Monday, April 1, 2024

Teva, Launch Therapeutics Enter Clinical Collaboration Agreement

(4/1, The Fly) ...Teva and Launch Therapeutics announced a clinical collaboration agreement to further accelerate the clinical research program of Teva's ICS-SABA. Teva and Abingworth, part of global investment firm Carlyle, also announced a strategic development funding agreement in which Abingworth provides Teva up to $150M to offset Teva's ICS/SABA program costs...If TEV-'248 receives U.S. FDA regulatory approval, Abingworth will be eligible to receive fixed payments as well as success payments based on ICS/SABA sales... Full

In the Healthcare Industry, Diversity is Crucial to Serve Patients Better, Says Teva VP

(3/31, The Jerusalem Post) ...During its third Women Leaders Summit, The Jerusalem Post highlighted women who are leading the way toward our nation's future amidst the backdrop of the October 7 tragedy and the ongoing Israel-Hamas conflict. [Amalia Adler-Waxman, Senior Vice President, Global Head of Sustainability and Head of Corporate Affairs of International Markets at Teva]...When awful events like this happen, we want to act right away—and that's exactly what Teva did in the immediate aftermath of October 7. We met a 300% increase in demand for medicines, supported our employees and cared for our communities. Then, when we were able to take a step back and see the situation from a broader perspective, we thought about the needs that were most relevant to Teva's unique expertise and that Teva is best suited to help address... Full

Women Leaders Reflect On the Tragedy of October 7 and the Path Forward at WLS Conference

(4/1, The Jerusalem Post) ...Amalia Adler-Waxman said that Teva launched the "Support the Soul" program designed to help Israelis heal and restore normalcy and optimism following October 7th, through training and supporting professional caregivers, strengthening resilience centers, implementing technology for the use of trauma treatment, and triggering professional and public awareness. "My call to action," she said, "aims at stakeholders that can help join the cause of treating Trauma in Israel to join and help us make a difference that will go a long way in our journey of healing."... Full

Teva, Following Hikma Complaint, Alleges Amarin 'Locked Up' Vascepa Ingredient to Block Generics

(3/29, Fraiser Kansteiner, Fierce Pharma) ...In a lawsuit filed Thursday, Teva said Amarin has engaged in "anticompetitive conduct to prevent and delay generic competition" to Vascepa-a fish oil-derived heart med. Teva contends Amarin deliberately "locked up the supply" of Vascepa's active pharmaceutical ingredient, icosapent ethyl, "in excess of its own needs."...If not for Amarin's hoarding strategy, Teva claims it would have been able to launch its Vascepa generic much earlier than in late 2022 and with better availability. Teva's complaint follows similar accusations from generics giant Hikma, which last year accused Amarin of similar API purchasing arrangements... Full

Samsung Bioepis Launches Half-Priced Soliris Biosimilar

(4/1, Shim Woo-hyun, The Korea Herald) ...According to Samsung Bioepis, the price for a vial of Epysqli here has been decided at 2.5 million won, around half the price of Soliris, 5.1 million won. Samsung Bioepis anticipated that the price cut would increase the availability of one of the most expensive treatments. The amount of money an adult patient pays for Soliris is known to reach some 400 million won per year... Full

Aurobindo Pharma Commissions 4 Plants to Manufacture Penicillin-G and Injectable Products in Andhra Pradesh

(4/1, Financial Express) ...Aurobindo Pharma on Monday announced that it has commissioned four manufacturing facilities for Penicillin-G, 6-Amino Penicillanic Acid (6-APA), Injectable products and Granulation, through its wholly owned subsidiaries. According to a report by news agency PTI, Penicillin-G (Pen-G) facility, located in a SEZ at Kakinada in Andhra Pradesh, has a production capacity of 15,000 tonne per annum and also 1.8 lakh tonne of gulcose, while 6-Amino Penicillanic Acid plant has a capacity to produce 3,600 tonne annually... Full

USFDA Gives Nod to Alembic Pharma's Breast Cancer Drug

(41, Financial Express) ...The tentative approval by the US Food & Drug Administration was for Ribociclib tablets of strength 200 mg, Alembic Pharmaceuticals said in a regulatory filing...It is the generic equivalent of Novartis' Kisqali tablets, the filing added... Full

Biocon Gains After Receiving MHRA UK Approval for Liraglutide Injection

(4/1, Business Standard) ...Biocon rose 1.17% to Rs 267.20 after the company has received an approval from the Medicines and Healthcare Products Regulatory Agency, U.K., for its complex formulation Liraglutide (gSaxenda). The said approval has received through its European partner, Zentiva... Full

US CDC's Adult RSV Vaccine Recommendations In Flux With Impending FDA Approvals

(3/29, Bridget Silverman, Pink Sheet) ...CDC Advisory Committee on Immunization Practices is evaluating the experience of the first RSV season with approved vaccines as it re-evaluates its shared clinical decision-making recommendation for GSK's Arexvy and Pfizer's Abrysvo in adults ages 60 and older. ACIP expects its June meeting will see votes on a third vaccine for adults =60 years, Moderna's mRNA-1345, and a new use for GSK's Arexvy in adults ages 50-59 at increased risk. Moderna presented Phase II/III data, emphasizing its enrollment of high-risk and frail patients and an exploratory endpoint based on shortness of breath... Sub. Req'd

The CDC Is Squandering the Breakthrough RSV Vaccine

(3/29, Katherine J. Wu, The Atlantic) ...When a new RSV vaccine for pregnant people arrived last fall, Sarah Turner, a family-medicine physician at Lutheran Hospital, in Indiana, couldn't help but expect some pushback. At most, about half of her eligible pregnant patients opt to get a flu vaccine, she told me, and "very few" agree to the COVID shot. But to Turner's surprise, patients clamored for the RSV shot—some opting in even more eagerly than they did for Tdap, which protects newborns against pertussis and had previously been her easiest sell... Full

Data Supports Safety, Efficacy of Biosimilar-to-Biosimilar Switching

(3/29, Laura Joszt, MA, AJMC) ...With a growing pool of data, the evidence supports the practice of biosimilar-to-biosimilar switching with no safety concerns and similar efficacy, according to a piece from Hillel P. Cohen, PhD, and Wolfram Bodenmueller, PhD, of Sandoz... Full

The Need for Biosimilars in Inflammatory Diseases and Regulatory Requirements for Approval

(3/29, Jamie T. Brogan, MSN, APRN, FNP-BC, Kostas N. Botsoglou, MD, Jordan Axelrad, MD, MPH, et al., The Center For Biosimilars) ...Drs Lio, Botsoglou, and Axelrad discuss the need for biosimilars in inflammatory diseases, and clinical pharmacist Dr Humphreys reviews the regulatory requirements for biosimilars to receive FDA approval...Overall, the exchange emphasizes the significance of biosimilars in expanding access to effective treatments for inflammatory diseases while navigating regulatory complexities and cost considerations... Full

An Overview of Adalimumab Biosimilars

(3/29, Jamie T. Brogan, MSN, APRN, FNP-BC, Kostas N. Botsoglou, MD, Jordan Axelrad, MD, MPH, et al., The Center For Biosimilars) ...The discussion highlights the need for proactive patient communication and regulatory compliance to facilitate smooth transitions between reference and biosimilar products. Clinicians express willingness to embrace interchangeable biosimilars to reduce administrative burdens and ensure uninterrupted patient care, underscoring the importance of effective communication and documentation within healthcare systems... Full

A Conversation With Greg Baker, RPh, CEO of AffirmedRx

(3/31, Peter Wehrwein, Managed Healthcare Executive) ...We believe the market needs to start saying that there's no other procurement process where we don't get this level of data and we stay with a vendor. Yet, for some reason, we continue to do it in the PBM industry. If they're actually saving us all the money, then why can't they show us all the data to prove it? And if they're not, there are companies like AffirmedRx that will show you all the data and prove where those savings go — and the fact that we're not making money on you. It'll be interesting to see how that plays out... Full

More Specialty Drugs Cost Less with New Pharmacy's Addition to Tricare Home Delivery

(3/29, Amanda Miller, Military.com) ...Two pharmacies, Express Scripts and Accredo, are now part of Tricare Home Delivery. Defense Health Agency officials confirmed that some users will have mail-order prescriptions with both Express Scripts and Accredo if they have both non-specialty and specialty prescriptions...The new contract adding Accredo to Tricare Home Delivery began March 1. DHA officials told Military.com that it "reduces beneficiary cost by increasing the number of specialty drugs available at mail order co-pays" and that Accredo's "enhanced clinical services," beyond just filling the prescription, promote "positive clinical outcomes."... Full

4 Things You Need to Know About Health Care Cyberattacks

(3/29, Reed Abelson, Margot Sanger-Katz, The New York Times) ...The recent cyberattack on the billing and payment colossus Change Healthcare revealed just how serious the vulnerabilities are throughout the U.S. health care system, and alerted industry leaders and policymakers to the urgent need for better digital security...Cybersecurity consultants and government officials have consistently identified health care as the sector of the U.S. economy most susceptible to attacks, and as much a part of the nation's critical infrastructure as energy and water... Sub. Req'd

Pharmacy Middlemen Are Driving Up Costs for Respiratory Medicines — It's Time to Act

(3/31, Tonya Winders, The Hill) ...Although some legislators have investigated inhaler prices, the outsized role that PBMs play in driving up out-of-pocket costs for patients continues to fly under the radar. Manufacturers continue to step up and intervene, implementing various and robust savings programs to lower patient out-of-pocket costs, but their efforts alone won't bring true affordability change for patients living with respiratory illnesses without meaningful PBM reform... Full

House Republicans Use a Big Lie to Stand Up for Big Pharma

(3/31, Andrew Perez, Rolling Stone) ...The Republican Study Committee, which represents roughly 80 percent of House Republican lawmakers, accused President Joe Biden and congressional Democrats of embracing "socialist price controls that will limit access to life-saving drugs for those who desperately need them," by enacting a pilot program allowing Medicare to negotiate prices on a handful of medicines for the first time. The budget pledges to repeal the program — which Biden recently called on Congress to expand in his State of the Union address... Full

GLP-1 Generics Would Be Dramatically Cheaper Than U.S. Price of Ozempic, Study Shows, But Still Profitable

(3/29, Annalisa Merelli, STAT) ...The study, led by Melissa Barber, a Yale postdoctoral fellow, and conducted in collaboration with Doctors Without Borders, a nonprofit medical organization working in low-resource and emergency settings, found that making a generic vial of insulin could cost $61 to $111 per year — 97% less than than the current market price in the U.S., based on an estimate that factors in a 10% to 50% profit margin..."While we are unaware of the analysis used in the study, we have always recognized the need for continuous evaluation of innovation and affordability levers to support greater access of our products," said Jamie Bennett, Novo Nordisk's director of media relations... Full

Study: More Biosimilar Competition Is Not Lowering Patient OOP Costs

(3/29, Skylar Jeremias, The Center For Biosimilars) ...Increased biosimilar competition has not led to lower out-of-pocket costs for patients with commercial health insurance. There is a need for targeted policy interventions to ensure patients can benefit from biosimilar savings and have access to more affordable medications. Factors contributing to the lack of reduction in patient OOP costs include variations in insurance benefit designs, higher reimbursement rates by insurers for clinician-administered drugs, and limited competition in the biosimilar market affecting biologic prices... Full

Let's Get Drug Pricing Legislation Right and Deliver Real Savings to Americans

(4/1, JC Scott, RealClearHealth) ...With the recent agreement to fund the government through the end of the fiscal year and the decision not to include provisions targeting pharmacy benefit companies, there is an opportunity to think again before misguided legislation is advanced that would do nothing to lower prescription drug costs for patients. PCMA and the pharmacy benefit companies we represent want to use this time to continue engaging policymakers to make sure that policies that are advanced will address their concerns, while not increasing costs for patients or limiting choices for employers and other plan sponsors... Full

GUEST VIEW: Protect Patients, Eliminate Pill Penalty

(3/30, Dan Leonard, InsideSources.com) ...Penalizing small-molecule therapies won't just make treatment less convenient in the long term, it will also cost lives. The pill penalty will contribute to as many as 116 million life-years lost, according to a study from the University of Chicago. The EPIC Act provides a clear solution to the IRA's distortion in incentives. It would equalize the exemption period for small-molecule drugs and biologics at 13 years, eliminating the IRA's pill penalty and not allowing misguided policy to ultimately pick winners and losers in innovation... Full

FTC, HHS Extend Public Comment Period on Generic Drug Shortages and Competition Request for Information

(3/29, The Federal Trade Commission and the U.S. Department of Health and Human Services) ...The Federal Trade Commission and the U.S. Department of Health and Human Services are extending the deadline for the public to comment on a joint Request for Information that seeks to understand how the practices of group purchasing organizations and drug wholesalers may be contributing to generic drug shortages. The new deadline is now May 30, 2024... Full

Big Business Bristles at USTR Reporting Change On Trade

(3/29, Tobias Burns, The Hill) ...The U.S. trade representative is changing its definition of barriers to trade in its annual report on international trade estimates, throwing out concepts long cherished by the tech industry and drawing the ire of some of the biggest business lobbies in the U.S...The USTR says the change looks at barriers to trade with foreign countries more from the countries' own sovereign perspectives and less from the perspective of the U.S., which U.S. multinationals say is minimizing their voice... Full

FDA Shifts IND Safety Reporting Over to FAERS in Finalized Guidance

(3/29, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration has finalized guidance specifying that after April 1, 2026, sponsors will have to submit investigational new drug safety reports for serious and unexpected suspected adverse events to FDA's Adverse Event Reporting System. Currently, these reports are submitted in electronic common technical document (eCTD) format using PDF files... Full

GAO Calls On FDA To Speed Up Rulemaking On BA/BE Studies

(3/29, Jessica Karins, InsideHealthPolicy) ...Exemptions in FDA regulations for clinical studies seeking to establish bioavailability or bioequivalence of generic drugs should be closed so the agency can respond to problems uncovered in clinical research inspections, according to a report from the Government Accountability Office that notes FDA has pushed back a proposed rulemaking on the issue several times. The GAO report notes FDA classified only 3% of clinical research inspections conducted in 2018-2020 as having serious deficiencies that could warrant regulatory action... Sub. Req'd

Pharma Targets Colorado Drug Affordability Board

(3/29, David Lim and Lauren Gardner, Politico) ...Amgen, the maker of autoimmune drug Enbrel, sued Colorado's Prescription Drug Affordability Board last week after the agency decided the medication is "unaffordable" for the state's patients. The company's suit argues that the law underpinning the board's authority is unconstitutional, preempts federal patent law and undermines interstate commerce..."It is a limit on payment, not on drug prices," Hemi Tewarson, executive director of the National Academy for State Health Policy, said. "That's just a key distinction."... Full

NY Stands Firm On Overdose Reversal Drug, Despite Competitors' Pleas

(3/31, Raga Justin, Times Union) ...The push to crack open New York's longstanding contract with the Maryland-based pharmaceutical company Emergent Devices to provide Narcan — a brand version of the drug naloxone that can reverse overdoses caused by potent opioids — has heated up recently, with several top lobbying firms on retainer in Albany ahead of the contract's renewal date in August... Full

Gov. Youngkin Should Sign the Prescription Drug Affordability Board Bill

(4/1, Bill Standley, Cardinal News) ...I hope that Governor Youngkin will hear the voices of Virginians who overwhelmingly support this legislation, regardless of their partisan preferences. And it is my sincere hope that he will sign this legislation, which will send a clear message to Virginians struggling with high prescription drug costs that help is on the way... Full

Gov. Youngkin, Please Veto the Prescription Drug Affordability Board Legislation

(4/1, Harry Gewanter, Cardinal News) ...Don't get me wrong: We critically need action now to address the patient's cost - not just the price - of prescription drugs. I've spent decades treating and working on behalf of children with rare and chronic diseases. I've seen families struggle to afford the medicines their kids need. However, the board's stated goal is a complete misdiagnosis of the problem. It won't help families and has significant potential to even create harm... Full

Critics Say U.K. Decision On ALS Drug Could Have ‘Chilling Effect' On Access to New Genetic Medicines

(4/1, Andrew Joseph, STAT Plus) ...Advocates told STAT that, because of NICE's determination, Biogen officials have indicated to them that the company may not seek regulatory approval for tofersen in the U.K. Biogen declined to comment on its filing plans, but said that "we do not see a way forward for tofersen" under NICE's standard review process. "This decision has exposed grave concerns about whether the U.K. is committed to patients accessing genetically targeted medicines, particularly in rare and ultra rare conditions," a company spokesperson said... Sub. Req'd

American Pharma Major Eli Lilly's Big Focus On India: Will the Company's Strategy Work?

(3/31, Neetu Chandra Sharma, Business Today) ...David A. Ricks, Chair & CEO of Eli Lilly & Co., says the US parent is working with the Indian team to develop a plan. "Our overarching goal is to distribute our medicines globally, including in India, as swiftly as possible, recognising the urgency for individuals with chronic diseases (diabetes and obesity)," he says. "However, we face a significant constraint concerning supply chain capacity, as our systems were initially designed for a smaller market than what the obesity segment demands. We must devise a strategy that balances supply availability with market demand," says the CEO... Full

NPPA Revises Ceiling Prices of 923 Scheduled Drug Formulations from April 1

(3/31, Sanket Koul, Business Standard) ...The Department of Pharmaceuticals on Sunday issued its annual list of revised ceiling prices for 923 scheduled drug formulations and revised retail prices of 65 formulations. The revised ceiling rates are scheduled to come into effect from April 1. The revision in ceiling and retail prices comes after the National Pharmaceutical Pricing Authority announced a 0.00551 per cent increase in prices of drugs included in the National List of Essential Drugs, on the basis of changes in the wholesale price index... Full

Contract Manufacturing: Pharma's New Growth Pill

(4/1, P B Jayakumar, Fortune India) ...Aurigene Pharmaceutical services, a subsidiary of Dr Reddy's Laboratories, has lined up big expansion in biologics over next three years. As a start, it is developing a facility for making therapeutic proteins, antibodies and viral vectors (tools to deliver genetic material into cells) at Genome Valley, a biotech park in Hyderabad, to enter contract development and manufacturing of biotech drugs. ‘'It will be operational in first half of 2024. We will provide integrated services right from clinical research to commercial manufacturing for small and large molecules,'' says Akhil Ravi, CEO, Aurigene Pharmaceutical Services... Full

Israel Warns Ireland Over Calls to Break Trade Links

(3/31, Petula Martyn, RTE) ...Calls for Ireland to break trade links with Israel have been growing louder, as the conflict in the Middle East rages on. On the same day that UN Secretary-General Antonio Guterres described blocked relief trucks on Egypt's side of the Gaza border "a moral outrage", Labour leader Ivana Bacik told her party's conference: "Now is the time for Ireland to break diplomatic and trade links with Israel." A spokesperson for the Israeli embassy said: "Attempting to disrupt trade between our two democratic states does nothing to help to stop the conflict or promote calm but instead has the effect of stimulating further division while targeting uninvolved parties... Full

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