Page 2 - Insulin

USFDA rejects proposed Biocon's Insulin Aspart application in CRL

Biotechnology major Biocon on Saturday said the US health regulator has issued a complete response letter for Biocon Biologics' application for Insulin Aspart, a proposed biosimilar for diabetes treatment. The US Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) to convey to the company that its initial review of an application is complete, and it cannot approve the application in its present form. "The CRL did not identify any outstanding scientific issues with the product. The CRL references the requirement for a satisfactory resolution of deficiencies from the pre-approval inspection (PAI) of our Malaysia facility for Insulin Aspart, held in August 2022," Biocon spokesperson said in a regulatory filing. The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022 that the agency found to be adequate and indicated that it would require a re-inspection of the Malaysia facility prior to the approval of the ..

Insulin maker GeneSys to invest $50-60 mn to set up plant in Hyderabad

Biotechnology company GeneSys Biologics Pvt Ltd is planning to invest USD 50-60 million to set up a new large-scale recombinant bulk manufacturing facility in Genome Valley here for the production of insulin analogues. The insulin analogues (medical insulin that are altered forms of the human hormone insulin) will be produced in the recombinant bulk manufacturing facility in which purified bulk insulin will be derived through fermentation. An official press release said the Hyderabad-based company has already invested approximately USD 50 million in its Genome Valley plant. Telangana IT and Industries Minister K T Rama Rao expressed delight over the expansion plans of GeneSys saying it will not only contribute to the growth of Hyderabad's biotech sector but also facilitate the company's ongoing collaboration with US-based Civica Rx. GeneSys has partnered with Civica Rx, a US non-profit generic drug company, to manufacture and distribute affordable insulin. The minister congratulat

Trying to lock in vendors who don't want to buy from China: Biocon CEO & MD

Siddharth Mittal, CEO & MD, Biocon, elaborates on his plans to grow this business further

A panoramic history of the cell

Pulitzer Prize winner Siddhartha Mukherjee's The Song of The Cell is a beautifully crafted exposition of the author's own lifelong fascination with the subject

Wockhardt likely to sell India business to cut debt, focus on UK: Analysts

Company left with low-margin brands in India after selling profitable ones

Glenmark launches drug to treat patients with insulin-resistant diabetes

Glenmark Pharmaceuticals on Thursday said it has launched Thiazolidinedione Lobeglitazone in the country for the treatment of type 2 diabetes in adults. The Mumbai-based drug firm has launched the medication under the brand name LOBG and is priced at around Rs 10 per tablet. Indians have a high prevalence of insulin resistance and that makes LOBG an appealing treatment option in managing uncontrolled Type 2 diabetes among insulin-resistant diabetic patients, Glenmark Pharmaceuticals said in a statement. The company had received approval from the Indian drug regulator, Drug Controller General of India, for manufacturing and marketing Lobeglitazone, based on a randomised, double-blind Phase 3 clinical trial conducted on adult Type 2 diabetic patients, aged 18 years and older. "As per the International Diabetes Federation, diabetes affects 74 million adults in India, of which, around 40 per cent of them seem to be insulin-resistant... "We are proud to introduce LOBG; an innovative an

NLEM 2022: Analysts see no major impact pharma companies' growth

The 2022 revision of the NLEM came after seven years. Most drugs that have been now brought into the NLEM include anti-infectives, anti-diabetics, anesthetics, etc

We're geared to launch a new molecule every 1-2 years: Biocon Biologics MD

In an interview, Arun Chandravarkar explains why a company must continue investing in R&D despite the impact on short-term Ebitda

Eyeing over 15% market share in US for insulin Glargine: Shreehas Tambe

The geopolitical incidents of the recent past as well as the pandemic have not really helped cost pressure: Tambe

Eris sees a sweet spot as it forays into insulin market, eyes 10% share

Eris Lifesciences (Eris) is foraying into an oligopolistic insulin market with its own insulin brand this month

USFDA rejects Biocon, Viatris application for Insulin Aspart

The company will respond to the CRL to satisfy the FDA's requests

US President Biden pledges savings on insulin, other drugs for Americans

President Joe Biden pledged that his social agenda legislation would deliver tangible savings on prescription drugs for all Americans

USFDA okays Biocon insulin Semglee as first interchangeable biosimilar drug

Semglee may now be substituted for Sanofi's Lantus by a pharmacist in the US

Biocon set for bigger insulin play, aims to reach one in five diabetics

Biocon Biologics CEO says portfolio to form a substantial part of $1 bn revenue target, to roll out insulin Aspart by next year

Malaysia plant boosts Biocon prospects in US and other key markets

Firm seen benefiting from operating leverage, biologic sales by FY22

Biocon, Mylan win patent case for insulin device against Sanofi in US

Development takes Biocon a step closer to commercialise its glargine biosimilar Semglee in America

Diabetes to be our focus in India, US: Wockhardt's Habil Khorakiwala

Wockhardt is present in emerging markets like Mexico, Brazil with insulins

New form of insulin may improve clinical delivery of drug for diabetics

The researchers synthesised an insulin analogue called glycoinsulin, and demonstrated that it can also lower blood glucose levels in preclinical studies

Strides Pharma likely to launch affordable insulin from Stelis stable

The Bengaluru-headquartered company believes Stelis could be a disruptor in insulin accessibility and affordability.

Plastic ban: Biocon may replace disposable insulin pens with reusables

Biocon's ready-to-use pre-filled disposable pen with insulin Glargine is manufactured at its plant in Bengaluru