Friday, June 7, 2024

On Improving Mental Health, Clinic Staff Have Wisdom to Share

(6/6, Kim Ofilas, Direct Relief) ...During a recent event at Direct Relief headquarters, several of these innovative clinics, each funded by Teva, had an opportunity to share insights and learn from one another. On May 20 and 21, Direct Relief, Teva, and the National Association of Free and Charitable Clinics hosted the Community Routes: Access to Mental Health Care Learning Summit. Teva has funded 11 clinics aimed at advancing health equity by increasing access to care for uninsured patients suffering from depression and anxiety in California, Florida, and New Jersey. This learning summit celebrated the extraordinary and often groundbreaking work of these clinics and their staff... Full

Focus: AbbVie's Tight Grip On Humira Market Raises Concerns About Biosimilars

(6/7, Patrick Wingrove, Reuters) ...AbbVie's top-selling arthritis drug Humira has held onto more than 80% of patients after facing nine lower-priced rivals in the U.S. in the last year, raising questions about whether the market for prescription biosimilars can survive in its current form, drug pricing experts and analysts say...At least seven drugmakers offered sharply discounted prices, but few patients used them until CVS removed AbbVie's Humira from its list of covered drugs...Teva and Organon said they are committed to the U.S. Fresenius...Organon biosimilar head Jon Martin said it would be worth the wait even if biosimilars took six years to gain 50% market share as they did when J&J's arthritis drug Remicade faced rivals starting in 2016... Full

Humira Clobbers Biosimilars in Battle for Part D Coverage

(6/6, John Gever, MedPage Today) ...Just about every Medicare Part D prescription drug plan on offer this year covers the original version of adalimumab (Humira), whereas only about half will pay for any of the several biosimilar versions currently approved, researchers found...The findings will be a disappointment to those who hoped the introduction of biosimilars would rein in the astronomical pricing typical of biologic drugs... Full

Pharm Exec Exclusive: Mark Cuban Talks Drug Pricing

(6/6, Miranda Schmalfuhs, PharmExec.com) ...In an email interview with Pharmaceutical Executive, Cuban stated that overcoming the challenge in providing affordable prescription drugs to the masses ultimately stems back to many of the practices employed by pharmacy benefit managers, which he said inhibits the impact of affordable options such as generic drugs and biosimilars. "All of the issues lead back to how big PBMs do business," Cuban said via email, referring to the likes of PBM stalwarts such as CVS Caremark, Express Scripts, and Optum Rx. "If companies start switching to smaller PBMs, all of this will be fixed. Controlling their own formularies will avoid this problem."... Full

Aurobindo's Eugia Prepares For ‘Muted' Growth In FY2025

(6/7, Urte Fultinaviciute, Generics Bulletin) ...While Eugia continues to look for ways to solve the future challenges amidst temporary plant closure, parent Aurobindo reported a "good" performance in FY2024, with expected continued growth, and gave an update on its Auro Peptides business and GLP-1s...In FY2024, Aurobindo also saw some growth in its global injectables and specialty sales. For Q4, the sales increased by 26% YoY to $143m, meanwhile, annual sales saw a growth of 31% YoY at $541m compared to last year's $414m... Global Sub. Full

‘Pegfilgrastim, We Are Definitely Going To Take It To The US Market,' Says Aurobindo

(6/6, Urte Fultinaviciute, Generics Bulletin) ..."We haven't ever developed this product for the US market," Aurobindo's president of biologics Makkapati Satakarni said about the firm's pegfilgrastim biosimilar. "But pegfilgrastim, we are definitely going to take it to the US market," Satakarni explained about the change of plans during the recent investor call for the financial fourth quarter and full year ending March 31, 2024...The firm also provided an update on other biosimilars and their progress... Global Sub. Full

Searchlight CEO Heads Up Division As Apotex Wraps Up Acquisition

(6/6, Dean Rudge, Generics Bulletin) ...Traditional generics and biosimilars firm Apotex has accelerated its growth within the specialty innovative branded pharmaceutical space, after quickly wrapping up its acquisition of fellow private Canadian company Searchlight Pharma...Apotex believes that its expertise in generics and biosimilars, combined with Searchlight's strong specialty and innovative branded product portfolio, will enhance the company's position as a "pharmaceutical powerhouse in Canada."... Global Sub. Full

FDA Explains Why it Rejected Vanda's Insomnia Application as Company Faces Takeover Bid

(6/6, Nicole DeFeudis, Endpoints News) ...The FDA said this week that it "cannot approve the application in its current form," and it is now providing an opportunity for a hearing to Vanda. Vanda criticized the FDA's latest action, telling Endpoints News on Thursday that "the FDA's deadline had long passed" when it filed its lawsuit...In its comments, the regulator detailed some of its concerns with Vanda's application, saying the company "does not provide substantial evidence of effectiveness for tasimelteon and does not demonstrate that the drug is safe for the treatment of insomnia."... Full

FDA Lays Out Donanemab Concerns Ahead of Meeting, As Lilly Vigorously Defends Safety

(6/6, Annalee Armstrong, Fierce Biotech) ...The docs for Eli Lilly's donanemab advisory committee meeting are in: the FDA has raised concerns about the use of tau PET imaging during the clinical trials, the cessation of dosing after amyloid clearance and whether the small risk of brain bleeds in patients taking antithrombotics outweighs the benefits... Full

Samsung Biologics Eyes Windfall Gain Amid US-China Rows

(6/6, Dae-Kyu Ahn, The Korea Economic Daily) ..."We have secured orders from 16 of the world's top 20 pharmaceutical companies by market capitalization," John Rim, president and chief executive officer of Samsung Biologics, told reporters during a press conferece held on the sidelines of the BIO International Convention 2024 in San Diego, CA on Wednesday...The CEO still bet big on the antibody therapy market, shrugging off looming concerns that the antibody treatment market with huge bio CDMO demand would wane due to the soaring demand for GLP-1 drugs for obesity treatment... Full

Eisai, Merck Sue Dr. Reddy's to Block Generic Copies of Lenvima

(6/6, Christopher Yasiejko, Bloomberg Law) ...Eisai Co. Ltd. and Merck & Co. accused a generic version of Lenvima proposed by Dr. Reddy's Laboratories Ltd. of infringing three patents for the blockbuster cancer drug. Two of the patents—US Patent Nos. 11,186,547 and 10,407,393—cover a high-purity quinoline derivative and a method for making it, according to a complaint filed Thursday in the US District Court for the District of New Jersey... Sub. Req'd

Staff at Drugmaker Under U.S. Scrutiny Worked with Chinese Military Scientists

(6/6, Kirsty Needham and Andrew Silver, Reuters) ...The news agency identified 10 patent filings that list six of WuXi AppTec's staff as co-inventors of altitude sickness drugs with six scientists from the PLA General Hospital in Beijing - China's top military medical school and research centre. The filings, which Reuters is reporting for the first time, were made in the U.S., Europe and China between 2018 and 2023... Full

Cost Remains Significant Barrier to Respiratory Care for Patients

(6/6, Ashley Gallagher, Pharmacy Times) ...The Global Initiative for Asthma and the National Asthma Education and Prevention Program Coordinating Committee recommend a single maintenance reliever therapy (SMART), according to an article published in The Journal of Allergy and Clinical Immunology: In Practice. A combination inhaled corticosteroid ICS-formoterol inhaler can be used for both maintenance as well as quick symptom relief... Full

Nine Years and Four Generics Later, The HIV Drug at the Center of the Shkreli Controversy Still Has a High Price

(6/6, Zachary Brennan, Endpoints News) ...List prices for Daraprim and its generics range widely. In 2023, Teva's generic version was about $235 per pill while Vyera Pharmaceuticals' brand-name version was $690 a pill, according to the nonprofit drug pricing research firm 3 Axis Advisors...Antonio Ciaccia, CEO of 3 Axis Advisors, told Endpoints News that "there is not a meaningful volume play for generic manufacturers, and they will attempt to generate revenue through keeping the price up rather than there being a mad dash to capture market share through aggressive price deflation. If one decided to drop the price to a few dollars a tablet, the market share gain would not outweigh the value of keeping the price up."... Full

FDA's Yim Talks Biosimilars – In A Reddit AMA

(6/7, David Wallace, Generics Bulletin) ...In an "ask me anything" Q&A on Reddit, Sarah Yim – director of the FDA's Office of Therapeutic Biologics and Biosimilars – offered some insights on the US biologics naming convention, biosimilar interchangeability, and the possibility of future competition on cell and gene therapies...Among a variety of responses, some of which simply explained the essentials of the US biosimilars market and registration pathway, Yim hinted at the FDA potentially revisiting the US naming convention that applies four-letter suffixes to the names of both biosimilars and new brand biologics... Global Sub. Full

AAM, BMS Ask FDA to Acknowledge Role of Third Parties in BA/BE Studies

(6/6, Ferdous Al-Faruque, Regulatory Focus) ...Stakeholders want the US Food and Drug Administration to acknowledge that testing sites used for bioavailability (BA) and bioequivalence (BE) studies are often operated and audited by third parties who should also bare responsibility for compliance and maintaining the facilities... Full

Medicare Part D Plans Poorly Cover Adalimumab Biosimilars

(6/6, Lucy Hicks, Medscape) ...As of January 2024, both high and low concentrations of Humira, the originator adalimumab product, are nearly universally covered by Medicare Part D plans, while only half of these plans covered adalimumab biosimilars, according to a new research letter published online on June 6, 2024, in JAMA. Of the plans that covered both, only 1.5% had lower-tier placement for biosimilars... Full

Why Prescription Drug Prices in the US Are So High: QuickTake

(6/6, Robert Langreth, Bloomberg Law) ...Prices for drugs in the US in 2022 were nearly three times as high as the average in 33 other countries where incomes are high or relatively high, according to an analysis by the research group Rand Health Care. It's a gap that has widened in recent years. In 2022, the annual cost of prescription medications was about $1,400 per person. Prescription drug spending in the US was about $634 billion in 2022, according to a study in the American Journal of Health-System Pharmacy, and expected to grow as much as 8% in 2023. That includes drug coverage by insurers and government health programs like Medicare, as well as a significant contribution from out-of-pocket spending by consumers... Sub. Req'd

Lawmakers Seek Input On New Legislation Building On Cures Act

(6/6, Jessica Karins, InsideHealthPolicy) ...Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) sent a letter to stakeholders Thursday (June 6) seeking input on how Congress should craft legislation building on the 21st Century Cures Act to bring next-generation medical treatments to market... Sub. Req'd

The Inflation Reduction Act Is Bad for Oncology Medicines

(6/6, Kirsten Axelsen, RealClearHealth) ...The price setting system in the Inflation Reduction Act will steer investment away from drugs for conditions common in seniors and disabled people and in particular small molecules. By distorting the odds of financial success for pills, and particularly pills for cancer treatment, the Inflation Reduction Act is playing a dangerous game with the future of better health through medicine... Full

ICYMI: Misaligned Policies Undermine Patient Access

(6/6, Michael Ybarra, MD, PhRMA) ...Recently, I participated in the "Unlocking Access to Treatments and Medicines" panel at Bamberg Health's U.S. Northeast Healthcare Innovation Summit, alongside Christina M. Annunziata, Senior Vice President of Extramural Discovery Science at the American Cancer Society, Hilary Marston, Chief Medical Officer at the FDA and Sawn Darshan Parekh, Chief Executive Officer of Roxborough Memorial Hospital. Throughout the conversation about the current challenges limiting access to lifesaving treatments, I advocated for policymakers to take actions to ensure that the latest scientific advancements make their way into the hands of patients... Full

FAH Questions the "Unintended Consequences" of Draft Drug Shortage Program

(6/6, Federation of American Hospitals) ...FAH made it clear that incentivizing providers to maintain a six-month supply of generic drugs may lead to unintended consequences, including resource diversion, logistical difficulties, and disparities between large and small health care providers. FAH urged the committee to reconsider these incentives and explore alternative strategies that balance the need for buffer inventories with broader health care objectives... Full

AHA Discusses Impact of Change Healthcare Cyberattack at Wall Street Journal Event

(6/6, AHA) ...Stacey Hughes, AHA executive vice president of government relations and public policy, spoke about the impact on hospitals and health systems, the government response to the attack, how UnitedHealth Group's size was a factor in the incident and what's next in federal cybersecurity policy in a discussion with Erik Decker, vice president and chief information security officer for Intermountain Health, and WSJ Reporter James Rundle... Full

At BIO, Signs Congress' Tough Stance On China is Chilling Biotech Relationships

(6/6, Jonathan Wosen and Meghana Keshavan, STAT Plus) ...A number of biotech companies in attendance at the meeting of the Biotechnology Innovation Organization told STAT they're actively looking to strike deals with U.S.-based drug manufacturers rather than companies named in the legislation, even though doing so will be more costly. An executive at a U.S.-based contract development and manufacturing organization, or CDMO, who spoke on condition of anonymity, said that "month to month, new business has gone through the roof."... Sub. Req'd

BIO Elevates State Policy, Patient Advocacy In Reorganization

(6/6, Sarah Karlin-Smith, Pink Sheet) ...BIO CEO John Crowley sat down with Pink Sheet at the industry's annual convention to discuss his vision for a newly restructured BIO, his thoughts on the upcoming US elections and whether he'd ever lead another biotech... Sub. Req'd

FDA Official Offers Compliance Updates, Discusses Enforcement Misperceptions

(6/6, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration recently launched a new web page to combat misperceptions about drug compliance actions, said Jill Furman, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research. She also noted that FDA is continuing to rely on the use of alternatives tools, such as remote interactive evaluations, and is using those methods as the basis for issuing warning letters and import alerts... Full

Florida Has Paid Vendor $50 Million So Far for Stalled Plan to Import Canadian Drugs

(6/6, Jeffrey Schweers, Orlando Sentinel) ...A cavernous warehouse owned by Life Science Logistics sits on an industrial street in Lakeland, built three years ago under a multimillion-dollar contract with the state to import and store prescription drugs from Canada...The 100,000-square-foot warehouse hasn't been used for its intended purpose. It's been the site of occasional DeSantis news conferences and provided temporary storage for COVID-19 medication, hurricane equipment and other humanitarian supplies. And even though it has no drugs to distribute, Dallas-based Life Science Logistics has been paid $50.3 million so far under the contract signed in 2020 and is slated to get $14.5 million more a year through 2026... Sub. Req'd

Pharma, Pharmacies Debate Drug Price Reform in Michigan House Committee

(6/6, Therese Boudreaux, The Center Square Michigan) ...A Michigan bill aimed at medical access for low-income and uninsured residents met opposition after recent investigations into the affiliated federal 340B drug pricing program...In response, some drug manufacturers had started notifying hospitals they will limit the number of affiliated contract pharmacies that can access the drug for the discount price, actions which prompted the Michigan bill... Full

IGBA Re-Elected to ICH Management Committee

(6/6, IGBA) ...The International Generic and Biosimilar Medicines Association welcomes the decision of the ICH General Assembly to re-elect the IGBA as a Management Committee Member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. IGBA joined the ICH as a full member of the General Assembly in June 2016 and was elected to the Management Committee in 2018... Full

Italy Starts Probe into Lucentis Biosimilar Delay Allegation

(6/7, Phil Taylor, Pharma Phorum) ...The Italian Competition Authority (Autorità Garante della Concorrenza e del Mercato or AGCM) said its probe also covers subsidiaries of Samsung Bioepis and Biogen and Roche's Genentech unit, and comes after it carried out inspections in Italy and the Netherlands. It cites an "anticompetitive agreement" in the market for Lucentis active ingredient, the anti-VEGF antibody ranibizumab. Specifically, the ACGM claims that the companies entered into a coordinated agreement to delay the entry into the Italian market of Byooviz, a Lucentis biosimilar developed by Samsung Bioepis and Biogen. Lucentis was developed by Genentech and marketed in Italy by Novartis... Full

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