The FDA has approved UCB Corp’s Cimzia® (certolizumab pegol) for the treatment of Crohn’s Disease (CD). The company aims to make the drug, which is a new, promising option for patients suffering from moderate to severe Crohn’s Disease, available in the U.S. in the next few days. Cimzia is the first and only pegylated anti-TNF? (anti-tumor necrosis factor-?). The excessive production of TNF? has been associated with a wide variety of diseases.

Cayenne Medical Inc. has received FDA clearance for the iFix(TM) Interference Screw System for use in bone-tendon-bone ACL reconstruction procedures. These are the first FDA approved screws to hit the market that are made from polyetheretherketone (PEEK) plastic, which is radiolucent and highly biocompatible and has superior biomechanical strength. PEEK is a completely bio-inert material and, hence, screws made from this material do not result in foreign body reactions in patients.

Israel-based Brainsway Ltd. reported positive results from the final stage of testing its noninvasive Transcranial Magnetic Stimulation (TMS) treatment for depression. TMS is a noninvasive technique for applying brief magnetic pulses to the brain. The company said that it had obtained satisfactory results from its first efficacy test on 64 patients. Brainsway now intends to file for an application for CE Mark certification from the EU and subsequently aim for an FDA approval.

The FDA has delayed the final approval of GlaxoSmithKline Plc’s Requip XL. The drug is a once-a-day oral treatment for Parkinson’s disease, a progressive neurological disorder that slows body movement. The delay affects SkyePharma Plc, since it uses the company’s slow release technology. The FDA is expected to announce a decision on the drug’s approval in the second quarter of this year.

Taro Pharmaceutical Industries Ltd. has received FDA approval for its NDA (New Drug Application) for Flo-Pred (prednisolone acetate oral suspension) in its NonSpil liquid drug delivery system. Flo-Pred is an anti-inflammatory agent used in the treatment of asthma, certain allergic and dermatologic conditions as well as various other indications. Taro expects to launch the product later this year. Adverse reactions common to corticosteroids include fluid retention, high blood pressure, high blood sugar, mood swings and weight gain.

Johnson & Johnson Pharmaceutical Research & Development has submitted an NDA (New Drug Application) for its tapentadol hydrochloride immediate release (IR) tablets to the FDA. Tapentadol is an investigational oral analgesic for treating moderate to severe acute pain. Clinical studies show that tapentadol has efficacy comparable to strong opioids. Over 25 million Americans suffer from acute pain every year, according to the American Pain Foundation.