Regulation

FDA asks Endo to withdraw opioid painkiller over abuse risks

The US Food and Drug Administration (FDA) has asked Endo Pharmaceuticals to withdraw its Opana ER (oxymorphone hydrochloride) from the market owing to increased abuse of the reformulated opioid pain medication.

FDA accepts Synergy’s sNDA for Trulance to treat adults with IBS-C

The US Food and Drug Administration (FDA) has accepted Synergy Pharmaceuticals’ supplemental New Drug Application (sNDA) Trulance (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).

ViiV Healthcare seeks EMA, FDA approvals for two-drug regimen to treat HIV-1 infection

ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer, and Shionogi, is seeking approval from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the HIV maintenance regimen with two medicines.

Pfizer’s Meningococcal Group B vaccine, Trumenba, gets approval in Europe

Pfizer has secured approval the European Commission (EC) for TRUMENBA (Meningococcal Group B Vaccine) for preventing invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older.

Sunovion receives complete response letter from FDA for SUN-101/eFlow for COPD

Sunovion Pharmaceuticals has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) for SUN-101/eFlow (glycopyrrolate) for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), such as chronic bronchitis and/or emphysema.

FDA panel recommends Pfizer’s epoetin alfa biosimilar to treat anemia

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of Pfizer's biosimilar to Amgen’s anemia drug Epogen (epoetin alfa) across all indications.

FDA approves Merck’s Keytruda for cancer patients with certain biomarkers

The US Food and Drug Administration (FDA) has granted accelerated approval to Merck’s Keytruda for patients whose cancers have a specific genetic feature (biomarker).

Genentech’s Actemra approved by FDA for giant cell arteritis treatment

Genentech’s Actemra (tocilizumab) subcutaneous injection has been approved by the US Food and Drug Administration (FDA) for the treatment of giant cell arteritis.

EC launches probe into Aspen’s pricing practices for cancer drugs

The European Commission has initiated a formal investigation to see whether Aspen Pharma had excessively priced five life-saving cancer medicines.