Premarket Biotech Digest | Sector News Brief

US News

Johnson & Johnson to Restructure Medical Devices Businesses- Johnson & Johnson (NYSE: JNJ) disclosed restructuring actions in its Medical Devices businesses in a regulatory filing. The restructuring will allow JNJ to better serve the needs of customers and patients in today’s evolving healthcare marketplace. The actions include strengthening the go-to-market model, accelerating the pace of innovation, further prioritizing key platforms and geographies and streamlining operations while maintaining high quality standards. The restructuring will not affect JNJ’s Consumer Medical Devices businesses, Vision Care and Diabetes Care. As part of the restructuring, JNJ expects to record pre-tax charges of approximately $2 billion to $2.4 billion, most of which are expected to be incurred by 2017. The company will slash 3,000 jobs at its medical devices unit as part of the restructuring effort. 

Osiris Issues Statement- Osiris Therapeutics (NASDAQ: OSIR) issued a response to recent statements posted to several websites. OSIR noted that in 2015, it established a competitive commercial infrastructure, achieved insurance coverage for more than 135 million lives and signed a major contract with a group of purchasing organization and multiple integrated delivery networks. OSIR said in its statement that these activities led to significant market penetration and share gains for Grafix in the wound care market. In 2015, OSIR also established distribution relationships with industry-leading marketing partners. 

Intrexon’s Subsidiary Expands Project in Brazil- Intrexon (NYSE: XON) announced that its subsidiary Oxitech and Piracicaba City Hall have expanded the 'Friendly Aedes aegypti Project' in Piracicaba, Brazil. The decision to expand the project was taken after strong results for controlling the Ae. aegypti mosquito population, the primary vector for dengue, chikungunya and Zika virus outbreaks around the world. 

MabVax Therapeutics Announces Loan and Security Agreement- MabVax Therapeutics (OTC: MBVX) disclosed in a regulatory filing that it has entered into a Loan and Security Agreement providing for second term loans to the company in an aggregate principal amount of up to $10 million. On January 15th, the company received an initial loan of $5 million under the loan agreement. 

CASI Pharmaceuticals Announces Initial Closing of Strategic Financing- CASI Pharmaceuticals (NASDAQ: CASI) announced that it has received approximately $10.3 million in a strategic financing. The financing was first announced on September 21, 2015. The initial closing yielded around $10.1 million to CASI after minimum offering expenses. 

Transgenomic Announces Launch of MX-ICP Panels for Liquid Biopsy- Transgenomic (NASDAQ: TBIO) announced the launch of MX-ICP RAS Analysis and the MX-ICP PIK3CA Analysis. The two new cancer panels are based on TBIO’s Multiplexed ICE-COLD PCR(TM) (MX-ICP) technology. 

Akorn Launches Buprenorphine and Naloxone Sublingual Tablets CIII- Akorn (NASDAQ: AKRX) announced the launch of Buprenorphine and Naloxone Sublingual Tablets CIII in 2 mg/0.5mg and 8mg/2mg strengths. The FDA had approved the drug in October last year. 

News From Europe 

Galapagos Advances CF Clinical Development- Galapagos (NASDAQ: GLPG) (AMS: GLPG) provided an update on progress made in cystic fibrosis (CF) programs. GLPG and AbbVie (NYSE: ABBV) aim to develop a triple CFTR combination therapy to address 90% of patients with CF. The two companies plan to develop multiple candidates and backups for each of the three components, with the goal of determining a potential triple combination. 

Summit Granted Key Patent- Summit Therapeutics (NASDAQ: SMMT) (AIM: SUMM) announced that the European Patent Office (EPO) has granted it a patent covering ridinilazole, a novel antibiotic. The patent covers the use of ridinilazole for the treatment of infections caused by the bacterium Clostridium difficile.  

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