Wednesday, February 28, 2024

Giving Israeli Big Pharma A Booster

(2/27, The Jewish Chronicle) ...Teva, Israel's biggest company, on its new focus on patents. Despite revenue of $13.9bn (£9.2bn) in 2009, 25 per cent more than in 2008, Teva Pharmaceuticals still has far to go to surpass the UK's largest drug manufacturer GlaxoSmithKline, which reported £23.7bn from its pharmaceutical activities last year. A glance at both companies' leading products also reveals a huge difference between GSK and Teva. The Israeli company is the world's largest manufacturer of generic drugs (pharmaceuticals that have expired patents), while GSK's portfolio holds mainly branded, patented drugs...But if Dr Aharon Schwartz, vice president of innovative ventures at Teva, has his way, then a far larger chunk of Teva's future revenue will be generated from lucrative branded drugs... Full

Teva, Jiangsu Nhwa Form Partnership to Market & Distribute Austedo in China

(2/28, Pharmabiz.com) ...Teva Pharmaceutical Investments Singapore Pte Ltd, a subsidiary of Teva Pharmaceutical Industries Ltd. and Jiangsu Nhwa Pharmaceutical Co., Ltd announced it formed a partnership for the marketing and distribution of Teva's Austedo (deutetrabenazine) for the treatment of neurodegenerative and movement disorders - chorea associated with Huntington's disease and tardive dyskinesia in adults. The partnership intends to increase patients' access to Teva's Austedo, leveraging Nhwa's leadership in China's neuro-psychiatric health sector... Full

Nickel and Dimed

(2/27, Debby Garbato, Drug Store News) ...Generics are vital for patients' financial and overall well-being. The Association for Accessible Medicines said generic and biosimilar savings totaled $408 billion in 2022. Of that, Medicare savings amounted to $130 billion ($2,563 per beneficiary). Combined, generics and biosimilars represent 90 percent of all U.S. prescriptions—but less than 18 percent of savings, with prices of generics declining by about 20 percent since 2019. AAM found that many scarce drugs were in the lowest price tiers... Full

Samsung Bioepis Achieves Ophthalmology Milestone With Korean Aflibercept Approval

(2/27, David Wallace, Generics Bulletin) ...Samsung Bioepis has declared itself "the first company to have obtained regulatory approvals for both Lucentis (ranibizumab) and Eylea (aflibercept) biosimilars" after its SB15 aflibercept candidate was approved in Korea as Afilivu... Global Sub. Full

Samsung Bioepis Announces New Biosimilar Partnership, Regulatory Updates

(2/27, Skylar Jeremias, The Center For Biosimilars) ...Samsung Bioepis provided multiple updates on its biosimilar projects, including a new partnership for its aflibercept biosimilar candidate as well as regulatory news in the European Union and Republic of Korea...The new partnership for SB15 marks the second in the ophthalmology space. In June 2022, the companies agreed on a marketing partnership concerning Amelivu, a ranibizumab product that has been on the Korean market since January 2023... Full

Amneal Signs Agreement with Zambon for Parkinson's Disease Therapy

(2/28, Pharmaceutical Technology) ...Amneal Pharmaceuticals has signed an exclusive licensing agreement with Zambon Biotech, granting the latter rights to commercialise IPX203 for the treatment of Parkinson's disease in several regions, including the European Union, the UK and Switzerland. An oral formulation of carbidopa / levodopa (CD/LD) extended-release capsules, IPX203 is being reviewed by the US Food and Drug Administration... Full

Celltrion Begins Shipment of Remsima SC for US Debut

(2/28, Park Se-ra, The Korea Herald) ...Biopharmaceutical giant Celltrion announced Wednesday that the first batch of its new autoimmune disease treatment Zymfentra, also known as Remsima SC, has been shipped for its planned debut in the US next month...The company said its more patient-friendly administration compared to the current intravenous injection version is expected to address the needs of both patients and health care professionals for more convenient treatment options... Full

Zydus Aims to Launch First New Drug in US by Early 2026

(2/27, Rishika Sadam and Leroy Leo, Reuters) ...India's Zydus Lifesciences is aiming to launch its first new drug in the United States by early 2026, looking to tap into the multi-billion dollar market for treating a type of liver disease, Managing Director Sharvil Patel told Reuters...Zydus will enter a competitive field, with an FDA decision on CymaBay's PBC drug due in August. Gilead Sciences announced its acquisition of CymaBay for $4.3 billion earlier in February...Zydus also plans on launching a generic version of Novo Nordisk's popular diabetes and weight-loss drug - Semaglutide - after its patent expires in India and has already started developing the injectable, Patel said... Full

Cosette Launches First US Generic To AbbVie's Rectiv

(2/27, Urte Fultinaviciute, Generics Bulletin) ...The US Food and Drug Administration has given the green light to Cosette Pharmaceuticals to launch the first generic version of originator AbbVie's Rectiv (nitroglycerin) ointment, 0.4%. The agency approved Cosette's abbreviated new drug application with 180 days of competitive generic therapy exclusivity. The company said it will "imminently commence commercial shipments" to trigger the six-month exclusivity period... Global Sub. Full

Viatris Licenses Idorsia's PhIII Heart and Lupus Drugs with $350M Upfront

(2/28, Ayisha Sharma, Endpoints News) ...Viatris has inked a deal with Idorsia for a pair of late-stage drug candidates in a move that may reflect Viatris' efforts to build its product development muscle. The development and commercialization partnership is based on two Phase III assets: P2Y12 inhibitor selatogrel for acute myocardial infarction and S1P1 receptor modulator cenerimod for systemic lupus erythematosus. Viatris also has the right of first negotiation and first refusal for certain other Idorsia assets... Full

Viatris Forecasts Strong 2024 Sales On Higher Demand for Branded Drugs

(2/28, Sneha S K, Reuters) ...Drugmaker Viatris forecast annual revenue above Wall Street estimates on Wednesday, banking on strong demand for its branded drugs such as Yupelri for lung disease and Breyna for asthma. The company said it expects 2024 revenue to be in the range of $15.25 billion to $15.75 billion, the midpoint of which is above analysts' average expectation of $15.30 billion, according to LSEG data... Full

Sawai Reports Slight Growth In Japan Amid Challenges

(2/27, Adam Zamecnik, Generics Bulletin) ...The company's third quarter results come during its planned withdrawal from the US and the recent implementation of administrative dispositions in Japan on grounds of GMP violations. Sawai Pharmaceutical has reported a slight growth in its net sales and core operating income in Japan compared to the last fiscal year in its financial third quarter, despite facing ongoing challenges abroad and at home... Global Sub. Full

A ‘Renaissance in Neuroscience' Could Deliver a Fresh Crop of Psychiatric Medicines

(2/28, Damian Garde, STAT Plus) ...The need for new, effective psychiatric treatments has only grown, and scores of biotech startups have been toiling in pharma's absence. Now, through a combination of scientific discovery and a little serendipity, the field has finally come up with a spate of promising new medicines... Sub. Req'd

Outages from Cyberattack at UnitedHealth's Change Healthcare Extend to Seventh Day as Pharmacies Deploy Workarounds

(2/27, Ashley Capoot, CNBC) ...Change Healthcare's systems are down for the seventh straight day after a cyber threat actor gained access to its network last week. Parent company UnitedHealth Group said most U.S. pharmacies have set up electronic workarounds to mitigate the impact...The disruption has not impacted provider cash flows yet since payments are typically issued one to two weeks after processing, UnitedHealth said Monday... Full

PBM Action Lags In Congress And At FTC As Targeting Commercial Plans Divides Republicans

(2/27, Sarah Karlin-Smith, Pink Sheet) ...PBM reform isn't expected to ride along with the next government funding packages, which could push any prospect of legislative reform closer to 2025. Meanwhile FTC says it is facing difficulty getting all the information for its investigation. Disagreement among Senate and House Republicans over whether to tackle commercial health plans in pharmacy benefits manager reform ultimately led the topic to be taken off the table as a ride-along measure for one of the upcoming government funding bills... Sub. Req'd

FTC Says Pharmacy Benefit Managers Are Stonewalling Requests for Information

(2/27, Ed Silverman, STAT Plus) ...A much-anticipated inquiry by U.S. antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022. The inquiry was begun by the Federal Trade Commission in response to the role that pharmacy benefit managers play in the cost of prescription medicines. Through their unique position, these companies — including CVS Caremark, Express Scripts, and OptumRx — help determine which medicines are covered by commercial health insurers and the prices that are paid at pharmacy counters, among other things... Sub. Req'd

Community Pharmacists Demand CMS Take Enforcement Action Against PBMs

(2/27, Luke Zarzecki, InsideHealthPolicy) ...As news surfaced Tuesday (Feb. 27) that Congress is punting long-debated pharmacy benefit manager reforms, the community pharmacy lobby demanded CMS immediately take enforcement action against improper PBM practices that the lobby says could cause nearly a third of independent pharmacies to shutter this year. The National Community Pharmacists Association wrote to CMS on Tuesday that PBMs have done little to change their policies even though CMS asked them in December to be ready to correctly bill pharmacists when new Medicare rules kicked in Jan. 1... Sub. Req'd

PBM Reform Advocates Hold Out Hope for Congressional Action

(2/27, Michael McAuliff, Modern Healthcare) ...Advocates for tougher restrictions on pharmacy benefit managers are not giving up after Congress reportedly shelved several proposals this week, even if lawmakers see no immediate path forward...Members of a new industry group, Transparency-Rx, composed of smaller PBMs who espouse more open operations, said they were at least heartened that PBM bills made it as far as they have. They predicted Congress eventually will act. "I think the lack of PBM language at this point in the budget package to me has to do with the broader contours about the budget negotiations and the dynamics between the two chambers not really relevant to the substantive support," said Transparency-Rx Managing Director Joe Shields in a briefing with reporters... Sub. Req'd

Biden Wants to Lower Drug Costs But How He Plans to is a Terrible Idea

(2/27, James Pooley, San Francisco Chronicle) ...In December, the Biden administration announced a plan to ensure that "taxpayer-funded drugs" are "reasonably available and affordable." A laudable goal, all can agree. But the proposed method is for the government to forcibly relicense the patents for drugs it considers too expensive and give them to generic competitors. That's a catastrophically harmful prescription. Putting patent rights in jeopardy would discourage investment in innovation — leading not only to fewer cutting-edge medications but to fewer life-changing technologies across all industries. However well-intentioned, it's a misguided plan... Full

More Pandemic-Style Price Fixing Won't Help Global Health

(2/27, Satya Marar, The Hill) ...This week, 19 House Ways and Means Committee members wrote to President Biden opposing broadening the pandemic-era waiver on intellectual property protections for COVID-19 vaccines. Despite evidence that the waiver failed to foster developing countries' access to these vaccines, left serious supply-chain deficits unresolved and threatened future drug development and innovation, the Biden administration and World Trade Organization are contemplating extending it to include COVID-19 diagnostic tools and therapeutics... Full

Generics, Gene Therapy Groups Have Concerns About FDA's AMT Program

(2/27, Jessica Karins, InsideHealthPolicy) ...FDA's new advanced manufacturing technology designation program could provide incentives encouraging manufacturers to speed adoption of new technologies that may help avert drug shortages or have other benefits, an attorney and former FDA official said, but the cell and gene therapy and generics industries are expressing concern about how the program might impact them... Sub. Req'd

Quality Officers Call For New Approaches To Reduce Global Manufacturing Change Complexity

(2/27, Bowman Cox, Pink Sheet) ...Pharmaceutical quality leadership proposes eight-step "dance" with complex global regulatory system for allowing manufacturing processes to improve more quickly. The data showed many authorities take more than the recommended six months to decide on post-approval changes, with assessments taking almost eight years in some cases... Sub. Req'd

Surely You Must be Kidding, PTO?!? "No, and Don't Call Me Shirley!" – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 1)

(2/28, Kurt R. Karst, FDA Law Blog) ...It's been a while since we last blogged on Patent Term Extension issues of interest. And with 2024 (September 24th) being the 40th anniversary of the enactment of the 1984 Hatch-Waxman Amendments—the statute that amended Title 35 of the United States Code to create PTEs for certain FDA-regulated products—and a recent spate of PTE-related items posted on regulations.gov, we thought we would peruse some decisions to see what's up at the Patent and Trademark Office PTE-wise. Well, we found much more than we thought we would. And some of our finds left us asking if the PTO has taken on the role of Dr. Rumack (Leslie Nielsen) in the 1980 movie "Airplane!". But all kidding aside, some of the recent decisions we found are rather distressing... Full

US FDA to Boost Inspections of Drug Manufacturing Units in India

(2/27, Rishika Sadam and Leroy Leo, Reuters) ...The U.S. drug regulator is set to increase the number of inspections at Indian drug manufacturing units in 2024 amid growing concerns over the quality of drugs, a top executive for the Food and Drug Administration told Reuters...The development comes as India's $42-billion pharmaceuticals industry works to grow its global presence, with the government pushing drug producers to implement good manufacturing practices to match global standards... Full

FDA Officials Argue for Retaining Advisory Committee Votes, Welcome Return to Face-to-Face Meetings

(2/27, Joanne S. Eglovitch, Regulatory Focus) ...Officials from the US Food and Drug Administration (FDA) argued that advisory committees should retain their voting procedures on whether to recommend drugs and said that such votes offer clarity on the committees' deliberations. Agency officials made these assertions at the 2024 Biopharma Congress meeting on February 26,. The officials also noted that there will be a return to face-to-face advisory committee meetings this fall... Full

States Guard Drug Discount Program as Pharma Wages Legal Battles

(2/28, Nyah Phengsitthy, Bloomberg Law) ...State legislation aiming to block discriminatory practices used against pharmacies in a federal drug discount program is ramping up this year despite legal challenges from the drug industry. The legislation is designed for the 340B Drug Pricing Program, a federal plan allowing covered entities such as qualifying safety-net hospitals, clinics, and other providers to purchase outpatient drugs at discounted prices from manufacturers participating in Medicaid...Opposition to the state legislation comes from the pharmaceutical industry. The major drugmaker lobbying group, the Pharmaceutical Research and Manufacturers of America, challenged Arkansas and Louisiana's laws, and AstraZeneca PLC and AbbVie Inc. are battling Louisiana in federal court... Sub. Req'd

Colorado Board's Vote On ‘Unaffordable' Drug Sets Up Litigation

(2/27, Celine Castronuovo, Bloomberg Law) ...Colorado's first-in-the-nation vote to pursue a cap on how much health plans pay for a prescription drug brings the state a step closer to facing litigation, a result analysts say is inevitable for states attempting to rein in the cost of medicines. The Colorado Prescription Drug Affordability Board voted Feb. 23 to move ahead with rulemaking to establish an upper payment limit for Amgen Inc.‘s arthritis drug Enbrel, a week after the five-member board determined the drug is "unaffordable" for Colorado patients... Sub. Req'd

Colorado Submits Amended Drug Importation Application To FDA

(2/27, Luke Zarzecki, InsideHealthPolicy) ...Colorado submitted its amended Canadian drug importation application to FDA on Tuesday (Feb. 27), including a scaled-back list of 24 drugs it plans import at a lower cost, including blockbuster drugs like Novo Nordisk's Ozempic and Vertex Pharmaceutical's Trikafta...The state's revised application says the program could save $51 million over a three-year period. At the earliest, HCPF estimates the program can start operating by late 2024, depending on when the application is approved by FDA... Sub. Req'd

Expensive Prescription Drug Costs Would Be Capped in Nebraska Under New Bill

(2/27, Sean MacKinnon, KETV 7 ABC) ...A bill introduced in the legislature today would create a board to "cap" prescription drug costs. The board would review 12 medications per year and recommend an upper limit based on the price of similar medications or what they cost in other countries...At the bill's hearing Tuesday, a lobbyist from Colorado came to Lincoln in opposition. "It is really not clear how an upper payment limit would operate, it's still an open question, as no state has done it yet," Katelin Lucariello with Pharmaceutical Research and Manufacturers of America said... Full

How The EU & UK's Contrasting Approaches To AI Regulation Could Impact Pharma

(2/27, Eliza Slawther, Pink Sheet) ...While EU preparations are underway to introduce strict legal requirements for all AI systems, the UK has doubled down on its flexible, non-regulatory framework. In this second of a two-part article, a lawyer explains the pros and cons of each for pharma and medtech firms..."The main risk of the EU's approach is the risk of duplication of requirements which leads to administrative burden and the potential for inconsistent requirements," [Jacqueline Mulryne, partner at multinational law firm Arnold & Porter] told the Pink Sheet... Sub. Req'd

Doctors' Protests Intensify In Korea As Essential Healthcare Challenges Highlighted

(2/28, Jung Won Shin, Pink Sheet) ...South Korea's healthcare services face both longer-term systemic challenges and short-term disruption from ongoing doctor walkouts over government plans to boost medical trainees. Meanwhile, the local pharma industry is calling for new measures to support the supply of essential drugs...There have been repeated shortages of essential medicines in Korea, which have further deteriorated since the COVID-19 pandemic. A recent Korea Pharmaceutical and Bio-Pharma Manufacturers Association report on the national status of essential drugs and measures to stabilize distribution noted that supplies of many products, including cold drugs and antipyretics, have faced repeated disruptions since the pandemic... Sub. Req'd

Pharma Industry Needs a Shot of GenAI to Shift Focus to Value from Volumes

(2/27, KV Kurmanath, The Hindu) ...Generative AI and data can propel India as a top player value-wise also, according to BioAsia and EY Parthenon (EY-P). In a white paper titled ‘From volume to value: Indian pharma's transformation with data and AI' released at the inaugural of BioAsia 2024 here on Tuesday, they said the industry set a target of breaching the $130-billion mark by 2030. "With the prevailing growth rate of 6.2 per cent, achieving this target seems improbable. Rather than relying on manufacturing simple generics, there is a heightened need to embrace diversification and value addition over volume," it said... Full

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