A new study has found that a combination of two drugs could enhance the immune system to treat one of the most common types of cancer in the world, bowel cancer. Also known as colorectal cancer, despite its widespread presence, the treatment options for this condition are limited. What the study specifically found was that this procedure could shrink the tumours caused by this condition by around 60%.
What Are The Drugs Involved
The trial involved the use of two immunotherapy drugs, botancilimab and balstilumab. It is a monoclonal antibody that works to stimulate the body's immune system to attack cancer. The study is a rather significant find, as it’s the first time that a consistent and durable response to immunotherapy has been reported in patients with solid MSS mCRC tumours.
The study was divided into several phases for more than 6 months. In the US trial, around around 101 patients with microsatile stable metastatic colorectal (MSS-mCRC) tumours showed a decrease . Around 61% of the patients experienced tumour shrinkage or stabilization after combined treatment with votancilumab and balstilumab. When it comes to downsides, diarrhea and fatigue were found to be the most common side effects or side effects of this drug.
These results are interesting and open to exploration. To date, immunotherapy has not been effective in patients with CNS-mCRC tumors. This study demonstrates the potential of the combination of botenlimab and balstilimab in the treatment of CNS mCRC, providing new hope for people diagnosed with colon cancer.
What Could This Mean For Bowel Cancer Treatment In The Future
The study is currently in the final stages of clinical trials, and the US Food and Drug Administration (FDA) hopes to quickly gain approval for its use because of the importance of this area that affects many people. The efficiency shown demonstrates the potential of botansilimab to contribute to broad antitumor immunity.
All in all, the combination of botensilimab and balstilimab represents a promising new direction in the treatment of colorectal cancer. This breakthrough could improve conditions for many patients worldwide and lights a new hope in the fight against this common disease. The results of this study show the effectiveness of immunotherapy in this field and how its potential to transform cancer treatment can only grow in the years to come.
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The Maharashtra Food and Drug Administration (FDA) has recently sparked headlines for bringing several known brands under its tight scrutiny. Cipla was one of them after the drug regulator cancelled one of its facility’s licenses over alleged violations associated with Reactin Plus tablets.
Soon after that, the Bombay High Court questioned the manner in which the action was taken, prompting the Maharashtra Food and Drug Administration (FDA) to withdraw its cancellation order.
The dispute has now become more about how far a regulator can go while enforcing drug safety rules, and whether due process was followed before cancelling the license.
Maharashtra FDA recently conducted an inspection of Cipla Pharma & Life Sciences’ carrying and forwarding facility at Wadki in Pune.
During an inspection in June, FDA officials found that the packaging of Reactin Plus, a Schedule H prescription medicine, described it as an “analgesic and antipyretic”. The FDA said this amounted to unauthorised advertising of a prescription drug and violated provisions of the Drugs and Cosmetics Act and Rules.
The regulator seized Reactin Plus stock worth around Rs 11.19 lakh and instructed that the product be recalled.
But the FDA said the recall directions were not fully complied with. A subsequent inspection also found discrepancies between physical stock, computerised records and purchase and sales data.
Medicines were reportedly found stored directly on the floor, with inadequate proper storage arrangements. Deficiencies were also identified in the handling of expired medicines.
Based on these findings, the FDA cancelled the drug-sale licenses of the facility with effect from August 27.
Maharashtra FDA Commissioner Tukaram Mundhe said, “The Food and Drug Administration will not show any leniency regarding the safety of medicines and the health of citizens.”
He added, “Any entity within the pharmaceutical manufacturing and distribution system found violating regulations will face stringent legal action.”
Cipla challenged FDA's action before the Bombay High Court. On August 30, the court criticised the regulator's approach, describing it as “high-handed” and saying the FDA had gone “overboard”. The court also questioned whether the principles of natural justice had been followed.
During the hearing, the court asked, “Do you feel you are a Lord and you can do anything?”
The court's concern was not necessarily that the FDA should not regulate Cipla. Instead, it questioned the manner and procedure through which the license was cancelled.
Following the court's intervention, the Maharashtra FDA withdrew the cancellation order and said it would issue a fresh show-cause notice before passing an order.
So, the license has been restored for now, but that does not mean the underlying regulatory concerns have disappeared.
Also read: Everest Hing Sale Prohibited By FSSAI; 3 Other Masalas Flagged For Violations
Cipla has maintained that the matter is under judicial consideration and therefore declined to comment in detail. The company said the FDA order relates to the operations of a C&F warehouse, rather than allegations concerning the medicine's safety or effectiveness.
According to mint, Cipla said, “Cipla has been a trusted healthcare organization for nine decades and continues to uphold the highest standards of quality, regulatory compliance, and patient safety.”
The company also clarified that the FDA order “does not allege any concerns relating to the safety, quality or efficacy of its products”.
The FDA action focuses on violations related to labelling, recall compliance, storage, inventory records and distribution practices.
It did not establish that Reactin Plus was unsafe, ineffective, or contaminated. Cipla has specifically said the order did not concern the product's safety, quality, or efficacy.
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One of the country's most popular condiment brands, Everest, is under tight FSSAI scrutiny after the food regulator ordered a temporary ban of sale of its hing (asafoetida) and a few masalas.
The Food Safety and Standards Authority of India (FSSAI) has prohibited the sale of compounded hing manufactured by Everest Food Products and Laljee Godhoo and Company after laboratory testing found samples that did not meet food safety standards.
The regulator has spotted compliance issues in three Everest spice blends. They include egg curry masala, chicken masala, and its widely sold garam masala.
To clarify, the three Everest masalas have not been banned permanently. They have been flagged for non-compliance, and the company has been asked to explain the violations and submit an action plan to resolve the said issues.
The action against hing came after a consumer complaint that prompted FSSAI to begin surveillance of major hing brands.
Samples were collected from Everest's facility in Mumbai and its manufacturing unit in Umbergaon, Gujarat, to be sent for laboratory testing.
According to FSSAI, its compounded hing samples tested contained only 0% to 3% alcohol-soluble extract, despite the prescribed minimum being 5%.
Compounded hing, which is not pure raw asafoetida, is a regulated food product made by blending raw hing with other ingredients like starches, flour, and gum Arabic. The required alcohol-soluble extract helps establish whether sufficient raw asafoetida is present in the final product.
FSSAI said the test results indicated that the products contained 30% to 40% less raw hing than required.
The regulator also found a separate problem in six varieties of raw hing tested at the Laljee Godhoo facility. Their starch content ranged between 15% and 32%, while the permitted maximum is 1%.
The regulator also detected non-compliance in Everest egg curry masala, chicken masala, and garam masala. However, unlike the hing products, these three spice blends have not been prohibited from sale.
The companies have been asked to explain the violations and submit action plans elaborating how they intend to comply with the food safety standards.
FSSAI has also advised the manufacturers to voluntarily recall substandard hing products already in the market.
Also read: US FDA Recalls Injectables Over Fiberglass, Steel Particles: See Affected Drugs
FSSAI's action is a preventive food safety measure. The regulator said the manufacturers must address the violations and ensure their compounded hing meets the prescribed standards. The prohibition on the product will remain in place until compliance requirements are met.
For consumers, the episode also highlights the fact how food adulteration or substandard manufacturing is not always visible to the naked eye. A spice may look, smell and taste perfectly fine while still failing a major food safety standard.
Laboratory testing is therefore crucial for identifying problems like incorrect composition or inadequate levels of the ingredient in a product.
This comes at a time when FSSAI is tightening rules over food standards and labelling. Just days ago, the regulator proposed hexagonal red, front-of-pack warning labels for packaged junk foods that are high in sugar, salt or saturated fats. It told the Supreme Court that the aim is to make such information easier for consumers to understand.
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The Food Safety and Standards Authority of India (FSSAI) has proposed putting prominent red, hexagonal warning labels on the front of packaged junk foods and beverages that are high in saturated fat, sugar or salt.
The proposal was submitted to the Supreme Court on August 28, marking a major update after years of debate over front-of-pack labelling.
The proposed labels would carry warnings like “HIGH FAT”, “HIGH SUGAR”, “HIGH SALT” or “HIGHLY SWEETENED BEVERAGE”, allowing consumers to identify products high in nutrients of concern without having to turn the packet around and decipher the nutrition panel.
At present, packaged foods generally provide nutritional information on the back or side of the package. For many shoppers, comparing the sugar, salt or fat content of several products can require some additional work of flipping and searching.
The proposed design is a red-coloured hexagonal symbol placed prominently on the front of the package. The first phase is expected to apply to products that are high in any two or more of the specified nutrients, according to the proposal reported by Reuters. The proposal also includes exemptions for certain foods that have single ingredients.
Also read: FSSAI Flags Food Firms For Misleading ‘100%’, ‘Energy Drink’, Immunity Claims
A prominent warning on the front of a packet could make it immediately obvious that a product contains high amounts of certain nutrients. This could be particularly useful when consumers are choosing between similar products.
It could also help parents make quicker decisions when buying packaged foods for children, who are increasingly being exposed to processed and ultra-processed foods.
The idea is not necessarily to tell consumers “never eat this”. Instead, the warning provides information before the purchase, allowing people to decide how frequently one should consume a type of packaged food.
A warning label, however, cannot compensate for an overall unhealthy diet, and consumers may still choose products carrying a warning. Its value lies in making important nutritional information harder to overlook.
The proposal comes after growing pressure from health activists and the Supreme Court, which has pushed the government to act on front-of-pack warnings amid concerns over rising obesity and chronic lifestyle diseases in India.
Also read: Centre Bans Cough & Cold Medicines For Children Under 4: What Parents Need To Know
The push for front-of-pack warnings is not coming only from health advocates. A recent LocalCircles survey of more than 83,000 consumers across 314 districts found strong support for prominent warnings on packaged foods and beverages high in sugar, salt or saturated fat.
80% of consumers said FSSAI should mandate such warnings, while another 11% wanted them specifically on ultra-processed foods. That means 91% supported front-of-pack warnings in some form, while only 4% felt existing format of nutrition information was more than enough.
Consumers also appeared to favour a warning that could be understood at a glance. 44% preferred a red warning symbol stating that a product was high in sugar, salt or saturated fat, while 27% chose traffic-light colour coding. Only 2% preferred a conventional black-and-white numerical nutrition panel.
But perhaps the most striking finding was what consumers said they would do with that information. 94% said a prominent warning would influence their buying decision.
Of these, 44% said they would avoid the product altogether, 26% would compare it with healthier alternatives and 24% would buy it less frequently. Only 6% said the warning would not affect their purchase.
The move has faced resistance from parts of the food and beverage industry. Companies and industry groups have argued that warning labels could be confusing or ineffective and that consumers should instead be encouraged to practise portion control.
Reuters reported that Coca-Cola India executive Mili Bhattacharya described it as “very simplistic” to believe that a symbol alone would significantly change people's diets.
Health advocates, however, have argued that consumers deserve clearer information about products that are high in nutrients linked to chronic disease.
Just a day before FSSAI proposed the red warning labels, Nestlé CEO Philipp Navratil said food manufacturers should be consulted as India develops its front-of-pack labelling rules.
According to Reuters, Navratil said the rules should be developed through a scientific approach and with input from food manufacturers.
The industry has previously pushed back against some proposals for warning labels, arguing that nutrition information needs to be presented in a way that gives consumers sufficient context rather than simply flagging individual nutrients.
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