Fda

Biocon arm Syngene eyes late-stage clinical supplies amid regulatory shift

As regulators ease biosimilar trial norms, Syngene International is expanding into late-stage clinical supply production, betting on biologics and peptide manufacturing for growth

FDA's top drug regulator resigns after officials probe 'serious concerns'

The head of the Food and Drug Administration's drug centre abruptly resigned on Sunday after federal officials began reviewing serious concerns about his personal conduct, according to a government spokesperson. Dr George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services' Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned on Sunday morning. Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency, Hilliard said. The departure came the same day that a drugmaker connected to one of Tidmarsh's former business associates filed a lawsuit alleging that he made false and defamatory statements during his time at the FDA. The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a longstand

Biocon Biologics expands diabetes portfolio with FDA approval for Kirsty

Interchangeable biosimilar to NovoLog in the US and will be available in prefilled pens and vials

Price pressures to intensify for drugmakers, says Sun Pharmaceutical

Sun Pharma expects global pricing strain due to policy shifts, as FY25 US sales rise 5.8% despite compliance challenges; specialty business lifts overall growth

Blinkit, Zepto resume operations in Maharashtra after FDA licence clearance

Blinkit and Zepto resume operations at closed facilities in Maharashtra after securing food safety licences and complying with corrective actions ordered by the FDA

Govt to increase checks on quick commerce dark stores amid hygiene issues

FSSAI to lead surprise inspections as complaints about poor hygiene and expired products in dark stores mount; packaged food brands urge quick commerce platforms to improve standards

Maharashtra FDA orders closure of Blinkit dark store amid licence issues

Blinkit's Balewadi dark store ordered closed by Maharashtra FDA for lack of food licence and unhygienic conditions amid rising scrutiny of quick commerce platforms

Zepto's food business licence cancelled in Dharavi over 'poor hygiene'

Maharashtra FDA suspends Zepto's food business licence in Dharavi after inspection reveals severe hygiene violations and non-compliance with food safety norms

FDA to crack down on fake paneer, cheese substitutes in Maharashtra

The Food and Drug Administration Department is taking strict action against those using fake paneer or cheese analogues (culinary replacements), Maharashtra Food and Drug Administration Minister Narhari Zirwal said on Saturday. In a statement, he said licences of those involved in trade and sale of fake food products will be cancelled. "Paneer is a favourite food item and has a huge demand in the market. Paneer is especially popular among children. However, the Food and Drug Administration has found in its investigation that consumers are sometimes being cheated by using fake paneer or cheese analogue," he said. "Action will be taken against such paneer sellers who mislead consumers. Action will be taken as per Food Safety and Standards Act," he said. According to the Food Safety and Standards (Labelling and Display Regulations) Rules 2020, it is mandatory to display information about all the ingredients and nutritional values of food sold to the consumers. Restaurants, hotels, ...

US FDA workers brace for mass layoffs amid health services job cuts

As they readied to leave work Monday, some workers at the Food and Drug Administration were told to pack their laptops and prepare for the possibility that they wouldn't be back, according to an email obtained by The Associated Press. Nervous employees roughly 82,000 across the nation's public health agencies waited to see whether pink slips would arrive in their inboxes. The mass dismissals have been expected since Secretary Robert F. Kennedy Jr. announced last week a massive reorganization that will result in 20,000 fewer jobs at the Department of Health and Human Services. About 10,000 will be eliminated through layoffs. The email sent to some at the FDA said staffers should check their email for a possible notice that their jobs would be eliminated, which would also halt their access to government buildings. An FDA employee shared the email with AP on condition of anonymity, because they weren't authorized to disclose internal agency matters. Kennedy has criticized the ...

FDA issues showcause notice to Aveo for illegal export of opioids

Maharashtra's Food and Drug Administration has issued a show cause notice to a pharmaceutical company here for alleged illegal export of opioids, an official said on Sunday. As per an official release of the FDA, the action was taken after the BBC's investigative report highlighted that Tapentadol and Carisoprodol manufactured in India were illegally exported to African countries, where they are misused for recreational purposes. Following the Central government's directives on Friday, a joint team of drug inspectors from the Centre and state government raided Aveo Pharmaceuticals, a Palghar-based company allegedly involved in exporting these drugs, the release stated. Authorities seized all existing stock, prohibited further production, and initiated stringent legal action against the company, the FDA said. The company has been served a show cause notice under the Drugs and Cosmetics Act 1940, and officials have assured that all necessary legal measures will be taken without any .

McDonald's E coli case count rises as officials inspect onion grower

Federal officials have reported more cases of E. coli poisoning among people who ate at McDonald's, as government investigators seeking the outbreak's source identified an onion grower of interest in Washington state. The Food and Drug Administration said 90 people across 13 states have fallen ill in the outbreak, up from 75 at the end of last week. The number of people hospitalised increased by five, to 27 people. One death has been tied to the outbreak. Officials have said raw, slivered onions on McDonald's Quarter Pounder hamburgers are the likely source of the E. coli. McDonald's said the onions came from a single supplier, the California-based Taylor Farms. The company has since recalled the yellow onions it sent to McDonald's and other restaurant chains. The FDA said Wednesday it has begun inspecting Taylor Farm's processing centre in Colorado Springs as well as an onion grower of interest in Washington state. It did not name the grower. More than 80 per cent of people with E

How safe is the pill? Substandard drugs on a decline amid crackdown

The first of a two-part series focuses on how quality audits and regulatory actions on pharma units nationwide are showing results

Elon Musk's Neuralink gains FDA breakthrough tag for vision implant

Neuralink's vision-restoring device, named Blindsight, is designed to allow even individuals who have lost both eyes and their optic nerves to regain sight

US FDA expands J&J's psoriasis drug Tremfya for inflammatory bowel disease

Drugmakers such as AbbVie, Eli Lilly and J&J are hustling for a share in an already-crowded, multi-billion market for treatments for inflammatory bowel diseases

USFDA still struggling to conduct pending drug inspections after Covid

Federal regulators responsible for the safety of the US drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the US and across the world, The Associated Press has found. An AP analysis of Food and Drug Administration data shows that agency staffers have not returned to roughly 2,000 pharmaceutical manufacturing firms to conduct surveillance inspections since before the pandemic. The firms that are overdue for safety and quality inspections represent about 42 per cent of the 4,700 plants that are currently registered to produce drugs for the US and previously underwent FDA review before May 2019, the AP found. Most of the overdue plants are in the US, but more than 340 are in India and China, countries that together make up the largest source of drug ingredients used in low-cost US prescriptions. Generic drugmakers are under intense pressure to cut their costs and some will do that by cutting quality, sa

US FDA declines to approve Regeneron's therapy for common blood cancer

FDA, in a so-called 'complete response letter', said that the sole issue identified for approval is related to findings from a pre-approval inspection at a third-party manufacturer

US FDA approves first nasal spray from ARS Pharmaceuticals' for allergies

Neffy's approval is based on 4 studies in 175 healthy adults without anaphylaxis that measured epinephrine concentrations in blood following administration of neffy

USFDA approves second Alzheimer's drug that can modestly slow disease

U.S. officials have approved another Alzheimer's drug that can modestly slow the disease, providing a new option for patients in the early stages of the incurable, memory-destroying ailment. The Food and Drug Administration approved Eli Lilly's Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer's. It's only the second drug that's been convincingly shown to delay cognitive decline in patients, following last year's approval of a similar drug from Japanese drugmaker Eisai. The delay seen with both drugs amounts to a matter of months about seven months, in the case of Lilly's drug. Patients and their families will have to weigh that benefit against the downsides, including regular IV infusions and potentially dangerous side effects like brain swelling. Physicians who treat Alzheimer's say the approval is an important step after decades of failed experimental treatments. I'm thrilled to have different options to help my patients, said Dr. Suzanne Schindler, a .

US FDA grants accelerated approval to Genfit, Ipsen's liver disease drug

Ipsen added that standard approval for Iqirvo may be contingent on confirmatory trials