FDA warns about danger of Pfizer's Geodon; Proposed law would hasten antibiotic approvals;

@FiercePharma: Kansas State researchers model U.S. outbreak of foot-and-mouth. Story | Follow @FiercePharma

@CarlyHFierce: I think BOLERO-1 might be my favorite trial name ever. Release | Follow @CarlyHFierce

> Lupin has launched an approved generic of Pfizer's ($PFE) pain drug Celebrex in the U.S. Release

> Johnson & Johnson's ($JNJ) Janssen unit has donated about 30,000 doses of its multidrug-resistant tuberculosis-fighting treatment, $30 million worth, to the U.S. Agency for International Development. Release

> The FDA warned that the Geodon antipsychotic pill sold by Pfizer, as well as generic versions of the drug, can trigger a potentially fatal skin reaction. Release

> Two U.S. Senators are pushing for new legislation that would allow the FDA to approve some antibiotics through a special "limited use" procedure in an effort to get antibiotics that can fight antibiotic-resistant bacteria to market. Story

Medical Device News

@FierceMedDev: DARPA's ElectRx seeks innovators to transform neuromodulation devices. More | Follow @FierceMedDev

@EmilyWFierce: #India's NPPA extends pricing policy on drugs, adding fuel to price cap fire. Story | Follow @EmilyWFierce

> Judge advises Bard to settle vaginal mesh implant cases. Article

> Strong one-year data for Boston Scientific chronic pain implant, but reimbursement change stymies sales. More

> FDA works to improve medical device approval times. News

Biotech News

@FierceBiotech: EuroBiotech: Shire steps up arGEN-X alliance, Big Pharma gives MRC drugs, Woodford backs Midatech IPO. More | Follow @FierceBiotech

@DamianFierce: $BMRN's buyout subs are called Falcons and Giants, which could be an NFL thing or a ref to some obscure fantasy novel. More | Follow @DamianFierce

> Shire chief: We want to be like Gilead, Biogen and Celgene. News

> ChemoCentryx soars on new hope for its once-maligned kidney drug. Story

> Novartis' psoriasis drug tops J&J's Stelara as it speeds toward approval. Article

And Finally... The FDA is giving the University of Alabama at Birmingham permission to study the use of a marijuana derivative to treat seizures in children. Story

Suggested Articles

Only months removed from a gamechanging label expansion for Vascepa, Amarin is scrambling after a district judge invalidated the drug's key patents.

Move over, Roche. There’s a new small-cell lung cancer therapy on the scene, and it belongs to AstraZeneca.

Fujifilm says it is prepared to ramp up production of Avigan for any country that wants to try it as a potential treatment for COVID-19.