The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
AstraZeneca has been awarded up to $486 million from the US government for the late-stage development and large-scale manufacturing of the company’s AZD7442, a cocktail of two monoclonal antibodies, for the potential treatment or prevention of...
Johnson & Johnson (J&J) reports it will contribute up to an additional $1 billion to an all-in settlement amount to resolve opioid litigation to bring the total settlement amount being provided by the company to $5 billion.
Last October...
Johnson & Johnson (J&J) has temporarily paused all dosing in its COVID-19 vaccine candidate trials, including its Phase III Ensemble trials, due to an unexplained illness in a study participant.
The company says that the participant’s...
Takeda and Arrowhead Pharmaceuticals, a Pasadena, California-based biopharmaceutical company, have entered into a collaboration and licensing agreement, in a deal worth up to $1.04 billion, to develop Arrowhead’s ARO-AAT, a RNA interference (RNAi)...
Mallinckrodt has voluntarily initiated Chapter 11 bankruptcy proceedings in the US as part of a plan to reduce the company’s debt by $1.3 billion and resolve potential liabilities relating to opioid litigation.
The entities that filed Chapter 11...
The US Food and Drug Administration (FDA) has issued guidance to provide sponsors of requests for emergency use authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an...
An upcoming DCAT webinar, featuring Graham Lewis, Vice President, Global Pharma Strategy, IQVIA, evaluates the market impact on the COVID-19 pandemic on companies’ pipelines, product launches, and performance and how industry fundamentals and...
Johnson & Johnson has announced that the European Commission (EC), acting on behalf of European Union (EU) member states, has approved an advance purchase agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of...
A roundup of news from China (Pfizer, CStone Pharmaceuticals), Luxembourg (Covis, AMAG Pharmaceuticals), and the US (Moderna, XtalPi).
China
Pfizer, CStone in $480-M Oncology Drug Pact in ChinaPfizer has formed a strategic collaboration, worth up...
The latest on manufacturing and potential treatments for COVID-19 with news from AstraZeneca, Pfizer, Eli Lilly and Company, Gilead Sciences, GSK, Eisai, and others.
EMA Begins Rolling Review of AstraZeneca’s COVID-19 VaccineThe Committee for...
Marksans Pharma, a Mumbai, India-based pharmaceutical company, is voluntarily recalling 76 lots of metformin hydrochloride extended-release (ER) tablets (USP 500 mg and 750 mg) to the consumer level in the US due to some lots exceeding acceptable...
Johnson & Johnson (J&J) has completed its acquisition of Momenta Pharmaceuticals, a Cambridge, Massachusetts-based company developing novel biologics for rare immune-mediated diseases and biosimilars, for $6.5 billion.
Momenta’s lead asset...
Bristol-Myers Squibb (BMS) has agreed to acquire MyoKardia, a Brisbane, California-based clinical-stage biopharmaceutical company focused on cardiovascular diseases, for $13.1 billion.
MyoKardia’s lead drug candidate is mavacamten, in Phase III...
Sanofi has completed its $3.68-billion acquisition of Principia Biopharma, a South San Francisco, California-based clinical-stage biopharmaceutical company focused on immune-mediated diseases. Sanofi had announced the acquisition in late August...
Sun Pharma, a wholly owned subsidiary of Sun Pharmaceutical Industries, a Mumbai, India-based pharmaceutical company, is the latest company recalling a metformin extended-release product due to a nitrosamine impurity, N-ntrosodimethylamine (NDMA),...
