Wednesday, November 20, 2024

Colorado Asks 10th Circuit to Send $60 Epi-Pen Reimbursement to State Court

(11/19, Amanda Pampuro, Courthouse News Service) ...Colorado on Tuesday asked the 10th Circuit to reverse a lower court's order refusing to redirect a pharmaceutical manufacturer to state court for reimbursement of losses under the state's $60 epi-pen program...Teva Pharmaceuticals USA sold 14,000 generic autoinjectors for children to Colorado wholesalers in 2022, then sold through pharmacies. Teva doesn't know how many devices went to uninsured people and would trigger the Colorado law, but typically charges $300 per two-pack. Teva sued Colorado in federal court in October 2023, claiming the law violated its Fifth Amendment right against government takings... Full

Lupin Aims To Be In The First Wave Of GLP-1s In Emerging Markets

(11/19, Urte Fultinaviciute, Generics Bulletin) ...Lupin is eyeing the off-patent GLP-1 space in India and other emerging markets, with plans to launch its first products in 2026 as the first wave of generics starts coming in, the firm's management disclosed during Lupin's recent Q2 FY2025 earnings call...While patents covering certain GLP-1 drugs do not expire until 2030 in some of the "more regulated" markets, except for Canada, Lupin sees a window of opportunity in India, South Africa, Latin America, the Philippines, and in some parts of Eastern Europe, as "those are the markets that are available for us to launch in 2026," said CEO Vinita Gupta... Global Sub. Full

USFDA Gives Nod to Lupin's Generic Formulation to Treat ADHD Symptoms

(11/20, Financial Express) ...Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for its generic formulation of Takeda's Adderall XR... Full

In The Nick Of Time: Xbrane Picks Up Intas As Global Nivolumab Partner

(11/19, Dave Wallace, Generics Bulletin) ...Having previously set itself a deadline of the end of November to strike a licensing deal for one of two biosimilar candidates – or risk failing to meet its working capital requirements – Sweden's Xbrane has now announced a global licensing partnership with Intas for its nivolumab Opdivo rival, with just days to spare... Global Sub. Full

Samsung Biologics Wins $668 Million CDMO Deal with European Pharma

(11/20, Dae-Kyu Ahn, The Korea Economic Daily) ...Samsung Biologics Co., the world's largest contract drugmaker, said on Wednesday it has signed two drug manufacturing contracts worth a combined $668 million with an unidentified European biopharmaceutical firm. The contracts, set to last until the end of 2031, are valued at 752.4 billion won ($539 million) and 178 billion won, respectively, Samsung said in a regulatory filing...Samsung Biologics said it has now partnered with 17 of the world's top 20 pharmaceutical companies and continues to extend contracts with existing clients to support them in advancing innovative therapies... Full

With Patent Settlement, BeiGene Defends Blockbuster Brukinsa from MSN's Generic Threat Until 2037

(11/19, Eric Sagonowsky, Fierce Pharma) ...As BeiGene works to change its corporate identity and grow the reach of its cancer offerings around the globe, the company has resolved one potential overhang by inking a patent settlement with MSN Pharmaceuticals over its star medicine Brukinsa. Under the terms of the deal, MSN will be able to launch its proposed Brukinsa generic in the U.S. on June 15, 2037, BeiGene said in a Tuesday press release. The date is "subject to potential acceleration or extension under certain customary circumstances," BeiGene noted... Full

Chinese Drugmaker Receives FDA Warning Letter After Management Hindered Inspection

(11/19, Anna Brown, Endpoints News) ...The FDA handed Chinese pharmaceutical company Tianjin Darentang Jingwanhong Pharmaceutical a warning letter after it removed information from translated manufacturing records and refused to let agency inspectors take photos during a facility visit. Tianjin Darentang employees informed the FDA inspectors they concealed information after "top management" told them to "protect" certain data, which "significantly hindered" the inspection, according to the letter published Tuesday... Full

'Some Call it the J.P. Morgan of Europe': Jefferies' London Conference Goes Big for 2024

(11/19, James Waldron, Fierce Biotech) ...Today, the biggest presentations have been moved to the ME hotel, where Big Pharma execs kicked off proceedings by drilling down into their BD strategies. They included Bristol Myers Squibb CFO David Elkins, who spelled out how the drugmaker's $1.5 billion cost-savings initiative this year will free up funds to invest into programs like the recently approved schizophrenia therapy Cobenfy and the radiopharmaceuticals acquired along with RayzeBio... Full

Drugmakers and Pharmacists Battle Over Who Gets to Make Obesity Drugs

(11/20, Sydney Lupkin, NPR) ...Novo Nordisk and Eli Lilly are moving to end compounding of their medicines for good. They say they are no longer in shortage (a necessary condition for legal compounding in this case), and that they are too difficult to compound anyway. The compounding industry disagrees. As the battle over who gets what share of the multi-billion dollar obesity drug market continues, some patients are left wondering how they're going to get their next injections — and from whom... Full

Drugmakers 'Not Doing Everything That They Could' to Widen Global Access, New Report Finds

(11/19, Max Bayer, Endpoints News) ...Novartis was ranked the top company for the first time, while GSK dropped to second place. Sanofi, Pfizer, AstraZeneca and Johnson & Johnson rounded out the top five (the last two were tied). The report focused on three key findings: licensing and technology transfers, clinical trial access, and making existing products available. The rankings, released Tuesday, were overshadowed by a broader concern that access has been hampered by a post-Covid slowdown, according to Access to Medicine Foundation CEO Jayasree Iyer... Full

With RFK Jr. Looming As Health Secretary, Pharma Execs Try to Project Stability

(11/19, Andrew Joseph, STAT Plus) ...So when President-elect Trump, who said Thursday that drug companies have "crushed" Americans, announced RFK Jr. as his pick for health secretary, the industry's share prices dove. But at an investor conference Tuesday, pharma executives who were asked about the prospect of an RFK Jr.-led Health and Human Services Department sought to project it was business as usual... Sub. Req’d

Drug Industry Treads Carefully After Stunning RFK Jr. Nomination

(11/20, Sylvan Lane, The Hill) ...Lobbyists said they anticipated Kennedy would get some kind of role in the administration but were surprised at his being picked for HHS secretary. They are now scrambling to figure out what kind of damage Kennedy could inflict were he to be confirmed. "Striking at the heart of a science-based industry like this by saying nonsensical stuff and actually having power to do something about it is bad news," said a lobbyist who works for drug companies. "I think right now they're in sort of like ‘holy s— mode.'"... Full

Oz's Embrace Of Alternative Medicine Could Influence CMS Policy

(11/19, Jessica Karins, InsideHealthPolicy) ...President-elect Donald Trump's proposed appointment of physician and TV personality Mehmet Oz to lead CMS could have an impact on the agency's coverage policies toward unproven treatments not tested by FDA, as well as Medicare's controversial coverage determinations on FDA-approved drugs for which CMS has required continued evidence collection... Sub. Req’d

Who Should Pay For Really Expensive Drugs?

(11/19, John C. Goodman, Forbes) ...A letter signed by a number of Democrats and Republicans in Congress supports a Biden administration proposed regulation that would remove many employer options. Instead of allowing normal market forces to play out, this regulation would allow drug companies to sell brand-name drugs at monopoly prices for virtually all patients with employer-provided health insurance. The result would be higher drug company profits and lower employee wages... Full

Walgreens Gets Nod for $100 Million Generic Drug Pricing Deal

(11/19, Jacklyn Wille, Bloomberg Law) ...Walgreen Co. received initial court approval for a $100 million class settlement resolving a seven-year-old lawsuit by customers who say the pharmacy chain overcharges for generic drugs when they're purchased using insurance. The deal, which also requires Walgreens to terminate its generic drug discount program, is expected to cover million of people and entities that paid for prescription drugs from Walgreens using insurance coverage since January 2007, according to the customers' settlement motion... Sub. Req’d

CVS, UnitedHealth, Cigna Sue to Block FTC Case Over Insulin Prices

(11/19, Annika Kim Constantino, CNBC) ...CVS Health, UnitedHealth Group and Cigna sued the Federal Trade Commission on Tuesday, claiming that the agency's case against drug supply chain middlemen over high insulin prices in the U.S. is unconstitutional. The complaint, filed in the U.S. District Court for the Eastern District of Missouri, is the latest move in a bitter legal fight between the three largest pharmacy benefit managers, or PBMs, in the U.S. and the FTC... Full

Lawmakers Are Poking Holes in Pharma's Favorite New Way to Market Medicines

(11/19, Shelby Livingston, Endpoints News) ...Drugmakers are taking different approaches to telehealth. Some, such as Pfizer, have partnered with behind-the-scenes telehealth platforms that connect to networks of clinicians who can treat multiple health problems, while Lilly and most recently Biogen sought partnerships with specialized venture-backed startups dedicated to treating specific health conditions, such as obesity or mental health. But all of the pharma companies have positioned their telehealth partnerships as a way to provide more convenience or access to doctors that might be difficult to see in person... Full

New Survey Finds Employers Overwhelmingly Satisfied With PBMs' Transparency, Flexibility And Savings

(11/19, PCMA) ..."These survey results should make clear to Congress that policies pushed by self-serving pharma interests would not only weaken the ability of PBMs to continue providing the services that employers clearly value, but they would also take away the choice and flexibility that employers say they want in choosing and contracting with the PBM that best serves their needs. The fact is these misguided policies targeting PBMs would be disastrous for employers, jeopardizing more than $1,000 per person in annual savings."... Full

Make Prescriptions More Affordable by Cutting Out Middlemen

(11/19, Angela Dingle, RealClearHealth) ...When they ran for office, congressional candidates from both parties pledged to bring down prescription drug costs. And unlike most campaign trail promises -- which are usually little more than hot air -- this pledge actually could soon become a reality. That's because both parties actually agree on one of the most effective reform strategies -- curbing the power of the middlemen largely responsible for soaring prices. Pharmacy benefit managers, or PBMs, are inflating what patients pay for drugs to pad their own bottom lines... Full

Florida Gov. DeSantis' Canadian Drug Import Plan Goes Nowhere After FDA Approval

(11/20, Phil Galewitz, KFF Health News) ...Florida Gov. Ron DeSantis hailed the FDA's approval of his plan in January, calling it a victory over the drug industry, which opposes importation on the grounds that it would lead to a surge in counterfeit medications. A Florida health official familiar with the importation program told KFF Health News there was no planned date yet for the state to begin importing drugs. The official asked not to be identified because they weren't authorized to speak publicly about the program... Full

The FDA Posts New and Revised PSGs

(11/19, Bob Pollock, Lachman Consultant) ...The OGD posted 29 new and 31 revised product-specific guidances today. The new list of PSGs covers drugs with various dosage forms including tablets, capsules, gels, oral suspensions, intramuscular extended-release suspensions, topical solutions, powders, ointments, other parenteral products and orally disintegrating tablets, and subcutaneous extended-release suspensions... Full

Medicines for Ireland Welcomes Political Parties' Commitments to Generic, Biosimilar and Value-Added Medicines Ahead of Election Day

(11/19, Medicines for Ireland) ...Noting the policy commitments, MFI Chair Paul Neill commented, "We are encouraged to see our calls reflected in political manifestos, demonstrating a clear commitment to improving the accessibility and sustainability of generic and biosimilar medicines. We know that Ireland is behind our EU counterparts when it comes to the availability of off-patent medicines to patients..."... Full

EMA Says No To Extending Clock-Stops For Immature Marketing Applications

(11/19, Vibha Sharma, Pink Sheet) ...The European Medicines Agency is clamping down on delays to its evaluation process caused by companies asking for extended clock-stops. Companies are increasingly submitting only interim data in their drug marketing applications, assuming they will be able to supplement it later by asking for longer clock-stops. The EMA is applying strict criteria on allowing clock-stop extensions specified in its 2009 guideline. As a result, requests for extended clock-stops due to immature application dossiers are no longer being granted... Global Sub. Full

EU's Wastewater Directive Imposes Unsustainable Costs, Warn Czech Pharma Stakeholders

(11/19, Aneta Zachová, Euractiv) ...The Council of the European Union has greenlighted a directive requiring pharmaceutical and cosmetic companies to cover significant costs of wastewater treatment, but Czech stakeholders are concerned it will impact essential medicines availability... Full

England's NICE Turns Down Cancer Drug Enhertu—Again—Amid Pricing Stalemate with AZ, Daiichi Sankyo

(11/19, Fraiser Kansteiner, Fierce Pharma) ...Talks with AZ and Daiichi to negotiate a fair price for Enhertu for treatment of advanced HER2-low breast cancer in the U.K. have "ended without agreement," the country's National Institute for Health and Care Excellence said in a media statement Tuesday. As a result, the agency's decision not to recommend AZ and Daiichi's cancer-fighting antibody will remain in place. Over the summer, NICE recommended against NHS England reimbursement for the therapy... Full

Dutch Trim Medicines Budget, But Cause Delayed Access to New Drugs, Says Pharma Industry

(11/10, Christoph Schwaiger, Euractiv) ...The Netherlands spends the least on medicines within the EU as a percentage of their healthcare budget. But it's at the cost of delayed access to new drugs, says the Dutch Association for Innovative Medicines...The figures show that while expenditure on drugs used by hospitals decreased by €129 million (4.9%) in 2022 compared to 2021, this was not part of a wider trend. The one-off dip was largely attributed to the emergence of generic variants of lenalidomide, an expensive cancer drug. The health authority said no similar scenarios for other drugs occurred in 2023... Full

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