In drug news, a generic 2% diclofenac sodium solution is now available, denosumab is promising to treat osteoporosis, and the FDA has approved sarilumab to treat adults with RA…
FDA Responds to New Drug Application for Baricitinib
Oxycodone Tablets Submitted to FDA Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).1 The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an…
The Birth and Growth of Biotechnology, and the Impact of Biologic Drugs on Rheumatology
Here’s a trivia question: Where were the big ideas for the field of biotechnology first discussed? Answer: At a since-demolished delicatessen in Waikiki Beach, Hawaii. Go figure. The year was 1972, and Stanley Cohen, MD, professor of medicine at Stanford University in Palo Alto, Calif., and Herbert Boyer, PhD, a former professor and biochemist at the…
Sanofi to Invest Further in Biologics
PARIS (Reuters)—Sanofi announced plans to invest 600 million euros ($673 million) annually over the next two to three years in the field of biologics production, an area of strong growth potential. In contrast to most drugs that are chemically synthesized, many biologics are produced using living cells. They are seen as a promising answer in…
Centrexion’s Chili-Based Painkiller Offers Relief for 6 Months—Study
(Reuters)—A synthetic version of a medicine traditionally extracted from chili plant relieved knee pain among osteoarthritis patients for up to six months, data showed, bringing Centrexion Therapeutics a step closer to developing a safe and effective analgesic. The drug, designed to be injected at the site of pain, is being developed by the privately-held company…
U.S. Supreme Court Speeds Copycat Biologic Drugs to Market
WASHINGTON (Reuters)—The U.S. Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies. The justices, in a 9–0 ruling, overturned a lower court…
FDA Asks Endo to Withdraw Opana ER Opioid
(Reuters)—The U.S. Food and Drug Administration said on Thursday it has asked Endo International to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company’s shares down as much as 13%. “After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer…
FDA Update: Romosozumab’s Uncertain Future; Plus Tocilizumab Approved for GCA
Due to possible heart-related side effects, romosozumab is no longer expected to be approved this year for the treatment of osteoporosis…
U.S. State, Local Government Lawsuits Over Opioids Face Uphill Battle
BOSTON (Reuters)—A growing number of U.S. states, counties and cities are filing lawsuits accusing drug companies of deceptively marketing opioid painkillers to downplay their addictiveness, but some lawyers say the industry’s highly regulated nature could pose a hurdle to their success. Ohio on Wednesday became the latest, and largest, state or local government to bring…
Pfizer Hikes U.S. Prices of 91 Drugs by Average 20% in 2017
(Reuters)—Pfizer Inc. has hiked the price of nearly a hundred drugs by an average of 20 percent so far this year in the U.S., the Financial Times reported on Friday. The U.S. drug maker raised the list price of 91 medicines—including that of its erectile dysfunction treatment, Viagra, and its pain drug, Lyrica—on June 1…
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