Friday, August 23, 2024

Health Canada Gives Nod to Lupin's Biosimilar to Treat Infection in Cancer Patients

(8/23, Financial Express) ...Global pharma major Lupin Limited on Friday announced that it has received approval from Health Canada for its biosimilar Pegfilgrastim. This product will be marketed under the brand name Armlupeg and manufactured at Lupin's Biotech facility in Pune, India... Full

Sun Pharma Launches Novel Therapy for Skin Disorders in India

(8/23, Financial Express) ...Sun Pharmaceutical Industries Limited on Friday announced that it has launched Tedizolid Phosphate tablets 200 mg in India under the brand name "STARIZO". According to the company's statement, STARIZO (Tedizolid Phosphate) is a novel, oxazolidinone-class antibacterial, used to treat Acute Bacterial Skin and Skin Structure Infection (ABSSSI)... Full

Sandoz Pulls US Sunosi ANDA, With Competition Still In The Distance

(8/22, Dean Ridget, Generics Bulletin) ...Generic competition to Axsome Therapeutics' Sunosi (solriamfetol) in the US has been tipped to remain from the market until 2040 at the earliest, after Sandoz withdrew its abbreviated new drug application referencing the sleep disorder drug. Patent-infringement litigation that was pending in the US District Court for the District of New Jersey has been dismissed following Sandoz's action... Global Sub. Full

FDA Approves Reformulated Covid Boosters for Fall Season

(8/22, Nicole DeFeudis, Endpoints News) ...The FDA cleared a new round of Covid-19 boosters from Moderna and Pfizer/BioNTech that this time target the KP.2 variant. The updated vaccines are expected to be available in the coming days, Moderna and Pfizer said Thursday. Both shots are now fully approved in children and adults 12 years and older, and authorized under emergency use for kids 6 months through 11 years old... Full

Despite Looming BIOSECURE Threat, Pharma Contracting Giant WuXi Bio Scoops Up New Projects

(8/22, Fraiser Kansteiner, Fierce Pharma) ...Wednesday, WuXi Bio said it added 61 new projects in the first six months of 2024, half of which came from the U.S. That compares favorably to the 46 new projects added over the same stretch in 2023 and demonstrates the company's resilience "[a]mid a dynamic geopolitical landscape," WuXi Bio noted in an earnings release. Most of the assignments are in their infancy, though, with 52 of the new projects covering preclinical candidates... Full

AstraZeneca Dismisses Rumours of Facility Relocation to US

(8/23, Phil Taylor, Pharma Phorum) ...AstraZeneca has said it has "no idea" where rumours of a plan to relocate a planned facility in the UK to the US have come from, adding: "They do not seem to be based on facts." The comments came in response to an article in the Financial Times this morning which claimed that AZ was considering a change in the location of a £450 million ($578 million) vaccines manufacturing plant from Speke in Liverpool to Philadelphia because the new Labour government is angling to reduce a subsidy programme... Full

Pure-Play Biosimilar Company Reports 10-Fold Revenue Increase for First Half of 2024

(8/22, Skylar Jeremias, The Center For Biosimilars) ...According to the report, Alvotech achieved record total revenues of $236 million for the first six months of 2024. Product revenues for the first half of 2024 reached $66 million, reflecting a 190% increase from the same period last year, with $53 million of that total generated in the second quarter alone... Full

Celltrion's Autoimmune Disease Biosimilars Achieve Solid Growth in Italy

(8/23, Lee Han-soo, Korea Biomedical Review) ...Celltrion said its autoimmune disease biosimilars are making significant strides in Italy, one of the five largest pharmaceutical markets in EU. The other four are Germany, Spain, the U.K., and France. Notably, the company's Italian subsidiary has successfully secured bids, particularly for Yuflyma (ingredient: adalimumab), a biosimilar referencing Humira to treat autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis... Full

Sawai's Missed Revenue Expectations Leave Analysts Lukewarm Despite Broader Optimism

(8/22, Adam Zamecnik, Generics Bulletin) ...The Japanese pharmaceutical giant reported a 2.7% growth in revenue to ¥44.3bn ($304.8m) compared to the first quarter of the past fiscal year. According to the company, this is largely due to the growth in sales of existing products launched before the 2014 fiscal year, as well as those launched in the 2023 financial year. Additionally, the company's gross profit rose by 8.6% to ¥14bn, while its core operating profit rose by 29.4% to ¥6.9bn... Global Sub. Full

With 36% Increase, Eli Lilly Leads Industry Wide Sales Boom in Q2

(8/22, Kevin Dunleavy, Fierce Pharma) ...Once again, fueled by booming sales of their GLP-1 products, Eli Lilly and Novo Nordisk were the top performers in the biopharma industry in the second quarter...Sanofi posted an 8% second-quarter increase, thanks largely to anti-inflammatory superstar Dupixent, which was up 29%. Teva, which was up 7% year over year and 9% sequentially, provided more evidence of the success of its transformation under CEO Richard Francis... Full

Transparency Will Unlock a Sustainable Pharmaceutical Future

(8/23, Brent Eberle, ALM Benefits Pro) ...While Cuban's cost-plus model for generic drugs is a positive step in the right direction, it does not fully address the root causes of high drug prices — we also need to look at the lack of transparency and adverse incentives in the traditional pharmacy benefit manager, or PBM, industry...To reform the industry and reduce the inefficiencies of a complex pharmaceutical supply chain, we need both a cost-plus pharmacy like Mark Cuban's, but we also need PBMs that use a similar pass-through model to clearly spell out how much a PBM is paying for drugs, including rebates, so employers can clearly see how much the company and its employees are paying for medications... Full

Why One Health System Thinks its New PBM Can Disrupt the Market

(8/23, Lauren Berryman, Modern Healthcare) ...The University of North Carolina-affiliated health system announced a plan this month to launch UNC Health Pharmacy Solutions, a "transparent" PBM for employers seeking an alternative to CVS Health subsidiary CVS Caremark, Cigna division Express Scripts and UnitedHealth Group unit OptumRx, which dominate the market..."Our costs were skyrocketing," [Penny DeFalco, executive director of managed pharmacy solutions at UNC Health] said. UNC Health has since in-sourced key PBM functions and customized its formulary to focus on lower net cost drugs... Sub. Req'd

PhRMA: CEOs' Statements Downplaying Effect Of Negotiated Prices Are Not True Gauge Of IRA

(8/22, Gabrielle Wanneh, InsideHealthPolicy) ...The brand pharmaceutical lobby says recent statements by some drug companies to their shareholders that the new maximum fair prices negotiated by Medicare for their products will not throw them off financially should not be taken as a sign that the Inflation Reduction Act's drug price negotiation program won't hinder the potential for innovation of crucial medicines in the future, in an email shared with reporters Tuesday (Aug. 20)... Sub. Req'd

Accelerated Approvals In Medicare: CED Guidance Notes Ongoing Concern With Surrogate Endpoints

(8/22, Cathy Kelly, Pink Sheet) ...The Centers for Medicare and Medicaid Services did not exempt FDA-approved drugs from the purview of Medicare coverage with evidence development in its final CED guidance, despite stakeholder requests. The guidance also signals ongoing discomfort with the relevance of surrogate endpoints in drugs cleared through the FDA accelerated approval pathway, stoking concern that there could be more CED policies imposed on accelerated approvals in the future. The guidance does not commit to a firm timeline for retiring CED policies, another stakeholder concern... Sub. Req'd

What Mark Cuban Wants to See from Kamala Harris' Business Policies

(8/22, Lloyd Lee, Business Insider) ...Mark Cuban is one of hundreds of VCs and tech entrepreneurs who have voiced support for Harris. The billionaire emailed Business Insider a few notes about what he likes about the nominee — healthcare transparency — and what he would like to see from Harris — more details about cryptocurrency — if he, as a business leader, was being pitched by the campaign... Full

AMCP's CEO Looks at the Complex Landscape Around Prescription Drug Costs

(8/22, Mark Hagland, Healthcare Innovation) ...Earlier this summer, Healthcare Innovation Editor-in-Chief spoke with AMCP CEO Susan Cantrell, RPh, MHL, to discuss some of her organization's key initiatives and areas of focus. Below are excerpts from that interview... Full

FDA's Updated Guidance On Interchangeable Biosimilars Gets Mixed Response

(8/22, Mary Ellen Schneider, Regulatory Focus) ...There has been a mixed response to the US Food and Drug Administration's (FDA) recent draft guidance update stating that clinical switching studies are generally not necessary to demonstrate that a biosimilar product is interchangeable with its reference product...The biosimilar manufacturer Celltrion USA commended the FDA for reducing the cost and complexity of receiving an "interchangeable" biosimilar designation. But the company also asked FDA to clarify what types of comparative clinical data are needed as part of showing that the product has met the standard as interchangeable... Full

Leqembi's UK Rollercoaster: A Yes From MHRA, A No From NICE

(8/22, Neena Brizmohun, Pink Sheet) ...While the drug regulator has approved Eisai/Biogen's early Alzheimer's disease treatment, the health technology assessment institute is worried that its benefits are too small to justify its costs – a concern that Eisai has pledged to address... Sub. Req'd

Deadly Indian Pharmaceutical Blast Blamed On Chemical Solvent Leak

(8/22, Rishika Sadam, Shivam Patel, Reuters) ...An explosion at a pharmaceutical factory in southern India on Wednesday, which killed at least 17 people and injured 36, was due to a chemical solvent leak, according to an internal government report accessed by Reuters on Thursday...The distilled solvent which leaked was identified as Methylene Tertiary Butyl Ether or MTBE, a flammable liquid used as an additive in unleaded gasoline to achieve more efficient burning, the U.S. Centers for Disease Control and Prevention (CDC) says on its website... Full

Govt Bans 156 Fixed-Dose Combo Drugs Over Risks

(8/23, Teena Thacker, The Economic Times) ...The government has banned 156 fixed-dose combination (FDCs) drugs-including antibiotics, antiallergics, painkillers, multivitamins and combination doses for treatment of fever and hypertension-after a review found they posed health risks in the biggest crackdown since 2016 when 344 FDCs were prohibited...The move could deal a blow to drugmakers including Sun Pharmaceuticals, Cipla, Dr Reddy's Laboratories (DRL), Torrent and Alkem, among others... Full

Indonesia Court Finds Drugmakers at Fault Over Toxic Cough Syrup, Awards Parents

(8/23, Stanley Widianto, Reuters) ...An Indonesian court ordered two local companies to pay up to 60 million rupiah ($3,850) to each family whose children died of an acute kidney injury or were seriously injured after consuming toxic cough syrup...Judges at the Central Jakarta court found a drugmaker and a supplier, Afi Farma and CV Samudera Chemical, at fault in the poisonings, according to a ruling released late on Thursday... Full

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