The glassblowers were in revolt. The island of Murano, in the 13th century, was a perfect home for the glassblowing industry. Connected to Venice through a system of bridges, Murano was surrounded by waters that protected the city from the furnaces that fueled the glassblowers’ craft. The Republic of Venice dominated trade throughout the Mediterranean,…
FDA Accelerates Approvals of Generic Versions of HCQ
On April 7, the FDA approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200 mg, for the treatment of: 1) uncomplicated malaria due to P. falciparum, P. malariae, P. ovale and P. vivax; 2) chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and 3) treatment of acute and chronic…
Not-for-Profit to Offer 20 Generic Drugs in 2019 to Alleviate Shortages
(Reuters)—A new not-for-profit supplier of generic drugs formed by a consortium of hospitals systems said it expects this year to be able to provide about 20 products to alleviate shortages of medicines used during surgeries and to treat life-threatening conditions, such as septic shock. Since the start-up of Civica Rx spearheaded by Intermountain Healthcare was…
U.S. Tribal Patent Deal Could Impact Generic Drug Market
(Reuters)—A groundbreaking deal between Allergan Plc. and a Native American tribe to shield the company’s patents in administrative proceedings could also be used be to protect them from challenges in federal court, legal experts say, potentially dealing a blow to generic competition. Allergan said on Friday it had transferred patents on its blockbuster dry eye…
U.S. House Panel Spotlights Use of FDA Rules to Slow Generic Drugs
WASHINGTON (Reuters)—Republican and Democratic lawmakers on Thursday discussed ways to prevent drugmakers from using rules developed to safeguard patients to instead block the sale of cheaper medicines. The focus at a hearing, held by members of the House Judiciary Committee’s antitrust subcommittee, was on the use by some brand name drug companies of a U.S….
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…
U.S. Could File Charges in Generic Drug Probe by Year-End
(Reuters)—U.S. prosecutors could file the first charges in their criminal investigation of generic drugmakers over suspected price collusion by the end of the year, Bloomberg reports. The antitrust investigation by the U.S. Department of Justice (DOJ) spans more than a dozen companies and about two dozen drugs, Bloomberg reports, citing people familiar with the matter….
Can Anything Contain Drug Costs in the U.S.?
(Reuters Health)—The U.S., which spends more on drugs than any other country, might contain costs by limiting market exclusivity for brand name medicines and changing coverage requirements for government health plans, some doctors argue. Although brand-name drugs account for only 10% of all dispensed prescriptions in the U.S., they make up 72% of drug spending,…
Cephalon, U.S. States Reach $125 Million Settlement Over Generic Drugs
WASHINGTON (Reuters)—Cephalon has reached a $125 million settlement with 48 states in connection with its alleged efforts to delay generic versions of its blockbuster sleep disorder drug modafinil (Provigil) from entering the market, New York Attorney General Eric Schneiderman said on Thursday. The settlement with Cephalon, now owned by Teva Pharmaceuticals, comes a little more…
EMA Flags Faulty Generic Drug Data, Backs Sales Halt
(Reuters)—The European Medicines Agency (EMA) recommended suspending sales of some generic drugs after a review found that data collected by a contract research company in India for their approval was unreliable. The EMA’s list included drugs made by some of the top generic drugmakers, including Teva Pharmaceutical Industries Ltd., Mylan NV and Novartis AG’s Sandoz….