Pickings by Pharma Veterans Fortnightly Newsletter #33 – October 26, 2025

Pickings by Pharma Veterans Fortnightly Newsletter #33 – October 26, 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.

PHARMACEUTICAL NEWS - PAKISTAN

• Pakistan is losing up to Rs. 50 billion every year because of non-evidence-based prescriptions and unethical marketing practices in the pharmaceutical sector. They warned that such practices are draining the country’s healthcare system, accelerating antimicrobial resistance (AMR), and damaging global confidence in local medicines. Speaking at the Health Asia 2025 Conference in Karachi, Drug Regulatory Authority of Pakistan (DRAP) Chief Executive Officer Dr. Obaidullah said that more than half of all medicines sold worldwide are either misprescribed or wrongly promoted. In Pakistan, he noted, irrational drug use consumes nearly one-fourth of the national health budget. “Sixty-five percent of Pakistan’s healthcare spending is out-of-pocket, yet a large portion is wasted on unnecessary prescriptions. This is both an ethical and economic failure,” he said during a session titled “Redefining Pharma Marketing: From Data Insights to Patient Impact.”

• Pakistan is preparing to launch its first-ever National Vaccine Policy to kickstart local vaccine manufacturing and reduce its 95 percent reliance on imported vaccines. Special Assistant to the Prime Minister on Industries and Production Haroon Akhtar Khan announced this while chairing a high-level meeting on Thursday.

• Six Iranian companies are participating in the 22nd Health Asia International Exhibition and Conference, being held from October 23-25 in Karachi, Pakistan. The Iran pavilion is showcasing the country’s achievements in the fields of infertility treatment, medical and therapeutic kits, laparoscopy, and the pharmaceutical industry, IRNA reported. Members of the Iranian delegation, led by Morad Nemati-Zargaran, Iran's commercial attaché in Pakistan, met with Muhammad Ubaidullah Malik, CEO of the Drug Regulatory Authority of Pakistan, on the sidelines of the exhibition, and discussed ways to develop cooperation.

• Federal Health Minister Syed Mustafa Kamal announced on Monday that Pakistan aims to raise its pharmaceutical and medical device exports to $30 billion over the next five years through a new fast-track licensing system, 24NewsHD TV reported. Chairing a review meeting of the Drug Regulatory Authority of Pakistan (DRAP), the minister emphasized that the government is fully committed to expanding the country’s presence in global healthcare markets. The session was attended by the Federal Secretary for Health, the CEO of DRAP, and other senior officials.

PHARMACEUTICAL NEWS - INDIA

• Torrent Pharmaceuticals Ltd. is said to proceed with its plan to raise funds in India's biggest bond issue so far this year, after the Competition Commission of India approved its acquisition of JB Chemicals & Pharmaceuticals Ltd. last week, Reuters reported citing bankers aware of the matter.

• India's southern state of Tamil Nadu has cancelled the licences of a cough syrup-maker linked to the deaths of several children over the past month, it said on Monday, as authorities search some of the firm's sites on suspicion of money-laundering. At least 19 children died in the central state of Madhya Pradesh after taking the syrup, which was banned after a test this month showed it contained nearly 500 times the permissible limit of diethylene glycol, a toxic chemical.

• Eli Lilly and Company (India) and Cipla Limited announced an agreement to distribute and promote tirzepatide in India under a second brand name, Yurpeak. Under the agreement, Cipla has the rights to distribute and promote Yurpeak, the second brand of tirzepatide in India. This strategic agreement aims to expand the availability of tirzepatide by enabling broader access across the country beyond cities where Lilly already has an established presence. Lilly will manufacture and supply Yurpeak to Cipla, and the price will be the same as Mounjaro.

• The Central Drugs Standard Control Organisation (CDSCO) has accepted drug major Eli Lilly's request to withdraw the coronavirus disease-2019 (Covid-19) indications of its rheumatoid arthritis drug baricitinib tablets, initially approved in May, 2021 for restricted emergency use. The drug regulator, on May 3, 2021, had issued approval to the company to use baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed Covid-19 in hospitalised adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Later, on November 15, 2021, the drug was allowed to be used for treatment of Covid-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. With the company's request for withdrawal of the 2 mg and 4 mg tablets from restricted use in emergency situation and the two permissions granted in the year 2021, the CDSCO said that the office acknowledges the withdrawal. "However, baricitinib tablets 2mg & 4mg may continue to be marketed for other approved indication i.e. Rheumatoid arthritis," added Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI).

• In the rapidly evolving R&D ecosystem, India has notably emerged as a favoured location for clinical trials, particularly during and after the COVID-19 pandemic, due to its scale, population diversity, and existing drug manufacturing infrastructure. India has 94,730 trials registered since 2000 as per the Clinical Trials Registry of India (CTRI), orienting as a strategic partner for pharmaceutical and biotechnology companies seeking efficient, diverse, and scalable clinical trial solutions. South-East Asia is quickly growing in number of reported clinical trials and was the only region not to see a decrease since the peak of trials during the COVID-19 pandemic, driven largely by trials in India2. This rapid expansion has elevated India to become the third-largest destination for conducting clinical trials globally as of 2024, growing at a CAGR of 80% from 2019. Approximately 18,000 new clinical trials were registered in India in 2024 alone, 50% more from the previous year.

PHARMACEUTICAL NEWS - BANGLADESH

• Raw materials worth around Tk200 crore belonging to pharmaceutical companies were destroyed in the recent fire at the Cargo Village of Hazrat Shahjalal International Airport, according to the Bangladesh Association of Pharmaceutical Industries (BAPI). BAPI Secretary General Zakir Hossain said at a joint press conference with the Exporters Association of Bangladesh (EAB) in the capital today (20 October) that the organisation had sent letters to 32 companies to assess their losses. "We saw that their raw materials worth Tk200 crore have been reduced to ashes," he said.

• The Bangladesh Association of Pharmaceutical Industries (BAPI) has said the country's pharmaceutical industry faces a potential financial loss of around Tk 40 billion due to the fire in the Cargo Village at Dhaka's Shahjalal International Airport. Leaders of the organization presented the figure at a press conference at its office in Tejgaon on Tuesday. BAPI Secretary General Zakir Hossain read a statement at the briefing. He said that immediately after the fire, they collected and analyzed data from many pharmaceutical companies. The analysis showed that raw materials worth around Tk 2.0 billion belonging to the country's top 45 pharmaceutical companies were destroyed in the fire. The total loss will be even higher when including damage sustained by other institutions. The burnt raw materials included critical components necessary for producing antibiotics, vaccines, hormones, diabetes, and cancer-related medications, according to Zakir.

• Following the devastating fire that gutted the import cargo village at the Dhaka airport, including its temperature-controlled storage facilities, importers of pharmaceutical raw materials will now be able to collect their consignments directly upon arrival. After a meeting with the Civil Aviation Authority of Bangladesh (CAAB) today (21 October), industry leaders said that the temporary arrangement will remain in place until the cold chain system is rebuilt, a process expected to take three months.

EUROPE – European Medicines Agency – EMA

• New Drug Approval Recommendations

o BRINSUPRI (brensocatib) – Insmed Netherlands B.V. Treatment of non-cystic fibrosis bronchiectasis. It is the first treatment for serious chronic lung disease.

o WAYRILZ (rilzbrutinib) – Sanofi B.V. Orphan Drug. For the treatment of immune thrombocytopenia in adult patients who are refractory to other treatments.

• Negative Recommendation

o REZUROCK (belumosudil) – Sanofi Winthrop Industrie. Orphan Drug. Treament of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy.

UNITED STATES – Food & Drug Administration – USFDA

• Drug Development

o Multiple Myeloma: Heidelberg Pharma AG has announced that USFDA has granted their drug candidate HDP-101(pamlectabart tismanitin) Fast Track Designation. The drug is being investigated for safety and antitumor activity in patients with relapsed or refractory multiple myeloma.

o Emphysema: Positive results from the global ElevAATe phase 2 study (clinical study identifier: NCT05856331) showed that efdoralprin alfa (SAR447537, formerly known as INBRX-101), met all primary and key secondary endpoints when dosed every three weeks (Q3W) or four weeks (Q4W) in adults with alpha-1 antitrypsin deficiency (AATD) emphysema, a rare disease.

o Immusoft of CA, a clinical-stage biotechnology company pioneering engineered B cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ISP-001, the Company's lead investigational therapy for the treatment of mucopolysaccharidosis type I (MPS I), a rare and life-threatening lysosomal storage disorder.

o Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III evERA Breast Cancer study. Data showed giredestrant in combination with everolimus significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 44% and 62% in the intention-to-treat (ITT) and ESR1-mutated populations, respectively, compared with standard-of-care endocrine therapy plus everolimus.

• New Drug Approvals

o EPIOXA (ribofalvin 5-phosphate) – Glaukos Corporation. Next generation corneal cross-linking therapy for the treatment of keratoconus.

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.