PharmaFrontiers: Navigating the New Wave of Healthcare Innovations

In the ever-evolving world of pharmaceuticals, groundbreaking advancements and strategic movements are shaping the future of healthcare. This week’s edition of PharmaBuzz delves into a series of pivotal developments that promise to redefine industry standards and patient care. From Abbvie’s full FDA approval for a novel ovarian cancer therapy to Theon Pharmaceuticals’ innovative triple-drug formulation for Type-2 diabetes, we’re witnessing a transformative era in medical treatment. Join us as we explore these milestones, including the integration of AI in medical research, the global shift in fertility trends, and major acquisitions that signal a new direction in the fight against chronic diseases. Stay tuned for an insightful journey through the latest pharmaceutical breakthroughs and what they mean for the world.

1. Abbvie’s ovarian cancer therapy gets full grant approval by US FDA

The US Food and Drug Administration announced on Friday that it has granted conventional approval for AbbVie's "guided missile" cancer therapy, Elahere, for patients with ovarian cancer.

Elahere belongs to a new class of medications known as antibody-drug conjugates, which specifically target cancer cells while potentially lowering damage to other cells.

AbbVie has placed its hopes in Elahere, which it purchased as part of a $10 billion buyout of ImmunoGen in November of last year, as its best-selling arthritis drug Humira faces newer competitors.

 

2. Dr Reddy’s and Pharmazz agreement for commercialization of "centhaquine" Brand name "lyfaquin" in India

Dr Reddy's Laboratories Ltd has signed a license agreement with Pharmazz, Inc to market the first-in-class novel medication Centhaquine in India. Centhaquine, developed by Pharmazz, is a resuscitative drug that the Drugs Controller General of India (DCGI) has approved for the treatment of hypovolemic shock.

According to the deal, Dr Reddy's has exclusive rights to market and distribute Centhaquine in India. Pharmazz will be entitled to both upfront cash and royalties. Dr. Reddy's will commercialize the medicine under the Lyfaquin brand, which it owns. In addition to India, Dr Reddy's has received marketing rights for Lyfaquin from Pharmazz in Nepal.

Hypovolemic shock is a life-threatening, frequently lethal condition. Severe blood or fluid loss caused by traumatic haemorrhage, postpartum haemorrhage, gastrointestinal bleeding, post-surgical bleeding, diarrhoea, or vomiting can result in hypovolemic shock, which can progress to multi-organ failure and even death. These illnesses are common in India, and they are associated with a high mortality rate. According to data from several Indian research and registries, the death rate in severe haemorrhages is roughly 10 to 15% despite the current standard of care. This highlights the need for a new resuscitative agent that can enhance the current standard of care.

3. “REDSHOT” Cadila pharmaceuticals a step towards addressing anemia.

Cadila Pharmaceuticals has announced the launch of a new iron injection, a next-generation treatment for iron deficient anaemia. The product will be marketed as Redshot FCM, which is fortified with the Ferric Carboxymallose formulation and is intended for administration to adults and pediatric patients over the age of one year, particularly those with oral iron resistance.

Redshot injection is an intravenous iron preparation that not only provides adequate levels of iron but also has an excellent safety record. With greater tolerability and little to no risk of allergy, the injection speeds haemoglobin level improvement while rapidly replenishing depleted iron stores. Intravenous infusion improves tolerability and allows for the use of high doses in a single treatment.

Anaemia, which is characterized by reduction in physical activity, overall weakness, lethargy, and weariness, frequently goes unrecognized and is poorly handled, especially in pregnancy, the elderly, and cancer patients. The injectable iron mixture fills this gap, as anaemia is common among cancer patients and has been associated to decreased survival rates. Anaemia during pregnancy, if left untreated, can complicate childbirth and endanger both mothers and babies.

 

4. First in India Triple-drug formulation for Type-2-diabetics launched by Theon Pharmaceuticals

Theon Pharma is pleased to announce the introduction of a novel pharmaceutical medicine combination for the treatment of type 2 diabetes for the first time in India. The combination was created in accordance with clinical trials and the guidelines established by the Drug Controller General of India (DCGI). Each film-coated bi-layered sustained-release tablet comprises linagliptin 5 mg/5 mg, dapagliflozin 10 mg/10 mg, and metformin hydrochloride (SR) 500 mg/1000 mg. This medication is a first-ever combination of linagliptin and dapagliflozin. In order to improve glycemic control, the combination is recommended for persons with type 2 diabetes mellitus (T2DM) in addition to diet and exercise.

Theon Pharmaceuticals Ltd.'s Managing Director, Amit Bansal, explains why this fixed-dose combo tablet containing metformin hydrochloride, dapagliflozin, and linagliptin is a good choice: glycemic control that is safer, quicker, and more sustained—a decrease in FPG, PPG, and HbA1c enhances the activity of beta cells and reduces insulin resistance.

It lowers pill burden (improving adherence and compliance), lowers blood pressure, helps lower body weight, and is often more affordable.

Commenting further, Punit Bansal, Director, Theon Pharmaceuticals, noted that the combination of linagliptin, dapagliflozin, and metformin hydrochloride corresponds with the 2018 Indian Council of Medical Research (ICMR) guidelines on the management of type 2 diabetes.

5. EYESULIN Novel Insulin usage approach to treat corneal conditions

ENTOD Pharmaceuticals stated on Tuesday that it is developing human insulin eye drops to address corneal disorders such as neurotrophic corneal ulcers and dry eyes.

Although insulin has typically been delivered via injection to diabetes patients worldwide to maintain blood sugar levels, current research from multiple global studies and literature searches has revealed its potential efficacy when used as eye drops. These data imply that insulin eye drops can help rebuild corneal tissue and treat ocular surface problems.

The company's next move is to initiate the drug regulatory approval process in India. This will begin with an application to the CDSCO for permission to conduct clinical studies with these eye drops. The company will then seek DCGI approval for commercialization.

ENTOD Pharmaceuticals' CEO, Nikkhil K Masurkar, said, "There is compelling and growing global evidence suggesting that insulin eye drops could revolutionize ophthalmic therapeutics. Our eye drop formulation, EyeSulin, would be the first of its kind in the world to treat eye conditions once approved. Upon regulatory clearance, we aim to produce these eye drops as part of the 'Make in India' initiative, making them accessible across India and globally at an affordable price. As far as our knowledge extends, no commercially viable insulin eye drops exist worldwide or are in development. Therefore, we are thrilled to lead the charge ahead of the US and other Western nations in pioneering this potentially groundbreaking eye medicine, poised to benefit millions."

6. Zepbound Surpasses Wegovy in the Battle for Obesity Treatment 

In a remarkable shift in the pharmaceutical landscape, Eli Lilly and Company’s Zepbound has overtaken Novo Nordisk’s Wegovy in new prescriptions for obesity treatment in the US. With a staggering 77,590 new prescriptions written in the first week of March alone, Zepbound is now leading the charge against obesity.

7. Novo Nordisk Foundation’s Leap into AI with Supercomputer Gefion

The Novo Nordisk Foundation is making a significant investment in the future of medical research by funding Gefion, a new supercomputer. Powered by NVIDIA AI, Gefion is set to revolutionize how medical data is processed, potentially leading to breakthroughs in disease understanding and drug discovery.

8. The Lancet Study Forecasts a Steep Decline in Global Fertility

A recent study published in The Lancet predicts a faster-than-expected decline in global fertility rates. By 2050, it’s projected that 155 of 204 countries (76%) will have fertility rates below the population replacement levels. This trend is expected to continue, with the number rising to 198 countries (97%) by 2100, signaling significant demographic shifts ahead.

9. AstraZeneca’s Strategic Acquisition of Fusion Pharmaceuticals

 In a bold move, AstraZeneca has acquired cancer radiopharmaceutical specialist Fusion Pharmaceuticals for up to $2.4 billion. Fusion’s innovative approach to cancer treatment involves next-generation radiotherapy that targets cancer cells with high precision while sparing healthy tissue. This acquisition comes as AstraZeneca’s profits soar, thanks in part to its robust oncology division.

10.  Cardior pharma brought up by Novo Nordisk for $1 Billion

Novo Nordisk A/S has agreed to buy Cardior Pharmaceuticals for up to $1 billion ($1.1 billion), as the Danish weight-loss drugmaker expands into cardiovascular disease medicines.

The maker of the popular obesity medicine Wegovy announced Monday that it will provide an upfront payment for Cardior, with subsequent payments contingent on meeting specified milestones.

Cardior is working on medicines that target microRNA, a type of molecule that helps regulate how much of particular proteins are produced inside a cell. The biotech's main possible treatment is meant to suppress aberrant amounts of a certain microRNA, with the goal of improving heart function over time.

The compound is currently in the second of three stages of patient trials.

As we close this edition of PharmaBuzz, we reflect on the remarkable strides taken by the pharmaceutical industry towards a healthier tomorrow. The stories we’ve shared today are not just news items; they’re beacons of hope for patients worldwide. They represent the relentless pursuit of innovation and the unwavering commitment to enhancing human health. As we continue to navigate the complexities of medical science and healthcare delivery, let’s celebrate these achievements and look forward to the next chapter of advancements that await us. Until our next update, stay informed and stay healthy.