Dutch drugmaker Prosensa jumps 54 percent in U.S. stock market debut

(Reuters) – Dutch drugmaker Prosensa Holding received a buoyant welcome in its market debut on the Nasdaq, a day after U.S. health regulators granted a “breakthrough status” to its drug to treat a rare disease. Prosensa’s shares opened $7 above its initial public offering price of $13 and were up 46 percent at $19.05 about an hour after they started trading. Prosensa developed drisapersen in partnership with GlaxoSmithKline Plc to treat Duchenne Muscular Dystrophy (DMD), a muscle-wasting disorder that affects one in every 3,500 newborn boys and has no available cure. …

Roche’s subcutaneous Herceptin gets EU green light

ZURICH (Reuters) – Swiss drugmaker Roche said on Friday that European regulators had given a green light to a new formulation of its breast cancer drug Herceptin, which it hopes will help extend the medicine’s shelf life. The European Medicines Agency (EMA) said that its experts had recommended approval of a new injectable version of Herceptin, which cuts down treatment time to just two to five minutes. It currently takes between 30 to 90 minutes to administer the drug intravenously. …

Regulators pave way for biosimilar drug breakthrough

LONDON/ZURICH (Reuters) – European regulators have cleared the way for the first serious threat to the makers of multibillion-dollar biotechnology drugs to treat diseases such as cancer and rheumatoid arthritis. The European Medicines Agency (EMA) said on Friday that its experts had backed approval of two copycat versions of Johnson & Johnson and Merck & Co’s blockbuster rheumatoid arthritis drug Remicade – the first time a green light has been given for such antibody-based medicines. …

Regulators pave way for dissimilar drug breakthrough

LONDON/ZURICH (Reuters) – European regulators have cleared the way for the first serious threat to the makers of multibillion-dollar biotechnology drugs to treat diseases such as cancer and rheumatoid arthritis. The European Medicines Agency (EMA) said on Friday that its experts had backed approval of two copycat versions of Johnson & Johnson and Merck & Co’s blockbuster rheumatoid arthritis drug Remicade – the first time a green light has been given for such antibody-based medicines. …

Mandela showing ‘great improvement’, ex-wife Winnie says

Members of the Tshwane gospel choir release 95 white balloons to mark the upcoming 95th birthday on July 18 of ailing former South African President Nelson Mandela as they sing in PretoriaJOHANNESBURG (Reuters) – Former South African President Nelson Mandela is showing a "great improvement" in his health compared to a few days ago, his ex-wife, Winnie Madikizela-Mandela, said on Friday. "I'm not a doctor but I can say that from what he was a few days ago there is great improvement," she told reporters outside Mandela's former home in the Johannesburg township of Soweto. (Writing by Ed Cropley; Editing by Pascal Fletcher)

Sanofi’s MS drugs get double boost in Europe

LONDON (Reuters) – Sanofi’s hopes in the multiple sclerosis market received a double boost on Friday as the European regulator backed an injectable treatment and adopted a more positive stance toward a pill for the neurodegenerative disease. The European Medicines Agency said it was recommending Lemtrada, Sanofi’s biggest MS drug hope, for relapsing-remitting MS, ending a quarter-century development saga for the injectable treatment. …

1 5 6 7 8 9 101