Pickings by Pharma Veterans Fortnightly Newsletter #32 – October 12, 2025

Pickings by Pharma Veterans Fortnightly Newsletter #32 – October 12, 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

• Marham has taken initiative to establish ‘Marham Therapy Clinic’ to help meet the demand for mental health support. It offers:

o Counseling & Psychological Therapy for stress, anxiety, depression, trauma, and relationship challenges. 

o Specialized Service including child therapy, couples therapy, family counseling, stress and anger management, and workplace mental wellness support. 

o Physical Therapy & Rehabilitation to help patients recover from pain, injuries, and mobility issues. 

o Hybrid Care Model with sessions available online across Pakistan in major cities.

o Qualified Experts including certified psychologists of Pakistan, counselors, and physiotherapists with years of clinical experience.

INDIA

• Once hailed as a global saviour, India’s drug manufacturing sector now finds itself under intense scrutiny for lapses that have cost children their lives and shaken the country’s moral standing in global health.

The recent deaths of children in Madhya Pradesh and Rajasthan after consuming the Coldrif cough syrup is a reminder of India’s regulatory frailty. Tests revealed Diethylene Glycol (DEG), a deadly industrial solvent used in brake fluid and antifreeze, at 48 per cent concentration - 480 times the legal limit. DEG kills, silently and quickly attacking kidneys, liver and nervous systems. That this syrup could circulate for nearly 20 years before being pulled from the shelves is not just corporate negligence, but regulatory inertia that has lethal consequences.

And this is not new. In 2022, over 70 children in Gambia died after taking Indian-made syrups exported by Maiden Pharmaceuticals. The WHO found “unacceptable amounts of Diethylene Glycol and Ethylene Glycol” in the syrups. Uzbekistan, in the same year, witnessed 65 children perish from Indian based Marion Biotech’s Dok-1 Max and Ambronol syrups, again linked to DEG contamination. Why does this keep happening? Because India’s pharmaceutical governance is fractured and underpowered. The Central Drugs Standard Control Organisation (CDSCO) and state drug controllers operate in silos, often stepping on each other’s toes frequently failing to step up. One inspector can be responsible for more than 200 manufacturing units, leaving quality checks sporadic and largely symbolic. The lack of a transparent, centralised database allows shoddy products to circulate freely. 

• Swiss healthcare major Roche Pharma has committed to invest 1.5 billion Swiss Franc in India over the next five years, a senior company executive said on Wednesday. The company announced this investment as part of the commitment made by the four-nation EFTA bloc under a trade pact with India. The agreement came into force on Wednesday. 

Under the deal, EFTA has committed to invest $100 billion in India over the next 15 years. The European Free Trade Association (EFTA) members are Iceland, Liechtenstein, Norway, and Switzerland. The pact was signed on March 10, 2024. Along with Roche, about 18 more firms of the bloc showed their interest in investing in India. These companies include Skyrrup, Kohinoor Ropes, LGT India, Hilti India, Kongsberg, Elkem, Borregaard, Bobst India, Bucher Hydraulics Private Limited, and Buhler India Pvt Ltd. The other firms include Furrer & Frey India Private Limited, Huber+Suhner (India), MSC Agency (India) Private Limited, and SIG Combibloc.

BANGLADESH

• In November 2026, Bangladesh is set to graduate from the United Nations' Least Developed Country (LDC) category. It is a moment many have called historic—a badge of honour earned through decades of hard work and resilience. An economy once synonymous with famine and aid dependency has become the world's second-largest garment exporter, lifting millions out of poverty in the process. But celebrating the graduation without addressing the challenges that come with it would be misleading. Graduation is not a fairy-tale ending; it comes with real risks, new rules, and the potential for painful shocks if they fail to prepare.

• The National Drug Policy, 1982 marked a revolutionary shift in Bangladesh's pharmaceutical industry. Following its adoption, domestic production surged, local companies gained market dominance, and Bangladesh began making headway in medicine exports. Today, local pharmaceutical firms meet 98 percent of the country's total demand, with export earnings of $177.42 million recorded in the first ten months of FY2024-25. Despite these achievements, one fundamental weakness persists: over 85 percent of the industry's key raw materials—or active pharmaceutical ingredients (APIs)—are imported. As a result, a substantial portion of the sector's contribution to GDP is effectively drained abroad. Moreover, this heavy dependency undermines consistent quality assurance and poses a challenge to the prospects of long-term stability, especially in the post-LDC period.

EUROPE – European Medicines Agency – EMA

• New Drug Approval Recommendations

o ENFLONSIA (clesrovimab) injection – Merck Sharp & Dohme B.V. For the prevention of respiratory syncytial virus and lower respiratory tract disease. Add-on to standard therapy for the treatment of generalised Myasthenia Gravis (gMG) in adult and adolescent patients aged 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

o KYINSU (Insulin icodec/ semaglutide) – Nove Nordisk A/S. Treatment of adults with type-2 diabetes mellitus insufficiently controlled on basal insulin or GLP-1 receptor agonists.

o LYNKUET (elinzanetant) – Bayer AG. Treatment of moderate to severe vasomotor symptoms.

o IMAAVY (nipocalimab) – Janssen Cilag International NV. Add-on to standard therapy for the treatment of generalized Myasthenia Gravis in adult and adolescent patients aged 12 years of age and older.

• Negative Recommendation

o No negative recommendations in this period.

UNITED STATES – Food & Drug Administration – USFDA

• Drug Development

o Hypertension: Positive full results from the BaxHTN Phase III trial showed baxdrostat demonstrated a statistically significant and clinically meaningful reduction in mean seated systolic blood pressure (SBP) at two doses (2mg and 1mg) compared with placebo at 12 weeks. Results were seen in patients with hard-to-control (uncontrolled and resistant) hypertension who received baxdrostat or placebo on top of standard of care.

Baxdrostat is a potential first-in-class, highly selective aldosterone synthase inhibitor (ASI) that targets one of the hormones driving elevated blood pressure and increased cardiovascular and renal risk. It is currently being investigated in clinical trials enrolling more than 20,000 patients globally, as a monotherapy for hypertension and primary aldosteronism, and in combination with dapagliflozin for chronic kidney disease and hypertension, and the prevention of heart failure in patients with hypertension.

o Ulserative Colitis: Johnson & Johnson today announced additional Week 12 results from the Phase 2b ANTHEM-UC study of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC). The study met its primary endpoint, with all once-daily icotrokinra dose groups achieving clinical response at Week 12 and showing clinically meaningful improvements versus placebo across key secondary endpoints.

o Parkinson’s Disease: Bayer AG and its wholly owned, independently operated subsidiary BlueRock Therapeutics LP, a clinical stage cell therapy company, today announced positive 36-month data from exPDite, a Phase I clinical trial of bemdaneprocel, an investigational cell therapy for the treatment of Parkinson's disease (PD). 

o Depression: Johnson & Johnson announced results from the Phase 3 MDD3005 26-week clinical trial evaluating the efficacy and safety of seltorexant compared to quetiapine extended release (XR) as an adjunctive treatment in adult and elderly patients with major depressive disorder (MDD) with insomnia symptoms. 

o Alzheimer’s Disease: Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BMS-986446, a potential best-in-class anti-microtubule binding region-tau (anti-MTBR-tau) antibody currently in Phase 2 development for the treatment of early Alzheimer’s disease. Fast Track Designation is intended to facilitate the development and expedite the review of investigational drugs that treat serious conditions and fill an unmet medical need.

• New Drug Approvals

o JASCAYD (nerandomilast) Tablets – Boehringer Ingelheim Pharmaceuticals Inc. A phosphodiestrase inhibitor indicated for the treatment of idiopathic pulmonary fibrosis in adult patients.

o INLURIYO (imlunestrant) Tablets – Eli Lilly & Co. An estrogen receptor antagonist indicated for the treatment of adults with ER-positive, HER2-negative, ESRI-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

o PALSONIFY (paltusotine) Tablets – Crinetics Pharmaceuticals Inc. A somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.

o FORZINITY (elamipretide hydrochloride) injection – Stealth BioTherapeutics Inc. A mitochondrial cardiolipin binder for the treatment of Barth syndrome. Barth syndrome is a rare but serious X-linked genetic disorder, caused by changes in phospholipid structure and metabolism. It may affect multiple body systems and is potentially fatal. The syndrome is almost exclusively diagnosed in males.

o KEYTRUDA QLEX (pembrolizumab abd berahyaluronidase alfa-pmph) injection – Merck.  A programmed death receptor-1, blocking antibody and endoglycosidase combination indicated for the treatment of mutlple types of cancer.

o ENBUMYST (bumetanide) nasal spray – Corstatsis Therapeutics Inc. A loop diuretic for the treatment of edema associated with CHF, hepatic and renal disease, including nephrotic syndrome.

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.