Monday, January 22, 2024

FTC Weighs Enforcement Against Companies Refusing To Delist Patents

(1/19, Maaisha Osman, InsideHealthPolicy) ...The spokesperson also told IHP that FTC is willing to engage in conversations with the companies that were warned and chose not to delist their patents...While GSK has agreed to delist its patent in response to FTC's warning, AstraZeneca, Boehringer Ingelheim and Teva reportedly are gearing up to contest the commission's claims, asserting the rightful listing of their patents. Boehringer Ingelheim tells IHP it is on firm ground. "We are confident that all Boehringer patents that are the subject of the FTC's letter are properly listed under FDA regulations and applicable law," the Boehringer Ingelheim spokesperson told IHP... Sub. Req'd

Sandoz to Buy Eye Drug Cimerli in $170 Million Deal

(1/22, John Revill, Reuters) ...Sandoz, opens new tab on Monday announced a deal to buy Cimerli, a biosimilar drug to treat vision impairment and loss, from Coherus BioSciences Inc. for $170 million. The drug is interchangeable with Lucentis, a product marketed by Roche's, opens new tab Genentech in the United States and by Novartis, opens new tab in the rest of the world, for all approved indications, Sandoz said... Full

Alvotech Lines Up US Biosimilar Approvals After FDA Inspection

(1/22, David Wallace, Generics Bulletin) ...Alvotech has revealed details of exactly when it expects to win US FDA approvals for its Teva-partnered Humira and Stelara biosimilars, after an agency reinspection of its manufacturing plant in Reykjavik, Iceland resulted in just a single "readily addressable" Form 483 observation... Global Sub. Full

Alvotech Stock Jumps 15% On Stelara, Humira Biosimilars Updates (Update)

(1/19, Val Brickates, Seeking Alpha) ...Shares of Alvotech jumped 15% Friday after the biotech company said that issues raised during a recent FDA inspection of its plant in Iceland shouldn't delay potential approvals of its Stelara and Humira biosimilars...Alvotech has been co-developing the product with Teva Pharmaceutical Industries. According to the FDA's website, a Form 483 is issued at the end of an inspection when an investigator "has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts."... Full

Coherus And Formycon's Ranibizumab Rapidly Ramps Up In US

(1/19, David Wallace, Generics Bulletin) ...Formycon has reported positive uptake trends in the US for its Coherus-partnered ranibizumab biosimilar at the end of 2023, mirroring recent success in the UK with marketing ally Teva. Formycon has recently seen positive uptake trends for its FYB201 biosimilar rival to Lucentis (ranibizumab) in both the US and UK, according to the latest figures revealed by the German developer. In the US, marketing partner Coherus BioSciences – which launched the product as Cimerli (ranibizumab-eqrn) in October 2022, accompanied by an interchangeability designation – reported a significant leap in uptake towards the end of 2023, Formycon revealed... Global Sub. Full

Dr Reddy's Grows Consumer Health Offering In UK And US

(1/22, Tom Gallen, Generics Bulletin) ...Dr Reddy's Laboratories has expanded its consumer health offering with a UK product launch and US portfolio acquisition. The Hyderabad, India-headquartered company has entered the UK OTC market with the launch of hay fever treatment Histallay. Containing 120mg fexofenadine hydrochloride, Histallay tablets offer 24 hours of relief from allergic rhinitis symptoms such as sneezing, runny nose and itchy eyes, according to Dr Reddy's... Global Sub. Full

Celltrion Reveals 2030 Ambition Amid 80mg High-Concentration Adalimumab Launch

(1/19, Dean Rudge, Generics Bulletin) ...Biosimilars giant Celltrion plans to almost quadruple its current portfolio of six products to 22 by the year 2030, targeting the potential to grow its revenue by at least fivefold by the beginning of the next decade, the Korean firm told the recent annual J.P. Morgan Healthcare Conference under its ‘From Pioneer to Innovator' business presentation... Global Sub. Full

Samsung Bioepis Wins Korean Approval for Soliris Biosimilar

(1/22, Pulse) ...Samsung Bioepis Co., a biopharmaceutical research and development unit under South Korea's Samsung Group, announced on Monday that it obtained product approval from the country's Ministry of Food and Drug Safety for its blood disorder treatment ‘SB12' (Episcli)... Full

Dongwha Pharm Acquires 4 of Celltrion's Over-The-Counter Products

(1/19, Lee Han-soo, Korea Biomedical Review) ...Dongwha Pharm said it acquired four over-the-counter products from Celltrion, which the latter purchased from Takeda Pharmaceuticals in 2020, for about 37.2 billion won ($27.8 million). The transaction includes medications such as the comprehensive cold medicine Whituben and Whituben Nasal Spray, the mouth ulcer treatment Albothyl, and a vitamin D and calcium supplement Calcichew, sold only in Hong Kong and Taiwan... Full

FDA Slaps Boxed Warning On Amgen's Osteoporosis Drug Prolia

(1/19, Kevin Dunleavy, Fierce Pharma) ...Use of Amgen's osteoporosis drug Prolia by those with advanced chronic kidney disease can increase the risk of calcium loss in the blood, according to the FDA. The U.S. regulator has added a new boxed warning for the blockbuster treatment, which has been on the market for 14 years and loses patent protection next year... Full

Exclusive: US FDA Finds New Manufacturing Lapses at Eli Lilly Plant

(1/19, Marisa Taylor and Maggie Fick, Reuters) ...U.S. inspectors recently uncovered new manufacturing problems at an Eli Lilly, opens new tab plant that has been under scrutiny by federal investigators, according to government records obtained by Reuters...Lilly said in a statement to Reuters that the company had asked the FDA to allow for "additional flexibility" to manufacture migraine treatment Emgality on a different production line if needed in the future... Full

Gilead $247 Million Antitrust Deal Over HIV Drugs Gets Final Nod

(1/19, Joyce E. Cutler, Bloomberg Law) ...Gilead Sciences Inc. won final approval Friday to pay $246.75 million to end allegations that anticompetitive conduct forced direct purchasers to pay more for drugs used to treat and prevent HIV...The settlement follows a California jury finding in June that Gilead and Teva Pharmaceutical Industries Ltd. didn't engage in an anticompetitive conspiracy to delay generic versions of HIV treatment Truvada and other drugs. The unanimous verdict in litigation, brought by end payors, individual health plans, and United Healthcare Services Inc., affirmed that a 2014 patent settlement between Foster City, Calif.-based Gilead and Israel-based Teva didn't violate antitrust law... Full

Superbug Crisis Threatens to Kill 10 Million Per Year by 2050. Scientists May Have a Solution

(1/21, Sandee LaMotte, CNN) ..."It's estimated that by 2050, 10 million people per year — that's one person every three seconds — is going to be dying from a superbug infection," said infectious disease epidemiologist Steffanie Strathdee, codirector of the first dedicated phage therapy center in North America, the Center for Innovative Phage Applications and Therapeutics, or IPATH, at UC San Diego School of Medicine... Full

In ‘March-In' Rights, Some See a Tool to Lower Drug Prices. Others See a Threat to Intellectual Property

(1/22, Ed Silverman, STAT Plus) ...Some maintain the move can help lower costs for pricey medicines, and the Biden administration recently took the contentious step of proposing a framework for when it would exercise these rights. Yet the idea has alarmed the pharmaceutical industry, which argues it may rob companies of revenue and, fundamentally, intellectual property rights... Sub. Req'd

E&C Dems Renew Call To Address Drug Shortages Through PAHPA

(1/19, Jessica Karins, InsideHealthPolicy) ...While reauthorization of a major pandemic law has been delayed by Congress' lengthy fight on appropriations, Democratic health leaders in the House aren't giving up and still hope to address drug shortages through a new iteration of the Pandemic and All-Hazards Preparedness Act. House Republicans have refused to attach drug shortage measures to their version of PAHPA extension legislation... Sub. Req'd

CR Extension Offers Extra Time For PBM Reform Passage

(1/19, Gabrielle Wanneh, InsideHealthPolicy) ...The status of several pharmacy benefit manager reforms remains up in the after Congress passed a new stopgap spending bill Thursday (Jan. 18) that temporarily extends federal government funding through March 1 and March 8, giving lawmakers and PBM reform advocates another seven weeks to hash out their differing PBM reform bills for possible movement alongside a March spending bill. Given the amount of time lawmakers spent to introduce and pass legislation to boost PBM transparency and accountability throughout 2023, Horizon Government Affairs CEO Joel White says lawmakers likely want to push their reforms over the finish line... Sub. Req'd

Greater Biosimilar Uptake Found in Medicare Advantage Than Traditional Medicare

(1/21, Cameron Santoro, The Center For Biosimilars) ...A cross-sectional study, published on the JAMA Health Forum, found biosimilar use and market share higher in Medicare Advantage plans compared with traditional Medicare plans for most biosimilar products, except for bevacizumab. Calculated cumulative data from May 2015 to September 2022 was used to evaluate biosimilar market shares for products with at least 1 biosimilar administration on or before September 30, 2019. A total of 20 biosimilar products were included, mainly used in Parts B and C, amongst 7 different product types... Full

Pharma Industry Fights Back Against More Pricing Negotiations

(1/19, The Pharma Letter) ...US healthcare lobbyist Vital Transformation has released a document outlining objections to the expansion of drug pricing policies under the Inflation Reduction Act...In its research, Vital Transformation states that government-mandated drug pricing policies could translate to a loss of over a million jobs within ten years, while risking billions in R&D investments. The group claims that 40% of affected drugs would "likely never have come to market" had the price controls been in effect during their development... Sub. Req'd

Federal Lawmakers Take First Steps Toward Oversight of $50 Billion in Opioid Settlements

(1/22, Aneri Pattani, KFF Health News) ...This month, Rep. Marcy Kaptur, D-Ohio, and Rep. Ashley Hinson, R-Iowa, introduced legislation that would write into law approved uses for the funds so they reach people most affected by the crisis...KFF Health News has been reporting for more than a year, a lack of transparency and enforcement has made it difficult to determine if states are meeting that 85% threshold. In at least two instances, counties used settlement funds to pay back old debt or shore up their budget. Other jurisdictions have made controversial purchases, including a lasso-like tool for police officers and body scanners for jails... Full

Generic Drug Pilot On Model-Informed Evidence Aims To Boost Review Efficiency

(1/21, Derrick Gingery, Pink Sheet) ...US FDA officials, hoping to kick start participation in the pilot, argue modeling decisions made early in development can help streamline the ANDA review later. US Food and Drug Administration officials emphasized the efficiency that its new Model-Integrated Evidence pilot could create for generic drug sponsors in a bid to encourage participation... Sub. Req'd

FDA Sets Aggressive Deadline for Inspection Overhaul

(1/22, John Wilkerson, STAT Plus) ...Food and Drug Administration officials hope to finish this year a massive overhaul of the way the agency inspects facilities that make drugs, medical devices, and food products, they said Friday. The reorganization was spurred by the FDA's mishandling of the infant formula crisis. The agency was slow to inspect a major infant formula plant despite a whistleblower complaint about deadly bacterial contamination at the facility. An investigation found that the delayed response was due in part to the agency's organization... Sub. Req'd

‘The Largest Reorganization In FDA's History': ORA Overhaul Better Thought Of As Agency-Wide Reorg

(1/20, Sarah Karlin-Smith, Pink Sheet) ...A majority of US Food and Drug Administration units – 15 out of its 21 offices – will be impacted by a pending reorganization that is currently awaiting clearance from higher ups in the Biden administration, outgoing principal deputy commissioner Janet Woodcock said on January 19. The reorganization, officially released in December 2023, has often been discussed as a revamp of the FDA's food program and inspections work done by the Office of Regulatory Affairs division. But the changes are going to impact many functions of the agency, per Woodcock... Sub. Req'd

CDER's Office of Compliance Kicks Off Annual Report Season with Rundown of 2023's Major Public Health Enforcement Initiatives

(1/22, John W.M. Claud, FDA Law Blog) ...The Office of Compliance at FDA's Center for Drug Evaluation and Research had a role in many of the major public health enforcement matters you may have read about last year. OCs recent 2023 Annual Report—covering the fiscal year from October '22 to September '23—puts some meat on the bones of those issues and describes how OC touches almost every area of enforcement that CDER undertakes. One of 12 offices at CDER, a look at its annual report tells us a great deal about CDER's enforcement priorities... Full

Like Many Missourians, I Had to Ration My Insulin. Drug Patent Abuse is Out Of Control

(1/21, Hattie Saltzman, The Kansas City Star) ...Extending drug monopoly pricing by decades means patients can't buy cheaper generic alternatives. The only recourse for competitors is to ask courts to invalidate those secondary patents. Upstarts win about 73% of the time, but cases are expensive ($2.5 million dollars median in 2019) and take years to complete. We need to end over-patenting before it happens... Full

Report Finds Some Drug Manufacturers Spend More On Advertising, Executives' Salaries Than New Research

(1/19, Danielle J. Brown, Maryland Matters) ..."Profit Over People" — a study by Public Citizen — comes as many Marylanders struggle to afford necessary prescription drugs and as health advocates argue that some medication prices are artificially high...Vincent DeMarco, president of Maryland Health Care for All, and several state lawmakers want to expand the authority of Maryland's Prescription Drug Affordability Board, which is tasked with reining in prices for drugs on the government health care plans in the state... Full

IGBA Support for a WHO Pandemic Agreement

(1/22, IGBA) ...The generic and biosimilar medicines industry globally, represented by the International Generic and Biosimilar medicines Association, supplies the overwhelming majority of prescription medicines to patients worldwide, and strongly supports ongoing multilateral efforts to achieve a robust WHO Pandemic Agreement... Full

Clarity ‘Urgently Needed' Over EU SPC Manufacturing Waiver

(1/19, David Wallace, Generics Bulletin) ...In the wake of a German court decision that Medicines for Europe says "adopted an inordinately restrictive interpretation of the SPC manufacturing waiver," the association has called for clarity and simplification of the SPC manufacturing waiver legislation, claiming that its use could otherwise be undermined... Global Sub. Full

Czech Health Official: Longer Patent Protection Will Not Boost Pharma Innovation

(1/22, Aneta Zachová, Euractiv) ...The Czech Ministry of Health says that providing longer regulatory protection, proposed by the pharma industry, will not solve the problem of the outflow of investment from Europe to the USA or boost innovative medicines, rejecting the industry's arguments...The Czech Deputy Health Minister Jakub Dvorácek sees the situation differently. According to him, there is "no equation mark" between the setting of the length of RDP and the level of innovative drug development in the EU. "I challenge the thesis, the narrative, that drug development and research in Europe depends on the RDP we have in place," Dvorácek told Euractiv... Full

EFPIA's Vision for the Future of Cancer Treatment in Europe Beyond 2025

(1/22, The Pharma Letter) ...The convergence of cutting-edge technologies and breakthroughs in the scientific understanding of cancer have enabled unprecedented opportunities for precision oncology, according to a posting on the European Federation of Pharmaceutical Industries and Associations. At the core of PO is the ability to identify optimal treatments tailored to each patient's unique biological characteristics, breaking away from conventional one-size-fits-all approaches centered around tumor location... Sub. Req'd

Editorial: The Guardian View On Medicine Shortages: A Global Issue for Which Britain Needs a Plan

(1/21, The Guardian) ...Worryingly, the Motor Neurone Disease Association claims that concerns raised with the health secretary, Victoria Atkins, and her department, have not been properly dealt with. Riluzole's manufacturer, Glenmark, has pointed to competing demands for limited stock of its active ingredient. That sufferers of such serious illnesses are facing these problems is obviously concerning. With around 100 medicines on a shortages list, the government appears under-prepared and slow to act... Full

Tough Medicine in 2024 for Ireland's Struggling Healthcare System

(1/19, Brian Maguire, Euractiv) ...The Irish government endured a tough 2023 fraught with bruising health battles, with complex legacy healthcare challenges set to be played out in 2024. Euractiv asked leading Irish stakeholders to explain what they see on Ireland's troubled healthcare horizon...The Department of Health expects to see continued progress towards universal healthcare and increased investment in health and social care services to help fund Ireland's healthcare transformation agenda, set out in Sláintecare and the coalition's Programme for Government... Full

Sweden Extends Grace Period Following Non-Urgent Label Changes

(1/19, Ian Schofield, Pink Sheet) ...The Swedish Medical Products Agency has revised its guidance on product labeling to allow pharma companies to be given more time to produce new pack leaflets and labels when certain changes are made to the product information...Under new rules that took effect on January 11, the MPA says that this period can now be extended to 12 months "after assessment in each individual case." Extensions will only be granted for "non-urgent and purely administrative changes to package leaflet and labeling." The move mainly involves changes that do not affect the "safety, handling or administration" of the product, the agency noted... Sub. Req'd

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