Two of five biomarkers found by Merrimack Pharmaceuticals Inc. ended up predictive of benefit from MM-121 in 34 percent of patients who took part in the company’s failed Phase II trial against ovarian cancer – a finding that took some of the sting out of the overall outcome.
Although opioid-induced constipation (OIC) has gotten most of the press in recent years, Charleston Laboratories Inc. may be about to change all that, given Phase III success with CL-108, which provides the pain relief of hydrocodone without the side effects that are even more prevalent: nausea and vomiting (OINV).
A surprise delay in the launch of Biogen Idec Inc.’s long-lasting recombinant factor VIII candidate for hemophilia A, Eloctate – partnered with Swedish Orphan Biovitrum (Sobi) – did little to dampen investor joy over third-quarter earnings, thanks to another home run with Tecfidera (dimethyl fumarate).
Dynavax Technologies Corp. gained financial traction for the continued traversal of its long road with hepatitis B virus (HBV) vaccine Heplisav, pulling down about $132 million in a pair of public offerings that will fund another, FDA-mandated Phase III trial.
With Rigel Pharmaceuticals Inc.’s R333 kaput in Phase II trials for skin lesions in discoid lupus erythematosus patients, attention has turned from the topical JAK/SYK inhibitor to fostamatinib, an oral SYK inhibitor bound for Phase III trials in the first half of next year in immune thrombocytopenic purpura (ITP).
Not yet fully emerged from stealth mode, Sideris Pharmaceuticals Inc. made known its $32 million Series A round as well as a potential $300 million deal with Novartis AG that includes the right to acquire Sideris and the iron-chelating candidate SP-420.
“Best case scenario” was the phrase flying around after last week’s approval of Actelion Ltd.’s Opsumit (macitentan), the next-generation dual endothelin receptor antagonist (ERA) for pulmonary arterial hypertension.
Specific guidance for companies aiming to more quickly develop drugs for chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) will be available next year from the FDA, said Janet Maynard, from the agency’s office of pulmonary, allergy and rheumatology products.
The first therapy for pulmonary arterial hypertension to be approved on endpoints measuring patient function rather than outcomes such as the six-minute walk test won the FDA’s blessing Friday.
Cancer immunotherapy gained another stamp of approval with the $23 million in gross proceeds raised by Advaxis Inc., which sold about 5.7 million shares plus warrants to buy about 2.8 million more, at a price of $4 per share and $0.01 per warrant.