Sanofi and AbbVie CEOs suffer pay cuts, FDA Warning Letters to Pfizer, Jubilant’s Indian operations
This week, Phispers brings you news about two antidepressants — J&J’s esketamine and Allergan’s rapastinel. While J&J’s drug bagged FDA approval, rapastinel failed in phase III trials. With troubles looming large ove...
FDA chief Gottlieb resigns; BMS-Celgene deal may get derailed due to shareholder opposition
This week, Phispers brings you news about the sudden and unexpected resignation of the USFDA commissioner Scott Gottlieb, a day after his crackdown on retailers selling tobacco to young people. The other big news came from BMS and Celgene — t...
Data integrity concerns at Dr Reddy’s; Roche, Ipsen make multi-billion dollar buys; Aceto files for bankruptcy
The world of pharmaceuticals witnessed considerable M&A activity over the last week. GE sold off its biopharma business to Danaher Corporation for US$ 21 billion. Roche bought Spark Therapeutics for US$ 4.8 billion, and Ipsen struck a US$ 1.3 b...
Teva to divest 11 sites this year; former Ranbaxy promoter files criminal compliant against brother
This week, Phispers brings you news about Israeli generic drug giant Teva, as it plans to close or divest 11 manufacturing sites in 2019 to reduce its cost and debt burden. India’s Serious Fraud Investigation Office has said the alleged fu...
Recurring cGMP problems at Lupin, Dr Reddy’s; Data-integrity concerns at Indoco, Vipor
Leading Indian companies, such as Dr Reddy’s Laboratories and Lupin Limited were issued a Form 483 by the US Food and Drug Administration’s (FDA) for deficiencies in their quality, production and equipment systems and poor handling o...
ICH seeks to standardize generic drugs; MIT research team develops insulin pill
This week, Phispers brings you news about a reflection paper released by the International Council on Harmonization (ICH) that seeks to standardize generic drugs across borders. In the US, a federal jury has ordered Takeda to pay Bayer US$ 155.19...
2018 compliance recap: Deficient inspections, fragile global supply chain and uncertain product quality
The heparin adulteration scandal had engulfed the world of pharmaceuticals in 2008. Ten years on, the spotlight returned to drug manufacturing as millions of blood pressure (BP) medicines were recalled due to the risk of them containing potential ...
Sandoz’s future in question; Articles on risks of generic drugs has FDA commissioner justifying inspection focus
This week, Phispers brings you news on Mylan bagging an FDA nod for its generic version of GSK’s blockbuster asthma treatment Advair Diskus. The agency also approved Evolus’ wrinkle treatment, which is expected to pose tough compet...
Big Pharma prepares for no-deal Brexit; Micro Labs in India fails EDQM inspection
This week, Phispers brings you news about how the ongoing recalls of sartans are likely to worsen the shortage of blood pressure drugs in the US. In the UK, Big Pharma announced their plans for a no-deal Brexit, while Novartis raised an alarm over ...
2018 was a landmark year for pharma, biotech sector; 2019 looks even better
In 2018, each month PharmaCompass published PharmaFlow — a compilation of all the major deals in the industry that took place in the preceding month. We begin 2019 with our annual compilation of the deals of 2018, packed with some exci...