The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Sun Pharmaceutical Industries, a Mumbai, India-headquartered pharmaceutical company, has agreed to acquire Pola Pharma, a Tokyo, Japan-based pharmaceutical company focused on the research and development, manufacture, sale, and distribution of...
In a move to advance digital health technologies, the US Food and Drug Administration (FDA) has issued a Federal Register notice, “Prescription Drug-Use-Related Software” to seek early input from the public on the agency’s proposed framework for...
Takeda Pharmaceutical Company has received clearance from the European Commission (EC) for its proposed $62-billion acquisition of Shire. Takeda and Shire received clearance from the US Federal Trade Commission for the proposed acquisition in July...
Allergan has decided not to pursue a $200-million expansion, first announced in 2016, at its manufacturing plant in Waco, Texas. Allergan had announced in 2016 plans to expand the Waco facility, which produces the company’s eye-care products,...
Moderna Therapeutics, a Cambridge, Massachusetts-based biotechnology company focusing on messenger RNA (mRNA) therapeutics, has filed a registration statement for an initial public offering with the US Securities and Exchange Commission with a...
The US Food and Drug Administration (FDA) plans to take new steps to modernize its inspections program with a new way of assessing, recording, and reporting the data from surveillance and pre-approval inspections for sterile drug products.
The FDA...
Sandoz, the generics arm of Novartis, is voluntarily recalling in the US one lot of losartan potassium hydrochlorothiazide tablets (USP 100 mg/25 mg), an anti-hypertension drug, to the consumer level. The product is being recalled due to a trace...
AstraZeneca has agreed to sell its US rights to Synagis (palivizumab), a drug for preventing lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV), for $1.5 billion to Swedish Orphan Biovitrum (Sobi), a Stockholm,...
Takeda Pharmaceutical Company plans to hold a shareholder meeting on December 5, 2018 to vote on matters relating to its proposed $62-billion acquisition of Shire. Takeda and Shire came to terms for a proposed acquisition of Shire by Takeda in...
As part of its third-quarter earnings, Pfizer reported lower-than-anticipated revenues from its Essential Health business segment primarily due to continued legacy Hospira sterile injectable pharmaceuticals (SIP) product shortages in the US. The...
Hikma Pharmaceuticals, an Amman, Jordan-based pharmaceutical company, has agreed to acquire Medlac Pharma Italy Co. (Medlac), an injectable manufacturing company in Hoa Lac Hi-Tech Park, Vietnam. The acquisition includes an injectable facility,...
Sanofi and Denali Therapeutics, a San Francisco, California-headquartered biopharmaceutical company developing drugs for treating neurodegenerative diseases, have partnered in a deal worth up to $1 billion ($125 million upfront) to develop multiple...
Boehringer Ingelheim (BI) has completed an expansion of its biomanufacturing facility in Fremont, California. With a two-year investment totaling EUR 200 million ($228 million), BI increasing its worldwide bioreactor capacity to 290,000...
ScieGen Pharmaceuticals, a Hauppauge, New York-based generic pharmaceutical company, is voluntarily recalling in the US lots of its irbesartan tablets (USP 75 mg, 150 mg, and 300 mg), an anti-hypertension drug, to the consumer level. The recall is...
Sandoz, the generics arm of Novartis, has decided to not pursue its submission for a biosimilar to Roche’s Rituxan (rituximab) in the US at this time. The decision follows a request by the US Food and Drug Administration (FDA) for additional...
