MediTech Chronicles

Alembic seeks to mix it with US and European players Indian pharmaceutical firm Alembic is seeking to expand its presence in the lucrative US and European drug markets through an expanded partnering programme.  The Gujarat-headquartered group, which is involved in both the active pharmaceutical ingredient (API) and pharmaceutical formulation markets, aims to grow internationally and double its annual turnover over the next two to three years, according to a report in India’s Business Standard. Company director Pranav Amin explained that the firm intends to file about 10-12 ANDAs every year and to tap potential in the generic markets of the US and Europe.  The company has also submitted around 22 drug master file (DMF) requests to regulatory agencies in Europe and the US in recent years in a bid to boost its roster of API clients.

GREEN INITIATIVES IN INDIA: Sustainable Practices in Pharma Manufacturing I n an age where environmental concerns are at the forefront of global discussions, every industry must take responsibility for its carbon footprint. The pharmaceutical manufacturing sector, in particular, has been under scrutiny for its environmental impact due to energy-intensive processes and waste generation. However, the industry is increasingly embracing sustainable practices, focusing on green initiatives to reduce its environmental footprint.  In this article, we will delve into the world of sustainable pharma manufacturing, with a special focus on green initiatives in India. Green initiatives in India’s pharma manufacturing refer to sustainable practices such as energy efficiency, renewable energy use, water conservation, green chemistry, and waste reduction to minimize environmental impact. Understanding the Need for Green Initiative: The pharmaceutical industry is a vital component of healthcare, ...

Dr Reddy's in collaboration with SkyePharma on delivery system Using two of SkyePharma's unique drug delivery systems, the UK company SkyePharma has agreed to conduct a feasibility study on an unnamed product with Dr Reddy's Laboratories of India. The study's expenses will be covered by Dr. Reddy's, and SkyePharma will also get a "small" up-front payment, according to the two businesses. Full development activities would start later this year, they stated, if the feasibility study is successful.  With organizations like GlaxoSmithKline, Roche, Schiele, Novartis, AstraZeneca, Nitec, and Abbott in the past, SkyePharma has collaborated on the development of both licensed pharmaceuticals as well as drugs in development that use the oral, inhalation, and topical drug delivery technologies of the UK company.  The FDA recently requested a second clinical study to gather additional efficacy data on the bronchodilator/steroid combination found in SkyePharma's p...

Competition intensifying for diabetes subjects; Acurian Acurian, a company that specializes in patient recruiting, has reached a significant business milestone with the addition of more than 50 percent of the country's type 2 diabetes population to its database.  Approximately 8 million of the estimated 16 million diagnosed type 2 or adult-onset diabetes are already on the company's books. The business maintains a database of almost 40 million patients in total. According to Rick Malcolm, PhD, CEO of Acurian, "It should come as no surprise that diabetes is one of the most strong indications in our database. However, given the fierce rivalry for research participants in this therapeutic field, the fact that more than half of the nation's type 2 diabetics are present and open to learning about clinical trials is definitely important to note.  According to him, Acurian can assist trial sponsors in gaining access to huge numbers of diabetic patients so they can successfull...

FDA lists drugs with potential safety issues A list of drugs currently being evaluated for potential safety issues by the US Food and Drug Administration (FDA) has been posted on its website. The list has been published under laws brought in last September that require the FDA to inform the public of new safety information or potential signals of serious risk. Information is to be published each quarter detailing drugs that have been identified as having potential safety issues based on reports in the FDA’s Adverse Event Reporting System (AERS). The list is intended to inform patients of potential safety issues and the agency has been keen to stress that there is no definite or casual relationship between the listed drugs and their risks.  The list is part of the FDA’s goal of improving communication with patients but could cause more harm than good if incorrectly interpreted .

Sandoz boosts Canadian production capacity Sandoz Canada, a unit of Novartis’ generics arm, has opened a second manufacturing plant at its site in Boucherville, Quebec, boosting local production capacity 66 per cent. The plant, which is due to be fully operational by mid September, comprises manufacturing, laboratory and warehousing space that the firm believes will give it the flexibility it needs to keep pace with increasing market demands.  Richard Saynor, Head of Commercial Operations for Asia-Pacific, Latin America, Canada and Turkey says that: “The new plant in Boucherville is highly significant for our Canadian operations, and for Sandoz worldwide. It will enable us to triple our production capacity in both vials and ampoules.  The new plant will manufacture a range of medicines, including opiate analgesics. We currently make 85 different molecules in Boucherville and the plant supplies products globally, although the bulk of sales are in Canada and the US.

Cholesterol- lowering drug given cancer all-clear Cancer fears about a cholesterol- lowering drug have turned out to be a 'statistical blip'. A class of cholesterol- lowering drug that had been implicated in a cancer scare has been cleared by epidemiologists using the results from two large ongoing clinical trials.   Preliminary results from the relatively small SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study had triggered the cancer scare in July. The trial was designed to investigate whether a combination of these two cholesterol- lowering drugs would help in cases of aortic stenosis, where a key heart valve is partially blocked. Simvastatin, a statin that has already been used in other drugs, works by blocking cholesterol synthesis in the body. The newer ezetimibe works by blocking the absorption of cholesterol from the gut.  A unusual pre-publication announcement from the SEAS study reported that, while the therapy did not help very much in aortic stenosis, canc...

Big pharma's pre-competitive collaboration Merck, Eli Lilly and Pfizer have provided funding to launch Enlight Biosciences, a for-profit venture that aims to advance breakthrough technologies for drug discovery and development. The lowdown: There has recently been increasing emphasis from industry on participating in non-profit collaborations to address issues in drug development that are considered to be pre-competitive.  Now, Merck, Eli Lilly and Pfizer, together with the venture capital firm PureTech Ventures and several leading academic researchers, have founded Enlight Biosciences.  This is a for-profit venture that will aim to tackle critical unmet industry needs with innovations from academia and start-up companies. Enlight Biosciences, based in Boston, USA, will direct up to US$39 million into technologies that strengthen the connection between preclinical research, clinical research and post-market use, such as techniques that could help predict human responses to exp...