Tuesday, February 20, 2024

Teva Pharm to Stay As Unified Generics, Branded Drugmaker, CEO Says

(2/20, Steven Scheer, Reuters) ...There has been speculation that Israel-based Teva - the world's largest generic drug maker - would split into two companies handling both the increasingly competitive generics business and its own branded drugs. However, the company will stay unified, and "from an infrastructure point of view, (the two businesses) complement each other incredibly well," Chief Executive Richard Francis said at a news briefing. The generics side "allows us to fund a lot of research and development we are doing in our innovative business," he said, citing Teva's collaborations on R&D with Israeli universities... Full

Taking Care of the Soul: 'Teva' Campaign to Strengthen Mental Resilience

(2/20, Lee Sivilia, The Jerusalem Posts) ...Yossi Ofek, CEO of Teva Israel and the Ukraine, Africa and Middle East countries cluster: "As the national pharmaceutical company of Israel, we have been engaged since the first day of the war, for the benefit of Israel, the wounded and the injured, the families of the evacuees and the security forces...Alongside all these, we realized that the greatest need now is the treatment of the national trauma and the strengthening of the professional therapists who do holy work despite personal difficulties and mental complexity. The program "Mental Caregivers" in collaboration with the Israeli trauma coalition, will support and train hundreds of professional therapists in the field of trauma, will strengthen the infrastructure of the resilience centers in the south and will even work to incorporate technological and digital innovation in treatments."... Full

GSK and Others Delist Orange Book Patents After FTC Targets Protections On Inhalers and Epinephrine Injectors

(2/16, Zachary Brennan, Endpoints News) ...Three pharma companies have agreed to delist some of the patents challenged by the Federal Trade Commission in November, part of a push by the agency to target practices it claims are limiting competition...The letter from Sen. Elizabeth Warren (D-MA) and Rep. Pramila Jayapal (D-WA) praised the response to FTC's challenges as "rapid, and significant." But the lawmakers also noted that "this rapid response reveals the extent to which drug manufacturers have been blatantly misusing the patent system." In their letter, they said that Boehringer Ingelheim, AbbVie, Teva, AstraZeneca, and Viatris didn't agree to delist any of their patents... Full

The Empty Adderall Factory A Drugmaker's Feud with the DEA is Exacerbating the ADHD Meds Crisis — At a Rate of 600 Million Missing Doses a Year.

(2/19, James D. Walsh, New York Magazine) ...There's been a national shortage of ADHD medication for more than a year and a half. According to the government and industry experts, there are multiple overlapping causes: manufacturing problems, labor issues, supply-chain failures, and a huge rise in demand during the pandemic. But Ascent claims there's another factor exacerbating the shortage, one that's completely sui generis: the fact that it's been shut down by the Drug Enforcement Administration... Full

Lupin Reports Near 300% Profit Growth Coupled With Launches

(2/16, Adam Zamecnik, Generics Bulletin) ...Lupin has reported a nearly 300% year-over-year growth in profits in its financial third quarter on the back of new launches, despite the ongoing impact of unrest in the Red Sea. Specifically, the company has singled out the impact of its seasonal products and its respiratory portfolio, which includes the recently approved and launched generic to Boehringer Ingelheim's Spiriva Handihaler (tiotropium bromide)... Global Sub. Full

Novartis, Zeroing in On Innovative Meds, Launches Strategic Review of India Outfit

(2/16, Angus Liu, Fierce Pharma) ...As part of a strategic review unveiled Friday, Novartis said it's evaluating its 70.68% position in Novartis India Limited, a local unit listed on BSE. Based on the closing price at the end of 2023, the shares owned by the parent group were worth $161 million, according to the Swiss pharma's annual report. The review won't necessarily be completed in 2024, Novartis said, and there's no guarantee that any transaction will come out of it... Full

Samsung Bioepis Posts Record-High Biosimilar Sales

(2/18, Shim Woo-hyun, The Korea Herald) ...Overseas biosimilar sales of Samsung Bioepis, a biosimilar developer under Samsung Group, reached an all-time high in 2023, according to its partner companies on Sunday. According to Samsung Bioepis' US partners, Biogen and Organon, sales of Samsung Bioepis' biosimilar products in overseas markets came to $1.36 billion, or some 1.8 trillion won in 2023. The figure was up 11 percent from $1.23 billion in 2022... Full

What's after Revlimid for Dr Reddy's, Cipla, and Sun Pharma?

(2/20, Vaibhavi Ranjan, Money Control) ...Frontline pharmaceutical majors Cipla, Sun Pharma and Dr Reddy's have had bumper earnings over the last few quarters, thanks to the high-margin blockbuster cancer drug Revlimid. But that effect could soon wear off in the coming quarters because of the high base effect and the impending entry of peers like Aurobindo Pharma who will be allowed to sell the drug. The patent for Revlimid will eventually expire in January 2026. That means the Big 3 of the Indian pharmaceutical industry will need to have other tongs in the fire to maintain the growth in earnings... Full

Biogen's Biosimilars Sales Rise, But Future Still Unknown

(2/16, Urte Fultinaviciute, Generics Bulletin) ...One year after announcing that its biosimilars business may find a new home, Biogen is yet to provide more concrete answers on these plans. During the firm's Q4 and full year 2023 earnings call, chief financial officer Michael McDonnell reiterated that the company continues to evaluate its options but did not specify any timelines or potential buyers. "We continue to explore strategic alternatives for this business and are working to ensure that we maximize its value for our shareholders," McDonnell said... Global Sub. Full

FDA Approves Medication Used to Treat Asthma for Use in People with Multiple Food Allergies

(2/19, Amanda Musa, CNN) ...The US Food and Drug Administration on Friday approved a medication called Xolair to help lessen the severity of an accidental allergic reaction in people who are allergic to multiple foods...For food allergy treatment, the estimated list price for Xolair ranges from about $2,900 for children to $5,000 for adults each month, according to Genentech. "The actual cost paid by most patients is typically lower based on their insurance coverage and other financial assistance programs available," Lindsey Mathias, a spokesperson for Genentech, told CNN on Monday... Full

Organon's Humira Biosimilar Gets Exclusive Spot On VA Formulary

(2/16, Nicole DeFeudis, Endpoints News) ...AbbVie's Humira is getting swapped out for Organon's biosimilar Hadlima on the US Department of Veterans Affairs' national formulary..."We expected the market to be slow," Organon's US biosimilar unit lead Jon Martin told Endpoints News on Friday. "We thought it would be a little bit stronger than it is today, but we didn't expect it to be a wholesale shift." Organon and Samsung launched Hadlima in July at an 85% discount to Humira. But despite a slate of new entrants in 2023, AbbVie executives say they're confident they can protect their market share through the next year or two... Full

Sanofi CEO: AI Promises a Great Era of Drug Discovery That Could Fundamentally Change Medicine–But Only if We Allow it to Deliver

(2/19, Paul Hudson, Fortune) ...In pharmaceutical research and development, AI is already delivering on its potential. AI and data analytics are driving breakthroughs that enable us to predict patient responses, increase the likelihood of clinical trial success, and determine individualized treatment plans for patients. With AI, we are breaking new barriers to unlock previously undruggable targets and bring forward new therapies for patients who currently have no treatment options. At Sanofi, leveraging AI to empower drug discovery and development is having a major impact... Full

Bayer Makes a Deal On Popular Contraceptive with Mark Cuban's Online Pharmacy

(2/19, Sydney Lupkin, NPR) ...Bayer is the latest name-brand drugmaker to dip its toe into the world of Mark Cuban's online pharmacy, Cost Plus Drugs..."As I look at our partnership with Cost Plus, I really look at this as a test and learn," says Sebastian Guth, president of U.S. Pharmaceuticals at Bayer. "It's a first initial step. We will learn and see what the results of this partnership are and may then decide to expand it further."...A Cost Plus Drugs spokesperson wrote in an email to NPR that most of the company's business is from cash-paying customers who skip their insurance, but the number of users whose insurance includes Cost Plus is "growing quickly." For those paying cash, Climara is also much cheaper at Cost Plus — $53 instead of $76 list price... Full

A Lawsuit Over a Controversial Sanofi Drug Shortage is Unexpectedly Revived

(2/20, Ed Silverman, STAT Plus) ...A U.S. appeals court revived a controversial lawsuit brought by nearly two dozen people who claimed they were harmed by a contaminated rare disease medicine sold by a Sanofi subsidiary and a subsequent rationing plan that only worsened their health. And if some upcoming procedural hurdles are cleared, the suit may shine a light on an unusual patient dilemma when a drug is in short supply... Sub. Req'd

Phage Therapy: Researchers Sharpen Another Arrow in the Quiver Against Antibiotic Resistance

(2/20, Deborah Balthazar, STAT) ...Lynn Cole was in a never-ending cycle of getting recurrent blood infections. And no antibiotic drugs managed to kill off her zombie-like bacteria...In June of 2020, her doctors turned to one last resort: an experimental therapy involving the use of a bacteriophage — a virus that infects and multiplies in bacteria, effectively blowing the bacteria up. With her family on board and "compassionate use" approval obtained from the Food and Drug Administration, doctors at the University of Pittsburgh School of Medicine administered the phage therapy. Within 24 hours, there were no signs of bacteria growing in her blood... Full

AstraZeneca Asks Federal Judge to Decide in its Favor in Drug Price Negotiations Lawsuit

(2/16, Katherine Lewin, Endpoints News) ...On Monday, AstraZeneca asked a federal judge to decide in its favor without a full trial, arguing that it "faces concrete and imminent injuries that directly result from the unconstitutional aspects of the Drug Price Negotiation Program, and they are redressable by this Court."...AstraZeneca filed its most recent brief after the judge ordered both sides to argue why AstraZeneca has standing to assert that the IRA violates the Fifth Amendment. "The Program also deprives AstraZeneca of its interest in a valuable economic benefit by reducing the price on a large swath of sales of its drug product FARXIGA," the filing continues. AstraZeneca received its initial offer from CMS on Farxiga on Feb. 1... Full

AAM Applauds FTC-HHS Probe Into Generic Drug Shortages

(2/19, Urte Fultinaviciute, Generics Bulletin) ...In response to the continued efforts to address the ongoing drug shortage crisis, the US Association for Accessible Medicines has commended the country's Federal Trade Commission and Department of Health and Human Services for their latest bid to "uncover the root causes and potential solutions to drug shortages."..."AAM commends HHS and FTC for seeking input on the impact of group purchasing organizations and wholesale distributors on the sustainability of generic drug competition," said AAM's interim president and CEO David Gaugh... Global Sub. Full

Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024

(2/18, Skylar Jeremias, The Center For Biosimilars) ...On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission...We'll be delving into the impact of recent developments on market dynamics, discussing how these advancements are reshaping strategies, influencing investment decisions, and ultimately, transforming patient care... Full

Biosimilar Substitution Within OCM Could Result in Lower Total Cost of Care

(2/16, Skylar Jeremias, The Center For Biosimilars) ...Researchers found that the total cost of care per oncology episode significantly lowered when biosimilar substitution was implemented in Medicare's Oncology Care Model, suggesting that biosimilar uptake can serve as a critical tool to mitigate risk and improve financial performance for providers... Full

A Dispute Over a Common Asthma Drug Leaves Patients Caught in the Middle

(2/19, Nathaniel Weixel, The Hill) ...Manufacturer GlaxoSmithKline stopped making Flovent on Jan. 1 and is instead offering an "authorized generic" version distributed through a different company. It's the same drug, just without the branding...Despite the lower list price, the PBMs argue it will cost more because of the complicated system of rebates drug companies pay to get their products on preferred coverage lists. Even if a drug's list price is higher, a manufacturer might pay the PBM higher rebates, so the net price for a health plan could end up being lower. CVS Caremark is giving preferential placement to Pulmicort instead of the authorized generic versions of Flovent... Full

CMS Expects Part D Plans To Go To Great Lengths Facilitating Participation In New Copay ‘Smoothing' Option

(2/19, Sarah Karlin-Smith, Pink Sheet) ...Medicare Part D plans must take a wide variety of steps prior to and throughout the plan year to ensure enrollees and pharmacies are aware of the program's new prescription payment plan and have several different ways to opt-in, under a new Centers for Medicare and Medicare Services draft guidance on the Inflation Reduction Act's co-pay "smoothing" plan. Starting in 2025, the IRA's Medicare Part D redesign offers beneficiaries with very high-cost prescriptions the option to spread their co-pays along monthly installments rather than paying the full cost at the time of prescription dispensing... Sub. Req'd

Richard Burr: There is a Path to Reducing Anti-Patient Drug Price Abuses | Opinion

(2/19, Richard Burr, The Charlotte Observer) ...For Americans to benefit from the tremendous medical innovation that brings treatments and cures, they need to be able to afford them. Patients deserve a transparent and fair process that helps make the drugs they need more affordable, not less. The most effective and quickest way to end anti-patient practices by PBMs and reduce the amount Americans pay out-of-pocket for their medicines is for Congress to pass these bipartisan reforms and for President Biden to sign them into law... Full

Knowing Actual Prices Will Help HHS Set The Maximum Fair Price Under The Inflation Reduction Act

(2/16, Steven M. Lieberman Paul B. Ginsburg, Health Affairs) ...By specifying upper limits on what manufacturers can charge Medicare for selected drugs, the Inflation Reduction Act delegates broad discretion to the secretary of the Department of Health and Human Services to set prices after assessing each drug's value. For HHS to evaluate whether the drug prices it sets for Medicare are fair and reasonable, it would be helpful to know the true prices that all other payers (both public and private) pay for the same drugs... Full

US Rivalry with China Expands to Biotech. Lawmakers See a Failure to Compete and Want to Act

(2/19, Didi Tang, Associated Press) ...U.S. lawmakers are raising alarms about what they see as America's failure to compete with China in biotechnology, warning of the risks to U.S. national security and commercial interests. But as the two countries' rivalry expands into the biotech industry, some say that shutting out Chinese companies would only hurt the U.S... Full

FDA's Generic Drugs Forum 2024: A Push for Accessible Healthcare

(2/16, Geeta Pillai, BNN) ...The FDA's commitment to enhancing generic drug access through regulatory considerations is a beacon of hope for millions. It emphasizes the agency's role not just as a regulator, but as a facilitator of progress in the health sector. As the forum concludes, the conversations and connections it spawns are expected to ripple through the industry, inspiring innovation and collaboration towards a future where quality healthcare is within everyone's reach... Full

Education Efforts to Help Increase Biosimilar Understanding and Acceptance

(2/14, Sarah Ikenberry, U.S. Food & Drug Administration) ...Hesitancy about using biosimilars may, in part, be due to lack of experience with the products, but it may also be due to a general lack of understanding of what they are and how FDA reviews and approves them. In response to this issue, CDER's Office of Therapeutic Biologics and Biosimilars has created resources to promote understanding of biosimilars, as outlined in the Biosimilars Action Plan. These programs include a variety of multimedia resources, online outreach, and other educational tools to inform patients and health care providers about the benefits and safety of biosimilars while dispelling misinformation... Full

Lamont Proposes Bill to Address Rising Healthcare Costs, But Advocates Say More is Needed

(2/19, Cris Villalonga-Vivoni, CTPost) ...When healthcare and prescription drugs become unaffordable, it becomes harder for people, especially older adults, to stick to their medication and treatment regimens, said Anna Doroghazi, associate state director for advocacy and outreach at AARP Connecticut...To address this, Gov. Ned Lamont proposed House Bill 5054, "An Act Addressing Health Care Affordability." The bill establishes two advisory boards under the state Office of Health Strategy to analyze various causes driving high healthcare costs and suggest strategies to remedy them. It would also allow OHS to create improvement plans at healthcare entities that exceed certain spending increase benchmarks... Full

European Group Demands Reform of Generics Procurement Policies

(2/19, The Pharma Letter) ...The trade group - which represents the generic, biosimilar and value-added medicines industries across Europe - has a newly-published position paper exploring how the current design of procurement rules in European Union member states, often aimed exclusively at reducing costs, has led to the consolidation of supply and increased risks for supply security. "Our position paper outlines key recommendations for future reform, both in the way we design tenders and select the best bidders"... Sub. Req'd

Pharma Package, Swedish MEPs Split Ahead of ENVI Vote

(2/19, Monica Kleja , Euractiv) ...Swedish Members of the European Parliament welcome updated EU pharmaceutical legislation but remain divided on diverse amendments, including on how to handle incentives for developing new antibiotics, though common ground for the Swedes exists on boosting the fight against antimicrobial resistance. As the European Parliament's ENVI committee prepares to vote on the new EU pharmaceutical framework, EURACTIV tested the political spectrum of Swedish MEPs, asking those close to the procedures about their current priorities. ENVI is set to vote on the proposed amendments and draft on March 11,, while a vote in the plenary is scheduled for April 1... Full

Originator Users in Finland Hesitant On Using Biosimilars

(2/16, Chelsie Derman, HCPLive) ...A recent survey in Finland found originator users are against switching to biosimilars—primarily due to their lack of biosimilar knowledge—but biosimilar users are not opposed to the interchange between biosimilar and originators. "Our findings indicate that patients' knowledge regarding biosimilars and biological medicines in general could be notably improved," wrote investigators, led by Mari Pölkki, PhD, from Oriola Corporation, Expert Services, in Espoo, Finland. "Patients' own awareness of their currently used biosimilar or originator was surprisingly weak."... Full

Outlook To Make Its Case For Ophthalmic Bevacizumab At High-Stakes EMA Meeting

(2/19, Neena Brizmohun, Pink Sheet) ...Developments are heating up on the regulatory front with regard to Outlook Therapeutics' bid to become the first company to secure EU marketing approval for an ophthalmic formulation of bevacizumab. Outlook's investigational product, brand name Lytenava (ONS-5010), for wet age-related macular degeneration (wet AMD), is listed as being up for a possible oral explanation meeting with the European Medicines Agency's human medicines committee, the CHMP, on February 20, according to the draft agenda of the latest CHMP monthly meeting taking place on 19-February 22... Sub. Req'd

How Transparent is the VPAG?

(2/20, Leela Barham, PharmaPhorum) ...Leela Barham takes a look at the transparency of the UK's new pricing and access scheme, the 2024 VPAG, based on public sources. Whilst it's early days, there is more in the public domain about VPAG than was known about VPAS, VPAG's predecessor, at this point in the scheme's implementation. With numerous commitments made in VPAG, time will tell how transparent the government's agencies and industry will be about progress and delivery, but there are reasons to be optimistic... Full

Azithromycin Leads Off UK Rises In January

(2/19, David Wallace, Generics Bulletin) ...January 2024 may have been a slightly more subdued month for UK generic price rises compared to the final month of last year – which saw riluzole prices spike heavily amid shortages – but there were still plenty of significant movements, according to the latest figures from WaveData. Based on trade prices to UK independent pharmacists, WaveData reported that the average price of azithromycin 250mg tablets in six-count packs leapt by 147% to £3.09 ($3.88) in January... Global Sub. Full

A Pitch to Walk the Fine Line Between Innovation and Access

(2/18, PT Jyothi Datta, The Hindu) ...India continues to be placed on the "Priority Watch List,", with seven countries including Argentina, Chile, China, Indonesia, Russia and Venezuela. Totally 29 countries have been placed on the PWL/Watch List. Industry-insiders and medicine access campaigners say that India needs to continue to campaign for flexibilities provided under international trade laws...Calling for a balance, the Association for Accessible Medicines said, "the Special 301 review is not a trade negotiation, it still should reflect the balance between innovation and access..."... Sub. Req'd

Data Exclusivity Demand In EFTA-India Deal: Access, Licensing, Other Implications

(2/18, Vibha Ravi,Pink Sheet) ...The contentious issue of data exclusivity has came to the fore once again after recent speculation that India could succumb to a demand made by the European Free Trade Association, comprising Switzerland, Norway, Iceland and Liechtenstein, to accept data exclusivity norms in a Free Trade Agreement under negotiation... Sub. Req'd

Brave New World: On the India-European Free Trade Association Agreement and IPR

(2/17, The Hindu) ...Expectations are high that a free trade agreement involving India and the European Free Trade Association is close to fruition. However, a bone of contention relates to intellectual property rights, and has persisted as an issue since 2008. Switzerland and Norway, which are prominent members of EFTA, host several of the pharmaceutical and biotechnology companies that are responsible for several of the drugs and therapeutics that underpin health care globally... Full

Australia Identifies HTA Challenges Posed By Emerging Technologies

(2/16, Ian Schofield, Pink Sheet) ...Emerging technologies such as advanced therapies, tumor-agnostic therapies, antibody-drug conjugates and microbiome-based therapies are likely to pose a challenge for existing health technology assessment, funding and subsidy pathways, according to a draft paper published by the Australian government... Sub. Req'd

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