New Approvals – Page 11 – media

FDA Approves Rucaparib for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

On April 6, 2018, the Food and Drug Administration(FDA) approved rucaparib (Rubraca®, Clovis Oncology Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
- Source: asco.org
- 544
- April 11, 2018
FDA New Approvals rucaparib
U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Previously Treated dMMR or MSI-H Metastatic Colorectal Cancer

Application based on results from Phase 2 CheckMate -142 study
- Source: investors.bms
- 620
- April 11, 2018
Bristol-Myers Squibb FDA New Approvals Opdivo
Sanofi’s PD-1 inhibitor starts EU review for skin cancer

The EMA has kicked off its review of Sanofi and Regeneron’s immuno-oncology drug cemiplimab, which is aiming to become the sixth drug in the PD-1/PD-L1 inhibitor class to reach the market.
- Source: Pmlive
- 560
- April 8, 2018
cemiplimab immuno-oncology New Approvals
Adherium receives OTC clearance for AstraZeneca’s Symbicort inhaler

Smart inhaler company Adherium announced last week that it has received 510(k) clearance for over-the-counter sales of its inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, called the SmartTouch for Symbicort.
- Source: MobiHealthNews
- 806
- April 7, 2018
COPD FDA New Approvals
FDA refuses to review Alkermes’ depression drug, demands additional clinical trials

The FDA has told Alkermes it needs to see data from “additional well-controlled clinical trials” before it will review a filing for approval of depression drug ALKS 5461. Alkermes plans to appeal the ruling, but at this stage it looks like the biotech’s attempt to get a mixed set of data past the FDA has failed.
- Source: fiercebiotech
- 715
- April 6, 2018
ALKS 5461 Depression New Approvals
EU reviews for Sanofi’s Dupixent, cemiplimab

European regulators have agreed to review Sanofi and Regeneron’s Dupixent for asthma and cemiplimab for advanced cutaneous squamous cell carcinoma.
- Source: pharmatimes
- 976
- April 4, 2018
asthma FDA New Approvals Sanofi
Eisai Submits Supplemental New Drug Application (sNDA) to FDA for FYCOMPA® (perampanel) Pediatric Indications

Eisai Inc. announced that it has submitted a supplemental New Drug Application (sNDA) for priority review to the U.S. Food and Drug Administration (FDA) for its antiepileptic drug FYCOMPA® (perampanel) CIII as monotherapy and adjunctive use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in pediatric patients (ages 2 to less than 12 years). The submission also proposes a pediatric indication for monotherapy and adjunctive use for primary generalized tonic-clonic seizures (PGTC) in children (ages 2 to less than 12 years) with epilepsy. The sNDA is for both the FYCOMPA tablet and oral suspension formulations.
- Source: prnewswire
- 652
- April 4, 2018
Eisai FDA FYCOMPA® New Approvals
Tele-rehabilitiaion platform TheraNow launches

Folks in need of physical therapy services may not have to leave the house for treatment. Therainc has just launched its latest product, TheraNow, an online platform that connects patients to physical therapists through teletherapy.
- Source: MobiHealthNews
- 735
- April 4, 2018
EHR New Approvals Telemedicine
UCB Announces Filing Acceptance with the China Food and Drug Administration for CIMZIA® (certolizumab pegol) for the Treatment of Moderate-to-Severe Rheumatoid Arthritis

UCB, a global biopharmaceutical company, announced the submission of an application for an Import Drug License to the Chinese Food and Drug Administration (CFDA) for the approval of CIMZIA® (certolizumab pegol) to treat moderate-to-severe rheumatoid arthritis (RA).
- Source: ucb
- 763
- April 3, 2018
CFDA CIMZIA® New Approvals RA
Palatin Technologies Announces Submission of Bremelanotide NDA to FDA for Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women

Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, announced that its exclusive North American licensee for bremelanotide, AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bremelanotide for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. If approved, bremelanotide would become the first and only as desired pharmacologic option in the U.S. indicated for the treatment of HSDD in premenopausal women.
- Source: drugs
- 575
- April 3, 2018
bremelanotide FDA New Approvals

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