WASHINGTON (Reuters)—The U.S. Food and Drug Administration moved on Wednesday to prevent pharmaceutical companies from “gaming” the system to block or delay entry of generic rivals. FDA Commissioner Scott Gottlieb said in a blog post that the agency plans to hold a public meeting on July 18 to identify ways pharmaceutical companies are using FDA…
Missouri Sues Opioid Manufacturers, Joining Two other U.S. States
(Reuters)—Missouri on Wednesday became the third U.S. state to accuse major drug manufacturers of fraudulently misrepresenting the risks of opioid painkillers now at the center of a national addiction epidemic. Missouri Attorney General Josh Hawley said his office filed a lawsuit in a state court in St. Louis against Purdue Pharma LP, Johnson and Johnson…
FDA Requests Removal of Opana ER; Plus Abatacept’s New Dosing Option
The FDA has asked the manufactures of Opana ER to remove the opioid from the U.S. market due to the public health risk of abuse…
News Updates for Diclofenac Sodium, Denosumab & Sarilumab
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…
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