FDA classifies Alkem, Aurobindo facilities as OAI; new CEO defends Gilead’s HIV prevention drug
This week, Phispers brings you news about the FDA classifying three plants of Indian drug major Aurobindo Pharma and an Alkem Laboratories plant in the US as Official Action Indicated (OAI). Gilead’s new CEO Daniel O’Day defended&n...
New book on quality issues in generic drugs sends FDA in damage control mode; 21 generic firms sued over price-fixing
This week, Phispers is loaded with news from the US. First, a coalition of 44 states sued Teva and 20 other generic companies for price fixing. Second, a new book titled ‘Bottle of Lies’, by investigative journalist Katherine Eba...
Insys founder Kapoor convicted in opioid scandal; FDA rules changing due to new technologies
This week, Phispers brings you news about John Kapoor, the founder of Insys who was found guilty of engaging in a bribery scheme to get doctors to prescribe a highly potent and addictive opioid. FDA granted approval to Pfizer’s rare and fatal...
EMA raises NDMA impurity concerns in diabetes drug made by Hetero; shareholder revolt rocks Bayer
This week, there is news on EMA telling companies using certain reagents to make diabetes drug — pioglitazone — to check their processes and rule out the presence of a nitrosamine impurity. Bayer faced shareholder revolt for p...
Another Lupin facility gets FDA’s OAI classification; layoffs at GSK’s R&D ops; Sandoz gets new CEO
This week Phispers has news on regulatory action, a new CEO appointment, lobbying, data theft and layoffs. Another plant of Indian drugmaker Lupin received an OAI letter from the USFDA. After companies like GSK, Eli Lilly and Genentech, data...
Top drugs and pharmaceutical companies of 2018 by revenues
The drug pricing debate continued to dominate news headlines in 2018, and many companies were in the news for lowering drug prices to make treatments more affordable. Despite that, most major pharmaceutical companies saw their sales grow in 2018.&n...
BMS-Celgene mega-merger gets shareholder nod; 10 people die in another industrial accident in China
This week, Phispers brings you an update on the US$ 74 billion BMS-Celgene mega-merger, which was facing investor opposition. The shareholders of BMS have approved the takeover of Celgene. French drugmaker Sanofi announced an innovative model to ma...
Apotex explores sale; Perrigo looks at selling prescription business; Takeda puts Latam biz on the block
This week, Phispers has good news for patients on sartan drugs. For the first time since nitrosamine impurities were discovered last year, the USFDA released a list of BP drugs that are safe for patient use. The EU launched a WTO case against Tur...
Astra strikes US$ 6.9 billion oncology deal with Daiichi; Cipla, Jubilant, Indoco’s FDA inspection updates
This week, Phispers brings you news about AstraZeneca’s US$ 6.9 billion deal with Japanese drug major Daiichi Sankyo, wherein the two will jointly develop a promising cancer therapy currently in phase III trials. Novartis acquired a portfolio...
US market offers niche opportunities, reveals manufacturer sales data from Medicare Part D
This week, PharmaCompass reviews the recently released data of the Medicare Part D Prescription Drug Program in the United States for calendar year 2017. The US market is the world’s largest and most important pharmaceutical market, accountin...