Pickings by Pharma Veterans Fortnightly Newsletter #30 – August 31, 2025

Pickings by Pharma Veterans Fortnightly Newsletter #30 – August 31, 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

• Patients in Pakistan will soon have access to safer and higher-quality medicines as the Drug Regulatory Authority of Pakistan (DRAP) has adopted international pharmaceutical standards for the inspection of drug manufacturing facilities, officials said on Monday. Through a landmark notification (S.R.O. 1587(I)/2025) issued on August 25, 2025, the Drap has replaced outdated local rules with internationally-recognized Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practice (GMP) guidelines. The change, Drap officials say, will align Pakistan’s drug industry with global best practices and directly improve the quality of medicines available to millions of patients. At the same time, the Central Licensing Board may, under specific circumstances, grant exemptions from certain conditions to facilitate implementation. Officials confirmed that the transition to the new system will be phased in over six months. The DRAP plans to work closely with pharmaceutical manufacturers to support compliance, recognizing that such a sweeping reform requires careful planning.

• A parliamentary panel on Thursday while expressing serious concerns over the cartelisation in the pharmaceutical industry has said that the government deregulated the prices to bring fair competition in the drug market but the pharma industry cartelised that resulted in the unprecedented price hike. The committee expressed serious displeasure over cartelisation in the pharmaceutical sector, declaring that unprecedented price hikes driven by profiteering cannot be tolerated at the expense of public health.

• Federal Minister for Health Mustafa Kamal met with a delegation of the Pakistan Pharmaceutical Manufacturers Association (PPMA) on Tuesday to discuss key reforms in the pharmaceutical sector. The CEO of the Drug Regulatory Authority of Pakistan (DRAP) and senior officials were also present. The meeting reviewed progress on implementing 2D barcodes to combat counterfeit medicines. Minister Kamal emphasized urgent action against spurious drugs and urged faster adoption of the system. Discussions also focused on developing local vaccine production. The Minister directed DRAP and industry leaders to create a roadmap for indigenous manufacturing to boost self-reliance and reduce foreign dependence.

• Pakistan is exploring avenues of collaboration with Russia to locally manufacture insulin, as a high-level meeting of the Drug Regulatory Authority of Pakistan (DRAP) was held on Thursday to discuss insulin production in collaboration with Russia.

INDIA

• The Directorate General of Foreign Trade (DGFT) has initiated dialogue with the pharma industry and other stakeholders on the prospects of the India-UK Free Trade Agreement (FTA). This initiative is a part of the Pharmaceuticals Export Promotion Council of India (Pharmexcil)’s collaboration with DGFT. India and the UK signed an FTA on July 24, 2025 as part of Prime Minister Narendra Modi’s UK visit. Prime Minister Modi met with British Prime Minister Keir Starmer. India exports USD 23.31 billion globally but Indian pharma export to UK accounts for under USD 1 billion, indicating significant headroom for growth. 

• India's contract research, development, and manufacturing organisation (CRDMO) sector is emerging as one of the most dynamic growth stories in the global pharmaceutical landscape. According to a recent Jefferies India report, the country's CRDMO, which has already reached revenues of around $3 billion, has grown at a compound annual growth rate (CAGR) of 14 per cent over the past five years. The report highlights that India's CRDMO industry has caught the attention of global investors, with its market capitalization now standing at $40-50 billion. While the Covid-19 pandemic temporarily skewed demand, the future looks stronger. Jefferies estimates an 18 per cent CAGR for the sector between FY25 and FY30, fueled by a visible drug pipeline, Big Pharma's diversification under the "China+1" strategy, and rising opportunities in weight-loss and Type 2 diabetes drugs.A central driver of this momentum is the shift away from dependence on Chinese CRDMOs.

• India's contract research, development, and manufacturing organisation (CRDMO) sector is emerging as one of the most dynamic growth stories in the global pharmaceutical landscape. According to a recent Jefferies India report, the country's CRDMO, which has already reached revenues of around $3 billion, has grown at a compound annual growth rate (CAGR) of 14 per cent over the past five years. The report highlights that India's CRDMO industry has caught the attention of global investors, with its market capitalization now standing at $40-50 billion. Jefferies estimates an 18 per cent CAGR for the sector between FY25 and FY30, fueled by a visible drug pipeline, Big Pharma's diversification under the "China+1" strategy, and rising opportunities in weight-loss and Type 2 diabetes drugs. A central driver of this momentum is the shift away from dependence on Chinese CRDMOs. 

• The additional 25 per cent tariff imposed by US President Donald Trump on Indian goods over New Delhi’s purchases of Russian oil have come into effect, raising the overall levy on exports to 50 per cent. Trump had first announced reciprocal tariffs of 25 per cent on India from August 7, alongside similar levies on about 70 other countries. He later doubled tariffs on Indian goods to 50 per cent, citing Russian crude imports, but allowed a 21-day window for negotiations. Several sectors, including textiles and apparels, gems and jewellery, seafood. The Indian pharmaceutical industry, a crucial supplier of generic drugs to the US, along with electronics and smartphones, including Apple iPhones, have been exempted from the tariffs.

• GSK has made known the delivery of its cutting-edge oncology treatment Jemperli (dostarlimab) and Zejula (niraparib) in India, a considerable move to elevate the provision of precision cancer treatments. GSK says that this accomplishment highlights the company’s dedication to the worldwide unmet need for the category of women’s cancer care.

BANGLADESH

• The hot topic these days is the graduation of Bangladesh from LDC – Least Developed Country to Developing Country. The exemptions and facilitation accorded during this period shall be withdrawn in November 2026 when the status changes.

• New drugs registration has been on halt for two years. A new Drug Control Committee has recently been formed but its constitution is being debated.

• Around 50 pharmaceutical firms have applied to the Directorate General of Drug Administration (DGDA) for registering 617 new medicines that include biologic drugs used for treating cancer and chronic diseases.

• The companies are set to lose patent protection ensured by a waiver under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in November 2026, when Bangladesh transitions to a developing country, say industry insiders. "If we can't secure registration soon, we'll miss the opportunity to manufacture these drugs royalty-free once Bangladesh graduates from Least Developed Country [LDC] status next year," Abdul Muktadir, president of Bangladesh Association of Pharmaceutical Industries, said in a press interview.

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

• Drug Development

o Oncology – Merck announced that the USFDA has granted Breakthrough Therapy status to Ifinatamab Deruxtecan for the treatment of adult patients with extensive=stage small cell lung cancer with diseases progression on or after platinum-based chemotherapy. 

o Oncology – SystImmune Inc., a clinical stage biotechnology company and Bristol Myers announced that the USFDA has granted the Breakthrough Therapy Designation to Izalontamab brengitecan for the treatment of locally advanced or metastatic non-small cell lung cancer.

o Obesity – Novo Nordisk lowers cost of Ozempic to $499 per month for self-paying patients.

o Obesity – Eli Lilly announced positive topline results from the Phase 3 ATTAIN-2 trial, evaluating Orforglipron an investigational oral GLP-1 receptor agonist, in adults with obesity or overweight and type 2 diabetes. 

o Obesity - Viking Therapeutics Inc. has announced positive topline results from the company’s Phase 2 clinical trial of the oral tablets formulation of VK2735, the company’s dual agonist of the GLP-1 and GIP receptors.

• New Drug Approvals

o DAWNZERA (donidalorsen) Injection – Ionis Pharmaceuticals Inc. The first and only RNA-targeted prophylactic treatment for hereditary angioedema.

o PAPZIMEOS (zopapogene imadenovec-drba) Injection – Precigen Inc. A non-replicating adenoviral vector-based immunotherapy for the treatment of adults with recurrent respiratory papillomatosis.

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.