Here are the top ten regulatory news stories to follow this week:
- Arbor Pharmaceuticals and Debiopharm International announced that the FDA has approved Triptodur for the treatment of pediatric patients 2 years and older with central precocious puberty. Full Story Here
- Bristol-Myers Squibb’s ORENCIA (abatacept) received FDA approval for treatment of active Psoriatic Arthritis (PsA) in adults. Orencia has been previously approved for Rheumatoid Arthritis. Full Story Here
- Pfizer has secured approval from the European Commission for BESPONSA (inotuzumab ozogamicin) as monotherapy for the treatment of acute lymphoblastic leukemia (ALL). Full Story Here
- Eli Lilly and Incyte announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) granted marketing approval for Olumiant (baricitinib) for the treatment of rheumatoid arthritis in patients with inadequate response to standard-of-care therapies. Full Story Here
- BioMarin has submitted a BLA to the US FDA for pegvaliase for the treatment of phenylketonuria, an inherited disorder that increases the levels of a substance called phenylalanine in the blood. Full Story Here
- Specialty pharmaceutical company SteadyMed Ltd. announced that it submitted an NDA to the FDA for its lead drug product candidate, Trevyent, for the treatment of Pulmonary Arterial Hypertension (PAH). Full Story Here
- Merck & Co. reported that the FDA has placed full clinical holds on two Phase III trials testing the company’s anti-PD-1 therapy Keytruda (pembrolizumab) in combination with other treatments for multiple myeloma. Full Story Here
- The EMA has granted orphan designation for RDD Pharma’s investigational drug for the treatment of fecal incontinence in patients with spinal cord injury. Full Story Here
- Shire has filed an IND application to the FDA for its gene therapy drug, SHP654, to treat hemophilia A. Full Story Here
- Ocular Therapeutics disclosed the receipt of the FDA manufacturing warning letter which could imperil the approval of their experimental eye drug: Full Story Here
In other news…
Canadian company Clementia Pharmaceuticals has filed to raise $115 million in an IPO. They want the cash to bankroll late-phase trials of a genetic bone disease program that it licensed from Roche. Full Story Here
In a filing with the US Securities and Exchange Commission Monday, Opexa Therapeutics and Acer Therapeutics announced a reverse merger agreement. The proposed merger is expected to close during the third quarter of 2017, pending shareholder approval for both Acer and Opexa. Upon approval, Opexa’s name will be changed to Acer Therapeutics Inc., and the new company would change its Nasdaq stock exchange ticker symbol to “ACER.” Full Story Here
Booming Jazz Pharmaceuticals has signed a 46,000 square foot lease in Philadelphia to accommodate their growth: Full Story Here
The FDA and the EMA released a draft joint plan to support the development of pediatric treatments for Gaucher disease — an approach the agencies say can apply to rare diseases in general. Full Story Here
Endo International announced that it will comply with the FDA’s request remove its opioid Opana ER (oxymorphone hydrochloride extended release) from the US market. Full Story Here
This is a weekly recap of selected industry news stories. You can read other additional blogs, see our recent job postings and learn more about us at www.dennispartners.com