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AstraZeneca has had high hopes for an immuno-oncology combination of Imfinzi and candidate tremelimumab. But after a high-profile miss last year, the combo has struck out again, this time in previously untreated patients with advanced non-small cell lung cancer—even when their tumors were riddled with mutations. [...]
Wed, Aug 21, 2019
Source FiercePharma
Dr. Reddy's Laboratories is becoming synonymous with Form 483s from the FDA: Already knocked four times this year, India's second-largest drugmaker now has a fifth notice to dwell on. This time, it's for an oncology plant with a history of faults. [...]
Wed, Aug 21, 2019
Source FiercePharma
Drugs that inhibit cancer-causing proteins known as kinases have driven nearly $100 billion in deals since 2010, SVB Leerink finds. And the analysts figure that drug class—and its propensity to drive acquisitions—will only grow, thanks to speedy FDA reviews, strong pricing trends and next-gen entrants. [...]
Wed, Aug 21, 2019
Source FiercePharma
A small group of hemophilia A patients in England have had access to Roche's Hemlibra in England for about a year. But now authorities signed off on funding for patients without inhibitors, enabling the Roche drug to treat about 8 times as many patients there. [...]
Wed, Aug 21, 2019
Source FiercePharma
The letter urges for regulation to restrict price promotions on food and drink products high in fat, sugar and salt. [...]
Wed, Aug 21, 2019
Source PharmaTimes
Both products are approved in adults for osteoporosis in various indications. [...]
Wed, Aug 21, 2019
Source PharmaTimes
The injection was made as the last two decades have witnessed dramatic, unpredicted changes in fertility levels. [...]
Wed, Aug 21, 2019
Source PharmaTimes
The 'life-changing' drug will be reimbursed for certain people with severe congenital haemophilia A. [...]
Wed, Aug 21, 2019
Source PharmaTimes
Pfizer
The Pfizer Foundation announced 20 grants* to help non-governmental organizations (NGOs), non-profits and social enterprises address critical health challenges related to infectious diseases, including the increasing threat of antimicrobial resistance (AMR), in some of the world's most vulnerable communities. [...]
Wed, Aug 21, 2019
Source WorldPharmaNews
AstraZeneca
AstraZeneca today announced positive results from the landmark Phase III DAPA-HF trial which showed that Farxiga (dapagliflozin) met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure (defined as hospitalisation or an urgent heart failure visit), compared to placebo. [...]
Tue, Aug 20, 2019
Source WorldPharmaNews
New research published in JAMA Oncology has found a lack of racial and ethnic diversity in clinical trials for cancer drugs. The study - conducted by researchers from UBC, the University of Texas MD Anderson Cancer Center, the Fred Hutchinson Cancer Center in Seattle and Baylor University in Texas - [...]
Mon, Aug 19, 2019
Source WorldPharmaNews
Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and paediatric patients [...]
Fri, Aug 16, 2019
Source WorldPharmaNews
Sponsors submitting pediatric study plans should consider whether a product affects adults and children similarly when choosing an approach, the FDA says. [...]
Fri, Jan 16, 2015
Source FDANews