Pickings by Pharma Veterans Newsletter #29 – August 17, 2025

Pickings by Pharma Veterans Newsletter #29 – August 17, 2025

This newsletter is the offering from Asrar Qureshi, Founder of Pharma Veterans. It will bring to you a selection of Pharma Industry news and developments from Pakistan, region, and the world. It will be published fortnightly on alternate Sundays. For queries and sending information, please send email to pharmaveterans2017@gmail.com.

SPECIAL NOTE

The objective of this newsletter is to share important news from the US and Europe, where exciting new research and development in drugs is going on. News from India, Bangladesh, and Pakistan are included to show where Pakistan stands vis-à-vis the region. This is done in order that Pharma Industry in Pakistan may take necessary actions for course setting and long-term strategy making.

PAKISTAN

• Highnoon Laboratories Limited has entered into a strategic partnership with Beximco Pharmaceuticals Limited, a leading pharmaceutical manufacturer based in Bangladesh. This alliance marks a significant milestone in Highnoon’s international expansion strategy, aimed at bringing advanced technologies therapies and novel dosage forms to the Pakistani market. Both companies are listed on the stock exchanges of their respective countries. The Memorandum of Understanding (MoU) was signed at Beximco’s headquarters in Dhaka by Dr Adeel Abbas, the co-chairman and chief executive officer (CEO) of Highnoon Laboratories Limited andRabbur Reza, the chief operating officer (COO) of Beximco Pharmaceuticals Limited. This partnership will focus on the distribution marketing and sales of specialised pharmaceutical products in Pakistan with an emphasis on respiratory diabetes and cardiovascular therapeutic segments. The collaboration is designed to strengthen Highnoon’s portfolio in these high-impact areas providing a competitive edge through innovative drug delivery systems and clinical advancements.

• The exports by Pakistani pharmaceutical companies grew by 34 percent to $457 million during FY25. The export figure during FY25 is the highest-ever in Pakistan’s history. The industry recorded exports of $341 million in FY24, $328 million in FY23, and $269 million in FY22.

INDIA

• Indoco Remedies has obtained final approval from the USFDA for its generic rivaroxaban tablets for US market.

• SCHOTT, the world leader in specialty glass production, has expanded its manufacturing plant in Jambusar, Gujarat, introducing syringe and cartridge glass tubing made in India.

• Eli Lilly launches Mounjaro KwikPen in India for diabetes care.

• Zydus Lifesciences Limited said it has completed clinical trials for desidustat – a novel oral drug for the treatment of anemia in patients with Chronic Kidney Disease (CKD) in China and is preparing for a commercial launch with its Chinese partner.

• In its third US-related transaction in six months, Senores Pharmaceuticals has agreed to buy two USFDA approved ANDAs from Teva Pharmaceuticals USA Inc., that have a business opportunity of US$ 120 million.

• Alkem Laboratories Limited is looking to accelerate its non-US business as part of long-term growth plans. It also announced the setting up of a subsidiary in Saudi Arabia.

• Lupin is partnering with Swiss major Sandoz Group AG to market Lupin’s biosimilar ranibizumab across multiple regions. Sandoz will oversee commercialization of the product across the European Union (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia, while Lupin will be responsible for manufacturing the product and regulatory submissions.

• PM Modi called for putting more energy into research and development of new drugs as he praised India’s achievement of being considered the pharmacy of the world due to its leadership position in supply of vaccines and affordable generic drugs.

BANGLADESH

• BNP Secretary General Mirza Fakhrul Islam Alamgir has warned that the government’s “opaque and one-sided policies and directives” are creating crises in the pharmaceutical sector. n a statement on Wednesday, Fakhrul said: “Recently, some opaque, unilateral directives and inaction by the government have created special risks in this potentially vital industry.” He highlighted that government-appointed bodies, including the Drug Control Committee (DCC), the Essential Medicines Task Force, and DCC’s technical subcommittees, lack representation from the Bangladesh Association of Pharmaceutical Industries (BAPI). Fakhrul stressed that “policy-making, regulation, and development in the pharmaceutical sector must be transparent, participatory, and reflect professionals’ input. Joint solutions with BAPI and all stakeholders will best serve national interests.” He criticised committees formed without industry participation and called for proactive decisions ahead of Bangladesh’s LDC graduation, describing the sector as a strategic national asset. The BNP leader noted that no new drug registrations have been issued for nearly two years, and price adjustments have been delayed, putting Bangladesh at risk of losing TRIPS exemptions. He urged swift registration of new drugs ahead of the country’s projected middle-income status in November 2026.

EUROPE – European Medicines Agency – EMA

• New Drug Approval Recommendations

o No new drug approvals in this period.

• Negative Recommendation

o No negative recommendations in this period..

UNITED STATES – Food & Drug Administration – USFDA

• Industry News

o Eli Lilly is facing legal challenge from a lawsuit filed in Texas that accuses the pharma company of bribing providers to prescribe its most profitable drugs, including the high-demand GLP-1 medications Mounjaro and Zepbound, that are used for weight loss and diabetes control.

• Drug Development

o Thrombocytopenia: Novartis has announced positive top-line results from VAYHIT2, a Phase III trial evaluating ianalumab plus eltrombopag in patients with primary immune thrombocytopenia previously treated with corticosteroid.

o Sjögren Disease: Novartis has announced positive top-line results from its Phase III trials evaluating ianalumab (VAY736) in adults with active Sjögren’s disease, a chronic, disabling autoimmune disease.

o GI: Vedanta Biosciences, a late clinical-stage biopharmaceutical company developing microbiome-based oral therapies for GI diseases, has announced that its candidate VE202 did not meet the primary end point of endoscopic response in the Phase II study.

o GERD: Braintree Laboratories, a part of Sebela Pharmaceuticals, has announced positive top-line results from the 24-week maintenance phase of the pivotal Phase III TRIUMpH clinical program evaluating tegoprazan, a novel potassium-competitive acid blocker in GERD.

• New Drug Approvals

o TONMYA (cyclobenzaprine hydrochloride) sublingual tablets – Tonix Pharmaceuticals Holding Corp. For the treatment of pain associated with fibromyalgia.

o BRINSUPRI (brensocatib) tablets – Insmed Incorporated. A dipeptidyl peptidase inhibitor for the treatment of patients with bronchiectasis.

o HERNEXEOS (zongertinib) tablets – Boehringer Ingelheim Inc.  A kinase inhibitor for the treatment of non-squamous, non-small cell lung cancer with HER2 tyrosine kinase domain activating mutations. 

o MODEYSO (dordaviprone) capsules – Jazz Pharmaceuticals Inc. A protease activator for the treatment of diffuse midline glioma.

o VIZZ (aceclidine) ophthalmic solution – LENZ Therapeutics Inc. A cholinergic agonist for the treatment of presbyopia in adults.

Disclaimer: I research through multiple resources for this newsletter and gratefully acknowledge their contribution. It may not be possible to give all references here for reasons of space, and I sincerely regret it.