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The solution to maximizing speed, accuracy and cost-efficiency is to digitize tech transfer across the entire product lifecycle
A Philadelphia jury has ordered Johnson & Johnson to pay a whopping $8 billion for a claim that the company failed to warn patients about serious side effects associated with an anti-psychotic drug.
For the first time ever, patients in the U.S. with a rare but painful skin disease will have access to an FDA-approved treatment.
Taking into account the hundreds of pharmaceutical CDMOs out there to choose from, picking the right CDMO can quickly become a daunting task. The good news is there are a couple of deciding factors that remain constant industry wide.
Last month 24 states and local governments reached a deal that was speculated to be worth more than $10 billion.
Beovu injections treat wet age-related macular degeneration that affects 20 million people worldwide, according to the company.
The U.S. FDA approved Gilead Sciences' Descovy for pre-exposure prophylaxis, or PrEP, among male adults and adolescents who are HIV-negative and considered to be at risk for sexually acquired HIV.
Mumbai-based Glenmark Pharmaceuticals has been issued an FDA warning letter for manufacturing issues at its Baddi plant.
Pfizer will front $250 million to gain rights to a phase 2 drug being developed to target a range of major diseases. Pfizer will front $250 million to gain rights to a phase 2 drug being developed to target a range of major diseases.
Johnson & Johnson has hired a former Bayer executive as its chief information officer.
pharma manufacturing news in review
Prestigious universities around the world have accepted at least $60 million in donations over the past five years from the family that owns Purdue Pharma, even as the drugmaker became entangled in lawsuits related to the opioid epidemic.
Johnson & Johnson has agreed to a $20.4 million settlement to avoid going to trial over the opioid-addiction crisis in two Ohio counties.
Two standout industry leaders from this year's class of honorees
The FDA has changed its story on whether or not the levels of a possible carcinogen in ranitidine are too high.
The Trump administration is reportedly getting set to nominate a new FDA commissioner
“Seeing something and saying something” can be applied to the life sciences when a lack of transparency could result in a company facing stiff regulatory action.
AstraZeneca announced that the FDA has rejected its new drug application for a chronic obstructive pulmonary disease (COPD) therapy.
Endo International announced that it has dropped its case against the U.S. FDA regarding the unlawful compounding of vasopressin from bulk drug substances.
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With regulatory bodies in the U.S. and EU investigating the presence of a probable carcinogen in ranitidine, Bangladesh has placed an outright ban on the popular heartburn drug.
Novartis announced that a Phase 3 trial of QMF149 in patients with uncontrolled asthma has met its primary endpoint.
Facing pressure to cut costs, Sanofi is reportedly looking at axing around 200 jobs in Japan.
The U.S. Federal Trade Commission (FTC) has requested for more information from AbbVie and Allergan on their $63 billion deal.