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Clinical Trial News

Granules India CEO Dr. K V Sitaram Rao Announces Resignation Effective July 2025

Leadership Change
  • Dr. Kandiraju Venkata Sitaram Rao has resigned from his position as Joint Managing Director and CEO of Granules India Limited, effective July 31, 2025.
  • The pharmaceutical executive brings over 29 years of experience in manufacturing, R&D, and business operations to his departure from the Indian generic drug manufacturer.
  • Granules India has acknowledged the resignation and is implementing measures to ensure a seamless leadership transition over the coming weeks.
  • Dr. Rao previously held senior leadership positions at PI Industries, Dr. Reddy's Laboratories, Jubilant Life Sciences, and Gujarat Heavy Chemicals Ltd.

Rigicon Initiates AUSOME Study for Artificial Urinary Sphincter FDA Approval

FDA Approval
  • Rigicon has begun patient enrollment in the AUSOME Study, a pivotal clinical investigation designed to support FDA Premarket Approval for its artificial urinary sphincter technology.
  • The first two patients were enrolled in the UK under the leadership of Dr. Rowland Rees, with the study evaluating safety, effectiveness, and patient-reported outcomes.
  • The company plans to expand enrollment across global urology centers and is developing additional product lines including electronic artificial urinary sphincter and penile prostheses.
  • Rigicon's device offers advancements in patient comfort, usability, and durability compared to existing artificial urinary sphincter solutions on the market.

Fecal Microbiota Transplantation Shows Safety and Tolerability in Six-Month Parkinson's Disease Pilot Study

  • A pilot study of 12 Parkinson's disease patients demonstrated that six-month fecal microbiota transplantation (FMT) therapy is safe and well-tolerated, with 92% completing the full treatment course.
  • Patients showed significant improvement in quality of life scores at two months, with trends toward improvement in non-motor symptoms, though these benefits were not sustained at six months.
  • The study represents the first evaluation of extended FMT therapy in Parkinson's disease, establishing a foundation for larger randomized controlled trials to assess therapeutic efficacy.

Bangladesh Pharmaceutical Companies Risk Losing Royalty-Free Access to 15 Biologic Drugs Due to Regulatory Delays

  • Bangladesh's pharmaceutical companies face losing the opportunity to produce at least 15 costly biologic drugs royalty-free due to regulatory hurdles that have stalled over 600 medicine registration applications for more than a year.
  • The Drug Control Committee, responsible for final approval of new medicines, has not convened for two years, creating a critical bottleneck as Bangladesh approaches its November 2026 transition from Least Developed Country status.
  • Local production of biologic medicines has dramatically reduced costs, with Adalimumab prices dropping from Tk 1.65-3.6 lakh to Tk 15,000 and Filgrastim from Tk 85,000-95,000 to Tk 7,000-8,000 per syringe.
  • Industry experts warn that missing the patent waiver window could increase drug prices by 25-30 percent, potentially pushing essential medicines out of reach for many patients.

Applied DNA Sciences Secures $600,000 Follow-On Order for Cancer Diagnostic Component

  • Applied DNA Sciences received a seventh follow-on order valued at more than $600,000 for multi-gram quantities of LineaDNA from a global IVD manufacturer.
  • The LineaDNA will be used as a functional component in a cancer diagnostic test, with deliveries scheduled across four quarterly shipments beginning in Q2 fiscal 2026.
  • The proprietary LineaDNA platform produces high-fidelity DNA free of adventitious sequences using cell-free production methods, offering advantages over conventional plasmid-based approaches.
  • This order represents continued commercial validation of Applied DNA's PCR-based synthetic DNA manufacturing technology in the diagnostics market.

PTAB Director Denies Amgen's IPR Challenges Against Bristol Myers Squibb's Opdivo Patents Based on Settled Expectations

Monoclonal Antibody
  • The USPTO Acting Director discretionarily denied two of Amgen's inter partes review petitions challenging Bristol Myers Squibb's Opdivo and Yervoy patents, citing "strong settled expectations" due to the patents being in force for six and seven years respectively.
  • The decision marks a significant shift in PTAB policy, as settled expectations had not previously been cited as grounds for discretionary denial in biosimilar-related IPRs, potentially making it more difficult for biosimilar manufacturers to challenge older patents.
  • Amgen is developing ABP 206, a biosimilar version of Opdivo, which generated $5.35 billion in U.S. sales for Bristol Myers Squibb in 2024.
  • A third IPR petition challenging a newer 2022 patent was referred to the Board for merit review, suggesting that patent age may be a critical factor in future discretionary denial decisions.

CytoDyn Files $100M Mixed Shelf Offering to Advance Leronlimab Through Phase III Trials

Oncology
  • CytoDyn Inc. filed a $100 million mixed securities shelf offering under SEC Form S-3 to provide capital flexibility for advancing its lead drug candidate leronlimab through Phase III trials.
  • Leronlimab, a CCR5 antagonist, is progressing through Phase II trials for oncology indications including triple-negative breast cancer and non-alcoholic steatohepatitis, with results expected at the 2025 ESMO meeting.
  • The strategic filing allows the company to issue various securities without repeated regulatory approvals, potentially minimizing dilution while funding critical clinical milestones.
  • The drug targets combined HIV and oncology markets estimated at over $150 billion, positioning CytoDyn for potential partnerships or licensing deals with larger pharmaceutical companies.

Indoco Remedies Receives EU GMP Certification for Sterile Manufacturing Facility in Goa

  • Indoco Remedies Limited has received EU Good Manufacturing Practices (GMP) certification from European Health Authorities for its sterile drug product manufacturing facility in Goa.
  • The certification confirms that Goa Plant II, located at Verna Industrial Estate in South Goa, complies with Good Manufacturing Practice requirements for sterile drug production.
  • The company's Managing Director emphasized their commitment to delivering quality and affordable medicines across global markets while adhering to cGMP standards.
  • Following the announcement, Indoco Remedies shares gained 1.78% to ₹316 apiece, with the stock showing 10.8% growth over the past month.

Biogen's Zurzuvae Receives EMA Panel Recommendation for Postpartum Depression Treatment

Drug Approval
  • The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing authorization for Biogen's ZURZUVAE (zuranolone) for treating postpartum depression in adults following childbirth.
  • The recommendation is based on the SKYLARK study, where ZURZUVAE demonstrated significant reduction in depressive symptoms as early as Day 3 and sustained through Day 45 compared to placebo.
  • If approved by the European Commission in Q3 2025, ZURZUVAE would become the first treatment specifically authorized within the European Union for postpartum depression.
  • The drug is a neuroactive steroid that enhances GABA activity and will be available as 20 mg, 25 mg, and 30 mg hard capsules.

Novel Dental Floss-Based Vaccine Delivery System Shows Promise Against Influenza in Preclinical Study

  • Researchers developed a needle-free vaccine delivery method using specialized dental floss that successfully protected all vaccinated mice from lethal influenza infection.
  • The floss-based approach triggered systemic immune responses with flu-fighting antibodies detected in bone marrow, saliva, and feces, suggesting potential for long-term immunity.
  • Human feasibility testing showed vaccine-coated dental picks reached gum tissue in approximately 60% of attempts among 27 healthy adults.
  • The method offers practical advantages including elimination of cold-chain storage requirements and potential for household distribution during pandemic outbreaks.

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