The start of the second state-level trial related to certain companies’ role in the U.S. opioid epidemic, slated to begin on January 20, 2020, in New York has been extended to March 20, 2020 according to Susquehanna International Group. The move, if confirmed, is surprising since the start date was moved up two months to January 20 last week.
The case against privately held Purdue Pharma, maker of Oxycontin (oxycodone), is being conducted separately through U.S. Bankruptcy Court.
FDA warns Mylan over quality issues at India site
The FDA has sent a Warning Letter to Mylan N.V. (MYL -1.1%) concerning “significant deviations” from good manufacturing practice for active pharmaceutical ingredients (API) at its Unit 8 facility in Vizianagaram, Andhra Pradesh, India.
An on-site inspection from May 27 – June 5 found the following deficiencies:
Failure to adequately maintain written procedures for the receipt, identification, testing and handling of raw materials (cited NDMA and NDEA contamination of valsartan).
Failure to clean equipment and utensils to prevent contamination or carry-over of a material that could affect the quality of the API.
The company has 15 working days to submit a response to the letter including its plan to promptly address the deviations. Failure to do so could put future FDA approvals at risk.
Editas adds to Celgene collaboration-stoked up move, shares ahead 4%
CRISPR/Cas9 gene editor Editas Medicine (EDIT +4%) is up on average volume, adding to yesterday’s 9% jump after it announced an amended collaboration agreement with Celgene (CELG) aimed at researching, developing and commercializing autologous and allogeneic alpha-beta T cell therapies for cancer and autoimmune diseases that will earn it an upfront $70M payment.
Under the terms of the amended deal, CELG will have the rights to in-license genome editing tools developed by EDIT for these therapies. For each program, it will pay EDIT milestones and royalties.
EDIT originally entered the collaboration in 2015 with Juno Therapeutics, acquired by Celgene in March 2018 for $9B. That agreement is set to expire in 2020.
The buying has spread to compatriots Intellia Therapeutics (NTLA +5.3%) and CRISPR Therapeutics (CRSP +3.3%)
Fed inquiry launched into Google-Ascension deal
“We are happy to cooperate with any questions about the project,” Google (GOOG, GOOGL) said in a blog post, confirming a federal inquiry into its deal with Ascension.
“We believe Google’s work with Ascension adheres to industry-wide regulations (including HIPAA) regarding patient data, and comes with strict guidance on data privacy, security, and usage.”
Earlier this week, the WSJ reported that Google was accessing and analyzing Ascension patient data without patient or doctor knowledge.
AbbVie sells $30B in bonds for Allergan takeover
Encouraged by low funding costs amid narrowing credit risk premiums, U.S. drugmaker AbbVie (NYSE:ABBV) has sold the largest block of bonds of the year to finance its $83B takeover of rival Allergan (NYSE:AGN).
$30B was raised from investors clamoring for investment-grade debt, in a bond offering split across 10 different maturities from 18 months to 30 years.
The deal was the biggest bond offering since CVS raised $40B in March last year to fund its takeover of Aetna and ranked as the fourth-largest bond sale ever completed.