report without the requisite data, analysis, or evidence (despite its subpoena power); condemned both vertical integration and dis-integration; and disregarded parts of the report that indicate PBMs lower costs and are being challenged by new entrants. We should expect more from our government... Full

Six Straight Quarters of Drug Shortages

(7/22, Tina Reed, Axios) ...The number of active drug shortages fell to 300 in the second quarter of this year after hitting an all-time high of 323, according to a tracker from the American Society of Health-System Pharmacists...It's the sixth straight quarter with at least 300 drugs on shortage, many of them critical to patient outcomes, the pharmacists' group said... Full

Drug Shortages Dip Slightly

(7/19, Lauren Gardner and David Lim, Politico) ...The decrease occurred over multiple drug categories on the tracker maintained by the American Society of Health-System Pharmacists. But the number of active shortages remains historically high despite the FDA's efforts to mitigate short supplies of critical medications for cancer and attention deficit hyperactivity disorder. "Until we see a longer trend, I think it's too soon to really make any assumptions," said Michael Ganio, ASHP senior director of pharmacy practice and quality... Full

Economic, Contracting Decisions Drive Oncology Drug Shortages

(7/19, Alana Hippensteele, Pharmacy Times) ...Although there was an acute oncology drug shortage in 2023, drug shortages in oncology have been occurring for approximately 10 to 15 years, Julie R. Gralow, MD, FACP, FASCO, chief medical officer and executive vice president for the American Society of Clinical Oncology (ASCO), explained during a panel discussion at the 2024 ASCO Annual Meeting. Further, the panelists explained that although many shortages may result from a single bottleneck that occurs because of the brittleness of the supply chain, they are economic in nature overall... Full

Off-Patent Group Trio Aims To Secure Transatlantic Drug Supply

(7/19, Urte Fultinaviciute, Generics Bulletin) ...Off-patent groups representing the US, Canada, and European Union have come together to form a transatlantic partnership, with the aim of strengthening the supply chain of generics and biosimilars between the three regions...An initiative that focuses on a transatlantic market could "leverage the strength of each market to enhance the health security of the three regions," by encouraging the "exchange of analyses, information and ongoing thinking, as well as foster collaboration regarding needed investment in R&D, capacity expansion, manufacturing and sustainable market policies."... Global Sub. Full

Top FDA Staff Are Pushing Review Teams To Be Comfortable With Regulatory Flexibility

(7/19, Sarah Karlin-Smith, Pink Sheet) ...Senior leadership in the FDA's drugs, biologics and devices centers want reviewers to feel more comfortable taking risks in product approvals, but may need more concrete examples of regulatory flexibility's success to convince them... Sub. Req’d

Small Pharmacy Closures Spur Statehouse Battles On PBM Practices

(7/22, Celine Castronuovo, Bloomberg Law) ...In 2024 state legislative sessions, lawmakers introduced more than 170 bills in 41 states seeking to regulate the entities that manage prescription drug benefits, according to the National Academy for State Health Policy. The top three PBMs—CVS Caremark, Cigna's Express Scripts, and UnitedHealth Group's OptumRx—control nearly 80% of the market. Groups representing small, independent pharmacies and chains unaffiliated with PBMs have focused their advocacy on PBM practices they say put the most financial pressure on pharmacists: low reimbursement rates, charging health plans more than they pay back to pharmacies in a practice known as spread pricing, and pushing patients toward large pharmacy chains affiliated with PBMs... Full

Vermont Attorney General Sues Two Major PBMs for Allegedly Driving Up Costs

(7/19, Max Bayer, Endpoints News) ...The lawsuit includes more than two dozen defendants, most of which are subsidiaries of PBM powerhouses CVS Health and Cigna-owned Express Scripts. The lawsuit does not include Optum Rx, the other major PBM owned by UnitedHealth Group, noting that the two named in the complaint control about 95% of the PBM market in Vermont. The suit argues that PBMs have too much control over the distribution of drugs in the state and are limiting access... Full

EU Commission Sets Out Plans For New Life Sciences Strategy

(7/19, Ian Schofield, Pink Sheet) ...The EU is planning to establish a new Biotech Act as part of a life sciences strategy that will help to boost European competitiveness in this sector, according to a set of "political guidelines" presented on July 18, by Ursula von der Leyen, the newly re-elected president of the European Commission. Von der Leyen also confirmed that the commission will next year propose a "Critical Medicines Act" as part of the drive to tackle the growing number of drug shortages, which will include measures to reduce the EU's reliance on overseas suppliers of medicines and ingredients... Sub. Req’d

European Commission President's Second-Term Pledge: Simpler Regulations, Better Funding and Tackling Shortages

(7/19, Ayisha Sharma, Endpoints News) ...Ursula von der Leyen won a second term as president of the European Commission on Thursday, with 401 votes in favor from a total of 719 in the European Parliament...One of her key promises is the new European Biotech Act for 2025. The legislation would aim to make it easier to bring biotechs to the market and will do so, in part, by smoothing the EU's complex regulatory processes, although details are yet to be spelled out. The new act will be part of the EU's broader Strategy for European Life Sciences, which will also allow for more public-private partnerships and boost collaboration between academia and businesses... Full

EU Antitrust Regulators Accept Vifor Pharma's Pledge Not to Disparage Rival

(7/22, Foo Yun Chee, Reuters) ...EU antitrust regulators on Monday accepted Australian group CSL unit Vifor Pharma's concessions to address potential anti-competitive behaviour towards a rival iron deficiency treatment medicine...Vifor will "launch a comprehensive and multi-channel communication campaign to rectify and undo the effects of the potentially misleading messages previously disseminated by Vifor regarding the safety of Monofer", the EU competition enforcer said... Full

Parexel Execs On Regulatory Harmonization, AI Impact, RWE Challenges

(7/22, Vibha Ravi, Pink Sheet) ...The Pink Sheet regularly speaks to industry stakeholders on such issues and recently sat down with executives at Parexel International Corp., a major global provider of biopharma services including contract research, to understand their views on global regulatory harmonization, collaborative initiatives like the EU Melloddy project, moves to improve clinical trial diversity and tackle imperfections of real-world data and trial design support for reimbursement decisions in the US... Sub. Req’d

Pharma MNCs Seek Relief from Price Control for Patented Drugs

(7/22, Teena Thacker, The Economic Times) ...The Organisation of Pharmaceutical Producers of India (OPPI), which represents prominent multinational pharma companies, has sought exemption for patented and orphan drugs from the government-set price controls, people in the know told ET. It has asked the government to do away with the existing practice of 50% price cuts upon patent expiry, arguing that the government's price-setting provisions will stymie innovation... Full

Number of Overcharging Cases and Demand Raised by NPPA Declines in 2023-24

(7/22, Pharmabiz.com) ...The number of cases initiated by NPPA against price regulation violations has declined to 95 in 2023-24, as compared to 148 in the previous fiscal year. The overcharged amount demanded including interest, during the year was a meagre Rs. 46.33 crore as compared to Rs. 141.81 crore demand with interest, in the previous fiscal year, according to data from the NPPA. However, the total amount realised during the year has seen a significant jump to Rs. 72.73 crore, which is a four-year high (starting from 2020-21), as compared to a meagre Rs. 5.10 crore in the previous fiscal year... Full

Pharma Sector Gears Up for Budget 2024-25; Calls for Innovation and Regulatory Reforms

(7/22, Express Pharma) ...Just a day before the union budget 2024-25 announcement, experts in pharma sector are united in their call for regulatory reforms, fiscal incentives, and enhanced innovation support... Full

Next Leg of Pharma Sector Growth Necessitates Skill Advancement, Innovation: Eco Survey

(7/22, Press Trust Of India) ...The domestic pharmaceutical industry needs skill advancement, innovation and a strong supply chain with the segment size expected to touch USD 130 billion by 2030, said Economic Survey 2023-24 tabled in Parliament on Monday. The Indian pharmaceutical market is currently valued at around USD 50 billion and is the world's third-largest by volume... Full

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