13 Sep 2018
Top Pharma & Biotech Deals, Investments, M&As in August 2018
In August, the biotech boom of 2018 continued unabated and the Wall Street Journal reported that investment banks have lured top biotech analysts with guaranteed pay packages of US$ 3 million or more. At this time of the yea...
13 Sep 2018
Sun, Dr. Reddy’s rework strategies to deal with US market; Novartis sells troubled US biz to Aurobindo
This week, Phispers has news on Indian generic drug makers. First, Sun Pharma and Dr. Reddy’s Laboratories announced their reworked strategies that are driven by severe pressures in the US market. While DRL plans to double i...
06 Sep 2018
Novartis plans job cuts in Switzerland; Researcher pleads guilty of stealing GSK’s trade secrets
This week, Phispers brings you details of the scam at GSK, wherein a former cancer researcher in the US stole trade secrets for the benefit of the companies she had started. Seven months ahead of the Brexit, Britain begins to f...
30 Aug 2018
Data integrity concerns in Japan at Kyowa Hakko; China biotech plant explosion probe
This week, Phispers brings you news on Kyowa Hakko, a Japanese manufacturer of amino acids, which received an FDA warning letter with a recommendation to implement data integrity remediation measures. There is also news on tech bi...
23 Aug 2018
FDA, EMA highlight more concerns over APIs from China; FDA slams Apotex’s India operations
This week, Phispers brings you more news on quality problems with active pharmaceutical ingredients from China. The FDA commissioner, through a series of tweets and press statements, announced that the US regulatory agency i...
16 Aug 2018
Top Pharma & Biotech Deals, Investments, M&As – July 2018
July may not have seen any big-ticket deals — i.e. deals in excess of US$ 1 billion — in the pharma and biotech space. Yet, deal making remained robust last month as well. Companies like Novartis, Roche, Lilly ...
16 Aug 2018
Headwinds at Mylan; Chinese API Adulteration Concerns Trigger Another US Drug Recall
This week in Phispers, we look at Mylan’s US operations that declined 22 percent due to lower volumes. Moreover, quality concerns and supply chain tactics led to more headwinds at the American drug major. Two Form 483s redac...
09 Aug 2018
High-level exit at Dr. Reddy’s; Drug stockpiling starts as firms face ‘no-deal Brexit’ blues
With Britain preparing for a ‘no-deal Brexit’, Phispers this week looks at how pharmaceutical companies are exploring various options, such as stockpiling, to equip themselves for such a scenario. In M&A news,...
02 Aug 2018
FDA releases GDUFA II fee for FY19; AstraZeneca probed on bribes to Iraqi terrorists
This week, Phispers brings you the FY19 user fee schedule under GDUFA II, released by the USFDA, which saw a significant hike for generic drug applicants. For the first time since its launch in 2014, Merck’s Keytruda beat Br...
30 Jul 2018
Kemiex reduces the risk of payment redirection frauds for pharma industry
The pharmaceutical industry is facing a daunting challenge of financial frauds where payments due to suppliers are getting re-directed to criminal bank accounts. This week, PharmaCompass speaks to Pau Franquet, CEO...