Showing posts from March, 2017

Mumbai Port Trust allots 156 dormitory blocks to Tata Memorial Centre for treatment of kids suffering from cancer

The Mumbai Port Trust , in a gesture has allotted 156 dormitory blocks to the  Tata  Memorial Centre for the children suffering from cancer. These children will be treated free of charge here, as per media reports. The project undertaken by the Mumbai Port Trust was part of its Corporate Social Responsiblity (CSR) which was initiated in 2015. The move will surely help those children suffering from cancer, who come to Mumbai along with their parents from across the country, some media reports have said. Earlier this month, in a major relief for cancer patients across the country, drug pricing regulator NPPA had slashed price of cancer medicines by close to 86 percent since March last year. In a tweet, he National Pharmaceutical Pricing Authority (NPPA) had also said that there has been “a significant price reduction in cancer drug prices since March 2016”. The price of drugs like Iressa of AstraZeneca Pharma India was brought down from Rs 29,259 to Rs 3,977and Dr Reddy’s laborat

Daiichi Sankyo receives Japanese approval for Narurapid & Narusus tablets to treat cancer pain

Daiichi Sankyo Company, Limited announced that its Japan domestic group company, Daiichi Sankyo Propharma Co., Ltd. has received approval for the manufacture and sales in Japan of Narurapid tablets 1 mg, 2 mg, 4 mg (immediate release formulation) and Narusus  tablets 2 mg, 6 mg, 12 mg, 24 mg (once daily extended release formulation) [generic hydromorphone hydrochloride] for cancer pain treatments.  Hydromorphone hydrochloride is an opiate, narcotic analgesic that has been available outside of Japan for over 80 years. It is the standard for pain management for cancer pain treatment according to foreign guidelines. Hydromorphone hydrochloride is one of the agents publicly offered for development by the Review Committee on Unapproved Drugs and Indications with High Medical Needs*. Daiichi Sankyo decided to develop the drug in 2012, and received a grant from the Pharmaceutical Development Support Center for its development. Daiichi Sankyo is committed to making unapproved and off-label dr

FDA Approves Bavencio to Treat Rare Form of Metastatic Skin Cancer

dults and children older than 12 years old with metastatic Merkel cell carcinoma (MCC) will now have access to the anti-PD-L1 immunotherapy Bavencio (avelumab) in the United States. It is the first treatment the Food and Drug Administration has approved for MCC, a rare and aggressive form of skin cancer. “While skin cancer is one of the most common cancers, patients with a rare form called Merkel cell cancer have not had an approved treatment option until now,” Richard Pazdur, MD, an FSA scientist, said in a  news release . “The scientific community continues to make advances targeting the body’s immune system mechanisms for the treatment of various types of cancer. These advancements are leading to new therapies—even in rare forms of cancer where treatment options are limited or non-existent.” Pazdur is the acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, and director of the FDA’s Oncology Center of Excellence. Ne

FIPB greenlights Fosun’s Gland Pharma buy

The Foreign Investment Promotion Board (FIPB) on Wednesday finally cleared the decks for Chinese pharma giant Shanghai Fosun Pharmaceutical Group (Fosun) to acquire majority stake in city-based Gland Pharma, a manufacturer of small volume parenterals (SVPs). The FIPB nod came five days after the board deferred clearance of the deal. In July last year, Gland Pharma and Shanghai Fosun Pharmaceutical Group had announced that the latter will be acquiring 86% stake in the privately-held Hyderabad-based company for a consideration of $1.26 billion (then around Rs 8,500 crore). Gland Pharma had informed that Fosun Pharma will be purchasing all the shares of the company owned by KKR Floorline Investments Pte Ltd, which amount to around 37%, in addition to shares of other shareholders of the company. Post-acquisition, Gland Pharma's founder P V N Raju and his son Ravi Penmetsa will remain on the board and Ravi Penmetsa will continue as the company's managing director and CEO. T

Oncology chain HCG to buy majority stake in Kenyan firm

Bangalore-based Healthcare Global Enterprises Ltd (HCG) has agreed to purchase a majority stake in a cancer-care centre in Kenya in its first overseas acquisition. HCG will buy a 93.66% stake in Nairobi-based Cancer Care Kenya Ltd for 93.15 million Kenyan shillings (about $905,000) in cash, the Indian company said in a stock-exchange filing. HCG will acquire the stake through step-down subsidiary HealthCare Global (Kenya) Pvt Ltd. HCG added that it has also signed a pact with Nairobi-based MP Shah Hospital and Cancer Care Kenya’s promoters to subscribe to shares of the target company. After this pact is concluded, HCG will have a 77.5% stake in Cancer Care Kenya while MP Shah Hospital will have 10%. The target company’s promoters will have the remaining 12.5% stake. “We expect to bridge the demand-supply gap existing in the cancer care space in Kenya, where patients have to travel out of the country for availing cancer care services due to inadequate treatment facilities in Ken

Oncology surgeons from North East India meet surgical robot

The Dr. Bhubaneswar Borooah Cancer Institute based in Guwahati saw an unusual rise in footfalls last week. In normal circumstances this would be seen as a sign of increase in the incidence of cancer in North East India. Dr A.C. Kataki, Director, Dr B Barooah Cancer Institute, however, attributes the rise in footfalls to over 200 oncologists and surgeons from North East India visiting the Centre to touch and feel a da Vinci Surgical Robot. The da Vinci Surgical Robot, often dubbed as the surgical saviour for patients who could now get rid of cancerous soft tissues while neatly kirting around the pain, blood loss, and long recovery time of conventional surgery, travelled from Kolkata to the eastern part of India. In addition to the doctors of Barooah Cancer Institute, surgeons from dozens of hospitals in Guwahati, Agartala, Dibrugarh, Digboi, Kohima, Shillong and Silchar got a much better appreciation of Robotic Surgery and its benefits as they experienced the use of this advance

Marketing + Font Resize - AstraZeneca receives Chinese marketing approval for Tagrisso to treat EGFR T790M mutation-positive metastatic NSCLC

AstraZeneca has announced that the China Food and Drug Administration (CFDA) has granted marketing authorisation for Tagrisso (osimertinib) 40 mg and 80mg once-daily oral tablets for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. Lung cancer is the most common form of cancer and the leading cause of cancer-related deaths in China.1 Approximately 30-40% of Asian patients with NSCLC have the EGFR mutation at diagnosis, and nearly two thirds of these patients whose disease progresses after treatment with an EGFR TKI develop the T790M mutation. Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said: “This is an important step forward for Tagrisso and a significant opportunity to bring a breakthrough medicine to patients wit

BioLineRx acquires Agalimmune to accelerate expansion of immuno-oncology pipeline

BioLineRx Ltd., a clinical-stage biopharmaceutical company focused on oncology and immunology, has acquired Agalimmune Ltd., a private UK-based company with an innovative, anti-cancer immunotherapy platform. Acquisition consideration consisted of a $6 million upfront payment, of which $3 million is in cash and the remainder in BioLineRx shares. Additional future payments may be made based on development and commercial milestones. Agalimmune’s lead compound is AGI-134, a synthetic alpha-Gal immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant anti-alpha-Gal antibodies to induce a systemic, specific anti-tumor response to the patient’s own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on, anti-metastatic immune response. AGI-134 has completed numerous pre-clinical studies, demonstrating robust protection against the development of secondary tumo

Cornerstone Pharma gets US FDA approval to initiate pivotal trial of CPI-613 in patients with AML and pancreatic cancer

Cornerstone Pharmaceuticals, a clinical-stage, oncology-focused pharmaceutical company, has announced a major milestone. Following successful End-of-Phase I (EOP1) Type B meetings with the US Food and Drug Administration (FDA), the company has been given a clear clinical and regulatory path forward to conduct pivotal trials of its lead compound, CPI-613, in patients with acute myeloid leukemia (AML) and pancreatic cancer. CPI-613 is Cornerstone Pharmaceuticals' first-in-class anticancer compound from its proprietary Altered Energy Metabolism Directed (AEMD) platform. The drug is designed to disrupt the altered energy production pathways in cancer cells by targeting the mitochondrial tricarboxylic acid (TCA) cycle, an indispensable process essential to cell multiplication and survival. The FDA has designated CPI-613 an orphan drug for the treatment of acute myeloid leukemia (AML), pancreatic cancer and myelodysplastic syndromes (MDS). "Our productive dialogue with the FD

UK Biobank, Regeneron, GSK to generate largest gene sequence data to improve drug discovery and disease diagnosis

Regeneron Pharmaceuticals has announced a major research initiative among the Regeneron Genetics Center (RGC), UK Biobank and GSK to generate genetic sequence data from the 500,000 volunteer participants in the UK Biobank resource. The initiative will enable researchers to gain valuable insights to support advances in the development of new medicines for a wide range of serious and life threatening diseases. Genetic evidence has revolutionized scientific discovery and drug development in recent years by providing clear links between genes and disease. Currently, an estimated 90% of potential medicines entering clinical trials fail to demonstrate the necessary efficacy and safety, and never reach patients. Many of these failures are due to an incomplete understanding of the link between the biological target of a drug and human disease. By contrast, medicines developed with human genetic evidence have had substantially higher success rates and patient care has benefited. UK Bioba

US FDA approves Bavencio injection 20 mg/mL for treatment of mMCC

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer has announced that the US Food and Drug Administration (FDA) has approved Bavencio (avelumab) Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel Cell Carcinoma (mMCC). This indication is approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Bavencio was developed, reviewed and approved through the FDA’s Breakthrough Therapy Designation and Priority Review programmes. Bavencio, a human anti-PD-L1 antibody, is the first FDA-approved therapy for patients with mMCC. Metastatic MCC is a rare and aggressive skin cancer, with fewer than half of patients surviving more than one year and fewer than 20% surviving beyond five years. “At

AIOCD opposes health ministry's plan to launch e-portal for regulating sale of drugs

All India Organisation of Chemists & Druggists (AIOCD) has opposed the Union health ministry's proposal to put in place electronic platform for regulating sale of drugs in India saying that the proposed initiative is irrational and impractical in the wake of inadequate IT infrastructure in the country making it difficult for stockists and chemists to upload drug sale data on the e-platform. Suresh Gupta, general secretary, AIOCD said “Its infeasible for retailers and stockists in remote and rural areas having limited or no internet connection to upload data related to every drug received, sold, returned to manufacturers by using mobile phones. A stockist sells more than 60,000-70,000 drug brands and deals with several retailers. Its not possible for him to upload data of every brand received, sold to retailers. It is also not feasible for retailers to upload every prescription on the portal and pay 1% of total cost of medicine subject to ceiling of  Rs. 200 per prescrip

Health ministry to establish e-enabled structure for regulating sale of medicines

Aiming to ensure availability of right drugs that meet the standards of quality to the patients, curbing anti-microbial resistance (AMR) and also regulating the supply of medicines through online/internet to persons or other entities in and outside India, the Union Health Ministry will soon establish a robust e-enabled structure for regulating sale of medicines in the country. In this regard, the ministry proposes to develop an electronic platform which will be developed and maintained by an autonomous body under the Union ministry of health and family welfare. All manufacturers will be required to register themselves with this portal and enter data relating to sale of drugs on the said e-platform to different distributors i.e. the stockists/wholesalers or otherwise with batch number, quantity supplied and expiry date of the batch. All stockists/wholesalers or other distributors will, also be required to register themselves on the said portal and enter details of stocks received and s

MammoAlert, advanced breast cancer test to be launched in India in 4 months

California based POC Medical System will launch the test 'MammoAlert' in India by July this year enabling women across the country to be screened safely at affordable cost with high accuracy and with minimal false positives. With this launch, India will become first country in the world to have next generation portable, blood based screening test for early breast cancer detection.  The company will shortly apply for CE Mark approval of MammoAlert and is expected to receive the approval within six weeks. Following this, the test will be launched in India. Besides this, it is also planning to apply for US FDA approval which takes 9 months. Its easier and cost effective for one to go for MammoAlert to make sure that she does not have breast cancer rather than opting for time consuming and costly mammography for the same. If the test results are positive, one should go for confirmatory test like mammography. Currently the company is in talks with all stakeholders in India inc