Friday, May 24, 2024
Please note: Teva Daily News will not publish Monday, May 27 in observance of the U.S. Memorial Day holiday. Publication will resume on Tuesday, May 28.
Top News
Stakeholders Seek Change To FDA's Generic Drug-Device Approach
(5/23, Jessica Karins, InsideHealthPolicy) ..."Complex generics remain complex," Andrew Graves, director of immunogenicity assessment at Teva Pharmaceuticals, said, although he added that research in the field has come a long way in the past few years. Graves recommended more efforts to standardize or harmonize metrics like assay sensitivity levels, which can apply to other drugs and help make investments worthwhile...Brandon Wood, director of regulatory affairs for generic sterile drugs at Teva, also recommended that FDA change its approach to human factors studies, which sponsors of generic drug-device products are required to conduct when the generic's design is different from the reference product in ways FDA believes could impact patients... Sub. Req'd
FDA: New Logic Model Sets Structured Approach to REMS Development
(5/23, Joanne S. Eglovitch, Regulatory Focus) ...Brian Malkin, the associate general counsel for regulatory law at Teva said the model puts into one place a set of best practices for developing a REMS. "If you are a start-up company and you have never done a REMS, you have a lot of learning to do, this is a good starting place for that."... Full
Teva Malta Ramps Up Investment in Clean Energy with Major Photovoltaic Systems Installation
(5/24, Malta Independent) ...In a significant move towards sustainability and renewable energy, Teva Malta announced the installation of two state-of-the-art Photovoltaic systems with a combined peak power of 631kWp at its plant in Bulebel. This initiative, which is part of Teva's global strategy to shift away from fossil fuels and embrace renewable energy sources, was undertaken at local level in partnership with Alternative Technologies Ltd, SunPower premier partners for the Maltese Islands, and Photonika Ltd...Patrick Cachia, Managing Director of Teva Malta, stated: "The completion of these photovoltaic systems installations marks a significant milestone in our journey towards sustainability."... Full
Barclays Reiterates Overweight Rating On Teva Pharma (TEVA)
(5/23, StreetInsider.com) ...Barclays analyst Balaji Prasad reiterated an Overweight rating and $20.00 price target on Teva Pharma. The analyst commented, "Positive read-through for TEVA incl. ALVO's Simlandi-led rev guidance raise -supported by POs placed for 1Mn+ units for '24; Strong commercial traction w/Evernorth agreement & expectations for broad formulary access by July 1. We expect this improved Simlandi outlook to translate to at least a $50M boost to TEVA's topline."... Sub. Req'd
ADHD Diagnoses Increasing, Becoming An 'Expanding Public Health Concern': CDC
(5/23, Jonathan Block, Seeking Alpha) ...Some of the most frequently prescribed ADHD medications are Johnson & Johnson's Concerta (methylphenidate), Takeda Pharmaceutical's Vyvanse (lisdexamfetamine), Novartis' Ritalin LA (methylphenidate), and Teva Pharmacueutical's Adderall (mixed amphetamine salts). Teva is also a major manufacturer of generic versions of ADHD drugs. The U.S. has been dealing with a shortage of ADHD medications since 2022. While a shortage of Adderall ended earlier this month, Teva noted, "We continue to see unprecedented demand."... Full
Industry News
Biocon Crosses $1Bn Threshold In Biosimilars Revenue
(5/23, Adam Zamecnik, Generics Bulletin) ...The Indian business crossed a major threshold as its biosimilars division earned over $1bn in revenue in the 2024 fiscal year, while also facing analyst skepticism over the performance of its other businesses...Looking at the segmental revenue contributions of the three businesses, Biocon's biosimilars division contributed 58% while its research services earned 23% of the share and the generics branch made up 19%... Global Sub. Full
Biocon Surges After Signing Exclusive Licensing Deal for Liraglutide with Handok
(5/24, Business Standard) ...Biocon jumped 4.19% to Rs 328.55 after the company announced the signing of an exclusive licensing and supply agreement with South Korea-based Handok for the commercialization of its vertically integrated & complex drug product Synthetic Liraglutide... Full
EC Approves Celltrion's Omlyclo for Allergic Conditions
(5/24, Pharmaceutical Technology) ...The European Commission has approved Celltrion's Omlyclo (CT-P39) – the first and only omalizumab biosimilar for reference product Xolair to be authorised in Europe to treat allergic conditions...Omlyclo represents the sixth biosimilar from Celltrion's portfolio to receive approval for use in the EU, joining the ranks of other approved biosimilars such as Herzuma (trastuzumab), Remsima (infliximab), Remsima SC (subcutaneous infliximab), Truxima (rituximab), Vegzelma (bevacizumab)and Yuflyma (adalimumab)... Full
European Medicines Agency (EMA) Validates Henlius and Organon Filings for Prolia® and Xgeva® (Denosumab) Biosimilar Candidate HLX14
(5/24, Organon) ...Shanghai Henlius Biotech, Inc. and Organon today announced that the European Medicines Agency has validated the marketing authorization applications for HLX14, an investigational Prolia® and Xgeva® (denosumab) biosimilar. Denosumab has been approved in various countries and regions under different trade names for a range of different indications such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others. In 2019, it was estimated that 32 million Europeans ages 50 or above had osteoporosis, 25.5 million of which were women... Full
Taro Shareholders Approve Merger with Sun Pharma
(5/23, Press Trust Of India) ...Shareholders of Taro have approved the company's merger agreement with Sun Pharma, the Mumbai-based drug major said on Thursday...The combined entity will enable the company to better serve the needs of patients, healthcare professionals and customers around the world, he added. Upon completion of the merger, currently expected to close in around 35 days, Taro will become a privately held company, wholly-owned by Sun Pharma and soon after its shares will be de-listed from the NYSE... Full
Niche Drugs: Sun Pharma Clocks $1Bn Sales in FY24
(5/24, Rupali Mukherjee, Times Of India) ...Sun Pharma — India's largest drugmaker — has reached a milestone as global sales of its innovative drugs crossed $1 billion in FY24, marking substantial growth for the company since it established its presence in the fast-growing US speciality market over a decade ago. Spurred by the huge potential, the company plans to further ramp up the specialty portfolio (innovative drugs) through its strategy of inorganic growth, increase R&D spends as well as in-license niche drugs for the global markets, Abhay Gandhi, Sun Pharma CEO of US and speciality business, told TOI... Full
Sun Pharma Races to Develop Its Obesity Drug Amid Global Crunch
(5/24, Advait Palepu and Satviki Sanjay, Bloomberg) ...Sun completed the first phase of study for its obesity and diabetes drug GL0034 and will begin the second phase of clinical trials before the end of the year, it said on Wednesday. Sector pioneers Novo Nordisk A/S and Eli Lilly & Co., which make blockbuster drugs Ozempic and Zepbound, have struggled to meet demand in a market that Bloomberg Intelligence estimates will top $80 billion in sales by 2030... Sub. Req'd
Local Pharma Companies Queue Up for JB Chemicals & Pharmaceuticals
(5/24, Reghu Balakrishnan and Viswanath Pilla, The Economic Times) ...Mankind Pharma, Dr Reddy's Laboratories, and Torrent Pharma are interested in acquiring JB Chemicals & Pharmaceuticals from KKR. KKR's investment arm, TAU Investment, owns 53.78% in JB Chemicals, worth Rs 14,020 crore. The company's revenue doubled to Rs 3,484 crore in FY24 under KKR's ownership. JB Chemicals has made four acquisitions in the last four years, investing $200 million. However, global private equity funds are not pushing for JB Chemicals due to high valuations... Full
Pfizer's Hospira Recalls 5 Injectable Drug Lots Due to Report of Leak, Potential Seal Issues
(5/23, Zoey Becker, Fierce Pharma) ...After a report of leaking product, Pfizer's Hospira unit is pulling five lots of sterile injectable medicines from distribution. The recall affects certain batches of the company's buprenorphine hydrochloride injection and its labetalol hydrocholoride injection, both of which come in Pfizer's Carpuject syringe device. While the company has not yet received reports of "any relevant" adverse events tied to the recalled batches, it opted to pull the meds due to the potential for incomplete crimp seals... Full
Express Scripts' New Partnership is An Olive Branch to Independent Pharmacies
(5/23, Rebecca Pifer, Healthcare Dive) ...The Cigna-owned PBM unveiled a collaboration on Thursday with pharmacy network CPESN USA to coordinate care delivery for seniors on Medicare with hypertension and diabetes, two common chronic conditions. CPESN's independent pharmacies will also help identify at-risk patients and improve medication management, according to a release... Full
New Biosimilars Continue to be Approved But Uptake Varies by Class
(5/23, Denise Myshko, Managed Healthcare Executive) ...Biosimilars launched to date account for 23% of molecule volume, but uptake has varied across therapeutic areas, according to the newest Use of Medicines report by IQVIA Institute for Human Data Science...Projecting to 2028, IQVIA predicts biosimilars will contribute to net price growth declines between 1% and 4%. Over the next five years, several branded biologics are expected to lose patent protection. The report predicted that loss of exclusivity for biologics and small generics will result in $93.6 billion in spending reductions by 2028... Full
How a Cyberattack Against St. Louis-Based Ascension is Disrupting Care at Hospitals Around the U.S.
(5/23, Olivia Aldridge, St. Louis Public Radio) ...Hospital staff are forced to write notes by hand and deliver orders for tests and prescriptions in person in the ongoing fallout from a recent ransomware attack at the national health system Ascension...A spokesperson said in a statement that "unusual activity" was first detected on multiple technology network systems Ascension uses on Wednesday, May 8. Later, representatives confirmed that some of Ascension's electronic health records systems had been affected, along with systems used "to order certain tests, procedures and medications."... Full
U.S. Policy & Regulatory News
Bertagnolli: ‘I Don't Ever Want To Have To Do March-In'
(5/23, Maaisha Osman, InsideHealthPolicy) ...National Institutes of Health Director Monica Bertagnolli told Inside Health Policy she prefers to collaborate with the pharmaceutical industry using her agency's newly proposed plan to improve access to medical products developed from NIH-owned inventions over using march-in authority...NIH intends to partner with the pharmaceutical industry to improve access to medical products under the new proposal, which Bertagnolli said Thursday could help avoid the need for "nuclear options" like march-in when patients lack access to medical products... Sub. Req'd
Health Watchdog Finds State Medicaid Drug Cost Data Inconsistent
(5/23, Ganny Belloni, Bloomberg Law) ...In a report released Thursday, the Department of Health and Human Services Office of Inspector General found some states didn't consistently validate the data on how much pharmacies were reimbursed for dispensing drugs to Medicaid patients enrolled in managed care plans. The audit revealed that of the 36 states that covered outpatient prescription drugs for Medicaid through managed care plans in January 2022, 28 states required the plans to report the paid amount for drug claims as the amount the plan or its pharmacy benefit manager reimbursed to the pharmacy... Sub. Req'd
Paul Kelly On the Prospects for Comprehensive PBM Reform | DC Roundtable Podcast
(5/23, Peter Wehrwein, Managed Healthcare Executive) ...Paul Kelly, of Capitol Advocacy & Government Affairs, LLC , and a veteran Washington, D.C., lobbyist, sees some obstacles to the Senate passig a comprehensive PBM bill. Kelly noted that Republican Sens. Mike Lee of Utah and Ron Johnson of Wisconsin, believe that PBMs are a market-based reform that emerged 20-30 years ago "that actually do some good in the system, so maybe we shouldn't be so hasty to move forward with these major reform."... Full
340B Contract Pharmacy Confusion: Another US Court Sides With Pharma, States Enact Roadblocks
(5/23, Cathy Kelly, Pink Sheet) ...The US appeals court for the District of Columbia affirms that drug companies may impose restrictions on the 340B discounts they provide to contract pharmacies in a case involving Novartis and United Therapeutics. Although the decision is a win for pharma, states are increasingly passing laws that prohibit manufacturers from imposing the restrictions, following the lead of Arkansas. The situation threatens to create a confusing patchwork of legal requirements across the country and underscores the need for US congressional action... Sub. Req'd
The Need For Holistic Policy Thinking In Medicare
(5/23, Brian C. DeBusk, Brian J. Miller, Craig Samitt and Kenny Kan, Health Affairs) ...This article addresses the history of the Medicare program and the current debate around the recent MedPAC estimate of MA overpayments. We propose nuanced analytical considerations to ensure accurate coding, address favorable selection, and foster a holistic policy future for Medicare... Full
FDA Releases FY23 GDUFA Science and Research Report
(5/24, The Pharma Letter) ...On Thursday, the US Food and Drug Administration's (FDA0 Center for Drug Evaluation and Research published its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Report...Through these collaborations, the FDA says that GDUFA-funded research helps to bridge the knowledge gaps in development of safe, effective, and high-quality generic drug products. The GDUFA science and research program is an essential component of FDA's mission to protect and promote public health... Sub. Req'd
FY 2023 GDUFA Science and Research Report
(5/23, U.S. Food & Drug Administration) ...GDUFA-funded research aims to improve the efficiency with which generic drugs can be developed and assessed, and benefits public health in two critical ways: making it more feasible for manufacturers to develop generic drugs, which can reduce the risk of drug shortages and facilitates competition; and enhancing patient access to treatment by helping make these products more available, allowing patients in the United States to obtain the medicines they need... Full
Consumer Alert: NYS Bill Could Cut Prescription Drug Prices in Half by Allowing Imports from Canada
(5/23, Deanna Dewberry, News 10 NBC) ...A bill being considered in the New York State Legislature could possibly cut your drug prices in half. The bill would make it legal for New York to import prescription drugs from Canada — but executing this plan is tougher than it sounds...That's because Canadian drug suppliers and health providers are deeply opposed to any import policy with the U.S. They're afraid it would cause drug shortages in Canada, and with good reason... Full
Preserving Health Care Equity: R.I'.s Fight to Stop Pharmaceutical Discrimination
(5/23, State Representative Jon D. Brien and Brian Leung, Boston Globe) ...House Bill 7879 and Senate Bill 2725 Defending Affordable Prescription Drug Costs Act is a rare chance for Rhode Island lawmakers to champion equitable, affordable care without burdening taxpayers because it requires no state funding. The legislation is Rhode Island's opportunity to hold pharmaceutical manufacturers accountable as stakeholders in our state effort to create a cohesive and efficient system capable of addressing the complex healthcare needs of Rhode Island's population... Full
International News
EU Medicines Procurement Policy Must 'Prescribe' Security of Supply for Patients
(5/23, Medicines for Europe) ...Today, the European Commission presented EU guidance on public procurement of medicines which is critical to improve the security of supply for patients and health systems. There is a need for concrete improvements to the procurement process, including better demand predictability and ensuring multiple suppliers on the market. Reform of generic and biosimilar medicine procurement policies is needed to encourage more manufacturers to invest in EU supply... Full
EU Medicines Procurement Policy Must 'Prescribe' Security of Supply for Patients
(5/24, The Pharma Letter) ...Most Economically Advantageous Tender (MEAT) award criteria for policy objectives, such as security of supply or environmental protection, should be aligned across the EU. Award criteria needs to recognise the significance of these investments and therefore move away from lowest price as the sole criteria for medicine procurement. This makes EU procurement guidance that would provide legal clarity to both procurers and suppliers extremely valuable... Sub. Req'd
Novel Antimicrobials: Firms Urged To Draw Up Access & Stewardship Plans For Lower-Income Countries
(5/23, Ian Schofield, Pink Sheet) ...Companies with novel antimicrobials in the later stages of development must make sure that they have "comprehensive and detailed access and stewardship plans" in place before their products are approved, says a new report from the Access to Medicine Foundation. These should include plans for targeting countries with high burdens of disease and disproportionately affected populations such as children, women and immunosuppressed patients, the report says. "Tackling the sheer scale and pace of drug resistance is a complex global health issue that will require action from pharmaceutical companies across several areas," declared Marijn Verhoef, the AMF's director of operations and research... Sub. Req'd
What Can Pharma Companies Do to Get Promising Antimicrobials to the Frontlines of Drug Resistance?
(5/23, Liza Laws, Outsourcing Pharma) ...According to the report, the race to create antibiotics and antifungals to conquer superbugs is falling perilously short, which the authors say is putting people across the world at risk. However, a shift in research and development, including investment in access and stewardship planning, can make a significant impact against antimicrobial resistance... Full
Huge Number of Deaths Linked to Superbugs Can Be Avoided, Say Experts
(5/23, Nicola Davis, The Guardian) ...Every year 750,000 deaths linked to drug-resistant superbugs could be prevented through better access to clean water and sanitation, infection control and childhood vaccinations, research suggests...Experts have warned that if the world does not prioritise action on AMR then there will be a steady increase in the death toll, with infants, elderly people, and those with chronic illnesses or requiring surgical procedures, at the highest risk... Full
European Commission Finalizes Joint Clinical Assessment Rules for Member Countries
(5/23, Lia DeGroot, Endpoints News) ...The European Commission on Thursday finalized rules on how it pools expertise from across the EU to assess the effectiveness of new drugs when compared to drugs already on the market. The rules are part of a broader initiative to bolster collaboration across the continent for evaluating and paying for new products... Full
Addressing Challenges: Perspectives from Innovate Health Forum 2024
(5/23, Miruna Macsim, Business Review) ...In the dynamic realm of healthcare innovation, the Innovate Health Forum 2024 recently hosted a thought-provoking panel titled "Challenges in Pharma Production and Distribution" Here, industry leaders shared profound insights into the evolving landscape of Romanian healthcare...Roxana Botea, Country Director at Johnson & Johnson Romania opens the discussion with a focus on innovation in healthcare, highlighting the importance of continued investment to improve access to new treatments and care standards... Full
Deadline Nears For Comments On WHO's Proposed Requirements For MAbs Targeting RSV
(5/23, Vibha Sharma, Pink Sheet) ...The World Health Organization has developed a draft addendum to its 2023 guideline on the evaluation of mAbs intended for the prevention or treatment of infectious diseases, focusing on supplementary aspects specific to respiratory syncytial virus disease. The World Health Organization is inviting stakeholder feedback on the aspects to consider when evaluating the safety and efficacy of monoclonal antibodies (mAbs) directed against respiratory syncytial virus antigens and intended primarily for pre-exposure prophylaxis in infants and young children... Sub. Req'd
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