New Delhi, July 18, 2017: Pharmaceutical stocks continued their momentum this week extending gains from the previous week. The news highlights in the sector this week include change of guard at Cadila Healthcare, Biocon getting thumbs-up from USFDA’s Oncologic Drugs Advisory Committee for its breast cancer biosimilar Trastuzumab, Divi’s Labs clearing a major regulatory hurdle, and Novartis getting USFDA advisory panel’s endorsement for the much-awaited breakthrough in CAR-T immunotherapy called CTL019, used for treatment of children and young adults with advanced leukemia according to Moneycontrol.com.
How did Pharma Index Perform?
The BSE Healthcare index gained 2 percent in the past week, while the benchmark Sensex increased 1.62 percent. Biocon (up 21.71 percent), Divi’s Laboratories (7.85 percent), Aurobindo Pharma (6.45 percent) and Alembic Pharma (5.76 percent) were the top gainers of the week.
Meanwhile, Sun Pharma (up 3.35 percent), Glenmark (2.64 percent), Cadila Healthcare (1.95 percent), Lupin (1.75 percent) were others that performed well; Cipla, Dr.Reddy’s and Torrent Pharma remained flat.
Here’s What Kept the Sector Buzzing:
Change of Guard at Cadila Healthcare
Moneycontrol.com also quoted Cadila, part of the Ahmedabad-based Zydus Cadila group, last week elevated Sharvil P Patel as the managing director of the company. Patel was serving as the joint managing director at the company. He is the only son of Pankaj Patel, the chairman and managing director of Cadila Healthcare. Pankaj Patel, who is stepping down as managing director, will continue as the chairman while taking up the mentor role.
Sharvil Patel in his first interview said that vision is to build a research-based pharma company, while maintaining the best standards in terms of quality and compliance in the industry.
Thumbs-up for Biocon from USFDA’s Oncologic Drugs Advisory Committee for breast cancer biosimilar trastuzumab.
The agency often follows the advice of ODAC in determining whether a product should come to market, although they are not required to follow it. If the breast cancer biosimilar drug gets USFDA nod, Biocon will become the first Indian drug maker to crack highly regulated US market for biosimilars.
Earlier this week, French drug regulator found lapses at Biocon’s Bommasandra facility in Bengaluru with respect to good manufacturing practices (GMP) for activities related to three biosimilar products.
USFDA Lifts Divi’s Import Alert
Divi’s said US FDA would lift the import alert imposed on unit-II at Visakhapatnam. Divi’s got an import alert under clauses 99-32 and 66-40 in March of 2017. The import alert under clause 99-32 will now be lifted, however, 66-40 import alert will remain, until the company convinces US FDA on its corrective and preventive action.
According to Viswanath Pilla reports filed in Moneycontrol.com Breakthrough Immune-cancer Therapy Gets Active Support of US FDA Panel Novartis pioneering new cancer drug won enthusiastic support from a federal advisory panel last, paving the way for approval of the first US gene therapy. The panel unanimously recommended USFDA to approve the drug, Tisagenlecleucel, for patients aged 3-25 with relapsed B-cell acute lymphoblastic leukemia (ALL), the most common form of US childhood cancer. The drug uses a new technology known as CAR-T, or chimeric antigen receptor T-cell therapy, which harnesses body’s own immune cells to recognise and attack malignant cells. In a clinical trial, around 83 percent of patients, who had relapsed or failed chemotherapy, achieved complete or partial remission three months post infusion.
