Showing posts from June, 2017


Homegrown pharma major Dr Reddy’s believes that replacing ‘Obamacare’ by another law in the US will pose risk to its business that can have adverse material effect on financial performance. The Trump administration in the US plans to repeal and replace The Patient Protection and Affordable Care Act(PPACA), nicknamed Obamacare. “Any changes in the PPACA, the Medicaid Part D program or other laws relating to drug pricing, coverage through Medicaid or Medicare, or other facets of the US healthcare market could have a material adverse effect on our results of operations, financial condition or business,” Dr Reddy’s said in a filing to US Securities and Exchange Commission (SEC). The Hyderabad-based firm also said there has been an increasing trend of manufacturing site audits by the USFDA and regulators in other developed countries and it could not guarantee that its efforts would prevent adverse outcomes, including warning letters or import bans. In March 2017, the US House of R

First-Ever FDA Approval of Anti-Cancer Drug Based on Biomarker and Not Cancer Type Is Encouraging for Mesothelioma Patients

Last week MesotheliomaHelp reported on the drive towards using DNA sequencing on cancer patients in an effort to determine the appropriate treatment based on the patients’ biomarkers. Keytruda, that targets the PD-L1 marker, was cited as an example in that article. Now, the U.S. Food and Drug Administration has granted accelerated approval to Keytruda as a treatment based solely on the genetic mutations of a cancer and not on the type of cancer. The  FDA  announced in a May 23 press release, that this is the first-ever approval of a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Keytruda has already been approved for in the U.S. for use in melanoma and lung cancer patients after a prior round of chemotherapy failed to stop progression of the disease. This approval is for unresectable or metastatic solid tumors, of any type, that have been identified as having a biomarker referred to as microsatellite instability-high (M

Varian Works with Sify Technologies to Host Data Remotely Across CTSI Network of Cancer Centers in India

In the first project of its kind outside the United States, Varian Medical Systems (NYSE:  VAR ) is working with Sify Technologies to provide software-as-a-service (SaaS) to radiotherapy centers across  India . The innovative service, which hosts oncology information and treatment planning software in the cloud and allows clinical teams to focus on treating patients, is being implemented as part of a multi-million dollar investment in treatment equipment and software across Cancer Treatment Services International CTSI's network of cancer hospitals in  India  and  South Asia . "CTSI is rapidly expanding its network across the region, and the cloud-hosted solution enables us to focus on delivering high quality, consistent care to our patients," said  Vishal Bali , CTSI's Chairman. "Our flagship  Hyderabad  facility, operated under the name American Oncology Institute (AOI), is the first in  India  to implement this innovative solution for remote software hostin

FDA moves to clear path for drugs aimed at cancer-causing genes

For years, doctors have identified cancers by the affected body part: lung, breast, kidney. Now, in a long-awaited move, U.S. drug regulators will simplify the approval of treatments targeting specific gene mutations that can spur tumors in a variety of organs. The Food and Drug Administration will soon announce a plan to update agency policies and facilitate the approval of critically needed drugs, including those known as tumor-agnostic therapies, which attack cancer-linked DNA, according to FDA Commissioner Scott Gottlieb. “This represents some of the biggest opportunities in medicine to treat and cure debilitating and, yes, very costly diseases,” Gottlieb wrote in remarks for his appearance Tuesday before the Senate panel responsible for overseeing the agency’s budget. The proposal, dubbed the Medical Innovation Access Plan, would answer President Trump’s call to speed drug approvals at what he called the “slow and burdensome” FDA in a February speech before Congress. The

Glenmark Pharma Buy Rights To Cancer Drug From US Firm

Glenmark Pharmaceuticals said it entered into a licensing agreement with Boston-based biopharmaceutical company APC Therapeutics Inc for exclusive rights for a cancer drug. The agreement covers a small molecule based on Antigen Presenting Cell (APC) biology, the Indian company said. “The compound has the potential to be used as a monotherapy or in combination with approved therapies to address unmet needs in cancer treatment,” it said. “This asset adds to our robust biologics pipeline of targeted IO therapies,” said Kurt Stoeckli, President and Chief Scientific Officer at Glenmark Pharmaceuticals. “The mechanism of action of APC biology is very intriguing and has the potential to be transformative in cancer treatment by triggering powerful immunologic responses to tumors that may lead to deeper and more durable responses to treatment.” Under the terms of the agreement, Glenmark will license the product from APC Therapeutics, and manage all clinical development including reg

FDA to Clear Path for Drugs Aimed at Cancer-Causing Genes

For years, doctors have identified cancers by the affected body part: lung, breast, kidney. Now, in a long-awaited move, U.S. drug regulators will simplify the approval of treatments targeting specific gene mutations that can spur tumors in a variety of organs. The Food and Drug Administration will soon announce a plan to update agency policies and facilitate the approval of critically needed drugs, including so-called “tumor-agnostic” therapies that target cancer-linked DNA, according to FDA Commissioner Scott Gottlieb. “The most tangible way we’re going to reduce health-care costs is by finding better treatments for a lot of costly diseases,” Gottlieb told the Senate panel responsible for overseeing the agency’s budget on Tuesday. The proposal, dubbed the Medical Innovation Development Plan, would answer President Donald Trump’s call to speed drug approvals at what he called the  “slow and burdensome”  FDA in a February speech before Congress. The agency has been approving ca

Dr Reddy's may file two new drugs with FDA by 2019

Drug maker Dr Reddy's Laboratories Limited has said that it is currently working on 16 new drug applications and out of which a drug to treat migraines has completed Phase-3 trials and another anti-cancer biologic agent is currently under Phase-3 trials.  According to filing with the US Securities and Exchange Commission, the city-based pharma company is expected to file the New Drug Application (NDA) with US Food and Drug Administration with regard the migraine drug in 2018 while it   is expected to submit license application for the cancer drug, it may approach the drug regulator in 2019.  "As of March 31, 2017, we had 16 active product development programs in our pipeline (for DFN-02- the drug to treat acute treatment of migraines, with or without aura in adults) Phase 3 is completed. Submission of NDA to USFDA is planned for 2018," it said.  Another (E7777-Treatment of Cutaneous T Cell Lymphoma) is an anti-cancer biologic agent in-licensed from EISAI limited...Pha

The Running Community That's Fighting to Change Health Care for Women In India

It's a sunny Sunday morning, and I'm surrounded by Indian women wearing saris, spandex, and tracheostomy tubes. All of them are eager to hold my hand as we walk, and to tell me all about their cancer journeys and running habits. Each year, the group of cancer survivors walks together up stone stairs and dirt paths to the top of Nandi Hills, an ancient hill forest on the outskirts of their hometown, Banaglore, India, to share their cancer stories with the rest of the group. The "survivors' hike" is a tradition meant to honor the cancer survivors and their family members who make up the running community of  Pinkathon —India's largest women-only racing circuit (3K, 5K, 10K, and half marathon)—as it heads into its annual race. As an American journalist interested in learning about Pinkathon, I feel lucky to be welcomed on the excursion. But now, I'm feeling less like a reporter and more like a woman, a feminist, and someone who lost her best friend to c

Astrazeneca Pharma India gains after DCGI nod for asthma drug

AstraZeneca Pharma  India  rose 1.47% to Rs 933 at 11:02  IST  on  BSE  after the company said it received import and market permission in Form 45 from Drug Controller General of  India  for  FDC  of inhalation powder. The announcement was made after market hours yesterday, 15 June 2017. Meanwhile, the S&P  BSE  Sensex was up 15.81 points, or 0.05% to 31,091.54. On the BSE, 2,453 shares were traded in the counter so far, compared with average daily volumes of 4,977 shares in the past one quarter. The stock had hit a high of Rs 955.65 and a low of Rs 930 so far during the day. The stock hit a 52-week high of Rs 1,146.95 on 24 August 2016. The stock hit a 52-week low of Rs 909 on 27 February 2017. The stock had underperformed the market over the past one month till 15 June 2017, falling 5.30% compared with 1.36% rise in the Sensex. The scrip had also underperformed the market in past one quarter, falling 2.92% as against Sensex's 4.81% rise. The scrip had also underp

'AI can help doctors fight cancer, but it’s not meant to replace them'

From mining medical records and designing treatment plans to developing precision medicines, artificial intelligence (AI) is playing a bigger role in healthcare. Shobita Dhar spoke to  Rob Merkel , general manager of oncology and genomics,  IBM Watson Health , about how the cognitive computing system is working with clinicians, researchers, businesses and governments worldwide, and in India, to solve healthcare challenges that range from cancer to diabetes. How can AI help the doctor? There is an overwhelming amount of information available to physicians today. In oncology alone, there are more than 160,000 studies published each year. Yet there are few tools to help doctors draw meaning from this knowledge. With training, AI technologies like Watson are assisting physicians to summarise patient records and synthesise the vast body of medical data — from clinical records to medical literature to genomics and even data from wearable devices like the Apple Watch — so that they can deliv