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akshay posted an update in the group
a day agoPharma News a day agoGlobal Pharma Industry Eyes Faster Patient Access with EU Regulatory Overhaul
The European Union has reached a landmark agreement to reform drug regulations, aiming to speed up patient access to medicines across the bloc. The new framework revises data and market exclusivity rules, supports antibiotic innovation, and strengthens supply…
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akshay posted an update in the group
4 days agoPharma News 4 days agoNew Cancer Drug License — Hope for Patients in India
As a practising doctor in India, I’m encouraged by the latest development: Dr Reddy’s Laboratories has signed an exclusive licensing agreement with Australia-based Immutep to market a promising new cancer drug — a move that could expand therapeutic options for patients across the…
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akshay posted an update in the group
a week agoPharma News a week agoIndia’s First Home-grown Antibiotic Is Here
As a doctor, I’m genuinely excited about a recent milestone in Indian medicine — the launch of Nafithromycin, the first antibiotic discovered, developed and clinically validated entirely in India.
This antibiotic — marketed as Miqnaf — promises a short, once-daily, three-day treatment for…
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neha posted an update in the group
a week agoPharma News a week agoIndian Firm’s Novel Antibiotic ‘Zaynich’ Gets FDA Nod for Review — A Big Step Against Drug-Resistant Infections
The United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Zaynich, a first-in-class antibiotic developed by Wockhardt Ltd., marking a historic milestone — it’s the first time an Indian…
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neha posted an update in the group
2 weeks agoPharma News 2 weeks agoFDA Clears New Gene Therapy for Spinal Muscular Atrophy — Big Hope for Older Children & Adults
A groundbreaking approval: the U.S. FDA has cleared Itvisma, a one-time gene therapy for patients aged 2 years and older with Spinal Muscular Atrophy (SMA), offering a potential lifeline for those previously beyond the reach of existing treatments.
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akshay posted an update in the group
2 weeks agoPharma News 2 weeks agoFDA Approves Novel Drug for Rare Fat-Metabolism Disorder
This week, the U.S. Food and Drug Administration (FDA) approved Plozasiran (brand name: Redemplo) — a new siRNA therapy for Familial Chylomicronemia Syndrome (FCS), a rare genetic disorder that causes dangerously high triglyceride levels.
✅ What This Means from a Doctor’s Perspective
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For…
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neha posted an update in the group
2 weeks agoPharma News 2 weeks ago🌟 India’s Home‑grown Antibiotic Breakthrough: A New Hope Against Drug‑Resistant Infections
As a practising physician in India, I’m thrilled by the recent announcement of Nafithromycin — the first antibiotic discovered and developed entirely within India.
For many of us on the front lines, antimicrobial resistance is a growing nightmare: rising…
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akshay posted an update in the group
2 weeks agoPharma News 2 weeks ago🩺 A Doctor’s Note on India’s Pharma Trade Scrutiny
I’m deeply concerned—but also cautiously hopeful—about the recent anti‑dumping probe India has launched into imports of Ethambutol Hydrochloride, a key API used in TB drugs.
From a medical standpoint:
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Access to TB medicines is non-negotiable—we rely on affordable, consistent supply to treat…
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neha posted an update in the group
2 weeks agoPharma News 2 weeks agoIndian Regulators Crack Down: Strict GMP Compliance Required by Year End
As a clinician, the latest move from drug regulators raises both concern and hope. The DCGI has issued a final directive: all pharma manufacturing plants must fully comply with updated Good Manufacturing Practice (GMP) rules by 31 December 2025, or face closure.
Why…
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akshay posted an update in the group
3 weeks agoPharma News 3 weeks agoCDSCO Releases Updated Draft Guidelines for AI-Enabled Medical Device Software
As a physician who increasingly relies on digital health tools, I find India’s latest move hugely significant: the CDSCO has published a draft guidance document for medical-device software (SaMD and SiMD), including AI/ML-based applications.
What this means for us at…
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akshay posted an update in the group
3 weeks agoPharma News 3 weeks agoIndia Expands CDSCO Workforce With 419 New Drug Inspectors
The Health Ministry has officially approved 419 new Drug Inspector posts under CDSCO to strengthen drug-quality surveillance across the country. This is one of the largest regulatory workforce expansions in years.As a doctor, here’s why this matters for all of us in healthcare:
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Stronger…
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neha posted an update in the group
3 weeks agoPharma News 3 weeks agoIndia’s GST Rate on Medical Devices Cut to 5%
The Indian government has reduced the Goods & Services Tax (GST) on a wide range of medical devices to 5% effective from 22 September 2025.
As a physician, this move signals both opportunity and responsibility:
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Patient affordability improves – With lower tax, devices such as diagnostics kits,…
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akshay posted an update in the group
4 weeks agoPharma News 4 weeks agoIndian Drugmaker Glenmark Pharmaceuticals Reports 72% Profit Surge — What It Means for Clinicians
As a physician, I pay attention not only to new medicines but also to how the pharma industry is evolving — because stronger companies often mean better supply, better innovation and improved access for my patients. Glenmark Pharmaceuticals…
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neha posted an update in the group
4 weeks agoPharma News 4 weeks agoNovo Nordisk Cuts Price of Wegovy by Up to 37% in India
The Danish drug-maker has reduced the Indian retail price of its obesity treatment Wegovy (semaglutide) by up to 37%, aiming to broaden access as competition in the weight-loss drug category intensifies.👨⚕️ From a Doctor’s Perspective
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Patient access improvement: Lowering the price means…
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akshay posted an update in the group
4 weeks agoPharma News 4 weeks agoIndia Launches ‘i-Passport’ for MedTech Startups
As a practicing physician, I believe meaningful change in healthcare doesn’t just come from new drugs — it comes from smarter systems too. Recently, the Andhra Pradesh MedTech Zone (AMTZ) in Visakhapatnam introduced the “i-Passport”, a streamlined gateway for med-tech and health-tech…
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akshay posted an update in the group
4 weeks agoPharma News 4 weeks agoWegovy Price Cut of Up to 37% in India
Novo Nordisk has cut the Indian price of its weight-loss drug Wegovy (semaglutide) by up to 37%.
Why this matters:-
Affordability is a major barrier in real-world practice; price reductions can increase adoption and allow more patients access.
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However, it also raises expectations: if we use the drug…
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Smart Cold-Chain Tech Lands for Clinics — Take on Vaccine Storage Upgrade
As a practising physician, I’m excited by a new development that directly impacts the front-line of patient care: a team from Blackfrog Technologies in Manipal has launched the EMON-25, an intelligent retrofit system that converts regular medical refrigerators into…
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akshay posted an update in the group
4 weeks agoPharma News 4 weeks ago⚠️ Regulation Tightens on Pharma Manufacturing
As a physician, patient safety is always front and centre—and recent regulatory action in India demands our attention. The Central Drugs Standard Control Organisation (CDSCO) has mandated that all pharmaceutical manufacturers must meet international standards by January 1, 2026—following a tragic…
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akshay posted an update in the group
5 weeks agoPharma News 5 weeks agoNew Drug & Device Milestones Highlight Shift to Innovation
Two recent announcements stand out for us in clinical practice:
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Finerenone (brand name Kerendia) has just received expanded approval in India for treating adult patients with heart‐failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF). This opens up treatment for a…
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akshay posted an update in the group
5 weeks agoPharma News 5 weeks agoIndia OKs Self-Certification for 1,000+ Medical Devices — A Doctor’s Take
As a clinician, I welcome any move that speeds access to safe, affordable equipment—but only if safety keeps pace. India will now allow self-certification for over a thousand low- to moderate-risk medical devices (think stethoscopes, wheelchairs, swabs, scissors). The aim…
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