Pharmafocus and Pharmafile

Pharmafocus and Pharmafile
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Pharmafocus and Pharmafile

 •  November 27

Recipharm, a leading contract development and manufacturing organisation (CDMO) has equipped three more of its facilities with serialisation capabilities in line with the US regulatory requirements in time for today’s introduction of the Drug Supply Chain Security Act (DSCSA). The facilities in Brescia, Italy and Karlskoga and Uppsala, Sweden, are...

Pharmafocus and Pharmafile

 •  November 27

President Donald Trump’s budget proposes to cut funding to the National Institutes of Health by $7.2 billion or 21%. Researchers at the Washington University School of Medicine assert that this is a move which, given that the NIH funded more than 90% of new drugs, could prove to have dramatic consequences. The team analysed past budget data from...

Pharmafocus and Pharmafile

 •  November 27

It’s been a rocky year for AstraZeneca, it has scored some major successes yet its year has been marred by the big failure of the Mystic trial – an announcement that knocked a big dent in the company’s share price, from which it is only just beginning to recover. One of the major bright spots that helped the company recover from this disaster was...

Pharmafocus and Pharmafile

 •  November 23

Teva’s troubled year needs little detailing, those following the company have seen it lurch from one piece of bad news to another. With the appointment of Kåre Schultz, the company hopes that it can take some hard decisions to turn around the company – one of the first steps seems to be to fire a large number of staff. Calacalist broke the story...

Pharmafocus and Pharmafile

 •  November 21

The decision had been left as a choice between Amsterdam and Milan, with the former being picked out of the hat by Matti Maasikas, Estonian Deputy Minister for EU Affairs, who was chairing the meeting. Amsterdam was considered one of the favourites for the agency from the start, alongside Milan, but Slovakian capital city, Bratislava, was also seen...

Pharmafocus and Pharmafile

 •  November 21

The German drugmaker hopes that the move will galvanise independent drug discovery and collaborative partnerships, as well as the identification of novel treatment solutions for patients. The available molecules are divided into two distinct groups. For the most part, molecules are offered via a simple shopping cart system and do not require any...

Pharmafocus and Pharmafile

 •  November 20

The authorisation covers all 28 EU member states in addition to Norway, Liechenstein and Iceland and marks the fourth biosimilar from the company to be approved in the region. Samsung Bioepis has already secured approval for biosimilar versions of Humira, Remicade and Enbrel. The South Korean company is hoping to carve out a slice of Herceptin’s...

Pharmafocus and Pharmafile

 •  November 15

Scott Gottlieb, the FDA’s Commissioner, issued an advisory about the medicinal plant-product known as kratom. The plant is known to act as a stimulant in low-doses and has opioid-like effects in higher doses, but whether it is directly harmful is a matter of serious debate. The plant has been used in Asia, where it originates, as a natural remedy...

Pharmafocus and Pharmafile

 •  November 13

The comments from Nevin came during a conference where he provided a keynote address for the 90th Annual National Conference of the Pharmaceutical Society of Nigeria. Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) released a statement to suggest Nevin’s claim were not based on evidence and would scare foreigners and...

Pharmafocus and Pharmafile

 •  October 30

with the signing of a memorandum of understanding. The relationship has come into force to streamline process development and clinical material production for small biotech start-ups focusing on novel drugs. To this end, the agreement will provide Samsung Biologics with access to MSD’s Mobius single-use technology, a platform which delivers...