Biopharma heavyweights Amgen, Pfizer and a number of other companies offered their unique takes on the biosimilar draft guidance from the EMA, calling for more clarity and some new additions before the final draft takes effect.
Drugmakers are bringing sterile injectables capacity back in-house according to a Frost & Sullivan analyst, who says industry risk aversion is the key driver.
Janssen has mirrored Pfizer’s concerns about the scale, price and robustness of using single-use technology for high-volume production but says industry collaboration could help bring standards in place.
The thin profit margins associated with relatively simple sterile products has led to a reluctance to invest in operations and shortages, according to an industry expert.
The climate for biomanufacturing has changed according to Pfizer, which has set out to win more contracting work for its hormone plant in Sweden and says it will even consider making large molecule drugs for Big Pharma rivals.
Harbour Antibodies has received a double boost this week raising $3.3m (€2.5m) for its transgenic H2L2 mice technology and adding Pfizer to its list of clients.
After patent expiration led to facility shuttering and cutbacks, Irish manufacturing will receive a $130m (€100m) boost to prepare for Pfizer’s new pipeline, the company says.
BioMarin will buy Pfizer’s biologics manufacturing plant in Shanbally, Cork, Ireland to add production capacity for its candidate mucopolysaccharidosis treatment.
Drug researchers will have greater access to some top selling molecules, including currently patented compounds atorvastatin, sildenafil and celecoxib, thanks to Sigma Aldrich’s new bioactives deal with US drug major Pfizer.
Pfizer’s new $214.8 million (€150m) biotechnology facility in Strangnas, Sweden was inaugurated yesterday, securing the country’s future in the company’s manufacturing network according to global manufacturing president Natale Ricciardi.
A Terre Haute, US resident has filed a lawsuit against Pfizer alleging that the company “negligently or recklessly” maintained its dam, resulting in the release of PCB.
Earlier this week, the US Food and Drug Administration suspended
the approval of a generic version of Pfizer's high blood pressure
drug Norvasc (amlodipine besylate) developed by India's Dr Reddy's
Laboratories. The...
