Page 2 - Drug Makers In India

Biocon Biologics signs deal, gets market entry for Yesafili in US by 2026

Biocon Biologics on Tuesday said it has inked a settlement and licensing pact with Regeneron, paving the way to commercialise its biosimilar product Yesafili in the US. Yesafili, a vascular endothelial growth factor (VEGF) inhibitor used to treat several types of ophthalmology conditions, is a biosimilar of its reference product Eylea (aflibercept). Biocon Biologics and Regeneron executed the settlement agreement to dismiss the pending appeal at the US Court of Appeals for the Federal Circuit (USCAFC) and the pending litigation at the US District Court for the Northern District of West Virginia, Clarksburg Division, Biocon Biologics said in a statement. The agreement enables the company, a unit of Biocon Ltd, to launch its product in the US in the second half of 2026 or earlier in certain circumstances, it added. The terms of the settlement are confidential, it stated. "This settlement clears the path for Biocon Biologics to be among the first to bring a reliable, high-quality ..

Sun Pharma stock up 2.15% as US court clears alopecia drug launch

According to market estimates, Leqselvi is projected to contribute $90 million to Sun Pharma's sales in FY26, and $125 million in FY27

US court clears Sun Pharma to launch Leqselvi for alopecia areata treatment

Sun Pharma is now preparing to launch the drug in US markets after facing legal issues since November 2024

India's pharma industry gets relief from Trump's reciprocal tariff

US President says India imposes 52% tariff on American imports and engages in currency manipulation and non-tariff barriers

Parliament panel asks single independent drug regulator for Ayush medicines

A parliamentary committee has recommended the consolidation of all AYUSH drug-related standard-setting processes under a single independent drug controller in alignment with the Drugs and Cosmetics Act, 1940, and its associated rules. To achieve this, the ministry should establish a streamlined and inclusive mechanism that actively involves stakeholders in the development of pharmacopoeial standards, ensuring greater efficiency and uniformity, said the Parliamentary Standing Committee on Health and Family Welfare in a report presented in the Rajya Sabha this week. Additionally, the Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) and Central Council for Research in Ayurvedic Sciences (CCRAS) may come together to coordinate and collaborate in this initiative, the committee emphasised in its 165th report on "Demands for Grants 2025-26 (Demand No. 4) of Ministry of Ayush". This will enhance the scientific testing and evaluation of a larger number of ASU&H .

Eliminate import duty on drugs from US: Pharma exporters to Centre

The exporters' worry is understandable as the US is the largest export market for Indian pharma accounting for 31.35 percent of India's overall pharma exports worth $27.8 bn

Contract drug makers urge govt to ease rules, reduce reliance on China

Contract drug manufacturers have gained from global companies' efforts to diversify their supply chain

Drugmakers tout AI efforts at conference amid US tariffs concerns

Drugmakers such as Amgen and contract manufacturers including Parexel highlighted AI's role in reducing the time taken to conduct certain parts of the trials

Sun Pharma Q3FY25 results: Net profit soars 15% to Rs 2,903.3 crore

Sequentially, revenue from operations grew by 2.9 per cent, whereas profit after tax (PAT) fell by 4.5 per cent

CDSCO flags 135 drugs for failing quality standards for December 2024

Most drugs found NSQ by central labs this month were produced in units located in cities such as Ahmedabad, Vadodara, Himachal Pradesh's Baddi, Puducherry, Roorkee and Haridwar

CDSCO flags 2 drugs as spurious, another 111 fail quality test in Nov '24

While the CDSCO alert has named the brands for which they found spurious samples, the alert, however, does not name the drugmakers

Mankind Pharma inks pact with Innovent for immunotherapy drug in India

Mankind Pharma Ltd and Innovent Biologics on Thursday announced a partnership to exclusively license and commercialise innovative immunotherapy drug Sintilimab, used in the treatment of cancer, in the Indian market. This strategic collaboration aims to address the critical challenges in cancer treatment and improve patient access to innovative therapeutic options in the region, the companies said in a joint statement. Marketed as TYVYT (sintilimab injection) in China, Sintilimab is co-developed by Innovent and Eli Lilly. "Sintilimab is not approved in India. Early next year, we will be filing for its regulatory approval in India and complete all mandatory regulatory processes, including the conducting of a phase 3 clinical trial by Mankind Pharma for its successful approval in India once we receive the permission from the regulator to conduct such clinical trials," a Mankind Pharma spokesperson said. Under the agreement with Innovent, Mankind Pharma will have exclusive rights to ..

AstraZeneca withdraws EU application for experimental lung cancer drug

Feedback from the EU indicated that the trial results, which the application was based on, showed that the drug did not significantly improve overall survival for patients

USFDA restricts imports of certain Viatris drugs made at India facility

The FDA has issued a warning letter to Viatris related to its drug manufacturing facility in Indore in the central Indian state of Madhya Pradesh

Drug maker Cipla gets 8 observations from USFDA for Bengaluru facility

Drug maker Cipla on Wednesday said the US health regulator has issued eight observations after inspecting its Bengaluru-based plant. The US Food and Drugs Administration (USFDA) conducted an inspection at the company's manufacturing facility in Virgonagar, Bengaluru from November 7- 13, the Mumbai-based based drug maker said in a filing to BSE. On conclusion of the inspection, the company received eight observations in Form 483, it added. The company said it will work closely with the USFDA and remain committed to addressing these observations comprehensively within stipulated time.

Drug firm Lupin names Claus Jepsen as President Global specialty business

Drug firm Lupin on Monday said it has appointed Claus Jepsen as President, Global Specialty business. Jepsen joins Lupin from Takeda Pharmaceuticals, where he led the Global Strategy for rare diseases. "His experience in leading specialty strategy, commercial planning and portfolio choices across key markets will enable us to build our Specialty brand business," Lupin CEO Vinita Gupta said.

Indian pharmacopoeia standard used by 11 countries: DCGI Rajeev Raghuvanshi

The WHO-led experts team approved India's vaccine regulatory system after an in-depth scientific review, conducted between September 16 and 20, as per a statement by the Ministry of Health and Family

CDSCO meets WHO standards for functional vaccine regulatory system

Drug regulator CDSCO and the National Regulatory Authority of India have met the standards set up by the World Health Organisation for a functional vaccine regulatory system A team of international experts from various countries led by the World Health Organisation (WHO) headquarters in Geneva reviewed India's vaccine regulatory system from September 16 to 20, the health ministry said in a statement. Safety, efficacy, and quality were the three basic parameters of assessment of vaccines, it said. The WHO has established global standards and benchmarks for assurance of vaccine quality through the development of tools and guidelines, benchmarking of the National Regulatory Authorities (NRA) and pre-qualification programme of vaccines, the statement said. The WHO NRA re-benchmarking was aimed to assess and document the status of the India regulatory system in the area of vaccine regulation, re-benchmark the status of the India vaccine regulatory system against the WHO NRA Global ...

'India's pharma exports expected to remain strong amid global slowdown'

Exports of India's pharmaceutical and meditech sectors are expected to sustain the growth momentum in the ongoing fiscal despite a slowdown in the global economy, a senior government official said on Wednesday. With the government revving up support for drug development in India, as many as 16 blockbuster molecules targeted for a wide range of therapeutic areas, including cancer, diabetes, HIV and tuberculosis, are in the pipeline to be produced in India, Department of Pharmaceuticals, Secretary Arunish Chawla told reporters on the sidelines of CII Pharma and Life Sciences summit here. "We have been analysing the export trends in the recent data. Even though there is a general slowdown in exports globally, the good news is that the Indian pharmaceuticals, biotech, and bulk drug exports have grown double-digit over the last year," he said in response to a query on export prospects of the pharma industry amid a global slowdown. He further said,"In the first four months of this year, .

Lupin inks pact with Scope Opthalmics to market eyecare products in Mexico

Drug maker Lupin on Monday said it has inked a distribution pact with Ireland-based Scope Ophthalmics to market a product range, indicated for the treatment of various eye conditions, in Mexico. The company has signed a distribution agreement with Scope for the registration and marketing of Moist Heat Mask, a Tea Tree Oil Eyelid Cleansing Gel and Tea Tree Oil Eyelid Wipes of the Optase range in Mexico. The products are used for eye conditions like dry eyes, blepharitis and meibomian gland dysfunction (MGD). "This expansion of our ophthalmology range reinforces our commitment to enhancing vision care for our patients, improving their quality of life," said Fabrice Egros, President Corporate Development and Growth Markets, Lupin. Through the signature of this collaboration with Lupin, Scope is expanding its footprint in Latin America, Scope CEO Tom Freyne stated. "Mexico is clearly a country of strategic importance for SCOPE where our innovative eyecare products, together with the