Shire's plans to squeeze more sales out of its blockbuster Adderall franchise are facing another delay, as the FDA wants more data on a new long-acting ADHD treatment that has languished in agency purgatory for years.
Biotech R&D is on a roll. For the third year in a row, the life sciences group at BDO has tracked a spike in R&D spending at a wide swath of public biotechs in the U.S. For drug developers with $50 million to $300 million in revenue, research budgets swelled 28%--to an average of $137 million--last year.
Endo found the magic number in its negotiations with Auxilium Pharmaceuticals, boosting its offer to $2.6 billion and finally convincing its target to abandon plans for a tax-saving deal.
After more than 25 years in drug development that culminated in a corner office at Calistoga Pharmaceuticals, Carol Gallagher decamped for the venture world last year, and now she has accepted a position at New Enterprise Associates to help nurture the next generation of disruptive biotechs.
Arrowhead Research watched its shares nose-dive after a peek at Phase II data on its in-development treatment for hepatitis B revealed that the RNAi therapy isn't measuring up to its preclinical promise.
Amgen has taken a big stride toward gaining regulatory approval for its biosimilar of Humira, AbbVie's megablockbuster anti-inflammatory. The Big Biotech reports today that its knockoff of Humira--dubbed ABP 501--hit its marks on equivalency for efficacy and safety for treating plaque psoriasis.
Fresh off signing up to buy Durata Therapeutics for $675 million, Actavis is making another overture for the embattled Allergan, Reuters reports, potentially setting up a bidding war with the dogged Valeant Pharmaceuticals.
Rescued from Pfizer's sweeping R&D cuts, Levicept's lead drug is a protein with promise in chronic pain, and the biotech has raised $15.7 million in venture and grant funding to follow through on its potential.
Chimerix reports that its pilot Phase III study of the powerful antiviral brincidofovir has posted promising preliminary data, cutting the risk of death from lethal adenovirus infections by as much as half or more.
Back in March, Chimerix hustled to put together a small Phase III pilot program to test its closely watched antiviral brincidofovir for adenovirus infections. Today, CEO Michelle Berrey says the company is now scrambling to put together another overnight study plan for Ebola rather than risk getting hit with a fresh round of compassionate-use demands.
Acacia Pharma says it gleaned positive results from a Phase III study of its experimental therapy designed to prevent postoperative nausea and vomiting. And now it's brought in the investment banker J.P. Morgan Cazenove to advise the board on what its next steps should be as it tries to position the treatment for regulatory approval and commercialization.
Bellicum Pharmaceuticals has switched up its deal with Ariad Pharmaceuticals, agreeing to hand over $50 million for a no-strings-attached license to some cell-signaling technology.
Bristol-Myers Squibb is pulling out of one key race in the global scramble to develop new blockbuster hepatitis C cocktails.
Following a trend among the companies that do Big Pharma's heavy lifting, global CRO INC Research has filed to go public, looking to raise $150 million.
Closely allied with Eli Lilly, TVM Capital Life Sciences has bumped up its latest fund past the $200 million mark with plans to bankroll up to 15 build-to-buy drug development projects.
Hyperion Therapeutics, which claims it was duped into a $570 million deal for an Israeli biotech, has reached a temporary agreement with the seller, calling off its lawyers for the moment while the two try to determine whether the drug at the heart of the acquisition has any future.
The Netherlands' Forbion Capital Partners has wrapped up the first close in a planned third fund, raking in $120 million with plans to stake a new generation of biotechs.
Alcobra is touting the benefits of its in-development ADHD treatment, saying the drug provided a statistically significant benefit over placebo--but only after the company removed data from four "extreme" responders from its analysis.
Troubled Teva is circling its research wagons around CNS and respiratory diseases, carving out more than $500 million in research costs over the next three years with plans to shelve or spin out 14 clinical programs as it retreats from women's health and oncology.