Showing posts from April, 2019

Delhi HC allows Alembic, Natco to export Bayer drug for specific purposes

The Delhi high court on Monday has allowed Alembic Pharmaceuticals and Natco Pharma to export cancer drug (sorafenib) and a blood thinner (rivaroxabin) for development, clinical trials and regulatory clearances. A divison bench of Justice S. Ravindra Bhat and Justice Sanjeev Sachdeva has agreed with the majority of the findings of the single bench comprising of Justice Rajiv Sahai Endlaw. “Sale, use, construction of patented products (by individuals and entities that do not hold patents) in terms of Section 107A of the Act for purposes both within the country and abroad is authorized and legal provided the seller ensures that the end use and purpose of sale/export is reasonably related to research and development of information in compliance with regulations or laws of India (or the importing country), for its submission in accordance with such laws. The impugned judgment of the learned single judge and the findings recorded on this aspect are accordingly affirmed. A dispute about the

Lynparza gets EC approval to treat advanced breast cancer

AstraZeneca and MSD Inc., have recently announced the European Commission(EC) has approved Lynparza (olaparib) as a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations (gBRCAm), and who have human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer. Under the licensed indication, patients should have previously been treated with an anthracycline and a taxane in the (neo) adjuvant or metastatic setting unless they were unsuitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy. Dave Fredrickson, Executive Vice President, Oncology, said: “With this approval, Lynparza provides patients throughout the EU with a targeted and oral chemotherapy-free treatment option for a difficult-to-treat cancer. It also reinforces the importance of testing for biomarkers including BRCA, ho

Merck wins USFDA approval for Keytruda as combo therapy for kidney cancer

The U.S. Food and Drug Administration has approved Merck & Co Inc’s cancer therapy, Keytruda, as part of a combination therapy for previously untreated patients with the most common type of kidney cancer, the company said on Monday. The drug was approved in combination with Pfizer Inc’s Inlyta to treat advanced renal cell carcinoma. The approval, which comes two months ahead of expectations, allows this combination therapy to get an early launch ahead of other rival products, Cowen analyst Yaron Werber said, after the company received FDA approval on Friday. The Keytruda/Inlyta combination could provide serious competition for Bristol-Myers Squibb Co’s immunotherapy combination of Opdivo and Yervoy, currently considered a gold standard for previously untreated advanced kidney cancer patients. Keytruda’s sales have surged past Opdivo’s, and the drug is expected to bring more than $10 billion for Merck this year, according to IBES data from Refinitiv. Merck’s Keytruda, which works b

Launch of Intas cancer drug could lower prices

Ahmedabad based Intas pharma has launched the biosimilar drug Bevacizumab in India used for treating several types of cancer including colorectal, lung and cervical cancer besides certain form of brain tumours. Bevacizumab is the spin off cancer drug of Swiss drug maker Roche pharma which sells it under the brand name of Avastin. Intas said that it will launch the drug at Rs 39,995 for 400mg, which is 60% lower than the currently available treatment option. Biosimilar drugs are the follow on versions of biologic drugs which are composed of sugars, proteins, nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologic drugs are different from chemical drugs as they are complex mixtures that are not easily identified or characterised. Intas would be sharing the Bevacizumab market with the likes of Zydus Cadila, Hetero and Reliance Lifesciences. The story of Bevacizumab has had its own share .. Intas spokesperson said that

Emcure launches generic breast cancer drug 40% cheaper than innovator’s

Pune-based Emcure Pharmaceuticals, which launched a generic version of Eisai Pharma’s innovator breast cancer drug Eribulin (brand name Halaven), aims to expand the market for the drug by 30 per cent. Emcure’s drug that would be sold under the brand name Eribilin is 40 per cent cheaper compared to the innovator drug. Globally, this is the first generic drug for the molecule Eribulin, which is sold under the brand name Halaven. Emcure plans to capture 25 per cent of the market for the drug as well as expand the market through this cheaper alternative to the innovator drug.  The current market size for drug used to treat metastatic breast cancer is around Rs 60 crore only as only about 20 per cent of the patients are able to afford the therapy which has a short infusion time of around 2-5 minutes and does not necessarily require hospitalisation. The cost of therapy for Emcure’s Eribilin is Rs 19,000 per vial. One cycle needs around four vials and a full treatment of four cycles wo