More than a month ahead of its scheduled PDUFA date, the FDA granted conditional approval for Spectrum Pharmaceuticals Inc.'s in-licensed peripheral T-cell lymphoma (PTCL) therapy, Beleodaq (belinostat), triggering a $25 million payment to the drug's owner, Topotarget A/S, and giving patients and doctors a new weapon against the fatal disease.
Actavis plc closed its $28 billion acquisition of Forest Laboratories Inc. Tuesday with new CEO and president, Brent Saunders, Forest's former chief, and the majority of Forest shareholders hanging on for the ride.
Rare disease specialist Synageva Biopharma Corp. reported top-line phase III data showing that sebelipase alfa (SBC-102), its enzyme replacement therapy for lysosomal acid lipase (LAL) deficiency, met its primary endpoint and several secondary endpoints.
Allergan Inc. chalked up a third FDA complete response letter (CRL) regarding Semprana (dihydroergotamine), the orally inhaled acute migraine treatment formerly known as Levadex, and the heart of its $958 million acquisition of MAP Pharmaceuticals Inc.
SAN DIEGO – With an untested approval pathway for biosimilars in the U.S., industry intellectual property experts well versed in the world of small-molecule generics told BIO 2014 attendees that the best path for bringing follow-on biologics to market remains muddy.
SAN DIEGO – Researchers and executives gathered to discuss the future of regenerative medicine at the 2014 BIO International Convention said they saw value and hazard in the current intellectual property (IP) landscape for the field.
SAN DIEGO – Early stage companies focused on regulatory milestones would do well to pay equal attention to the changing reimbursement concerns, said panelists representing their potential future backers and buyers at the BIO 2014 convention. More than ever, investors are looking for reassurance that if and when a product reaches market, it will make its way on to managed care formularies, a key element in achieving return on investment.
Cubist Pharmaceuticals Inc. gained FDA approval Friday evening for Sivextro (tedizolid phosphate), realizing the first big payoff from its $704 million acquisition of Trius Therapeutics Inc.
SAN DIEGO – As an anticipated cast of 15,000 dealmakers, regulators, scientists and others converge here for the BIO International Convention, dealmaking is likely to hit a fevered pitch while digital health, a new topic this year, takes root.
Johnson & Johnson Thursday unveiled a string of new equity investments and research collaborations formed by its network of new innovation centers to advance early stage therapeutic, medical device, diagnostic and consumer health programs. The line-up showcases the work of Johnson & Johnson Innovation LLC just as the industry's next crop of small innovators prepares to meet up with potential partners at the BIO International Convention in San Diego next week.
