Friday, September 6, 2024

Glenmark Shells Out A Further $25M To Resolve Civil Price-Fixing Charges

(9/5, David Wallace, Generics Bulletin) ...Glenmark Pharmaceuticals has agreed to pay out a further $25m in the US, "to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug," the US Department of Justice has announced...Behavior covered by the allegations also involved Teva, which last year agreed a settlement of its own, following in the footsteps of several other generics firms linked to wide-ranging price-fixing allegations... Global Sub. Full

Glenmark Joins Growing List of Drugmakers to Settle Long-Running US Price-Fixing Claims

(9/5, Fraiser Kansteiner, Fierce Pharma) ...The latest update in the antitrust case comes after Glenmark and fellow generics maker Teva last August admitted to running a pravastatin price-fixing scheme. As part of the deferred prosecution agreement, both companies agreed to fork over criminal penalty payments and divest their respective drug lines for pravastatin...The claims against Teva and Glenmark are part of a broader price-fixing probe that has also implicated companies like Mylan, Lupin, Sun Pharma and Sandoz... Full

Cipla Scion Back, Vice-Chair Stepping Down

(9/5, Anju Ghangurde, Generics Bulletin) ...Kamil Hamied, son of Cipla's outgoing vice-chair M K Hamied, is set to re-join the company as non-executive director, following his "entrepreneurial journey." Does it signal a shift in the promoter group's immediate considerations amid past stake sale speculation or mark routine top-level executive changes... Global Sub. Full

Connect Reduces China Workforce, Mulls Strategy for Potential Dupixent Rival

(9/6, James Waldron, Fierce Biotech) ...As part of its transition into a U.S.-focused company, Connect had already reduced its Chinese headcount by around 15% in the year leading up to July, with "further reductions in the China workforce expected by end of year."...The company has since received "favorable feedback" from the FDA about potential phase 3 trials for rademikibart in both asthma and atopic dermatitis. But in a second-quarter earnings report yesterday, Connect said it is still "considering whether advancing rademikibart into a phase 3 program is the appropriate next step versus other development opportunities for rademikibart, which could be completed without additional financing."... Full

GSK's Asthma Drug Nucala Meets Main Goal in Study On Treating Smoker's Lungs

(9/6, Yadarisa Shabong, Reuters) ...British drugmaker GSK said on Friday that its asthma drug, Nucala, met the main goal of a late-stage study in treating patients with chronic obstructive pulmonary disease (COPD), or smoker's lungs. Patients treated with Nucala and an inhaled maintenance therapy for up to 104 weeks had a lower annualised rate of moderate or severe exacerbations than those given a placebo, GSK said... Full

Strides Pharma Jumps Nearly 4% On USFDA Approval for Singapore Arm's Respiratory Diseases Drug

(9/6, CNBC TV 18) ...In an exchange filing, Strides Pharma said that its step-down wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore has received USFDA approval for the generic version of Theophylline Extended-Release Tablets, 300 mg and 450 mg...The company added that it is the first approved applicant for the drug and is eligible for 180 days of Competitive Generic Therapy (CGT) exclusivity... Full

FDA Approves Amneal and Shilpa's Oncology Product BORUZU

(9/6, Pharmaceutical Technology) ...The US Food and Drug Administration has approved Amneal Pharmaceuticals and Shilpa Medicare's oncology product BORUZU for subcutaneous administration...The product will be launched with a unique J-code [alphanumeric codes used for non-oral medications] in the second quarter of 2025... Full

Lilly Unveils More Positive Late-Stage Data for its Once-Weekly Insulin

(9/5, Katherine Lewin, Endpoints News) ...In two Phase 3 trials, dubbed QWINT-1 and QWINT-3, Lilly's efsitora alfa showed non-inferior A1C reduction compared with the most frequently used daily basal insulins, with both studies hitting primary endpoints, Lilly said...Paul Owens, Lilly's VP of global brand development for insulins/glucagon, told Endpoints News that "weekly insulin is an area of significant interest to Lilly and we will continue to make data-driven decisions on future development and regulatory submissions."... Full

Samsung Bioepis Settles Patent Dispute with Alexion, Readies US Launch of Soliris Biosimilar

(9/6, Lee Han-soo, Korea Biomedical Review) ...Samsung Bioepis has reached a settlement with Alexion Pharmaceuticals, ending their patent dispute over the blockbuster drug Soliris (ingredient: eculizumab) in the U.S. This agreement clears the path for Samsung Bioepis to launch its biosimilar version, Epysqli, in the U.S. market... Full

Dr Reddy's CTO-6 in Srikakulam, AP, Facility Assessment Concludes Successfully After US FDA's VAI Inspection

(9/6, Pharmabiz.com) ...Dr Reddy's, a global pharmaceutical company, has announced that further to its intimation of June 7, 2024, on the inspection conducted by the United States Food & Drug Administration at its active pharmaceutical ingredients manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh, the company has received the Establishment Inspection Report... Full

Cigna Offers Discounted Stelara Biosimilar, Building On Humira Move

(9/5, Max Bayer, Endpoints News) ...Evernorth, the health services arm of insurance behemoth Cigna, is planning to make a Stelara biosimilar available for $0 out-of-pocket for select patients...The biosimilar will be produced by Quallent Pharmaceuticals, another Cigna company, which collaborates with Boehringer Ingelheim and should be available to patients beginning in early 2025... Full

Cigna CEO David Cordani Eyes Growth for Specialty Pharmacy, PBMs

(9/5, Lauren Berryman, Modern Healthcare) ..."We looked at the biosimilar opportunity and we were quite bullish and excited," [Cigna Group CEO David Cordani] said. "At the most macro-level, our society needs the rapid evolution of biosimilars to create more affordability [and] capacity for additional medications that are coming down the pipe: gene therapies, cell therapies, personalized medications, etc."... Sub. Req’d

Why We Can't Have Nice Things: Can Mark Cuban Make Prescriptions Affordable Again?

(9/5, Eric Boehm, Reason) ..."Drug prices in this country are so high because there is zero transparency in the system, and when there's zero transparency in a market, there is no way for it to be efficient," says Mark Cuban, the serial entrepreneur, investor on Shark Tank, and guest on the first episode of the second season of Why We Can't Have Nice Things...More transparent pricing would have a bigger impact if more Americans were in control of their own health care spending, argues Michael Cannon, the director of health policy for the Cato Institute... Full

Purdue Pharma Gets Extension for Sackler Settlement Talks

(9/5, Dietrich Knauth, Reuters) ...Purdue Pharma on Thursday received an 18-day extension of a years-long pause on litigation against its owners, members of the wealthy Sackler family, after convincing a U.S. bankruptcy judge that the additional time will aid settlement negotiations... Full

To Choose the Best First-line Drug for CML, Consider Efficacy and Cost

(9/6, Sharon Worcester, MA, Medscape) ...For survival, generic imatinib remains the gold standard, Elias Jabbour, MD, said during a session at the annual meeting of the Society of Hematologic Oncology in Houston. For treatment-free remission, generic dasatinib or another generic second-generation TKI is needed, but not yet available in the United States, so generic imatinib is the best current choice, said Jabbour, a professor of medicine in the Department of Leukemia at MD Anderson Cancer Center, Houston... Full

FDA Has Massive Backlog of Factory Inspections as Staffers Leave for Private Sector Jobs

(9/5, Matthew Perrrone and Nicky Forster, Associated Press) ...An AP analysis of Food and Drug Administration data shows that agency staffers have not returned to roughly 2,000 pharmaceutical manufacturing firms to conduct surveillance inspections since before the pandemic, raising the risks of contamination and other issues in drugs used by millions of Americans... Full

5 Takeaways from AP's Report On the Big Backlog of Uninspected Drug Factories

(9/5, Matthew Perrone and Nicky Forster, Associated Press) ...The overdue drug plants identified by the AP represent about 42% of the firms that are currently registered to produce drugs for the U.S. and previously underwent FDA surveillance inspections before May 2019. The plants make hundreds of critical medicines, including antibiotics, blood thinners and cancer therapies... Full

Generic and Biosimilar Medicines Save $445 Billion in 2023

(9/5, AAM) ..."On the eve of the 40th anniversary of the Hatch-Waxman Act, we stand at a critical crossroads," said David Gaugh, Interim President and CEO of AAM. "With manufacturing facilities located in nearly half of U.S. states, today's generic and biosimilar manufacturers form an integral and essential part of the healthcare system. But we cannot afford to take our generic and biosimilar industries for granted."... Full

Biosimilar Medicines Saved $12.4 Billion in 2023

(9/5, Biosimilars Council) ..."The good news: biosimilars continue to deliver quality care at lower prices," said Craig Burton, Executive Director for the Biosimilars Council. "However, the biosimilars market faces severe challenges to its long-term sustainability. Swift legislative and regulatory action to safeguard biosimilar competition is vital."... Full

US Medicare To Offer Guidance On Real World Evidence To Support Coverage

(9/5, Cole Werble, Pink Sheet) ...CMS continues to suggest observational studies can fulfill Coverage with Evidence Development requirements to gain coverage. More details are on the way in upcoming guidance on fit-for-purpose CED trials with more details on the features, sources and conduct. Fundamentally, the study design, analysis plan and data sources should be sufficient to answer the intended questions, the agency said... Sub. Req’d

Obesity Drugs Will Get Broad Commercial Coverage In 2025 Despite Cost Concerns, Survey Says

(9/5, Cathy Kelly, Pink Sheet) ...A strong majority of employers responding to the latest Business Group on Health health care strategy survey said they will cover GLP-1 drugs for obesity in their employee health plans in 2025. BGH members who responded to the annual survey, which was fielded in June and July, included 125 large, self-insured employers spanning all industries... Sub. Req’d

Pharmacy Price-Setting Boards Help Big Business, Not Patients | GUEST COMMENTARY

(9/6, Robert Popovian, The Baltimore Sun) ...Ultimately, instead of standing with patients and small business owners, Maryland policymakers are siding with powerful business entities and perpetuating a system that disadvantages those who need affordable and accessible healthcare the most. Maryland policymakers should instead focus on patient-centered solutions that benefit the most vulnerable patients, not policies that benefit insurance middlemen... Sub. Req’d

Keynoter Doug Long Sees Fragility, ‘Pretty Anemic' Launches As He Looks Ahead to Retirement | PBMI 2024

(9/5, Peter Wehrwein, Managed Healthcare Executive) ...In what is likely to be one of his final presentations, Doug Long, MBA, painted a fairly bleak picture of U.S. healthcare system and the prospects for the pharmaceutical industry in this keynote address this morning at the Pharmacy Benefit Management Institute Annual National Conference in Orlando, Florida... Full

House Set To Vote On BIOSECURE Act Next Week

(9/5, Maaisha Osman, InsideHealthPolicy) ...A bill that would bar American companies and federal agencies from contracting with certain foreign-owned biotech firms is slated for a vote on the House floor next week, as part of the suspension list...Some industry experts have warned ending relationships with China biotech companies could lead to drug shortages and supply chain disruptions, and have suggested changes to the BIOSECURE Act to address the issue... Sub. Req’d

BIOSECURE Act Heads for Possible Vote in House of Representatives Next Week

(9/5, Fraiser Kansteiner, Fierce Pharma) ...Look no further than the recent survey by L.E.K. Consulting, which found that the bill had already dramatically undermined U.S.-based life science companies' confidence in working with Chinese firms. U.S. companies were most concerned about working with Chinese CDMOs, followed by contract research organizations and drug development partners, according to L.E.K.'s poll... Full

Hospitals, Drug Makers Battle In Court Over States' 340B Laws

(9/5, Gabrielle Wanneh, InsideHealthPolicy) ...The American Hospital Association, American Society of Health-System Pharmacists and 340B Health are pressing a Missouri district court to dismiss drug maker Novartis' motion for a preliminary injunction of the state's law permitting eligible providers to contract with an unlimited number of pharmacies to dispense prescription drugs purchased under the 340B drug discount program. Hospital groups also recently submitted briefs in support of similar laws drug makers are challenging in Arkansas, Maryland and West Virginia... Sub. Req’d

How Will Biosecure Act Impact Indian Pharma Companies? Aditya Khemka Explains

(9/6, The Economic Times) ...Aditya Khemka: I think the Biosecure Act will benefit a lot of Indian pharma companies who actually do business with global innovators. It may also benefit those API manufacturers who do business with global generic pharma companies... Full

India Takes Tiny Steps Back from its China Dependency

(9/6, The Economic Times) ...Dinesh Dua, former chairman of Pharmexcil (Pharmaceuticals Export Promotion Council of India) said that China is a major player in penicillin G and the initiative of starting its production in India will be a major victory for India. "About 30,000 metric tonnes of penicillin is imported from China. China ensured closure of production in the entire world, including India, on account of huge government support in terms of subsidies, infrastructure support, ease of doing business (EODB) in regulatory landscape, cheap labour, etc.," Dua said... Full

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