Thursday, February 29, 2024

Israel's Mental Health Infrastructure Must Be Fortified to Assist Those Treating Trauma - Opinion

(2/29, Mark Sabag, The Jerusalem Post) ...Trauma is now a health crisis and an estimated 2 million Israelis – a quarter of those impacted by that terrible day – could develop post-traumatic stress disorder symptoms that could last five years or longer...To help address these needs, Teva has launched Support the Soul (Metaplim Banefesh) – mobilizing partners with diverse skill sets from Israel and around the world to bolster Israel's mental health infrastructure. The comprehensive, holistic program is focused on supporting mental health therapists because the resilience of our country is in their hands... Full

Maryland to Get $238M As Part of MASSIVE Opioid Settlement with Walmart, Walgreens, More

(2/28, Anthony G. Brown Maryland Attorney General) ...Maryland Attorney General Anthony G. Brown announced that his Consumer Protection Division's ("Division") Opioids Enforcement Unit ("Opioids Unit") has finalized settlements with Teva, Allergan, Walmart, and Walgreens, after multi-year investigations of these opioids-makers' or chain pharmacies' involvement in fueling the opioid crisis in Maryland. The settlements are expected to provide $238 million to be used in Maryland's and its subdivisions' efforts to fight the opioid crisis... Full

Maryland Announces $238M in New Opioid Settlements with Walgreens, Walmart, Two Drugmakers

(2/28, Angela Roberts, The Baltimore Sun) ...One of the opioid manufacturers involved in the latest settlements — Teva, which is based in Israel — marketed and sold extremely dangerous and addictive rapid-onset fentanyl products, according to the news release, which cites documents filed Wednesday morning in Frederick County Circuit Court...Under the settlement agreement, Teva will be required to pay restitution to the state for 13 years. The news release estimated that the state will bring in about $70.3 million from that agreement... Sub. Req'd

Multiple Hospital Groups Point to Opioid Crisis for Financial Struggles

(2/28, Madeline Ashley, Becker's Hospital Review) ...Over 20 hospitals and affiliated companies have united in multidistrict litigation that suggests in a complaint that drug distributors, pharmacies and other entities have contributed to the opioid epidemic, which has negatively affected hospital finances and strained patient aid capabilities...The plaintiffs claim the companies engaged in opioid marketing, distribution and sales are taking advantage of hospital responsibilities to treat communities affected by addiction. Defendants listed in the lawsuit include pharmaceutical company AbbVie, Walgreens, CVS, Walmart, Teva Pharmaceuticals, and Johnson & Johnson... Full

Cardinal Health Annual Research Report Examines Milestone Year in Biosimilars

(2/29, Cardinal Health) ...Today, Cardinal Health released its 2024 Biosimilars Report: insights on a pivotal year of evolution and expansion, an analysis of key recent economic, competitive, legislative and societal developments in biosimilars. The publication highlights legislative developments and new treatments, including adalimumab biosimilars. The report also provides the perspectives of retina specialists on biosimilars, ahead of the expected launch of multiple new biosimilars for retinal diseases... Full

EuroAPI Appoints New CEO and Lays Out Restructuring Plan As Manufacturer's Losses Mount

(2/28, Fraiser Kansteiner, Fierce Pharma) ...Overseeing the four-year plan, dubbed FOCUS-27, will be new chief executive Ludwig de Mot—an industry veteran with a track record at "companies undergoing transformation," EuroAPI said in an earnings release Wednesday...EuroAPI said its reorganization project will include streamlining its active pharmaceutical ingredients portfolio, becoming a more "focused" contract development and manufacturing organization, developing a "rationalized" industrial footprint and transforming into a "leaner organization."... Full

Sandoz Enters $265 Mln Settlement Agreement in U.S. Price-Fixing Case

(2/29, Bartosz Dabrowski, Reuters) ...Swiss generic and biosimilar manufacturer Sandoz on Thursday said it had entered into a $265 million settlement agreement in a price-fixing case in the United States. The company said its U.S. subsidiaries had agreed to pay $265 million in a lawsuit with a class of direct drug purchasers, an agreement that does not contain any admission of wrongdoing by the Swiss company... Full

After Idorsia Deal, Viatris' Dealmaking Appetite Remains Strong, CEO Says

(2/28, Fraiser Kansteiner, Fierce Pharma) ...On the back of its $350 million deal for two late-stage Idorsia assets, Viatris will continue to be "opportunistic" when it comes to making future business development grabs—especially on the commercial side—executives said on a call with analysts Wednesday...When it comes to dealmaking opportunities, Viatris will continue to focus on its bread-and-butter therapeutic areas in dermatology, gastrointestinal and ophthalmology, Smith added... Full

Celltrion's Operating Profit Inches Up in 2023 On Robust Biosimilars Biz

(2/29, Lee Han-soo, Korea Biomedical Review) ...Celltrion said it reported consolidated sales of 2.1 trillion won ($1.5 billion) and operating income of 651 billion won in 2023, down 4.71 percent and up 0.66 percent, respectively, from the previous year...Looking ahead, Celltrion expects to enter a high-growth phase in 2024, with projected revenues of 3.5 trillion won and earnings before interest, tax, depreciation, and amortization of 1.6 trillion won, aiming for an EBITDA margin of over 40 percent... Full

Celltrion Applies for Actemra Biosimilar CT-P47's Sales License in Korea

(2/29, Korea Biomedical Review) ...Celltrion said Thursday that it has completed submitting a marketing authorization application for CT-P47, a biosimilar to Actemra (tocilizumab) for treating autoimmune diseases, to the Ministry of Food and Drug Safety...Celltrion has completed filing for approvals for five pipeline products -- Stelara biosimilar CT-P43, Xolair biosimilar CT-P39, Eylea biosimilar CT-P42, Prolia biosimilar CT-P41, and Actemra biosimilar CT-P47 – and are winning their marketing authorization. Celltrion aims to win approval for these pipelines by 2025, bringing the total number of biosimilar products to 11 in addition to the six already commercialized... Full

Mabwell's Denosumab Biosimilar Shows Similar Efficacy To Xgeva

(2/28, Urte Fultinaviciute, Generics Bulletin) ...Mabwell's denosumab biosimilar MW032 has demonstrated similarity in efficacy to Amgen's Xgeva in solid tumor patients with bone metastasis. The Shanghai-based firm noted that this was the "first recorded trial to systematically compare the efficacy, population pharmacokinetics, and safety profile" of both drugs in this specific patient population in a 53-week Phase III trial... Global Sub. Full

Fresenius Kabi Introduces Cyclophosphamide for Injection, USP

(2/28, Contract Pharma) ...Now available in the U.S., Cyclophosphamide for Injection, USP is the newest addition to Fresenius Kabi's broad portfolio of generic oncology injectables. "The introduction of Cyclophosphamide for Injection adds another critical treatment to our broad and leading oncology portfolio that offers lower-cost options for treating cancer," said John Ducker, president and CEO of Fresenius Kabi USA... Full

Pfizer is About to Make a Big Push in Cancer. Will Investors Listen?

(2/29, Matthew Herper, STAT Plus) ...Pfizer has a big problem. The drug giant hopes that new drugs to treat cancer are the solution. Shares in the drugmaker fell 44% last year, and it now has a market capitalization of only $150 billion — a quarter that of Eli Lilly and half that of longtime rival Merck...On Thursday, executives are holding an investor briefing to try to convince shareholders that its bet will pay off. In an interview with STAT, Pfizer CEO Albert Bourla was insistent that the deal's potential is being missed... Sub. Req'd

GSK Settles Another Lawsuit On Heartburn Drug Zantac in California

(2/29, Eva Mathews, Reuters) ...GSK agreed to confidentially settle another lawsuit in California that had alleged its discontinued heartburn drug Zantac caused cancer, the latest in a series of settlements made by the British drugmaker to end costly litigation. The case, which was set to begin trial on April 2, will be dismissed. GSK does not admit to any liability in this settlement with Boyd/Steenvoord, it said on Thursday... Full

Mental Health Crisis Fuels the Post-Pandemic Rise in Medication Use

(2/29, Cecilia Garzella, USA Today) ...A USA TODAY analysis of Medicaid data for the 60 most used psychiatric drugs showed a growing number of people sought mental health treatment and medication during the pandemic as it pushed people into isolation and dismantled support systems. The analysis also revealed a lingering effect of the pandemic: Mental health-related prescriptions rose further in 2022, up 12% from 2019, outpacing the less than 1% growth in overall prescriptions. That includes prescriptions for generic Zoloft, the most common antidepressant medication, which rose 17% over the same period. More than half of these drugs saw an increase in prescriptions since 2019, and the steepest increase was among ADHD drugs: Concerta and generic Adderall... Full

CDC Braces for Shortage After Tetanus Shot Discontinued, Issues New Guidance

(2/28, Alexander Tin, CBS News) ...The Centers for Disease Control and Prevention is urging doctors to conserve shots of a kind of tetanus vaccine, as the agency braces for a potential shortage of those shots this year...This year's shortage risk stems from a decision by nonprofit vaccinemaker MassBiologics to discontinue production of its Td vaccine, branded as TdVax. Supplies of the shot will likely run low as soon as this summer from the shot's distributor Grifols, the CDC told a panel of its vaccine advisers Wednesday... Full

The ‘Major Challenge' of Recycling Plastics from Asthma Inhalers and Insulin Pens

(2/28, Nick Iannelli, WTOP News) ..."It is a major challenge being able to responsibly manage the end of life of these kinds of devices," said Tom Szaky, CEO of TerraCycle, a recycling company that has become a global leader in recycling hard-to-recycle materials. According to Szaky, the problem centers around the actual cost of recycling certain items...According to TerraCycle, the company has been recycling asthma inhalers in the U.K. through a partnership with Teva Pharmaceuticals since 2016, with Teva funding the actual cost of collecting and processing the devices. "In that period of time, we've collected and recycled about half-a-million asthma inhalers," said Szaky... Full

Last-Ditch Calls For PBM Reform Roll In Despite Omission From Skinny Health Bill

(2/28, Gabrielle Wanneh, InsideHealthPolicy) ...Long-sought bipartisan pharmacy benefit manager reforms were torpedoed from an emerging skinny health package this week after key House and Senate Republicans sparred over whether private insurers should be part of the reforms, and PBM reform advocates are now lobbying to get broad-based PBM reforms passed before the year's end... Sub. Req'd

White House to Hold a Listening Session On Reforming Pharmacy Benefit Managers

(2/28, Ed Silverman, STAT Plus) ...In a bid to combat prescription drug costs, the White House will hold a listening session on Monday in search of ways to reform pharmacy benefit managers, according to people familiar with the plans...Among those invited is Mark Cuban, whose Cost Plus Drug Company is trying to transform the marketplace by avoiding the largest middlemen when reaching benefits agreements with employers... Sub. Req'd

PBM Reform Advocates Preach Optimism As Congress Delays Action

(2/28, Noah Tong, Fierce Healthcare) ...It appears unlikely that major, bipartisan priority items — like site neutral payment and pharmacy benefit manager reform, as well as substance use disorder policies — will be included in the upcoming government funding bill March 8, news outlets have reported...A joint statement by the National Association of Chain Drug Stores, the National Alliance of State Pharmacy Associations and other groups, said in a letter that reforms on PBMs are needed "without delay."... Full

Stakeholders Hope Bill Will Create IRA Drug Negotiation Parity Between Biologics and Small Molecules

(2/29, Greg Slabodkin, BioSpace) ..."We worked very closely with Reps. Davis, Guthrie and Murphy for the introduction of the EPIC Act," Incubate Executive Director John Stanford told BioSpace. "We may see similar legislation as well but it all amounts to fixing the small molecule penalty." Stanford said the IRA's provision is "a real disincentive towards one type of medicine." By creating a price control mechanism after nine years, the IRA effectively "shuts off access to 50% of a drug's revenues which come in years 10 to 13," Stanford added. "That's devastating to the formulas of how we decide to allocate money as investors."... Full

Biotechs Heed Political Headwinds for Drug Pricing Negotiations and Partnerships

(2/28, Justine Ra, Pharmaceutical Technology) ...The extended reach of US government and international relations is leaving biotechs with the challenge of navigating the everchanging waters of drug policy, experts said at the 2024 BIO CEO & Investor Conference in New York...Another aspect that has lately been in the news is the collaboration with foreign biotech companies, particularly from China. A few weeks ago, it was announced that a bipartisan group of lawmakers are actively pursuing a formal investigation and sanctions against WuXi given the company's alleged connections to the Chinese military... Full

A Lack of Transparency Drives PBM Fees and Restrictions, Reducing Competition

(2/29, Justin Leventhal, RealClearHealth) ...An open competitive market for PBM services requires manufacturers, hospitals, and insurers to have all the facts. Transparency in the form of reporting requirements on fees, pass through rates, and excluded medicines, would help provide all three groups with the information they need to make informed choices between PBMs, reducing prescription drug costs by introducing transparency and competition into a market that currently lacks both... Full

Bernie Sanders Wants To Rein In Drug Prices. Is He Asking The Right Questions?

(2/28, Rita Numerof, Forbes) ...Serious efforts to address the cost of drugs, access to them, and life expectancy in the U.S. require a broader, constructive approach to the healthcare ecosystem. Legislators, pharmaceutical CEOs, payers, PBMs, and other stakeholders need to work together to evaluate the current system, eliminate perverse incentives, and outline the steps required to fix healthcare. Piecemeal solutions won't move the needle... Full

Califf Lays Out Drug Shortage Landscape, Talks Post-Market Data Collection for Accelerated Approvals

(2/28, Lia DeGroot, Endpoints News) ...Efforts to inspect generic drug facilities around the world could end up worsening US shortages of several key medicines if they lead to halted manufacturing, said FDA Commissioner Robert Califf, underscoring the challenges faced by the agency on drug supply issues. Califf, speaking at a virtual event hosted by Reuters, said that the FDA's inspection work could actually lead to more shortages if inspectors find issues that lead to manufacturing lines being shut down... Full

Colorado Is Trying to Cap a Drug's Price. Big Pharma Has Other Plans

(2/28, Andrew Perez, Rolling Stone) ...A state board in Colorado is working to make history by becoming the first in the country to cap the price of a drug it deems unaffordable. Amid an aggressive industry lobbying campaign, Colorado lawmakers are now weighing a poison pill measure that would blow up the plan and similar efforts in the future. The episode highlights the vast power of Big Pharma and how difficult it is to lower drug prices in the United States... Full

‘We Need To Act Now': Medicines For Europe On Procurement Policies

(2/28, Urte Fultinaviciute, Generics Bulletin) ...The European off-patent drug organization provided several recommendations for medicines procurement to minimize the current focus on lowest-price tenders that are harming competition in the region. Current EU procurement rules that focus on reducing the costs of acquiring medicines have led to the consolidation of supply and increased risk for supply security, said Medicines for Europe in its latest position paper... Global Sub. Full

Generics Industry Welcomes "Safeguards" On Unitary SPC Use

(2/28, The Pharma Letter) ...Medicines for Europe, a trade group for the European generics and biosimilars industry, has welcomed the position adopted today by the European Parliament regarding SPC regulation...The Unitary SPC will significantly expand the geographical coverage of the rules, covering countries where drugs are not normally launched or may be launched late. As a result, Medicines for Europe said that robust safeguards were essential to prevent misuse of the system... Sub. Req'd

Parliament's Balanced Stand On Unitary SPC Regulation Rewards Innovation Via An Efficient Unitary SPC System that Protects Against Access to Medicines Delays

(2/28, Medicines for Europe) ...Commenting on the report, Adrian van den Hoven, Director General of Medicines for Europe said "The position of the Parliament goes in the right direction and rightfully bans patent linkage. The pre-grant opposition will ensure a timely grant of SPCs for innovative drugs (a maximum 14 months or 12 with an expedited procedure) and prevent monopoly extensions for those drugs that do not have a legal right to an SPC because they are not innovative.”... Full

EU Parliament OKs Legislation To ‘Reduce Cost & Burden' Of Patent Extensions

(2/28, Ian Schofield, Pink Sheet) ...New EU rules on extending the effective patent life of medicinal products drew nearer today after the European Parliament voted through two draft regulations that aim to make it easier to seek supplementary protection certificates (SPCs) with effect in all EU member states...Its rapporteur for the draft legislation, Tiemo Wölken, said the new rules would benefit the European industry by reducing the cost and burden of obtaining or maintaining an SPC... Sub. Req'd

MHRA Streamlines Approval Process for Established Medicines

(2/29, Pharmaceutical Technology) ...The UK Medicines and Healthcare products Regulatory Agency has announced process changes in its latest guidance aimed at enhancing the efficiency of assessing established therapies. Set to come into effect on March 1, 2024, the guidance incorporates these changes to streamline the approvals process for applicants... Full

How Lilly Is Helping To Address The UK's ‘Postcode Lottery' For Cancer Drugs

(2/28, Eliza Slawther, Pink Sheet) ...Some innovative cancer drugs are not reaching eligible patients in the UK, despite securing positive reimbursement opinions from NICE. Eli Lilly explains how industry can be "part of the solution" through partnership initiatives...Eli Lilly, one of the pharmaceutical companies that contributed to the report, told the Pink Sheet that patients face a "postcode lottery" when it comes to accessing innovative oncology drugs... Sub. Req'd

Shifting Strategies of MNCs Amidst the Ascendance of Indian Pharma

(2/29, The Pharma Letter) ...The tides are shifting. As multinational entities such as Novartis, AstraZeneca and Sanofi recalibrate their strategies in India, spurred by intensified local competition and patent expiries, domestic pharma players like Cipla, Torrent Pharma, Eris Lifesciences, and JB Chemicals are asserting their prominence... Sub. Req'd

Apotex Gains Canadian Rights To Five Eye Assets From Harrow

(2/28, Adam Zamecnik, Generics Bulletin) ...The Canadian company Apotex has snapped up rights to five ophthalmic products from eyecare pharma player Harrow as part of an exclusive out-licensing agreement that will grant the Canadian player commercialization and development rights to assets at different stages of development in its country... Global Sub. Full

Singapore & South Korea's Recognition Of GMP Inspections To Cut Burden For Companies

(2/28, Vibha Sharma, Pink Sheet) ...Drug regulatory authorities in Singapore and South Korea have signed a mutual recognition agreement that will allow them to rely on each other's good manufacturing practice certificates and inspection outcomes relating to drug manufacturing sites in the two countries. The MRA, signed by Singapore's Health Sciences Authority and Korea's Ministry of Food and Drug Safety, is expected to reduce the regulatory burden on pharmaceutical and biologics manufacturers in the two regions by reducing the need for duplicative onsite GMP inspections by the two agencies... Sub. Req'd

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