* How should combination product
companies monitor impacts of product, process or regulatory changes?
While at Medtronic Inc, Dr Shafer held various roles in neuromodulation research, drug-device combination product
development, and management.
"By adding sarolaner to selamectin, we have produced an innovative combination product
with a broad endo-and ectoparasiticide spectrum for cats and kittens," says Tara Bidgood, DVM, PhD, Diplomate ACVCP, Executive Director, Veterinary Professional Services, Zoetis Petcare.
Shares of Alkermes (ALKS) are slipping in pre-market trading after the FDA posted briefing documents ahead of the November 1st meeting of the Psychopharmacologic Drugs Advisory Committee to evaluate a pending New Drug Application for a combination product
containing buprenorphine and samidorphan, referred to as ALKS 5461 during development and as BUP/SAM hereafter.
Annual spend - PS6,317,927 | Oxycodone and Naloxone combination product
- is used to treat severe pain and can also be used in restless legs syndrome.
Successful combination product
launches for newer, cutting-edge medicines require four critical process scale-up considerations by the delivery platform manufacturer to ensure it is safe and produced to meet demand.
* Chronic illness riders, which account for 59 percent of the combination product
market share, recorded a growth rate of 38 percent.
The "Combination Product
Regulatory Fairness Act of 2015"(S.
While the development of a combination product
comes with significant patient benefits through technology and molecule innovation, reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities.
According to the companies, challenging conditions in agricultural markets driven by weak crop prices, especially in row crops, coupled with focus on the organisational merger of Chemtura AgroSolutions, Agriphar and Arysta LifeScience contributed to an unsuccessful launch of the first combination product
under the agreement.
Struktol TR 055 is a combination product
designed to offer more external lubricity for improved flow and metal release.