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...

Sanofi and AbbVie CEOs suffer pay cuts, FDA Warning Letters to Pfizer, Jubilant’s Indian operations

14 Mar 2019

Radio Compass

PharmaCompass.com

View: 1477

Read More

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...

FDA chief Gottlieb resigns; BMS-Celgene deal may get derailed due to shareholder opposition

07 Mar 2019

Radio Compass

PharmaCompass.com

View: 1663

Read More

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...

Data integrity concerns at Dr Reddy’s; Roche, Ipsen make multi-billion dollar buys; Aceto files for bankruptcy

28 Feb 2019

Radio Compass

PharmaCompass.com

View: 1623

Read More

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...

Teva to divest 11 sites this year; former Ranbaxy promoter files criminal compliant against brother

21 Feb 2019

Radio Compass

PharmaCompass.com

View: 1648

Read More

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...

Recurring cGMP problems at Lupin, Dr Reddy’s; Data-integrity concerns at Indoco, Vipor

21 Feb 2019

Radio Compass

PharmaCompass.com

View: 1379

Read More

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...

ICH seeks to standardize generic drugs; MIT research team develops insulin pill

14 Feb 2019

Radio Compass

PharmaCompass.com

View: 681

Read More

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 ...

2018 compliance recap: Deficient inspections, fragile global supply chain and uncertain product quality

14 Feb 2019

Radio Compass

PharmaCompass.com

View: 2171

Read More

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...

Sandoz’s future in question; Articles on risks of generic drugs has FDA commissioner justifying inspection focus

07 Feb 2019

Radio Compass

PharmaCompass.com

View: 1890

Read More

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 ...

Big Pharma prepares for no-deal Brexit; Micro Labs in India fails EDQM inspection

31 Jan 2019

Radio Compass

PharmaCompass.com

View: 1006

Read More

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...

2018 was a landmark year for pharma, biotech sector; 2019 looks even better

31 Jan 2019

Radio Compass

PharmaCompass.com

View: 1046

Read More

PharmaCompass