Top Regulatory News Stories – Week Ending October 5, 2018

This was a big week for Paratek Pharmaceuticals which received US FDA approval for two new molecular entities.  On Monday Paratek announced that the FDA has approved SEYSARA™ (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.     Then on Wednesday Paratek announced that the FDA has approved NUZYRA™ (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI).

The FDA approved Insmed’s Arikayce (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC) in a limited population of patients with the disease who do not respond to conventional treatment (refractory disease).

The FDA also approved Antares Pharma’s injectable drug to treat low testosterone levels in men, the company said, nearly a year after being rejected.

Genentech/Roche snagged a new regulatory approval for its hemophilia treatment, Hemlibra. On Thursday the UFDA approved the medication for hemophilia A patients who do not have factor VIII inhibitors.

Sanofi announced that its skin cancer drug, Libtayo (cemiplimab), made in partnership with Regeneron was approved by the FDA. This is the first FDA approval of a drug specifically for advanced metastatic cutaneous squamous cell carcinoma.

Clovis Oncology announced today that the FDA has granted Breakthrough Therapy designation for Rubraca® (rucaparib) as a monotherapy treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy.

bluebird bio announced that the EMA has accepted the company’s MAA for its investigational LentiGlobin™ gene therapy for the treatment of adolescents and adults with transfusion-dependent β-thalassemia (TDT) and a non-β0/β0 genotype.

Puma Biotechnology has been advised that its licensing partner CANbridge Pharmaceutical Inc received confirmation that China’s National Medical Products Administration (NMPA) has accepted its NDA for NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, following adjuvant trastuzumab based-therapy.

The FDA warned that differences in how drugmakers and compounders label the strength of injectable drugs may lead to dangerous dosing errors.

The FDA is on track to break their all-time record for new drug approvals per year in 2018:

In other news…

Momenta Pharmaceuticals said that it is cutting its workforce by half — a reduction of 110 jobs — and will gut much of its leadership team as part of a dramatic restructuring.

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