Pickings by Pharma Veterans Fortnightly Newsletter #31 – September 13, 2025

Pickings by Pharma Veterans Fortnightly Newsletter #31 – September 13, 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

• A parliamentary committee was informed on Tuesday that the surge in medicine prices has become a serious issue in Pakistan, while the pharmaceutical industry is leaving the country due to corruption within the sector. During the Senate Standing Committee on Health meeting, chaired by Senator Amir Waleeduddin Chishti, the federal health minister discussed the decision to lift restrictions on medicines, which would depend on the results of an upcoming survey report. The health minister expressed concern over the price hikes, mentioning that several pharmaceutical companies had exited Pakistan due to corrupt practices in the industry. He also noted that, in the past, legal action was typically limited to filing FIRs against the CEOs of pharmaceutical companies. This process has now been revised to include more comprehensive accountability.

• The Special Investment Facilitation Council (SIFC) held an emergent meeting with the Pakistan Pharmaceutical Manufacturers Association (PPMA) to review recent reforms and export prospects. The session was attended by PPMA Chairman Tauqeer ul Haq, Vice Chairman and Executive Director Col. Nayyar, and Special Assistant to the Prime Minister on Industries Haroon Akhtar. The SIFC delegation was led by its Director General. PPMA thanked SIFC for endorsing changes to the drug law that address directors liability. The industry said the deregulation policy delivered visible gains. Medicine shortages were resolved and pharmacies saw steady supply. The PPMA reported that pharmaceutical exports rose 34% following the reforms. PPMA raised concerns about a third party survey commissioned by the drug regulator on the Prime Minister advice. Industry representatives said they were not included in that exercise and called for greater consultation. The SIFC team noted the concern and agreed to maintain dialogue with industry stakeholders. SIFC and SAPM Haroon Akhtar strongly supported the deregulation approach.

• Pakistan Pharmaceutical Manufacturers Association (PPMA) chairman Tauqeer Ul Haq said pharmaceutical firms have made some 40 life-saving drugs available again in the country that are prescribed to get cured from diseases including malaria and tuberculosis (TB). The therapies had gone out of production and disappeared from local markets after their cost of production surged beyond their retail price. Local companies resumed their production and they were made available again to patients to treat diseases after the government revised their prices under the hardship cases and de-regulated non-essential medicine pricing, enabling pharmaceutical firms to determine medicine price themselves, he added.

INDIA

• Biocon Limited, an innovation-led global biopharmaceutical company, announced the inauguration of its first US manufacturing facility in Cranbury, New Jersey, by its wholly owned subsidiary. Biocon acquired the Oral Solid Dosage (OSD) facility from Eywa Pharma Inc. in 2023 and has since invested over USD 30 million to establish a state-of-the-art plant with an annual production capacity of 2 billion tablets. A few products have already been commercialized from the site, with several more in the pipeline. This investment helps Biocon diversify its manufacturing base, strengthen its supply chain and accelerate the expansion of its global footprint.

• The GST Council’s decision to introduce significant GST cuts in the pharmaceutical sector is a significant step toward affordable healthcare. The GST will be reduced on all medicines from 12% to 5%, while 36 critical lifesaving drugs for ailments such as cancer and rare disorders have been exempted from the tax structure. The lowering of GST rates would enhance the affordability of essential healthcare. The Council’s proposal to reduce the GST rates from 12% to 5% on pharma job work services would benefit people as this would “strengthen public health and industry growth, promote equitable healthcare access, strengthen public health and industry growth, and reinforces India’s position as a global pharma leader”.

• Biocon Foundation, the Corporate Social Responsibility (CSR) arm of Biocon Group held the groundbreaking ceremony for the construction of a new Government High School building in Kodamballi, Channapatna Taluk of Karnataka. This school is imparting education to over 250 children who come from 23 surrounding villages.

BANGLADESH

• Novartis (Bangladesh) Limited has been renamed as Nevian Lifescience PLC, following the acquisition of its majority shares by Radiant Pharmaceuticals Limited from Novartis AG Switzerland . This milestone has been achieved after fulfilling all statutory and regulatory requirements, ensuring a seamless and compliant transition, while the shareholding status of Bangladesh Chemical Industries Corporation (BCIC) in the Company remains unchanged.

• Renata PLC, a listed drug manufacturer, has launched its first product in the Canadian pharmaceutical market. It will sell Desogestrel/Ethinylestradiol (0.15 mg/0.03 mg) tablets, an oral contraceptive that contains two hormones, Desogestrel and Ethinylestradiol, in fixed amounts. Manufactured at Renata's Health Canada-approved potent product facility, the medicine will be commercialised through a strategic partnership with Ambicare Pharmaceuticals Inc under the brand names Miley 21 and Miley 28, according to a disclosure.

• Despite being decently paid, pharmaceutical sales representatives in Bangladesh endure grueling hours, constant pressure to meet sales targets, and social indignities that often rob them of personal and family life. In front of the Bangladesh Medical University (PG Hospital/BSMMU) C-Block, Abdur Rahman and a dozen other pharmaceutical sales representatives had taken refuge under the trees. The midday heat was punishing, with the humidity making it worse. "Suited, booted and well paid," said Abdur Rahman, the dark circles under his eyes a tell-tale sign of sleep deprivation. "But I don't have a personal life and or any idea about how my children are growing up." Rahman has been in the job for over 15 years across many companies, but none of those years were any less stressful than the others. "It's a life of indignity. The Ansars at government hospitals, the guards in private hospitals, the chemists in pharmacy stores look down upon us."

Top 30 Pharma Companies in BD

EUROPE – European Medicines Agency – EMA

• New Drug Approval Recommendations

o No new drug approvals in this period. The Committee for Medicinal Products for Human Use (CHMP) shall meet from September 15 – 18. Recommendation shall be made public after that.

• 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.

• New Drug Approvals

o INLEXZO (gemcitabine) intravesical system – Johnson & Johnson. Treatment for patients with BCG-unresposive non-muscle invasive bladder cancer.

o WAYRILZ (rilzabrutinib) tablets – Sanofi. A kinase inhibitor for the treatment of adult patients with persistent or chronic immune thrombocytopenia who have had insufficient response to previous treatment.

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.