Tuesday, December 10, 2024

Teva Divests Takeda JV, Pivots To Innovative Drugs In Japan

(12/9, Lisa Takagi, Generics Bulletin) ...Teva is divesting Teva Takeda, its joint venture with Takeda Pharmaceutical in Japan, as it seeks to focus on bringing innovative medicines to the Japanese market. The JV will be acquired by JKI Co., Ltd., a firm established by the Japanese private equity firm J-Will Partners... Global Sub. Full

Organon Sets Sights On Future Frontiers In Biosimilars

(12/9, Adam Zamecnik, Generics Bulletin) ...Following its recent presentation of results for the third quarter of the 2024 fiscal year, Organon's US biosimilars lead Jon Martin spoke to Generics Bulletin about the company's adalimumab plans and strategy with upcoming launches, as well as how these will benefit from the firm's focus on women's health... Global Sub. Full

Formycon And MS Pharma Add Ustekinumab To MENA Alliance

(12/9, Dave Wallace, Generics Bulletin) ...Clearly happy with its existing biosimilars alliances with MS Pharma in the Middle East and North Africa region, German developer Formycon has struck a further deal with its MENA partner for local rights to the FYB202 ustekinumab rival to Stelara. MS Pharma said it "plans to submit for regulatory approval in MENA countries at the earliest opportunity."... Global Sub. Full

AbbVie's Parkinson's Disease Drug Improves Patient Mobility in Late-Stage Study

(12/9, Mariam Sunny, Reuters) ...The late-stage study tested the safety and efficacy of flexible doses of the once-daily drug, tavapadon, ranging from 5 milligrams (mg) to 15 mg, as a monotherapy, the company said on Monday..."Although questions remain on tavapadon's competitive profile, this shows at least some payoff for the Cerevel transaction," said Piper Sandler analyst Christopher Raymond... Full

Amgen's Blincyto Keeps 96% of Pediatric Leukemia Patients Alive and Disease-Free in 'Practice Changing' 3-Year Study

(12/9, Zoey Becker, Fierce Pharma) ...In newly diagnosed pediatric patients with B-cell acute lymphoblastic leukemia (B-ALL) that fits into the National Cancer Institute's definition of standard risk, the three-year disease-free survival rate for those treated with Blincyto and chemotherapy was 96% compared with 87.9% for chemotherapy alone, Amgen reported Saturday... Full

GSK's Drug Combo Shown to Cut Risk of Death by 42% in Type of Blood Cancer

(12/9, Yadarisa Shabong, Reuters) ...British drugmaker GSK said on Monday its experimental cancer drug Blenrep in combination with other treatments reduced the risk of death by 42% in multiple myeloma, a common type of blood cancer, at or after first relapse compared to an existing treatment...GSK is gearing up for five major new drug launches in 2025, including Blenrep – which the company expects to have a more than 3 billion pound ($3.83 billion) peak year sales potential... Full

BTK Inhibitors from AstraZeneca, Eli Lilly and BeiGene Take Center Stage in CLL

(12/9, Max Gelman and Nicole DeFeudis, Endpoints News) ...AstraZeneca and Eli Lilly outlined how their drugs Calquence and Jaypirca can help patients with chronic lymphocytic leukemia (CLL). Individuals live with CLL chronically, unlike more aggressive cancers like acute lymphoblastic leukemia or multiple myeloma, and if they relapse often have other effective drugs to turn to. In addition, BeiGene reported five-year follow-up data for its drug Brukinsa in first-line CLL... Full

AbbVie Survey Singles Out Emotional Impact of CLL Diagnosis On Black, Hispanic and Asian Patients

(12/9, Andrea Park, Fierce Pharma) ...A new survey from AbbVie digs into the emotional experience of a chronic lymphocytic leukemia (CLL) diagnosis and, according to the company, is the first to break down the results by race/ethnicity to highlight the differing mental health impacts and desired support resources for patients of diverse backgrounds... Full

AbbVie, Genmab Tout Epkinly Combos in Earlier Lines of Non-Hodgkin Lymphoma

(12/9, Nicole DeFeudis, Endpoints News) ...Epkinly plus R-CHOP is being tested in an ongoing Phase 3 trial in the first-line setting. Allam Fakhoury, AbbVie's therapeutic area lead in hematology oncology, told Endpoints News that the Phase 3 study in DLBCL is fully enrolled, and the company is "evaluating when the readout will be." Meanwhile, in the FL arm, the partners said Epkinly combined with rituximab and lenalidomide achieved a 96% overall response rate in 111 previously treated patients at a median follow-up of just over two years... Full

Sandoz Specialty Summit 2024: Advancing Patient Access to Quality Treatments

(12/10, Vietnam Investment Review) ...500 healthcare professionals, 11 chairpersons, and 15 distinguished speakers for in-depth discussions on advancements in patient care came together in the Specialty Summit 2024 held by Sandoz Vietnam, the wholly owned subsidiary of the global leader in generic and biosimilar medicines, on December 7 in Hanoi and Ho Chi Minh City. According to Charaf Eddine Kadri, general director of Sandoz Vietnam, the company is committed to supporting healthcare professionals... Full

UTC Bid to Delay $71 Million Award to Sandoz Shot Down by Judge

(12/9, Christopher Yasiejko, Bloomberg Law) ...United Therapeutics Corp. failed to delay enforcement of a $70.6 million judgment awarded to Sandoz Inc. in an antitrust case over Remodulin, as a New Jersey federal judge expressed concerns about the company's future financial certainty... Sub. Req’d

EuroAPI Vaults Operating Chief into CEO Role as it Embarks Upon 'New Chapter'

(12/9, Fraiser Kansteiner, Fierce Pharma) ...Drug ingredients specialist EuroAPI on Monday said it had accepted the resignations of Ludwig de Mot as CEO and Viviane Monges as chair of the manufacturer's board. In turn, EuroAPI has appointed its chief operating officer, David Seignolle, to immediately take up the helm as CEO. At the same time, Emmanuel Blin, a former Bristol Myers Squibb executive who's been part of EuroAPI's board since 2022, will take over the board chair post, EuroAPI said in a release... Full

Optum Rx Switches Up Humira Biosimilar Coverage for 2025

(12/9, Denise Myshko, Managed Healthcare Executive) ...Beginning Jan. 1, 2025, Optum Rx will prefer a different set of Humira biosimilar on its commercial formularies. UnitedHealth Group's pharmacy benefit manager, one of the three largest in the United States, is favoring Amgen's Amjevita (adalimumab-atto) over Sandoz's Hyrimoz (adalimumab-adaz) and Cyltezo (adalimumab-adbm)...Optum Rx is removing Hyrimoz, Cyltezo and the nonbranded adalimumab-adaz, based on a review by Formulary Watch of Optum Rx's Select Standard Formulary effective Jan. 1, 2025, compared with January 2024 list... Full

Some Research Shows Patients Don't Stick with GLP-1s for Long. Amazon Pharmacy and Ro Say They're Changing That

(12/9, Nicole Wetsman and Shelby Livingston, Endpoints News) ...Patients who get their GLP-1 weight loss medication prescriptions filled at Amazon Pharmacy are more likely to keep taking the medications than other published research shows, Amazon Pharmacy Vice President John Love told Endpoints News...Commonly cited research from the pharmacy benefit manager Prime Therapeutics in July found that only about 15% of people who started a weight loss medication were still taking the drug after two years. About 29% were still on the drug after one year. But Love said that internal data show that Amazon Pharmacy patients had a 250% higher adherence rate after two years... Full

Cancellation of Kids' Asthma Medication Continues to Cause Turmoil for Mass. Families

(12/9, Jason Laughlin, Boston Globe) ...Massachusetts families are still struggling to find alternatives almost a year after GlaxoSmithKline canceled a widely prescribed children's asthma medication, a problem given renewed urgency as flu and respiratory virus season sets in. Flovent HFA, GSK's brand name for its discontinued inhaler, hasn't been available since December 2023 when, in response to new federal price limits, the company introduced an essentially identical authorized generic version. The company stated the move was done to keep an important drug available, "potentially at a lower cost." But, perversely, the generic is generally more expensive and now fewer insurers are covering the replacement... Full

Next in Baltimore's Opioid Case: Seeking $5 Billion to Rectify Drugs' Harm

(12/10, Madeleine O'Neill, The Baltimore Banner) ...Baltimore is seeking more than $5 billion at a second trial phase, known as an abatement hearing, that begins Wednesday and could last for several days. A judge, not a jury, will decide how much money the drug distributors have to pay during this phase. The city believes the money would help address chronic problems caused by substance abuse. The drug companies say the city's request should be rejected entirely... Full

Dems Push To Stop Patent Thickets In Lame Duck After USPTO Scraps Rule

(12/9, Gabrielle Wanneh, InsideHealthPolicy) ...Just after the United States Patent and Trademark Office (USPTO) scrapped a proposed rule that would have prohibited brand drug makers from asserting more patents than necessary on a drug to extend its market exclusivity, Democrats are pushing to include a measure to stop so-called patent thickets to save $1.8 billion in the lame-duck health package they are negotiating with Republicans, sources say... Sub. Req’d

Trump Pegs PBM Reform A Priority, Wyden Pushes Hard For Lame-Duck Reforms

(12/9, Gabrielle Wanneh, Sigi Ris, InsideHealthPolicy) ...Trump said during a Sunday (Dec. 8) Meet the Press interview that cracking down on the role pharmacy benefit managers play in keeping prescription drug costs high for Americans will be a top priority for his upcoming administration. Trump said after a recent meeting with drug companies, HHS Secretary-nominee Robert F. Kennedy Jr., CMS Administrator-nominee Mehmet Oz and their teams, addressing the opaque PBM market and its impact on drug prices will be one of the first things the administration looks into to curb costs for patients and the government... Sub. Req’d

The Pharma Industry Isn't Lobbying Against RFK Jr.'s Nomination for a Top Health Role

(12/9, Rachel Cohrs Zhang and John Wilkerson, STAT Plus) ...The CEOs of Pfizer, Eli Lilly, and the brand-drug lobby PhRMA flew down to President-elect Trump's hotel in Palm Beach, Fla. this week to dine with Trump and RFK Jr., Axios reported. Eli Lilly's products include the weight loss drug Zepbound, while Pfizer makes Covid-19 vaccines that RFK Jr. has criticized. Pharma industry execs and lobbyists have largely issued polite statements about working with both sides of the aisle. "We want to work with the Trump administration to further strengthen our innovation ecosystem and improve health care for patients," PhRMA CEO Stephen Ubl said in a written statement... Sub. Req’d

ASBM Responds to PCMA: Put Patients First, Not PBM Profits

(12/9, Alliance for Safe Biologic Medicines) ...As the Senate moves this week to advance passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. 2035), the Alliance for Safe Biologic Medicines (ASBM) reiterates its opposition to the self-interested efforts of the Pharmaceutical Care Management Association (PCMA), which strongly supports this bill that prioritizes insurance company and pharmacy benefit manager (PBM) profits over patient safety and maintaining physician trust. Since the bill was introduced, ASBM has worked to educate physicians, patients, and policymakers on how the legislation would dangerously undermine FDA safety standards... Full

NDAA Cuts BIOSECURE Act But Emphasizes Drug Onshoring

(12/9, Jessica Karins, InsideHealthPolicy) ...The defense authorization deal reached over the weekend leaves out the hotly debated BIOSECURE Act that would cut ties between U.S. biotech and "companies of concern" linked to adversarial countries like China, but the compromise includes several other measures aimed at onshoring production to the United States, including a proposal to explore a Department of Defense-funded manufacturing facility... Sub. Req’d

Inertia For Supply Chain Change May Stick Even If BIOSECURE Fails

(12/10, Sarah Karlin-Smith, Pink Sheet) ...The BIOSECURE Act was left out of the National Defense Authorization Act despite attempts at a last-minute compromise, leaving a difficult road for the legislation to be enacted in 2024. Experts believe industry will continue diversifying supply chains and de-emphasizing reliance on China even if the legislation dies. Many planned supply chain changes are still in early stages and companies continue to make big investments in China... Global Sub. Full

OGD Official Statistics for First Month of FY 2025 Reported—ANDA Submissions Off to Slow Start

(12/9, Bob Pollock, Lachman Consultants) ...According to the first FY 2025 Generic Drugs Program Monthly and Quarterly Activities Report (here), the OGD had a good month for approval actions, issuing 62 full-approval actions and 20 tentative-approval actions for a total of 82. Only one month in FY 2024 had a higher combined total for these two metrics... Full

US Supreme Court Will Not Hear Drug Industry Challenge to Arkansas Contract Pharmacy Law

(12/9, Brendan Pierson, Reuters) ...The U.S. Supreme Court on Monday declined to hear an appeal by the nation's leading drug industry group challenging an Arkansas law requiring pharmaceutical companies to offer discounts on drugs dispensed by third-party pharmacies that contract with hospitals and clinics serving low-income populations... Full

A Year Later, Florida's Drug Importation Plan Is Misguided As Ever

(12/9, Sally Pipes, Forbes) ...Nearly five years after DeSantis first proposed his importation plan and a year after it took effect, Florida has not imported a single Canadian drug. That may be a blessing in disguise. Drug importation schemes may have bipartisan support, but they won't do much to save patients money. And as Florida has shown, there's no guarantee they can even work... Full

EMA Issues Guidelines On Shortage Mitigation, Prevention Plans

(12/9, Joanne S. Eglovitch, Regulatory Focus) ...On Monday, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued two guidelines offering more granular information on how drugmakers should implement shortage mitigation plans (SMPs) and shortage prevention plans (SPPs)... Full

EMA Homes In On How To Improve RWD Quality

(12/9, Neena Brizmohun, Pink Sheet) ...Draft EU guidance on how to assess and improve the quality of real-world data (RWD) that is used for regulatory purposes is out for consultation until January 31, 2025. The document focuses on the subset of RWD recorded within routine clinical practice and is intended to be used by the European medicines regulatory network, pharmaceutical companies and other stakeholders. It includes practical recommendations on how to characterize the systems and processes that underpin data, and a set of metrics to assess data quality dimensions... Global Sub. Full

Drug Company Monopolies to Be Cancelled, Health Ministry to Look into Generics, Says PM

(12/10, Ragananthini Vethasalam, Rahimy Rahim and Gerard Gimino, The Star) ...The monopoly of some drug companies will be cancelled and the Health Ministry will look towards generic medication to control the cost of medicines, says Datuk Seri Anwar Ibrahim. Noting that the cost of medicines has been rising uncontrollably, the Prime Minister noted that the drug purchases over the past few years had resulted in a monopoly. Therefore, he said the commitment of one or two companies will be cancelled... Full

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