Page 38 - Pharma Sector

Zydus Lifesciences gets final approval from USFDA to manufacture ulcer drug

Sucralfate Tablets USP, 1 gram had annual sales of $84 million in the United States

AstraZeneca Pharma India gets DCGI's nod for cancer-treating drug

AstraZeneca Pharma India Ltd on Wednesday said it has received an approval from the Drug Controller General of India (DCGI) for the cancer drug trastuzumab deruxtecan for treatment of metastatic breast cancer. The company said it has been granted approval to import and market trastuzumab deruxtecan used in the treatment of select "HER-2 positive" breast cancer. "The India approval is based on a global, head-to-head, randomised, open label, registrational Phase III trial DESTINY Breast 03. Globally, trastuzumab deruxtecan is approved in more than 40 countries, including the US, for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer," AstraZeneca Pharma India said in a statement. HER2 is a form of growth-promoting protein expressed on the surface of multiple tumours, including breast, gastric, lung and colorectal cancers, and is one of the biomarkers expressed in breast cancer tumours, it added. "India's approval of trastuzumab deruxtecan mark

India emerging as favourable place to conduct medical trials: PwC India

India has the potential to increase global clinical trials in the country by five times in the coming years, a report has said, with experts highlighting the significant opportunities for biopharma companies to leverage India's rich diversity and robust healthcare infrastructure to develop innovative treatments. The joint report by the USA India Chamber of Commerce & PwC India titled, Clinical Trial opportunities in India which will be released at the virtual edition of the 17th annual BioPharma & Healthcare Summit 2023 to be held on Wednesday in Boston also indicates that through several key drivers, India is emerging as a favourable destination to conduct clinical trials. According to the report, the private sector is a well-suited channel for the top biopharma to conduct more efficient clinical trials with easier and faster access to investigators and patients. According to the report, India has the potential to increase global clinical trials in the country by five times ..

LIVE: Mandaviya announces development of 157 new govt nursing colleges

Catch live updates from across the globe here

Govt approves National Medical Devices Policy 2023, eyes 12% market share

Mansukh Mandaviya, Union health minister, said that the policy has been designed keeping in mind the need to have a holistic policy framework and will accelerate the growth of this sector

Abbott recalls a batch of thyroid disorder drug for labelling error

Thyronorm has no quality issue, mislabeled batch was invoiced in Madhya Pradesh and Telangana: Company

Someone duplicated cough syrup to defame India: QP Pharma on WHO's alert

The World Health Organisation has issued a 'WHO Medical Product Alert' after "Substandard (contaminated)" Guaifenesin Syrup TG Syrup was found in the Marshall Islands and Micronesia

Mankind Pharma IPO subscribed 8% so far on Day 1; GMP down 30% in 10 days

The Rs 4,326-crore public issue's price band is set in the range of Rs 1,026-1,080 per share. The issue will close on Thursday, April 27

India business to boost pharma, after US sales prove to be a mixed bag

Hospitals to recover from sluggish Q3; diagnostics growth rate at pre-Covid levels

Results preview: India business to put a spring in pharma's step

Hospitals to recover from sluggish Q3; diagnostics' growth rate at pre-Covid levels

Indian drug regulation standards should be at par with world: NITI Aayog

The NITI Aayog has recommended that Indian standards of drug regulation should be on par with global standards as well as aligned with the International Council for Harmonisation guidelines while promoting ease of doing business. The apex public policy think tank of the central government also suggested creating a separate authority to regulate medical devices in the country which is currently being monitored by the Drugs Controller General of India (DCGI). The recommendations have been made during the ongoing inter ministerial consultation on the New Drugs, Medical Devices and Cosmetics Bill, 2023. The draft New Drugs, Medical Devices and Cosmetics Bill, 2023, which seeks to replace the existing Drugs and Cosmetics Act of 1940, was put up on public domain in July last year seeking feedback from stakeholders. It has been revised and sent for inter-ministerial consultation. On clinical trials, the NITI Aayog said the draft bill should reflect the intent of overcoming the hesitancy

Big pharma: Here's why India's drug industry needs a major overhaul

The latest drug recalls just add to a long line of scandals that have tainted the pharma sector of India

Inverse H&S in pharma index could revive a positive bias for short-term

Pharma shares like Aurobindo Pharma, Zydus Lifesciences, Sun Pharmaceutical Industries Ltd, Glenmark Pharmaceuticals may rise up to 14 per cent.

Morepen Labs zooms 18% on USFDA nod with NIL observations for HP facility

Earlier this month, the company had incorporated a wholly-owned subsidiary, Morepen RX.

Specialty scale-up, product mix: Sun's medicine cabinet piques brokerages

In the near term, higher R&D costs and a recent acquisition to weigh on earnings growth

Multiple triggers likely to help Zydus to continue with its outperformance

New launches in the US, market share gains and steady domestic growth are positives

Serum Institute tops profit charts among unlisted firms amid Covid war

Surge in demand for Covishield led to a huge spike in its revenues and profits

India working on single-window portal for drug regulation processes

System will bring together stakeholders like manufacturers, distributors, state-run agencies to ensure quality

Industries minister inaugurates Himachal Pavilion at Pharma Live Expo

The state government participated in the country's largest pharma expo to showcase the pharma ecosystem and invite potential medical devices players for investments

Analysts turn cautious on Cipla as US FDA action delays key US launches

Analysts believe that some of the recent observations from the US FDA are critical in nature and could lead to a potential Official Action Indicated (OAI) classification for the Indore plant