CIPLA LIMITED | MedPath

Cipla Launches ZEMDRI (Plazomicin) in India to Combat Antimicrobial Resistance

a day ago

• Cipla has introduced ZEMDRI (Plazomicin), a novel intravenous aminoglycoside treatment for complicated urinary tract infections (cUTI) including pyelonephritis in adult patients in India. • The drug demonstrates promising activity against multi-drug resistant bacteria, including Carbapenem-resistant Enterobacteriaceae (CRE), addressing a critical challenge in managing resistant infections in India. • ZEMDRI's approval was supported by the EPIC clinical trial, the first randomized controlled study of once-daily aminoglycoside therapy for cUTI treatment, with Cipla generating India-specific pathogen data to validate its effectiveness.

Cipla Receives VAI Status from USFDA for Two Manufacturing Facilities

3 days ago

• Cipla's Goa API facility and Sitec Labs' Mahape analytical testing facility have both received Voluntary Action Indicated (VAI) status from the USFDA following recent inspections. • The Goa Medispray facility inspection concluded with one observation in Form 483, while the Mahape facility received two observations during its February 2025 inspection. • The VAI classifications allow both facilities to continue operations while addressing the minor compliance issues identified by regulators, representing positive regulatory outcomes for the global pharmaceutical company.

Pulmatrix to Divest Phase 2-Ready Migraine Treatment and iSPERSE Technology Ahead of Cullgen Merger

7 days ago

• Pulmatrix plans to divest its clinical assets including PUR3100, a Phase 2-ready inhaled treatment for acute migraine, as part of its upcoming merger with Cullgen expected to close in June 2025. • The company's proprietary iSPERSE technology, which enables efficient pulmonary drug delivery with 146 granted patents, will also be divested as Pulmatrix transitions to focus on Cullgen's protein degradation platform. • First quarter 2025 financial results showed zero revenue (down from $5.9M in Q1 2024) with $7.7M cash on hand, which the company believes is sufficient to fund operations through the anticipated merger closing.

Taiwan's Formosa Pharmaceuticals Signs Exclusive Licensing Deal with Almac Discovery for ADC Development

13 days ago

• Taiwan-based Formosa Pharmaceuticals has entered into an exclusive licensing agreement with Northern Ireland's Almac Discovery to develop novel antibody-drug conjugates for cancer treatment. • The partnership combines Formosa's antibody expertise with Almac's proprietary drug-linker technology, aiming to address unmet needs in oncology with more targeted therapeutic approaches. • This collaboration represents a significant expansion of Taiwan's growing presence in the global biopharmaceutical sector, particularly in the rapidly evolving ADC market.

Lupus Nephritis Market Expected to Grow as Novel Therapies Enter Clinical Trials

14 days ago

• The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions. • Several innovative therapies are advancing through clinical trials, including CAR-T cell treatments from companies like Allogene Therapeutics, Adicet Bio, and Caribou Biosciences, which received FDA Fast Track designations. • Key pharmaceutical players including Aurinia Pharmaceuticals, AstraZeneca, and Roche are developing treatments such as voclosporin, anifrolumab, and obinutuzumab to address the significant unmet needs in lupus nephritis management.

FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities to Level Global Oversight

16 days ago

• The FDA has announced plans to significantly expand unannounced inspections at foreign manufacturing facilities producing food, medicines, and medical products for U.S. consumers. • Despite receiving advance notice of inspections, foreign facilities were found to have serious deficiencies more than twice as often as domestic sites, highlighting the need for stricter oversight. • FDA Commissioner Dr. Martin Makary emphasized ending the "double standard" where foreign manufacturers received advance notice while U.S. companies faced rigorous unannounced inspections.

Cipla Advances Inhaled Antifungal Therapy with Phase III Trial Approval for Itraconazole Dry Powder

a month ago

• Cipla has received CDSCO panel approval to proceed with Phase III clinical trials for inhaled itraconazole dry powder (PUR1900) at a 40mg dose, following successful Phase II results. • The novel inhaled formulation targets Aspergillus infections in patients with cystic fibrosis and potentially other respiratory diseases, offering a direct-to-lung delivery approach. • In a separate development, Cipla also secured regulatory approval to conduct Phase III trials for Revefenacin Inhalation Solution (175 mcg/3ml), a long-acting muscarinic antagonist for COPD treatment.

Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate

a month ago

• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests. • The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods. • The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.

Cipla Receives USFDA Approval for Generic Version of Cancer Drug Abraxane

a month ago

• Cipla has secured USFDA approval for paclitaxel protein-bound particles for injectable suspension, a generic version of Bristol Myers Squibb's Abraxane, indicated for treating multiple cancer types. • The company plans to launch the generic cancer treatment in the US market during the first half of fiscal year 2025-26, earlier than previously anticipated guidance. • Analysts project the generic Abraxane could generate between $20-50 million in revenue for Cipla, despite market competition from 3-4 other generic players currently active in the segment.

Lilly's Mounjaro Demonstrates Superior Efficacy in Head-to-Head Trials Against Diabetes Competitors

2 months ago

• Eli Lilly's Mounjaro (tirzepatide) has shown superior efficacy in reducing HbA1c levels and body weight compared to Novo Nordisk's Ozempic in clinical trials, offering new hope for the 35 million Americans with type 2 diabetes. • As the first dual-action medication that stimulates both GLP-1 and GIP receptors, Mounjaro achieved mean HbA1c reductions of 1.7% to 2.4% across trials, with participants losing between 12-25 pounds depending on dosage. • Recently launched in India following CDSCO approval, Mounjaro is now indicated for both chronic weight management in adults with obesity or overweight with comorbidities, and as an adjunct treatment for type 2 diabetes mellitus.

Hikma Pharmaceuticals Prepares to Launch Generic Versions of Ozempic and Wegovy

2 months ago

• Hikma Pharmaceuticals is in talks with global partners to develop generic versions of semaglutide, the active ingredient in Novo Nordisk's blockbuster weight loss drugs Ozempic and Wegovy. • Patents for Novo Nordisk's semaglutide drugs will begin expiring in 2026 in markets including Canada, China, India, and Brazil, with other regions following between 2028 and 2032. • Hikma's CEO Riad Mishlawi compared the impact of GLP-1 weight loss medications to penicillin, noting they address obesity-related comorbidities in a market potentially worth $80-140 billion.

Indian Pharma Companies to Launch Generic Empagliflozin at 90% Lower Cost

2 months ago

• Several Indian pharmaceutical companies are preparing to launch generic versions of Empagliflozin following Boehringer Ingelheim's patent expiry on March 11, potentially transforming diabetes treatment accessibility. • Mankind Pharma plans to offer the diabetes medication at approximately Rs 6 per tablet, a 90% reduction from the innovator's price of Rs 60, with most generic versions expected to cost between Rs 9-14 per tablet. • The affordable generics will significantly reduce therapy costs for India's 10.1 crore diabetic patients, most of whom pay out-of-pocket, while still providing benefits for heart failure and chronic kidney disease management.